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Patient Safety and Quality PDF
Patient Safety and Quality PDF
An Evidence-Based
Handbook for Nurses
Agency for Healthcare Research and Quality
U.S. Department of Health and Human Services
540 Gaither Road
Rockville, MD 20850
Editor:
Ronda G. Hughes, Ph.D., M.H.S., R.N.
Disclaimer: The opinions expressed in this document are those of the authors
and do not reflect the official position of AHRQ or the U.S. Department of Health
and Human Services.
This document is in the public domain and may be used and reprinted without
permission, except those copyrighted materials noted for which further reproduction is
prohibited without specific permission of the copyright holder. Citation of the source is
appreciated.
Suggested Citation:
Hughes RG (ed.). Patient safety and quality: An evidence-based handbook for nurses.
(Prepared with support from the Robert Wood Johnson Foundation). AHRQ Publication
No. 08-0043. Rockville, MD: Agency for Healthcare Research and Quality; March 2008.
ii
Foreword
The Agency for Healthcare Research and Quality (AHRQ) and the Robert Wood Johnson
Foundation (RWJF) are pleased to have jointly sponsored the development of this handbook for
nurses on patient safety and quality. Patient Safety and Quality: An Evidence-Based Handbook
for Nurses examines the broad range of issues involved in providing high quality and safe care
across health care settings.
We know that nurses are at the center of patient care and therefore are essential drivers of
quality improvement. From the Institute of Medicine’s reports, including To Err is Human and
Keeping Patient’s Safe: Transforming the Work Environment of Nurses, we know that patient
safety remains one of the most critical issues facing health care today and that nurses are the
health care professionals most likely to intercept errors and prevent harm to patients. For us, both
at AHRQ and RWJF, improving patient safety and health care quality is embedded in our
mission and at the core of what we do.
We strongly believe that the safety and quality of health care in this nation is dependent upon
the availability of the best research possible and on our ability to deliver the results of that
research into the hands of providers, policymakers, and consumers so that all can make better
decisions. We believe the result will be improved health care and safety practices, which will be
manifested in measurably better outcomes for patients.
Given the diverse scope of work within the nursing profession in this country, AHRQ and the
RWJF expect that the research and concepts presented in the book will be used to improve health
care quality by nurses in practice, nurse-educators, nurse-researchers, nursing students, and
nursing leaders. The 89 contributors to this book represent a broad range of nurse-researchers
and senior researchers throughout this nation.
The product of this joint effort underscores the commitment of AHRQ and the RWJF to
achieving a health care system that delivers higher quality care to everyone. We believe that
high-quality health care can be achieved through the use of evidence and an enabled and
empowered nursing workforce.
We welcome written comments on this book. They may be sent to Ronda Hughes, Agency
for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850.
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Preface
Errors pervade our lives in our homes, on the roads, and in our places of work. Each hour of
each day, patients and clinicians are affected by near errors and the consequences of adverse
events. The effects of health care errors and poor quality health care have impacted all our
lives—sometimes directly, at other times indirectly. Even during the writing of this book, many
of the authors had firsthand experiences with near errors, adverse events, and a level of poor-
quality care that should never have been presented to any patient. Given the importance of health
and health care in our lives, the purpose of this book is to bring safety and quality to the forefront
in nursing.
Throughout these pages, you will find peer-reviewed discussions and reviews of a wide range
of issues and literature regarding patient safety and quality health care. Owing to the complex
nature of health care, this book provides some insight into the multiple factors that determine the
quality and safety of health care as well as patient, nurse, and systems outcomes. Each of these
51 chapters and 3 leadership vignettes presents an examination of the state of the science behind
quality and safety concepts and challenges the reader to not only use evidence to change
practices but also to actively engage in developing the evidence base to address critical
knowledge gaps. Patient safety and quality care are at the core of health care systems and
processes and are inherently dependent upon nurses. To achieve goals in patient safety and
quality, and thereby improve health care throughout this nation, nurses must assume the
leadership role.
Despite being a relatively new field of inquiry, particularly in terms of how patient safety and
quality are now defined, the need to improve the quality and safety of care is the responsibility of
all clinicians, all health care providers, and all health care leaders and managers. As clinicians,
we are obligated to do our best, regardless of whether we are acting as a clinician or a patient.
Just as we say there are “good patients” and “bad patients,” clinicians as patients can
unfortunately be considered “bad patients” because they may know too much, ask too many
questions, or are not up-to-date on the research or current practice standards. Yet that is a
mindset that must end and become a part of history, not to be repeated. Instead, nurses need to
ensure that they and other team members center health care on patients and their families. All
patients—whether they include ourselves, our loved ones, or the millions of our neighbors
throughout this country—need to be engaged with clinicians in their care.
Each of the chapters in this book is organized with a background section and analysis of the
literature. At the end of each chapter, you will find two critical components. First, there is a
“Practice Implications” section that outlines how the evidence can be used to inform practice
changes. Practice leaders and clinicians can use this information, based on the state of the
science, to guide efforts to improve the quality and safety of delivering services to patients.
Second, there is a “Research Implications” section that outlines research gaps that can be
targeted by researchers and used by clinicians to inform and guide decisions for practice. Faculty
and graduate students will find innumerable questions and issues that can be used to develop
dissertation topics and grant applications to uncover the needed evidence.
In all but a few chapters, you will find evidence tables. These tables were developed by
critically assessing the literature, when possible, and present invaluable insight as to the type and
quality of research that can inform practice, clarify knowledge gaps, and drive future research.
As the reader will observe, the majority of patient safety and quality research presented in the
evidence tables represent cross-sectional studies. In fact, 81 percent of the studies exploring the
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various aspects of safety and quality employed cross-sectional study designs, predominately
representing assessments at single sites of care and using qualitative surveys. This may be the
byproduct of the challenges of the research process (including sources of funding) or the
challenges of engaging in collaborative research. From this review of the literature, we can learn
the importance of the need for longitudinal, multisite analyses to bring us forward into the next
generation of evidence-based knowledge.
Great is the importance of nurses being involved throughout the research process and
collaborating with interdisciplinary teams throughout care settings. Then, too, it is critical that
nursing leaders and managers, clinical leaders, and nurses across care settings engage in a
lifelong pursuit of using data and information as well as research evidence to inform practice.
Combined with experiential knowledge, analyses, and evidence, nurses will be challenged to
continuously improve care processes and encourage our peers and interdisciplinary colleagues to
make sure patients receive the best possible care, regardless of where they live, their race or
gender, or their socioeconomic circumstances.
The chapters in this book are organized into six sections. Each chapter can be read
independently of the others; however, some do make reference to other chapters, and a greater
understanding of the breadth and depth of patient safety and quality can be better obtained by
reading the book in its entirety. Highlights from the chapters are summarized by section as
follows:
In Section I – Patient Safety and Quality, patient safety is discussed as being foundational to
quality, where nurses can be invaluable in preventing harm to patients and improving patients’
outcomes (chapter 1). Even though the quality and safety of health care is heavily influenced by
the complex nature of health care and multiple other factors, nurses have been held accountable
for harm to patients, even when other clinicians and health care providers and characteristics of
the care system in which they work often have—almost without exception—greater roles and, in
some respects, have ensured that an error would happen (chapters 2 and 3). With the many
challenges facing health care today, the Institute of Medicine’s 11-volume Quality Chasm series
brings to light the multitude of issues and factors that individuals and organizations, both within
and outside of nursing and health care, need to understand and to work together to overcome
(chapter 4). Moving toward and securing a culture of safety throughout health care will, by
definition, acknowledge the influence of human factors in all clinicians, the results of human-
system interfaces and system factors, and will institutionalize processes and technology that will
make near errors and errors very rare (chapter 5). This paradigm shift will enable nurses to think
more critically and clinically (chapter 6), and to achieve greater insights as to how education,
training, and experience are needed and can be leveraged to ultimately achieve high-quality care
in every care setting and for all patients.
To improve patient safety and quality, one needs to understand the state of the science at
hand, as well as strategies that can be behind effective utilization of evidence and
implementation of change, as discussed in Section II – Evidence-Based Practice. It is here that
one can learn that implementing evidence into practice can be accomplished though several
approaches—often more than one simple intervention is possible—and by early on engaging key
stakeholders to move toward adoption of change by translating research-based evidence into
everyday care (chapter 7). Yet in assessing the state of the science, it becomes apparent that the
majority of care afforded patients is not evidence based, emphasizing the need for health services
research to examine progress toward safer and higher-quality care and to assess new and
innovative practices (chapter 8). While the future of health care is uncertain, clinicians must
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continually assess, understand, and meet the needs of patients and prepare themselves to meet
emerging health needs we might not expect (chapter 9).
Due to innumerable pressures to improve patient safety and quality, it may be important to
focus on those areas of care delivery, as discussed in Section III – Patient-Centered Care, that
are significantly influenced by nursing care. Providing health care is all about patients and their
needs and meeting those care needs in settings where the majority of care is provided by
clinicians—or, in certain circumstances, where loved ones and family members supplement
nursing care or solely provide for the care needs of patients in community settings. Almost all
the adverse events and less-than-optimal care afforded patients can be prevented, beginning by
implementing research in practice. Situations in which failure to use evidence can be detected
can include when preventable patients falls with injury occur (chapter 10), when illness-related
complications are missed and lead to functional decline in the elderly (chapter 11), and when
pressure ulcers develop in patients of any age (chapter 12). For nurses, ensuring and/or providing
evidence-based, safe, and high-quality care become even more challenging when patients need
care in their homes and subsequently rely on care rendered by family members and loved ones—
care that can be dependent upon the guidance of nurses (chapter 13). Not only can the resources
and functionality of the community or home setting pose potential threats to the safety of patients
and may relegate them to care of a lower quality, but those who care for patients may also
succumb to the physical and emotional demands of providing informal care; amelioration can
require broadening nursing care to caregivers (chapter 14).
Nursing can also have a significant effect on the outcomes of specific groups of patients,
particularly in preventing not only adverse events but the lasting effects of comorbidities and
symptoms. The reason behind focusing on these specific populations is that their unique needs
must not be considered less important than those of the majority. In the case of children, who are
some of the most vulnerable patients due to developmental and dependency factors, it is difficult
to provide safe, high-quality care that meets their unique needs. Instead, nurses need to use
current best practices (chapter 15) to avert potentially lifelong comorbidities and address
symptoms—and develop new practices when the evidence is not available. It is also important to
focus on simple strategies to prevent morbidity—not just preventing adverse events—and ensure
that patients receive preventive care services whenever possible, especially when the use of these
services is supported by evidence (chapter 16). Especially for patients with moderate to severe
pain, it is also important to prevent the adverse effects of their diseases and conditions by
working with patients to manage their pain, promoting healing and improving function (chapter
17). And finally, in the case of potential adverse effects of polypharmacy in the elderly, nurses
can also focus on simple strategies to improve adherence to intended therapies and detect
unnecessary side effects, thereby improving medication safety (chapter 18).
Beyond the influence of evidence on quality processes and outcomes, there are health care
system and organization factors and characteristics to consider. As discussed in Section IV –
Working Conditions and the Work Environment for Nurses, evidence concerning the impact of
health care system factors illustrates that working conditions and the work environment, which
are heavily influenced by leaders, can have a greater impact on the safety and quality of health
care than what an individual clinician can do. Instead of aggregating the various aspects of
working conditions, the chapters in this section define and focus on specific aspects of key
factors associated with patient and systems outcomes, centering on the importance of leadership.
The leadership and management of health care organizations and health systems are pivotal
to safer and higher quality of care because they direct and influence: which model of care is used
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to organize inpatient care services for patients (chapter 19); whether or not the organization
embraces and is committed to fostering and sustaining a climate of safety and high-quality care
(chapter 21); the impact of external factors, and the functionality and organization of
microsystems within the context of the organization and relationships with others (chapter 22);
how the specific care needs of patients are met with sufficient numbers of the right types of
nurses (chapter 23 and chapter 25); how resource allocations and cost-saving strategies that
involve restructuring, mergers, and organizational turbulence impact care delivery and patient
outcomes (chapter 24 and chapter 29); the type of work environment that influences work stress
and patient outcomes (chapter 26 and chapter 27); and how the actual physical environment and
care processes influence the workload and workflow of nursing care (chapter 28, chapter 30,
chapter 31).
Taken together, leadership throughout organizations, led by nurse executives and influenced
by physicians, is critical in determining whether or not safety and high-quality care can be
achieved through daily teamwork, collaboration, and communication (chapter 20). It is because
of the importance of senior nursing leadership that emphasis is put on the moral imperative that
senior nursing leadership has to lead health care in the quest for safer and higher-quality care
(vignette a), to demonstrate the right type of leadership (vignette b), and to excel in the right
competencies (e.g., business skills and principles, communication and relationship management,
and professionalism) (vignette c).
Nursing leaders must actively work with and enable staff to transform the current work
climate and care delivery. Section V – Critical Opportunities for Patient Safety and Quality
Improvement puts forth several critical opportunities that leaders and staff can work together to
achieve success. In almost every care setting and situation, effective communication is essential.
Not only do clinicians need to constantly communicate in a professional and technical way
(chapter 32) and with team members in a way that is respectful and attuned to individual
differences (chapter 33), clinicians must also ensure that the right information is communicated
to next caregiver or health care provider so that the safety and quality of care is not compromised
(chapter 34).
Other opportunities for improvement center on the necessity to continually assess near errors
and errors, not only those events that harm patients, and put in place strategies to avert the
recurrence of both the near error and errors. Assessing and evaluating near errors and errors—
and the ability to avert the recurrence of errors—is dependent upon having information that is
reported by clinicians (chapter 35), so that some errors (e.g., wrong-site surgery) never happen
(chapter 36). Many initiatives to improve patient safety and health care quality have focused on
medication safety. While many medication errors are prevented from harming patients because a
nurse detected the error, monitoring and evaluating both near misses and adverse drug events can
lead to the adoption of strategies to decrease the opportunities for errors, including unit dosing,
using health information technology (chapter 37), and reconciling a patient’s medications
(chapter 38).
The nature of the work and the stress of caregiving can place nurses and patients at risk for
harm. Moving patients, being in close proximity to therapeutic interventions, the implications of
shift work and long work hours (chapter 39 and chapter 40), and ignoring the potential risk of
injury and the impact of fatigue can increase the risk of occupational injury. It follows then that,
because of the nature of the work, the proximity of nurses to patients, and the chronic and acute
needs of patients, particular attention must be given to preventing health care–associated
infections through known effective strategies, such as environmental cleanliness, hand hygiene,
viii
protective barriers (chapter 41), and strategies to address ventilator-acquired pneumonia (chapter
42).
The influence of nurse practitioners and of the new generation of doctorate-level nurse
clinicians has the potential of enabling significant improvements in critical opportunities for
patient safety and quality improvement (chapter 43). The opportunities to demonstrate the
influence of these clinical leaders is endless. The last section of this book, Section VI – Tools for
Quality Improvement and Patient Safety, focuses on the strategies and technologies that can be
used to push health care to the next level of quality. One of the tools that can be used is quality
methods, including continuous quality improvement, root cause analysis, and plan-do-study-act
(chapter 44). Quality and patient safety indicators can also be used to assess performance and
monitor improvement (chapter 45). These, as well as other tools, are integral in efforts to develop
and demonstrate nursing excellence (chapter 46). With recent developments in information
technologies, there are many potential benefits that can be afforded by these technologies that
can facilitate decisionmaking, communication of patient information (chapter 47, chapter 48,
chapter 49), therapeutic interventions (so long as the information technologies are used and
function properly) (chapter 49), and education and training (chapter 51).
All of these various issues and factors come together to define the complexity and scope of
patient safety and quality care but also the necessity for multifaceted strategies to create change
within health care systems and processes of care. In using evidence in practice, engaging in
initiatives to continually improve quality, and striving for excellence, nurses can capitalize on the
information from this book and lead health care in the direction that it should and needs to be
heading to better care for the needs of patients. What it all comes down to is for us, as nurses, to
decide what kind of care we would want as patients then to do all that is possible to make that
happen. Today we may be doing what we can, but tomorrow we can improve. With this evidence
and the call to action to nurses, in 5 years from now, headlines and research findings should
carry forth the message that there are significant improvements in the quality and safety of health
care throughout this nation, and it was because nurses led the way.
Ronda G. Hughes
Editor
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Peer Reviewers
Daleen Aragon—Orlando Regional Elaine Larson—Columbia University, NY
Healthcare, FL Kathy Lee—University of California at San
William Baine—AHRQ, MD Francisco, CA
Mary Barton—AHRQ, MD Michael Leonard—Kaiser Permante, CA
Mary Blegen—University of California at Sally Lusk—University of Michigan, MI
San Francisco, CA David Meyers—AHRQ, MD
Barbara Braden—Creighton University, NE Jack Needleman—University of California
Nancy Bergstrom—University of Texas, at Los Angeles, CA
Houston, TX D.E.B. Potter—AHRQ, MD
Peter Bruehaus—Vanderbilt University, TN Peter Pronovost—Johns Hopkins University,
Helen Burstin—National Quality Forum, MD
DC Amanda Rischbieth—Australia
Carol Cain—Kaiser Permante, CA Carol Romano—DHHS/USPHS, MD
Carolyn Clancy—AHRQ, MD Judy Sangel - AHRQ, MD
Sean Clarke—University of Pennsylvania, Cynthia Scalzi—University of Pennsylvania,
PA PA
Marilyn Chow—Kaiser Permante, CA Carol Scholle—University of Pittsburgh
Beth Collins-Sharp—AHRQ, MD Medical Center Presbyterian Hospital, PA
Kathy Crosson—AHRQ, MD Jean Ann Seago—University of California
Linda Lindsey Davis—Duke University, NC at San Francisco, CA
Ellen Mockus D’Errico—Loma Linda Joan Shaver—University of Illinois at
University, CA Chicago, IL
Joanne Disch—University of Minnesota, Maria Shirey—Shirey & Associates, IN
MN Jean Slutsky—AHRQ, MD
Anita Hanrahan—Capital Health, Kaye Spence—Children’s Hospital at
Edmonton, Alberta Westmead, Sydney, Australia
Aparana Higgins—Booz | Allen | Hamilton, Janet Tucker—University of Aberdeen,
NY United Kingdom
Kerm Henrickson—AHRQ, MD Tasnim Vira—University of Toronto,
Judith Hertz—Northern Illinois University, Ontario
IL Judith Warren—University of Kansas, KS
Ronda Hughes—AHRQ, MD Jon White—AHRQ, MD
Rainu Kaushal—Harvard-Partners, MA Zane Robinson Wolf—La Salle University,
Ron Kaye—FDA, MD PA
Marge Keyes—AHRQ, MD Laura Zitella—Stanford University Cancer
Christine Kovner—New York University, Center, CA
NY
Jeanette Lancaster—University of Virginia,
VA
David Lanier—AHRQ, MD
xi
Contributing Authors
Kathryn Rhodes Alden, M.S.N., R.N., Amy S. Collins, B.S., B.S.N., M.P.H.
I.B.C.L.C. Centers for Disease Control and
University of North Carolina at Chapel Prevention
Hill Karen Cox, R.N., Ph.D., C.N.A.A.,
Kristine Alster, Ed.D., R.N. F.A.A.N.
University of Massachusetts at Boston Children’s Mercy Hospitals and Clinics,
Lisa Antle, A.P.R.N., B.C., A.P.N.P Kansas City, MO
University of Wisconsin Milwaukee Leanne Currie, D.N.Sc., M.S.N., R.N.
College of Nursing Columbia University School of Nursing
Elizabeth A. Ayello, Ph.D., R.N., A.P.R.N., Margaret J. Cushman, Ph.D.(c), R.N.,
B.C., C.W.O.C.N., F.A.P.W.C.A., F.H.H.C., F.A.A.N.
F.A.A.N. University of Massachusetts at Boston
Advances in Skin and Wound Care Maureen Ann Dailey, R.N., M.S.
Jane H. Barnsteiner, Ph.D., R.N., F.A.A.N. Columbia University School of Nursing
University of Pennsylvania School of Elizabeth Dayton, M.A.
Nursing and Hospital of the University of Johns Hopkins University
Pennsylvania Andrea Deickman, M.S.N., R.N.
Ann Bemis, M.L.S. iTelehealth Inc.
Rutgers, The State University of New Joanne Disch, Ph.D., R.N., F.A.A.N.
Jersey University of Minnesota School of
Patricia Benner, R.N., Ph.D., F.A.A.N. Nursing
Carnegie Foundation for the Advancement Molla Sloane Donaldson, Dr.P.H., M.S.
of Teaching M.S.D. Healthcare
Mary A. Blegen, Ph.D., R.N., F.A.A.N. Nancy E. Donaldson, R.N., D.N.Sc.,
School of Nursing, University of F.A.A.N.
California, San Francisco University of California, San Francisco,
Jacqueline F. Byers, Ph.D., R.N., C.N.A.A., School of Nursing
C.P.H.Q. Carol Fowler Durham, M.S.N., R.N.,
College of Nursing, University of Central University of North Carolina at Chapel
Florida, Orlando Hill
Carol H. Cain, Ph.D. Victoria Elfrink, Ph.D., R.N.B.C.
Care Management Institute, Kaiser College of Nursing of Ohio State
Permanente University and iTelehealth Inc.
Pascale Carayon, Ph.D. Carol Hall Ellenbecker, Ph.D., R.N.
University of Wisconsin-Madison University of Massachusetts at Boston
Claire C. Caruso, Ph.D., R.N. Marybeth Farquhar, R.N., M.S.N., C.A.G.S.
National Institute for Occupational Safety Agency for Healthcare Research and
and Health Quality
Sean P. Clarke, R.N., Ph.D., C.R.N.P., Kathy Fletcher, R.N., G.N.P., A.P.R.N.-
F.A.A.N. B.C., F.A.A.N.
University of Pennsylvania School of University of Virginia Health System
Nursing
xii
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Mary Ann Friesen, M.S.N., R.N., C.P.H.Q. Courtney H. Lyder, N.D., G.N.P., F.A.A.N.
Center for American Nurses, Silver University of Virginia
Spring, MD Mary Mandeville, M.B.A.
Jeanne M. Geiger-Brown, Ph.D., R.N. University of Illinois, Chicago
University of Maryland School of Nursing Karen Dorman Marek, Ph.D., M.B.A., R.N.,
Karen K. Giuliano, R.N., Ph.D., F.A.A.N. F.A.A.N.
Philips Medical Systems University of Wisconsin Milwaukee
Barbara Given, Ph.D., R.N., F.A.A.N. College of Nursing
Michigan State University College of Diana J. Mason, R.N., Ph.D., F.A.A.N.
Nursing American Journal of Nursing
Ayse P. Gurses Margo McCaffery, R.N., F.A.A.N.
University of Minnesota-Twin Cities Pain management consultant
Saira Haque, M.H.S.A., Doctoral candidate Pamela H. Mitchell, Ph.D., R.N., C.N.R.N.,
Syracuse University F.A.A.N., F.A.H.A.
Kerm Henriksen, Ph.D. University of Washington School of
Agency for Healthcare Research and Nursing
Quality Deborah F. Mulloy, M.S.N., C.N.O.R.,
Ronda G. Hughes, Ph.D., M.H.S., R.N. Doctoral student
Agency for Healthcare Research and University of Massachusetts at Boston
Quality School of Nursing
Bonnie M. Jennings, D.N.Sc., R.N., Cindy L. Munro, R.N., A.N.P., Ph.D.,
F.A.A.N. F.A.A.N.
Colonel, U.S. Army (Retired) and health Virginia Commonwealth University
care consultant School of Nursing
Meg Johantgen, Ph.D., R.N. Mike R. Murphy, R.N., B.S.N., M.B.A.
University of Maryland School of Nursing Synergy Health/St. Joseph’s Hospital
Gail M. Keenan, Ph.D., R.N. Audrey L. Nelson, Ph.D., R.N., F.A.A.N.
University of Illinois, Chicago James A. Haley Veterans’ Hospital,
Margaret A. Keyes, M.A. Tampa, FL
Agency for Healthcare Research and Michelle O’Daniel, M.H.A., M.S.G.,
Quality VHA West Coast
Ruth M. Kleinpell, Ph.D., R.N., F.A.A.N. Eileen T. O’Grady, Ph.D., R.N., N.P.
Rush University College of Nursing, Nurse Practitioner World News and The
Chicago, IL American Journal for Nurse Practitioners
Susan R. Lacey, R.N., Ph.D. Ann E. K. Page, R.N., M.P.H.
Nursing Workforce and Systems Analysis, Institute of Medicine
Children’s Mercy Hospitals and Clinics, Chris Pasero, R.N.
Kansas City, MO Pain management consultant
Jane A. Lipscomb, Ph.D., R.N., F.A.A.N. Emily S. Patterson, Ph.D.
University of Maryland School of Nursing Cincinnati VA Medical Center and Ohio
Carol J. Loveland-Cherry, Ph.D., R.N., State University
F.A.A.N. Nirvana Huhtala Petlick
University of Michigan School of Nursing Rutgers, The State University of New
Vicki A. Lundmark, Ph.D. Jersey
American Nurses Credentialing Center Shobha Phansalkar, R.Ph., Ph.D.
Harvard Medical School
xiii
Contributing Authors
xiv
Acknowledgments
Without a doubt, this could not have been accomplished without the contribution and
dedication of many people, both internally and externally to the Agency for Healthcare Research
and Quality (AHRQ). A special note of gratitude is extended to each author and peer reviewer,
who willingly shared their expertise and dedication to making health care better and safer. This
project would not have been possible without financial support from the Robert Wood Johnson
Foundation and the AHRQ, as well as the time authors committed to this project. Invaluable
support was given by Carolyn Clancy, Helen Burstin, Tonya Cooper, Susan Hassmiller, David
Lanier, and David Meyers throughout the 2-year process of bringing this project together.
Sincere gratitude is also extended to AHRQ’s Office of Communications and Knowledge
Transfer (OCKT), specifically Randie Siegel (project oversight), David I. Lewin
(copyediting/production management), and Morgan Liskinsky (marketing plan). Further
gratitude is extended to OCKT’s editorial contractors (Helen Fox, Roslyn Rosenberg, and Daniel
Robinson). Additional thanks go to Joy Solomita, of AHRQ’s Center for Primary Care,
Prevenrion, and Clinical Partnerships (CP3), for all her efforts during the finalization process.
Lastly, this book was dependent upon the invaluable assistance of Caryn McManus, Reneé
McCullough, Lynette Lilly, and other librarians throughout the country, who helped search for
and retrieve thousands of articles and book chapters.
Ronda G. Hughes
xv
Contents
Foreword
Carolyn M. Clancy, M.D., and Risa Lavizzo-Mourey, M.D., M.B.A.
Preface – General Overview/Executive Summary
Ronda G. Hughes, Ph.D., M.H.S., R.N.
List of Peer Reviewers
Acknowledgments
Introduction
The goal of this chapter is to provide some fundamental definitions that link patient safety
with health care quality. Evidence is summarized that indicates how nurses are in a key position
to improve the quality of health care through patient safety interventions and strategies.
Quality Care
Many view quality health care as the overarching umbrella under which patient safety
resides. For example, the Institute of Medicine (IOM) considers patient safety “indistinguishable
from the delivery of quality health care.”1 Ancient philosophers such as Aristotle and Plato
contemplated quality and its attributes. In fact, quality was one of the great ideas of the Western
world.2 Harteloh3 reviewed multiple conceptualizations of quality and concluded with a very
abstract definition: “Quality [is] an optimal balance between possibilities realised and a
framework of norms and values.” This conceptual definition reflects the fact that quality is an
abstraction and does not exist as a discrete entity. Rather it is constructed based on an interaction
among relevant actors who agree about standards (the norms and values) and components (the
possibilities).
Work groups such as those in the IOM have attempted to define quality of health care in
terms of standards. Initially, the IOM defined quality as the “the degree to which health services
for individuals and populations increase the likelihood of desired health outcomes and are
consistent with current professional knowledge.”4 This led to a definition of quality that appeared
to be listings of quality indicators, which are expressions of the standards. Theses standards are
not necessarily in terms of the possibilities or conceptual clusters for these indicators. Further,
most clusters of quality indicators were and often continue to be comprised of the 5Ds—death,
disease, disability, discomfort, and dissatisfaction5—rather than more positive components of
quality.
The work of the American Academy of Nursing Expert Panel on Quality Health focused on
the following positive indicators of high-quality care that are sensitive to nursing input:
achievement of appropriate self-care, demonstration of health-promoting behaviors, health-
related quality of life, perception of being well cared for, and symptom management to criterion.
Mortality, morbidity, and adverse events were considered negative outcomes of interest that
represented the integration of multiple provider inputs.6, 7 The latter indicators were outlined
more fully by the National Quality Forum.8 Safety is inferred, but not explicit in the American
Academy of Nursing and National Quality Forum quality indicators.
The most recent IOM work to identify the components of quality care for the 21st century is
centered on the conceptual components of quality rather than the measured indicators: quality
care is safe, effective, patient centered, timely, efficient, and equitable. Thus safety is the
foundation upon which all other aspects of quality care are built.9
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Patient Safety
A definition for patient safety has emerged from the health care quality movement that is
equally abstract, with various approaches to the more concrete essential components. Patient
safety was defined by the IOM as “the prevention of harm to patients.”1 Emphasis is placed on
the system of care delivery that (1) prevents errors; (2) learns from the errors that do occur; and
(3) is built on a culture of safety that involves health care professionals, organizations, and
patients.1, 10 The glossary at the AHRQ Patient Safety Network Web site expands upon the
definition of prevention of harm: “freedom from accidental or preventable injuries produced by
medical care.”11
Patient safety practices have been defined as “those that reduce the risk of adverse events
related to exposure to medical care across a range of diagnoses or conditions.”12 This definition
is concrete but quite incomplete, because so many practices have not been well studied with
respect to their effectiveness in preventing or ameliorating harm. Practices considered to have
sufficient evidence to include in the category of patient safety practices are as follows:12
• Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk
• Use of perioperative beta-blockers in appropriate patients to prevent perioperative
morbidity and mortality
• Use of maximum sterile barriers while placing central intravenous catheters to prevent
infections
• Appropriate use of antibiotic prophylaxis in surgical patients to prevent postoperative
infections
• Asking that patients recall and restate what they have been told during the informed-
consent process to verify their understanding
• Continuous aspiration of subglottic secretions to prevent ventilator-associated pneumonia
• Use of pressure-relieving bedding materials to prevent pressure ulcers
• Use of real-time ultrasound guidance during central line insertion to prevent
complications
• Patient self-management for warfarin (Coumadin®) to achieve appropriate outpatient
anticoagulation and prevent complications
• Appropriate provision of nutrition, with a particular emphasis on early enteral nutrition in
critically ill and surgical patients, to prevent complications
• Use of antibiotic-impregnated central venous catheters to prevent catheter-related
infections
Many patient safety practices, such as use of simulators, bar coding, computerized physician
order entry, and crew resource management, have been considered as possible strategies to avoid
patient safety errors and improve health care processes; research has been exploring these areas,
but their remains innumerable opportunities for further research.12 Review of evidence to date
critical for the practice of nursing can be found in later chapters of this Handbook.
The National Quality Forum attempted to bring clarity and concreteness to the multiple
definitions with its report, Standardizing a Patient Safety Taxonomy.13 This framework and
taxonomy defines harm as the impact and severity of a process of care failure: “temporary or
permanent impairment of physical or psychological body functions or structure.” Note that this
classification refers to the negative outcomes of lack of patient safety; it is not a positive
classification of what promotes safety and prevents harm. The origins of the patient safety
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Defining Patient Safety, Quality Care
problem are classified in terms of type (error), communication (failures between patient or
patient proxy and practitioners, practitioner and nonmedical staff, or among practitioners),
patient management (improper delegation, failure in tracking, wrong referral, or wrong use of
resources), and clinical performance (before, during, and after intervention).
The types of errors and harm are further classified regarding domain, or where they occurred
across the spectrum of health care providers and settings. The root causes of harm are identified
in the following terms:8
•
Latent failure—removed from the practitioner and involving decisions that affect the
organizational policies, procedures, allocation of resources
•
Active failure—direct contact with the patient
•
Organizational system failure—indirect failures involving management, organizational
culture, protocols/processes, transfer of knowledge, and external factors
•
Technical failure—indirect failure of facilities or external resources
Finally, a small component of the taxonomy is devoted to prevention or mitigation activities.
These mitigation activities can be universal (implemented throughout the organization or health
care settings), selective (within certain high-risk areas), or indicated (specific to a clinical or
organizational process that has failed or has high potential to fail).
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
nurse and physician cognitive diagnostic and treatment decisions, more effective diagnostic and
therapeutic processes, and better nursing surveillance.19, 20
Further, when we consider the key role of communication or communication lapses in the
commission of error, the role of nursing as a prime communication link in all health care settings
becomes evident. The definition of “error chain” at PSNet clearly indicates the role of leadership
and communication in the series of events that leads to patient harm. Root-cause analyses of
errors provide categories of linked causes, including “(1) failure to follow standard operating
procedures, (2) poor leadership, (3) breakdowns in communication or teamwork, (4) overlooking
or ignoring individual fallibility, and (5) losing track of objectives.”21 This evidence was used in
developing the cause portion of the National Quality Forum’s patient safety taxonomy and is
further discussed in other chapters of this book.
Conclusion
Patient safety is the cornerstone of high-quality health care. Much of the work defining
patient safety and practices that prevent harm have focused on negative outcomes of care, such
as mortality and morbidity. Nurses are critical to the surveillance and coordination that reduce
such adverse outcomes. Much work remains to be done in evaluating the impact of nursing care
on positive quality indicators, such as appropriate self-care and other measures of improved
health status.
Author Affiliation
Pamela H. Mitchell, Ph.D., R.N., C.N.R.N., F.A.A.N., F.A.H.A., associate dean for research,
professor of biobehavioral nursing and health systems, and Elizabeth S. Soule Distinguished
Professorship of Health Promotion at the University of Washington School of Nursing. E-mail:
[email protected].
References
1. Aspden P, Corrigan J, Wolcott J, et al., eds. Patient 5. Lohr KN. Outcome measurements: concepts and
safety: achieving a new standard for care. Washington, questions. Inquiry 1988; 25(1):37-50.
DC: National Academies Press; 2004.
6. Mitchell PH, Lang NM. Framing the problem of
2. Adler M, Goman W. Quality. In: Adler M, Goman W, measuring and improving healthcare quality: has the
eds. The great ideas: a syntopicon of great books of Quality Health Outcomes Model been useful? Med
the Western world. Chicago: Encyclopedia Britannica; Care 2004; 42:II4-11.
1952:p. 513-6.
7. Mitchell PH, Heinrich J, Moritz P, et al. Outcome
3. Harteloh PPM. The meaning of quality in health care: measures and care delivery systems: Introduction and
a conceptual analysis. Health Care Analysis 2003; purposes of the conference. Medical Care 1997;
11(3):259-67. 35(11):NS1-5.
4. Lohr K, Committee to Design a Strategy for Quality 8. National Quality Forum. National consensus standards
Review and Assurance in Medicare, eds. Medicare: a for nursing-sensitive care: an initial performance
strategy for quality assurance, Vol. 1. Washington, measure set. Washington, DC: National Quality
DC: National Academy Press; 1990. Forum; 2004. p. 40.
4
Defining Patient Safety, Quality Care
9. Committee on the Quality of Health Care in America. 16. Lang N. Issues in quality assurance in nursing. Paper
Crossing the quality chasm: A new health system for presented at issues in evaluation research: an
the 21st century. Washington, DC: National Academy invitational conference, December 10-12, 1975.
Press; 2001. Kansas City, KS: American Nurses Association; 1976.
10. Clancy CM, Farquhar MB, Sharp BA. Patient safety in 17. Tourangeau AE, Cranley LA, Jeffs L. Impact of
nursing practice. J Nurs Care Qual Jul-Sep nursing on hospital patient mortality: a focused review
2005;20(3):193-7. and related policy implications. Qual Saf Health Care
Feb 2006;15(1):4-8.
11. AHRQ PSNet Patient Safety Network. Patient safety.
http://psnet.ahrq.gov/glossary.aspx#P. Accessed 18. Mitchell PH, Lang NM. Nurse staffing: a structural
October 20, 2007. proxy for hospital quality? Med Care. Jan
2004;42(1):1-3.
12. Shojania KG, Duncan BW, McDonald KM, et al., eds.
Making health care safer: a critical analysis of patient 19. Kahn KL, Keeler EB, Sherwood MJ, et al. Comparing
safety practices. Evidence Report/Technology outcomes of care before and after implementation of
Assessment No. 43 (Prepared by the University of the DRG-based prospective payment system. JAMA.
California at San Francisco-Stanford Evidence-based Oct 17 1990; 264(15):1984-8.
Practice Center under Contract No. 290-97-0013).
Rockville, MD: Agency for Healthcare Research and 20. Rubenstein L, Chang B, Keeler E, et al. Measuring the
Quality; July 2001. AHRQ Publication No. 01-E058, quality of nursing surveillance activities for five
Summary. diseases before and after implementation of the DRG-
based prospective payment system. Paper presented at
13. National Quality Forum. Standardizing a patient safety Patient outcomes research: examining the
taxonomy: a consensus report. Washington, DC: effectiveness of nursing practice, 1992; Bethesda,
National Quality Forum; 2006. MD.
14. Nightingale F. In: Goldie SM, ed. "I have done my 21. AHRQ PSNet Patient Safety Network. Error chain.
duty”: Florence Nightingale in the Crimean War, http://psnet.ahrq.gov/glossary.aspx#E. Accessed
1854-56. Manchester: Manchester University Press; October 20, 2007.
1987.
5
Chapter 2. Nurses at the “Sharp End” of Patient Care
Ronda G. Hughes
Background
The work environment in which nurses provide care to patients can determine the quality and
safety of patient care.1 As the largest health care workforce, nurses apply their knowledge, skills,
and experience to care for the various and changing needs of patients. A large part of the
demands of patient care is centered on the work of nurses. When care falls short of standards,
whether because of resource allocation (e.g., workforce shortages and lack of needed medical
equipment) or lack of appropriate policies and standards, nurses shoulder much of the
responsibility. This reflects the continued misunderstanding of the greater effects of the
numerous, complex health care systems and the work environment factors. Understanding the
complexity of the work environment and engaging in strategies to improve its effects is
paramount to higher-quality, safer care. High-reliability organizations that have cultures of safety
and capitalize on evidence-based practice offer favorable working conditions to nurses and are
dedicated to improving the safety and quality of care. Emphasis on the need to improve health
care systems to enable nurses to not be at the “sharp end” so that they can provide the right care
and ensure that patients will benefit from safe, quality care will be discussed in this chapter.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 1
organization than others because resources can be “randomly” distributed, creating inequities in
quality and safety.5 The number of hazards and risks can be reduced by targeting their root
causes. In doing so, the path between active failures when the error occurred would be traced to
the latent defects in the organization, indicating leadership, processes, and culture. Then, if
organizational factors (e.g., latent factors) become what they should be, few active causes of
accidents will come about.
The Institute of Medicine (IOM) stated that safety was dependent upon health care systems
and organizations, and patients should be safe from injury caused by interactions within systems
and organizations of care.6 Organizational factors have been considered the “blunt end” and
represent the majority of errors; clinicians are considered the “sharp end.” Therefore, to prevent
errors, the organizations in which humans work need to be adapted to their cognitive strengths
and weaknesses and must be designed to ameliorate the effects of whatever human error occurs.
The most effective strategies to improve safety target latent factors within organizations and
systems of care. This point is emphasized by the IOM, which further stated that the safety and
quality of care would be improved by holding systems accountable, redesigning systems and
processes to mitigate the effects of human factors, and using strategic improvements.7
According to Reason,2 a large part of mental functioning is automatic, rapid, and effortless.
This automatic thinking is possible because we have an array of mental models (e.g., schemata)
that are expert on some minuscule recurrent aspect of our lives (e.g., going to work). Many errors
result from flaws in thinking that affect decisionmaking.8, 9 Ebright and colleagues10 assert that
nurses’ ability to make logical and accurate decisions and influence patient safety is associated
with complex factors, including their knowledge base and systems factors (e.g., distractions and
interruptions), availability of essential information, workload, and barriers to innovation. The
effects of these factors are complicated by the increasingly complex nature of nursing’s roles and
responsibilities, the complex nature of preventing errors from harming patients, and the
availability of resources.10
When errors occur, the “deficiencies” of health care providers (e.g., insufficient training and
inadequate experience) and opportunities to circumvent “rules” are manifested as mistakes,
violations, and incompetence.11, 12 Violations are deviations from safe operating procedures,
standards, and rules, which can be routine and necessary or involve risk of harm. Human
susceptibility to stress and fatigue; emotions; and human cognitive abilities, attention span, and
perceptions can influence problem-solving abilities.2 Human performance and problem-solving
abilities are categorized as skill based (i.e., patterns of thoughts and actions that are governed by
previously stored patterns of preprogrammed instructions and those performed unconsciously),
rule based (i.e., solutions to familiar problems that are governed by rules and preconditions), and
knowledge based (i.e., used when new situations are encountered and require conscious analytic
processing based on stored knowledge). Skill-based errors are considered “slips,” which are
defined as unconscious aberrations influenced by stored patterns of preprogrammed instructions
in a normally routine activity. Distractions and interruptions can precede skill-based errors,
specifically diverting attention and causing forgetfulness.2 Rule-based and knowledge-based
errors are caused by errors in conscious thought and are considered “mistakes.”13 Breaking the
rules to work around obstacles is considered a rule-based error because it can lead to dangerous
situations and may increase one’s predilection toward engaging in other unsafe actions. Work-
arounds are defined as “work patterns an individual or a group of individuals create to
accomplish a crucial work goal within a system of dysfunctional work processes that prohibits
the accomplishment of that goal or makes it difficult”14 (p. 52). Halbesleben and colleagues15
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Nurses at the “Sharp End”
assert that work-arounds could introduce errors when the underlying work processes and
workflows are not understood and accounted for, but they could also represent a “superior
process” toward reaching the desired goal.
Clinicians’ decisionmaking and actions are also influenced by the “human condition.”
Reason5, 16 asserted that because of the fallibility of the human condition, we can change the
working conditions so that the potential for errors is reduced and the effect of errors that do
occur is contained. Humans are limited by difficulty in attending to several things at one time,
recalling detailed information quickly, and performing computations accurately.6 As discussed
by Henriksen and colleagues,17 the scientific field of human factors focuses on human
capabilities and limitations and the interaction between people, machines, and their work
environment. The focus is on system failures, not human failures, and on meeting the needs of
the humans interacting within it. Systems would be redesigned and dedicated to continuous
improvement to protect against human error by employing simplification, automation,
standardization of equipment and functions, and decreasing reliance on memory.18 The “work
system” would account for the interrelatedness of the individual, tasks, tools and technologies,
the physical environment, and working conditions.19 Conditions that make errors possible would
be redesigned to reduce reliance on memory, improve information access, error-proof processes,
standardize tasks, and reduce the number of handoffs.20, 21 Errors would be identified and
corrected and over time there would be fewer latent failure modes and fewer errors. However,
because patient outcomes are dependent upon human-controlled processes, health care settings
will never be 100 percent safe.
The IOM defined patient safety as freedom from accidental injury. 6 Adverse events are
defined as injuries that result from medical management rather than the underlying disease.22, 23
While the proximal error preceding an adverse event is mostly considered attributable to human
error, the underlying causes of errors are found at the system level and are due to system flaws;24
system flaws are factors designed into health care organizations and are often beyond the control
of an individual.25, 26 In other words, errors have been used as markers of performance at the
individual, team, or system level. Adverse events have been classified as either preventable or
not,21, 27 and some preventable adverse events (fewer than one in three) are considered to be
caused by negligence.28 The concept of an error being preventable has not been widely
understood in its context, and definitions have been conflicting and unreliable,21, 29 partially
because the source of the majority of errors have been ascribed to vague systems factors,30 and
the relationship between errors and adverse events is not fully understood.30, 31
Although the true number of errors and adverse events may not be known because of
underreporting, failure to recognize an error, and lack of patient harm, it is difficult to understand
the pervasiveness of errors because there are differences in definitions of reportable errors and
adverse events.32 Research and quality improvement initiatives have focused predominately on
medication safety because of existing information systems and the potential frequency for which
errors can occur. In the case of medications, the types and causes of errors describe how nurses
are at the “sharp end.” Medications pose the largest source of errors, yet many do not result in
patient harm.33, 34 Since errors actually occur during the process of medication therapies, the
usual ‘practice’ has been to blame individuals.35, 36 A medication intervention goes from
prescribing, transcribing, and dispensing to administration. Physicians are primarily responsible
for prescribing medications and nurses are primarily responsible for administering medications
to patients. Errors made by physicians can be intercepted by pharmacists and nurses, errors made
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by pharmacists can be intercepted by nurses, and errors made by nurses could potentially be
intercepted by peers or patients.
Several classifications of health care errors have been posed.37–39 Classifications or
categorizations of errors have been based on types of adverse events,40–42 incident reports,38, 39
individual blame,37 and system causes. Given what is known about error causation,1, 5, 6, 16
particularly what has been learned from root-cause analysis and failure modes and effects
analysis, when errors/adverse events involve clinicians, classifications/taxonomies of errors
would be centered on all the related systems factors and would consider them the major
contributors of the error/adverse event.5, 16 For example, one classification of errors differentiates
endogenous errors (i.e., arise within the individual or team) from exogenous errors (i.e., arise
within the environment).43 Endogenous errors are generally either active or latent2 and result
from departure from normative knowledge-based, skill-based, or rule-based behaviors.44
The complexity of factors involved in errors and adverse events is exemplified in medication
safety. Researchers have found that between 3 percent and 5 percent,45 34 percent,46 40 percent,47
or 62 percent48 of medication errors are attributable to medication administration. For an
administration error to not occur, the nurse would be at the “sharp end,” having the responsibility
to intercept it. Administration errors have been found to be the result of human factors, including
performance and knowledge deficiencies;49 fatigue, stress, and understaffing were found to be
two major factors for errors among nurses.50 Administering medications can take up to 40
percent of the nurse’s work time,51 and medication administration errors have been found to be
due to a lack of concentration and the presence of distractions, increased workloads, and
inexperienced staff.48, 52, 53 If we consider what has been learned in other industries, medication
administration errors would also be caused by systems factors, such as leadership not ensuring
sufficient training, maldistribution of resources, poor organizational climate, and lack of
standardized operating procedures.54
Since the publication of the IOM’s To Err Is Human,6 millions of dollars of research funds—
e.g., from the Agency for Healthcare Research and Quality (AHRQ) and the Robert Wood
Johnson Foundation—have been devoted to building the evidence base in patient safety research.
Findings reported from the IOM and other related research is being disseminated on key aspects
of patient safety. It is interesting to note that before the publication of To Err Is Human, the
major focus of patient safety was on individual blame and malpractice.55 Since the publication of
To Err Is Human, that has no longer been the case and there is more focus on the need to
improve health care organizations,56 but the concerns associated with malpractice have not
dissipated. In fact, concerns about malpractice have thwarted many patient safety improvement
efforts primarily because of the need for data collection and analysis as well as performance
measures to inform patient safety changes.57
The focus on the responsibilities and influences of systems does not negate the challenge of
understanding error and accepting the inevitability of many errors while concurrently increasing
the quality of health care. It is not possible for every aspect of health care and every setting of
care to be 100 percent error free, and leaders and clinicians are challenged to define what is an
acceptable level of error. Because safety is foundational to quality,58 one way to define quality is
providing “the right care, at the right time, for the right person, in the right way.”59 In doing so,
efforts to improve safety and quality need to address concerns with potential overuse, misuse,
and underuse of health care services that can threaten the quality and safety of care delivered to
patients. Since patient safety, and quality in many respects, “is a new field, identifying which
safe practices are effective has presented a significant challenge”60 (p. 289), in part because of
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the resource requirements, the complex nature of changing practice, and the influences of units
within the whole.60
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Yet, many organizations do not meet the standards of high-reliability organizations (HROs).
Reason and colleagues81 described the “vulnerable system syndrome” as a cluster of
organizational pathologies that interact, making some systems more liable to unsafe practices
that threaten patient safety. These pathologies (e.g., blame, denial, and the pursuit of financial
excellence) are perpetuated in work environments by leaders and peers targeting individuals at
the “sharp end,” simultaneously failing to question core beliefs, recognize systemic causes, or to
implement systemwide reforms. Reason and colleagues further asserted that indicators of
vulnerabilities of the work environment, such as a culture of individual blame, were associated
with workplace cultures that influenced safety and could be categorized as (1) high reliability
(where recognizing how safety can be improved is rewarded), (2) pathological (where
punishment and covering up of errors/failures are pervasive and new ideas are discouraged), or
(3) bureaucratic (where failures are considered isolated, systematic reforms are avoided, and new
ideas are problematic). An indicator of the presence of work environment vulnerabilities and
patient safety improvements could be whether or not an organization has Joint Commission
accreditation.82
Nurses perceive multiple and complex work environment factors that influence nurse and
patient outcomes, including the quality of leadership and management, staffing resources,
workload,83 job stress and anxiety, teamwork, and effective communication.84 Heath and
colleagues asserted that in healthy work environments, nurses “feel valued by their organization,
have standardized processes in place, have staff empowerment, have strong leadership, feel a
sense of community, and recognize that strategic decision-making authority [influences] how
their units were run and how scarce resources were disseminated”85 (p. 526–7). Healthy work
environments are also places where safe and high-quality nursing care is expected and rewarded.
Healthy work environments also need to foster effective communication, collaborative
relationships, and promote decisionmaking among all nurses.85 Unhealthy work environments
can have adverse consequences on the quality of care delivered as well as nurses’ intention to
leave the profession.1, 86–88
As proposed by Stone and colleagues,89 there are microclimates (e.g., a unit or department)
that function within the larger context of the organization. These microclimates or
“microsystems” have a core team of health care professionals; a defined population of patients
they are responsible for; and information, staff, and health technologies that provide support to
the work of the clinicians.90
Yet, the majority of this research has examined outcomes at the hospital-wide level, and not
at the unit level. Since the work environment within microclimates/microsystems can be
different than that found organization-wide, it would be important to focus on these subunits to
support efforts to standardize common care processes, to better examine process and outcome
measures and what subunit factors and organization-wide factors contribute to less-than-optimal
care, to emphasize the impact of multidisciplinary teams throughout the organization, and to
ascertain how lessons learned in these subunits could be applied organization-wide.90
High-Reliability Organizations
Inherently related to high-performing organizations, HROs are defined as organizations that
function daily under high levels of complexity and hazards. Reliable organizations have
“procedures and attributes that make errors visible to those working in the system so that they
can be corrected before causing harm”6 (p. 152) and produce consistent results. Accordingly, the
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Nurses at the “Sharp End”
IOM has advocated for hospitals to transition into HROs to improve the quality and safety of
care.6 In HROs, reliability and consistency are built into organizational routines where errors can
have catastrophic consequences. In health care, reliability is defined as the “measurable ability of
a health-related process, procedure, or service to perform its intended functions in the required
time under commonly occurring conditions”91 (p. 82). Applying the theory behind high
reliability organizations and normal accident theory (e.g., understanding how health system
factors affect safety), patient safety improvements have been linked to high-reliability safety
interventions, including double checking, and improving the validity of root-cause analyses.92
Because improving safety is complex and should be continuous,2, 4, 11 HROs continually
measure their performance, learn from experience, and take action to resolve problems when
they are discovered. HROs have a (1) preoccupation with avoiding failure, (2) reluctance to
simplify interpretations, (3) sensitivity to operations, (4) commitment to resilience, and (5)
deference to expertise.93, 94 A preoccupation with avoiding failures is based on comprehensive
error reporting, where human failure is accepted as being inevitable, and being overconfident
because of successes is considered highly risky. A reluctance to simplify interpretations is
supported by thoroughly examining situations. Being sensitive to operations involves being
constantly concerned about the unexpected and recognizing that active errors result from latent
errors in the system. Committing to resilience involves being able to identify, control, and
recover from errors, as well as developing strategies to anticipate and responds to the
unexpected. Having deference to expertise means that everyone is involved and decisions are
made on the front line.94
Health care leaders and researchers have been looking to HROs in industry, such as the
National Aeronautics and Space Administration, aviation, and the U.S. Postal Service,21, 94, 95 to
apply their lessons learned to health care. HROs are known to approach safety from a systems
perspective, involving both formal structures and informal practices, such as open inquiry and
deep self-understanding that complement those structures.96 Through careful planning and
design, HROs have been found to share common features: (1) auditing of risk—to identify both
expected and unexpected risks; (2) appropriate reward systems—for safety-related behaviors; (3)
system quality standards—evidence-based practice standards; (4) acknowledgment of risk—
detecting and mitigating errors; and (5) flexible management models—promoting teamwork and
decentralized decisionmaking.97 Shapiro and Jay asserted that health care organization can
become HROs though “(1) attitude change, (2) metacognitive skills, (3) system-based practice,
(4) leadership and teamwork, and (5) emotional intelligence and advocacy”98 (p. 238).
Implementing quality and safety improvement strategies in organizational
microclimates/microsystems, and for that matter organization-wide, should be predicated on
increasing the subunits’ awareness of how they function and mindfulness of the reliability of
their outcomes. Mindfulness is a “combination of ongoing scrutiny of existing expectations,
continuous refinement and differentiation of expectations based on newer experiences,
willingness and capability to invent new expectations that make sense of unprecedented events,
and a more nuanced appreciation of context and ways to deal with it, and identification of new
dimensions of context that improve foresight and current functioning”94 (p. 42). Mindfulness
speaks to the interrelationships among processes of perception and cognition that stimulate a rich
awareness of and hypervigilance for emerging factors and issues that could threaten the quality
of care and enable the identification of actions that might be taken to deal with the threats to
quality.94 Weick and Sutcliff94 argue that organizations can become HROs when they become
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competencies that reflect the nature of nursing in improving patient and systems outcomes,
including evidence-based practice, patient-centered care, teamwork and collaboration, safety,
quality improvement, and informatics.106
Opportunity, power, and the composition of the workforce within organizations influence
what nurses are able to do and how they are able to use resources to meet patients’ needs.
Lashinger and colleagues76, 107–109 have found that the empowerment of staff nurses increased
with greater responsibilities associated with job advancements and was related to the nurses’
commitment to the organization, burnout, job autonomy, their ability to participate in
organizational decisionmaking, as well as job strain and work satisfaction.110 Because work
environment factors influence the perceptions of nurses as being supported in their work, having
a sense of accomplishment,111 and being satisfied with their work, it is important to empower
staff to manage their own work, collaborate in effective teams,112 and practice nursing in
“optimal” conditions.113 Professional empowerment in the workplace is derived from
competence and interactions with colleagues and other clinicians within organizations—and with
patients—as well as by demonstrating knowledge and gaining credibility.114 For nurses,
structural empowerment can have a direct effect on their experience of providing care in their
work environment.115 Models of care, such as a professional practice model, not only can
improve work satisfaction, but they can facilitate patient and nursing outcomes.116
Patient-Centered Care
In Crossing the Quality Chasm, the IOM recommended that “all health care organizations,
professional groups, and private and public purchasers should adopt as their explicit purpose to
continually reduce the burden of illness, injury, and disability, and to improve the health and
functioning of the people of the United States”7 (p. 39). For this recommendation to be realized,
the IOM asserted that health care would have to achieve six aims: to be safe, effective, patient-
centered, timely, efficient, and equitable. The IOM also asserted that health care for the 21st
century would need to be redesigned, ensuring that care would be based on a continuous healing
relationship, customized inclusion of patient needs and values, focused on the patient as the
source of control, and based on shared knowledge and the free flow of information. Patient-
centered care would improve health outcomes and reduce or eliminate any disparities associated
with access to needed care and quality.117–119
Patient-centered care is considered to be interrelated with both quality and safety.7 The role
of patients as part of the “team” can influence the quality of care they receive120, 121 and their
outcomes.122, 123 The IOM recommended that clinicians partner with patients (and the patient’s
family and friends, when appropriate)124 to realize informed, shared decisionmaking, improve
patient knowledge, and inform self-management skills and preventive behaviors. Patients seek
care from competent and knowledgeable health professionals to meet their physical and
emotional needs. Within this framework, the clinician’s recommendations and actions would be
customized to the patient and informed by an understanding of the patient’s needs, preferences,
knowledge and beliefs,125 and when possible, would enhance the patient’s ability to act on the
information provided. It follows then that an effective clinician-patient partnership would include
informed, shared decisionmaking and development of patient knowledge and skills needed for
self-management of chronic conditions.
Patients and families have been and are becoming more involved in their care. Findings from
several studies have indicated that patients who are involved with their care decisions and
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management have better outcomes than those patients who are not,126, 127 although some
researchers indicate that the evidence concerning the impact of patient-centered care is
variable.128 Patient self-management, particularly for chronic conditions, has been shown to be
associated with improvements in quality of life129 and health status, decreased utilization of
services,130 and improved physical activity.131, 132 The Chronic Care Model developed by Wagner
and colleagues133–135 similarly emphasized the importance of actively engaging patients in
achieving substantial improvements in care. Patient-centeredness is increasingly recognized as
an important professional evolution124 and holds enormous promise for improving the quality
and safety of health care. Yet, patient-centered care has not become the standard of care
throughout care systems and among all clinicians as recommended by the IOM.7, 136 For patient-
centered care to become the “standard” care process, care processes would need to be redesigned
and the roles of clinicians would need to be modified137, 138 to enable effective teamwork and
collaboration throughout care settings.
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surgical errors)152 and higher mortality.153 Poor teamwork as well as disrespectful, rude, and
insulting behaviors have no place in health care and can potentially increase unsafe practices.154–
156
In a comparison of medicine to aviation, physicians were found to be significantly more
supportive of hierarchical models of practice, where junior physicians would not question their
seniors.152 Hierarchical structures have been found to have an adverse influence on
communication among team members and patient outcomes.157, 158 Nursing’s participation in
teams is further limited under a hierarchical, mechanistic structure when nurses focus on tasks.159
Other barriers that have been found to inhibit the effectiveness of nurses in teams were their
perceptions of teamwork, having different teamwork skills, and the dominance of physicians in
team interactions.160 When physicians view hospitals as a “platform[s] for their work and do not
see themselves as being part of [the] larger organization”1 (p. 144), physicians may not only
thwart the work of nurses, but the organization’s efforts to improve the quality and safety of care.
When anyone within organizations exhibit intimidating or disruptive behaviors and when there
are inappropriate hierarchies, breakdowns in teamwork, and loss of trust, decreased morale and
turnover are expected among staff; patients can expect to be harmed and will likely seek care
elsewhere.1, 161–163
The work environment, communication and collaboration among clinicians, and
decisionmaking are also linked to leadership and management within health care
organizations.164–166 Some authors have argued that performance of organizations and the use of
evidence in practice were factors dependent upon leadership, particularly among middle/unit-
based clinical management.167–169 The personality and attitudes of leaders has been shown to
have an impact on safety170, 171 and on perceptions about how safety is managed.172 Visible,
supportive, and transformational nursing leadership to address nursing practice and work
environment issues is critical as is nursing and medical leadership to ensure that the work
environment supports caregivers and fosters collaborative partnerships. However, giving
encouragement is not generally stated as a high-priority role of health care supervisors.
Traditionally, technical skills and productivity on the job were aspects that received the
supervisor's primary focus. However, there is a growing appreciation that encouragement is a
transformational leadership technique that is related to productivity on the job and to quality
work. Use of encouragement is a leadership technique that fits in today's people-oriented work
climate.1
Evidence-Based Practice
Evidence should be used in clinical decisionmaking whenever possible. The need for
improving quality using evidence was described by Steinberg and Luce as “the recognition that
there is much geographic variation in the frequency with which medical and surgical procedures
are performed, the way in which patients with a given disease are managed, patient outcomes,
and the costs of care, which cannot be explained by differences in patients’ demographic or
clinical characteristics”173 (p. 80). Indeed, findings from research continue to provide
information that illustrates that only some patients are receiving the recommended quality of
care,117, 174–176 and errors continue to adversely impact patient outcomes. Steinberg and Luce go
on to state that there is “strong evidence that much of the care that is being provided is
inappropriate (that is, likely to provide no benefit or to cause more harm than good)” and that
there are “indications that many patients are not receiving beneficial services”173 (p. 80). Some
examples of these concerns are associated with determining health care interventions and
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medication safety. Patients can be harmed if their symptoms and needs are not assessed
accurately,177 if the wrong type of intervention is selected,178–180 and if patients do not receive
information they need to manage their care.181 Certain types of medication errors, such as the
wrong drug, wrong dose,182 and polypharmacy,183 threaten the quality of therapeutic
interventions and the safety of patient care by aggravating the patient’s preintervention health
status.
Another reason that health care quality needs to improve and be based on evidence is
“continuously rising health care costs”173 (p. 80). In a country that spends more per capita than
anywhere else in the world, patients do not necessarily have better outcomes.184 Often without
knowing it, clinicians have one of the greatest roles in controlling (or increasing) the cost of
health care. What type of care is given to patients is sensitive to clinicians (e.g., nurses and
physicians) as well as organizational structures, policies, and resources. The skill mix and
number of nurses has been found to be associated with adverse events, longer lengths of stay in
hospitals, and higher health care costs.185–187 Findings from research have indicated that
understaffing is associated with an increase in errors and adverse events, such as medication
errors, pressure ulcers, health care associated infections, and increased mortality rates in
hospitalized patients. 86, 185, 188–195 To address workforce shortages, organizations have used
financial and shift work incentives, used part-time workers, and improved the image and job
satisfaction, among other things.196, 197 All of these strategies increase the cost of health care.
The combined concern about the growing cost of care and the effects of poor-quality care on
patients has resulted in action by the Centers for Medicare and Medicaid Services (CMS) and
other insurers to put in place financial penalties for hospitals that have preventable events, such
as readmission, never events (e.g., wrong-site surgery), health care associated infections,198
pressure ulcers, and patient falls with injury. These financial penalties reflect policy based on
research that has indicated a significant association between nurse staffing and adverse patient
outcomes,185, 187, 192 and quality measures that have been put forth as being sensitive to nursing
care.199, 200 Adverse patient outcomes are also sensitive to the care directed by physicians, even
when physicians and hospitals have a financial incentive to provide specific elements of quality
care. This was recently found in a comparison of treatments and outcomes for 5 conditions at 54
hospitals participating in a Medicare pay-for-performance pilot program to the treatments and
outcomes at 446 hospitals not participating in the program. The researchers in this investigation
found the financial incentive of pay-for-performance was not associated with significant
improvement in quality of care or outcomes.201 Because health care costs are expected to
continue to increase, it is important to ensure that costs of health care are not unnecessarily high
and that patients receive quality care and are not exposed to preventable adverse events. Nurse
leaders and clinical practitioners should be required to be actively engaged with other clinicians
and leaders in assessing and monitoring the care of patients and their outcomes, as well as in
driving quality improvement efforts to prevent the reoccurrence of these high-risk adverse
events.
However, not all evidence is equal. It can be based on research that is not generalizable to
other settings and populations173, 202, 203 and may be difficult to translate into practice without
further testing and the development of guidelines.203 Even when research is available, it is often
not used in practice,204, 205 and adapting the research to practice can be challenging because of
numerous barriers and deficits of facilitators to change.206, 207 A systematic review of
interventions aimed at increasing the use of evidence in practice found that greater success was
achieved when clinicians were involved in education about and in intervention strategies that
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Nurses at the “Sharp End”
were centered on using evidence in practice with local opinion leaders and multidisciplinary
teams. The investigators further asserted that to effectively use research in practice, nurses
should use the right evidence to inform and evaluate practice change interventions,
longitudinally assess the effects of the intervention using the measures for multiple outcomes,
and use a methodologically rigorous approach to design the implementation and evaluation of
the intervention.208
Evidence-based practice has been defined as using data and information, often from diverse
sources, to guide practice. When evidence is available, clinicians must locate and then consider
the generalizability of its findings and usability in the practice setting. Randomized controlled
trials (RCTs) have been considered the best standard for clinical practice, but they are not
available for many common clinical situations and are generalizable only to the population
studied during the trial. Clinicians use a broad range of practice knowledge, especially when
evidence is not available. Sandars and Heller209 proposed using the concept of knowledge
management, which involves generating research-based evidence, synthesizing the evidence
base, communicating that knowledge, and applying it to care processes. Another option would be
to employ quality improvement methods, such as Plan-Do-Study-Act, to inform practice.50 Horn
and Gassway210 proposed using practice-based evidence for clinical practice improvement that is
based on the selection of clinically relevant alternative interventions, includes a diverse study
population from heterogeneous practice settings, and utilizes data about a broad range of health
outcomes.210 Thus, when evidence is not available, clinicians should use their experience and
data and information from other forms of inquiry.
A Culture of Safety
The IOM encouraged the creation of cultures of safety within all health care organizations.6
A safety culture is defined as “the product of the individual and group values, attitudes,
competencies and patterns of behavior that determine the commitment to, and the style and
proficiency of, an organization’s health and safety [programs]”211 (p. 2). An organization’s
culture is based on its history, its mission and goals, and its past and current leadership. Gadd
and Collins211 found that organizations with a positive safety culture were characterized by
communication guided by mutual trust, shared perceptions of the importance of safety, and
confidence that error-preventing strategies would work.
The terms “culture” and “climate” have been used interchangeably. Organizational climate
refers to the atmosphere of aggregate attitudes and perceptions of how individuals feel about
their places of work, which are associated with both individual and team motivation and
satisfaction. The climate within an organization represents a moveable set of perceptions related
to conditions within the workplace,212 which can be changed by the values, attributes, skills,
actions, and priorities of organization leaders and mangers. A safety climate is a type of
organizational culture and is the result of effective interplay of structure and processes factors
and the attitude, perception, and behavior of staff related to safety. A climate of safety is
represented by employee perceptions of: the priority of safety within the work environment on
their unit and across the organization, and is influenced by management decisions; safety norms
and expectations; and safety policies, procedures, and practices within the organization.211
It follows then that the higher the safety culture, the safer and better the quality of care.
When researchers compared the safety cultures of hospitals to the aviation industry—which has
been associated with high safety cultures—they found that the safety climate in hospitals was
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worse; and within hospitals, the safety culture was worse in operating rooms and emergency
departments.213, 214 The perceptions of safety within a hospital have been found to be more
positive among leaders and managers than among those directly involved in care;215 nurses
reported the lowest numbers for a safety culture.216 Hospital staff have been found to understand
the importance of safety in their work and their role in patient safety, and to judge patient safety
according to their perception of workplace safety and leadership commitment.217 The perceptions
of hospital staff of the patient safety culture have also been found to be associated with
empowerment (e.g., being able to practice nursing optimally) and characteristics of Magnet
hospitals.113 Additionally, more errors were found in organizations and units with poor safety
cultures. In fact, some researchers found that the safety climate predicted the occurrence of
medication errors, that the level of safety was associated with the unit-specific and hospital-wide
climates, and that a positive safety climate in a unit could compensate for the detrimental effects
of a low hospital-wide climate.218
Developing and transitioning to a culture of safety requires strong, committed leadership by
executives, hospital boards, and staff.5 According to the IOM, the essential elements of an
effective safety culture include the commitment of leadership to safety and empowering and
engaging all employees in ongoing vigilance through communication, nonhierarchical
decisionmaking, constrained improvisation, training, and rewards and incentives.1 The
Association of Operating Room Nurses issued guidance about creating such a patient safety
culture, emphasizing the necessity of the following components: (1) a reporting culture, (2) a
flexible culture, (3) a learning culture, (4) a wary culture, and (5) a just culture.219
Yet, it should be understood that changing the culture within an organization is difficult and
can happen only over time.2, 5 Throughout time, nurses have frequently been treated differently if
they were involved in an error/adverse event, being at the sharp end of blame because they can
stand between errors.220, 221 Thus, for nurses to not be at the sharp end of blame, it is important
for organizational leaders and managers to establish a just culture that values reporting, where
errors can be reported without fear of retribution;222-224 where staff can trust leaders to make a
distinction between blameless and blameworthy; and where the organization seeks to ferret out
the root causes of that error, focusing on systems and process factors. Just as important,
organizational leaders, managers, and staff need to learn from the continuous assessment of
safety culture and make efforts to continually improve organizational performance4, 5 and
demonstrate success in safety improvements.215
If an organization’s culture is based on secrecy, defensive behaviors, professional
protectionism, and inappropriate deference to authority, the culture invites threats to patient
safety and poor-quality care.225 Several factors can impede the development of a culture of
safety, including (1) a clinician’s tendency to view errors as failures that warrant blame, (2) the
focus of nurse training on rules rather than knowledge, (3) punishing the individual rather than
improving the system,226, 227 and (4) assuming that if a patient was not injured, that no action is
required.227 Each of these factors stems from organizations and the people in them having
unrealistic expectations of clinical perfection, refusing to accept the fallibility of humans, and
discounting the benefit of effective multidisciplinary teams.1, 151
Changing an organization’s culture of safety should begin with an assessment of the current
culture, followed by an assessment of the relationship between an organization’s culture and the
health care quality228, 229 and safety within the organization. Several tools have been developed to
measure the safety culture within organizations to inform specific interventions and opportunities
for improvement. They have focused on dimensions of a patient safety climate, including
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Nurses at the “Sharp End”
leadership and management (e.g., personality and attitudes), teamwork, communication, staffing,
attitudes/perceptions about safety, responses to error, policies, and procedures. Some of these
tools could be used for individual or team assessment, or to compare organization-wide
perceptions or unit-specific perceptions.230 A recent tool that was developed can be used to
differentiate patient from staff safety and types of clinicians.218 Another of these tools
(www.ahrq.gov/qual/hospculture/#toolkit) developed for AHRQ has been used to compare safety
cultures among hospitals.
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errors and near misses, and (3) be better at diminishing patient harm if an error occurs. For these
reasons, changes to the error-producing structural factors of an organization by themselves do
not lead to expected improvements in quality.246, 247 Several organizations have reported
difficulties in improving patient safety because of the need for transparency in reporting on
performance measures, lack of standardization and functionality of information technology, and
no clear pathway identified for improvement.248 Other difficulties could be associated with the
results of the improvement initiative itself. For example, the introduction of computerized
provider order entry systems for medication therapy prevented some errors from happening (e.g.,
related to illegible handwriting), but introduced other errors that might have been avoided with
better implementation strategies.249
There are many change strategies, from single focus to multifaceted, that have centered on a
structural approach and have been used successfully to create quality and patient safety
improvements. One approach would be to implement bundles of evidence-based interventions to
simultaneously improve multiple outcomes,207 using health information technology when
possible. Other strategies have focused on the components of the change process that need to be
addressed. Caramanica and colleges250 asserted that a successful quality improvement strategy
was based on the alignment of the goals of the organization with goals for quality and patient
safety improvement, collaboration using interdisciplinary teams, applying evidence-based
practice, and monitoring and assessing excellence. Quality improvement strategies that align
with the values and beliefs of individuals and build on current processes can determine the pace
and diffusion of change.251 As discussed in chapter 44, “Quality Methods, Benchmarking, and
Measuring Performance,” many organizations have used the Plan-Do-Study-Act approach to
implement change, particularly rapid-cycle improvement. A similar strategy used the Reach-
Effectiveness-Adoption-Implementation-Maintenance framework to translate research into
practice.252 The Department of Veterans Affairs has approached patient safety improvement by
targeting key strategies, including leaders creating an environment of acceptance, establishing
clear goals, creating a fair system that does not focus on blame, creating a transparent system for
decisionmaking, facilitating root-cause analysis, requiring leadership and management to be
visibly involved, and evaluating performance.253, 254 While organizations’ characteristics differ,
as do characteristics of leaders and managers, success can be realized through continuous
improvement with careful attention to finding a balance that avoids so much change that change
fatigue results.255
The IOM asserted that improvements must target organizational factors by using information
technologies, developing effective teams, standardizing procedures with evidence, and using data
and information to monitor performance.7 Focusing on the role, the influence, and the
complexity of health care systems by thinking about the “big picture” involves understanding
how a specific issue or outcome of concern interacts with numerous factors, both within and
external to the system. In doing so, it may be more feasible to solve recurring problems with
ineffective processes and poor outcomes, even when previous attempts have failed.256 In the case
of medication safety, efforts to significantly reduce medication administration errors must also
consider errors associated with prescribing, transcribing, and dispensing errors, as well as errors
associated with health information technologies, product labeling,257 therapeutic consistency
across care settings (e.g., medication reconciliation), and miscommunication of drug allergies.
For health care systems and organizations to improve safety and quality, they need to learn to
improve existing knowledge and processes, understand what is and is not working well, and both
adopt and discover better ways to improve patient outcomes.258
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Nurses at the “Sharp End”
Practice Implications
To bring the effects of the sharp end away from nurses and put them squarely on the
shoulders of health care organizations and systems, there needs to be significant changes in how
health care is structured and how it is delivered to patients. While the roles and responsibilities of
nurses have changed over the years, including “risk management, quality assurance, case
management, clinical trials coordinator, and patient care manager among numerous others,”271
the diversity of skills, roles, and training272 places nurses in critical positions to lessen the
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incidence of variation by collecting and assessing data, working with interdisciplinary teams,
examining performance, and driving evidence-based practice.
From the literature reviewed in this chapter, there are key strategies that can be used to effect
change, and subsequently, the quality and safety of care will be improved. The major factor in
creating improvement is understanding and accounting for the complexity of health care
organizations, health care systems, care processes, and patient needs. To begin, senior nurse
leaders need to work with staff to identify and prioritize areas and establish goals to address the
issues that are associated with poor-quality and unsafe care. Executive leadership and managers
need to be committed to investing both their time and resources to improving the safety and
quality of care. As organizations begin plans and reassess the need for changes, nurses will need
to be proactive in redesigning care models and redefining the work of nurses,273 whether the
initiatives will initially impact only a single unit or group of clinicians, or are aimed at being
systemwide. Furthermore, efforts to improve quality and safety must have involvement and
commitment from all stakeholders.
The foundation of quality and safety improvement initiatives needs to be centered on systems
factors, not individuals. Nurse leaders, colleagues, and State boards of nursing registration
should understand the significant impact of systems factors in any instance when individual
culpability is sought, particularly when appraising and disciplinary action is unfortunately taken
against an individual clinician (e.g., State boards of licensure and malpractice cases). The
responsibility of nurse leaders and State boards of nursing is to determine when errors and
adverse events result from deliberate malfeasance as opposed to a mixture of systems factors.
Without considering the nature and effect of systems factors, action taken against an individual
would not appear to be evidence-based and latent factors will continue, waiting to “ensnare”
another nurse.
To improve patient safety and the quality of care, it is important to determine the best
strategy and be willing to alter the strategy if necessary to create change. Not all strategies that
have been successful in other organizations will be successful in your organization; some
interventions have too small a sample size or information about them to be considered as a
possible strategy in your organization. As an initiative is implemented, it could be that what was
thought to have been generalizable needs to be tailored to the unique characteristics of your
organization. Change initiatives should be either evidence based or based on data and
information internal to your organization (e.g., incident reports), and should address measures to
evaluate improvements in patient safety and quality.199, 274 Throughout the process of
implementing changes, it is important for data and information to be continually monitored and
assessed to track performance. It is only through strategic decisions and interventions that the
sharp end held against nursing will transition to the organizations in which nurses work.
Research Implications
The nurse’s role in and ability to change patient safety and quality improvement within
health care systems is a relatively new field of research, but consideration must be given to more
than 60 years of nursing research that has implications for both safety and quality processes and
nursing, patient, and organizational outcomes. Future research will need to better define the
theoretical foundations behind the relationships between organizational systems factors, clinical
processes, and patient safety and quality outcomes. It is also important for future research to
focus on improving and widening the assessment of the impact of patient safety and quality
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Nurses at the “Sharp End”
improvements on the incidence of the broad array of errors that can and do occur in nurses’ work
environments. For example, leaders and clinicians need to understand the association between an
organization’s culture of safety and patient outcomes as well as how nurses can influence
executives to lead working environment improvements. In addition, and probably more
important, future research needs to address how research and evidence can be translated into and
become the new standard of practice, avoiding the lengthy process now involved, which could
take as long as 10 to 17 years.275
Conclusion
Everything about health care is complex. There are complex care processes, complex health
care technologies, complex patient needs and responses to therapeutic interventions, and
complex organizations. There are tremendous opportunities and challenges in improving the
quality and safety of health care, but the majority require purposeful redesign of health care
organizations and processes. Organizations that are committed to high-quality and safe care will
not place nurses at the “sharp end” of care, but will focus on system improvements. Recognizing
the complexity of care and how several factors combine at a specific time and result in errors and
adverse events, organizations, leaders, and clinicians will dedicate themselves to using data and
evidence and to continuously improve the quality and safety of care, even when there are
complex challenges.
Author Affiliation
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
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Health Prof 2006;29(1):126-53. Health Care 2003;12:405-10.
203. Mendelson D, Carino TV. Evidence-based medicine in 216. Sorra J, Famolaro T, Dyer N, et al. Hospital survey on
the United States—de rigueur or dream differed? patient safety culture 2008 comparative database
Health Aff 2005;24(1):133-136. report. (Prepared by Westat, Rockville, MD, under
contract No. 233-02-0087, Task Order 18). Rockville,
204. Davis DA, Taylor-Vaisey A. Translating guidelines MD: Agency for Healthcare Research and Quality;
into practice: a systematic review of theoretic March 2008. AHRQ Publication No. 08-0039.
concepts, practical experience and research evidence
in the adoption of clinical practice guidelines. CMAJ 217. Weingart SN, Farbstein K, Davis RB, et al. Using a
1997;157(4):408-16. multihospital survey to examine the safety culture. Jt
Comm J Qual Patient Saf 2004;30(3):125-32.
205. Livesey EA, Noon JM. Implementing guidelines: what
works. Arch Dis Child 2007;92:ep129-34. 218. Zohar D, Livne Y, Tenne-Gazit O, et al. Healthcare
climate: a framework for measuring and improving
206. Grol R, Grimshaw J. From best evidence to best patient safety. Crit Care Med 2007;35(5):1312-7.
practice: effective implementation of change in
patients’ care. Lancet 2003;362:1225-30. 219. AORN. AORN Postion Statement: Creating a patient
safety culture. 2006. Available at: www.aorn.org/
207. Litch B. How the use of bundles improves reliability, PracticeResources/AORNPositionStatements/Position
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220. Coles J, Pryce D, Shaw C. The reporting of adverse 233. Longo DR, Hewett JE, Schubert S. Rural hospital
clinical incidents—achieving high quality reporting: patient safety systems implementation in two states. J
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University of Birmingham; 2001. 234. Morrissey J. Patient safety proves elusive. Five years
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UK; University of Birmingham; 2001.
235. Beauregard K. Patient safety, elephants, chickens, and
222. Jones B. Nurses and the code of silence, in Rosenthal mosquitoes. Plast Surg Nurs 2006;26(3):123-5;quiz
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237. Scalise D. 5 years after IOM …the evolving state of
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Human”: what have we learned? JAMA 246. Blumenthal D, Kilo CM. A report card on continuous
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Making health care safer: a critical analysis of patient in U.S. hospitals. Health Aff 2003;22(2):154-66.
safety practices. Evidence Report Technology
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30
Chapter 3. An Overview of To Err is Human:
Re-emphasizing the Message of Patient Safety
Molla Sloane Donaldson
Introduction
On November 29, 1999, the Institute of Medicine (IOM) released a report called To Err is
Human: Building a Safer Health System.1 The IOM released the report before the intended date
because it had been leaked, and one of the major news networks was planning to run a story on
the evening news.2 Media throughout the country recognized this opportunity for a headline story
describing a very large number of hospital deaths from medical errors —possibly as great as
98,000 per year. The problem in other care settings was unknown, but suspected to be great.
The search was on to find out who was to blame and how to fix the problem. Congressional
hearings were subsequently held. Governmental agencies, professional groups, accrediting
organizations, insurers, and others quickly responded with plans to define events and develop
reporting systems. Health care organizations were put on the defensive. Recognizing that
individual accountability is necessary for the small proportion of health professionals whose
behavior is unacceptable, reckless, or criminal, the public held organizational leadership, boards,
and staff accountable for unsafe conditions. Yet imposing reporting requirements and holding
people or organizations accountable do not, by themselves, make systems safer.
What was often lost in the media attention to hospital deaths from medical errors cited by To
Err is Human was the original intent of the IOM Committee on Quality Health Care in America,
which developed the report. That committee believed it could not address the overall quality of
care without first addressing a key, but almost unrecognized component of quality; which was
patient safety. The committee’s approach was to emphasize that “error” that resulted in patient
harm was not a property of health care professionals’ competence, good intentions, or hard work.
Rather, the safety of care—defined as “freedom from accidental injury”3 (p. 16)—is a property of
a system of care, whether a hospital, primary care clinic, nursing home, retail pharmacy, or home
care, in which specific attention is given to ensuring that well-designed processes of care
prevent, recognize, and quickly recover from errors so that patients are not harmed.
This chapter focuses on the principles described in the IOM report, many of which can be
mapped to what are now called safe practices4 and all of which are valuable guides. This chapter
is not intended to address the growing body of evidence; rather, the chapter summarizes the
starting point—the IOM recommendations based on the literature and the knowledge of the
committee members who developed the report.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
actions to prevent error) has the greatest potential effect, just as in preventive public health
efforts.
The IOM committee recognized that simply calling on individuals to improve safety would
be as misguided as blaming individuals for specific errors. Health care professionals have
customarily viewed errors as a sign of an individual’s incompetence or recklessness. As a result,
rather than learning from such events and using information to improve safety and prevent new
events, health care professionals have had difficulty admitting or even discussing adverse events
or “near misses,” often because they fear professional censure, administrative blame, lawsuits, or
personal feelings of shame. Acknowledging this, the report put forth a four-part plan that applies
to all who are, or will be, at the front lines of patient care; clinical administrators; regulating,
accrediting, and licensing groups; boards of directors; industry; and government agencies. It also
suggested actions that patients and their families could take to improve safety.
The committee understood that need to develop a new field of health care research, a new
taxonomy of error, and new tools for addressing problems. It also understood that responsibility
for taking action could not be borne by any single group or individual and had to be addressed by
health care organizations and groups that influence regulation, payment, legal liability, education
and training, as well as patients and their families. The report called on Congress to create a
National Center for Patient Safety within the Agency for Healthcare Research and Quality, to
develop new tools and patient care systems that make it easier to do things right and harder to do
things wrong. This handbook is a direct result of the implementation of those recommendations.
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Overview of To Err is Human
done more slowly and sequentially, are perceived as more difficult, and require conscious
attention. Examples include making a differential diagnosis and readying several types of
surgical equipment made by different manufacturers. Errors here are due to misinterpretation of
the problem that must be solved and lack of knowledge. Keeping in mind these two different
kinds of tasks is helpful to understanding the multiple reasons for errors and is the first step in
preventing them.
People make errors for a variety of reasons that have little to do with lack of good intention
or knowledge. Humans have many intellectual strengths (e.g., large memory capacity and an
ability to react creatively and effectively to the unexpected) and limitations (e.g., difficulty
attending carefully to several things at once and generally poor computational ability, especially
when tired).12 Improving safety requires respecting human abilities by designing processes that
recognize human strengths and weaknesses.
There are many opportunities for individuals to prevent error. Some actions are clinically
oriented and evidence-based: communicating clearly to other team members, even when
hierarchies and authority gradients seem to discourage it; requesting and giving feedback for all
verbal orders; and being alert to “accidents waiting to happen.” Other opportunities are broader
in focus or address the work environment and may require clinical leadership and changing the
workplace culture: simplifying processes to reduce handoffs and standardizing protocols;
developing and participating in multidisciplinary team training; involving patients in their care;
and being receptive to discussions about errors and near misses by paying respectful attention
when any member of the staff challenges the safety of a plan or a process of care.
However, large, complex problems require thoughtful, multifaceted responses by individuals,
teams, and organizations. That is, preventing errors and improving safety require a systems
approach to the design of processes, tasks, training, and conditions of work in order to modify
the conditions that contribute to errors. Fortunately, there is no need to start from scratch. The
IOM report included some guidance based on what was known at the time, and other specific
evidence has accumulated since then that can be put in practice today. Designing for safety
requires a commitment to safety, a thorough knowledge of the technical processes of care, an
understanding of likely sources of error, and effective ways to reduce errors.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
departments where there is little time to react to unexpected events—and consequences can be very
serious. Although most early studies focused on the hospital setting, medical errors present a
problem in all settings, including outpatient surgical centers, physician offices and clinics, nursing
homes, and the home, especially when patients and families are asked to use increasingly
complicated equipment.
Patients should not be harmed by the health care system that is supposed to help them, but the
solution does not lie in assigning blame or urging health professionals to be more careful. In what
seems to be a simple example, an ICU nurse was wheeling a patient on a gurney to radiology when
his knee struck a fire extinguisher hanging on the wall, resulting in the patient needing extra care.
In response, the nurse may have been scolded by her supervisor and told to be more careful, or
punished in some other way; everyone would feel the problem had been solved. Yet, would that
make the hospital safer? Would it prevent other events that are similar but slightly different in
circumstances from happening with other staff and patients in other units? The answer is an
emphatic no.
Improving safety, arises from attention to the often multiple latent factors that contribute to
errors and in some cases, to injury. In the above example, such factors included: 1) the nurse
having to move the patient herself because transport had never arrived; 2) a change in hospital
policy, so that only one instead of two people guide gurneys; 3) the failure to mount the fire
extinguisher in a recessed niche; 4) the decision to transport a seriously ill patient rather than
having mobile equipment come to him, requiring extra “handoffs” and opportunities for injury; and
5) poor gurney design, making steering difficult, and possibly still other factors.
4
Overview of To Err is Human
♦ Part 3: Role of Consumers, Professionals, and Accreditation Groups – The IOM believed
that fundamental change would require pressure and incentives from many directions,
including public and private purchasers of health care insurance, regulators (including the
Food and Drug Administration), and licensing and certifying groups. A direct result was the
announcement of new standards on safety from the Joint Commission and a report, Safe
Practices for Better Health Care. A Consensus Report, by the National Quality Forum.10
♦ Part 4: Building a Culture of Safety – The IOM urged health care organizations to create
an environment in which safety becomes a top priority. This report stressed the need for
leadership by executives and clinicians and for accountability for patient safety by boards of
trustees. In particular, it urged that safety principles known in other industries be adopted,
such as designing jobs and working conditions for safety; standardizing and simplifying
equipment, supplies and processes; and avoiding reliance on memory. The report stressed
medication safety in part because medication errors are so frequent11 and in part because a
number of evidenced-based practices were already known and needed wider adoption.
Though at the time of publication, the levels of evidence for each category varied, the
members of the committee believed that all were important places to begin to improve safety.
The committee recognized that some actions could be taken at the national level as described
in the recommendations contained in Parts 1–3. Yet if patient safety were really to improve, the
committee knew it would take far more than reporting requirements and regulations. Creating
and sustaining a culture of safety (Part 4) is needed, which would require continuing local action
by thousands of health care organizations and the individuals working in these settings at all
levels of authority. Hospital leadership must provide resources and time to improve safety and
foster an organizational culture that encourages recognition and learning from errors. A culture
of safety cannot develop without trust, keen observation, and extensive knowledge of care
processes at all levels, from those on the front lines of health care to those in leadership and
management positions.
1. User-Centered Design
Understanding how to reduce errors depends on framing likely sources of error and pairing
them with effective ways to reduce them. The term “user-centered design” builds on human
strengths and avoids human weaknesses in processes and technologies.12 The first strategy of
user-centered design is to make things visible⎯including the conceptual model of the
process⎯so that the user can determine what actions are possible at any moment, for example,
how to return to an earlier step, how to change settings, and what is likely to happen if a step in a
process is skipped. Another principle is to incorporate affordances, natural mappings, and
constraints into health care. Although the terms are strange, their meaning can be surprisingly
easily applied to common everyday tasks, both in and out of the workplace.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
6
Overview of To Err is Human
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
discharged shortly after surgery and knows nothing about sterile technique or the design of the
device. Another ubiquitous example is the warnings and dosage information on medication
bottles, which many patients cannot understand how to apply.
Conclusion
Now, 7 years after the release of To Err is Human, extensive efforts have been reported in
journals, technical reports, and safety-oriented conferences. That literature described the
magnitude of problems in a variety of care settings, the efforts to make change, and the results of
those efforts in improving patient safety. Many of those studies are referenced and discussed
throughout this book. Other authors have written incisively about what progress has and has not
been made in the past 7 years and the challenges in creating cultures of safety.20, 21 The greatest
challenge we all face is to learn, use, and share better information about how to prevent harm to
patients.
8
Overview of To Err is Human
Author Affiliation
Molla Sloane Donaldson, Dr.P.H., M.S., principal, M.S.D. Healthcare; e-mail:
[email protected].
References
1. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is 12. Norman DA. The Design of Everyday Things. New
human: building a safer health system. Washington, York: Doubleday/Currency; 1988.
DC: National Academy Press, Institute of Medicine;
1999. 13. Leape LL, Kabcenell A, Berwick DM, et al. Reducing
Adverse Drug Events. Boston: Institute for Healthcare
2. News Release: Medical Errors Report for Immediate Improvement; 1998.
Release, Nov. 29, 1999, National Academy of
Sciences. “Preventing Death and Injury from Medical 14. Savitz LA, Jones CB, Bernard S. Quality indicators
Errors Requires Dramatic, System-Wide Changes.” sensitive to nurse staffing in acute care settings.
Hendriksen K, Battles JB, Marks ES, Lewin DI, eds.
3. Reason JT. Human Error. New York, NY: Cambridge Advances in Patient Safety: From Research to
University Press; 1990. Implementation. Vol. 4, Programs, Tools & Products.
AHRQ Publication No. 05-0021-4. Rockville, MD:
4. Safe Practices for Better Health Care. Fact Sheet. Agency for Healthcare Quality and Research, 2005;
AHRQ Publication No. 04-P025, March 2005. Agency p.375-85.
for Healthcare Research and Quality, Rockville, MD.
Executive Summary of the National Quality Forum’s 15. Clarke SP, Aiken LH. More nursing, few deaths. Qual
report, Safe Practices for Better Healthcare: A Saf Health Care, 2006; 15:2-3.
Consensus Report is available at
www.ahrq.gov/qual/nqfpract.htm. 16. Needleman J, Buerhaus PI, Stewart M, et al. Nurse
staffing in hospitals: is there a business case for
5. The Joint Commission on Accreditation of Healthcare quality? Health Affairs, 2006; 25(1):204-11.
Organizations. Sentinel Event.
http://www.jointcommission.org/SentinelEvents/ 17. Cook RI. Two Years Before the Mast: Learning How
[accessed October 31, 2006]. to Learn About Patient Safety. Presented at
“Enhancing Patient Safety and Reducing Errors in
6. Cook RI, Woods D, Miller C. A tale of two stories: Health Care.” Rancho Mirage, CA, November 8–10;
contrasting views of patient safety. Chicago: National 1998.
Patient Safety Foundation; 1998.
18. Garg AX, Adhikari NK, McDonald H, et al. Effects of
7. Reason J. Human error: models and management. computerized clinical decision support systems on
BMJ. 2000;320:768-70. practitioner performance and patient outcomes: a
systematic review. JAMA, 2005; 293(10):1261-3.
8. Leape LL. Error in medicine JAMA, 1994;272
(23):1851-57. 19. Koppel R, Metlay JP, Cohen A, et al. Role of
computerized physician order entry systems in
9. Haberstroh CH. “Organization, design and systems facilitating medication errors. JAMA, 2005;
analysis.” In Handbook of Organizations. J. J. March, 293(10):1223-38.
ed. Chicago: Rand McNally; 1965.
20. Leape LL, Berwick DM. Five years after To Err is
10. National Quality Forum. Executive Summary, Safe Human. What Have We Learned? JAMA 2005; 293:
Practices for Better Health Care. A Consensus Report 2384-90.
2003. http://www.ahrq.gov/qual/nqfpract.pdf.
21. Wachter RM. The end of the beginning: patient safety
11. Barker KN, Flynn EA, Pepper GI, et al. Medication five years after “To Err is Human.” Health Affairs,
errors observed in 36 health care facilities. Arch Intern 2004; 30 (Web Exculsive): W4 534-43.
Med, 2002; 162:1897-903.
9
Chapter 4. The Quality Chasm Series: Implications for
Nursing
Mary K. Wakefield
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
2
The Quality Chasm Series and Nursing
This section focuses on nursing implications associated with selected issues, concepts,
findings, and recommendations specifically embedded in 4 of the 11 reports: To Err Is Human,
Crossing the Quality Chasm, Health Professions Education: A Bridge to Quality, and Quality
Through Collaboration: The Future of Rural Health Care (often referred to as the rural report).
The identified nursing implications in these four reports give a sense of the relevance and utility
of these reports to the nursing discipline. The first two reports discussed in this chapter
established the scope of the problems associated with compromises in quality of health care and
offered a framework for addressing those problems. The third report, on health professions
education, described the critical role health professions education plays in facilitating or
impeding the delivery of consistent, high-quality health care. The nursing profession, central to
health care delivery, is a pivotal audience for this report.
The Future of Rural Health Care addresses the long-standing lack of attention brought to
rural health care quality in spite of the fact that between one-fourth and one-fifth of the
population resides in rural America. This report sheds light on the unique features of rural health
care and tailored approaches to addressing quality shortcomings. Particularly relevant to nurses,
however, is that The Future of Rural Health Care introduced innovative approaches that move
beyond health care and focus on the quality of the health of populations. Whether viewed from a
rural or urban context, the latter orientation is an important focus for nurses to consider in their
future work and research.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
were reviewed and established the evidence base for the IOM’s Committee on Quality of Health
Care in America determination that error is a cause of very significant and widespread injury and
mortality. Many of the research studies focused on activities that incorporated nursing functions
such as medication processes. Additionally, a number of the reviewed studies helped to
illuminate the predeterminants of error.
Due to the dearth of evidence to serve as the basis for some of the conclusions and
recommendations in this report, the IOM acknowledged that current understanding of the
epidemiology of errors was fragmented. Calls for research efforts were evident throughout the
report. “Research and analysis are not luxuries in the operation of safety systems. They are
essential steps in the effective redesign of systems”2 (p. 181). Clearly there is opportunity for
nurse researchers, along with others, to make significant and important contributions to address
this knowledge deficit with needed evidence.
In addition to increasing awareness of the scope and significance of medical errors, a set of
strategies and recommendations were advanced to encourage patient safety and quality
improvement. Major emphasis is placed on (1) the essential role of leadership in addressing
errors, (2) the need for and structure of error reporting systems, (3) the development of
performance standards, and (4) recommendations regarding elements key to safety design in
health care systems. The committee producing the report devoted considerable attention to
making the case that perfection based on human performance—while a long-standing
expectation of the work of nurses, physicians, and others—is both faulty and dangerous. In
reorienting expectations from a focus on individuals to a focus on systems, the report clearly and
firmly stated that to eliminate the source of a vast majority of errors and near misses, health care
systems must be designed to make it very hard for nurses and others to make errors. This
orientation runs directly counter to long-held views by both the public and health care providers
themselves: that mistakes are solely the result of individual provider actions and that blame
should be assigned accordingly. The report refocused attention on the need to construct systems
that make it easy for nurses and others to engage in safe practices and difficult to execute actions
that are unsafe.
4
The Quality Chasm Series and Nursing
of accrediting bodies, such as the Joint Commission (formerly known as the Joint Commission
on Accreditation of Healthcare Organizations [JCAHO]). The Joint Commission National Patient
Safety Goals (NPSGs) are very prescriptive and explicit in their impact on aspects of nursing
practice. For example, the Joint Commission’s safety goals include standardizing handoff
communications, including an opportunity to ask and respond to questions, and a goal to
encourage the active involvement of patients and their families in the patient’s care as a patient
safety strategy14 (e.g., patient- and family-centered care).
External drivers also include steps being taken by the Centers for Medicare and Medicaid
Services to link reporting performance on quality indicators with payment. These payment
changes reward hospitals that publicly report their performance on a predetermined set of quality
indicators, many of which are directly or indirectly influenced by nursing actions. Private sector
entities such as insurance companies are moving in similar directions. The intense interest in
aligning payment with performance (i.e., health sector income and patient outcome) has
significant implications for nursing. Put simply, maintaining and strengthening the financial
health of hospitals and other segments of the health care delivery system is linked in no small
part to the practice of nursing in these facilities. Consequently, alignment of reimbursement with
quality is redirecting the attention of health care administrators. To the extent that research
continues to link nursing practices, staffing, and other characteristics (e.g., educational
background and number of hours worked) to the quality of patient care, nursing will be
positioned to receive considerably more attention from health care system leadership.
Recognizing that more could be done to improve patient outcomes the report called for the
incorporation of patient safety considerations into clinical practice guidelines, as well as the
development of guidelines specifically focused on patient safety. Particular attention is paid to
the need for engaging interdisciplinary approaches to guideline development. Nurses’ expertise
and functions clearly overlap with a number of other disciplines in particular content areas (e.g.,
mental health care and critical care). This overlap makes this recommendation difficult to pursue,
but appropriate to nursing as well as other disciplines. Nursing education, as well as State and
national nursing organizations, can expand efforts to engage interdisciplinary partners in
developing shared academic curricula and conference and meeting content. Additionally, nurse
clinicians, researchers, and others should further the development of safety aspects of clinical
guidelines development in concert with representatives of other health care disciplines.
Another report recommendation called for professional organizations to firmly commit to an
agenda focused on patient safety, with specific efforts targeted toward health professions
education. Efforts can emerge through curriculum development, the inclusion of safety content
on conference agendas, and ongoing in-service education. Various nursing organizations have
responded to aspects of this recommendation. However, in light of many competing priorities,
expanding and sustaining this focus over time and across multiple venues will challenge nurses
and the nursing profession.
The final external driver addressed in the report addressed whether or not the public is
engaged in safety improvement efforts. Professional organizations, particularly those that
represent nurses, can help to accomplish this by working with both the public and policymakers.
Some national nursing organizations already have made safety part of their public policy agenda
(e.g., the Association of Operating Room Nurses). Nevertheless, there is substantial work that
could occur to create new efforts that educate and engage the broader public in health care safety
activities. As a profession, nursing commands considerable trust from the American public. Also,
nursing places high value on the importance of educating individuals, families, and communities
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
about health and health care in order to fully engage them as partners in their health.
Consequently, nurses are particularly well positioned to engage in the challenging work of
assisting the public to understand both the complexity of patient safety and error, and the actions
they can engage in to help ensure they receive safe health care. Individual nurses can engage this
type of effort in concert with other health team members. This work can also be done through
nursing organizations and in tandem with insurers, employers, and others who recognize the
pivotal role health care consumers can play in ensuring the delivery of safe care.
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The Quality Chasm Series and Nursing
adverse events such as cardiac or respiratory arrest.15 With the help of nursing knowledge and
research, other equally important high-impact care processes will be developed over time.
• Principle 5: Creating a learning environment addresses the extremely complex work of
changing organizational and academic cultures so that error is viewed as an
opportunity to learn.
A learning environment does not seek to fix blame, but ensures that reporting systems have
well-developed approaches for communicating how identified problems will be addressed. Also
important, given the historical power gradient among nurses and physicians and others, is the
free flow of information without the inhibiting hierarchies.2 Learning environments ensure that
all staff have high comfort levels in communicating any and all safety concerns. Some of the
most complex patient safety work involves creating organizational cultures and expectations that
embrace these features. Redesigning the education of the next generation of nurses so they are
capable of maximizing their contributions in these environments is a necessary component.
Nurse leaders should play key roles in ensuring that patient safety programs inside health
care organizations are highly visible, implement nonpunitive reporting processes, and
incorporate safety principles into daily practice, all of which are called for in the
recommendations of To Err Is Human. The second report, Crossing the Quality Chasm,
describes at greater length the use of internal and external approaches to meaningfully improve
the quality of health care.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
United States.”3 (p. 39). In contemplating this statement, nurses might ask what the collective
contribution of nursing is and should be to achieving this purpose. How do we pursue this goal?
How do we know whether we and other stakeholders in the U.S. health care system are making
progress toward achieving it? The Quality Chasm report adds more specificity to this
recommendation by setting out six aims (see Table 2). To achieve the aims of the purpose
statement articulated above, the Quality Chasm report suggests that these six aims should be the
focus of nurses and other clinicians, and should be pursued in all health care settings.
Aim Description
1. Safe care Avoiding injuries to patients
2. Effective care Providing care based on scientific knowledge
3. Patient-centered care Providing respectful and responsive care that ensures that patient values
guide clinical decisions
4. Timely care Reducing waits for both recipients and providers of care
5. Efficient care Avoiding waste
6. Equitable care Ensuring that the quality of care does not vary because of characteristics
such as gender, ethnicity, socioeconomic status, or geographic location.
Illustrations of the relevance and integral nature of nursing to achieving these aims are
illustrated below.
• Aim 1—Safe Care
The Quality Chasm noted, “The health care environment should be safe for all patients, in all
of its processes, all of the time. This standard of safety implies that organizations should not have
different, lower standards of care on nights and weekends or during times of organizational
change”3 (p. 45). Recognizing the particular danger that handoffs can pose to patients, the report
notes that handoffs are frequently the first place where patient safety is compromised. Clearly,
part and parcel of the work of nurses are the transactions that occur among nurses and others as
information, components of care processes, and patients themselves are handed off to others.
Nursing work is punctuated by patient transfers from one environment to another (e.g., inter- and
intra-institutional transfers of patients), from shift to shift, or communication from one clinician
to another (e.g., information given by a nurse to different physical therapists caring for the same
patient). Moreover, because of their ongoing contact with patients and their families, nurses are
in pivotal positions to both inform and incorporate the observations and concerns of these
individuals into creating safe care environments. To do so require nurses to consider all
information conveyed to them by patients and family members and to encourage that
communication.
• Aim 2—Effective Care
The provision of effective nursing care rests on the development and use of nursing evidence,
as well as evidence produced by other disciplines with relevance to nursing practice. Effective
care is based on evidence derived from four types of research: laboratory experiments, clinical
trials, epidemiological research, and outcomes research, including case reports.3 Outcomes
research, critical to improving care quality, uses information about how well interventions work
on a large, generalizable scale. Nurse researchers engage in all four types of research, and each
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The Quality Chasm Series and Nursing
type is capable of informing aspects of care delivery and care quality. Nevertheless, there is a
paucity of research to undergird the application of many interventions, nursing and non-nursing
alike. Looking to the future, the Quality Chasm report suggests that “the knowledge base about
effective care and its use in health settings will constantly expand through improved methods of
accessing, summarizing and assessing information and making it available at the point of care for
the patient”3 (p. 48), Already, information technology systems in some health care settings
provide immediate access to clinical guidelines, step-by-step approaches to procedures, and other
information that is based on research evidence or, in its absence, expert judgment.
In addition to expecting the further development of and adherence to an evidence base, the
Quality Chasm report also highlights the importance of nurses and other clinicians systematically
and continually reviewing the outcomes of the care that they provide. Currently, care results are
rolled up and reflected in overall performance indicators for nursing homes and hospitals. With
some exceptions, there is relatively limited information that is currently collected, assessed, and
fed back to nurses to help them better understand their individual impact on care quality and
thereby assist them in improving their performance. Clearly, efforts that have resulted in the
development of nursing indicators are a step in this direction. This is one more important area in
which nurses can engage to further the quality improvement agenda.
• Aim 3—Patient-Centered Care
Aspects of patient-centered nursing care have long been incorporated in nursing education
programs. However, the meaning of the term has evolved and the extent to which it is met is
variable. Gerteis and colleagues16 put forward a set of dimensions of patient-centered care,
including respect for patients’ values, preferences, and expressed needs; coordination and
integration of care; information, communication, and education; physical comfort; emotional
support; and involvement of family and friends. Considerable nursing and other research remains
to be done to better delineate the outline of this concept and strategies for addressing it. A related
concept, population-centered care, is discussed extensively in the IOM report Quality Through
Collaboration: The Future of Rural Health. This important concept has even less evidence-based
approaches to help guide its achievement.
• Aim 4—Timely Care
Timeliness of care delivery is often compromised, almost regardless of where a consumer
comes in contact with health care. From emergency rooms to schools, nurses see first hand the
difficulties in providing timely access to care. Timeliness is compromised when patients needing
immediate medical attention find themselves in overcrowded emergency rooms, or individuals
without health insurance are delayed in accessing health care or there is a lack of available
clinicians. Delays like these are too often the norm. Many factors, both internal and external to
the care environment, impact timeliness. Internal to delivery systems, analyzing and refining the
actual design of effective processes is overlooked. Instead, the blunt instrument used to drive
timeliness is often the expectation for nurses and other clinicians to do more and, in some cases,
faster. This approach itself can, at times, compromise care quality.
Efforts to improve timeliness are multifaceted. One of the essential tools to address parts of
this challenge is technology. The expanded use of call-a-nurse lines, e-mail exchanges between
clinicians and patients, and consumer access to telemedicine applications linking rural and urban
facilities, are part of the developing technology-based toolkit needed to increase timely access to
care.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Table 3. Simple Rules for the 21st Century Health Care System
Professional autonomy drives variability Customization based on patient needs and values
10
The Quality Chasm Series and Nursing
Preference is given to professional roles over the system Cooperation among clinicians
As with the aims for improvement, implementing this entire set of rules in the redesign of
health care systems has implications for nursing practice, education, and research. While nursing
can be considered in the context of each of the current and new rules, only a few of the rules are
discussed here in order to illustrate their relevance to nursing. For example, operationalizing the
first new rule, care based on continuous healing relationships, focuses on ensuring that patients
have the care they need when they need it. Continuity and coordination should trump
fragmented, disconnected care efforts. Conceivably, this rule could directly influence where,
how, and when nursing care is available to patients. Moreover, the Internet is likely to play a
pivotal role in its application. Another example, the third rule—the patient is the source of
control—is designed to facilitate decisionmaking by patients rather than authoritarian or
paternalistic decisionmaking by health care providers. While often considered in the context of
physician-patient communication, this rule has implications for the approaches nurses bring to
patient engagement. However, in addition to individual nurse efforts to incorporate this
orientation into patient care, major system-level changes will be needed to allow patients to
exercise their preferred degree of control. Such system-level redesign, particularly as it relates to
nurse-patient interactions, will benefit from nursing input.
Regarding new rule four, shared knowledge and free flow of information, Quality Chasm
cited evidence that giving patients access to their own health and clinical information improves
care processes and health outcomes. Clearly, electronic personal health records and Web-based
information have considerable potential to enhance patient knowledge and stimulate healthy
behavior. However, there is limited information about how nurses can help patients to fully
harness these information resources. Nurses can lead efforts to make these rules actionable
across health systems, particularly as they influence the redesign of nursing practice, the nurse-
patient relationships, the relationships between nurses and other disciplines, and the relationship
of nurses to care processes. Additionally, these expectations should be incorporated into nursing
curricula to ensure that nurses are able to engage and support the refinement and application of
important features of redesigned health care systems. In the process, nurses learn not just the
changes necessary for improving quality of care, but also the skills and knowledge essential to
fully participate in the change process associated with quality improvement efforts.
Deploying these rules requires the participation of virtually all stakeholders. Nursing is
clearly a key partner in the convening of health profession associations as well as key industry
and quality organization representatives to lead this transformation, expand the research
underlying the rules, and develop an agenda to examine progress and next steps related to actions
supporting the application of this rules set. A total of 7 years has passed since the release of the
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Quality Chasm report. No doubt progress in health care redesign vis-à-vis the rules set has
occurred during this time. However, there is considerably more work to be done in each of these
areas.
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The Quality Chasm Series and Nursing
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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The Quality Chasm Series and Nursing
important to nurses and others: that is, there is a paucity of research available on the quality of
rural health care. As with urban health care, the limited rural research that does exist indicates
variability of care quality.11 This circumstance underscores the need for nurses and others with
interest and expertise in rural health to further expand knowledge in this largely ignored area.
One particular area needing nursing inquiry is the extent to which rural health care delivery
reflects activity and progress toward achieving the six aims for improvement.
A unique contribution of the Future of Rural Health report is the application of the six aims
to improve not just care quality delivered in health care organizations, as has been discussed in
earlier reports, but also to target efforts that can improve the quality of health in the general
population. Nurses in rural communities can be pivotal in helping to build a local community
focus on both the quality of health and the quality of health care. The report provides illustrative
examples of the application of each of the six aims and community level interventions to achieve
those aims. Much of the work of targeting efforts toward improving the quality of population
health will involve nurses and other leaders in rural health care settings working with community
leaders in local schools, government, and other sectors. How to effectively engage this collective
focus to advance population health should be a priority research area.
As with most of the reports in the IOM Quality Chasm series, the theme of leadership
emerged in The Future of Rural Health. In this case, particular attention is given to the need for
rural health system leaders to embrace and drive quality improvement within their organizations
as well as the need to engage larger issues of population health quality. An identified strength of
many rural communities is the familiarity that people have with each other and the various local
community sectors. Also, often typical of rural communities is the orientation and practice of
engaging across sectors to achieve community-level outcomes. This characteristic can help to
facilitate new efforts around building quality into population health.11
The Future of Rural Health report pivots from the major components of the Crossing the
Quality Chasm report and frames the issues in a rural context. For example, priority issues such
as information technology applications, quality improvement infrastructure components,
workforce considerations, and the aims for improvement are all viewed through the prism of a
rural context. In addition, The Future of Rural Health cited relevant rural examples of each of the
six aims, considering them in the context of the community as well as the context of health care
delivery. Measures of the safety aim included measuring community characteristics such as
occupational accident rates in rural areas and toxic environmental exposure/risk from pesticides.
Brief discussions focused on community-level strategies for improving safety, effectiveness in
community health improvement, and community-centered care that reflects responsiveness to the
aggregated needs, values, and other characteristics of the local community. Clearly, the
broadened application of the six aims for improvement in a rural community context offers an
area for research and reconfigured interdisciplinary efforts that include stakeholders outside of
traditional health care settings. The community-level application of the six aims, revamped to
consider unique characteristics of urban areas, also should be highly relevant to urban
communities and populations.
Too frequently, research conducted on quality and safety interventions in urban health care
settings has been directly generalized to the often very different environments, staffing mix, and
patient populations found in rural health care settings. For example, deploying rapid response
teams in rural areas needs to take into consideration the different staff mix available on site in
rural settings. Relevant research on functions common to rural health care settings is extremely
limited. For example, there is minimal nursing research on the processes involved in patient
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
stabilization and transfer. This is a set of activities common to rural hospitals but far less
frequently performed in urban hospitals. Research on patient outcomes associated with these
processes is virtually nonexistent. More efforts need to be directed toward developing and
determining relevant rural knowledge and tools, appropriate performance measures, and the
development of data feedback capabilities. To begin to fill knowledge gaps and improve health
care quality and population health, access to the science of quality improvement and acquiring
related expertise is pivotal. This includes acquiring competence in evaluating, adopting, and
adapting this new knowledge area for application in rural environments.18
In addition to identifying gaps in research knowledge and new framing of aims for
application to quality improvement in rural population health, the Future of Rural Health report
also addressed internal and external drivers of quality improvement specific to rural health
systems. For example, unlike most urban hospitals, which are reimbursed through the
prospective payment system, a large subset of rural hospitals are designated as critical access
hospitals. These hospitals receive cost-based reimbursement, and there are currently no
requirements linking Medicare payment to reporting on quality indicators, as is the case with
prospective payment system hospitals. The report states that no providers, rural or urban, should
be excluded from public reporting. However, mechanisms for linking cost-based reimbursement
to quality indicators and eventually patient outcomes need to be developed for rural health care
facilities. Additionally, determining how best to report and assign meaning to data extracted
from small numbers of patient encounters remains a challenge.
In terms of drivers internal to rural health care settings, the job design of nurse leaders
typically requires them to manage multiple roles and expectations. For example, frequently, the
nurse responsible for quality assurance and improvement in a facility carries many other
responsibilities as well. Given the limited numbers of nurses and other personnel in rural
communities, efficiently acquiring and applying quality improvement knowledge and related
skills can be particularly challenging. Conversely, because health care providers tend to be
relatively few in number, information and new care approaches are often rapidly diffused
throughout small rural facilities.
The report devoted significant attention to characteristics essential to the rural health care
workforce. Building on the Health Professions Education report, The Future of Rural Health
noted that the five identified competencies are all relevant to rural health care, but the
applications may be different. Interdisciplinary teams may consist of individuals geographically
separated, but who share involvement in the ongoing care of individuals. Electronic intensive
care units are an example. Under these circumstances, applying team concepts may have special
ramifications for nurses and others. While research findings from some of these practices
indicated markedly improved patient morbidity and mortality, there was virtually no research
base on which to guide the configuration and deployment of these types of teams.
The Future of Rural Health also advocated for educational preparation that includes rural-
relevant practice knowledge and rural clinical experience. The role of rural consumers in
acquiring quality care is also discussed, with attention given to the fact that their role in
managing their health may be operationalized differently compared to their urban counterparts
given resource availability, etc. For example, access to certain clinicians, including home health
nurses and diabetes nurse educators, may be enabled through Web and other technology
applications. Yet minimal study of the quality of these encounters has been undertaken.
Although technology offers the promise of linking sparsely populated areas to health care
services, there is a digital divide between rural and urban areas across the country. To the extent
16
The Quality Chasm Series and Nursing
that electronic connectivity is essential for care continuity, special effort needs to be made to
overcome these challenges. Public policy is and will continue to play a major role in bridging
this divide, offering nurses another area to engage in issues concerning rural access to quality
health care.
Future Directions
In summary, the Quality Chasm series of reports emphasized a number of key attributes of
the architecture needed to build a safe, consistently high-performing health care system.
Expressed throughout the reports were serious concerns about the status of contemporary health
care. Essential features of high-quality care systems—such as workforce competencies, effective
application of internal and external drivers, progress toward achieving the six identified aims for
improvement, and the application of a set of rules to systems redesign—are far from where they
should be. The Quality Chasm series called for leadership in education, practice, and research to
drive needed change. The series called for major overhaul of not just the organizations in which
health care providers work, but the education of health care providers themselves. The series
made a special effort to recognize the unique needs of specific populations, such as those in rural
communities or those with mental health problems, and recommended approaches to more
effectively deliver quality care to those populations. Based on the challenges and
recommendations set forth, it is clear that significant work remains to be done.
Specific to the nursing profession, nurse educators, clinicians, and researchers need to help
build state-of-the-art and state-of-the-science approaches for redesigning nursing care processes,
using information technology between nurses and patients and nurses and other clinicians;
acquiring, managing, and appropriately applying new knowledge and skills; preparing nurses to
function effectively in teams; and evaluating nurses’ performance in this regard. Regardless of
the settings in which nurses practice, much more effort must be devoted to care coordination for
individuals with chronic conditions, while diligently measuring both performance and outcomes.
Nurses have a substantive and essential role in helping to apply the quality framework articulated
in the IOM Quality Chasm series. And nurses clearly have a role in developing additional
approaches and new features to the quality agenda. Active engagement in patient safety and
quality improvement efforts is relevant to all nurses. Unlike the minimal progress from
Nightingale’s time until now, hopefully future nurses will be able to reflect back to the beginning
of the 21st century and determine that nursing made significant strides. They will see
improvement in both the quality of health and health care quality due to an improved role of
nurses in providing quality care.
Research Implications
Every report in the Quality Chasm series calls for specific, targeted research to further
develop the evidence base related to quality care. Research targeting quality improvement has
been supported and implemented by various stakeholders, ranging from health profession
organizations to Federal agencies to health providers themselves. Findings and implications are
being applied in a variety of ways, from changing internal drivers of quality such as work
structure (e.g., rapid response teams) to altering external drivers of quality (e.g., paying providers
for performance based on evidence-based quality indicators). While nurses have been part of
many of the research activities, significant research remains to be done.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The following is a compilation of some of the exemplar areas of research derived from the
four reports reviewed in this section. These research areas are both relevant to nursing and are
areas for which nursing’s contribution is important.
• The role of leaders in addressing errors and designing safety and quality into health care
systems is a common thread throughout the IOM Quality Chasm report series. Currently, the
work design of practice in clinical settings introduces significant potential for executing
unsafe actions. This is particularly relevant to nursing, given that much of the care delivered
in health systems is nursing care.
Research Focus: Identify how to effectively lead, design, test, and change safety structures
and processes in health systems, in addition to researching the safety of structures and processes
themselves (e.g., effective strategies for teaching and achieving consistent application of the
Situation-Background-Assessment-Recommendation [SBAR] model of communication.)
Research is needed that continues the work of determining high-risk structures, functions, and
processes in various types of health care delivery settings, focusing on ways to make unsafe
nursing activity and practices extremely difficult to carry out (e.g., identify potentially unsafe
work-arounds). Design research to test the effectiveness of simulated team approaches to care
processes that move beyond established simulations, such as responding to cardiac arrest.
• Public, standardized reporting of serious medical errors is recommended, and a number of
States have implemented error reporting systems. Recently, Federal legislation related to
reporting errors has been enacted.
Research Focus: Policy research should determine effective means for conveying public
information in ways that facilitate consumer choice of care settings and drive quality
improvement at the level of care delivery.
• Encourage health care consumers to actively participate in ensuring the delivery of safe care.
Research Focus: Determine effective strategies to inform and engage consumers in ways
that help ensure their receipt of safe, high-quality care. Nurses, working with other stakeholders
such as insurers and employers, should test messages and delivery structures designed to ensure
that consumers receive safe care; for example, develop strategies for consumers to use when (1)
querying clinicians about self-care processes, (2) making informed choices about health care
interventions, (3) designing Web-based support groups for geographically dispersed consumers
with chronic conditions.
• Using external factors such as paying for quality performance can drive quality
improvement. Examples exist of health systems that have tested the intervention of using
payment incentives to improve performance (e.g., Premier demonstration project funded by
the Centers for Medicare & Medicaid Services).
Research Focus: Successful pay-for-performance models should be replicated. To facilitate
this initiative, research that isolates nursing characteristics contributing to performance
improvement will be useful to informing dissemination and efficient adoption of these models.
• Creating learning environments is a prerequisite to systemwide delivery and improvement of
care quality.
Research Focus: Test approaches to construct and sustain organizational cultures oriented
toward safe and high-quality care. This focus includes altering power gradients in clinical
settings to ensure free flow of information and testing approaches to educating teams of health
profession students in academic settings to maximize communication, problem identification,
and systemwide corrections.
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The Quality Chasm Series and Nursing
• Even when evidence exists regarding effective approaches to care delivery, this information
is not consistently applied.
Research Focus: Research is needed to determine communication approaches and incentives
that encourage behavior change and the adoption of evidence-based approaches to nursing care.
• The Quality Chasm report series proposes a set of new rules to guide health care systems,
including rules such as the need for transparency, anticipation of patient needs, and the
patient as the source of control.
Research Focus: More research is needed to assist with effective application of each of the
new rules. For example, nurse researchers could consider how to restructure care relationships
and processes to determine how to move from a system that reacts to patient needs to one that
anticipates patient needs.
• Population-centered care is a concept central to The Future of Rural Health: In this report the
six aims for improvement discussed in many of the other IOM reports were considered in a
population rather than a health care system context. However, an evidence base needs to be
developed to better understand how to construct this concept for the purpose of improving
health and health care.
Research Focus: Significant research is needed to understand possible benefits as well as
clarify population-centered care as a means to improve population health. A key area of focus is
to determine how to effectively engage rural stakeholders—community leaders, educational
leaders, and representatives from other sectors—to achieve measurable improvements in
population health. Additionally, inquiry regarding the extent to which rural health care delivery
systems reflect progress toward achieving the six aims for improvement is very limited. For
example, minimal research exists on the process of patient stabilization and transfer from rural
hospital emergency rooms to other facilities, and yet this is a common function of many rural
facilities.
• The Future of Rural Health discusses the importance of linking facilities and providers
across geographic distances as a means to build efficient quality improvement infrastructure.
Connecting clinicians using IT to provide access to locally unavailable care has been
implemented in terms of telemental health, e-Intensive Care, and other IT-based services.
Research Focus: Patient outcomes associated with some technology-based interventions
(e.g., e-intensive care units) have been evaluated, but very little is known about how to guide the
configuration and deployment of these virtual teams, the members of which exist at geographic
distance from each other. Access to home health nurses, diabetes nurse educators, and others
may be enabled through the Web and other technology applications, but the associated costs,
patient outcomes, etc., are not yet well established through a body of research. Fairly limited
efforts have been undertaken to support these technology-based interventions through payment
methods as opposed to time-limited grant funding.
• The Health Professions Education report advances five competencies considered essential to
the ability of providers to deliver high-quality care.
Research Focus: Educational research is needed to determine how to facilitate learning and
adequately assess each of the core competencies in health profession students across disciplines
(e.g., utilize evidence-based practices).
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Author Information
Mary Wakefield, Ph.D., R.N., F.A.A.N. Associate Dean for Rural Health and Director,
Center for Rural Health; School of Medicine and Health Sciences; University of North Dakota;
Grand Forks, ND. E-mail: [email protected].
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bridge to quality. Washington, DC: National care model. Report to the Commonwealth Fund; Oct.
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9. Institute of Medicine. Patient safety: achieving a new 18. Coburn AF, Wakefield M, Casey M, et al. Assuring
standard for care. Washington, DC: National rural hospital patient safety: what should be the
Academies Press; 2003. priorities? J Rural Health, 2004 Fall;20:314-26.
20
Chapter 5. Understanding Adverse Events: A Human
Factors Framework
Kerm Henriksen, Elizabeth Dayton, Margaret A. Keyes, Pascale Carayon, Ronda
Hughes
Introduction
In addition to putting the spotlight on the staggering numbers of Americans that die each
year as a result of preventable medical error, the Institute of Medicine’s (IOM’s) seminal
report, To Err is Human: Building a Safer Health System, repeatedly underscored the
message that the majority of the factors that give rise to preventable adverse events are
systemic; that is, they are not the result of poorly performing individual nurses, physicians, or
other providers.1 Although it was not the intent of To Err is Human to treat systems thinking
and human factors principles in great detail, it cited the work of many prominent human
factors investigators and pointed out the impressive safety gains made in other high-risk
industries such as aviation, chemical processing, and nuclear power. One of the beneficial
consequences of the report is that it exposed a wide audience of health services researchers
and practitioners to systems and human factors concepts to which they might not otherwise
have been exposed. Similarly, the report brought to the attention of the human factors
community serious health care problems that it could address. Today, both health care and
human factors practitioners are venturing beyond their own traditional boundaries, working
together in teams, and are benefiting from the sharing of new perspectives and clinical
knowledge. The purpose of the present chapter is to further this collaboration between health
care and human factors, especially as it is relevant to nursing, and continue the dialog on the
interdependent system factors that underlie patient safety.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
that shape their activities may or may not be a good fit for their strengths and limitations.
When these system factors and the sensory, behavioral, and cognitive characteristics of
providers are poorly matched, substandard outcomes frequently occur with respect to effort
expended, quality of care, job satisfaction, and perhaps most important, the safety of patients.
Many nursing work processes have evolved as a result of local practice or personal
preference rather than through a systematic approach of designing a system that leads to
fewer errors and greater efficiency. Far too often, providers and administrators have fallen
into a “status quo trap,” doing things simply because they always have been done that way.
Human factors practitioners, on the other hand, take into account human strengths and
weaknesses in the design of systems, emphasizing the importance of avoiding reliance on
memory, vigilance, and followup intentions—areas where human performance is less
reliable. Key processes can be simplified and standardized, which leads to less confusion,
gains in efficiency, and fewer errors. When care processes become standardized, nurses have
more time to attend to individual patients’ specialized needs, which typically are not subject
to standardization. When medical devices and new technology are designed with the end user
in mind, ease of use and error detection or preventability are possible, in contrast to many
current “opaque” computer-controlled devices that prevent the provider from understanding
their full functionality.
The field of human factors does not focus solely on devices and technology. Although
human factors research emerged during World War II as a result of equipment displays and
controls that were not well suited to the visual and motor abilities of human operators, each
subsequent decade of human factors work has witnessed a broadening of the human
performance issues considered worthy of investigation. More recently, a number of human
factors investigators with interests in health care quality and safety advocated addressing a
more comprehensive range of sociotechnical system factors, including not only patients,
providers, the tasks performed, and teamwork, but also work environments or microsystems,
organizational and management issues, and socioeconomic factors external to the
institution.4–7 One of the lessons stemming from a systems approach is that significant
improvements in quality and safety are likely to be best achieved by attending to and
correcting the misalignments among these interdependent levels of care. Managing the
system interdependencies of care, as evidenced by continued major breakdowns such as
inadequate transitions of patient care, is a major challenge faced by providers and their
human factors partners alike.
Understanding Systems
At a very basic level, a system is simply a set of interdependent components interacting to
achieve a common specified goal. Systems are such a ubiquitous part of our lives that we
often fail to recognize that we are active participants in many systems throughout the day.
When we get up in the morning, we are dependent on our household systems (e.g., plumbing,
lighting, ventilation) to function smoothly; when we send our children off to school, we are
participants in the school system; and when we get on the highway and commute to work, we
are participants (and sometimes victims) of our transportation system. At work, we find
ourselves engaged simultaneously in several systems at different levels. We might report to
work in a somewhat self-contained setting such as the intensive care unit (ICU) or operating
room (OR)—what human factors practitioners refer to as microsystems—yet the larger
system is the hospital itself, which, in turn, is likely to be just one facility in yet a larger
health care system or network, which in itself is just one of the threads that make up the
fabric of our broader and quite diffuse national health care system. The key point is that we
need to recognize and understand the functioning of the many systems that we are part of and
2
A Human Factors Framework
how policies and actions in one part of the overall system can impact the safety, quality, and
efficiency of other parts of the system.
Systems thinking has not come naturally to health care professionals.8 Although health
care providers work together, they are trained in separate disciplines where the primary
emphasis is the mastery of the skills and knowledge to diagnose ailments and render care. In
the pursuit of becoming as knowledgeable and skillful as possible in their individual
disciplines, a challenge facing nursing, medicine, and the other care specialties is to be aware
of the reality that they are but one component of a very intricate and fragmented web of
interacting subsystems of care where no single person or entity is in charge. This is how the
authors of To Err is Human defined our health system:1
Health care is composed of a large set of interacting systems—paramedic, and
emergency, ambulatory, impatient care, and home health care; testing imaging
laboratories; pharmacies; and so forth—that are coupled in loosely connected
but intricate network of individuals, teams, procedures, regulations,
communications, equipment, and devices that function with diffused
management in a variable and uncertain environment. Physicians in
community practice may be so tenuously connected that they do not even view
themselves as part of the system of care.
A well-known expression in patient safety is that each system is perfectly designed to
achieve exactly the results that it gets. It was made popular by a highly respected physician,
Donald Berwick of the Institute of Healthcare Improvement, who understands the nature of
systems. If we reap what we sow, as the expression connotes, and given that one does not
have to be a systems engineer to understand systems, it makes sense for all providers to
understand the workings of the systems of which they are a part. It is unfortunate that today
one can receive an otherwise superb nursing or medical education and still receive very little
instruction on the nature of systems that will shape and influence every moment of a
provider's working life.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and the organization alike. The similarity among these independently derived models is quite
striking, in that they are all sociotechnical system models involving technical, environmental,
and social components.
4
A Human Factors Framework
individuals who were involved in events leading up to a mishap and those who are called
upon to investigate it after it has occurred is knowledge of the outcome. Investigators have
the luxury of hindsight in knowing how things are going to turn out; nurses, physicians, and
technicians at the sharp end do not. With knowledge of the outcome, hindsight bias is the
exaggerated extent to which individuals indicate they could have predicted the event before it
occurred. Given the advantage of a known outcome, what would have been a bewildering
array of nonconvergent events becomes assimilated into a coherent causal framework for
making sense out of what happened. If investigations of adverse events are to be fair and
yield new knowledge, greater focus and attention need to be directed at the precursory and
antecedent circumstances that existed for sharp end personnel before the mishap occurred.
The point of investigating preventable adverse health care events is primarily to make sense
of the factors that contribute to the omissions and misdirected actions when they occur.11, 12
This in no way denies the fact that well-intended providers do things that inflict harm on
patients, nor does it lessen individual accountability. Quite simply, one has to look closely at
the factors contributing to the adverse event and not just the most immediate individual
involved.
In addition to hindsight bias, investigations of accidents are also susceptible to what
social psychologists have termed the attribution error.13 Human observers or investigators
tend to make a fundamental error when they set out to determine the causal factors of
someone’s mistake. Rather than giving careful consideration to the prevailing situational and
organizational factors that are present when misfortune befalls someone else, the observer
tends to make dispositional attributions and views the mishap as evidence of some inherent
character flaw or defect in the individual. For example, a nurse who administers the wrong
medication to an emergency department (ED) patient at the end of a 10-hour shift may be
judged by peers and the public as negligent or incompetent. On the other hand, when
misfortune befalls individuals themselves, they are more likely to attribute the cause to
situational or contextual factors rather than dispositional ones. To continue with the example,
the nurse who actually administered incorrect medication in the ED may attribute the cause to
the stressful and hurried work environment, the physician’s messily scribbled prescription, or
fatigue after 10 intense hours of work.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
6
A Human Factors Framework
In brief, many adverse events result from this unique interaction or alignment of several
necessary but singly insufficient factors. Weaknesses in these factors typically are present in
the system long before the occurrence of an adverse event. All that is needed is for a
sufficient number to become aligned for a serious adverse event to occur.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The distinction made by Reason between latent conditions and active errors, shown along
the left margin of Figure 1, also is very important.11, 17 In health care, active errors are
committed by those providers (e.g., nurses, physicians, technicians) who are in the middle of
the action, responding to patient needs at the sharp end.18 Latent conditions are the potential
contributing factors that are hidden and lie dormant in the health care delivery system,
occurring upstream at the more remote tiers, far removed from the active end. These latent
conditions—more organizational, contextual, and diffuse in nature or design related—have
been dubbed the blunt end.18 The distinction between latent conditions and active errors is
important because it allows us to clearly see that nurses, who have the greatest degree of
patient contact, are actually the last line of defense against medical error (and hence the most
vulnerable). As such, nurses can inherit the less recognized sins of omission and commission
of everyone else who has played a role in the design of the health care delivery system.
Reason perhaps makes this point best:10
Rather than being the main instigators of an accident, operators tend to be
inheritors of system defects created by poor design, incorrect installation,
faulty maintenance and bad management decisions. Their part is usually that
of adding a final garnish to a lethal brew whose ingredients have already been
long in the cooking.
The human factors framework outlined here allows us to examine a wide range of latent
conditions that are part of the health care sociotechnical system in which providers reside.
Individual Characteristics
Figure 1 identifies individual characteristics as a first-tier factor that has a direct impact
on provider performance and whether that performance is likely to be considered acceptable
or substandard. Individual characteristics include all the qualities that individuals bring with
them to the job—things such as knowledge, skill level, experience, intelligence, sensory
capabilities, training and education, and even organismic and attitudinal states such as
alertness, fatigue, and motivation, just to mention a few. The knowledge and skills that health
8
A Human Factors Framework
Human-System Interfaces
The human-system interface refers to the manner in which two subsystems— typically
human and equipment—interact or communicate within the boundaries of the system. This is
shown as a third-tier factor in Figure 1. Nurses use medical devices and equipment
extensively and thus have plentiful first-hand experience with the poor fit that frequently
exists between the design of the devices' controls and displays and the capabilities and
knowledge of users. One approach for investigating the mismatches between devices and
people is to recognize there is an expanding progression of interfaces in health care settings,
each with their own vulnerabilities and opportunities for confusion.26, 27 Starting at the very
center with the patient, a patient-device interface needs to be recognized. Does the device or
accessory attachment need to be fitted or adapted to the patient? What physical, cognitive,
and affective characteristics of the patient need to be taken into account in the design and use
of the device? What sort of understanding does the patient need to have of device operation
and monitoring? With the increasing migration of sophisticated devices into the home as a
result of strong economic pressures to move patients out of hospitals as soon as possible, safe
home care device use becomes a serious challenge, especially with elderly patients with
comorbidities who may be leaving the hospital sicker as a result of shorter stays, and where
the suitability of the home environment may be called into question (e.g., home caregivers
are also likely to be aged, and the immediate home environment layout may not be conducive
to device use). In brief, the role of the patient in relation to the device and its immediate
environment necessitates careful examination. At the same time, the migration of devices into
the home nicely illustrates the convergence of several system factors—health care economics,
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
shifting demographics, acute and chronic needs of patients, competency of home caregivers,
supportiveness of home environments for device use—that in their collective interactivity and
complexity can bring about threats to patient safety and quality of care.
Providers of care are subject to a similar set of device use issues. Human factors
practitioners who focus on the provider (user)–device interface are concerned about the
provider's ability to operate, maintain, and understand the overall functionality of the device,
as well as its connections and functionality in relation to other system components. In
addition to controls and displays that need to be designed with human motor and sensory
capabilities in mind, the device needs to be designed in a way that enables the nurse or
physician to quickly determine the state of the device. Increasing miniaturization of
computer-controlled devices has increased their quality but can leave providers with a limited
understanding of the full functionality of the device. With a poor understanding of device
functionality, providers are at a further loss when the device malfunctions and when swift
decisive action may be critical for patient care. The design challenge is in creating provider-
device interfaces that facilitate the formation of appropriate mental models of device
functioning and that encourage meaningful dialogue and sharing of tasks between user and
device. Providers also have a role in voicing their concerns regarding poorly designed devices
to their managers, purchasing officers, and to manufacturers.
The next interface level in our progression of interfaces is the microsystem-device
interface. At the microsystem level (i.e., contained organizational units such as EDs and
ICUs), it is recognized that medical equipment and devices frequently do not exist in stand-
alone form but are tied into and coupled with other components and accessories that
collectively are intended to function as a seamless, integrated system. Providers, on the other
hand, are quick to remind us that this is frequently not the case, given the amount of time they
spend looking for appropriate cables, lines, connectors, and other accessories. In many ORs
and ICUs, there is an eclectic mix of monitoring systems from different vendors that interface
with various devices that increases the cognitive workload placed on provider personnel.
Another microsystem interface problem, as evidenced by several alerts from health safety
organizations, are medical gas mix-ups, where nitrogen and carbon dioxide have been
mistakenly connected to the oxygen supply system. Gas system safeguards using
incompatible connectors have been overridden with adapters and other retrofitted
connections. The lesson for providers here is to be mindful that the very need for an adaptor
is a warning signal that a connection is being sought that may not be intended by the device
manufacturer and that may be incorrect and harmful.28
Yet other device-related concerns are sociotechnical in nature, and hence we refer to a
sociotechnical-device interface. How well are the technical requirements for operating and
maintaining the device supported by the physical and socio-organizational environment of the
user? Are the facilities and workspaces where the device is used adequate? Are quality
assurance procedures in place that ensure proper operation and maintenance of the device?
What sort of training do providers receive in device operation before using the device with
patients? Are chief operating officers and nurse managers committed to safe device use as an
integral component of patient safety? As health information technology (HIT) plays an
increasing role in efforts to improve patient safety and quality of care, greater scrutiny needs
to be directed at discerning the optimal and less-than-optimal conditions in the sociotechnical
environment for the intelligent and proper use of these devices and technologies.
10
A Human Factors Framework
number of years. More recently, the health care profession has begun to appreciate the
relationship between the physical environment (e.g., design of jobs, equipment, and physical
layout) and employee performance (e.g., efficiency, reduction of error, and job satisfaction).
The third tier in Figure 1 also emphasizes the importance of the physical environment in
health care delivery.
There is a growing evidence base from health care architecture, interior design, and
environmental and human factors engineering that supports the assertion that safety and
quality of care can be designed into the physical construction of facilities. An extensive
review by Ulrich and colleagues29 found more than 600 studies that demonstrated the impact
of the design of the physical environment of hospitals on safety and quality outcomes for
patients and staff. A diverse range of design improvements include better use of space for
improved patient vigilance and reduced steps to the point of patient care; mistake proofing
and forcing functions that preclude the initiation of potentially harmful actions;
standardization of facility systems, equipment, and patient rooms; in-room placement of sinks
for hand hygiene; single-bed rooms for reducing infections; better ventilation systems for
pathogen control; improved patient handling, transport, and prevention of falls; HIT for quick
and reliable access to patient information and enhanced medication safety; appropriate and
adjustable lighting; noise reduction for lowering stress; simulation suites with sophisticated
mannequins that enable performance mastery of critical skills; improved signage; use of
affordances and natural mapping; and greater accommodation and sensitivity to the needs of
families and visitors. Reiling and colleagues30 described the design and building of a new
community hospital that illustrates the deployment of patient safety-driven design principles.
A basic premise of sound design is that it starts with a thorough understanding of user
requirements. A focus on the behavioral and performance requirements of a building's
occupants has generally been accepted in architecture since the early 1970s.31–33 Architects
have devised methods—not dissimilar to function and task analysis techniques developed by
human factors practitioners—that inventory all the activities that are performed by a
building's occupants as well as visitors. Table 2 lists just a small sample of questions that
need to be asked.34, 35
• What are the relationships and exchanges between building dwellers and visitors?
• How many people will be moving about within the facility, for what purpose, and how frequently?
• What are the demographics (e.g., age, gender) and special characteristics of building users?
• What user groups require special equipment, fixtures, furnishings, placement, signage, safety
features, and security components?
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• What are the recommended circulation patterns for facilitating information, equipment, and supply
flow between spaces?
• What are the design provisions for advances in health information technology?
• What space adjacency requirements exist?
• What provisions with respect to user groups need to be made for temperature, humidity, ventilation,
illumination, noise, distraction, hazards, and climatic conditions?
Given the vast amounts of time spent on hospital units and the number of repetitive tasks
performed, nurses as an occupational group are especially sensitive to building and
workplace layout features that have a direct bearing on the quality and safety of care
provided. When designing workplaces in clinical settings, human capabilities and limitations
need to be considered with respect to distances traveled, standing and seated positions, work
surfaces, the lifting of patients, visual requirements for patient monitoring, and spaces for
provider communication and coordination activities. Traveling unnecessary distances to
retrieve needed supplies or information is a waste of valuable time. Repetitious motor activity
facilitates fatigue. Information needed by several people can be made easily accessible
electronically, communication and coordination among providers can be maximized by
suitable spatial arrangements, and clear lines of sight where needed can be designed for
monitoring tasks.
At the time of this chapter’s writing, the U.S. hospital industry is in the midst of a major
building boom for the next decade, with an estimated $200 billion earmarked for new
construction. Nursing has an opportunity to play a key role in serving on design teams that
seek to gain a better understanding of the tasks performed by provider personnel. By
employing the accumulating evidence base, hospitals can be designed to be more effective,
safe, efficient, and patient-centered. Or they can be designed in a way that repeats the
mistakes of the past. Either way, the physical attributes that hospitals take will impact the
quality and safety of health care delivery for years to come.
Organizational/Social Environment
As shown in the third tier of Figure 1, the organizational/social environment represents
another set of latent conditions that can lie dormant for some time; yet when combined with
other pathogens (to use Reason's metaphor10), can thwart the system's defenses and lead to
error. Adverse events that have been influenced by organizational and social factors have
been poorly understood due, in large part, to their delayed and dormant consequences. These
are the omnipresent, but difficult to quantify factors—organizational climate, group norms,
morale, authority gradients, local practices—that often go unrecognized by individuals
because they are so deeply immersed in them. However, over time these factors are sure to
have their impact.
In her analysis of the Challenger disaster, Vaughn36 discovered a pattern of small,
incremental erosions to safety and quality that over time became the norm. She referred to
this organizational/social phenomenon as normalization of deviance. Disconfirming
information (i.e., information that the launch mission was not going as well as it should) was
minimized and brought into the realm of acceptable risk. This served to reduce any doubt or
uneasy feelings about the status of the mission and preserved the original belief that their
systems were essentially safe. A similar normalization of deviance seems to have happened in
health care with the benign acceptance of shortages and adverse working conditions for
nurses. If a hospital can get by with fewer and fewer nurses and other needed resources
without the occurrence of serious adverse consequences, these unfavorable conditions may
12
A Human Factors Framework
continue to get stretched, creating thinner margins of safety, until a major adverse event
occurs.
Another form of organizational fallibility is the good provider fallacy.37, 38 Nurses as a
group have well-deserved professional reputations as a result of their superb work ethic,
commitment, and compassion. Many, no doubt, take pride in their individual competence,
resourcefulness, and ability to solve problems on the run during the daily processes of care.
Yet, as fine as these qualities are, there is a downside to them. In a study of hospital work
process failures (e.g., missing supplies, malfunctioning equipment, incomplete/inaccurate
information, unavailable personnel), Tucker and Edmondson39 found that the failures elicited
work-arounds and quick fixes by nurses 93 percent of the time, and reports of the failure to
someone who might be able to do something about it 7 percent of the time. While this
strategy for problem-solving satisfies the immediate patient care need, from a systems
perspective it is sheer folly to focus only on the first-order problem and do nothing about the
second-order problem—the contributing factors that create the first-order problem. By
focusing only on first-order fixes or work-arounds and not the contributing factors, the
problems simply reoccur on subsequent shifts as nurses repeat the cycle of trying to keep up
with the crisis of the day. To change this shortsightedness, it is time for nurse managers and
those who shape organizational climate to value some new qualities. Rather than simply
valuing nurses who take the initiative, who roll with the punches while attempting quick
fixes, and who otherwise “stay in their place,” it is time to value nurses who ask penetrating
questions, who present evidence contrary to the view that things are alright, and who step out
of a traditionally compliant role and help solve the problem-behind-the-problem. Given the
vast clinical expertise and know-how of nurses, it is a great loss when organizational and
social norms in the clinical work setting create a culture of low expectations and inhibit those
who can so clearly help the organization learn to deliver safer, higher quality, and more
patient-centered care.
Management
Conditions of poor planning, indecision, or omission, associated with managers and those
in decisionmaking positions, are termed latent because they occur further upstream in Figure
1 (tier four), far away from the sharp-end activities of nurses and other providers. Decisions
are frequently made in a loose, diffuse, somewhat disorderly fashion. Because
decisionmaking consequences accrue gradually, interact with other variables, and are not that
easy to isolate and determine, those who make organizational policy, shape organizational
culture, and implement managerial decisions are rarely held accountable for the consequences
of their actions. Yet managerial dictum and organizational practices regarding staffing,
communication, workload, patient scheduling, accessibility of personnel, insertion of new
technology, and quality assurance procedures are sure to have their impact. As noted earlier,
providers are actually the last line of defense, for it is the providers who ultimately must cope
with the shortcomings of everyone else who has played a role in the design of the greater
sociotechnical system. For example, the absence of a serious commitment to higher quality
and safe care at the management level is a latent condition that may become apparent in terms
of adverse consequences only when this “error of judgment” aligns itself with other system
variables such as overworked personnel, excessive interruptions, poorly designed equipment
interfaces, a culture of low expectations, and rapid-paced production schedules for treating
patients.
Compared to providers, managers and decisionmakers are much better positioned to
actually address the problems-behind-the-problem and be mindful of the interdependencies of
care. Managers and decisionmakers have the opportunity to work across organizational units
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
of care and address the discontinuities. With perhaps a few exceptions, there is very little
evidence that managers and leaders actually spend much time in attending to the complex
interdependencies of care and areas of vulnerability in their institutions. While they may not
have the same clinical know-how as sharp end personnel, they certainly have the corporate
authority to involve those with clinical expertise in needed change efforts. Thus, a new role
for health care leaders and managers is envisioned, placing a high value on understanding
system complexity and focusing on the interdependencies—not just the components.38 In this
new role, leaders recognize that superb clinical knowledge and dedication of providers is no
match for the toll that flawed and poorly performing interdependent systems of care can take.
In brief, they aim to do something about the misalignments.
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A Human Factors Framework
Unlike other sectors of the economy, health care remained untouched for too long by
advances in information technology (except, perhaps, for billing purposes). That is no longer
the case, given the recent implementation of electronic health records, computer physician
order entry systems, barcoding systems, and other technologies by early adopters. However,
lofty expectations that usher in new technology are quickly dampened by unintended
consequences.41, 42 One of the early lessons learned is that successful implementation
involves more than just technical considerations—the nature of clinical work, the design of
well-conceived interfaces, workflow considerations, user acceptance and adoption issues,
training, and other organizational support requirements all need to be taken into account. Still
another external development that will likely have an impact on clinical practice in the years
to come is the passage of the Patient Safety and Quality Improvement Act of 2005. It
provides confidentiality protections and encourages providers to contract with patient safety
organizations (PSOs) for the purpose of collecting and analyzing data on patient safety events
so that information can be fed back to providers to help reduce harm to patients. With the
confidentiality protections mandated by the act, providers should be able to report patient
safety events freely without fear of reprisal or litigation. Finally, given the availability of
numerous medical Web sites and a national press network sensitized to instances of
substandard clinical care and medical error, today's patients are better informed and a bit less
trusting with respect to their encounters with the health system.
Preoccupation with failure Adverse events are rare in HROs, yet these organizations focus
incessantly on ways the system can fail them. Rather than letting
success breed complacency, they worry about success and know
that adverse events will indeed occur. They treat close calls as a sign
of danger lurking in the system. Hence, it is a good thing when nurses
are preoccupied with the many ways things can go wrong and when
they share that "inner voice of concern" with others.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Reluctance to simplify interpretations When things go wrong, less reliable organizations find convenient
ways to circumscribe and limit the scope of the problem. They
simplify and do not spend much energy on investigating all the
contributing factors. Conversely, HROs resist simplified
interpretations, do not accept conventional explanations that are
readily available, and seek out information that can disconfirm
hunches and popular stereotypes. Nurses who develop good
interpersonal, teamwork, and critical-thinking skills will enhance their
organization's ability to accept disruptive information that disconfirms
preconceived ideas.
Commitment to resilience Given that errors are always going to occur, HROs commit equal
resources to being mindful about errors that have already occurred
and to correct them before they worsen. Here the idea is to reduce or
mitigate the adverse consequences of untoward events. Nursing
already shows resilience by putting supplies and recovery equipment
in places that can be quickly accessed when patient conditions go
awry. Since foresight always lags hindsight, nursing resilience can be
honed by creating simulations of care processes that start to unravel
(e.g., failure to rescue).
It should be noted that not everyone in health care has been receptive to comparisons
between health care delivery and the activities that take place in other high-risk industries
such as aircraft carrier operations or nuclear power. Health care is not aviation; it is more
complex and qualitatively different. While all of this may be true, it probably also is true that
health care is the most poorly managed of all the high-risk industries and very late in coming
to recognize the importance of system factors that underlie adverse events. The one thing that
the other high-risk industries clearly have in common with health care is the human
component. Sailors that work the decks of aircraft carriers have the same physiologies as
those who work the hospital floor. They get fatigued from excessive hours of operation in the
same way as those who occupy the nurses’ station. When the technology and equipment they
16
A Human Factors Framework
use is poorly designed and confusing to use, they get frustrated and make similar types of
mistakes as those in health care who have to use poorly designed medical devices. When the
pace of operations pick up and they are bombarded with interruptions, short-term memory
fails them in exactly the same way that it fails those who work in hectic EDs and ICUs. They
respond to variations in the physical environment (e.g., lighting, noise, workplace layout) and
to social/organizational pressures (e.g., group norms, culture, authority gradients) in a very
similar fashion to those in health care who are exposed to the same set of factors. While the
nature of the work may be dramatically different, the types of system factors that influence
human performance are indeed very similar. The take-home message of all this is that the
human factors studies that have been conducted in the other high-risk industries are very
relevant to health care, and nursing in particular, as we continue to learn to improve the skills,
processes, and system alignments that are needed for higher quality and safer care.
Conclusion
The complex and demanding clinical environment of nurses can be made a bit more
understandable and easier in which to deliver care by accounting for a wide range of human
factors concerns that directly and indirectly impact human performance. Human factors is the
application of scientific knowledge about human strengths and limitations to the design of
systems in the work environment to ensure safe and satisfying performance. A human factors
framework such as that portrayed in Figure 1 helps us become aware of the salient
components and their relationships that shape and influence the quality of care that is
provided to patients. The concept of human error is a somewhat loaded term. Rather than
falling into the trap of uncritically focusing on human error and searching for individuals to
blame, a systems approach attempts to identify the contributing factors to substandard
performance and find ways to better detect, recover from, or preclude problems that could
result in harm to patients. Starting with the individual characteristics of providers such as
their knowledge, skills, and sensory/physical capabilities, we examined a hierarchy of system
factors, including the nature of the work performed, the physical environment, human-system
interfaces, the organizational/social environment, management, and external factors. In our
current fragmented health care system, where no single individual or entity is in charge, these
multiple factors seem to be continuously misaligned and interact in a manner that leads to
substandard care. These are the proverbial accidents in the system waiting to happen. Nurses
serve in a critical role at the point of patient care; they are in an excellent position to not only
identify the problems, but to help identify the problems-behind-the-problems. Nurses can
actively practice the tenets of high-reliability organizations. It is recognized, of course, that
nursing cannot address the system problems all on its own. Everyone who has a potential
impact on patient care, no matter how remote (e.g., device manufacturers, administrators,
nurse managers), needs to be mindful of the interdependent system factors that they play a
role in shaping. Without a clear and strong nursing voice and an organizational climate that is
conducive to candidly addressing system problems, efforts to improve patient safety and
quality will fall short of their potential.
17
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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1. Kohn LT, Corrigan JM, Donaldson MS, eds. To err 15. Perrow C. Normal accidents—living with high-risk
is human: building a safer health system. A report technologies. New York: Basic Books; 1984.
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prerequisite to effective risk management. Qual
2. Sanders M, McCormick E. Human factors Health Care 2001;10(Suppl. II):ii21-ii25.
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3. Chapanis A, Garner W, Morgan C. Applied
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for the analysis of risk and safety in medicine. BMJ 20. Hendrickson F. The four P’s of human error in
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6. Carayon P, Smith M. Work organization and
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7. Vicente K. The human factor. New York: Med Dosim 1990;15:185-91.
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22. Cannon-Bowers J, Salas E. Making decisions
8. Schyve P. Systems thinking and patient safety. In: under stress: implications for individual and team
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Advances in patient safety: from research to Association; 1998.
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for Healthcare Research and Quality; 2005. p.1-4. 23. Fleishman E, ed. Human performance and
productivity. Vol. 3. (Alluisi E, Fleishman E, eds.)
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24. Wickens C, Hollands J. Engineering psychology
10. Reason, J. Human error. Cambridge: Cambridge and human performance. 3rd ed. Upper Saddle
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technology and human error. Indianapolis, IN:
John Wiley and Sons; 1987. p. 23-30.
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28. ECRI. Preventing misconnections of lines and 37. Wears R. Oral remarks at the SEIPS short course
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29. Ulrich R, Simring C, Quan X, et al. The role of the Madison; 2004.
physician environment in the hospital of the 21st
century: a once-in-a-lifetime opportunity. Report to 38. Henriksen K, Dayton E. Organizational silence and
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San Luis Obispo, CA: Blake Printery; 1979.
19
Chapter 6. Clinical Reasoning, Decisionmaking, and
Action: Thinking Critically and Clinically
Patricia Benner, Ronda G. Hughes, Molly Sutphen
Background
This chapter examines multiple thinking strategies that are needed for high-quality clinical
practice. Clinical reasoning and judgment are examined in relation to other modes of thinking
used by clinical nurses in providing quality health care to patients that avoids adverse events and
patient harm. The clinician’s ability to provide safe, high-quality care can be dependent upon
their ability to reason, think, and judge, which can be limited by lack of experience. The expert
performance of nurses is dependent upon continual learning and evaluation of performance.
Critical Thinking
Nursing education has emphasized critical thinking as an essential nursing skill for more than
50 years.1 The definitions of critical thinking have evolved over the years. There are several key
definitions for critical thinking to consider. The American Philosophical Association (APA)
defined critical thinking as purposeful, self-regulatory judgment that uses cognitive tools such as
interpretation, analysis, evaluation, inference, and explanation of the evidential, conceptual,
methodological, criteriological, or contextual considerations on which judgment is based.2 A
more expansive general definition of critical thinking is
. . . in short, self-directed, self-disciplined, self-monitored, and self-corrective
thinking. It presupposes assent to rigorous standards of excellence and mindful
command of their use. It entails effective communication and problem solving
abilities and a commitment to overcome our native egocentrism and
sociocentrism. Every clinician must develop rigorous habits of critical thinking,
but they cannot escape completely the situatedness and structures of the clinical
traditions and practices in which they must make decisions and act quickly in
specific clinical situations.3
There are three key definitions for nursing, which differ slightly. Bittner and Tobin defined
critical thinking as being “influenced by knowledge and experience, using strategies such as
reflective thinking as a part of learning to identify the issues and opportunities, and holistically
synthesize the information in nursing practice”4 (p. 268). Scheffer and Rubenfeld5 expanded on
the APA definition for nurses through a consensus process, resulting in the following definition:
Critical thinking in nursing is an essential component of professional
accountability and quality nursing care. Critical thinkers in nursing exhibit these
habits of the mind: confidence, contextual perspective, creativity, flexibility,
inquisitiveness, intellectual integrity, intuition, openmindedness, perseverance,
and reflection. Critical thinkers in nursing practice the cognitive skills of
analyzing, applying standards, discriminating, information seeking, logical
reasoning, predicting, and transforming knowledge6 (Scheffer & Rubenfeld,
p. 357).
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The National League for Nursing Accreditation Commission (NLNAC) defined critical thinking
as:
the deliberate nonlinear process of collecting, interpreting, analyzing, drawing
conclusions about, presenting, and evaluating information that is both factually
and belief based. This is demonstrated in nursing by clinical judgment, which
includes ethical, diagnostic, and therapeutic dimensions and research7 (p. 8).
These concepts are furthered by the American Association of Colleges of Nurses’ definition
of critical thinking in their Essentials of Baccalaureate Nursing:
Critical thinking underlies independent and interdependent decision making.
Critical thinking includes questioning, analysis, synthesis, interpretation,
inference, inductive and deductive reasoning, intuition, application, and
creativity8 (p. 9).
Course work or ethical experiences should provide the graduate with the
knowledge and skills to:
• Use nursing and other appropriate theories and models, and an appropriate
ethical framework;
• Apply research-based knowledge from nursing and the sciences as the basis
for practice;
• Use clinical judgment and decision-making skills;
• Engage in self-reflective and collegial dialogue about professional practice;
• Evaluate nursing care outcomes through the acquisition of data and the
questioning of inconsistencies, allowing for the revision of actions and goals;
8
• Engage in creative problem solving (p. 10).
Taken together, these definitions of critical thinking set forth the scope and key elements of
thought processes involved in providing clinical care. Exactly how critical thinking is defined
will influence how it is taught and to what standard of care nurses will be held accountable.
Professional and regulatory bodies in nursing education have required that critical thinking
be central to all nursing curricula, but they have not adequately distinguished critical reflection
from ethical, clinical, or even creative thinking for decisionmaking or actions required by the
clinician. Other essential modes of thought such as clinical reasoning, evaluation of evidence,
creative thinking, or the application of well-established standards of practice—all distinct from
critical reflection—have been subsumed under the rubric of critical thinking. In the nursing
education literature, clinical reasoning and judgment are often conflated with critical thinking.
The accrediting bodies and nursing scholars have included decisionmaking and action-oriented,
practical, ethical, and clinical reasoning in the rubric of critical reflection and thinking. One
might say that this harmless semantic confusion is corrected by actual practices, except that
students need to understand the distinctions between critical reflection and clinical reasoning,
and they need to learn to discern when each is better suited, just as students need to also engage
in applying standards, evidence-based practices, and creative thinking.
The growing body of research, patient acuity, and complexity of care demand higher-order
thinking skills. Critical thinking involves the application of knowledge and experience to identify
patient problems and to direct clinical judgments and actions that result in positive patient
outcomes. These skills can be cultivated by educators who display the virtues of critical thinking,
including independence of thought, intellectual curiosity, courage, humility, empathy, integrity,
perseverance, and fair-mindedness.9
2
Critical Reasoning, Decisonmaking, and Action
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
An essential point of tension and confusion exists in practice traditions such as nursing and
medicine when clinical reasoning and critical reflection become entangled, because the clinician
must have some established bases that are not questioned when engaging in clinical decisions
and actions, such as standing orders. The clinician must act in the particular situation and time
with the best clinical and scientific knowledge available. The clinician cannot afford to indulge
in either ritualistic unexamined knowledge or diagnostic or therapeutic nihilism caused by
radical doubt, as in critical reflection, because they must find an intelligent and effective way to
think and act in particular clinical situations. Critical reflection skills are essential to assist
practitioners to rethink outmoded or even wrong-headed approaches to health care, health
promotion, and prevention of illness and complications, especially when new evidence is
available. Breakdowns in practice, high failure rates in particular therapies, new diseases, new
scientific discoveries, and societal changes call for critical reflection about past assumptions and
no-longer-tenable beliefs.
Clinical reasoning stands out as a situated, practice-based form of reasoning that requires a
background of scientific and technological research-based knowledge about general cases, more
so than any particular instance. It also requires practical ability to discern the relevance of the
evidence behind general scientific and technical knowledge and how it applies to a particular
patient. In dong so, the clinician considers the patient’s particular clinical trajectory, their
concerns and preferences, and their particular vulnerabilities (e.g., having multiple comorbidities)
and sensitivities to care interventions (e.g., known drug allergies, other conflicting comorbid
conditions, incompatible therapies, and past responses to therapies) when forming clinical
decisions or conclusions.
Situated in a practice setting, clinical reasoning occurs within social relationships or
situations involving patient, family, community, and a team of health care providers. The expert
clinician situates themselves within a nexus of relationships, with concerns that are bounded by
the situation. Expert clinical reasoning is socially engaged with the relationships and concerns of
those who are affected by the caregiving situation, and when certain circumstances are present,
the adverse event. Halpern19 has called excellent clinical ethical reasoning “emotional reasoning”
in that the clinicians have emotional access to the patient/family concerns and their
understanding of the particular care needs. Expert clinicians also seek an optimal perceptual
grasp, one based on understanding and as undistorted as possible, based on an attuned emotional
engagement and expert clinical knowledge.19, 20
Clergy educators21 and nursing and medical educators have begun to recognize the wisdom
of broadening their narrow vision of rationality beyond simple rational calculation (exemplified
by cost-benefit analysis) to reconsider the need for character development—including emotional
engagement, perception, habits of thought, and skill acquisition—as essential to the development
of expert clinical reasoning, judgment, and action.10, 22–24 Practitioners of engineering, law,
medicine, and nursing, like the clergy, have to develop a place to stand in their discipline’s
tradition of knowledge and science in order to recognize and evaluate salient evidence in the
moment. Diagnostic confusion and disciplinary nihilism are both threats to the clinician’s ability
to act in particular situations. However, the practice and practitioners will not be self-improving
and vital if they cannot engage in critical reflection on what is not of value, what is outmoded,
and what does not work. As evidence evolves and expands, so too must clinical thought.
Clinical judgment requires clinical reasoning across time about the particular, and because of
the relevance of this immediate historical unfolding, clinical reasoning can be very different from
the scientific reasoning used to formulate, conduct, and assess clinical experiments. While
4
Critical Reasoning, Decisonmaking, and Action
scientific reasoning is also socially embedded in a nexus of social relationships and concerns, the
goal of detached, critical objectivity used to conduct scientific experiments minimizes the
interactive influence of the research on the experiment once it has begun. Scientific research in
the natural and clinical sciences typically uses formal criteria to develop “yes” and “no”
judgments at prespecified times. The scientist is always situated in past and immediate scientific
history, preferring to evaluate static and predetermined points in time (e.g., snapshot reasoning),
in contrast to a clinician who must always reason about transitions over time.25, 26
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
assessment and clinical judgment (i.e., reasoning across time about changes in the particular
patient or the clinician’s understanding of the patient’s condition) fall into the Greek Aristotelian
category of phronesis. Dewey32 sought to rescue knowledge gained by practical activity in the
world. He identified three flaws in the understanding of experience in Greek philosophy: (1)
empirical knowing is the opposite of experience with science; (2) practice is reduced to techne or
the application of rational thought or technique; and (3) action and skilled know-how are
considered temporary and capricious as compared to reason, which the Greeks considered as
ultimate reality.
In practice, nursing and medicine require both techne and phronesis. The clinician
standardizes and routinizes what can be standardized and routinized, as exemplified by
standardized blood pressure measurements, diagnoses, and even charting about the patient’s
condition and treatment.27 Procedural and scientific knowledge can often be formalized and
standardized (e.g., practice guidelines), or at least made explicit and certain in practice, except
for the necessary timing and adjustments made for particular patients.11, 22
Rational calculations available to techne—population trends and statistics, algorithms—are
created as decision support structures and can improve accuracy when used as a stance of inquiry
in making clinical judgments about particular patients. Aggregated evidence from clinical trials
and ongoing working knowledge of pathophysiology, biochemistry, and genomics are essential.
In addition, the skills of phronesis (clinical judgment that reasons across time, taking into
account the transitions of the particular patient/family/community and transitions in the
clinician’s understanding of the clinical situation) will be required for nursing, medicine, or any
helping profession.
Thinking Critically
Being able to think critically enables nurses to meet the needs of patients within their context
and considering their preferences; meet the needs of patients within the context of uncertainty;
consider alternatives, resulting in higher-quality care;33 and think reflectively, rather than simply
accepting statements and performing tasks without significant understanding and evaluation.34
Skillful practitioners can think critically because they have the following cognitive skills:
information seeking, discriminating, analyzing, transforming knowledge, predicating, applying
standards, and logical reasoning.5 One’s ability to think critically can be affected by age, length
of education (e.g., an associate vs. a baccalaureate decree in nursing), and completion of
philosophy or logic subjects.35–37 The skillful practitioner can think critically because of having
the following characteristics: motivation, perseverance, fair-mindedness, and deliberate and
careful attention to thinking.5, 9
Thinking critically implies that one has a knowledge base from which to reason and the
ability to analyze and evaluate evidence.38 Knowledge can be manifest by the logic and rational
implications of decisionmaking. Clinical decisionmaking is particularly influenced by
interpersonal relationships with colleagues,39 patient conditions, availability of resources,40
knowledge, and experience.41 Of these, experience has been shown to enhance nurses’ abilities to
make quick decisions42 and fewer decision errors,43 support the identification of salient cues, and
foster the recognition and action on patterns of information.44, 45
Clinicians must develop the character and relational skills that enable them to perceive and
understand their patient’s needs and concerns. This requires accurate interpretation of patient
data that is relevant to the specific patient and situation. In nursing, this formation of moral
agency focuses on learning to be responsible in particular ways demanded by the practice, and to
6
Critical Reasoning, Decisonmaking, and Action
pay attention and intelligently discern changes in patients’ concerns and/or clinical condition that
require action on the part of the nurse or other health care workers to avert potential
compromises to quality care.
Formation of the clinician’s character, skills, and habits are developed in schools and
particular practice communities within a larger practice tradition. As Dunne notes,
A practice is not just a surface on which one can display instant virtuosity. It
grounds one in a tradition that has been formed through an elaborate development
and that exists at any juncture only in the dispositions (slowly and perhaps
painfully acquired) of its recognized practitioners. The question may of course be
asked whether there are any such practices in the contemporary world, whether
the wholesale encroachment of Technique has not obliterated them—and whether
this is not the whole point of MacIntyre’s recipe of withdrawal, as well as of the
post-modern story of dispossession11 (p. 378).
Clearly Dunne is engaging in critical reflection about the conditions for developing character,
skills, and habits for skillful and ethical comportment of practitioners, as well as to act as moral
agents for patients so that they and their families receive safe, effective, and compassionate care.
Professional socialization or professional values, while necessary, do not adequately address
character and skill formation that transform the way the practitioner exists in his or her world,
what the practitioner is capable of noticing and responding to, based upon well-established
patterns of emotional responses, skills, dispositions to act, and the skills to respond, decide, and
act.46 The need for character and skill formation of the clinician is what makes a practice stand
out from a mere technical, repetitious manufacturing process.11, 30, 47
In nursing and medicine, many have questioned whether current health care institutions are
designed to promote or hinder enlightened, compassionate practice, or whether they have
deteriorated into commercial institutional models that focus primarily on efficiency and profit.
MacIntyre points out the links between the ongoing development and improvement of practice
traditions and the institutions that house them:
Lack of justice, lack of truthfulness, lack of courage, lack of the relevant
intellectual virtues—these corrupt traditions, just as they do those institutions and
practices which derive their life from the traditions of which they are the
contemporary embodiments. To recognize this is of course also to recognize the
existence of an additional virtue, one whose importance is perhaps most obvious
when it is least present, the virtue of having an adequate sense of the traditions to
which one belongs or which confront one. This virtue is not to be confused with
any form of conservative antiquarianism; I am not praising those who choose the
conventional conservative role of laudator temporis acti. It is rather the case that
an adequate sense of tradition manifests itself in a grasp of those future
possibilities which the past has made available to the present. Living traditions,
just because they continue a not-yet-completed narrative, confront a future whose
determinate and determinable character, so far as it possesses any, derives from
the past30 (p. 207).
It would be impossible to capture all the situated and distributed knowledge outside of actual
practice situations and particular patients. Simulations are powerful as teaching tools to enable
nurses’ ability to think critically because they give students the opportunity to practice in a
simplified environment. However, students can be limited in their inability to convey
underdetermined situations where much of the information is based on perceptions of many
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
aspects of the patient and changes that have occurred over time. Simulations cannot have the
sub-cultures formed in practice settings that set the social mood of trust, distrust, competency,
limited resources, or other forms of situated possibilities.
Experience
One of the hallmark studies in nursing providing keen insight into understanding the
influence of experience was a qualitative study of adult, pediatric, and neonatal intensive care
unit (ICU) nurses, where the nurses were clustered into advanced beginner, intermediate, and
expert level of practice categories. The advanced beginner (having up to 6 months of work
experience) used procedures and protocols to determine which clinical actions were needed.
When confronted with a complex patient situation, the advanced beginner felt their practice was
unsafe because of a knowledge deficit or because of a knowledge application confusion. The
transition from advanced beginners to competent practitioners began when they first had
experience with actual clinical situations and could benefit from the knowledge gained from the
mistakes of their colleagues. Competent nurses continuously questioned what they saw and
heard, feeling an obligation to know more about clinical situations. In doing do, they moved
from only using care plans and following the physicians’ orders to analyzing and interpreting
patient situations. Beyond that, the proficient nurse acknowledged the changing relevance of
clinical situations requiring action beyond what was planned or anticipated. The proficient nurse
learned to acknowledge the changing needs of patient care and situation, and could organize
interventions “by the situation as it unfolds rather than by preset goals48 (p. 24). Both competent
and proficient nurses (that is, intermediate level of practice) had at least two years of ICU
experience.48 Finally, the expert nurse had a more fully developed grasp of a clinical situation, a
sense of confidence in what is known about the situation, and could differentiate the precise
clinical problem in little time.48
Expertise is acquired through professional experience and is indicative of a nurse who has
moved beyond mere proficiency. As Gadamer29 points out, experience involves a turning around
of preconceived notions, preunderstandings, and extends or adds nuances to understanding.
Dewey49 notes that experience requires a prepared “creature” and an enriched environment. The
opportunity to reflect and narrate one’s experiential learning can clarify, extend, or even refute
experiential learning.
Experiential learning requires time and nurturing, but time alone does not ensure experiential
learning. Aristotle linked experiential learning to the development of character and moral
sensitivities of a person learning a practice.50 New nurses/new graduates have limited work
experience and must experience continuing learning until they have reached an acceptable level
of performance.51 After that, further improvements are not predictable, and years of experience
are an inadequate predictor of expertise.52
The most effective knower and developer of practical knowledge creates an ongoing dialogue
and connection between lessons of the day and experiential learning over time. Gadamer, in a
late life interview, highlighted the open-endedness and ongoing nature of experiential learning in
the following interview response:
Being experienced does not mean that one now knows something once and for all
and becomes rigid in this knowledge; rather, one becomes more open to new
experiences. A person who is experienced is undogmatic. Experience has the
effect of freeing one to be open to new experience … In our experience we bring
8
Critical Reasoning, Decisonmaking, and Action
nothing to a close; we are constantly learning new things from our experience …
this I call the interminability of all experience32 (p. 403).
Practical endeavor, supported by scientific knowledge, requires experiential learning, the
development of skilled know-how, and perceptual acuity in order to make the scientific
knowledge relevant to the situation. Clinical perceptual and skilled know-how helps the
practitioner discern when particular scientific findings might be relevant.53
Often experience and knowledge, confirmed by experimentation, are treated as oppositions,
an either-or choice. However, in practice it is readily acknowledged that experiential knowledge
fuels scientific investigation, and scientific investigation fuels further experiential learning.
Experiential learning from particular clinical cases can help the clinician recognize future similar
cases and fuel new scientific questions and study. For example, less experienced nurses—and it
could be argued experienced as well—can use nursing diagnoses practice guidelines as part of
their professional advancement. Guidelines are used to reflect their interpretation of patients’
needs, responses, and situation,54 a process that requires critical thinking and
decisionmaking.55, 56 Using guidelines also reflects one’s problem identification and problem-
solving abilities.56 Conversely, the ability to proficiently conduct a series of tasks without
nursing diagnoses is the hallmark of expertise.39, 57
Experience precedes expertise. As expertise develops from experience and gaining
knowledge and transitions to the proficiency stage, the nurses’ thinking moves from steps and
procedures (i.e., task-oriented care) toward “chunks” or patterns39 (i.e., patient-specific care). In
doing so, the nurse thinks reflectively, rather than merely accepting statements and performing
procedures without significant understanding and evaluation.34 Expert nurses do not rely on rules
and logical thought processes in problem-solving and decisionmaking.39 Instead, they use
abstract principles, can see the situation as a complex whole, perceive situations
comprehensively, and can be fully involved in the situation.48 Expert nurses can perform high-
level care without conscious awareness of the knowledge they are using,39, 58 and they are able to
provide that care with flexibility and speed. Through a combination of knowledge and skills
gained from a range of theoretical and experiential sources, expert nurses also provide holistic
care.39 Thus, the best care comes from the combination of theoretical, tacit, and experiential
knowledge.59, 60
Experts are thought to eventually develop the ability to intuitively know what to do and to
quickly recognize critical aspects of the situation.22 Some have proposed that expert nurses
provide high-quality patient care,61, 62 but that is not consistently documented—particularly in
consideration of patient outcomes—and a full understanding between the differential impact of
care rendered by an “expert” nurse is not fully understood. In fact, several studies have found
that length of professional experience is often unrelated and even negatively related to
performance measures and outcomes.63, 64
In a review of the literature on expertise in nursing, Ericsson and colleagues65 found that
focusing on challenging, less-frequent situations would reveal individual performance
differences on tasks that require speed and flexibility, such as that experienced during a code or
an adverse event. Superior performance was associated with extensive training and immediate
feedback about outcomes, which can be obtained through continual training, simulation, and
processes such as root-cause analysis following an adverse event. Therefore, efforts to improve
performance benefited from continual monitoring, planning, and retrospective evaluation. Even
then, the nurse’s ability to perform as an expert is dependent upon their ability to use intuition or
insights gained through interactions with patients.39
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
10
Critical Reasoning, Decisonmaking, and Action
intended to provide guidance for specific areas of health care delivery.84 The clinician—both the
novice and expert—is expected to use the best available evidence for the most efficacious
therapies and interventions in particular instances, to ensure the highest-quality care, especially
when deviations from the evidence-based norm may heighten risks to patient safety. Otherwise,
if nursing and medicine were exact sciences, or consisted only of techne, then a 1:1 relationship
could be established between results of aggregated evidence-based research and the best path for
all patients.
Evaluating Evidence
Before research should be used in practice, it must be evaluated. There are many
complexities and nuances in evaluating the research evidence for clinical practice. Evaluation of
research behind evidence-based medicine requires critical thinking and good clinical judgment.
Sometimes the research findings are mixed or even conflicting. As such, the validity, reliability,
and generalizability of available research are fundamental to evaluating whether evidence can be
applied in practice. To do so, clinicians must select the best scientific evidence relevant to
particular patients—a complex process that involves intuition to apply the evidence. Critical
thinking is required for evaluating the best available scientific evidence for the treatment and
care of a particular patient.
Good clinical judgment is required to select the most relevant research evidence. The best
clinical judgment, that is, reasoning across time about the particular patient through changes in
the patient’s concerns and condition and/or the clinician’s understanding, are also required. This
type of judgment requires clinicians to make careful observations and evaluations of the patient
over time, as well as know the patient’s concerns and social circumstances. To evolve to this
level of judgment, additional education beyond clinical preparation if often required.
Sources of Evidence
Evidence that can be used in clinical practice has different sources and can be derived from
research, patient’s preferences, and work-related experience.85, 86 Nurses have been found to
obtain evidence from experienced colleagues believed to have clinical expertise and research-
based knowledge87 as well as other sources.
For many years now, randomized controlled trials (RCTs) have often been considered the
best standard for evaluating clinical practice. Yet, unless the common threats to the validity (e.g.,
representativeness of the study population) and reliability (e.g., consistency in interventions and
responses of study participants) of RCTs are addressed, the meaningfulness and generalizability
of the study outcomes are very limited. Relevant patient populations may be excluded, such as
women, children, minorities, the elderly, and patients with multiple chronic illnesses. The
dropout rate of the trial may confound the results. And it is easier to get positive results
published than it is to get negative results published. Thus, RCTs are generalizable (i.e.,
applicable) only to the population studied—which may not reflect the needs of the patient under
the clinicians care. In instances such as these, clinicians need to also consider applied research
using prospective or retrospective populations with case control to guide decisionmaking, yet
this too requires critical thinking and good clinical judgment.
Another source of available evidence may come from the gold standard of aggregated
systematic evaluation of clinical trial outcomes for the therapy and clinical condition in question,
be generated by basic and clinical science relevant to the patient’s particular pathophysiology or
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
care need situation, or stem from personal clinical experience. The clinician then takes all of the
available evidence and considers the particular patient’s known clinical responses to past
therapies, their clinical condition and history, the progression or stages of the patient’s illness
and recovery, and available resources.
In clinical practice, the particular is examined in relation to the established generalizations of
science. With readily available summaries of scientific evidence (e.g., systematic reviews and
practice guidelines) available to nurses and physicians, one might wonder whether deep
background understanding is still advantageous. Might it not be expendable, since it is likely to
be out of date given the current scientific evidence? But this assumption is a false opposition and
false choice because without a deep background understanding, the clinician does not know how
to best find and evaluate scientific evidence for the particular case in hand. The clinician’s sense
of salience in any given situation depends on past clinical experience and current scientific
evidence.
Evidence-Based Practice
The concept of evidence-based practice is dependent upon synthesizing evidence from the
variety of sources and applying it appropriately to the care needs of populations and individuals.
This implies that evidence-based practice, indicative of expertise in practice, appropriately
applies evidence to the specific situations and unique needs of patients.88, 89 Unfortunately, even
though providing evidence-based care is an essential component of health care quality, it is well
known that evidence-based practices are not used consistently.
Conceptually, evidence used in practice advances clinical knowledge, and that knowledge
supports independent clinical decisions in the best interest of the patient.90, 91 Decisions must
prudently consider the factors not necessarily addressed in the guideline, such as the patient’s
lifestyle, drug sensitivities and allergies, and comorbidities. Nurses who want to improve the
quality and safety of care can do so though improving the consistency of data and information
interpretation inherent in evidence-based practice.
Initially, before evidence-based practice can begin, there needs to be an accurate clinical
judgment of patient responses and needs. In the course of providing care, with careful
consideration of patient safety and quality care, clinicians must give attention to the patient’s
condition, their responses to health care interventions, and potential adverse reactions or events
that could harm the patient. Nonetheless, there is wide variation in the ability of nurses to
accurately interpret patient responses92 and their risks.93 Even though variance in interpretation is
expected, nurses are obligated to continually improve their skills to ensure that patients receive
quality care safely.94 Patients are vulnerable to the actions and experience of their clinicians,
which are inextricably linked to the quality of care patients have access to and subsequently
receive.
The judgment of the patient’s condition determines subsequent interventions and patient
outcomes. Attaining accurate and consistent interpretations of patient data and information is
difficult because each piece can have different meanings, and interpretations are influenced by
previous experiences.95 Nurses use knowledge from clinical experience96, 97 and—although
infrequently—research.98–100
Once a problem has been identified, using a process that utilizes critical thinking to recognize
the problem, the clinician then searches for and evaluates the research evidence101 and evaluates
potential discrepancies. The process of using evidence in practice involves “a problem-solving
approach that incorporates the best available scientific evidence, clinicians’ expertise, and
12
Critical Reasoning, Decisonmaking, and Action
patient’s preferences and values”102 (p. 28). Yet many nurses do not perceive that they have the
education, tools, or resources to use evidence appropriately in practice.103
Reported barriers to using research in practice have included difficulty in understanding the
applicability and the complexity of research findings, failure of researchers to put findings into
the clinical context, lack of skills in how to use research in practice,104, 105 amount of time
required to access information and determine practice implications,105–107 lack of organizational
support to make changes and/or use in practice,104, 97, 105, 107 and lack of confidence in one’s
ability to critically evaluate clinical evidence.108
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
14
Critical Reasoning, Decisonmaking, and Action
dialogical nature of clinical reasoning and addresses the centrality of perception and
understanding to good clinical reasoning, judgment and intervention.
Clinical Grasp *
Clinical grasp describes clinical inquiry in action. Clinical grasp begins with perception and
includes problem identification and clinical judgment across time about the particular transitions
of particular patients. Garrett Chan20 described the clinician’s attempt at finding an “optimal
grasp” or vantage point of understanding. Four aspects of clinical grasp, which are described in
the following paragraphs, include (1) making qualitative distinctions, (2) engaging in detective
work, (3) recognizing changing relevance, and (4) developing clinical knowledge in specific
patient populations.
*
This section of the paper was condensed and paraphrased from Benner, Hooper-Kyriakidis, and Stannard.23
Patricia Hooper-Kyriakidis wrote the section on clinical grasp, and Patricia Benner wrote the section on clinical
forethought.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
student whether she had asked the nurse or the patient about the dosage. Upon the student’s
questioning, the nurse did not know why the patient was receiving the high dosage and assumed
the drug was for heart disease. The patient’s staff nurse had not questioned the order. When the
student asked the patient, the student found that the medication was being given for tremors and
that the patient and the doctor had titrated the dosage for control of the tremors. This deliberate
approach to teaching detective work, or modus operandi thinking, has characteristics of “critical
reflection,” but stays situated and engaged, ferreting out the immediate history and unfolding of
events.
Clinical Forethought
Clinical forethought is intertwined with clinical grasp, but it is much more deliberate and
even routinized than clinical grasp. Clinical forethought is a pervasive habit of thought and
action in nursing practice, and also in medicine, as clinicians think about disease and recovery
trajectories and the implications of these changes for treatment. Clinical forethought plays a role
in clinical grasp because it structures the practical logic of clinicians. At least four habits of
thought and action are evident in what we are calling clinical forethought: (1) future think, (2)
clinical forethought about specific patient populations, (3) anticipation of risks for particular
patients, and (4) seeing the unexpected.
Future think. Future think is the broadest category of this logic of practice. Anticipating
likely immediate futures helps the clinician make good plans and decisions about preparing the
environment so that responding rapidly to changes in the patient is possible. Without a sense of
salience about anticipated signs and symptoms and preparing the environment, essential clinical
judgments and timely interventions would be impossible in the typically fast pace of acute and
intensive patient care. Future think governs the style and content of the nurse’s attentiveness to
16
Critical Reasoning, Decisonmaking, and Action
17
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
clamped. So there were no issues with the suction or whatever. He had a Foley
catheter. He had a feeding tube, a chest tube. I can’t even remember but there
were a lot.
As noted earlier, a central characteristic of a practice discipline is that a self-improving
practice requires ongoing experiential learning. One way nurse educators can enhance clinical
inquiry is by increasing pedagogies of experiential learning. Current pedagogies for experiential
learning in nursing include extensive preclinical study, care planning, and shared postclinical
debriefings where students share their experiential learning with their classmates. Experiential
learning requires open learning climates where students can discuss and examine transitions in
understanding, including their false starts, or their misconceptions in actual clinical situations.
Nursing educators typically develop open and interactive clinical learning communities, so that
students seem committed to helping their classmates learn from their experiences that may have
been difficult or even unsafe. One anonymous nurse educator described how students extend
their experiential learning to their classmates during a postclinical conference:
So for example, the patient had difficulty breathing and the student wanted to give
the meds instead of addressing the difficulty of breathing. Well, while we were
sharing information about their patients, what they did that day, I didn’t tell the
student to say this, but she said, ‘I just want to tell you what I did today in clinical
so you don’t do the same thing, and here’s what happened.’ Everybody’s listening
very attentively and they were asking her some questions. But she shared that.
She didn’t have to. I didn’t tell her, you must share that in postconference or
anything like that, but she just went ahead and shared that, I guess, to reinforce
what she had learned that day but also to benefit her fellow students in case that
thing comes up with them.
The teacher’s response to this student’s honesty and generosity exemplifies her own approach to
developing an open community of learning. Focusing only on performance and on “being
correct” prevents learning from breakdown or error and can dampen students’ curiosity and
courage to learn experientially.
Seeing the unexpected. One of the keys to becoming an expert practitioner lies in how the
person holds past experiential learning and background habitual skills and practices. This is a
skill of foregrounding attention accurately and effectively in response to the nature of situational
demands. Bourdieu29 calls the recognition of the situation central to practical reasoning. If
nothing is routinized as a habitual response pattern, then practitioners will not function
effectively in emergencies. Unexpected occurrences may be overlooked. However, if
expectations are held rigidly, then subtle changes from the usual will be missed, and habitual,
rote responses will inappropriately rule. The clinician must be flexible in shifting between what
is in background and foreground. This is accomplished by staying curious and open. The clinical
“certainty” associated with perceptual grasp is distinct from the kind of “certainty” achievable in
scientific experiments and through measurements. Recognition of similar or paradigmatic
clinical situations is similar to “face recognition” or recognition of “family resemblances.” This
concept is subject to faulty memory, false associative memories, and mistaken identities;
therefore, such perceptual grasp is the beginning of curiosity and inquiry and not the end.
Assessment and validation are required. In rapidly moving clinical situations, perceptual grasp is
the starting point for clarification, confirmation, and action. Having the clinician say out loud
how he or she is understanding the situation gives an opportunity for confirmation and
disconfirmation from other clinicians present.111 The relationship between foreground and
18
Critical Reasoning, Decisonmaking, and Action
background of attention needs to be fluid, so that missed expectations allow the nurse to see the
unexpected. For example, when the background rhythm of a cardiac monitor changes, the nurse
notices, and what had been background tacit awareness becomes the foreground of attention. A
hallmark of expertise is the ability to notice the unexpected.20 Background expectations of usual
patient trajectories form with experience. Tacit expectations for patient trajectories form that
enable the nurse to notice subtle failed expectations and pay attention to early signs of
unexpected changes in the patient's condition. Clinical expectations gained from caring for
similar patient populations form a tacit clinical forethought that enable the experienced clinician
to notice missed expectations. Alterations from implicit or explicit expectations set the stage for
experiential learning, depending on the openness of the learner.
Conclusion
Learning to provide safe and quality health care requires technical expertise, the ability to
think critically, experience, and clinical judgment. The high-performance expectation of nurses is
dependent upon the nurses’ continual learning, professional accountability, independent and
interdependent decisionmaking, and creative problem-solving abilities.
Author Affiliation
Patricia Benner, R.N., Ph.D., F.A.A.N., Carnegie Foundation for the Advancement of
Teaching. E-mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
Molly Sutphen, Ph.D., Carnegie Foundation for the Advancement of Teaching. E-mail:
[email protected].
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Nurs 2005;105(9):40-51. unexpected. Assuring high performance in an age
of complexity. San Francisco: Jossey-Bass; 2001.
23
Chapter 7. The Evidence for Evidence-Based Practice
Implementation
Marita G. Titler
Background
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
A recent conceptual framework for maximizing and accelerating the transfer of research
results from the Agency for Healthcare Research and Quality (AHRQ) patient safety research
portfolio to health care delivery was developed by the dissemination subcommittee of the AHRQ
Patient Safety Research Coordinating Committee.37 This model is a synthesis of concepts from
scientific information on knowledge transfer, social marketing, social and organizational
innovation, and behavior change (see Figure 1).37 Although the framework is portrayed as a
series of stages, the authors of this framework do not believe that the knowledge transfer process
is linear; rather, activities occur simultaneously or in different sequences, with implementation of
EBPs being a multifaceted process with many actors and systems.
2
Evidence-Based Practice Implementation
to adopt and consistently use evidence-based research findings and innovations in everyday
practice. Implementing and sustaining EBPs in health care settings involves complex
interrelationships among the EBP topic (e.g., reduction of medication errors), the organizational
social system characteristics (such as operational structures and values, the external health care
environment), and the individual clinicians.35, 37–39 A variety of strategies for implementation
include using a change champion in the organization who can address potential implementation
challenges, piloting/trying the change in a particular patient care area of the organization, and
using multidisciplinary implementation teams to assist in the practical aspects of embedding
innovations into ongoing organizational processes.35, 37 Changing practice takes considerable
effort at both the individual and organizational level to apply evidence-based information and
products in a particular context.22 When improvements in care are demonstrated in the pilot
studies and communicated to other relevant units in the organization, key personnel may then
agree to fully adopt and sustain the change in practice. Once the EBP change is incorporated into
the structure of the organization, the change is no longer considered an innovation but a standard
of care.22, 37
In comparison, other models of EBP (e.g., Iowa Model of Evidence-based Practice to
Promote Quality of Care16) view the steps of the EBP process from the perspective of clinicians
and/or organizational/clinical contexts of care delivery. When viewing steps of the EBP process
through the lens of an end user, the process begins with selecting an area for improving care
based on evidence (rather than asking what findings ought to be disseminated); determining the
priority of the potential topic for the organization; formulating an EBP team composed of key
stakeholders; finding, critiquing, and synthesizing the evidence; setting forth EBP
recommendations, with the type and strength of evidence used to support each clearly
documented; determining if the evidence findings are appropriate for use in practice; writing an
EBP standard specific to the organization; piloting the change in practice; implementing changes
in practice in other relevant practice areas (depending on the outcome of the pilot); evaluating
the EBP changes; and transitioning ongoing quality improvement (QI) monitoring, staff
education, and competency review of the EBP topic to appropriate organizational groups as
defined by the organizational structure.15, 40 The work of EBP implementation from the
perspective of the end user is greatly facilitated by efforts of AHRQ, professional nursing
organizations (e.g., Oncology Nursing Society), and others that distill and package research
findings into useful products and tools for use at the point of care delivery.
When the clinical questions of end users can be addressed through use of existing evidence
that is packaged with end users in mind, steps of the EBP process take less time and more effort
can be directed toward the implementation, evaluation, and sustainability components of the
process. For example, finding, critiquing, and synthesizing the evidence; setting forth EBP
recommendations with documentation of the type and strength of evidence for each
recommendation; and determining appropriateness of the evidence for use in practice are
accelerated when the knowledge-based information is readily available. Some distilled research
findings also include quick reference guides that can be used at the point of care and/or
integrated into health care information systems, which also helps with implementation.41, 42
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
promoting and sustaining adoption of EBPs. Examples of translation studies include describing
facilitators and barriers to knowledge uptake and use, organizational predictors of adherence to
EBP guidelines, attitudes toward EBPs, and defining the structure of the scientific field.11, 47–49
Translation science must be guided by a conceptual model that organizes the strategies being
tested, elucidates the extraneous variables (e.g., behaviors and facilitators) that may influence
adoption of EBPs (e.g., organizational size, characteristics of users), and builds a scientific
knowledge base for this field of inquiry.15, 50 Conceptual models used in the translating-research-
into-practice studies funded by AHRQ were adult learning, health education, social influence,
marketing, and organizational and behavior theories.51 Investigators have used Rogers’s
Diffusion of Innovation model,35, 39, 52–55 the Promoting Action on Research Implementation in
Health Services (PARIHS) model,29 the push/pull framework,23, 56, 57 the decisionmaking
framework,58 and the Institute for Healthcare Improvement (IHI) model59 in translation science.
Study findings regarding evidence-based practices in a diversity of health care settings are
building an empirical foundation of translation science.19, 43, 51, 60–83 These investigations and
others18, 84–86 provide initial scientific knowledge to guide us in how to best promote use of
evidence in practice. To advance knowledge about promoting and sustaining adoption of EBPs in
health care, translation science needs more studies that test translating research into practice
(TRIP) interventions: studies that investigate what TRIP interventions work, for whom, in what
circumstances, in what types of settings; and studies that explain the underlying mechanisms of
effective TRIP interventions.35, 49, 79, 87 Partnership models, which encourage ongoing interaction
between researchers and practitioners, may be the way forward to carry out such studies.56
Challenges, issues, methods, and instruments used in translation research are described
elsewhere.11, 19, 49, 78, 88–97
Research Evidence
What Is Known About Implementing Evidence-Based Practices?
Multifaceted implementation strategies are needed to promote use of research evidence in
clinical and administrative health care decisionmaking.15, 22, 37, 45, 64, 72, 77, 79, 98, 99 Although
Grimshaw and colleagues65 suggest that multifaceted interventions are no more effective than
single interventions, context (site of care delivery) was not incorporated in the synthesis
methodology. As noted by others, the same TRIP intervention may meet with varying degrees of
effectiveness when applied in different contexts.35, 49, 79, 80, 87, 100, 101 Implementation strategies
also need to address both the individual practitioner and organizational
perspective.15, 22, 37, 64, 72, 77, 79, 98 When practitioners decide individually what evidence to use in
practice, considerable variability in practice patterns result,71 potentially resulting in adverse
patient outcomes.
For example, an “individual” perspective of EBP would leave the decision about use of
evidence-based endotracheal suctioning techniques to each nurse and respiratory therapist. Some
individuals may be familiar with the research findings for endotracheal suctioning while others
may not. This is likely to result in different and conflicting practices being used as people change
shifts every 8 to 12 hours. From an organizational perspective, endotracheal suctioning policies
and procedures based on research are written, the evidence-based information is integrated into
the clinical information systems, and adoption of these practices by nurses and other practitioners
is systematically promoted in the organization. This includes assuring that practitioners have the
4
Evidence-Based Practice Implementation
necessary knowledge, skills, and equipment to carry out the evidence-based endotracheal
suctioning practice. The organizational governance supports use of these practices through
various councils and committees such as the Practice Committee, Staff Education Committee,
and interdisciplinary EBP work groups.
The Translation Research Model,35 built on Rogers’s seminal work on diffusion of
innovations,39 provides a guiding framework for testing and selecting strategies to promote
adoption of EBPs. According to the Translation Research Model, adoption of innovations such
as EBPs are influenced by the nature of the innovation (e.g., the type and strength of evidence,
the clinical topic) and the manner in which it is communicated (disseminated) to members
(nurses) of a social system (organization, nursing profession).35 Strategies for promoting
adoption of EBPs must address these four areas (nature of the EBP topic; users of the evidence;
communication; social system) within a context of participative change (see Figure 2). This
model provided the framework for a multisite study that tested the effectiveness of a multifaceted
TRIP intervention designed to promote adoption of evidence-based acute pain management
practices for hospitalized older adults. The intervention improved the quality of acute pain
management practices and reduced costs.81 The model is currently being used to test the
effectiveness of a multifaceted TRIP intervention to promote evidence-based cancer pain
management of older adults in home hospice settings. * This guiding framework is used herein to
overview what is known about implementation interventions to promote use of EBPs in health
care systems (see Evidence Table).
*
Principal Investigator: Keela Herr (R01 grant no. CA115363-01; National Cancer Institute (NCI))
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
computer decision-support software that integrates evidence for use in clinical decisionmaking
about individual patients.40, 104, 111–114 There is still much to learn about the “best” manner of
deploying evidence-based information through electronic clinical information systems to support
evidence-based care.115
Methods of Communication
Interpersonal communication channels, methods of communication, and influence among
social networks of users affect adoption of EBPs.39 Use of mass media, opinion leaders, change
champions, and consultation by experts along with education are among strategies tested to
promote use of EBPs. Education is necessary but not sufficient to change practice, and didactic
continuing education alone does little to change practice behavior.61, 116 There is little evidence
that interprofessional education as compared to discipline-specific education improves EBP.117
Interactive education, used in combination with other practice-reinforcing strategies, has more
positive effects on improving EBP than didactic education alone.66, 68, 71, 74, 118, 119 There is
evidence that mass media messages (e.g., television, radio, newspapers, leaflets, posters and
pamphlets), targeted at the health care consumer population, have some effect on use of health
services for the targeted behavior (e.g., colorectal cancer screening). However, little empirical
evidence is available to guide framing of messages communicated through planned mass media
campaigns to achieve the intended change.120
Several studies have demonstrated that opinion leaders are effective in changing behaviors of
health care practitioners,22, 68, 79, 100, 116, 121–123 especially in combination with educational
outreach or performance feedback. Opinion leaders are from the local peer group, viewed as a
respected source of influence, considered by associates as technically competent, and trusted to
judge the fit between the innovation and the local situation.39, 116, 121, 124–127 With their wide
sphere of influence across several microsystems/units, opinion leaders’ use of the innovation
influences peers and alters group norms.39,128 The key characteristic of an opinion leader is that
he or she is trusted to evaluate new information in the context of group norms. Opinion
leadership is multifaceted and complex, with role functions varying by the circumstances, but
few successful projects to implement innovations in organizations have managed without the
input of identifiable opinion leaders.22, 35, 39, 81, 96 Social interactions such as “hallway chats,”
one-on-one discussions, and addressing questions are important, yet often overlooked
components of translation.39, 59 Thus, having local opinion leaders discuss the EBPs with
members of their peer group is necessary to translate research into practice. If the EBP that is
being implemented is interdisciplinary in nature, discipline-specific opinion leaders should be
used to promote the change in practice.39
Change champions are also helpful for implementing innovations.39, 49, 81, 129–131 They are
practitioners within the local group setting (e.g., clinic, patient care unit) who are expert
clinicians, passionate about the innovation, committed to improving quality of care, and have a
positive working relationship with other health care professionals.39, 125, 131, 132 They circulate
information, encourage peers to adopt the innovation, arrange demonstrations, and orient staff to
the innovation.49, 130 The change champion believes in an idea; will not take “no” for an answer;
is undaunted by insults and rebuffs; and, above all, persists.133 Because nurses prefer
interpersonal contact and communication with colleagues rather than Internet or traditional
sources of practice knowledge,134–137 it is imperative that one or two change champions be
identified for each patient care unit or clinic where the change is being made for EBPs to be
enacted by direct care providers.81, 138 Conferencing with opinion leaders and change champions
6
Evidence-Based Practice Implementation
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
individual physician’s practices can be effective but may be perceived as punitive; data feedback
must persist to sustain improved performance; and effectiveness of data feedback is intertwined
with the organizational context, including physician leadership and organizational culture.60
Hysong and colleagues67 found that high-performing institutions provided timely,
individualized, nonpunitive feedback to providers, whereas low performers were more variable
in their timeliness and nonpunitiveness and relied more on standardized, facility-level reports.
The concept of useful feedback emerged as the core concept around which timeliness,
individualization, nonpunitiveness, and customizability are important.
Users of an innovation usually try it for a period of time before adopting it in their
practice.22, 39, 147 When “trying an EBP” (piloting the change) is incorporated as part of the
implementation process, users have an opportunity to use it for a period of time, provide
feedback to those in charge of implementation, and modify the practice if necessary.148 Piloting
the EBP as part of implementation has a positive influence on the extent of adoption of the new
practice.22, 39, 148
Characteristics of users such as educational preparation, practice specialty, and views on
innovativeness may influence adoption of an EBP, although findings are equivocal.27, 39, 130, 149–
153
Nurses’ disposition to critical thinking is, however, positively correlated with research use,154
and those in clinical educator roles are more likely to use research than staff nurses or nurse
managers.155
Social System
Clearly, the social system or context of care delivery matters when implementing
EBPs.2, 30, 33, 39, 60, 84, 85, 91, 92, 101, 156–163 For example, investigators demonstrated the effectiveness
of a prompted voiding intervention for urinary incontinence in nursing homes, but sustaining the
intervention in day-to-day practice was limited when the responsibility of carrying out the
intervention was shifted to nursing home staff (rather than the investigative team) and required
staffing levels in excess of a majority of nursing home settings.164 This illustrates the importance
of embedding interventions into ongoing processes of care.
Several organizational factors affect adoption of EBPs.22, 39, 79, 134, 165–167 Vaughn and
colleagues101 demonstrated that organizational resources, physician full-time employees (FTEs)
per 1,000 patient visits, organizational size, and whether the facility was located in or near a city
affected use of evidence in the health care system of the Department of Veterans Affairs (VA).
Large, mature, functionally differentiated organizations (e.g., divided into semiautonomous
departments and units) that are specialized, with a focus of professional knowledge, slack
resources to channel into new projects, decentralized decisionmaking, and low levels of
formalization will more readily adopt innovations such as new practices based on evidence.
Larger organizations are generally more innovative because size increases the likelihood that
other predictors of innovation adoption—such as slack financial and human resources and
differentiation—will be present. However, these organizational determinants account for only
about 15 percent of the variation in innovation adoption between comparable organizations.22
Adler and colleagues168 hypothesize that while more structurally complex organizations may be
more innovative and hence adopt EBPs relatively early, less structurally complex organizations
may be able to diffuse EBPs more effectively. Establishing semiautonomous teams is associated
with successful implementation of EBPs, and thus should be considered in managing
organizational units.168–170
8
Evidence-Based Practice Implementation
As part of the work of implementing EBPs, it is important that the social system—unit,
service line, or clinic—ensures that policies, procedures, standards, clinical pathways, and
documentation systems support the use of the EBPs.49, 68, 72, 73, 103, 140, 171 Documentation forms or
clinical information systems may need revision to support changes in practice; documentation
systems that fail to readily support the new practice thwart change.82
Absorptive capacity for new knowledge is another social system factor that affects adoption
of EBPs. Absorptive capacity is the knowledge and skills to enact the EBPs; the strength of
evidence alone will not promote adoption. An organization that is able to systematically identify,
capture, interpret, share, reframe, and recodify new knowledge, and put it to appropriate use, will
be better able to assimilate EBPs.82, 103, 172, 173 A learning organizational culture and proactive
leadership that promotes knowledge sharing are important components of building absorptive
capacity for new knowledge.66, 139, 142, 174 Components of a receptive context for EBP include
strong leadership, clear strategic vision, good managerial relations, visionary staff in key
positions, a climate conducive to experimentation and risk taking, and effective data capture
systems. Leadership is critical in encouraging organizational members to break out of the
convergent thinking and routines that are the norm in large, well-established
organizations.4, 22, 39, 122, 148, 163, 175
An organization may be generally amenable to innovations but not ready or willing to
assimilate a particular EBP. Elements of system readiness include tension for change, EBP-
system fit, assessment of implications, support and advocacy for the EBP, dedicated time and
resources, and capacity to evaluate the impact of the EBP during and following implementation.
If there is tension around specific work or clinical issues and staff perceive that the situation is
intolerable, a potential EBP is likely to be assimilated if it can successfully address the issues,
and thereby reduce the tension.22, 175
Assessing and structuring workflow to fit with a potential EBP is an important component of
fostering adoption. If implications of the EBP are fully assessed, anticipated, and planned for, the
practice is more likely to be adopted.148, 162, 176 If supporters for a specific EBP outnumber and
are more strategically placed within the organizational power base than opponents, the EBP is
more likely to be adopted by the organization.60, 175 Organizations that have the capacity to
evaluate the impact of the EBP change are more likely to assimilate it. Effective implementation
needs both a receptive climate and a good fit between the EBP and intended adopters’ needs and
values.22, 60, 140, 175, 177
Leadership support is critical for promoting use of EBPs.33, 59, 72, 85, 98, 122, 178–181 This support,
which is expressed verbally, provides necessary resources, materials, and time to fulfill assigned
responsibilities.148, 171, 182, 183 Senior leaders need to create an organizational mission, vision, and
strategic plan that incorporate EBP; implement performance expectations for staff that include
EBP work; integrate the work of EBP into the governance structure of the health care system;
demonstrate the value of EBPs through administrative behaviors; and establish explicit
expectations that nurse leaders will create microsystems that value and support clinical
inquiry.122, 183, 184
A recent review of organizational interventions to implement EBPs for improving patient
care examined five major aspects of patient care. The review suggests that revision of
professional roles (changing responsibilities and work of health professionals such as expanding
roles of nurses and pharmacists) improved processes of care, but it was less clear about the effect
on improvement of patient outcomes. Multidisciplinary teams (collaborative practice teams of
physicians, nurses, and allied health professionals) treating mostly patients with prevalent
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
chronic diseases resulted in improved patient outcomes. Integrated care services (e.g., disease
management and case management) resulted in improved patient outcomes and cost savings.
Interventions aimed at knowledge management (principally via use of technology to support
patient care) resulted in improved adherence to EBPs and patient outcomes. The last aspect,
quality management, had the fewest reviews available, with the results uncertain. A number of
organizational interventions were not included in this review (e.g., leadership, process redesign,
organizational learning), and the authors note that the lack of a widely accepted taxonomy of
organizational interventions is a problem in examining effectiveness across studies.82
An organizational intervention that is receiving increasing attention is tailored interventions
to overcome barriers to change.162, 175, 185 This type of intervention focuses on first assessing
needs in terms of what is causing the gap between current practice and EBP for a specified topic,
what behaviors and/or mechanism need to change, what organizational units and persons should
be involved, and identification of ways to facilitate the changes. This information is then used in
tailoring an intervention for the setting that will promote use of the specified EBP. Based on a
recent systematic review, effectiveness of tailored implementation interventions remains
uncertain.185
In summary, making an evidence-based change in practice involves a series of action steps
and a complex, nonlinear process. Implementing the change will take several weeks to months,
depending on the nature of the practice change. Increasing staff knowledge about a specific EBP
and passive dissemination strategies are not likely to work, particularly in complex health care
settings. Strategies that seem to have a positive effect on promoting use of EBPs include audit
and feedback, use of clinical reminders and practice prompts, opinion leaders, change
champions, interactive education, mass media, educational outreach/academic detailing, and
characteristics of the context of care delivery (e.g., leadership, learning, questioning). It is
important that senior leadership and those leading EBP improvements are aware of change as a
process and continue to encourage and teach peers about the change in practice. The new
practice must be continually reinforced and sustained or the practice change will be intermittent
and soon fade, allowing more traditional methods of care to return.15
10
Evidence-Based Practice Implementation
to converse with busy clinicians about the evidence-based rationale for doing fall-risk
assessment, and to help them understand that fall-risk assessment is an external
regulatory agency expectation because the strength of the evidence supports this patient
safety practice.
• Third, didactic education alone is never enough to change practice; one-time education
on a specific safety initiative is not enough. Simply improving knowledge does not
necessarily improve practice. Rather, organizations must invest in the tools and skills
needed to create a culture of evidence-based patient safety practices where questions are
encouraged and systems are created to make it easy to do the right thing.
• Fourth, the context of EBP improvements in patient safety need to be addressed at each
step of the implementation process; piloting the change in practice is essential to
determine the fit between the EBP patient safety information/innovation and the setting
of care delivery. There is no one way to implement, and what works in one agency may
need modification to fit the organizational culture of another context.
• Finally, it is important to evaluate the processes and outcomes of implementation. Users
and stakeholders need to know that the efforts to improve patient safety have a positive
impact on quality of care. For example, if a new barcoding system is being used to
administer blood products, it is imperative to know that the steps in the process are being
followed (process indicators) and that the change in practice is resulting in fewer blood
product transfusion errors (outcome indicators).
Research Implications
Translation science is young, and although there is a growing body of knowledge in this area,
we have, to date, many unanswered questions. These include the type of audit and feedback (e.g.,
frequency, content, format) strategies that are most effective, the characteristics of opinion
leaders that are critical for success, the role of specific context variables, and the combination of
strategies that are most effective. We also know very little about use of tailored implementation
interventions, or the key context attributes to assess and use in developing and testing tailored
interventions. The types of clinical reminders that are most effective for making EBP knowledge
available at the point of care require further empirical explanation. We also know very little
about the intensity and intervention dose of single and multifaceted strategies that are effective
for promoting and sustaining use of EBPs or how the effectiveness differs by type of topic (e.g.,
simple versus complex). Only recently has the context of care delivery been acknowledged as
affecting use of evidence, and further empirical work is needed in this area to understand how
complex adaptive systems of practice incorporate knowledge acquisition and use. Lastly, we do
not know what strategies or combination of strategies work for whom, in what context, why they
work in some settings or cases and not others, and what is the mechanism by which these
strategies or combination of strategies work.
This is an exciting area of investigation that has a direct impact on implementing patient
safety practices. In planning investigations, researchers must use a conceptual model to guide the
research and add to the empirical and theoretical understanding of this field of inquiry.
Additionally, funding is needed for implementation studies that focus on evidence-based patient
safety practices as the topic of concern. To generalize empirical findings from patient safety
implementation studies, we must have a better understanding of what implementation strategies
work, with whom, and in what types of settings, and we must investigate the underlying
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
mechanisms of these strategies. This is likely to require mixed methods, a better understanding
of complexity science, and greater appreciation for nontraditional methods and realistic
inquiry.87
Conclusion
Although the science of translating research into practice is fairly new, there is some guiding
evidence of what implementation interventions to use in promoting patient safety practices.
However, there is no magic bullet for translating what is known from research into practice. To
move evidence-based interventions into practice, several strategies may be needed. Additionally,
what works in one context of care may or may not work in another setting, thereby suggesting
that context variables matter in implementation.80
Author Affiliation
University of Iowa Hospitals and Clinics, Department of Nursing Services and Patient Care.
Address correspondence to: Marita G. Titler, Ph.D., R.N., F.A.A.N., University of Iowa
Hospitals and Clinics, Department of Nursing Services and Patient Care, 200 Hawkins Drive RM
T10 GH, Iowa City, IA 52242-1009; e-mail: [email protected].
Search Strategy
Several electronic databases were searched (MEDLINE®, CINAHL®, PubMed®) using terms
of evidence-based practice research, implementation research, and patient safety. (The terms
“quality improvement” or “quality improvement intervention research” were not used.) The
Cochrane Collaboration–Cochrane Reviews was also searched to look for systematic reviews of
specific implementation strategies, and the Journal of Implementation Science was also
reviewed. I also requested the final reports of the TRIP I and TRIP II studies funded by AHRQ.
Classic articles known to the author were also included in this chapter (e.g., Locock et al.123 ).
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20
Figure 1. AHRQ Model of Knowledge Transfer
21
Social System
22
Communication
Characteristics of Communication
the EBP Process of Adoption
Users of the
EBP
Evidence Table. Evidence-Based Practice in Nursing
age.
with hospital-
specific
circumstances; (5)
document and
publicize positive
outcomes; (6)
maintain
effectiveness of
data feedback.
Data feedback that
profiles an
individual
physician’s
practices can be
effective but may
be perceived as
punitive. Data
feedback must
persist to sustain
improved
performance.
Effectiveness of
data feedback
might be
intertwined with the
organizational
context, including
physician
leadership and
organizational
culture.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Carter 200561 Evaluation of Cross-sectional Cross-sectional study of Study setting was Association between There was a strong
the relationship study physicians’ knowledge two academic physician knowledge and inverse relationship
between about Joint National primary care BP control. Covariates of between BP control
physicians’ Committee (JNC) 7 clinics located in presence of diabetes, rates and correct
knowledge of hypertension guidelines the same patient age. responses by
hypertension (level 4). academic medical physicians on the
guidelines and Outcomes were BP center. The knowledge test (r =
blood pressure values of patients each sample was 32 -0.524; p = .002).
(BP) control in physician treated. primary care Strong correlation
their patients. physicians and was also found
613 patients they between correct
treated. Mean age responses on the
of physicians was knowledge survey
41 years and a higher mean
(Standard systolic BP (r =
Deviation [SD]. = 0.453; p = .009).
10.9), majority When the
were men (66%). covariates of
patient age and
27
diabetes were
added to the
model, there was
no longer a
significant
association
between physician
about interacting with the standard arm, continued to receive noted for patient
providers, knowledge of there were 843 quarterly data-feedback survey data.
ADA recommendations, patients at reports, conference calls
and provider baseline and 665 with other centers, and a
performance of key in the followup yearly in-person meeting
processes of care (levels standard intensity with other health centers.
1 and 2). group. 993 The high intensity sites
patients were in received the standard
the high intensity intensity interventions
arm at baseline plus additional support in
and 818 organizational change
postinterventions strategies, chronic care
high intensity management, and
group. Mean age strategies to engage
of subjects ranged patients in behavioral
from 56 to 58, a change designed to get
majority were them to be more active in
female, and white. their care.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Davey 2005187 To estimate the Systematic RCTs, quasi-randomized 66 studies (43 Interventions were A wide variety of
effectiveness of literature review. controlled trials, interrupted time categorized as interventions has
persuasive Evidence level 1. controlled before and series studies, 13 persuasive interventions been shown to be
interventions, (Table 3.1) after studies, and RCTs, 6 controlled (distribution of effective in
restrictive interrupted time series before/after educational materials; changing antibiotic
interventions, studies (levels 2 and 3). studies, 2 local consensus process; prescribing for
and structural Outcomes were controlled clinical educational outreach hospitalized
interventions appropriate antibiotic trials, 1 cluster visits; local opinion patients. Restrictive
(alone or in prescribing and patient clinical trial, 1 leaders; reminders interventions have
combination) in outcomes, including cluster provided verbally, on a greater
promoting length of stay, inpatient randomized trial. paper, or via the immediate impact
prudent mortality, and 28-day The majority of computer; audit and than persuasive
antibiotic mortality (levels 1 and 2). studies (42) were feedback), restrictive interventions,
prescribing to from the United interventions (formulary although their
hospital States. Study restrictions, prior impact on clinical
inpatients. participants were authorization outcomes and long-
health care requirements, therapeutic term effects are
professionals who substations, automatic uncertain.
prescribe stop orders and antibiotic
29
is yet evolving.
Feldman Tested a basic RCT. Prospective randomized Older adults with Basic e-mail reminder Basic and
200564 and an Evidence level 2 trail with 3 groups heart failure (n = upon patient admission augmented
augmented e- (Table 3.1) (control, basic e-mail 628; x age = 72) to the nurses’ care that intervention
Murtaugh mail reminder to reminder, augmented e- and nurses (n = highlighted 6 HF-specific significantly
77
2005 improve mail reminder). Outcome 354; x age = clinical practices for improved delivery
evidence-based measures were nursing 43.6; 93% female) improving patient of evidence-based
care of practices and patient outcomes. Augmented care over control
caring for those
individuals with outcomes. patients. intervention included group; augmented
heart failure Level 1 outcomes. basic e-mail reminder intervention
Home health care
(HF) in home agency in a large plus package of material improved care
health care urban setting. for care of HF patient more than basic
settings. (medication intervention.
management, prompter
card for improving
communication with
physicians, self-care
guide for patients) and
followup outreach by a
clinical nurse specialist
(CNS) who served as an
expert peer.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Foxcroft and Organizational Systematic RCT, controlled clinical 121 papers were Entire or identified No high-quality
Cole 2000188 infrastructures literature review. trial, and interrupted time identified as component of an studies that
to promote series (levels 2, 3, 7). potentially organizational reported the
evidence-based Unit of intervention was relevant, but no infrastructure to promote effectiveness of
nursing practice. organizational, studies met the effective nursing organizational
comprising nurses or inclusion criteria. interventions. infrastructure
groups of professionals After relaxing the interventions to
including nurses. criteria, 7 studies promote evidence-
Outcomes = objective were included and based nursing
measures of evidence- all used a practice were
based practice (levels 1 retrospective case identified.
and 2). study design (15). Conceptual models
that were assessed
positively against
criteria are briefly
included in this
review.
Greenhalgh Diffusion, Systematic Metanarrative review. Comprehensive 7 key topic areas Complex process
22
2005 spread, and literature review. report of factors addressed: requiring multiple
31
oncology
consultants.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Horbar 200466 To evaluate a Clustered Cluster randomized trial 114 hospitals with The multifaceted 18- The proportion of
coordinated, randomized trial. with randomization at the membership in the month intervention infants 23 to 29
multifaceted hospital level (level 2). Vermont Oxford included quarterly audit weeks gestational
implementation Outcomes were Network, not and feedback of data, age receiving
intervention proportion of infants participating in a evidence reviews, an surfactant in the
designed to receiving their first dose formal quality interactive 3-day training delivery room was
promote of surfactant in the improvement workshop, and ongoing significantly higher
evidence-based delivery room, proportion collaborative, with support to participants in the intervention
surfactant of infants treated with the majority of via conference calls and than the control
therapy. surfactant who received infants born in the e-mail discussion. group for all infants
their fist dose more than hospital rather (OR = 5.38). Those
2 hours after birth, and than transferred in who received
time after birth at which and born in 1998 surfactant more
the first dose of and 1999; than 2 hours after
surfactant was received the first birth was
administered; proportion dose of surfactant significantly lower
of all infants who within 15 minutes in the intervention
developed a after birth. than control group
pneumothorax, and Subjects were (OR = 0.35). There
35
single approach
(OR = 1.92). Letter
reminders were
similar to phone
reminders in
effectiveness (OR =
1.89). Reminder
and recall
interventions were
effective for
children and adults
in all types of
settings.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Jamtvedt Use of audit and Systematic Randomized trails (level 85 studies. 53 Audit and feedback Audit and feedback
200670 feedback to literature review. 2). Outcome measures = trials in North defined as any summary can be effective in
improve Metaregression noncompliance with America, 16 in of clinical performance of improving
professional along with visual guideline Europe, 8 in health care over a professional
practice. and qualitative recommendations (level Australia, 2 in specified period of time, practice with effects
analyses. 2). Thailand, 1 in delivered in written, generally
Evidence level 1 Uganda. In most electronic, or verbal moderate. Absolute
(Table 3.1). trials, the format. effects of audit and
professionals were feedback are more
physicians; in 2 likely to be larger
studies the when baseline
providers were adherence to
nurses, and 5 recommended
involved mixed practice is low.
providers. Audit and feedback
should be targeted
where it is likely to
effect change.
Jones 200471 Improvement of Clustered RCT. An intervention study to 12 long-term care Education for staff; No significant
39
pain practices in Evidence level 2 improve pain practices sites in resident educational treatment effect for
nursing homes. (Table 3.1). (RCT). The intervention Colorado—6 in video; designation of a 3- staff knowledge or
was implemented in 6 urban sites and 6 member internal pain staff attitudes; staff
nursing homes (level 2). in rural sites. team; pain vital sign; site in the treatment
Outcomes = pain Nursing homes visits with discussion of group were 2.5
knowledge and attitudes ranged in size feedback reports; pain times more likely to
of staff; pain assessment from 65 to 150 rounds and chose an
administered, using a convenience single practice preventive services that protocol for
protocol-driven sample of patients within with internal are needed using a USPSTF
model for a single practice (n = medicine, family nursing model under the recommendations
comprehensive 987) and a usual care medicine, and guidance of a protocol was associated
preventive group (n = 666) obtained pediatric clinics. agreed upon by the with a significantly
services in a from a random sample of Patients receiving medical staff. higher percentage
low-income households from the care in this clinic of preventive
outpatient postal zip codes served between January services initiated
setting. Focus by the same practice and September (99.6%) in the
was on (level 3). 2001. Children = experimental arm
preventive Outcomes were 514 (about 170 in as compared to
services as percentage of preventive each of 3 age usual care group
recommended services initiated in the groups: 0–2, 3–7, (18.6%) (p < .001).
by the U.S. treatment arm versus the 8–17; 63% African
Preventive comparison arm (level American). Adults
Services Task 1). = 473 (about 170
Force in each age group
(USPSTF). 18–49 and 50–64;
130 in 65 or older;
76% African
American).
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Locock 2001123 Role of opinion Systematic Case studies using Variety of acute Local opinion leaders Both expert and
leader in literature review. principally qualitative care and primary defined as those peer opinion
innovation and methods. care settings. perceived as having leaders have
change. Outcomes = Evaluation of particular influence on important and
effectiveness of opinion PACE project100 the beliefs and actions of distinct roles to play
leaders in promoting and Welsh Clinical their colleagues, either in promoting
change/adoption of National positive or negative. adoption of EBPs.
evidence-based Demonstration Opinion leadership
practices (level 2.) Project. is part of a wider
process that cannot
be understood in
isolation of other
contextual
variables with
which it may
interact. The value
of the expert
opinion leader is in
the initial stages of
41
getting an idea
rolling, endorsing
the evidence, and
translating it into a
form that is
acceptable to
practitioners and
lower in the
intervention arm
than the
comparison arm (P
= .02). There was
no significant
difference for total
antimicrobial use,
rate of urine
cultures obtained,
overall
hospitalization, or
mortality.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
Lozano 2004174 To test the Cluster RCT. RTC. 42 primary care 3 treatment arms were Children in the
effectiveness of Outcomes were practices in 3 usual care, provider (MD, planned care arm
2 annualized asthma locales and PA, NP) oriented strategy had 13.3 fewer
implementation symptom days, asthma- targeted 3–17- of targeted education symptoms annually
interventions in specific functional health year-old children through an on-site peer (P = .02) and 39%
reducing status, and frequency of with mild to leader, and an lower oral steroid
asthma brief oral steroid bursts moderate organizational approach burst rate per year
symptom days (level 1). persistent asthma that combined the relative to usual
as compared to enrolled in provider education with a care (P = .01).
usual care. practices affiliated nurse-run intervention Those in the peer
with man- (planned care arm) to leader arm showed
aged care better organize chronic a 36% decrease in
organizations. asthma care in the annualized steroid
Among the 638 primary care practice. bursts per year as
patient subjects, compared to usual
the mean age was care (P = .008).
9.4 years (SD = Improvements in
3.5); the majority asthma-specific
were white (66%) functional status
43
characteristics of
outreach visits
important to
success.
O’Brien 1999116 Assessment of Systematic RCTs (level 2). Focus was on Use of providers In 3 trials that
the use of local literature review. Outcomes were health care nominated by their measured patient
opinion leaders Evidence level 1 objectively measured providers colleagues as outcomes, 1
on the practice (Table 3.1). provider performance in responsible for educationally influential. achieved an impact
of health a health care setting or patient care. 8 studies met inclusion on practice. Only 2
professionals or health outcomes (levels criteria. A variety of trials provided
patient 1 and 2). patient problems were strong evidence for
outcomes. targeted. improving
performance of
health care
providers. Local
opinion leaders
may be important
change agents for
some problems.
Issue Related Study Design & Study Study Setting &
*
Source to EBP Design Type Outcome Measure(s) Study Population Study Intervention Key Findings
O’Brien 2001118 Assess the Systematic Randomized trials and 32 studies met The intervention was The few studies
effects of literature review. well-designed quasi- inclusion criteria defined as continuing that compared
educational Evidence level 1 experimental studies with 30 RCTs. 24 education: meetings, didactic education
meetings on (Table 3.1). (levels 2 and 3). studies were in conferences, lectures, to no intervention
professional Outcomes were North America, 2 workshops, seminars, did not show an
practice and objectively measured in the United symposia, and courses effect on
health care health professional Kingdom, and 1 that occurred off-site professional
outcomes. practice behaviors or each in Australia, from the practice setting. practice. Studies
patient outcomes in a Brazil, France, Education was defined that used
setting where health Indonesia, Sri as didactic interactive
care was provided Lanka, and (predominately lectures education were
(levels 1, 2, 3). Zambia. Most of with Q and A), or more likely to be
the study interactive (sessions that effective in
participants were involved some type of improving practice.
physicians; 4 interaction in small, Studies did not
included nurses, moderate, or large include information
and 3 other health groups). 7 studies were to determine what
professionals. didactic and 25 were makes some
interactive. Duration and interactive
45
*Study design type: Use the following numbers for categories to reference the specific type of evidence (“evidence level”):
1. Meta-analysis
2. Randomized controlled trials
49
3. Non-randomized trials
4. Cross-sectional studies
5. Case control studies
6. Pretest and post-test (before and after) studies
7. Time series studies
8. Noncomparative studies
Background
The provision of high-quality, affordable, health care services is an increasingly difficult
challenge. Due to the complexities of health care services and systems, investigating and
interpreting the use, costs, quality, accessibility, delivery, organization, financing, and outcomes
of health care services is key to informing government officials, insurers, providers, consumers,
and others making decisions about health-related issues. Health services researchers examine the
access to care, health care costs and processes, and the outcomes of health services for
individuals and populations.
The field of health services research (HSR) is relied on by decisionmakers and the public to
be the primary source of information on how well health systems in the United States and other
countries are meeting this challenge. The “goal of HSR is to provide information that will
eventually lead to improvements in the health of the citizenry.”1 Drawing on theories,
knowledge, and methods from a range of disciplines,2 HSR is a multidisciplinary field that
moves beyond basic and applied research, drawing on all the health professions and on many
academic disciplines, including biostatistics, epidemiology, health economics, medicine, nursing,
operations research, psychology, and sociology.3
In 1979, the Institute of Medicine defined HSR as “inquiry to produce knowledge about the
structure, processes, or effects of personal health services”4 (p. 14). This was expanded upon in
2002 by AcademyHealth, the professional organization of the HSR field, with the following
definition, which broadly describes the scope of HSR:
Health services research is the multidisciplinary field of scientific investigation
that studies how social factors, financing systems, organizational structures and
processes, health technologies, and personal behaviors affect access to health
care, the quality and cost of health care, and ultimately our health and well-being.
Its research domains are individuals, families, organizations, institutions,
communities, and populations.5
More specifically, HSR informs and evaluates innovations in health policy. These include
changes in Medicare and Medicaid coverage, disparities in access and utilization of care,
innovations in private health insurance (e.g., consumer-directed health plans), and trends among
those without health insurance.6–10 The health care industry continues to change, and HSR
examines the impact of organizational changes on access to care, quality, and efficiency (e.g.,
growth in for-profit hospital systems). As new diagnostic and treatment technologies are
introduced, HSR examines their impact on patient outcomes of care and health care costs.
The definition of HSR also highlights the importance of examining the contribution of
services to the health of individuals and broader populations. HSR applied at the population level
is particularly important in understanding health system performance and the impact of health
policy on the public’s health. In the United States, the National Healthcare Quality Report,11
National Healthcare Disparities Report,12 and Healthy People Year 201013 exemplify our
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
capacity for monitoring quality and assessing change. These reports tell us that the American
quality of care is inconsistent and could be substantially improved. The associated cost of health
care services is monitored by the Centers for Medicare & Medicaid Services (CMS). CMS
reports tell us that American health care is the most expensive in the world, consuming
approximately 16 percent of America’s gross domestic product.14
Beyond health policy, HSR examines the process of care and the interactions of patients and
providers. For example, HSR methods have been developed to describe doctor-patient
communication patterns and examine their impact on patient adherence, satisfaction, and
outcomes of care.15–17
Advances in HSR measurement methodologies have made possible policy innovations.
Prospective payment of hospitals, nursing homes, and home health care by Medicare became
possible with the development of robust case-mix measurement systems.18 CMS was able to
initiate a pay-for-performance demonstration, rewarding hospitals with better quality
performance, using valid and robust measures of quality.14 Innovations in health care policy are
frequently made possible by advances in measurement of indicators of health system
performance.
2
Health Services Research
Federal agencies fund HSR. The diversification of funding comes, in part, from the recognition
that HSR is important in managing health care systems, such as the Veterans Health
Administration, and provides essential information on the translation of scientific discoveries
into clinical practice in American communities, such as those funded by National Institutes of
Health. It is estimated that total Federal funding of HSR was $1.5 billion in 2003, of which
AHRQ was responsible for approximately 20 percent.24
Private funding of HSR has also grown over time. Funding by private foundations has a
significant role and complements Federal funding. Among the many foundations funding HSR
are the Robert Wood Johnson Foundation, Commonwealth Fund, Kaiser Family Foundation,
Kellogg Foundation, and Hartford Foundation. Other private funding sources include the health
care industry, for example, pharmaceutical companies, health insurers, and health care systems.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
care than the majority population, even after accounting for differences in access to health
services.
Crossing the Quality Chasm concludes that for the American health care system to attain
these goals, transformational changes are needed.25 The field of HSR provides the measurement
tools by which progress toward these goals is assessed, as seen in the National Healthcare
Quality Report.11 Equally important, health services researchers are developing and evaluating
innovative approaches to improve quality of care, involving innovations in organization,
financing, use of technology, and roles of health professionals.
4
Health Services Research
care on patients. The structure, process, and outcome dimensions of quality are influenced by
both internal and external factors.
Process of Care
The interactions between the health care providers and patients over time comprise the
process of health care. The process of care may be examined from multiple perspectives: the
sequence of services received over time, the relationship of health services to a specific patient
complaint or diagnosis, and the numbers and types of services received over time or for a
specific health problem. Examining the time sequence of health care services provides insights
into the timeliness of care, organizational responsiveness, and efficiency. Linking services to a
specific patient complaint or diagnosis provides insights into the natural history of problem
presentation and the subsequent processes of care, including diagnosis, treatment, management,
and recovery. Examining the natural history of a presenting health complaint across patients will
reveal variations in patterns of care. For example, presenting complaints for some patients never
resolve into a specific diagnosis. An initial diagnosis may change as more information is
obtained. Patients may suffer complications in the treatment process. Also, the process of care
may provide insights into outcomes of care (e.g., return visit for complications). Generally it is
not possible to examine the process of care and determine how fully the patient has recovered
prior health status by the end of the episode of treatment. For this reason, special investigations
are needed to assess outcomes of care.
Evaluation of the process of care can be done by applying the six goals for health care
quality.25 Was the patient’s safety protected (i.e., were there adverse events due to medical errors
or errors of omission)? Was care timely and not delayed or denied? Were the diagnosis and
treatments provided consistent with scientific evidence and best professional practice? Was the
care patient centered? Were services provided efficiently? Was the care provided equitable?
Answers to these questions can help us understand if the process of care needs improvement and
where quality improvement efforts should be directed.
Outcomes of Care
The value of health care services lies in their capacity to improve health outcomes for
individuals and populations. Health outcomes are broadly conceptualized to include clinical
measures of disease progression, patient-reported health status or functional status, satisfaction
with health status or quality of life, satisfaction with services, and the costs of health services.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Historically, quality assessment has emphasized clinical outcomes, for example, disease-specific
measures. However, disease-specific measures may not tell us much about how well the patient
is able to function and whether or not desired health outcomes have been achieved. To
understand the patients’ outcomes, it is necessary to ask patients about their outcomes, including
health status, quality of life, and satisfaction with services. HSR has developed valid and robust
standardized questionnaires to obtain patient-reported information on these dimensions of health
outcomes. As these are more widely applied, we are learning about the extent to which health
care services are improving health.
6
Health Services Research
their treatments. The efficacy question is: What impact does a clinical intervention have under
ideal conditions?
In contrast, effectiveness research is undertaken in community settings and generally
includes the full range of individuals who would be prescribed the clinical intervention. Many of
these individuals will have multiple health problems and be taking multiple medications, unlike
those who were recruited to the RCT. Effectiveness research is seeking to answer the question:
Who will benefit from the clinical intervention among all those people in the community who
have a specific health problem(s)?
Both efficacy and effectiveness questions are important. Logically, effectiveness research
would be conducted after finding the clinical intervention to be efficacious. However, there are
many treatments for which no efficacy information exists; the treatments are accepted as
common practice, and it would not be ethical to withhold treatments from a control group in an
RCT. As a result, effectiveness research may not have the benefit of efficacy findings.
The routine use of an RCT to evaluate efficacy began in the 1960s and is the accepted
procedure for evaluating new medications. However, this standard is not applied across all health
care services and treatments. Most surgical procedures are not evaluated using an RCT. Intensive
care units have never been evaluated using an RCT, nor are nurse staffing decisions in hospitals
or the evaluation of many medical devices. We currently accept different standards of evidence
depending on the treatment technology. As a result, the level of evidence guiding clinical and
public health decisionmaking varies.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The economic impact of receiving free care in one plan versus being in a plan requiring
payment out-of-pocket of deductibles and co-insurance had the expected impact on utilization.
Those paying a share of their medical bills utilized approximately one-third fewer doctor visits
and were hospitalized one-third less frequently.
The impact on 10 health measures of free health insurance versus paying a portion of medical
care costs out of pocket was evaluated. The findings were that there was largely no effect on
health as measured by physical functioning, role functioning, mental health, social contacts,
health perceptions, smoking, weight, serum cholesterol, diastolic blood pressure, vision, and risk
of dying.46 The exceptions were that individuals with poor vision improved under free care, as
did low-income persons with high blood pressure.
Medicare preventive services experiment. A more recent example of RCT methods applied
in HSR is the Baltimore Medicare Preventive Services Demonstration. The study evaluated the
impact on cost and outcomes of offering a defined preventive services package to Medicare
beneficiaries. This was compared to usual Medicare coverage, which paid for few preventive
services. The preventive services coverage being evaluated included an annual preventive visit
with screening tests and health counseling. The physician could request a preventive followup
visit during the year, which would also be covered. Medicare beneficiaries (n = 4,195) were
randomized to preventive services (the intervention group) or usual care (the control group).
Sixty-three percent of those in the intervention group had at least one preventive visit.
Significant differences were found in health outcomes between intervention and control groups.
Among the 45 percent with declining health status, as measured by the Quality of Well-Being
scale,47 the decline was significantly less in the group offered preventive services. Mortality was
also significantly lower in the intervention group. There was no significant impact of preventive
services on utilization and cost.48
8
Health Services Research
were no more effective in controlling psychotic symptoms than the first-generation drug. There
was one exception, the drug Clozapine.51 Furthermore, second-generation medications showed
significant side effects that can affect health outcomes. These included weight gain, metabolic
changes, extrapyramidal symptoms, and sedation effects. Each medication showed a somewhat
different side-effect risk profile. From a positive perspective, the findings indicated that the
clinician and patient can choose any of these medications as first-line treatment except
Clozapine, which is generally used for treatment-resistant cases due to more intensive clinical
monitoring requirements. The ultimate choice of treatment will depend on the patient’s ability to
tolerate side effects that vary by drug.
The conduct of any RCT is resource intensive, requiring the recruitment of participants, and
participants must give informed consent to be randomized. The rationale for making this
investment may depend on the importance of the policy or practice issue. As shown, RCT
methods can be applied to address policy and clinical care concerns with effectiveness. To the
extent that the RCT includes a broad cross-section of people who would be affected by a policy
or receive a clinical treatment, this methodology provides robust effectiveness findings.
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
variation in outcomes. Ideally, the nonequivalent group comparison makes it possible to compare
the effectiveness of alternative treatments and assess the impact of poor access to care. One
limitation of this methodology is the limit of current knowledge regarding all relevant disease
risk factors. Even when risk factors are known, limits on data availability and accuracy of risk
factor measurement have to be considered.
Risk adjustment methods are also used to make cost comparisons across health care
providers to determine which providers are more efficient. Instead of adjusting for disease risk
factors, adjustments are made for the costliness of the patient mix (case mix) and differences in
costs of labor, space, and services in the local area. Comparisons may be made to assess
efficiency of providing specific services (e.g., hospitalization, office visit, or laboratory test).
These comparisons would use case-mix measures that adjust for the costliness of different mixes
of hospital episodes.18 Comparisons of the total cost of care for insured populations would apply
case-mix measures that adjust for disease and health factors that affect total cost of care.54
10
Health Services Research
applications of administrative data include assessing efficiency, timeliness, and equity. The
limitation is that there are many health conditions and health outcomes that cannot currently be
measured using administrative data.
Survey questionnaires. Neither the medical record nor the administrative data capture
information on the patient’s experience in health or patient-reported outcomes of care. Survey
questionnaires are routinely used to obtain information on patient satisfaction in health plans. A
widely used example is the Consumer Assessment of Healthcare Providers and Systems or
CAHPS.57
Information on the impact of health conditions on health and functional status has to come
from the patient. This may be obtained at the time of a visit or hospitalization. However, to
assess patient outcomes of care, systematic followup of patients after the completion of treatment
is generally required. This can be done using mail questionnaires, telephone interviews, or in-
person interviews. The HSR field has developed health-status and quality-of-life measures that
can be used no matter what health conditions the patient has.47, 58–60 Numerous condition-specific
measures of outcome are also used.53
Effectiveness research relies on a range of data sources. Some are routinely collected in the
process of medical care and patient billing. Others may require special data collection, including
medical record abstracts to obtain detailed clinical data and survey questionnaires to gain
information on the patient’s perspective on treatment and outcomes. Efficient strategies for
examining effectiveness may use administrative data to examine a limited set of data on all
patients, and a statistically representative sample of patients for in-depth analysis using data from
chart abstracts and survey questionnaires.
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
treatment into existing practice.62 More needs to be learned how to assist health care providers to
overcome barriers to the adoption of evidence-based practices.
The described data sources and methods can be applied in clinical settings to assess
conformance to evidence-based quality criteria and provide feedback to clinicians. If electronic
health records are available, the feedback and reminders may be directly incorporated into the
medical record and seen by the clinician at the time of a visit. Intermountain Health Care utilizes
its electronic health records to monitor adherence to evidence-based quality standards and to
provide decision support to clinicians when seeing patients. This strategy has contributed to
substantial improvements in their quality performance.63
Outcomes management system. In 1988, Paul Ellwood proposed the adoption of outcomes
management system (OMS) as a method to build clinical intelligence on “what treatments work,
for whom, and under what circumstances.”64 OMS would require linking information on the
patient’s experience with outcomes of care and information on diagnosis and treatment that
would usually come from the medical record.
In 1991, the Managed Health Care Association, an employer organization, brought together a
group of employers and their health plan partners who were interested in testing the OMS
concept in health plans.65 To do so would require a set of methods that could be widely applied
across health plans with differing information systems. The methodology chosen was for each of
16 health plans to identify all adult enrollees with at least two diagnoses of asthma over the
previous 2 years. A stratified sample was chosen with half of the enrollees having more severe
asthma (e.g., hospitalization or emergency room visit in the past 2 years) and the other enrollees
having less severe asthma (outpatient visits only). Each adult received a questionnaire asking
about their asthma treatment and health status. Followup surveys were done in each of 2
successive years to track changes over time.
The findings were compared to national treatment recommendations for adult asthma.66
Across the health plans, 26 percent of severe asthmatics did not have a corticosteroid inhaler, and
42 percent used it daily, as recommended.67 Only 5 percent of patients reported monitoring their
asthma using a home peak flow meter. Approximately half of adults with asthma reported having
the information they needed to avoid asthma attacks, to take appropriate actions when an asthma
flare-up occurs, and to adjust medications when their asthma gets worse. Health plans used the
baseline findings to develop quality-improvement interventions, which varied across health
plans. Followup surveys of the patient cohort provided feedback to health plans on their success
in improving asthma treatment and outcomes over time.
Conclusion
This chapter has provided a definition and history of the field of health services research and
discussed how this field is examining quality-of-care issues and seeking to improve quality of
care. Comparisons of current practice to evidence-based standards with feedback to clinicians
and the integration of patient-reported outcomes are two examples of how HSR tools can be used
to provide quality-improvement information for health care organizations. These examples
utilize multiple data sources, including medical records, patient surveys, and administrative data.
The opportunities for nurse researchers to provide invaluable contributions to the growing field
of health services research are innumerable.
12
Health Services Research
Author Affiliations
Donald Steinwachs, Ph.D.; Director, Health Services Research and Development Center;
Bloomberg School of Public Health; Johns Hopkins University; Baltimore, MD. E-mail:
[email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N.; Senior Health Scientist Administrator; Center for
Primary Care, Prevention, and Clinical Partnerships; Agency for Healthcare Research and
Quality; Rockville, MD. E-mail: [email protected].
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Health Services Research
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15
Chapter 9. Synergistic Opportunity to Connect
Quality Improvement and Emergency Preparedness
Sally Phillips, Ronda G. Hughes, and Lucy A. Savitz
Background
A critical element in the mission of health care organizations is high quality health care.
Organizationally, the hospital enterprise is a hierarchical structure that has separate functional
charges, lines of authority, and personnel resources for quality improvement and emergency
management. The overall umbrella of safety and health care delivery can be viewed to
encompass quality improvement and emergency preparedness, and nursing plays an integral role
in ensuring continuous quality improvement. The interaction of quality improvement and
emergency preparedness resources in hospital settings promises to yield a combined effect that is
greater than the sum of their individual efforts to ensure patient safety and enhanced health care
quality. By strengthening communication channels and fostering opportunities for collaborative
project implementation across quality improvement, emergency preparedness and organizational
functions can be highly synergistic.
*
RTI Master Task Order Contract No. 290-00-0018, L.A. Savitz, Director; 2004.
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general knowledge of the hospital industry—was obtained, affording the opportunity to identify
several common practices. The leadership of the administrative emergency management function
in health care organizations was often former military personnel with security experience or
individuals who had worked their way up through increasing responsibility in
facility/environmental services. Only those organizations with the most visible commitment to
emergency preparedness also had clinical champions who partnered with the administrative
emergency management function. Conversely, quality management typically had clinical leaders
(i.e., physicians and/or nurses) with some training or on-the-job experience in health care
administration. These individuals were repeatedly trained through continuing education and
professional society meetings, used a journal specifically dedicated to implementation science
(visit http://www.implementationscience.com), and reinforced change management principles
using the Institute for Healthcare Improvement collaborative model (visit http://www.ihi.org). A
corollary for support of similar change management efforts does not exist for emergency
management. However, fostering transfunctional collaboration of emergency preparedness and
quality improvement is promising; both the Joint Commission (see the Joint Commission–issued,
revised emergency management standards that were effective January 1, 2008 – visit
http://www.jcrinc.com/28380) and the American Hospital Association are working toward
increasing opportunities for such dialogues.
Recent experience with Hurricane Katrina has highlighted the “soft underbelly” of hospital
preparedness and emphasized the inseparable role that emergency management plays in the
overall quality and safety of health care delivery. The emergency preparedness of this country is
based on a robust health care delivery system. The public expects and is entitled to receive the
highest quality evidence-based care within the most efficient delivery system possible. At times
of crisis be it a disaster, natural or man made, or a major infectious disease, SARS or Pandemic,
the already stressed health care system operating at the margins will be challenged to deliver this
level of care without concerted planning and cooperation. Nurse executives must lead a cultural
shift towards using evidence-based management and clinical practices (Williams 2006) in both
quality improvement and emergency preparedness. Principal team players must include nurses,
who are the essential back-bone of successful change efforts in hospitals (Savitz & Kaluzny,
2000). The extent to which nursing leaders, including middle managers, can be engaged in
change management activities (Dopson & Fitzgerald, 2006) for emergency preparedness will be
an important investment in successful design and implementation of targeted interventions.
There is not good visibility for emergency preparedness commitment on the part of clinical staff
in operational areas demonstrated, for example by most staff avoiding required drills failing to
see the priority from their leaders. Health system leadership can change this by appropriately
acknowledging and rewarding such efforts and modeling the commitment.
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Connecting Quality Improvement & Emergency Preparedness
role as caregivers and clinical managers. Consequently, it would be possible to link knowledge-
based learning about how interventions are implemented (a.k.a., implementation science) so that
advancements in our understanding are not confined to any single aspect of quality health care
delivery, but are opportunities for cross-fertilization and synergy.
As stated by Mittman,4 implementation science focuses on a second level of research
translation where one takes evidence-established benchmarks from limited settings (i.e., level 1
translation) to practice innovations, and more broadly to disseminate that knowledge.
Implementation science (or second-level research translation) is an evolving, multidisciplinary
area, and the terminology has not yet been consistently established. For example, Chapter 7
(“The Evidence for Evidence-Based Practice Implementation”) in this Handbook discusses
“translation science” to describe the same concept. Despite the inconsistent terminology,
researchers and practitioners are committed to implementing and disseminating promising
practices.
The notion of an implementation deficit between what is planned versus achieved and the
challenge of effectively translating research into practice has a long-standing literature base,
primarily in organizational studies and public policy analysis.6, 8, 9 In terms of nursing, the
research has been inconclusive even about the evidence for specific interventions.10 A
generalized conceptual model of translational implementation, based on Rogers’s seminal work,6
has been incorporated into numerous change management efforts such as the RE-AIM11, 12
(Figure 2).
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 1
What we know from reported studies and have been learning in subsequent research is that
change will be a nonlinear process stymied by individual and organizational barriers.2, 13–16
Attempts to advance implementation science in health care have focused on the factors that
affect adoption and sorting out different strategies to accelerate that second level of translating of
research into practice.2, 17, 18 A recent report by Hamel19 described the conditions necessary for
management innovation that produced bold breakthroughs in how business was done, including
commitment to a big problem (e.g., bioterrorism preparedness), new approaches (e.g.,
application of information technology such as electronic medical records), deconstruction of
management orthodoxies (via exchanged resources and knowledge between the quality
improvement and emergency management silos), and shared stories from diverse organizations
that redefined what is possible. Early adopters lead the way.
Over the past decade, targeted research related to understanding how clinical process
innovations are adopted has been funded by the AHRQ. Building on that base effort, the AHRQ
funded the Partnership for Advancing Quality Together (PAQT) grant * (part of the AHRQ’s
Partnerships for Quality initiative) to achieve the following specific aims: strengthen an existing
research network that promotes sharing of local innovations, explore factors that impede and
facilitate inter- and intra-organizational sharing of knowledge, provide a mechanism to test the
transportability of clinical process innovations, influence the breadth and depth of the evidence
base for quality improvement, and accelerate the rate at which knowledge utilization occurs.
Underlying these aims was a directive to explore the potential synergies between quality
improvement and emergency preparedness.
Collaborative efforts to address these issues was done in a focused manner through 17
applied research projects, which led to several important findings and strategies for supporting
knowledge transfer and implementation science that are relevant to both quality improvement
and emergency preparedness. The three main findings are:
*
AHRQ 5 U18 HS13706.
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we have learned29 that there is a life cycle associated with organizational learning, and where an
organization or unit sits on that life cycle is influenced by staff tolerance for change and
experience with innovation implementation over time. Whether the evidence is self-generated or
modeled from reports in the literature, a primary issue is how to appropriately target intended
end users. Novel approaches and use of preexisting dissemination channels will be needed to
accelerate the rate at which such knowledge is put into practice.
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Connecting Quality Improvement & Emergency Preparedness
routinization is important; and we have the tools to monitor such evolution in comparing and
contrasting a single intervention across multiple clinical sites.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 1
is targeted injury detection systems. Surveillance systems for bioterrorism have been
deployed at the health system (e.g., Intermountain Healthcare during the Winter
Olympics) and regional levels for monitoring select illness and disease patterns to
mitigate potential events.
• Performance measurement: Performance measurement in quality improvement is
currently getting a great deal of attention50 due to the early mantra of leading thinkers like
Juran—you can’t manage what you can’t measure. Boards are now asking for emergency
preparedness measures to ascertain comparative readiness. *
As illustrated by these examples, both areas—quality improvement and emergency
preparedness—are focused on preparedness, and both face the challenge of how to implement
targeted interventions. As one seeks to implement new programs and interventions in complex
health care settings, one faces the same challenges associated with adoption, implementation,
and maintenance of the intervention. Teams in both domains should consistently report both
successes and failures within their settings and in publications that reach those most likely to use
such information and be open to understanding how such reports can advance their respective
work. Further, taking successful quality improvement or emergency preparedness interventions
and disseminating such promising practices across a health system, a community, and/or to the
industry is a hurdle at best.
*
The American Hospital Association is currently fielding a survey that is intended to generate data that will yield
comparative results on hospital preparedness.
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Connecting Quality Improvement & Emergency Preparedness
Visibility with facility leadership and a six-step approach have been developed from
observed implementation efforts over the past 2 years. This generalized approach to
dissemination and implementation is both evidence- and experience-based, having been used
successfully in leading partner health systems for both bioterrorism preparedness and quality
improvement interventions.
Key among these six steps is the preparation of the training manual (the conduit) and the site-
specific clinical champions (linking agents), which are believed to be essential in accelerating
innovation diffusion and institutionalization. * The constructs of conduits and linking agents were
recently conceptualized by Rogers6 within his diffusion of innovation framework and related
literature. Conduits are those tools or dissemination vehicles developed to facilitate uptake of
research into practice (i.e., a DVD and companion training manual). Using conduits has been a
major focus of our applied research and dissemination efforts to date. Linking agents have been
described both in terms of agencies within a system (e.g., community hospital policies) and
individuals (e.g., staff nurses implementing guideline recommendations); linking agents are the
same as opinion leaders/champions or change agents. While the importance of conduits and
linking agents are separately acknowledged in the change management and quality improvement
literature, integration of the conduit and linking agent constructs into formal implementation
planning processes has not been done.
Practice Implications
As a hospital addresses quality improvement throughout its operating structure, it should be
examining all aspects of performance relating to delivering safe and high-quality services to its
patients in all situations. These quality improvement efforts not only address the day-to-day
services and functions, but also address the ability to meet those challenges presented during an
emergency. Institutions should be incorporating evidence-based quality improvement measures
that build on efforts already in place and begin to build the evidence and experience for
emergency preparedness that complement these efforts. Maintaining separate structures for these
activities is not only inefficient, but counterproductive.
As health care systems institute change management efforts, they should be incorporating
emergency preparedness initiatives. Health care organizations should address a series of
emergency preparedness activities and should initiate them within their quality improvement
framework. For example, if an exercise is conducted to test the emergency preparedness plan,
meeting one of the performance standards of the Joint Commission accreditation, it should be set
up within a quality improvement framework. The institutional or unit performance should be
measured for emergency preparedness using evidence-based tools like the one developed by
AHRQ.51 This quality improvement strategy—deployed throughout the system to address
efficiency, effectiveness, and safety/quality—is no different or separate from this one dimension
of emergency preparedness. As the metric of preparedness performance is measured, focused
quality improvements can be initiated.
There is an impressive body of quality improvement literature that can be brought to bear on
emergency preparedness. However, the literature on the metrics for preparedness and quality
*
The research evidence for this approach is reviewed in depth in Chapter 7 of this Handbook.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 1
improvement is scant and inconclusive.52 Health care organizations on the cutting edge of this
field are encouraged to report the use of evidence-based tools and piloted quality improvement
measures in the literature and share their experience with colleagues. It was mentioned earlier in
this paper that there are few forums that address institutional emergency preparedness measures
that are initiated within a quality improvement framework. Hospitals and health systems should
create opportunities for dialogue and shared learning; they should support the development of
leaders within their organizations who bridge the chasm between the two activities. Nurses are
well positioned to provide such leadership. The astute manager of these organizations should
address vital strategies for reorganization that merge these activities and consider the career path
for clinical leaders within the organization who can participate and provide leadership in the
planning and evaluation strategies for these innovations. To achieve organizational awareness
and commitment, the merged mission activities need to be supported though open dialogues and
structured committee discussions at all levels of the organization affected by emergency
preparedness.
The emergency preparedness activities thrust on an organization can either be presented as an
annoying add-on function that distracts the organization from its primary mission, or they can be
incorporated into the fabric of the mission and staff roles. The unique exercises and training
activities required for emergency preparedness could be expanded to incorporate testing and
evaluating new quality improvement measures. For example, resuscitation competency training
in the emergency department could easily be incorporated into a drill testing the emergency
department’s response to an explosive or mass-casualty attack—thereby testing a day-to-day
activity that can be measured for improvement and instituting remedial training alongside other
skills and competencies for an effective emergency response. Also, essential in emergency
preparedness planning are critical functions and strategies that require activities to protect the
staff and the facility (e.g., avoiding contact with an infectious agent or a contaminant). Strategies
such as fit testing masks, decontamination procedure, mass prophylaxis of staff and their
families, and enhanced infection control measures are not unique to emergency preparedness
and, therefore, are easily accommodated in day-to day-quality improvement, education, and
training requirements of any health care institution. A good clinical champion from the infectious
disease department (usually a nurse) can easily translate the interrelatedness of the two functions
and readily get on board with an integrated approach.
Research Implications
This is an exciting and dynamic area in which little is currently known. Nurse leaders, nurse
researchers and other nurses should and can have a critical role in taking these aforementioned
concepts and design strategies, building on quality improvement and emergency preparedness
methods, and demonstrating their effectiveness and impact. High priority should be given to
developing and testing models that can be generalizable and actionable for clinicians that clearly
define the roles and impact of nursing leadership. In so doing, the actual process of integrating
quality improvement and emergency preparedness needs to be clearly delineated so that the
successes of demonstration projects can be understood and replicated, particularly in preparation
for unanticipated catastrophic events.
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Connecting Quality Improvement & Emergency Preparedness
Conclusions
Nursing leadership has the opportunity to use new emergency preparedness evidence- and
experienced-based measures that are or can be developed and disseminated. To realize this
integrated approach locally, it is essential to embed interventions into the fabric of work and
make these efforts visibly present so that staff are perpetually readied for the day-to-day issues of
improving quality and safety, and the extraordinary issues of an unanticipated catastrophic event.
With strong mission leadership to merge the two areas structurally and functionally, acceptance
of valid measures and cross-integration can be achieved. In conclusion, hospital leadership
should
1. Recognize the synergies between quality improvement and emergency preparedness,
providing support, visibility, and performance feedback for these shared functions;
2. Empower clinical leaders to formally bridge the gap and share knowledge across these
functional areas; and
3. Support the evidence base by providing resources to contribute to the literature on
implementation science that can foster modeling in other facilities and communities.
Building the evidence base and recognizing the synergies between quality improvement and
emergency preparedness is vital for the safety of patients in the resource-constrained
environment in which we provide hospital care. Executive management is challenged to think
prospectively to connect the dots and take advantage of these synergies to efficiently provide the
highest quality health care possible to their patients.
Author Affiliations
Sally Phillips, Ph.D., R.N., director for Public Health Emergency Preparedness Research,
Center for Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research
and Quality. E-Mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Center for
Primary Care, Prevention and Clinical Partnerships, Agency for Healthcare Research and
Quality. E-mail: [email protected].
Lucy A. Savitz, Ph.D., M.B.A., senior associate, Domestic Health, Abt Associates. E-mail:
[email protected].
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Technol Asses 2004;8(6):iii-iv, 1-72. 23. Dickersin K. Systematic reviews in epidemiology:
why are we so far behind? International
10. Thompson DS, Estabrooks CA, Scott-Findlay S, et al. Epidemiological Association 2002;31:6-12.
Interventions aimed at increasing research use in
nursing: a systematic review. Implement Sci 24. Callaham M, Wears RL, Weber E. Journal prestige,
2007;2:15. publication bias, and other characteristics associated
with citation of published studies in peer-reviewed
11. Glasgow RE. RE-AIMing research for application: journals. JAMA 2002;287(21):2847-50.
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12. Majid DJ, Estabrooks PA, Brand DW, et al. 2001;17(3):400-8.
Translating patient safety research into clinical
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al., eds. Advances in patient safety, Volume 3. management: from theory to practice in health care.
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Healthcare Research and Quality; February 2005.
(p.163-172). AHRQ Publication No. 050021-3. 27. Steinberg EP, Luce BR. Evidence based? Caveat
emptor! Health Aff Jan/Feb 2005;80-92.
13. Carroll JS, Edmondson AC. Leading organizational
learning in health care. Qual Saf Health Care 2002 28. Sackett DL. Evidence-based medicine. Semin
Mar;11(1):51-6. Perinatol 1997;21(1):3-5.
14. French B. Contextual factors influencing research use 29. Savitz LA, Kaluzny AD, Kelly DL. A life cycle
in nursing. Worldviews Evid Based Nurs model of continuous clinical process innovation. J
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discussion 315-6.
15. Ovretveit J, Gustafson D. Using research to inform
quality programmes. BMJ 2003;326:759- 61. 30. Leape LL, Rogers G, Hanna D, et al. Developing and
implementing new safe practices: voluntary adoption
16. Beer M, Nohria N. Cracking the code of change. through statewide collaboratives. Qual Saf Health
Harv Bus Rev 2000;78(3):133-41, 216. Care 2006;15:289-95.
17. Ovretveit J. Formulating a health quality 31. Dopson S, Locock L, Chamers D, et al.
improvement strategy for a developing country. Int J Implementation of evidence-based medicine:
Health Care Qual Assur Inc Leadersh Health Serv evaluation of the Promoting Action on Clinical
2004;17(7):368-76. Effectiveness programme. J Health Serv Res Policy
2001;6(1):23-31.
18. Farquhar CM, Stryer D, Slutsky J. Translating
research into practice: the future ahead. Int J Qual 32. Grimshaw J, McAuley LM, Bero LA, et al.
Health Care 2002 Jun;14(3):233-49. Systematic reviews of the effectiveness of quality
improvement strategies and programmes. Qual Saf
19. Hamel G. The why, what, and how of management Health Care 2003 Aug;12(4):298-303.
innovation. Harv Bus Rev 2006 Feb;84(2):72-84,
163. 33. Bero LA, Grilli R, Grimshaw JM, et al. Closing the
gap between research and practice: an overview of
20. Kovner AR, Elton JJ, Billing J. Evidence-based systematic reviews of interventions to promote the
management. Front Health Serv Manage implementation of research findings. The Cochrane
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21. Shortell SM, Zazzali JL, Burns LR, et al.
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Connecting Quality Improvement & Emergency Preparedness
34. Helfrich CD, Savitz LA, Swiger KD, et al. Adoption 44. Levi L, Bregman D, Geva H, et al. Hospital disaster
and implementation of mandated diabetes registries management simulation system. Prehosp Disaster
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Jul;33(1 Suppl):S50-8; quiz S59-65.
45. Levi L, Bregman D. Simulation and management
35. Pfeffer J, Sutton RK. The smart-talk trap. Harv Bus games for training command and control in
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36. Pfeffer J, Sutton RI. Evidence-based management.
Harv Bus Rev 2006;84(1):62-74, 133. 46. Agency for Healthcare Research and Quality.
Effectiveness of continuing medical education.
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38. Leonard M, Graham S, Bonacum D. The human emergency assistance line and triage hub (HEALTH)
factor: the critical importance of effective teamwork model. Rockville, MD: AHRQ; January 2005. AHRQ
and communication in providing safe care. Qual Saf Publication No. 05-0040.
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48. Hick JL, O’Laughlin DT. Concept of operations for
39. Kaluzny AD, Konrad TR, McLaughlin CP. triage of mechanical ventilation in an epidemic. Acad
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51. 49. Agency for Healthcare Research and Quality.
Effectiveness of Continuing Medical Education.
40. Agency for Healthcare Research and Quality. Rockville, MD: Agency for Healthcare Research and
Training of hospital staff to respond to a mass Quality; January 2007. AHRQ Publication No. 07-
casualty incident, structured abstract. Rockville, MD: E006.
Agency for Healthcare Research and Quality; April
2004. AHRQ Publication No. 04-E015-2. 50. Institute of Medicine. Performance measurement:
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the Johns Hopkins/Agency for Healthcare Research
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Ann Emerg Med 2007 Oct 13 [Epub ahead of print]. Bioterrorism preparedness and response: use of
information technologies and decision support
42. Leiba A, Drayman N, Amsalem Y, et al. Establishing systems, structured abstract. Rockville, MD: Agency
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capacity. Rockville, MD: Agency for Healthcare
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2004;328:269-71.
13
Chapter 10. Fall and Injury Prevention
Leanne Currie
Background
Fall and injury prevention continues to be a considerable challenge across the care continuum.
In the United States, unintentional falls are the most common cause of nonfatal injuries for
people older than 65 years. Up to 32 percent of community-dwelling individuals over the age of
65 fall each year, and females fall more frequently than males in this age group.1, 2 Fall-related
injuries are the most common cause of accidental death in those over the age of 65, resulting in
approximately 41 fall-related deaths per 100,000 people per year. In general, injury and mortality
rates rise dramatically for both males and females across the races after the age of 85, but males
older than 85 are more likely to die from a fall than females.2-6 Unfortunately, fall-related death
rates in the United States increased between 1999 and 2004, from 29 to 41 per 100,000
population.2, 7 Sadly, these rates are moving away from the Healthy People 2010 fall-prevention
goal, which specifically seeks to reduce the number of deaths resulting from falls among those
age 65 or older from the 2003 baseline of 38 per 100,000 population to no more than 34 per
100,000.8 Thus, falls are a growing public health problem that needs to be addressed.
The sequelae from falls are costly. Fall-related injuries account for up to 15 percent of
rehospitalizations in the first month after discharge from hospital.9 Based on data from 2000,
total annual estimated costs were between $16 billion and $19 billion for nonfatal, fall-related
injuries and approximately $170 million dollars for fall-related deaths across care settings in the
community.10, 11 Several factors have been implicated as causes of falls and injuries; to date,
however, no definitive predictor profile has been identified. Although the underlying status of
the individual who sustains a fall may contribute to the fall and subsequent injury, the trauma
resulting from the fall itself is most often the cause of morbidity and mortality.
Over the past 20 years gerontology researchers, spearheaded by Mary Tinnetti from Yale
University, have carried out a significant amount of research to address the problem of falls and
injuries in the community. However, ubiquitous use of successful interventions is not yet in place
in the community. As health care moves toward patient-centered care, and as a growing body of
research provides guidance for widespread fall-prevention programs, fall- and fall-related-injury
prevention now has the potential to be addressed across the care continuum.
Inpatient fall prevention has been an individual area of concern for nursing for almost 50
years.12, 13 Traditional hospital-based incident reports deem all inpatient falls to be avoidable, and
therefore falls are classified as adverse events. Indeed, falls are the most frequently reported
adverse events in the adult inpatient setting. But underreporting of fall events is possible, so
injury reporting is likely a more consistent quality measure over time and organizations should
consider judging the effects of interventions based on injury rates, not only fall rates. Inpatient
fall rates range from 1.7 to 25 falls per 1,000 patient days, depending on the care area, with
geropsychiatric patients having the highest risk.14-18 Extrapolated hospital fall statistics indicate
that the overall risk of a patient falling in the acute care setting is approximately 1.9 to 3 percent
of all hospitalizations.16-18 In the United States, there are approximately 37 million
hospitalizations each year;19 therefore, the resultant number of falls in hospitals could reach more
than 1 million per year.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Injuries are reported to occur in approximately 6 to 44 percent of acute inpatient falls.5, 20-23
Serious injuries from falls, such as head injuries or fractures, occur less frequently, 2 to 8 percent,
but result in approximately 90,000 serious injuries across the United States each year.20 Fall-
related deaths in the inpatient environment are a relatively rare occurrence. Although less than 1
percent of inpatient falls result in death, this translates to approximately 11,000 fatal falls in the
hospital environment per year nationwide. Since falls are considered preventable, fatal fall-
related injuries should never occur while a patient is under hospital care.
In the long-term care setting, 29 percent to 55 percent of residents are reported to fall during
their stay.24, 25 In this group, injury rates are reported to be up to 20 percent, twice that of
community-dwelling elderly. The increase in injury rates is likely because long-term care
residents are more vulnerable than those who can function in the community.26 Rubenstein27
reported 1,800 long-term care fatal falls in the United States during1988. The current number of
long-term care fatal falls has not been estimated; however, there are 16,000 nursing homes in the
United States caring for 1.5 million residents in 2004.28 This population will likely grow in the
coming years, thus fall and injury prevention remains of utmost concern.
2
Fall and Injury Prevention
concordance between chart abstraction and minimum dataset reporting for a group of long-term
care facilities. A more recent development in the long-term care setting, the Nursing Home
Quality Initiative, promotes the collection of a list of enhanced quality indicators, including those
that track declines in functional and cognitive status.34, 37 The Agency for Healthcare Research
and Quality (AHRQ) has elected to monitor only postoperative hip fracture as their fall-related
preventive quality indicator, which is consistent with thinking that monitoring fall-related
injuries is a more dependable measure of quality.39, 40 However, tracking of all fractures would
be of benefit. The Health Plan Employer Data and Information Set has recently added Fall Risk
Assessment to its dataset, which will provide a method to benchmark the evaluation of fall risk
between health insurance providers.41 However, application of fall- and injury-prevention
programs is not included as an indicator, which will make it difficult to benchmark these
important measures. Increased and more accurate monitoring of these elements has the potential
to reduce falls among nursing home residents; however, the effect of these efforts has yet to be
established.
Falls and related injuries have had varying definitions.42, 43 Falls may be precipitated by
intrinsic or extrinsic factors. Intrinsic factors are those that have a physiologic origin, and
extrinsic factors are those precipitating from environmental or other hazards. Distinguishing
between intrinsic or extrinsic risk factors can facilitate identification of preventive strategies.
According to Tinetti, Speechley, and Ginter,44 a fall in the nonhospitalized geriatric population is
defined as “an event which results in a person coming to rest unintentionally on the ground or
lower level, not as a result of a major intrinsic event (such as a stroke) or overwhelming hazard.”
Agostini, Baker, and Bogardus45 adapted this definition for the inpatient, acute, and long-term
care areas to define a fall as “unintentionally coming to rest on the ground, floor, or other lower
level, but not as a result of syncope or overwhelming external force.”
Other definitions are broader and include falls related to intrinsic events such as syncope or
stroke. For example, Nevitt’s46 definition of a fall is “falling all the way down to the floor or
ground, or falling and hitting an object like a chair or stair.” The ANA–NDNQI provides an all-
inclusive definition47 (p. 26):
An unplanned descent to the floor (or extension of the floor, e.g., trash can or
other equipment) with or without injury. All types of falls are included, whether
they result from physiological reasons or environmental reasons.
The International Classification of Diseases 9 Clinical Modifications (ICD-9-CM) uses
several codes to categorize falls, all of which have broad descriptions: Accidentally bumping
against moving object caused by crowd with subsequent fall (E917.6); Fall on or from ladders or
scaffolding (E881); Fall from or out of building or other structure (E882); Other fall from one
level to another (E884); Fall on same level from slipping, tripping, or stumbling (E885); Fall on
same level from collision, pushing, or shoving by or with another person (E886); and Other and
unspecified fall (E888).48 In the inpatient care setting, E888 is the code that is typically used to
record a fall in a medical record. However, this ICD-9-CM code is not consistently used for
reporting; therefore, institutions generally rely on incident reports as the method of counting fall
events.48
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Fall-related injuries in the community, home care, and long-term care areas are generally
characterized by ICD-9-CM diagnoses for the related injured body part. In contrast, incident
reports in the acute care setting use the following ANA–NDNQI fall-related injuries categories:
(1) None indicates that the patient did not sustain an injury secondary to the fall.
(2) Minor indicates those injuries requiring a simple intervention.
(3) Moderate indicates injuries requiring sutures or splints.
(4) Major injuries are those that require surgery, casting, further examination (e.g., for a
neurological injury).
(5) Deaths refers to those that result from injuries sustained from the fall.29
According to Morse,21 inpatient falls can be classified into three categories: accidental falls
(derived from extrinsic factors, such as environmental considerations), anticipated physiologic
falls (derived from intrinsic physiologic factors, such as confusion), and unanticipated
physiologic falls (derived from unexpected intrinsic events, such as a new onset syncopal event
or a major intrinsic event such as stroke). Morse asserts that using this classification,
approximately 78 percent of the falls related to anticipated physiologic events can be identified
early, and safety measures can be applied to prevent the fall. Research to identify precursors to
unexpected intrinsic events, such as screening for predictors of syncopal events, might increase
the early identification of anticipated physiologic falls, which could ultimately prevent more
falls.49-51
The definition of a fall is consistent with that of a medical error: “the failure of a planned
action to be completed as intended” (i.e., error of execution) or “the use of a wrong plan to
achieve an aim” (i.e., error of planning).52, 53 For example, an error of execution might be the
failure to perform the planned action of placing a call light within the patient’s reach, and an
error in planning might be to provide aggressive physical therapy before a patient's balance has
been established. An error of commission is “an error that occurs as a result of an action taken,”
for example, a fall that occurs subsequent to a behavioral health patient's electroconvulsive
therapy. An error of omission, “an error which occurs as a result of an action not taken,” might
occur if the patient is not assessed for fall and injury risk, which prevents appropriate
interventions from being applied. Latent errors related to fall and injury prevention are those in
which an agency does not apply appropriate standards, training, or support for the practice-based
fall- and injury-prevention processes. Recent efforts by the Joint Commission (formerly the Joint
Commission on Accreditation of Healthcare Organizations [JCAHO]) in its National Patient
Safety Goals advocate for institution-wide risk assessment for falls and documentation of a fall-
prevention program.54 These efforts have the potential to eliminate latent errors related to falls
and injuries. Monitoring errors might occur if the patient is not monitored to identify fall risk, or
if the patient is not monitored to identify a post-fall injury such as a subdural hematoma.
This review summarizes the current research related to fall and injury prevention. The
chapter is organized to present research from two perspectives: (1) community setting, and (2)
acute and long-term settings. For each setting, the research that addresses risk factors, risk
assessment instruments, and fall- and injury-prevention interventions are reviewed. Reports on
the outcomes of fall- and injury-prevention research using experimental or quasi-experimental
research design is summarized in tables at the end of the chapter.
4
Fall and Injury Prevention
Research Evidence
Falls and Related Injuries in the Community
In the following section, research about falls and related injuries in the community were
identified and categorized as follows: risk factor identification, risk assessment instruments, and
prevention strategies.
Risk factors in the community. The pivotal research of Tinetti, Speechly and Ginter44
related to fall and injury prevention in community-dwelling individuals older than 65 years
identified the following risk factors for falling: (1) postural hypotension, (2) use of any
benzodiazepine or sedative-hypnotics, (3) use of four or more prescription medications, (4)
environmental hazards, and (5) muscular strength or range of motion impairments. Other
researchers have identified additional patient or treatment risk factors: (1) comorbidities,
including diabetes, diabetic foot ulcer,55 stroke,56 syncope,57 anemia,58, 59 Alzheimer’s disease,60
Parkinson’s disease,61 vitamin D deficiency,62, 63 and vitamin D deficiency in combination with
low creatinine clearance;64 (2) patient characteristics, including fallophobia (also known as “fear
of falling”),65, 66 gait problems (e.g., weakness and impaired sensation),67 postural hypotension,
inability to get out of chair, impaired ability to perform ADLs, frailty,68-70 inability to follow
instructions,71 and inability to adapt to changing environment;72 and (3) other characteristics,
including recent hospitalization,9 nonsupportive footwear (e.g., slippers),73 reckless wheelchair
use,74 environmental hazards, and use of psychotropic medication.75, 76 Age and gender are also
associated with falls and fall-related morbidity and mortality. Fall rates increase with age,77 and
in community-dwellers between 65 and 85 years of age, females are more likely to fall, but
males are more likely to die from fall-related injuries than females in this group.1, 2
The roles of ethnicity and race in relation to falls and injury have also been studied. Reyes-
Ortiz and colleagues78 examined risk factors for Mexican-Americans and found that in the
community, the risk factors are the same as for their White counterparts. Hanlon and colleagues79
examined predictors of falls between Caucasians and African Americans and found that African
Americans were 23 percent less likely to fall than Whites (odds ratio = 0.77). Faulkner and
colleagues80 explored this difference in women and found that Caucasian women were 50
percent more likely to fall than African American women, although this was not statistically
significant (relative risk = 1.50, 95% confidence interval [95% CI] = 0.90–2.49). The researchers
further examined situations leading to falls and found that circumstances differed by ethnicity:
Caucasian women were more likely to fall outdoors versus indoors (odds ratio = 1.6, 95% CI =
1.0–2.7) and laterally versus forward (odds ratio = 2.0, 95% CI = 1.1–3.4), but less likely to fall
on the hand or wrist (odds ratio = 0.6, 95% CI = 0.3–1.0). This research suggests that activities
differ between older African American women and their Caucasian counterparts and should be
considered when making fall- and injury-prevention plans.
Risk factors for injury in the community. Risk factors for injury in the community are
increasingly well characterized. Porthouse and her research team81 performed a comprehensive
cohort study of almost 4,300 women older than 70 years and confirmed the following risk factors
for various types of fall-related fractures: (1) fall in the past 12 months, (2) increasing age, (3)
previous fracture, and (4) low body weight. This work also identified that smoking was not
associated with fracture risk. A growing body of research is examining vitamin D deficiency as a
risk factor for fracture; however, results are conflicting to date, but bear further research.81, 82
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Colon-Emeric and colleagues83 used data from a large community epidemiologic study to
identify whether historical and functional information could help to predict fracture risk. The
researchers identified nine characteristics that were predictors of fracture: (1) female sex, (2) age
greater than 75 years, (3) White race, (4) body mass index (BMI) of less than 22.8 kg/m2, (5)
history of stroke, (6) cognitive impairment, (7) one or more ADL impairments, (8) one or more
Rosow-Breslau impairments (e.g., perform heavy work, walk a mile, climb stairs), and (9)
antiepileptic drug use. Ohm and colleagues84 recently identified that elderly community-dwelling
individuals with traumatic head injuries were more likely to die based on the use of antiplatelet
therapy (relative risk = 2.5 for those taking antiplatelet therapies; P = 0.016). A similar body of
research related to chronic subdural hematomas has identified that patients on anticoagulant or
antiplatelet therapy are at higher risk for chronic subdural hematoma and that many of these are
first identified when a patient is evaluated after a fall.85 Many injury risk factors are consistent
with fall risk factors, accentuating the need for effective screening of elderly community-
dwelling individuals. However, factors that make people more susceptible to injury, such as
antiplatelet therapy, establish the need for additional safety measures for individuals at risk for
injury. Table 1 lists the intrinsic and extrinsic risk factors for falls, injuries, and fall-related
deaths in the community.
Table 1. Risk Factors for Falls, Injuries, and Fall-Related Deaths in the Community
6
Fall and Injury Prevention
Risk assessment instruments for community dwellers. Tinetti86 developed a fall risk
assessment index based on the following nine risk factors: mobility, morale, mental status,
distance vision, hearing, postural blood pressure, back examination, medications, and ability to
perform ADLs. This instrument has been the most widely used and tested, with a reported
sensitivity of 80 percent and specificity of 74 percent.87 Other instruments used in the
community include the following (with reported sensitivities and specificities in parentheses): (1)
Berg Balance Test (sensitivity = 77 percent; specificity = 86 percent), (2) Elderly Fall Screening
Test (sensitivity = 93 percent; specificity = 78 percent), (3) Dynamic Gait Index (sensitivity = 85
percent; specificity = 38 percent), and (4) Timed Get Up and Go test (sensitivity = 87 percent;
specificity = 87 percent).87 Aside from the Timed Get Up and Go test, which takes less than a
minute for a health care provider to administer, these instruments generally take 15 to 20 minutes
to complete.87
Lord and colleagues88 recently evaluated the effect of an exercise-related fall-prevention
program, but found that the intervention was not useful in community dwellers who were not
screened for risk. The researchers concluded that screening to identify individuals at high risk for
falls would be necessary for a successful fall-prevention program. Further research to identify the
most accurate, yet easy-to-use risk assessment instrument would be necessary to move these
efforts forward.
A recent systematic review by Scott and colleagues89 examined fall risk assessment
instruments in the community. The authors concluded that, in general, risk assessment
instruments are available; however, most have been tested in only one setting. Therefore, further
validation studies should be conducted on fall risk assessment instruments before any specific
instrument can be recommended.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
A potential time point for risk assessment is in the emergency department (ED). Several
researchers have examined the effect of fall- and injury-prevention interventions applied to
patients who are discharged from the ED after a noninjury or nonserious-injury fall. The
overarching goal of these studies is to evaluate the ability of comprehensive risk assessment
followed by targeted interventions to prevent future falls and fall-related injuries. Several studies
have successfully shown that screening followed by tailored management can decrease repeat
falls.42, 90-94 Close and colleagues42 found that fall rates were reduced by 61 percent and recurrent
falls were reduced by 67 percent for patients who had comprehensive risk assessment after a fall,
compared to individuals who received standard treatment. Davison and colleagues90 found a 36
percent decrease in fall rates after 1 year for patients who received a multimodal intervention for
fall prevention after being identified as a faller on admission to the ED. In addition, these
researchers noted an increase in falls self-efficacy, which is a measure of an individual’s
perception of their ability to manage situations where they are at high risk for falling – the higher
self-efficacy, the more able a person is able to manage high risk situations. In a related study,
Lee, Hurley, and colleagues91 conducted a randomized controlled trial to examine the impact of a
personal emergency response system and found that there was no difference between treatment
and control groups for self-efficacy or patient anxiety. The Lee and colleagues study is
informative in that emergency contact alone was not sufficient to improve a patient’s belief in
their ability to manage fall risk situations. Although no standardized instrument has yet been
developed for use in the ED environment, the potential for the prevention of falls and related
injuries in the community would be increased with the accurate identification of patients at risk
for falls while they are in the ED.
Automated risk assessment in the community setting. To date, a limited number of
computer-based, community-based fall assessment instruments have been described. By far the
most complex and integrated is the Fall Risk Assessment and Management System, which was
developed by the Australia Family Practice Group for use in the community by family practice
physicians.95 Fall Risk Assessment and Management System includes automated
recommendations after the clinician executes a thorough patient assessment. Although this
system appears promising, its efficacy has not yet been reported.
Lord, Menz, and Tiedemann96 describe an electronic fall risk assessment instrument that
provides a method to measure several risk factors, including vision, peripheral sensation, muscle
force, reaction time, and postural sway. Although this instrument is thorough, it is meant for use
by a physical therapist or a physician, nurse practitioner, or physician assistant for a focused fall
risk assessment, rather than as a triage or screening tool. The novel aspect of this instrument is
the comparison of the individual’s score to the normative scores for each of the assessments,
which provides the clinician with an anchor and may facilitate improved screening over time.
However, the predictive validity of this instrument has not been reported, and its use may be
limited to a fall-prevention clinic.
Another electronic fall risk assessment instrument, described by Dyer and colleagues,97 is an
electronic checklist in a fall-prevention clinic. Unfortunately, the researchers concluded that the
clinic itself was more successful than the instrument in identifying risk factors for falling,
underscoring the reality that the implementation of an instrument without associated policy and
procedure changes may have limited effect.
The presence of these automated systems indicates that there is movement toward
computerized fall risk assessment. Indeed, many clinical information systems have adapted
paper-based assessment instruments for use in the acute care setting. However, the efficacy of
8
Fall and Injury Prevention
these systems has not been reported, and their effectiveness is likely to be constrained by the
limits of the original instrument, the system in which they are placed, and the design team in
ensuring that the automated instrument accurately reflects the original instrument.
Prevention strategies in the community. To date, several reviews conducted to examine the
evidence available to support practice in this area have identified the need for multimodal,
interdisciplinary prevention programs; the need for more accurate risk assessment instruments;
and the need for more research related to this complex and costly problem.11, 98-107
Cumming100 reviewed 21 trials and concluded that exercise programs were the most
promising, and reduction of antipsychotic medications should be considered. However,
Cumming also concluded that none of the reviewed research studies provided a definitive
prevention strategy. Chang and collaborators99 conducted a similar review targeted at examining
interventions for older adults in the community and found that multimodal assessments with
targeted intervention reduced risk of falls by 37 percent, and that exercise interventions reduced
fall risk by 14 percent. Hill-Westmoreland, Soeken, and Spellbring38 conducted a recent meta-
analysis, including a sensitivity analysis, which identified an improved effect on fall prevention
in the community when individualized management was added to exercise interventions. They
concluded that exercise interventions were not sufficient in and of themselves, and interventions
needed to be tailored to address individual risk factors.
Researchers have explored several other individual prevention strategies, including fall
prevention clinics, exercise interventions with leg strengthening (e.g., Tai Chi), vitamin D
supplements, home visits for safety evaluations, cataract surgery, and cardiac pacing. Falls and
balance clinics present a promising community-based solution to the problem of falls.108 Perell
and colleagues109 found a 50 percent reduction in fall rates for patients who were screened at a
clinic and who had tailored interventions applied; however, this study had no control group and
the researchers did not report injury rates, so the results are tentative. Clinics such as these
provide focused intervention planning for patients identified at risk for falling, but the success of
such clinics is contingent upon accurate identification of high-risk patients.
Identification of recurrent fallers via comprehensive screening followed by tailored
interventions has been successful at reducing recurrent falls. Screening and intervention done in
the ED reduced recurrent falls by 36 percent in one study,90 and a nurse-led intervention that
provided home assessment and tailored interventions reduced recurrent falls by 38 percent in
another study.110 Hogan and colleagues111 also evaluated tailored interventions for patients who
had had a fall within the past 3 months. They found no significant differences between the
intervention and control groups in fall rates or time to first fall; however, the intervention group
had a longer time between falls (P = 0.001). However, the Hogan and colleagues study limited
inclusion criteria to patients older than 65 years of age who had fallen in the past 3 months, and
these two factors alone are likely insufficient to determine risk. These recent studies add to early
work in the PROFET study, which found a 61 percent decrease in falls for patients who were
identified in the ED and who had subsequent detailed risk assessment and tailored
interventions.42
Exercise-related interventions are by far the most commonly studied individual community
prevention strategy. Most of this research indicates that exercise is beneficial for patients, and
some research demonstrates that exercise regimes that involve leg strengthening and balance
training, such as Tai Chi, are most effective.112-122 Robertson and colleagues123 performed a
meta-analysis of four studies that examined effects of home exercise programs. They found in
the pooled effect analysis that both fall and injury rates decreased by 35 percent. Exercise in
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
conjunction with cognitive behavioral therapy, where patients are taught how to increase self-
awareness about risky situations, has demonstrated promising results, including a longer time to
first fall and decreased injuries.124 Unfortunately, this work did not demonstrate an effect on falls
efficacy, fear of falling, or actual fall rates. More recently, balance training has been compared to
general exercise, and results show that balance training can prevent falls in the nonfrail elderly,
but not in the frail elderly.125 Lin and colleagues126 found that deployment of large scale Tai Chi
training to the general community had mixed results. Luukinen and colleagues127 found a
decrease in fall and injury rates with a targeted exercise program when compared to usual care,
but the results were statistically significant only in a group that was not homebound—suggesting
that early intervention may be more effective. Further research to explore interventions for
homebound community dwellers, particularly for the very old and frail, will be important.
Laboratory studies indicate that calcium and vitamin D reduce bone loss,128 and a growing
body of work is examining the ability for vitamin D supplementation to prevent fractures in
individuals who are vitamin D deficient. A meta-analysis performed by Bischoff-Ferrari and
team129 revealed that larger doses of vitamin D supplementation (700–800 IU/deciliter) reduced
the risk of fracture by up to 26 percent, whereas smaller doses of vitamin D (400 IU/deciliter) did
not reduce fracture risk. However, research to date has been inconclusive, and larger, more
recent studies have indicated that the use of vitamin D does not reduce fracture risk in the
general community.130 On the other hand, vitamin D supplementation may be integral in
preventing falls themselves:131 Recently, Latham and colleagues132, 133 demonstrated that vitamin
D intake is an individual predictor for fall reduction, primarily by improving muscle strength.
Bischoff-Ferrari and colleagues134 have also identified a reduction in fall risk for women, but not
for men, using vitamin D supplementation. Although these results are promising, more research
is required to identify best practice recommendations related to vitamin D deficiency screening
and vitamin D supplementation or other bone-supporting medication regimes.
Other researchers are exploring the ability for osteoporosis-prevention medications to reduce
fracture risk.135 Sato and colleagues136, 137 reported that risedronate, an oral bisphosphonate for
osteoporosis prevention, was effective at preventing fracture in older females, older males who
have had a stroke, and older females with Alzheimer’s disease. A recent large study by
McCloskey and colleagues138 (N = 5579) demonstrated a 20–29 percent decrease in clinical
fractures in community-dwelling females older than 75 years with and without osteoporosis who
were prescribed clodronate 800 mg daily. However, this study did not find a decrease in hip
fractures. Recent reports of adverse side effects of large doses of bisphosphonates, including
osteonecrosis of the jaw, indicate that further research is warranted and that patients should be
monitored for side effects of these drugs. Other related fall prevention efforts include home
assessment for risk factors with the implementation of safety devices such as handrails, nonslip
surfaces on stairs, and removal of throw rugs.139-143 Researchers who conducted a recent
randomized controlled trial found that thin-soled shoes were found to be the best type of shoe for
patients, rather than running shoes, which have sticky soles.144 Research addressing syncope-
related falls indicate that cardiac pacing may be appropriate for individuals with syncope.145
Summary of community-based research on falls and related injuries. In summary,
authors of several reviews have examined the efficacy of community-based fall- and injury-
prevention programs. These reviewers have indicated that individualized multimodal
interventions are effective at reducing falls and related injuries in the community setting.105
However, multimodal interventions are not in place across primary care areas, which hinders
their potential efficacy, and the aging community would likely benefit from large-scale
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Fall and Injury Prevention
implementation of these proven preventive interventions. (See Evidence Tables 1 through 9 for
individual study results.)
Falls and Related Injuries in the Acute and Long-Term Care Settings
Fall and related injury prevention is a major focus for both acute and long-term health care
organizations. In 2005, the Joint Commission added the requirement for fall risk assessment and
periodic reassessment as a National Patient Safety Goal in the acute care setting.54 The goal of
this requirement is to ensure that all patients are screened for falls and thus seeks to reduce harm
from falls. However, the outcome is unpredictable because fall and injury risk assessment
instruments have shown inconsistent reliability and validity A more promising extension of this
goal starting in 2006 and continuing forward is the additional requisite of implementing and
evaluating a fall-prevention program.146 National compliance with these goals has the potential
to significantly impact the problem of falls in the acute care setting. Efforts to enhance quality of
care in the long-term care environment via improved reporting have the potential to reduce falls
and related injuries in these particularly vulnerable patients; however, the successful
implementation of fall-prevention programs will be necessary to improve the problem.
Falls in the acute and long-term care settings have several possible consequences. Recurrent
falls have been identified as contributing to increases in the length of stay (LOS) in elderly
psychiatric patients.147 However, some research has suggested that LOS itself may be a predictor.
A fall may also lead to a poorer quality of life because of fallophobia, a fear of future falls,
which may itself contribute to fall risk.148 Injuries occur in between 6 and 44 percent of falls in
the acute care setting.20, 21, 23 In the long-term care population, between 9 and 15 percent of falls
result in injury, with approximately 4 percent of these falls resulting in fractures.149 Additionally,
patients who have underlying disease states are more susceptible to injuries; for example,
osteoporosis can increase the risk for fracture, and bleeding disorders can increase the risk for
subdural hematomas.150 Moreover, fall-related injuries increase resource utilization: injuries
from falls lead to increased LOS and an increased chance of unplanned readmission or of
discharge to residential or nursing home care.151 Furthermore, inpatients who have incurred an
injury due to a fall have approximately 60 percent higher total charges than those who did not
fall or those who fell and did not sustain an injury.152
Evans and colleagues,153 via the Joanna Briggs Institute, performed a systematic review of
the evidence up to 1997 for fall and injury prevention in the acute care setting. They examined
200 studies related to identification of predictors, risk assessment instrument development and
testing, and fall- and injury-prevention interventions. Of these studies, only two were
randomized controlled trials (RCTs). The trial by Tideiksaar and colleagues154 examined the use
of bed alarms to notify staff when patients at high risk for falls got out of bed; however, this
study had a sample size that was too small to identify an effect from using bed alarms. The other
RCT examined the use of colored bracelets to identify patients at high risk for falls. Again, the
study results were inconclusive.155 Evans and colleagues concluded that the fall risk assessment
instruments available were not generalizable. However, they did not adequately compare the
psychometric properties of the instruments in question; rather they evaluated research related to
the implementation of such instruments, which was relatively weak up to that time. In addition,
Evans and colleagues concluded that individual interventions were not more useful that any of
the fall-prevention programs that might be developed at a particular institution for a specific
subset of patients. However, recent research has seen a growing number of RCTs, which will
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
facilitate the ability to make stronger practice recommendations for this complex and challenging
problem.
For this review, research related to falls and related injuries in the acute and long-term care
settings were identified and categorized as follows: risk factor identification, risk assessment
instruments, and prevention strategies. Each category of research is discussed below.
Acute care and long-term care risk factors. Factors associated with patients at risk of
falling in the acute care setting have been explored extensively, particularly over the past two
decades.17, 87, 156-160 Evans and colleagues161 conducted a systematic review of research and
identified 28 risk factors for falling, including impaired mental status, special toileting needs,
impaired physical status, and to some extent age and medications. Oliver and colleagues159
reviewed risk factor and risk assessment literature and identified five risk factors consistent
across studies: unsteady gait, increased toileting needs, confusion, sedative-hypnotics, and
history of falling. In the long-term care environment, risk factors are largely the same, with the
addition of inability to transfer effectively162 and short-term memory loss.163 Although ability to
transfer and short-term memory function might be characterized by unsteady gait and confusion,
these items are expressly captured via the LTCMDS.
Research has consistently demonstrated that multiple factors are associated with falling in
elderly and hospitalized patients and that fall risk increases as the number of factors increases.98,
153, 156-159, 164-166
Although increased age is a strong predictor of falling in the community,
increased age has not always been identified as a predictor in the acute care setting. Some studies
have found increased age to be a risk factor,17, 165 but others have found that increased age is not
a factor in acute care.157, 167, 168 Comorbidities and impaired functional status may be more
important predictors of falls and subsequent injury in this setting.150, 157 Recent work by
Hendrich169 did not support the association between increasing age (older than 65 years) and
increasing risk of falling in the inpatient environment. Instead, Hendrich and colleagues169 found
that confusion was the most important risk factor associated with the risk of falling. Nevertheless,
age must be considered when discussing injury associated with falls because often with age
comes frailty. Several researchers have identified gender as a risk factor, with female gender
being a stronger risk factor in the older population170 and male gender a stronger factor in the
younger population.167, 169, 171 A recent retrospective analysis by Krauss and colleagues170 found
that altered mental status was not a factor in falls, but that patients in academic medical centers
were more likely to fall. This research was limited because it did not control for patient acuity or
staffing levels.
Harwood and colleagues172, 173 reviewed the literature related to visual problems and falls and
found that uncorrected visual impairment nearly doubled the risk of falling. Cardiovascular
causes of falls derive predominantly from neurally mediated disorders (e.g., vasovagal syncope)
and cardiac abnormalities (e.g., arrhythmias, infarction, valvular stenosis).174, 175 Time of day has
also been implicated; Tutuarimia and colleagues176 identified a higher rate of falls on the night
shift, but this is inconsistent with other research and may in fact be explained by staffing patterns.
Association of falls to the lunar cycle has also been explored, but no association was found.177
Vitamin D deficiency has been implicated as a risk factor for falls and fracture in the long-
term care setting.178 In addition, elevated alkaline phosphatase and low serum parathyroid
hormone have been identified as predictors for falls,179, 180 and anemia has also been
implicated.181
A number of researchers are exploring the relationship between nurse-to-patient staffing
ratios and an increase in the incidence of falls.20, 176, 182-184 Some of this work has identified an
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Fall and Injury Prevention
inverse association between licensed nurse staffing ratios and fall rates (i.e., a higher proportion
of nurses is associated with lower fall rates);176, 182, 184, 185 however, the overall the results are
inconclusive.186 In addition, a growing body of research related to failure to rescue, defined as
being “based on the premise that although deaths in hospitals are sometimes unavoidable, many
can be prevented,”187-189 supports the inclusion of unanticipated physiologic events in the
definition of falls since the patient’s safety issues should be addressed at all times. Other
researchers examining nurse staffing ratios and fall rates suggest that fall rates are reduced by
increasing the number of nurse aids rather than licensed nursing staff.190 This is potentially
supported by recent work by Krauss and colleagues;191 of the fallers in their case-control study,
85 percent of those in need of assistance or supervision with ambulation fell while not being
supervised.
Certain subgroups of patients have been identified at higher risk because of the inherent
characteristics of their disease process or treatment modalities. These groups include geriatric,
behavioral health, oncology, rehabilitation, stroke, and multiple sclerosis patients. In the
behavioral health setting, fall rates range from 4.5 to 25 falls per 1,000 patient days.192, 193
Researchers have identified the typical faller in the behavioral health setting as a female with a
history of falls; who was younger than 65 years of age; who was experiencing anxiety and
agitation; and who was receiving a sedative, a tranquilizer, or a laxative.194 Irvin195 explored risk
factors in the psychiatric setting and found that gait or balance problems and history of falls were
the primary predictors. Although many of these characteristics are consistent with patients in the
acute care setting, younger age and comorbidities such as depression and psychosis are often
predictors in the behavioral health population.196-199 In addition, treatments specific to behavioral
health patients are different than those in the acute care setting. For example, patients being
treated for late-life depression are at risk for falling in the first weeks of using a tricyclic
antidepressant and should be monitored closely while they are adjusting to the new medication.75
De Carle and Kohn200, 201 have described risk factors in behavioral health patients and have
identified electroconvulsive therapy as a predictor.
Patients in rehabilitation units are also at higher risk, likely because they have suffered
neurological injuries such as stroke or head injury, which precipitate muscle weakness, impaired
cognition, and impulsivity.202-205 In addition, these patients are being physically challenged,
which places them in higher-risk situations and thus at greater risk for falling.206
In the pediatric inpatient setting, fall rates range from 0 to 0.8 per 1,000 patient days.207
These rates are very low compared to adult inpatient and long-term care rates. The factors that
limit the number of falls in this population are unclear, but may be related to increased
supervision of pediatric patients via higher nurse-to-patient staffing ratios and the common
practice of parents staying with pediatric inpatients.
Injury risk factors in the acute and long-term care setting. In general, injury risk factors
are similar across care areas. Vassallo and colleagues208 examined the risk factors associated
with injury in a group of inpatient fallers and found that three factors were associated with
injuries related to falls: (1) history of falls, (2) confusion, and (3) unsafe gait. In addition to these,
Rothschild and colleagues134 identified physiological processes, such as increased bleeding
tendencies and osteoporosis, as factors that increased risk for bleeding or fracture. The risk for
medications or physiologic factors to precipitate injuries related to bleeding have been explored
on a limited basis in the inpatient population. Contrary to results in the community,84 Stein and
team209 found that hospitalized stroke patients who are anticoagulated are not at higher risk for
injury than nonanticoagulated patients; however, this study was small and the issue warrants
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
further research. Bond and colleagues210 examined over a 4-year period the risk for bleeding
injury among 1,600 patients who fell while hospitalized. These researchers found that half of the
patients were on thrombotic therapy and that the incidence of fall-related intracranial hemorrhage
was low, even in persons taking warfarin. The authors suggested that selection bias may be a
factor because physicians might withhold anticoagulant therapy for patients who have a higher
fall risk. More recently, Spector and colleagues211 performed a large study of nursing homes and
found that 85 percent of fractures were caused by falls, and that those with epilepsy, those with
agitation, and those taking anticonvulsants had the highest risk of sustaining a fracture if they fell.
Table 2. Risk Factors for Falls and Injuries in Acute and Long-Term Care
Intrinsic Risk Factors Fall Risk Injury Risk
Demographics
• Age Across ages Older
• Gender Male Female
Cognitive Function
• Agitation Yes Yes
• Anxiety Yes No data
• Cognitive impairment Yes No data
• Impulsivity Yes No data
• Inability to follow instructions Yes No data
• Short-term memory loss Yes No data
Physical Function
• Fall history Yes Yes
• Fatigue Yes No data
• Gait problems Yes No data
• Impaired muscle strength Yes No data
• Impaired physical functioning Yes No data
• Toileting needs increased Yes No data
• Postural hypotension Yes No data
• Visual impairment Yes No data
Physiologic Status
• Alkaline phosphatase level elevated Yes No data
• Anemia Yes No data
• Parathyroid hormone deficiency Yes Yes
• Prolonged bleeding time No data Yes
• Vitamin D deficiency Yes Yes
Comorbidities
• Alzheimer’s disease Yes No data
• Depression Yes No data
• Diabetes Yes No data
• Comorbidities in general Yes No data
• Multiple sclerosis Yes No data
• Parkinson disease Yes No data
• Stroke Yes No data
• Syncope Yes No data
Medications
• Anticoagulants No data Yes
• Antiepileptics Yes No data
• Chemotherapeutics Yes No data
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Fall and Injury Prevention
Acute care risk assessment instruments. Many tools have been developed to identify
patients at highest risk for falling in the acute care setting.21, 159, 167, 169, 212-215 Perell and
colleagues87 reviewed risk assessment tools and identified 6 functional assessment instruments
and 15 fall risk assessment instruments developed by nursing. Vassallo and colleagues216
concurrently examined the predictive validity in the acute care setting of four commonly used
risk assessment instruments (STRATIFY, Downton, Tullamore, and Tinetti) and found that the
STRATIFY instrument was the easiest to use, was most effective of the four at predicting falls in
the first week of inpatient admission (total predictive accuracy of 66.6 percent), but had the
poorest sensitivity (68.2 percent).
The most commonly reported risk assessment instrument is the Morse Falls Risk Assessment
Tool.217 In 2002, O’Connell and Myers218 conducted psychometric testing with this tool on 1,059
patients admitted to an Australian hospital. In this study, the Morse Falls Risk tool had a
sensitivity of 83 percent and a specificity of 29 percent, but a positive predictive value of only 18
percent. This resulted in a very high false-positive rate, with the tool identifying more than 70
percent of patients who did not fall at high risk for falling. This research was confounded by the
fact that the interventions were applied based on the instrument’s predictions; therefore, the
predictive validity cannot be conclusively stated. The STRATIFY Falls Prediction tool also had a
low positive predictive value (30 percent) and relatively low sensitivity (66 percent) and
specificity (47 percent).212
The Heinrich Falls Risk Model I is reported to be more robust (sensitivity, 77 percent;
specificity, 72 percent) than either of the others, and the Hendrich Falls Risk Model II
demonstrated even more improvement (sensitivity, 74.9 percent; specificity 73.9, percent;
positive predictive value, 75 percent).169 The inclusion of a Get Up and Go test in the Heinrich II
tool was the major change between version I and version II. The Get Up and Go test evaluates a
person’s ability to rise from a chair in a single movement, which is an assessment method that
has been explored in earlier fall-prediction research. It is surprising that the sensitivity and
specificity of the tool increases only slightly with the addition of this factor, underscoring the
complexity of predicting patient falls. In addition, prospective evaluation of the use of the
Hendrich II instrument has yet to be reported.
Several studies have tested the predictive validity of fall risk assessment instruments in
relation to the judgment of nurses. Myers and Nikoletti219 concluded that neither the fall risk
assessment instrument nor nurses’ clinical judgment acted as a reliable predictor. Eagle and
colleagues220 compared the Functional Reach test, the Morse Falls Scale, and nurses’ clinical
judgment in the rehabilitation and geriatric environment. This study also concluded that the two
standardized assessment processes were no better at predicting falls than the clinical judgment of
nurses. A limitation in both of these studies was that the evaluation occurred only at one time
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
point close to admission, which does not account for the variability of patient status throughout a
patient’s hospital stay.
In the domain of rehabilitation medicine, Ruchinskas221 compared structured assessments—
including the Mini-Mental State Exam, the Geriatric Depression Scale, the Functional
Intervention Model, and the clinical judgment of physical and occupational therapists—on
admission and discharge. This study concluded that the clinical judgment of therapists had a
positive predictive power of 33 percent and a negative predictive power of 82 percent. However,
the more accurate predictors of falling for the patients in their sample were a history of falls and
presence of a neurological diagnosis. In the residential care environment, Lundin-Olson and
colleagues222 found that clinical judgment can contribute to the accurate prediction of fall risk,
but is not sufficient on its own as a valid predictor.
Although fall-prediction research has been performed for two decades, it is clear that fall
prevention is a complex problem that cannot be solved by risk assessment alone, hence the
dissatisfaction with available risk assessment instruments.
Long-term care assessment instruments. Lundin-Olson and colleagues223 developed the
Mobility Interaction Fall Chart (MIF chart), which is an instrument based on a patients’ ability to
walk and talk at the same time, the ability to maintain pace while carrying a glass of water, visual
impairment, and difficulty concentrating. When the predictive validity of the MIF chart was
evaluated, the researchers found that the chart was helpful only when used in conjunction with
clinical judgment and knowledge of a patient’s history of falls, thus making the use of this
instrument on its own limited.222
The Downton instrument, originally developed in the community setting, characterizes risk
by five factors: (1) increased dependency, (2) cognitive impairment, (3) increased number of
physical symptoms, (4) presence of anxiety, and (5) presence of depression.224 This instrument
has recently been prospectively evaluated in the long-term care setting with a reported sensitivity
ranging from 81 to 95 percent and specificity ranging from 35 to 40 percent.225 Although the
specificity is low, this instrument might provide a standardized measure to identify those at risk
in the long-term care environment.
Becker and colleagues162 have recently described an algorithm to assess fall risk in the long-
term care setting, categorizing long-term care residents into three subgroups: (1) residents
requiring assistance to transfer, (2) residents able to transfer with history of falls and requiring
the use of restraints, and (3) residents able to transfer and with no history of falls but with urinary
incontinence and visual impairment. The researchers found that the residents with the history of
falls were at highest risk for falls, which is consistent with other research in this domain, but
might be useful to tailor interventions and would warrant prospective evaluation.
Acute care pediatric risk assessment instruments. Falls in the acute care pediatric setting
are relatively rare; however, standardized assessment may be beneficial to reduce falls and
injuries in this population. Graf207 has recently developed an instrument for acute care pediatric
risk assessment. According to Graf, factors associated with pediatric falls include (1) seizure
medication (odds ratio 4.9), (2) orthopedic diagnosis, (3) not using an IV (odds ratio 3.6), (4)
physical/occupational therapy ordered, and (5) LOS (odds ratio 1.84 for every 5 days). This
model has a sensitivity and specificity of 69 percent and 84 percent, respectively, and is being
prospectively evaluated by the investigator with the hope that standardized assessment will
facilitate reduction in these already-low rates.
Automated risk assessment in the acute and long-term care settings. Recent national
patient safety efforts highlight the promise of using informatics processes to manage patient
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Fall and Injury Prevention
safety issues such as the management of patient falls. However, to date, most automated risk
assessment techniques in the acute care setting are electronic versions of existing fall risk
assessment instruments, with limited use of computerized decision support.167, 226, 227 Promising
new work in data mining for fall prediction has demonstrated that use of the LTCMDS has the
potential to use existing data to generate risk models for patients in this setting.
Volrathongchai228 has recently explored the ability to use computerized data mining techniques
to identify elderly residents of long-term care facilities who were at risk for falls. Although this
work has not been prospectively evaluated, the research found that the use of these data mining
techniques, in conjunction with nursing knowledge, had the potential to identify fallers.
Acute and long-term care prevention strategies. The goal of any fall- and injury-
prevention effort is to decrease adverse outcomes for the patients who are most vulnerable to
falling. A beneficial consequence of fall- and related-injury-prevention programs is the potential
to streamline resource use, with the added potential for decreased costs associated with this
problem.229-231 To date, however, a ubiquitous fall- and injury-prevention strategy has not been
identified for hospitalized patients, and implementation of multifaceted strategies is often
difficult to introduce in the complex clinical environment.232
Several reviews have examined fall-prevention strategies in the acute and long-term care
settings.98, 99, 153, 159, 233 Oliver, Hopper, and Seed234 examined 10 studies, including 3 RCTs and 7
prospective studies with historical controls. Oliver and colleagues found that the pooled effects
ratio was 1.0 (95% CI = 0.60–1.68), indicating that overall the interventions were not able to
prevent falls. More recently, Oliver and colleagues235 have performed a meta-analysis of fall-
and injury-prevention strategies and found a decrease in fall rates with multimodal intervention
and a decrease in hip fractures with hip protectors in the long-term care setting. Agostini, Baker,
and Bogardus98 conducted a review of the literature related to fall prevention for hospitalized and
institutionalized older adults. This review did not pool the results, but examined the literature
related to the use of armbands, bed alarms, and restraints for fall prevention, all of which will be
discussed individually below.
The use of physical restraints to prevent falls has been refuted because restraints limit
mobility, contribute to injuries, and don’t prevent falls.236, 237 Agostini and colleagues98 examined
literature related to fall prevention via restraint and side rail use, as well as fall rates when
restraints were removed. Six studies found that restraints were associated with increased injuries,
and restraint and side rail removal did not increase fall rates. Evans, Wood, and Lambert238 also
examined the literature and found 16 studies that examined restraint minimization, concluding
that restraint-minimization programs involving effective staff education can reduce injuries and
do not increase fall rates.
Several individual fall-prevention interventions have been examined, including the use of
armband identification bracelets, exercise regimen, postfall assessment, bed alarms, toileting
regimen, and vitamin D supplementation. Mayo and colleagues155 conducted a randomized
controlled trial to examine if armbands would help identify high-risk patients in a rehabilitation
unit and prevent falls in the high-risk group. The researchers, however, found that high-risk
patients with a blue armband had higher fall rates than those without the armband. Despite
widespread use, only one study from 1993 has examined bed alarms. Tideiksaar and
colleagues154 found that bed alarms were an effective method for fall prevention (relative risk =
0.32), but the intervention warrants further research. An associated intervention, a movement
detector, has recently been developed. Kwok and colleagues239 studied movement detectors and
found no difference between intervention and control groups. However, a pilot study examined
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
the use of a movement detection patch attached to the thigh, which alerts clinicians when elderly
long-term care residents are moving about.240 Kelly and colleagues found a 91 percent decrease
in falls during the 1-week testing period. Although this study quality was poor, the intervention
might be suitable for select patients and bears further testing. Rask and colleagues224 and Taylor
and colleagues225 evaluated the use of a fall-prevention program with a fall coordinator in the
long-term care setting; they found that the control nursing homes had increases in fall rates over
4 years, whereas the intervention nursing homes had stable fall rates during the same time period.
Mulrow and colleagues241 examined the effects of a physical therapy exercise intervention
for frail long-term care residents and found that fall rates increased in the intervention group.
However, the intervention group in this study also showed an increase in general strength and a
decrease in the use of assistive devices, making one wonder if the physical therapy intervention
sought to decrease the use of assistive devices in inappropriate situations. Rubenstein and
colleagues242 examined the ability for post-fall assessment to identify underlying factors that
could be remedied to prevent further falls. Choi and colleagues243 examined the effect of Tai Chi
in the long-term care setting and found a 38 percent decrease in falls in the Tai Chi group, but
this was not statistically significant (relative risk = 0.62; 95% CI = 0.32–1.19). A larger study
may demonstrate statistical significance. A more recent study by Nowalk244 reported no
difference between groups who received strength training. The authors concluded that long term
care residents may require individualized training, rather than group training.
Bakarich, McMillan, and Prosser245 examined the impact of a toileting regimen for elderly
confused patients with mobility problems in the acute care units of a large metropolitan teaching
hospital. The researchers found that there were 53 percent fewer falls during shifts in which the
risk assessment and toileting intervention was used, but that compliance with the assessment and
intervention was difficult to maintain. More recently, Klay and Marfyak246 found that a
continence specialist in the long-term care environment reduced falls by 58 percent. Vitamin D
has also reduced falls in elderly females in the long-term care setting by up to 49 percent, and in
both males and females by 25 percent.129, 134, 178, 247, 248 Further investigation of the use of vitamin
D in the acute care and rehabilitation setting for fall and injury prevention is warranted. Jensen
and colleagues249 examined the effect of exercise training on elderly residential care patients and
found an increase in strength and balance, and a nonstatistically significant decrease in falls. This
study was limited by its small sample size and unequal distribution of important risk factors such
as Mini-Mental State Exam scores across groups.
As with community interventions, tailored, multipronged prevention strategies are being
shown to be more effective in acute and long-term care settings than individual interventions
alone. Hofmann and colleagues250 used three concurrent interventions—staff education, an
exercise program, and environmental modifications—for a frail elderly population. The
concurrent use of these interventions decreased the fall rate by 38 percent and decreased the
fracture rate by 50 percent. Haines and colleagues251 also examined a multipronged intervention
involving staff and patient education, an exercise program, and the use of hip protectors.
Researchers found a 22 percent decrease in falls and a 28 percent decrease in injuries in the
intervention group.
One of the most promising studies by Jensen and her research team252 investigated the effects
of a comprehensive fall risk assessment and tailored intervention program in the long-term care
setting. The intervention included assessment via the Mobility Interaction Fall Chart, visual
evaluation, medication evaluation, and delirium screening by all members of the care team—
physicians, nurses, and physical and occupational therapists. This research demonstrated that the
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Fall and Injury Prevention
comprehensive assessment and tailored interventions reduced falls by 51 percent and injuries by
77 percent over a 34-week period. Healy and colleagues253 also found a statistically significant
reduction in falls (RR = 0.71) by applying a tailored plan of care to adult inpatients who were
deemed at high risk for a fall based on having had a previous fall. In effect, this research used
history of fall as a method to triage high-risk patients, who then received a comprehensive risk
assessment with targeted interventions. This research did not demonstrate a decrease in injuries;
however, further research using this technique will be useful. McMurdo, Millar, and Daly254
found up to a 55-percent reduction in fall rates in a group of 133 nursing home residents with
comprehensive risk assessment and balance training, but these results were not statistically
significant. A larger sample size would provide a better understanding of the effect of the
intervention.
Other research examining multimodal interventions have had mixed outcomes. A recent
study by Vassallo and colleagues255 in long-term care facilities found a decrease in falls was
nullified when the results were controlled for LOS. However, controlling for LOS removes the
ability for LOS to be identified as a predictor, which may be the case for patients who stay
longer in a hospital setting. Kerse and colleagues256 found that in a group of nursing homes,
long-term care residents who were randomized to risk assessment followed by tailored
interventions showed an increase in falls (incident rate ratio = 1.34; P = 0.018). Semin-Goossens,
van der Helm, and Bossuyt257 evaluated the effect of a guideline with semistructured
interventions and found that fall rates in high-risk neurology and medical patients were not
reduced. The researchers attributed the failure of the program to resistance by nurses to changing
attitudes toward falls with the statement that nurses did not find falls troublesome enough.
However, the failure was more likely due to system issues, such as ability to implement and
agreement with the guideline, and training issues, which are common with guideline
implementation failures.258, 259 In addition, the Semin-Goossens guideline did not use a
standardized risk assessment instrument, which might have made it difficult to identify patients
at risk. Fonda and colleagues260 studied a multimodal process-improvement plan and found that
after 3 years, fall rates were decreased by 19 percent and injuries were decreased by 77 percent.
Furthermore, this effect was sustained with continued use of the multimodal intervention.
Schwendimann and others261 found a moderate, but not statistically significant decrease in fall
rates, and no change in injury rates after implementing an interdisciplinary fall-prevention
program. Lane262 found no decrease in patient fall rates before and after implementation of a fall-
prevention program. Although the results of multimodal studies are conflicting, it is important to
note that none of the studies of multimodal interventions—whether effective or ineffective
results—controlled for staffing ratios or skill mix.
An increasing number of studies are examining the prevention of injury in the acute and
long-term care settings. Hip protectors have been evaluated in the long-term care environment
since the early 1990s. Although early work found that hip protectors were effective in reducing
hip fractures in the frail or osteoporitic elderly,263 more recent work indicates that compliance
with using hip protectors is difficult to maintain, making recommendation for hip protector use
conditional.264, 265 Ray and colleagues266 examined the ability of a 2-day staff safety education
plan to reduce serious fall-related injuries and found that this intervention was not effective, but
the result may have been confounded by lack of staff compliance with the safety plan. (See
Evidence Tables 1 to 9 for individual study results.)
Summary of acute and long-term care falls and related injuries. In summary, fall
prevention in the acute and long-term care settings is a complex and demanding problem with
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
multiple patient types and risk factors to manage. Standardized risk assessment with multimodal
tailored interventions appears to be the most successful method of prevention; however,
implementation of comprehensive interventions across care settings can be challenging. Further
research toward overcoming barriers to implementation, guideline adherence, staffing ratios, and
tailored interventions for newly identified risk factors such as vitamin D deficiency and anemia
are warranted. Furthermore, research must be conducted on a larger scale to demonstrate
generalizability and to be able to translate evidence into practice.
Research Implications
In the community setting, identification of the best timing for screening and reassessment is
needed. Identification of methods to build fall- and injury-prevention programs in the community
is needed to guide policymakers. In the acute and long-term care settings, large multisite
intervention studies that use multimodal interventions tailored for individual risk factors and that
control for comorbidities, acuity, staffing, and other environmental factors are needed. Cost-
20
Fall and Injury Prevention
effectiveness studies to characterize the impact of fall- and injury-prevention programs are
needed in the acute and long-term care settings.
Community:
• Screen all patients over 65 during routine or other • Examine risk factors related to race and gender.
visit. • Identify barriers to widespread screening.
• For patients who screen positive, refer to fall-injury • Examine barriers to establishment of fall-injury
prevention clinic for focused fall-injury risk prevention clinics.
assessment, if available.
• Use a standardized risk assessment tool, such as • Validate risk assessment instruments across culture,
Tinetti’s 9-item screening tool for (1) mobility, (2) race, and language.
morale, (3) mental status, (4) distance vision, (5) • Examine predictive validity of injury risk factors such
hearing, (6) postural blood pressure, (7) back as antiplatelet therapy, bleeding disorders, vitamin D
examination, (8) medications, and (9) ability to deficiency, and chronic subdural hematomas.
perform activities of daily living (ADLs). • Develop instruments for patient self-assessment for
(Note: This tool does not overtly assess for injury risk.) fall and injury risk.
• For patients > 65 years who present to the emergency • Examine the effect of identification in the ED using
department (ED) with a fall, refer to primary care large, multicenter randomized controlled trials.
provider for focused fall-injury risk assessment. • Identify barriers to widespread adoption.
Evidence-Based Practice Recommendations Research Implications
21
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Fall Prevention:
• Provide balance training with leg strengthening, such • Examine effect of starting balance training at younger
as Tai Chi. age (i.e., 50 years).
• Examine barriers to establishment and use of balance
training centers.
• Monitor medication side effects for patients older than • Identify medications with minimal side effect profiles
65. for patients older than 65.
• Limit medications to fewer than four, if possible. • Examine medication dosing for groups of medications.
• Monitor and treat calcium and vitamin D deficiency. • Examine factors related to calcium and vitamin D
metabolism in relation to muscle function.
• Manage underlying disorders such as cardiac-related • Explore factors to manage groups of disorders.
syncope, diabetes, and vision problems (e.g., • Explore other diseases that may predict falls.
cataracts).
• Provide home safety modifications. • Explore barriers to home safety modification.
• Educate about use of thin-soled shoes (not running • Further explore shoe type for specific patient groups.
shoes).
• Provide education about how to manage risky • Explore fall prevention self-management strategies.
situations.
Injury Prevention:
• Monitor for calcium and vitamin D deficiency; provide • Conduct large studies that control for comorbidities,
supplements for fracture prevention. age, and other factors to explore efficacy of hip
protectors in the community.
• Increase screening for patients on anticoagulant • Identify safety measures for bleeding-injury
therapy, those with bleeding disorders, and for the frail prevention.
and very old. • Explore interventions for the very old and frail.
• Use bisphosphonates for patients with documented • Explore safety of long-term use of bisphosphonates.
osteoporosis.
22
Fall and Injury Prevention
Fall Prevention
• Educate staff about safety care. • Examine impact of safety education across
• Train medical team, including students and residents, interdisciplinary team.
for fall-injury risk assessment and postfall
assessment.
• Use alarm devices. • Examine impact of alarms on caregiver satisfaction.
• Monitor medication side effects and adjust as needed. • Examine effect of computerized decision support for
medication management.
• Adjust environment (e.g., design rooms to promote • Examine cost effectiveness of environmental
safe patient movement). adjustments.
• Provide exercise interventions (e.g., Tai Chi) for long- • Examine usefulness of exercise interventions for
term care patients. acute care patients.
• Provide toileting regimen for confused patients (e.g., • Study barriers to maintaining and sustaining
check patients every 2 hours). monitoring activities.
• Monitor and treat calcium and vitamin D levels for • Examine effects of calcium and vitamin D
long-term care patients. management for acute care patients.
• Treat underlying disorders such as syncope, diabetes, • Examine constellations of disorders that might
and anemia. precipitate falls.
Injury Prevention
• Limit restraints use. • Identify methods to overcome barriers to restraints
reduction.
• Lower bedrails. • Study efficacy of environmental changes.
• In addition to fall rates, monitor injury rates. • Establish fatal fall rates across settings.
• Use hip protectors for geriatrics and long-term care. • Identify methods to overcome barriers to use of hip
protectors.
• Use floor mats. • Examine effect of safety flooring.
• Monitor prothrombin time, international normalized • Identify safety measures for bleeding-injury
ration (PT/INR) for patients at risk for falling. prevention.
• Ensure postfall assessment. • Examine barriers to postfall assessment.
• Use bisphosphonates for patients with documented • Explore safety of long-term use of bisphosphonates.
osteoporosis.
Conclusion
Falls and related injuries are an important issue across the care continuum. National efforts in
the community via Healthy People 2010, in the acute care setting via the Joint Commission’s
National Patient Safety Goals, and in the long-term care setting via the Nursing Home Quality
Initiative project have the potential to significantly reduce falls and related injuries. The growing
number of randomized controlled trials related to fall-prevention efforts is promising. However,
most of these studies have been carried out in the community and long-term care environments,
with few randomized controlled trials evaluating fall- and injury-prevention measures in the
acute care setting. As with other nursing-sensitive quality indicators, recent research
demonstrating an association between fall rates and nurse staffing ratios needs to be more fully
explored. In addition, further research needs to explore automated methods of assessing and
communicating fall risk, better methods for risk identification, and the identification of
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
prevention measures. Indeed, with coordinated efforts to apply the evidence to practice, the
problem of falls might be managed more effectively.
Search Strategy
MEDLINE,® the Cumulative Index to Nursing and Allied Health Literature (CINAHL®), and
Cochrane databases from inception to March 2007 were searched for medical subject heading
terms, both individual terms and combinations of the following: accidental falls, patient safety,
medical errors, nursing-sensitive quality indicators, and fall prevention. In addition, references
from relevant articles were searched using the snowball technique, as were archives of select
nursing research and gerontology journals. The Related Links function in MEDLINE was also
used to maximize the search strategy. Google, Google Scholar, and citations from identified
articles were also searched for additional possible references. Articles related to occupational
falls, sports-related falls, alcohol-related falls, and physical abuse-related falls were excluded.
Articles that reported physiologic characteristics that are suspected to preclude falls but that did
not examine falls or fall-related injuries as outcomes were also excluded because the causative
effect on falls and fall-related injuries is, to date, inconclusive. Further, articles that were
published in a foreign language were excluded. Two hundred and twenty seven articles were
reviewed. Sixty-one of these were intervention research studies related to fall and injury
prevention (32 from the community setting; 33 from the acute and long-term care setting).
Author Affiliation
Leanne Currie, D.N.Sc., M.S.N., R.N., assistant professor, Columbia University School of
Nursing; e-mail: [email protected].
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chi exercise on physical fitness and fall prevention in 255. Vassallo M, Vignaraja R, Sharma JC, et al. The effect
fall-prone older adults. J Adv Nurs. Jul of changing practice on fall prevention in a
2005;51(2):150-7. rehabilitative hospital: The hospital injury prevention
study. J Am Geriatr Soc. Mar 2004;52(3):335-9.
244. Nowalk MP, Prendergast JM, Bayles CM, et al. A
randomized trial of exercise programs among older 256. Kerse N, Butler M, Robinson E, et al. Fall prevention
individuals living in two long-term care facilities: in residential care: A cluster, randomized, controlled
The fallsfree program. J Am Geriatr Soc. Jul trial. J Am Geriatr Soc. Apr 2004;52(4):524-31.
2001;49(7):859-65.
34
Fall and Injury Prevention
257. Semin-Goossens A, van der Helm JM, Bossuyt PM. 262. Lane AJ. Evaluation of the fall prevention program in
A failed model-based attempt to implement an an acute care setting. Orthop Nurs. 1999;18(6):37-44.
evidence-based nursing guideline for fall prevention.
J Nurs Care Qual. Jul-Sep 2003;18(3):217-25. 263. Lauritzen JB, Petersen MM, Lund B. Effect of
external hip protectors on hip fractures. Lancet. Jan 2
258. Rubinson L, Wu AW, Haponik EE, et al. Why is it 1993;341(8836):11-3.
that internists do not follow guidelines for preventing
intravascular catheter infections? Infect Control Hosp 264. O'Halloran PD, Cran GW, Beringer TR, et al. A
Epidemiol. 2005;26(6):525-33. cluster randomised controlled trial to evaluate a
policy of making hip protectors available to residents
259. Cabana MD, Rand CS, Powe NR, et al. Why don't of nursing homes. Age Ageing. Nov 2004;33(6):582-
physicians follow clinical practice guidelines?: A 8.
framework for improvement. JAMA. 1999;282:1458-
65. 265. O'Halloran PD, Murray LJ, Cran GW, et al. The
effect of type of hip protector and resident
260. Fonda D, Cook J, Sandler V, et al. Sustained characteristics on adherence to use of hip protectors
reduction in serious fall-related injuries in older in nursing and residential homes--an exploratory
people in hospital. Med J Aust. 2006;184(8):372-3. study. Int J Nurs Stud. May 2005;42(4):387-97.
261. Schwendimann R, Buhler H, De Geest S, et al. Falls 266. Ray WA, Taylor JA, Brown AK, et al. Prevention of
and consequent injuries in hospitalized patients: fall-related injuries in long-term care: A randomized
Effects of an interdisciplinary falls prevention controlled trial of staff education. Arch Intern Med.
program. BMC Health Serv Res. 2006;6(1):69. Oct 24 2005;165(19):2293-8.
35
Evidence Table 1. Reviews Examining Fall-Prevention Interventions in the Community
rates
Chang Fall and injury Meta- Design: Review Setting: Multiple Falls: Multimodal assessments with targeted
99
2004 prevention in analysis Outcomes: Fall Community interventions; 40 intervention reduced risk of falls by 37 percent,
the community rates trials reviewed and exercise interventions reduced fall risk by
Population: Older 14 percent.
adults
Hill- Fall and injury Meta- Design: Meta- Setting: Multiple Falls: Decrease in fall rates when individualized
Westmore- prevention in analysis analysis Community interventions; 12 management added to exercise interventions.
land 200538 the community Outcomes: Fall Population: Older studies reviewed
rates adults in long-term
care setting
Stevenson Fall and injury Systematic Design: Setting: Review of Fractures:
2005135 prevention in Review Systematic review Community calcium, vitamin • Calcium, with or without vitamin D, reduces
the community Outcomes: D, and fractures in patients with high risk for fracture.
Fracture, vertebral Population: Older bisphosphonates • Calcium with vitamin D can prevent fractures
and nonvertebral women at risk for in women not at risk for fractures.
fracture
*
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Safety Issue Design Study Design, Study Setting & Study
*
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Shekele Fall and injury Meta- Design: Meta- Setting: Mulriple Falls:
200311 prevention in analysis analysis Community interventions Multifactorial fall prevention programs decrease
the community Outcomes: Fall fall rates
and injury rates Population:
Medicare recipients
37
†
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Source Safety Issue Design Study Design, Study Setting & Study Study Key Finding(s)
†
Related to Type Study Outcome Population Intervention
Clinical Measure(s)
Practice
Lightbody Tailored RCT Design: RCT Setting: Community Home Recurrent Falls: Reduced by 38 percent
2002110 interventions for assessment for
falls in the Outcomes: Falls, Population: 348 medication, Falls: Decreased falls in intervention group, but
community functional ability, consecutive patients ≥ ECG, blood not statistically significant.
emergency 65 years who were pressure,
department visits, discharged from cognition, visual Admissions and bed days: Fewer fall-related
admission to emergency room after acuity, hearing, admissions and bed days in intervention group (8
hospital sustaining a fall vestibular and 69, respectively) than the control group (10
dysfunction, and 233, respectively).
balance,
mobility, feet
and footwear
Nikolaus Tailored RCT Design: RCT Setting: Patients Comprehensive Falls: Intervention group had 31 percent fewer
141
2003 interventions for identified in university- geriatric falls than control group (incidence rate ratio =
falls in the affiliated geriatric assessment 0.69, 95% CI = 0.51–0.97).
community Outcomes: hospital; intervention followed by
39
Number of falls, carried out in patients’ diagnostic home Falls: For subgroup with ≥2 falls during previous
compliance with homes visit and home year, there was a 37 percent decrease in falls
recommendations Population: intervention or a (incident rate ratio = 0.63, 95% CI = 0.43–0.94).
360 patients showing comprehensive
functional decline, geriatric
especially in mobility, assessment
admitted to a geriatric with
hospital (mean age 81.5 recommendatio
years) ns
Nitz Tailored RCT Design: pilot Setting: Australia; Balance training Falls: Intervention and control groups both
108
2004 interventions for RCT academic medical sessions once a showed reduction in fall rates, but no differences
falls in the Outcomes: Fall center week for 10 between groups.
community rates, balance Population: 73 adults weeks Balance measures: Improved for intervention
Robertson Exercise- Meta- Design: Meta- Setting: Community Muscle Falls and injuries: Fall and injury rates decreased
2002123 related analysis analysis of four setting: nine cities and strengthening and by 35 percent; no difference between genders.
interventions studies towns in New Zealand balance retraining • Fall rate incidence rate ratio (IRR) = 0.65, 95%
for fall exercises CI = 0.57–0.75
prevention in Outcomes: Fall Population: 1,016 designed • Participants reporting a fall in the previous year
the community rates, injury rates women and men ages specifically to had a higher fall rate (IRR = 2.34, 95% CI =
65 to 97 prevent falls 1.64–3.34).
• Injury rate IRR = 0.65, 95% CI = 0.53–0.81.
Barnett Exercise- RCT Design: RCT Setting: Weekly group Falls: Fall rates decreased by 40 percent in the
113
2003 related Community, South exercise program exercise group (IRR = 0.60, 95% CI = 0.36–
interventions Outcomes: Fall Western Sydney, with ancillary 0.99).
for fall rates, balance, Australia. home exercises
prevention in muscle strength, over 1 year Balance measures: Improved in exercise group.
the community fear of falling Population: 163
subjects ≥ 65 years Other measures: No difference between groups
identified as at risk of in strength, reaction time, and walking speed or
falling using a on Short-Form 36, Physical Activity Scale for the
standardized Elderly or fear of falling.
assessment screen by
general practitioner or
physical therapist
Safety Issue Design Study Design, Study Setting & Study
‡
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Wolf Exercise- RCT Design: RCT Setting: Intense Tai Chi Falls: Fall rates decreased in Tai Chi group, but
2003122 related 20 congregate living exercise program no statistical difference between groups (relative
interventions Outcomes: Time facilities in the greater or wellness risk = 0.75, 95% CI = 0.52–1.08).
for fall to first fall, fall Atlanta area education
prevention in rates, balance program
the community Population: 291
women and 20 men
ages 70 to 97 who
were transitioning to
frailty
Clemson Exercise- RCT Design: RCT Setting: Community Occupational Falls:
2004 114 related therapy home • 31 percent reduction in falls for both genders
interventions Outcomes: Fall Population: 310 men visits, lower-limb (relative risk = 0.69, 95% CI = 0.50–0.96; P =
for fall rates and women ≥ 70 balance and 0.025).
prevention in years who had had a strength training, • For men alone, 68 percent reduction in falls
the community fall in the previous 12 environmental (relative risk = 0.32, 95% CI = 0.17–0.59).
43
for fall mobility, physical Netherlands inspired by Tai (2.5 falls/yr), but not statistically significant.
prevention in performance, and Chi or For frail subjects: Risk of becoming a faller in the
the community self-reported Population: 287 daily mobility exercise groups increased almost 3 times
disability elderly men and activities (hazard ratio = 2.95; 95% CI = 1.64-5.32).
women (mean age +/- or For pre-frail subjects: Risk of becoming a faller
standard deviation, control decreased by 61 percent (hazard ratio = 0.39;
85+/-6yrs) 95% CI = 0.18–0.88).
Lin 2006126 Exercise- RCT Design: RCT Setting: 6 rural Tai Chi training Falls: 50 percent greater decrease in fall rates
related villages in Taiwan: 2 plus fall- among the Tai Chi practitioners (relative risk =
interventions villages received prevention 0.5; 95% CI = 0.11–2.17), but not statistically
for fall Outcomes: Falls, intervention, 4 villages education significant.
prevention in fall-related acted as controls or Tinetti Balance Scale: Tai Chi practitioners
the community injuries, related Population: fall-prevention increased by 1.8 points (95% CI = 0.2–3.4).
functional 1,200 men and education alone Tinetti Gait Scale: Tai Chi practitioners increased
outcomes women by 0.9 point (95% CI = 0.1–1.8).
≥ 65 years screened; Fear of Falling: No significant changes in the fear
88 participants of falling.
Safety Issue Design Study Design, Study Setting & Study
‡
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Luukinen Exercise- RCT Design: RCT Setting: Community, Suggestions for For all subjects:
2007127 related home-dwelling Finnish a program Falls:
interventions Outcomes: Fall consisting of • 12 percent decrease in falls from baseline for
for fall rates, time to first Population: 555 older home exercise, intervention group (hazard ratio = 0.88, 95% CI
prevention in fall men and women (67 walking exercise, = 0.74–1.04).
the community percent ≥ 85 years), group activities, • 7 percent decrease in all falls, but not
most with history of self-care statistically significantly (hazard ratio = 0.93,
recurrent falls or at exercise, 95% CI = 0.80–1.09).
least one mobility risk or routine care For subjects not homebound:
factor Falls:
• 22 percent decrease in falls (hazard ratio =
0.78, 95% CI = 0.64–0.94).
• 12 percent decrease in first four falls (hazard
ratio = 0.88, 95% CI = 0.74–1.05).
45
2004178 prevent falls RCTs Population: 1,237 700–800IU/d 22 percent (corrected odds ratio = 0.78, 95% CI
and fall-related participant in the five Small dose = 400 = 0.64–0.92).
injuries in the Outcomes: studies IU/d Fracture:
community Fracture • Vitamin D 700–800IU/d reduced the risk of
fracture by up to 26 percent.
• Vitamin D 400 IU/d did not reduce fracture
risk.
Numbers needed to treat: 15 patients would
need to be treated with vitamin D to prevent 1
person from falling.
Sensitivity analysis of 5 additional studies: Total
sample 10,001 – smaller effect size (corrected
relative risk = 0.87, 95% CI = 0.80–0.96).
§
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Safety Issue Design Study Design, Study Setting & Study
§
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Avenell Meta- Design: Setting: Community Vitamin D or an Vitamin D or analogue alone:
2005107 analysis Metanalysis of analogue alone, • No effect on hip fracture (relative risk = 1.17;
RCTs or quasi- or 95% CI = 0.98–1.41).
randomized trials Poplulation: 7 trials; vitamin D with • No effect on vertebral fracture (relative risk =
18,668 participants calcium, 1.13; 95% CI = 0.50–2.55).
Outcomes: or
• Any new fracture (relative risk = 0.99; 95% CI
Fractures Placebo, no
= 0.91–1.09).
intervention, or
Vitamin D or analogue with calcium:
calcium
• Marginal reduction in hip fractures (relative
risk = 0.81; 95% CI = 0.68–0.96).
• Marginal reduction in nonvertebral fractures
(relative risk = 0.87; 95% CI = 0.78–0.97).
• No effect on vertebral fractures.
• Calcitriol may be associated with an increased
incidence of adverse effects.
47
Grant Physiologic RCT Design: Setting: Patients 800 IU vitamin D Falls: No differences between groups (hazard
2005130 interventions to Factorial-design identified in 21 UK daily ratio = 0.94; 95% CI = 0.81–1.09).
prevent falls trial hospitals then treated or
and fall-related at home after 1,000 mg calcium Fractures:
injuries in the Outcomes: New discharge daily • No difference between vitamin D and placebo
community low-energy or (hazard ratio = 1.02; 95% CI = 0.88–1.19).
fractures Population: 5,292 800 IU vitamin D • No difference between combination treatment
people ≥ 70 years (85 plus 1,000mg and placebo.
percent female) with calcium daily
new low-trauma or
fracture, and who placebo
were mobile before
that fracture
**
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Evidence Table 6. Studies Examining Environmental Interventions in Acute and Long-Term Care (listed chronologically)
Kelly Environmental Pretest Design: Setting: Medicare unit Movement Falls: Fall rates decreased from 4.0 falls per 100
240
2002 interventions and Crossover design of a skilled nursing detection patch patient days to 3.4 falls per 100 days for patients
for fall post- for 1 week facility attached to the with movement detection patches.
prevention in test Population: 47 thigh
acute and study Outcomes: Fall patients at high risk for
long-term care rates falls
Kwok Environmental RCT Design: RCT Setting: Two geriatric Bed-chair Falls: No difference in fall rates between chair
2006222 interventions stroke rehabilitation pressure sensor alarm group and control group.
for fall Outcomes: wards in a or
prevention in Physical restraints convalescent hospital control Restraints: No difference in physical restraint use
acute and use, fall rates in Hong Kong between chair alarm group and control group.
long-term care
Population: 180
geriatric patients
perceived by nurses to
be at risk of falls
††
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Evidence Table 7. Studies Examining Physical Activity Interventions in Acute and Long-Term Care (listed chronologically)
Safety Issue Design Study Design, Study Setting & Study
Related to Type ‡‡ Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Mulrow Physical RCT Design: RCT Setting: 1academic Individually Falls: Fall rates increased in the intervention
241
1994 activity nursing home and 8 tailored one-on- group (79 versus 60; P = 0.11).
interventions Outcomes: Fall community nursing one physical
for fall rates homes therapy sessions
prevention in Population: or
acute and 194 frail long-term Friendly visits
long-term care care residents
Nowalk Physical RCT Design: RCT Setting: 2 long-term Resistance- Falls and other outcomes: Time to first fall, time
2001244 activity care facilities endurance with to death, number of days hospitalized, and
interventions Outcomes: Fall enhanced incidence of falls did not differ among the
for fall rates Population: exercise treatment and control groups (P > 0.05).
prevention in 110 elderly men and or
acute and women (avg. age 84), Tai Chi with
long-term care capable of ambulating enhanced
51
Lane Multimodal Pretest, Design: Pre-post Setting: Medical- Fall-prevention Falls: No decrease in patient fall rate was found
262
1999 interventions in post-test and comparative, surgical/critical care program between patients who fell before and after
acute and descriptive unit; large community implementation of the program.
long-term care design hospital system
Population: 292
Outcomes: older patients
Fall rates
McMurdo Multimodal RCT Design: RCT Setting: Nursing Assessment/ Falls: 55 percent reduction in fall rates for group
254
2000 interventions in home residents modification and with exercise training, but not statistically
acute and Outcomes: Falls seated balance significant (odds ratio = 0.45; 95% CI = 0.19–
long-term care and fractures Population: 133 exercise training 1.14).
residents ≥ 84 years program
or
reminiscence
therapy
§§
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-test
(before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature reviews,
(12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus reports,
(17) Published guidelines, (18) Unpublished research, reviews, etc.
Safety Issue Design Study Design, Study Setting & Study
§§
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Jensen Multimodal RCT Design: cluster Setting: 9 residential Comprehensive Falls: 51 percent reduction in falls (adjusted
2002249 interventions in RCT care facilities located fall risk odds ratio = 0.49; 95% CI = 0.37–0.65).
acute and Outcomes: Fall in northern Sweden assessment and
long-term care rates, time to first Population: tailored Injuries: 77 percent reduction in fall-related
fall, fall-related 439 residential care interventions injuries (adjusted odds ratio = 0.23; 95% CI =
injuries residents ≥ 65 years 0.06–0.94).
Bischoff Multimodal RCT Design: Double- Setting: Long-stay 1,200 mg Falls: 49 percent reduction of falls in the group
2003247 interventions in blind RCT geriatric care calcium plus 800 that received calcium plus vitamin D (95% CI =
acute and Population: IU vitamin D daily 14–71; P < 0.01).
long-term care Outcomes: Fall 122 elderly women or 1,200 mg
rates (mean age, 85.3 calcium daily
years; range, 63–99
years)
Hofmann Multimodal Pretest, Design: Pretest, Setting: 120-bed Concurrent: Staff Falls: 38 percent reduction in fall rates (P =
250
2003 interventions in post-test post-test nursing home education, 0.0003).
acute and exercise, and Injuries: 50 percent reduction in injury rates (P
53
256
2004 interventions in RCT care homes followed by ratio = 1.34; 95% CI = 1.06–1.72).
acute and tailored
long-term care Outcomes: Fall Population: interventions
rates 628 residents
Vassallo Multimodal Non- Design: Quasi- Setting: 3 geriatric Medication Falls:
208
2004 interventions in randomized experimental wards adjustment, • 25 percent decrease in falls in the intervention
acute and trial environmental group, but not statistically significant (relative
long-term care Outcomes: Fall Population: assessment, risk = 0.75; 95% CI = 0.53–1.05).
rates, injury 825 consecutive wristbands • No reduction in recurrent fallers.
rates, repeat fall geriatric patients
rates Injuries: No reduction in injuries.
Flicker Multimodal RCT Design: Setting: Multicenter Vitamin D 10,000 Falls: 27 percent decrease in falls in
248
2005 interventions in Randomized, study in 60 assisted IU once, then intervention group (incident rate ratio = 0.73;
acute and placebo- living facilities and 89 1,000 IU daily 95% CI = 0.57–0.95).
long-term care controlled, nursing homes plus 600 mg
double-blind trial across Australia calcium Injuries: 31 percent decrease in injuries, but not
Population: or statistically significant (odds ratio = 0.69; 95%
Outcomes: Falls 625 residents (avg. placebo plus 600 CI = 0.40–1.18).
and fall-related age 83 years) with mg calcium
fractures vitamin D deficiency
Safety Issue Design Study Design, Study Setting & Study
§§
Related to Type Study Outcome Study Population Intervention Key Finding(s)
Source Clinical Measure(s)
Practice
Klay Multimodal Pretest, Design: Pretest, Setting: Connecticut Individualized Falls: 58 percent reduction in falls after
2005246 interventions in post-test post-test long-term care center continence treatment with individual continence program.
acute and study Outcomes: Population: 42 program
long-term care Urinary tract female residents who
infections, were incontinent or
pressure ulcers, had urgency related
and falls to overactive bladder
Fonda Multimodal Pretest, Design: Pretest, Setting: Long-term Multistrategy Falls: 19 percent reduction in the number of
260
2006 interventions in post-test post-test care setting, Australia approach: work falls per 1,000 patient days (12.5 v 10.1; P =
acute and study practice 0.001).
long-term care Outcomes: Fall Population: All changes,
rates, fall-related patients admitted to environmental/ Falls: 77 percent reduction in the number of
injuries the unit equipment falls resulting in serious injuries per 1,000
changes, staff patient days (0.73 v 0.17; P < 0.001).
education
Schwendi- Multimodal Design: Serial Setting: 300-bed Interdisciplinary Falls: Decrease in fall rates, but not statistically
55
mann interventions in survey design urban public hospital falls-prevention significant (pre-9.0, post-7.8; P = 0.086).
2006261 acute and Population: Adult program Injuries: No change in injury rate.
long-term care Outcomes: Fall patients in internal
rates, fall-related medicine, geriatrics,
injuries and surgery
***
Study Design Type: (1) Meta-analysis, (2) Randomized controlled trials, (3) Nonrandomized trials, (4) Cross-sectional studies, (5) Case control studies, (6) Pretest and post-
test (before and after) studies, (7) Time series studies, (8) Noncomparative studies, (9) Retrospective cohort studies, (10) Prospective cohort studies, (11) Systematic literature
reviews, (12) Literature reviews, nonsystematic/narrative, (13) Quality-improvement projects/research, (14) Changing-practice projects/research, (15) Case series, (16) Consensus
reports, (17) Published guidelines, (18) Unpublished research, reviews, etc.
Chapter 11. Reducing Functional Decline in
Hospitalized Elderly
Ruth M. Kleinpell, Kathy Fletcher, Bonnie M. Jennings
Background
The elderly, or those older than 65 years, currently represent 12.5 percent of the U.S.
population, and are projected to increase to 20 percent of the population by 2030—growing from
35 million to 72 million in number.1, 2 By 2050, 12 percent of the population, or one in eight
Americans, will be 75 years of age or older.3 In 2002, the elderly accounted for 12.7 million (41
percent) of the 31.7 million hospitalizations in the United States,4 and these numbers are
expected to increase significantly as the population ages. Targeting the care needs of the
hospitalized elderly and awareness of risks for illness-related complications are urgent concerns
for managing acute health care conditions in this population.4
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Age-Associated Changes
A number of known physiological changes occur with aging, including reduced muscle
strength and aerobic capacity, vasomotor instability, baroreceptors insensitivity and reduced total
body water, reduced bone density, reduced ventilation, and reduced sensory capacity.4, 11, 12
Comorbid conditions and chronic illness may heighten these changes. Muscle mass and muscle
strength are reduced with aging and contribute to a reduction of physical activity.12 With aging,
alterations in autonomic function, including baroreceptor insensitivity, occurs. Age-associated
reduction in body water and plasma volume may predispose the elderly to syncope. Respiratory
mechanics are also altered with aging, with reduced ventilation, increased residual capacity, and
reduced arterial oxygen tension.12 Other age-associated changes include reduced bladder
capacity and increased urine production, prostrate enlargement, bone demineralization, loss of
taste and smell, decreased skin integrity, and reduction in sensory input.12, 13
As a result, the elderly are at higher risk for adverse physiological consequences during acute
illness, including impairment in functional status. Frailty—a state of musculoskeletal weakness
and other secondary, widely distributed losses in structure and function—has been found to be
attributed to decreased levels of activity and has been linked to the process of aging.14 Advanced
age, acute and chronic disease and illness, functional limitations, and deconditioning all
contribute to the older adult’s vulnerability to functional decline during hospitalization.
Functional decline—the inability to perform usual activities of daily living due to weakness,
reduced muscle strength, and reduced exercise capacity—occurs due to deconditioning and acute
illness during hospitalization.15
Functional Status
Functional status is determined by the ability to perform activities of daily living (ADLs)—
eating, dressing, bathing, ambulating, and toileting—and instrumental ADLs (IADLs)—
shopping for groceries, meal preparation, housework, laundry, getting to places beyond walking
distance, managing medications, managing finances, and using a telephone.4 It is estimated that
up to 8 percent of community-dwelling elders need assistance with one or more ADLs. Among
those age 85 and older, the percentage who live at home but need assistance or who live in a
nursing home increases significantly to 56 percent of women and 38 percent of men.4 Chronic
illness and comorbidities can directly impact functional status in the elderly. Chronic health care
conditions that are most prevalent in the elderly include heart disease, hypertension, arthritis,
diabetes, and cancer.3 Acute illness due to chronic disease and chronic comorbidities accounts
for a significant number of hospitalizations in the elderly.
2
Reducing Functional Decline
muscle fatigue that results is associated with reduced muscle blood flow, red cell volume,
capillarization, and oxidative enzymes.17 Accelerated bone loss can lead to a higher risk for
injury to bones and joints, including hips and spine.18
Sources: Amella EJ. Presentation of illness in older adults. Am J Nurs 2004;104:40-52. Creditor MC. Hazards of
hospitalization of the elderly. Ann Intern Med 1993;118: 219-23. Convertino VA. Cardiovascular consequences of bed
rest: effect on maximal oxygen uptake. Med Sci Sports Exerc 1997;29:191-6.
Deconditioning, which results in a decrease in muscle mass and the other physiologic
changes related to bed rest, contributes to overall weakness.19 Functional decline can then occur
as a consequence of those physiologic changes and result in inability to perform usual ADLs.19
Low levels of mobility and bed rest were common occurrences during hospitalization for the
elderly.20 Deconditioning and functional decline from baseline was found to occur by day 2 of
hospitalization in elderly patients.21 Loss of functional independence during hospitalization
resulted from not only the effects of acute illness, but also from the inability to maintain function
during hospitalization.22 In assessing physical activity of 500 hospitalized elderly patients, those
who remained in bed or who had chair activity rarely received physical therapy, had physician
orders for exercises, or performed bedside strengthening exercises.21 Comparisons of functional
assessment at baseline and day 2 of hospitalization in 71 patients over the age of 74 years
demonstrated declining ability in mobility, transfer, toileting, feeding, and grooming.23 Between
day 2 and discharge, 67 percent demonstrated no improvement and 10 percent experienced
further decline, highlighting the potential for delayed functional recovery in the hospitalized
elderly.23 A followup of 489 hospitalized elders age 70 years and older revealed that the
prevalence of lower mobility in hospitalized elderly was significant, with 16 percent
experiencing low levels of mobility, 32 percent experiencing intermediate levels of mobility, and
29 percent experiencing a decline in an ADL activity.20 Yet for almost 60 percent of bed-rest
episodes, there was no documented medical indication for limiting mobility status.
Preadmission health and functional status of the elderly can indicate risk of further functional
decline associated with hospitalization. In examining the baseline functional status of 1,212
hospitalized patients age 70 years and older, the use of ambulation assistive devices, such as
canes and walkers, was predictive of functional decline associated with hospitalization.24 Use of
a walker was associated with a 2.8 times increased risk for decline in ADL function by the time
of hospital discharge (P = 0.0002). Moreover, 3 months after discharge, patients who had used
an assistive device prior to hospitalization were more likely to have declined in both ADL status
(P = 0.02) and IADL status (P = 0.0003).24 Other risk factors found to be predictive of
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
functional decline in the elderly during hospitalization included having two or more
comorbidities, taking five or more prescription medications, and having had a hospitalization or
emergency room visit in the previous 12 months.25
Associations between functional status and other risk factors such as cognitive status must
also be considered. Hospital-related complications or inadequate hospital care have been linked
to the development of delirium in the hospitalized elderly.26 Impairment in cognitive status was
found to be associated with changes in functional status in the hospitalized elderly. A study of
2,557 patients from two teaching hospitals examined the association between level of impaired
performance on a cognitive status screen and maintenance and recovery of functioning from
admission through 90 days after discharge. Performance on a brief cognitive screen on admission
was strongly related to subsequent change in function. Among patients who needed help
performing one or more ADLs at the time of admission, 23 percent of patients with moderate to
severely impaired cognitive performance, 49 percent of patients with mildly impaired cognitive
performance, and 67 percent of patients with little or no impairment in cognitive performance
recovered the ability to independently execute an additional ADL by discharge (P < 0.001).22
Additional studies identified that prolonged recovery and continued ADL limitations occurred
after hospitalization. In following 1,279 patients age 70 years and older after hospital discharge,
a study found that 59 percent reported no change in ADL status, 10 percent reported
improvement, and 39 percent reported declined ADL status at discharge when compared to
preadmission status. At 3 months after discharge, 40 percent reported a new ADL or IADL
disability compared with preadmission, reflecting the potential for continued functional decline
after hospitalization for acute illness.27
Yet, the loss of functional independence is not an inevitable consequence of hospitalization
for the elderly.28, 29 Evidence exists that targeted interventions can impact the degree of
functional independence for hospitalized elders.30
Research Evidence
Targeted measures that have proven beneficial in mitigating functional decline during
hospitalization have included comprehensive geriatric assessments to identify patients at risk,
structured geriatric care models, dedicated hospital units for acute care of the elderly, and the use
of specific resources to enhance care for the hospitalized elder.
4
Reducing Functional Decline
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
72.9 percent did not walk at all per 3-hour period of observation, 18.6 percent walked once, 5.1
percent twice, and only 3.4 percent walked more than twice.35 The median time of ambulation
was 5.5 minutes. Of the 32 patients who walked in the hallways, 46.8 percent (n = 15) did so
alone, 41 percent (n = 13) walked with a therapist, 41 percent (n = 13) walked with a member of
the nursing staff, and 18.8 percent (n = 6) walked with a family member.
Based on the results of the CGA, functional problems or potential problems are identified
and specific interventions can be implemented to promote functional ability in hospitalized
elders. A number of interventions, including structured exercise, progressive resistance strength
training, and walking programs, have been implemented to target elder care functioning during
hospitalization.35, 37, 38 A randomized control trial of a hospital-based general exercise program
with 300 hospitalized elders that was started during hospitalization and continued for 1 month
after discharge did not affect length of stay, but did demonstrate better IADL function at 1 month
after discharge.38 Measures to improve endurance—including exercise to enhance orthostatic
stability, daily endurance exercise to maintain aerobic capacity, or specific resistance exercises to
maintain musculoskeletal integrity17, 39, 40—need further study on their impact in reducing
functional decline in hospitalized elders. As hospital-based exercise programs require
coordination and focused implementation plans, strategies for adopting them need to recognize
the shortened length of hospital stay and the effects of acute illness on the patients’ ability to
participate.
In addition to utilizing tools to assess the elderly hospitalized patient, assessments of the
hospital culture for providing elder care can also be beneficial. The Geriatric Institutional
Assessment Profile was specifically developed to assess hospital workers’ knowledge, attitudes,
and perceptions of caring for elders, as well as the adequacy of the institutional environment to
meet hospitalized elders’ needs.41 It is recommended to help identify both the strengths in elder
care and the opportunities for improvement.42
6
Reducing Functional Decline
formulate an individualized plan of care. Use of the program demonstrated significant results:
only 14 percent of patients had a decline on ADL scores, compared to a decline in 33 percent of
the control group.
Acute Care for Elderly (ACE) units. Models of care incorporate a variety of interventions
to promote positive outcomes for the hospitalized elderly. Specific programs have also been
tested on specialized units within the hospital setting. These units, termed Acute Care for the
Elderly (ACE units), provide dedicated care to the hospitalized elderly.
Originating in the early 1990s, the ACE unit concept has been adopted by organizations as a
strategy to provide care to elderly patients during hospitalization.48–49 ACE units promote a
focused model of care that integrates geriatric assessment into medical and nursing care of
patients in an interdisciplinary environment.50 The focus is to provide expert care while
simultaneously keeping patients mobile and preventing the loss of normal daily routines.49 ACE
units include specially designed environmental changes to promote activity such as ambulation
in hallways, exercise facilities, and social gathering areas.51 Multidisciplinary teams composed of
geriatric physicians; nurses; dietician; social worker; pharmacist; and occupational, speech, and
physical therapists regularly discuss the plan of care for each patient.49 Major components of the
ACE unit concept include patient-centered nursing care (daily assessment of functional needs by
nursing, nursing-based protocols to improve outcomes, daily rounds by a multidisciplinary team),
a prepared environment, planning for discharge, and medical care review.10, 52
Another model, designed to improve functional outcomes of acutely ill hospitalized elders,
was tested in a randomized control trial with 1,794 patients 70 years of age and older in one unit
of a hospital. A number of interventions were implemented under the direction of the primary
nurse, including baseline and ongoing assessment of risk factors; following protocols to improve
self-care, continence, nutrition, mobility, sleep, skin care, and cognition; conducting daily rounds
with a multidisciplinary team; and environmental enhancements such as handrails, uncluttered
hallways, large clocks and calendars, elevated toilet seats, and door levers.29 Results indicated
that 21 percent of intervention patients were classified as much better in ADL activity abilities,
13 percent as better, 50 percent as unchanged, 22 percent as worse, and 9 percent as much worse.
In the control group, 13 percent were classified as much better, 11 percent as better, 54 percent
as unchanged, 13 percent as worse, and 8 percent as much worse (P = 0.0009). While the
program interventions improved functional status in a significant percentage of the patients, the
majority of the patients in both the intervention and control groups were unchanged or worse at
the time of discharge. At 3 months after discharge, the groups did not differ significantly in terms
of ADL or IADL abilities.29 The results of this study suggested that while targeted interventions
can improve functional independence in the hospitalized elderly, some patients will continue to
experience functional decline, despite focused interventions.
Research comparing ACE units and standard medical care units has demonstrated positive
outcomes, with improvements in ADL function and fewer transfers to nursing home settings
after discharge.29 A randomized controlled study of 1,531 elders age 70 years and older
demonstrated that use of an ACE unit improved processes of care and promoted patient and
provider satisfaction without increasing hospital length of stay or costs.51 Additional study on the
cost effectiveness of ACE units has demonstrated significant reductions in average length of stay
(0.8 day) and a cost savings of $1,490 compared to control patients on two medical-surgical units,
a savings that translated to $1.3 million in 9 months48 as well as no increase in hospital costs.53
The NICHE model. An additional model focusing on improving hospital care for the elderly,
the Nurses Improving Care of Health System Elders (NICHE) project, was initiated in the early
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
1990s. The project is a national program focused on promoting evidenced-based care for
elders.42, 54 Resources include best practice protocols, educational materials, nursing care models
to replicate, and assessment tools. A unique series of online assessment tools, Try This, is
available at www.hartfordign.org/resources/education/tryThis.html. Assessments of the NICHE
program indicate that fewer patients were acutely confused at discharge,55 restraint use was
reduced by more than 60 percent, serious injuries related to falls were reduced by 30 percent,
there were beginning signs of reduction in the incidence of aspiration pneumonia and urinary
tract infection, and patient mobility equipment was standardized.56 Outcome reports from
implementation of NICHE also included increased nursing knowledge of geriatric care,
decreased length of stay, and reduced costs.42, 56–58 The NICHE model of care is currently a
voluntary program, and while additional outcomes-based research is needed, implementation of
the program components by all hospital settings would facilitate best practices for elder care.
The geriatric resource nurse model is the most widely used NICHE model. In the geriatric
resource nurse model, unit-based nurses acquire competency in elder care and improve care by
modeling best practices and providing consultation for elder care.42, 56, 57 Implementation reports
highlight anecdotal evidence of benefit, but researched-based outcome evaluations is limited.
One study of 173 hospitalized elders demonstrated improvements in outcome measures,
including functional and cognitive status from admission to discharge when managed by the
geriatric resource nurse model; however, a comparison of a subset of the intervention patients
and a control group of patients revealed no differences in patient outcomes.30 Further research on
this model of care for hospitalized elders is required.
8
Reducing Functional Decline
• Functional status or the ability to perform self-care and physical needs activities is an important
component of independence for the elderly. Maintaining function is central to fostering health and
independence in the hospitalized elderly.
• The hospitalized elderly are at risk for decreased mobility and functional decline.
• Hospitalization has been shown to be associated with low mobility and functional disability.
• Comprehensive initial and ongoing geriatric assessments assist in identifying the older adult at
risk for decline, enabling timely and targeted implementation strategies.
• Targeting risk factors—cognitive impairment, prehospitalization functional impairment, and low
social activity level—that can contribute to functional decline during hospitalization can promote
better outcomes for elders.
• Encouraging activity during hospitalization can help to prevent functional decline. Interventions
such as structured exercise, progressive resistance strength training, and walking programs have
been implemented to target elder care functioning during hospitalization.
• Redesign of the environment and processes of hospital care can improve the quality of the care
delivered to the hospitalized elderly.
• Key elements and features of successful intervention programs targeting functional outcomes in
the hospitalized elderly include
○ Baseline and ongoing assessment of risk factors
○ Protocols aimed at improving self-care, continence, nutrition, mobility, sleep,
skin care, and cognition
○ Daily rounds with a multidisciplinary team
○ Protocols to minimize adverse effects of selected procedures (e.g., urinary catherization)
and medications (e.g., sedative-hypnotic agents) and limit the use of mobility restrictors
(lines, tubes, and restraints)
○ Environmental enhancements, including handrails, uncluttered hallways, large
clocks and calendars, elevated toilet seats, and door levers
○ Encouraging mobilization during hospitalization
• Specialty geriatric nursing care can positively impact elder care in the hospital setting.
• The potential for delayed functional recovery should be considered in discharge planning for
hospitalized elders.
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
A number of important considerations for addressing potential risks for the hospitalized elder
are outlined in Table 5.
2. Adverse effects of immobility and bed rest Incorporate the use of practice guidelines to address
potential adverse effects, including prevention of skin
breakdown, fall prevention, treating delirium, prevention
of pressure ulcers, and management of urinary
incontinence.
10
Reducing Functional Decline
Research Implications
To improve the quality and safety of care for hospitalized elderly patients, the following
questions deserve further investigation:
• What interventions are the most effective in enhancing functional status in the
hospitalized elderly?
• What is the impact of single-site successful models of care in multiple hospital care
settings?
• What is the cost effectiveness of intervention programs aimed at targeting functional
decline in the hospitalized elderly?
Future research on reducing functional decline in the hospitalized elderly should target the
following significant gaps in research:
• Additional research on the impact of models of care for the hospitalized elderly
(including NICHE) is needed to build evidence-based practice recommendations. Most of
the existing “evidence” comes from small randomized studies, nonrandomized studies,
case studies, and expert opinion.
• Hospital design outcomes research is warranted to further evaluate the impact of redesign
interventions in enhancing outcomes for hospitalized elders.
• Most research on interventions targeting functional status during hospitalization of the
elderly was conducted at single-site locations. Therefore, it is not clear if the findings can
be generalized to other settings. Additional research is needed that focuses on
multidisciplinary interventions with larger sample sizes and in multicenter, randomized
clinical studies.
• A conceptual model for targeting functional decline in the hospitalized elderly is needed.
Factors to be considered include the fact that the elderly are a heterogeneous group—
some are frail upon admission and others are robust. The hospitalized elderly come to the
hospital with different comorbidities and reasons for admission. Polypharmacy in the
elderly needs to also be considered. In addition, the tertiary care environment is not a
living environment, creating a dissonance between the goals of restorative care and
environmental function.
• While structured models of care focusing on assessment, physical therapy, ADL protocol
use, and multidisciplinary team care have demonstrated significant benefits on
independence for hospitalized elders, relatively simple interventions such as hallway
walking, communal dining, and group therapy need to be further examined.
• Nursing-focused interventions aimed at promoting functional independence for
hospitalized elders need further exploration in formal research studies.
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Conclusion
This chapter has presented an overview of research and evidence-based practices for elderly
care during hospitalization to prevent functional decline. A number of other chapters in this book
further address related areas, such as averting patient falls, preventing pressure ulcers, symptom
management, and other aspects of care for the hospitalized elder. Continued research and
dissemination of best practices will lead to additional strategies that nurses can use to improve
the quality of health care and outcomes for hospitalized elders. Assessment of function and
targeting interventions during hospitalization are critically important to acute care of older
adults.71 The impact of functional decline on resource utilization and health care costs may
further reinforce the need to assess and intervene to prevent functional decline.72 Additional
research on factors influencing functional decline will also provide information for nurses to
present to administrators to develop programs to identify and mitigate functional decline in the
hospitalized elderly.
Acknowledgments
The authors would like to acknowledge Mary H. Palmer, Ph.D., R.N.C., F.A.A.N., Helen W.
& Thomas L. Umphlet Distinguished Professor in Aging, University of North Carolina at Chapel
Hill, and Eileen M. Sullivan-Marx, Ph.D., C.R.N.P., F.A.A.N., associate professor, associate
dean for Practice & Community Affairs, and Shearer Endowed Term Chair for Healthy
Community Practices, University of Pennsylvania School of Nursing, for their review and
suggestions for editing of the chapter.
Author Affiliations
Ruth M. Kleinpell, Ph.D., R.N., F.A.A.N., Rush University College of Nursing, Chicago,
Illinois; e-mail: [email protected].
Kathy Fletcher, R.N., G.N.P., A.P.R.N.-B.C., F.A.A.N., University of Virginia Health
System, Charlottesville, Virginia; e-mail: [email protected].
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N., Colonel, U.S. Army (Retired), and health care
consultant; e-mail: [email protected].
12
Reducing Functional Decline
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15
Chapter 12. Pressure Ulcers: A Patient Safety Issue
Courtney H. Lyder, Elizabeth A. Ayello
Background
Pressure ulcers remain a major health problem affecting approximately 3 million adults.1 In
1993, pressure ulcers were noted in 280,000 hospital stays, and 11 years later the number of ulcers
was 455,000.2 The Healthcare Cost and Utilization Project (HCUP) report found from 1993 to
2003 a 63 percent increase in pressure ulcers, but the total number of hospitalizations during this
time period increased by only 11 percent. Pressure ulcers are costly, with an average charge per
stay of $37,800.2 In the fourth annual HealthGrades Patient Safety in American Hospitals Study,
which reviewed records from about 5,000 hospitals from 2003 to 2005, pressure ulcers had one of
the highest occurrence rates, along with failure to rescue and postoperative respiratory failure.3
Given the aging population, increasingly fragmented care, and nursing shortage, the incidence of
pressure ulcers will most likely continue to rise.
Preventing pressure ulcers has been a nursing concern for many years. In fact, Florence
Nightingale in 1859 wrote, “If he has a bedsore, it’s generally not the fault of the disease, but of the
nursing”4 (p. 8). Others view pressure ulcers as a “visible mark of caregiver sin”5 (p. 726)
associated with poor or nonexistent nursing care.6 Many clinicians believe that pressure ulcer
development is not simply the fault of the nursing care, but rather a failure of the entire heath care
system7—hence, a breakdown in the cooperation and skill of the entire health care team (nurses,
physicians, physical therapists, dietitians, etc.).
Although the prevention of pressure ulcers is a multidisciplinary responsibility, nurses play a
major role. In 1992, the U.S. Agency for Healthcare Research and Quality (AHRQ, formerly the
Agency for Health Care Policy and Research) published clinical practice guidelines on preventing
pressure ulcers.8 Much of the evidence on preventing pressure ulcers was based on Level 3
evidence, expert opinion, and panel consensus, yet it served as a foundation for providing care.
Although the AHRQ document was published 15 years ago, it still serves as the foundation for
providing preventive pressure ulcer care and a model for other pressure ulcer guidelines developed
afterward. Nurses are encouraged to review these comprehensive guidelines. The document
identifies specific processes (e.g., risk assessment, skin care, mechanical loading, patient and staff
education, etc.) that, when implemented, could reduce pressure ulcer development, and the
literature suggests that following these specific processes of pressure ulcer care will reduce the
incidence of ulcers. Research also suggests that when the health care providers are functioning as
a team, the incidence rates of pressure ulcers can decrease.9 Thus, pressure ulcers and their
prevention should be considered a patient safety goal.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
occur relatively early in the admissions process. For patients in the hospital, they can occur within
the first 2 weeks.11 With the increased acuity of elderly patients admitted and decreased lengths of
stay in hospital, new data suggest that 15 percent of elderly patients will develop pressure ulcers
within the first week of hospitalization.12 For those elderly residents admitted to long-term care,
pressure ulcers are most likely to develop within the first 4 weeks of admission.13
Mortality is also associated with pressure ulcers. Several studies noted mortality rates as high
as 60 percent for older persons with pressure ulcers within 1 year of hospital discharge.14, 15 Most
often, pressure ulcers do not cause death; rather the pressure ulcer develops after a sequential
decline in health status. Thus, the development of pressure ulcers can be a predictor of mortality.
Studies further suggested that the development of skin breakdown postsurgery can lead elders to
have major functional impairment post surgical procedure.
The cost to treat pressure ulcers can be expensive; the HCUP study reported an average cost
of $37,800.2 Cost data vary greatly, depending on what factors are included or excluded from the
economic models (e.g., nursing time, support surfaces). It has been estimated that the cost of
treating pressure ulcers is 2.5 times the cost of preventing them.16 Thus, preventing pressure ulcers
should be the goal of all nurses.
Etiology
Pressure ulcers develop when capillaries supplying the skin and subcutaneous tissues are
compressed enough to impede perfusion, leading ultimately to tissue necrosis. Since 1930, we
have understood that normal blood pressure within capillaries ranges from 20 to 40mm Hg; 32mm
Hg is considered the average.17 Thus, keeping the external pressure less than 32 mm Hg should be
sufficient to prevent the development of pressure ulcers. However, capillary blood pressure may
be less than 32 mm Hg in critically ill patients due to hemodynamic instability and comorbid
conditions; thus, even lower applied pressures may be sufficient to induce ulceration in this group
of patients. Pressure ulcers can develop within 2 to 6 hours.18, 19 Therefore, the key to preventing
pressure ulcers is to accurately identify at-risk individuals quickly, so that preventive measures
may be implemented.
Risk Factors
More than 100 risk factors of pressure ulcers have been identified in the literature. Some
physiological (intrinsic) and nonphysiological (extrinsic) risk factors that may place adults at risk
for pressure ulcer development include diabetes mellitus, peripheral vascular disease, cerebral
vascular accident, sepsis, and hypotension.20 A hypothesis exists that these physiological risk
factors place the patients at risk due to impairment of the microcirculation system.
Microcirculation is controlled in part by sympathetic vasoconstrictor impulses from the brain and
secretions from localized endothelial cells. Since neural and endothelial control of blood flow is
impaired during an illness state, the patient may be more susceptible to ischemic organ damage
(e.g., pressure ulcers).21
Additional risk factors that have been correlated with pressure ulcer development are age of 70
years and older, current smoking history, dry skin, low body mass index, impaired mobility,
altered mental status (i.e., confusion), urinary and fecal incontinence, malnutrition, physical
restraints, malignancy, history of pressure ulcers, and white race.22–25 Although researchers have
noted that the white race is a predictor of pressure ulcers, the small number of nonwhite patients in
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Pressure Ulcers and Patient Safety
most pressure ulcer studies makes this finding questionable. The few studies that have included
sufficient numbers of black people for analysis purposes have found that blacks suffer more severe
pressure ulcers than nonblacks.26, 27 Only one nursing study found that blacks had a higher
incidence rate of pressure ulcer than whites.28 In a study funded by AHRQ using the New York
State Inpatient Data Set 1998–2000, Fiscella and colleagues29 found that African Americans were
more likely to develop pressure ulcers than other races in hospitals. Moreover, a 2004 study
investigating black/white differences in pressure ulcer incidence found that after controlling for
eight resident characteristics and three facility characteristics, race was significantly associated
with pressure ulcer incidence (hazard ratio comparing blacks with whites = 1.31, 95% confidence
interval = 1.02–1.66).30
Risk Assessment
What tool and how often a pressure ulcer risk assessment should be done are key questions in
preventing pressure ulcers. Due to the number of risk factors identified in the literature, nurses
have found the use of risk assessment tools helpful adjuncts to aid in the identification of patients
who may be at high risk. Most health care institutions that use pressure ulcer risk assessment tools
use either the Braden Scale or Norton Scale, with the Braden scale being the most widely used in
the United States. The Braden Scale is designed for use with adults and consists of 6 subscales:
sensory perception, moisture, activity, mobility, nutrition, and friction and shear.31 It is based on
the conceptual schema of linking the above clinical situations to the intensity and duration of
pressure or tissue tolerance for pressure.32 The copyrighted tool is available at
http://www.bradenscale.com.braden.pdf. The scores on this scale range from 6 (high risk) to 23 (low
risk), with 18 being the cut score for onset of pressure ulcer risk. Research has shown that hospital
nurses could accurately determine pressure ulcer risk 75.6 percent of the time after an interactive
learning session on the Braden scale.33 Nurses were best at identifying persons at the highest and
lowest levels of risk and had the most difficultly with patients with mild levels of risk (scores of
15–18).34
The Norton Scale was developed in the United Kingdom and consists of five subscales:
physical condition, mental condition, activity, mobility, and incontinence.35 The total score ranges
from 5 (high risk) to 20 (low risk).
The Braden Scale and Norton Scale have been shown to have good sensitivity (83 percent to
100 percent, and 73 percent to 92 percent, respectively) and specificity (64 percent to 77 percent,
and 61 percent to 94 percent, respectively), but have poor positive predictive value (around 40
percent and 20 percent, respectively).36 The Norton and Braden scales show a 0.73 Kappa statistic
agreement among at-risk patients, with the Norton Scale tending to classify patients at risk when
the Braden scale classifies them as not at risk. The net effect of poor positive predictive value
means that many patients who will not develop pressure ulcers may receive expensive and
unnecessary treatment. Moreover, optimal cutoff scores have not been developed for each care
setting (e.g., medical intensive care versus operating room). Thus, nurses still need to use their
clinical judgment in employing preventive pressure ulcer care. A recent systematic review of risk
assessment scales found that the Braden Scale had the optimal validation and the best
sensitivity/specificity balance (57.1 percent/67.5 percent) when compared to the Norton Scale
(46.8 percent/61.8 percent) and Waterlow Scale (82.4 percent/27.4 percent).37 It should be noted
that the Waterlow skill is a pressure ulcer prediction tool used primarily in Europe.
In recent years, several new prediction tools have been developed (FRAGMMENT Score and
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Schoonhoven Prediction Rule); however, these tools lack sufficient evidence to evaluate their
predictive validity.38, 39 Thus, the use of a validated pressure ulcer risk assessment tool like the
Braden Scale should be used, given the fair research-based evidence. The U.S. Centers for
Medicare and Medicaid Services (CMS) recommends that nurses consider all risk factors
independent of the scores obtained on any validated pressure ulcer prediction scales because all
factors are not found on any one tool.40
The usefulness of clinical informatics to assess and prevent pressure ulcers has been explored.
A quality improvement study involving 91 long-term care facilities evaluated the usefulness of
Web-based reports alerting nursing staff to a resident’s potential risk for pressure ulcers.41 Only
one-third of long-term care facilities used the Web-based reports regularly to identify at-risk
patients. Several key characteristics of facilities that were high users emerged:
• Administrative level and nursing staff buy-in and support
• Development of an actual process integrating the risk reports into ongoing quality
improvement processes
• Having “facility champions” to keep the effort focused and on track
There is no agreement on how frequently risk assessment should be done. There is general
consensus from most pressure ulcer clinical guidelines to do a risk assessment on admission, at
discharge, and whenever the patient’s clinical condition changes. The appropriate interval for
routine reassessment remains unclear. Studies by Bergstrom and Braden42, 43 found that in a skilled
nursing facility, 80 percent of pressure ulcers develop within 2 weeks of admission and 96 percent
develop within 3 weeks of admission. The Institute for Healthcare Improvement has recently
recommended that in hospitalized patients, pressure ulcer risk assessment be done every 24
hours44 rather than the previous suggestion of every 48 hours.45
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Pressure Ulcers and Patient Safety
evaluate the cost effectiveness of the pressure ulcer prevention protocol after a 3-year period. The
implementation of a pressure ulcer prevention protocol showed mixed results. Initial reductions in
pressure ulcer incidence were lost over time. However, clinical results of ulcer treatment improved
and treatment costs fell during the 3 years.51
A more recent nursing study examined the effects of implementing the SOLUTIONS program,
which focuses pressure ulcer prevention measures on alleviating risk factors identified by the
Braden Scale, in two long-term care facilities.52 The quasi-experimental study found that after 5
months of implementing the SOLUTIONS program, Facility A (150 beds) experienced an 87
percent reduction in pressure ulcer incidence (from 13.2 percent to 1.7 percent), which was highly
significant (P = 0.02). Facility B (110 beds) experienced a corresponding 76 percent reduction
(from 15 percent to 3.5 percent), which was also highly significant (P = 0.02). Gunningberg and
colleagues52 investigated the incidence of pressure ulcers in 1997 and 1999 among patients with
hip fractures and found significant reductions in incidence rates (55 percent in 1997 to 29 percent
in 1999). The researchers attributed these reductions in pressure ulcer incidence rates to
performing systematic risk assessment upon admission, accurately staging pressure ulcers, using
pressure-reducing mattresses, and continuing education of staff. Thus, the use of comprehensive
prevention programs can significantly reduce the incidence of pressure ulcers in long-term care.
The use of quality improvement models, where systematic processes of care have been
implemented have also been shown to reduce overall pressure ulcer incidence. In one study
involving 29 nursing homes in three States, representatives of the 29 nursing homes attended a
series of workshops, shared best practices, and worked with one-on-one quality improvement
mentors over 2 years.53 This study found that six of eight prevention process measures (based on
AHRQ prevention guidelines) significantly improved, with percentage differences between
baseline and followup ranging from 11.6 percent to 24.5 percent. Another study using similar
methods involving 22 nursing homes found 8 out of 12 processes of care significantly improved.7
Moreover, the study found that pressure ulcer incidence rates decreased in the nursing homes.
Nursing homes with the greatest improvement in quality indicator scores had significantly lower
pressure ulcer incidence rates than the facilities with the least improvement in quality indicator
scores (P = 0.03).
In the acute care setting, several studies have attempted to demonstrate that the
implementation of comprehensive pressure ulcer prevention programs can decrease the incidence
rates. However, no studies could be found that eliminated pressure ulcers. One large study
evaluated the processes of care for hospitalized Medicare patients at risk for pressure ulcer
development.7 This multicenter retrospective cohort study used medical record data to identify
2,425 patients ages 65 and older discharged from acute care hospitals following treatment for
pneumonia, cerebral vascular disease, or congestive heart failure. Charts were evaluated for the
presence of six recommended pressure ulcer prevention processes of care. This study found that
at-risk patients who used pressure-reducing devices, were repositioned every 2 hours, and
received nutritional consults were more likely to develop pressure ulcers than those patients who
did not receive the preventive interventions. One explanation for this finding may be the amount
of time (48 hours) before the preventive measures were implemented. Given the acuity of patients
entering hospitals, waiting 48 hours may be too late to begin pressure ulcer prevention
interventions. Thus, despite this one study, there is significant research to support that
implementing comprehensive pressure ulcer prevention programs reduces the incidence of
pressure ulcers.
A key component of research studies that have reported reduction of pressure ulcers is how to
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
sustain the momentum over time, especially when the facility champion leaves the institution. It is
clear from the evidence that maintaining a culture of pressure ulcer prevention in a care setting is
an important challenge, one that requires the support of administration and the attention of
clinicians.
Skin Care
Although expert opinion maintains that there is a relationship between skin care and pressure
ulcer development, there is a paucity of research to support that. How the skin is cleansed may
make a difference. One study found that the incidence of Stages I and II pressure ulcers could be
reduced by educating the staff and using a body wash and skin protection products.54
The majority of skin care recommendations are based on expert opinion and consensus.
Intuitively nurses understand that keeping the skin clean and dry will prevent irritants on the skin
or excessive moisture that may increase frictional forces leading to skin breakdown.
Individualized bathing schedules and use of nondrying products on the skin are also recommended.
Moreover, by performing frequent skin assessments, nurses will be able to identify skin
breakdown at an early stage, leading to early interventions. Although there is a lack of consensus
as to what constitutes a minimal skin assessment, CMS recommends the following five parameters
be included: skin temperature, color, turgor, moisture status, and integrity.40
The search for the ideal intervention to maintain skin health continues. One study compared
hyperoxygenated fatty acid compound versus placebo compound (triisotearin) in acute care and
long-term care patients.55 These researchers found that using hyperoxygenated fatty acid
significantly (p-0.006) reduced the incidence of ulcers. Pressure ulcer incidence was lower in an
intervention group of acute care patients when topical nicotinate was applied (7.32 percent)
compared to lotion with hexachlorophene, squalene, and allantoin in the control group (17.37
percent).56
There are several key recommendations to minimize the occurrence of pressure ulcers. Avoid
using hot water, and use only mild cleansing agents that minimize irritation and dryness of the
skin.8, 57 Avoid low humidity because it promotes scaling and dryness, which has been associated
with pressure ulcer development.23 During skin care, avoid vigorous massage over reddened, bony
prominences because evidence suggest that this leads to deep tissue trauma. Skin care should focus
on minimizing exposure of moisture on the skin.58 Skin breakdown caused by friction may be
mitigated by the use of lubricants, protective films (e.g., transparent and skin sealants), protective
dressings (e.g., hydrocolloids), and protective padding.
Mechanical Loading
One of the most important preventive measures is decreasing mechanical load. If patients
cannot adequately turn or reposition themselves, this may lead to pressure ulcer development. It is
critical for nurses to help reduce the mechanical load for patients. This includes frequent turning
and repositioning of patients.
Very little research has been published related to optimal turning schedules. The first such
nursing study was an observational one that divided older adults into three turning treatment
groups (every 2 to 3 hours [n = 32], every 4 hours [n = 27], or turned two to four times/day [n =
41]).59 These researchers found that older adults turned every 2 to 3 hours had fewer ulcers. This
landmark nursing study created the gold standard of turning patients at least every 2 hours. Some
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Pressure Ulcers and Patient Safety
researchers would suggest that critically ill patients should be turned more often. However, one
survey study investigating body positioning in intensive care patients found that of 74 patients
observed, 49.3 percent were not repositioned for more than 2 hours.60 Only 2.7 percent of patients
had a demonstrated change in body position every 2 hours. A total of 80–90 percent of respondents
to the survey agreed that turning every 2 hours was the accepted standard and that it prevented
complications, but only 57 percent believed it was being achieved in their intensive care units. A
more recent study by DeFloor and colleagues61 suggests that depending on the support surface
used, less-frequent turning may be optimal to prevent pressure ulcers in a long-term care facility.
Several nurse researchers investigated the effect of four different turning frequencies (every 2
hours on a standard mattress, every 3 hours on a standard mattress, every 4 hours on a viscoelastic
foam mattress, and every 6 hours on a viscoelastic foam mattress). The nurse researchers found
that the incidence of early pressure ulcers (Stage I) did not differ in the four groups. However,
patients being turned every 4 hours on a viscoelastic foam mattress developed significantly less
severe pressure ulcers (Stage II and greater) than the three other groups. Although the results of
this study may indicate less turning may be appropriate when using a viscoelastic foam mattress,
additional studies are needed to examine optimal turning schedules among different populations.
Reddy and colleagues62 have raised questions about the methodology in the Defloor and
colleagues study, leading them to recommend that it may be too soon to abandon the every-2-hours
turning schedule in favor of every 4 hours based on this one study. Thus, there is emerging
research to support the continued turning of patients at least every 2 hours.
How a patient is positioned may also make a difference. Lateral turns should not exceed 30
degrees.63, 64 One randomized controlled trial that studied a small sample of 46 elderly patients in
the 30-degree-tilt position and the standard 90-degree side-lying position found no significant
difference in the development of pressure ulcers between the two groups.65
Support Surfaces
The use of support surfaces is an important consideration in pressure redistribution. The
concept of pressure redistribution has been embraced by the NPUAP.66 You can never remove all
pressure for a patient. If you reduce pressure on one body part, this will result in increased pressure
elsewhere on the body. Hence, the goal is to obtain the best pressure redistribution possible.
A major method of redistributing pressure is the use of support surfaces. Much research has
been conducted on the effectiveness of the use of support surfaces in reducing the incidence of
pressure ulcers. A comprehensive literature review by Agostini and colleagues67 found that there
was adequate evidence that specially designed support surfaces effectively prevent the
development of pressure ulcers. However, a major criticism of the current support surface studies
was poor methodologic design. Agostini and colleagues noted that many studies had small sample
sizes and unclear standardization protocols, and assessments were not blind.
Reddy and colleagues62 have provided a systematic review of 49 randomized controlled trials
that examined the role of support surfaces in preventing pressure ulcers. No one category of
support surface was found to be superior to another; however, use of a support surface was more
beneficial than a standard mattress. A prospective study evaluating the clinical effectiveness of
three different support surfaces (two dynamic mattress replacement surfaces and one static foam
mattress replacement) found that an equal number of patients developed pressure ulcers on each
surface (three per surface).68 The researchers concluded no differences in the support surface
effectiveness, yet large differences in the cost. (Dynamic mattress replacements cost
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
approximately $2,000 per mattress, compared to $240 per mattress for static foam mattress
replacements.) Given the similar clinical effectiveness, cost should be considered in determining
the support surface.
Four randomized controlled trials evaluated the use of seat cushions in pressure ulcer
prevention, and found no difference in ulcer incidence among groups except between foam and gel
cushions.62 Despite the dearth of research that correlates seat cushions and preventing pressure
ulcers, expert opinion supports the use of seat cushions.
The CMS has divided support surfaces into three categories for reimbursement purposes.68
Group 1 devices are those support surfaces that are static, they do not require electricity. Static
devices include air, foam (convoluted and solid), gel, and water overlays or mattresses. These
devices are ideal when a patient is at low risk for pressure ulcer development. Group 2 devices are
powered by electricity or pump and are considered dynamic in nature. These devices include
alternating and low-air-loss mattresses. These mattresses are good for patients who are at
moderate to high risk for pressure ulcers or have full-thickness pressure ulcers. Group 3 devices,
also dynamic, comprises only air-fluidized beds. These beds are electric and contain
silicone-coated beads. When air is pumped through the bed, the beads become liquid. These beds
are used for patients at very high risk for pressure ulcers. More often they are used for patients with
nonhealing full-thickness pressure ulcers or when there are numerous truncal full-thickness
pressure ulcers. The NPUAP has suggested new definitions for support surfaces that move away
from these categories and divide support surfaces into powered or nonpowered.69 Whether these
new definitions will be embraced by CMS is yet to be determined.
There remains a paucity of research that demonstrates significant differences in the
effectiveness of the various classifications of support surfaces in preventing or healing pressure
ulcers. Therefore, nurses should select a support surface based on the needs and characteristics of
the patient and institution (e.g., ease of use, cost). It is imperative to have the pressure
redistribution product (e.g., mattress or cushion) on the surface where the patients are spending
most of their time, in bed or a chair. However, being on a pressure-redistributing mattress or
cushion does not negate the need for turning or repositioning.
Nutrition
Controversy remains on how best to do nutritional assessment for patients at risk for
developing pressure ulcers. The literature differs about the value of serum albumin; some literature
reports that low levels are associated with increased risk.70 While the AHRQ pressure ulcer
prevention guideline suggests that a serum albumin of less than 3.5 gm/dl predisposes a patient for
increased risk of pressure ulcers, one study reveals that current dietary protein intake is a more
independent predictor than this lab value.8, 42 In the revised Tag F-314 guidance to surveyors in
long-term care, CMS recommends that weight loss is an important indicator.40 Evaluation of the
patient’s ability to chew and swallow may also be warranted.
The literature is unclear about protein-calorie malnutrition and its association with pressure
ulcer development.70 Reddy and colleagues62 suggested that the widely held belief of a
relationship between nutrition intake and pressure ulcer prevention was not always supported by
randomized controlled trials. Some research supported the finding that undernourishment on
admission to a health care facility increases a person’s likelihood of developing a pressure ulcer.
In one prospective study, high-risk patients who were undernourished on admission to the hospital
were twice as likely to develop pressure ulcers as adequately nourished patients (17 percent and
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Pressure Ulcers and Patient Safety
71
9 percent, respectively). In another study, 59 percent of residents were undernourished and 7.3
percent were severely undernourished on admission to a long-term care facility. Pressure ulcers
occurred in 65 percent of the severely undernourished residents, while no pressure ulcers
15
developed in the mild-to-moderately undernourished or well-nourished residents.
Reddy and colleagues62 concluded that nutritional supplementation was beneficial in only one
of the five randomized controlled trials reviewed in their systematic analysis of interventions
targeted at impaired nutrition for pressure ulcer prevention. Older critically ill patients who had
two oral supplements plus the standard hospital diet had lower risk of pressure ulcers compared to
those who received only the standard hospital diet.72
Empirical evidence is lacking that the use of vitamin and mineral supplements (in the absence
of deficiency) actually prevents pressure ulcers.73 Therefore, oversupplementing patients without
protein, vitamin, or mineral deficiencies should be avoided. Before enteral or parental nutrition is
used, a critical review of overall goals and wishes of the patient, family, and care team should be
considered.74 Despite the lack of evidence regarding nutritional assessment and intervention,
maintaining optimal nutrition continues to be part of best practice.
Cleansing
Once the pressure ulcer develops, the ulcer should be cleaned with a nontoxic solution.
Cleaning the ulcer removes debris and bacteria from the ulcer bed, factors that may delay ulcer
healing.76 No randomized control studies could be found that demonstrated the optimal frequency
or agent for cleansing a pressure ulcer. A Cochrane review of published randomized clinical trials
found three studies addressing cleansing of pressure ulcers, but this systematic review produced
no good trial evidence to support any particular wound cleansing solution or technique for
pressure ulcers.77 Therefore, this recommendation remains at the expert opinion level. Nurses
should use cleansers that do not disrupt or cause trauma to the ulcer.78 Normal saline (0.9 percent)
is usually recommended because it is not cytotoxic to healthy tissue.79 Although the active
ingredients in newer wound cleansers may be noncytotoxic (surfactants), the inert carrier may be
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
cytotoxic to healthy granulation tissue.80 Thus, nurses should be cognizant of the ingredients in
cleansing agents before using them on pressure ulcers.
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Pressure Ulcers and Patient Safety
discrimination. The new staging system has six stages: suspected deep tissue injury, Stage I, Stage
II, Stage III, Stage IV, and Unstageable. Table 1 presents the NPUAP definition, and Table 2
illustrates the differences between the old and new pressure ulcer staging systems.
Deep Tissue A pressure-related injury to Purple or maroon localized • The area may be preceded
Injury subcutaneous tissues under area of discolored intact skin by tissue that is painful, firm,
intact skin. Initially, these or blood-filled blister due to mushy, boggy, warmer, or
lesions have the appearance damage of underlying soft cooler, as compared to
of a deep bruise, and they tissue from pressure and/or adjacent tissue.
may herald the subsequent shear. • Deep tissue injury may be
development of a Stage III–IV difficult to detect in
pressure ulcer, even with individuals with dark skin
optimal treatment. tones.
• The area may rapidly evolve
to expose additional layers
of tissue, even with optimal
treatment.
Stage I An observable Intact skin with nonblanchable • The area may be painful,
pressure-related alteration of redness of a localized area, firm, soft, warmer, or cooler,
intact skin whose indicators usually over a bony as compared to adjacent
as compared to an adjacent prominence. tissue.
or opposite area on the body • Stage I may be difficult to
may include changes in one detect in individuals with
or more of the following dark skin tones.
parameters: skin temperature • May indicate at-risk persons
(warmth or coolness), tissue (a heralding sign of risk).
consistency (firm or boggy
feel), sensation (pain, itching),
and/or a defined area of
persistent redness in lightly
pigmented skin; in darker skin
tones, the ulcer may appear
with persistent red, blue, or
purple hues.
Stage II Partial thickness skin loss Partial thickness loss of Presents as a shiny or dry
involving the epidermis and/or dermis presenting as a shallow ulcer without slough
dermis. The ulcer is shallow open ulcer with a red, or bruising. This stage should
superficial and presents pink wound bed without not be used to describe skin
clinically as an abrasion, slough. May also present as tears, tape burns, perineal
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Pressure Ulcer Previous NPUAP Staging 2007 NPUAP Definitions 2007 NPUAP Descriptions
Stage Definitions to Accompany Revised
Definitions
The Stage I pressure ulcer may be more difficult to detect in darkly pigmented skin. A quality
improvement study in several nursing homes found that by empowering the nursing assistants with
education (skin assessment), use of pen lights to assess darker skin, mirrors, and financial reward,
the researchers were able to reduce the Stage I pressure ulcers in residents with darkly pigmented
skin.88 One method for delineating Stage I pressure ulcers in darkly pigmented skin may be the use
of high-resolution ultrasound. Although ultrasound is widely used as a safe and cost-effective
technique for noninvasive visualization of specific human anatomy, its use for skin assessment is
just now available. Ultrasound utilizes the echoes of sound waves to create images of soft tissue
anatomy.89 A probe transmits sound waves into the body. High-frequency ultrasound (20MHZ)
12
Pressure Ulcers and Patient Safety
will provide high resolution images of the skin and underlying soft tissue, and because the images
are related to tissue density (not pigment), the clinician’s assessment ability is enhanced
significantly. A recent study strongly suggests that clinicians should consider high-frequency
ultrasound as an improved method for identifying and implementing good pressure ulcer
preventive care.90
The assessment and staging of pressure ulcers remains at the expert opinion level.
Debridement
The presence of necrotic devitalized tissue promotes the growth of pathologic organisms and
prevents wounds from healing.91 Experts believe that debridement is an important step in the
overall management of pressure ulcers. No randomized control trials could be found that
demonstrated that one debridement technique is superior. Thus, the best method of debridement is
determined by the goals of the patient, absence or presence of infection, pain control, amount of
devitalized tissue present, and economic considerations for the patient and institution.92–94 There
are five types of debridement: sharp, mechanical, autolytic, enzymatic, and biosurgery.
Sharp debridement (use of scalpel or laser) is probably the most effective type of debridement
because of the time involved to remove the devitalized tissue.95 Sharp debridement should always
be considered when the patient is suspected of having cellulites or sepsis.96 Mechanical
debridement uses a nonselective, physical method of removing necrotic tissue and debris from a
wound using mechanical force. One common form of mechanical treatment is wet-to-dry gauze to
adhere to the necrotic tissue, which is then removed. Upon removal of the gauze dressing, necrotic
tissue and wound debris are also removed. The challenge with mechanical debridement is the
possibility that healthy granulation tissue may be removed as well, along with the devitalized
tissue, thereby delaying wound healing and causing pain. Thus, CMS suggests that this method of
debridement be used in limited circumstances.40
Autolytic debridement involves the use of semiocclusive (transparent film) and occlusive
dressings (hydrocolloids, hydrogels, etc.), which creates an environment for the body’s enzymes
to break down the necrotic tissue.97 Enzymatic debridement uses proteolytic enzymes (i.e.,
papain/urea, collagenase) to remove necrotic tissue.98 This form of debridement is considered drug
therapy; therefore it should be signed on the medication record. Finally, biosurgery (maggot
therapy) is another effective and relatively quick method of debridement.99 This type of
debridement is especially effective when sharp debridement is contraindicated due to the exposure
of bone, joint, or tendon.99
Bacterial Burden
Managing bacterial burden is an important consideration in pressure ulcer care. All pressure
ulcers contain a variety of bacteria. Pressure ulcer bacterial contamination should not impair
health.100 Of great concern is when a colony of bacteria reaches 105 or 106 organisms per gram in
the ulcer.101 At these levels, the pressure ulcer can be considered infected. Healing can be impeded
when wounds have high levels of bacteria. Robson and Heggers101 found in 32 pressure ulcers that
spontaneous healing occurred only when the microbial population was controlled.
Experts agree that swab cultures should not be used to determine wound infection.102 Rather a
tissue biopsy should be conducted to determine the qualitative and quantitative assessment of any
aerobic and anaerobic organisms present.103 Clinical signs that the pressure ulcer may be infected
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
include malodorous, purulent exudate; excessive draining; bleeding in the ulcer; and pain.104, 105
One study investigating the validity of clinical signs and symptoms used to identify localized
chronic wound infections found signs associated with secondary wounds (i.e., serous exudate,
delayed healing, discoloration of granulation tissue, friable granulation tissue, pocketing at the
base of the wound, foul odor, and wound breakdown) were better predictors of wound infection
than the classic signs of infection (i.e., increasing pain, erythema, edema, heat, and purulence).106
Overall, these researchers concluded that increasing pain and wound breakdown were both
sufficient clinical indicators of infected wounds with 100 percent specificity. Thus, when these
signs are present, the nurse should seek additional treatments for the patient. This will help to
safeguard the patient from further ulcer complications.
The use of oral antibiotics or topical sulfa silverdiazine has also been found to be effective in
decreasing the bioburden in the ulcer bed.107, 108 Treatment using silver-impregnated dressings has
been shown to be somewhat effective in decreasing bacterial bioburden load. One in vivo study
found that silver-based dressings decreased specific bacteria (e.g., Eschericha coli, Candida
albicans, and Staphylococcus aureas).109 However, a systematic review of the research literature
found only three randomized controlled trials covering 847 participants. This Cochrane review
determined that based on only three randomized controlled trials, there remains insufficient
evidence to recommend the use of silver-containing dressings or topical agents for treatment of
infected or contaminated chronic wounds.110
The use of antiseptics to reduce wound contamination continues to be a controversial topic.
The ideal agent for an infected pressure ulcer would be bactericidal to a wide range of pathogens
and noncytotoxic to leukocytres. In vitro studies of 1 percent povidone-iodine have been found to
be toxic to fibroblast, but a solution of 0.005% sodium hypochlorite (P = 0.001) caused no
fibroblast toxicity and was still bactericidal to Staphylococcus aureus.111 Another common
antiseptic with conflicting data is sodium hypochlorite (Dakins solution). Studies suggest that
0.005 percent concentration of sodium hypochlorite to be bactericidal; however, its use can also
cause inhibition of fibroblast and neutrophil migration necessary for pressure ulcer healing.112
Conversely, other in vitro studies suggest that 0.005 percent sodium hypochlorite did not inhibit
fibroblasts. McKenna and colleagues examined the use of 0.005 percent sodium hypochlorite,
0.001 percent povidone-iodine, 0.0025 percent acetic acid, and 0.003 percent hydrogen peroxide
on various clinical isolates.111 These researchers found that sodium chlorite significantly inhibited
(P = 0.001) the growth of all bacteria tested (Staphylococcus aureas, Escherichia coli, Group D
enterococci, Pseudomonas aeruginosa, and Bacteroides fragilis) without inhibiting fibroblast
activity, whereas povidone-iodine and acetic acid reduced only specific bacteria.
Exudate Management
The use of dressings is a major component in maintaining a moist environment. There are more
than 300 different modern wound dressings available to manage pressure ulcers.113 Most dressings
can be broken down into seven classifications: transparent films, foam islands, hydrocolloids,
petroleum-based nonadherents, alginates, hydrogels, and gauze. Few randomized controlled
studies have been conducted to evaluate the efficacy of dressings within a specific classification.
Therefore, no one category of wound dressings (independent of gauze) may be better than another
category. Most research evaluating the effects of dressings usually compare gauze (standard) to
modern wound dressings (nongauze).114, 115, 116 These studies are inherently flawed because gauze
dressings are not classified as a modern wound dressing; thus equivalent comparisons cannot be
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Pressure Ulcers and Patient Safety
made. The studies usually have small sample sizes; thus inferences can be difficult to make.
However, one study investigating wound-healing outcomes using standardized validated protocols
found that primarily using nongauze protocols of care matched or surpassed the best previously
published results on similar wounds using gauze-based protocols of care, including protocols
applying gauze impregnated with growth factors or other agents. Thus, nongauze protocols of care
should be used to accelerate pressure ulcer healing.117
Nutrition
The use of high-protein diets for patients with protein deficiency is essential to wound healing.
One small study (n = 12) has suggested that 1.25 g protein/L/kg/day to 1.50 g protein/L/kg/day is
needed to promote wound healing.118 However, Mulholland and colleagues119 suggested in a 1943
journal article that as much as 2.0 g protein/L/kg/day is essential for wound healing. To underscore
that increasing protein does have a positive effect on wound healing, researchers investigated 28
malnourished patients with a total of 33 truncal pressure ulcers.120 The researchers found that
patients who received the 24-percent protein intake had significant decrease (P = 0.02) in truncal
pressure ulcer surface area compared to the group on 14-percent protein intake. Clearly, increasing
protein stores for patients with pressure ulcers who are malnourished is essential; however, it is
unclear from the literature what the optimum protein intake requirement is for patients with
pressure ulcers. Most promising: the use of amino acids such as argine, glutamine, and cysteine
have been noted to assist in ulcer healing.121 However, there remains a paucity of data to
substantiate these claims; thus their use should be tempered with the overall goals of the patient.
Pain Management
Pressure ulcers can be painful. In particular, patients with Stage IV ulcers can experience
significant pain.122, 123 A cross-sectional study of patients with a mix of chronic wounds found that
wound stage was positively related to severity of pain.123 Moreover, pain catastrophizing was
positively related to pain intensity and higher levels of affective distress and depressive symptoms.
Hence, the goal of pain management in the patient with pressure ulcers should be to eliminate the
cause of pain, to provide analgesia, or both. This goal was supported recently by the World Union
of Wound Healing Societies consensus document, Principles of Best Practice: Minimizing Pain at
Wound Dressing-Related Procedures.124 Pain at dressing-related procedures can be managed by a
combination of accurate assessment, suitable dressing choices, skilled wound management, and
individualized analgesic regimens. Dressing removal can potentially cause damage to delicate
tissue in the wound and surrounding skin. Thus, clinicians should use multiple methods to address
the pressure ulcer pain. This may include using dressing that mitigates pain during dressing
changes, such as dressings containing soft-silicone, and administering analgesic prior to dressing
changes.
Monitoring Healing
Presently, there are two instruments that are often used to measure the healing of pressure
ulcers. The Pressure Ulcer Scale for Healing (PUSH) was developed by the NPUAP in 1997.125
The PUSH tool is copyrighted and available on NPUAP’s Web site.84 It quantifies the pressure
ulcer with respect to surface area, exudate, and type of wound tissue. Using a Likert scale from 1
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
to 10 for length and width, a Likert scale from 1 to 3 for exudate amount, and a Likert scale from
1 to 4 for tissue type, the nurse can determine whether a pressure ulcer is healing or nonhealing.
Each of the three ulcer characteristics is recorded as a subscore, then the subscores are added to
obtain the total score. A comparison of total scores measured over time provides an indication of
the improvement or deterioration of the pressure ulcer.
Few studies have been published that measure the validity and reliability of the PUSH tool. A
study investigating the PUSH tool’s content validity found that it had both content validity (P =
0.01) and correlational validity (P = 0.05) to monitor the changing pressure ulcer status.126
Moreover, a recent prospective study by Gardner and colleagues106 of 32 pressure ulcers found
that 21 ulcers (66 percent) healed during the 6-month study period, and 11 (34 percent) did not heal.
The PUSH scores decreased significantly (P = 0.001) over time among the healed ulcers but did
not among the unhealed ulcers. Thus, the PUSH tool was shown to be a valid instrument for
measuring healing in a clinical setting.
The Bates-Jensen Wound Assessment Tool (BWAT; formerly the Pressure Sore Status Tool,
PSST) was developed in 1992 and is also widely used.127 The BWAT consists of 15 items. The
first 2 items are related to location and shape of the ulcer. The remaining 13 items are scored on the
basis of descriptors of each item and ranked on a modified Likert scale (1 being the healthiest
attribute of the characteristic and 5 being the least healthy attribute of the characteristic). The 13
BWAT characteristics that are scored are size, depth, edges, undermining, necrotic tissue type,
necrotic tissue amount, exudate type, exudate amount, skin color surrounding wound, peripheral
tissue edema, peripheral tissue induration, granulation tissue, and epithelialization. The 13 item
scores are summed to provide a numerical indicator of wound health or degeneration.
There is a paucity of validation studies for the BWAT. However, content validity has been
established by a panel of 20 experts. Interrater reliability was established by the use of two wound,
ostomy, and continence nurses who independently rated 20 pressure ulcers on 10 patients.
Interrrater reliability was established at r = 0.91 for first observation and r = 0.92 for the second
observation (P = 0.001).128 A recent study examined wound-healing outcomes with standardized
assessments using the BWAT. Most of the 767 wounds selected to receive the standardized
protocols of care were Stage III–IV pressure ulcers (n = 373; mean healing time 62 days). Partial
thickness wounds healed faster than same-etiology full thickness wounds.117 This finding further
adds to the validation of the BWAT tool for measuring wound healing.
Adjunctive Therapies
The use of adjunctive therapies is the fastest growing area in pressure ulcer management.
Adjunctive therapies include electrical stimulation, hyperbaric oxygen, growth factors and skin
equivalents, and negative pressure wound therapy. Except for electrical stimulation, there is a
paucity of published research to substantiate the effectiveness of adjunctive therapies in healing
pressure ulcers.
Electrical stimulation is the use of electrical current to stimulate a number of cellular processes
important to pressure ulcer healing.129 These processes include increasing the fibroblasts,
neutrophil macrophage collagen, DNA synthesis, and increasing the number of receptor sites for
specific growth factors.129 Eight randomized controlled studies were found in the literature.
Electrical stimulation appears to be most effective on healing recalcitrant Stages III and IV
pressure ulcers.130 A meta-analysis of 15 studies evaluating the effects of electrical stimulation on
the healing of chronic ulcers found that the rate of healing per week was 22 percent for the
16
Pressure Ulcers and Patient Safety
electrical stimulation group compared to 9 percent for the control group.131 Thus, electrical
stimulation should be considered for nonhealing pressure ulcers.
Negative pressure wound therapy is widely used, although few randomized controlled trials
have been published. This therapy promotes wound healing by applying controlled localized,
negative pressure to the wound bed.132–134 In one prospective study investigating nonhealing
pressure ulcers, 24 patients were randomized into two groups (wet-to-moist dressings or
vacuum-assisted closure).133 Those patients receiving negative pressure wound therapy had a
66-percent reduction in wound depth (P = 0.0001), compared to the wet-to-moist dressings group,
which had a 20-percent wound depth reduction.133 Much more research is needed on the benefits
of negative pressure wound therapy for treating pressure ulcers, but there is emerging evidence
that this therapy may be helpful in assisting the healing of pressure ulcers.
The use of growth factors and skin equivalents in the healing of pressure ulcers remains under
investigation, although the use of cytokine growth factors (e.g., recombinant platelet-derived
growth factor-BB [rhPDGF-BB]) and fibroblast growth factors (bFGF) and skin equivalents have
been shown to be effective in diabetic and venous ulcers. Three small randomized controlled trials
have suggested that growth factors had beneficial results with pressure ulcers, but the findings
warrant further exploration.135–137 When we learn more about the healing cascade, the appropriate
use of growth factors in pressure ulcer treatment may become clearer.
The use of electroceuticals—highly refined electromagnetic fields that can accelerate the
body’s natural anti-inflammatory response, thereby aiding wounds to heal faster—is showing
some promising results. One animal study used a prospective, randomized, double-blind,
placebo-controlled design to evaluate the effect of a specific noninvasive radiofrequency-pulsed
electromagnetic field signal on tendon tensile strength at 21 days after transection in a rat
model.138 This study found an increase in tensile strength of up to 69 percent (136.4 + 31.6 kg/cm2)
at the repair site of the rat Achilles' tendon at 3 weeks after transection and repair, compared with
the value (80.6 + 16.6 kg/cm2 ) in nonstimulated control animals. Although electroceuticals are
promising, additional research is needed to recommend them for pressure ulcer treatment.
The use of therapeutic ultrasound for pressure ulcers has also been explored. A Cochrane
review found three published randomized clinical trails using therapeutic ultrasound.139 It was
concluded that there was no evidence of the benefit of ultrasound therapy in the treatment of
pressure ulcers. Thus, additional studies are needed before this therapy can be supported.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Implications
Since the original publications of the AHRQ pressure ulcer prevention and treatment
guidelines in 1992 and 1994, some progress has been made in our understanding of pressure ulcer
care. Nursing research is needed to address many gaps in our understanding of pressure ulcer
prevention and treatment. Many risk factors for pressure ulcer development have been identified;
however, a hierarchy of risk factors has not been determined. Thus, research to determine the
essential risk factors is still needed. There also remains a dearth of research determining the role
that race and ethnicity may have on pressure ulcer development. A small body of research is
emerging to suggest that people of color may have an increased risk for pressure ulcer
development. Thus, nurses must actively recruit minority participants to further explore this
important variable. Another promising area of nursing research is the use of pressure ulcer
prediction tools. Although the Braden Scale was originally published nearly two decades ago, it
remains the gold standard. As the patient population continues to change, nursing research is
needed to develop and validate newer pressure ulcer prediction tools.
There is a paucity of research on the effects of good skin care on pressure ulcer development.
Randomized clinical trials are needed to validate specifics aspects of skin care (bathing schedules,
cleansing solutions, water temperature, etc.) and their association with pressure ulcer development.
Nursing research can also play a major role in closing the knowledge gap regarding optimal
turning/repositioning schedules. Emerging research suggests that turning/repositioning every 2
hours may not be necessary when using dynamic support surfaces. However, randomized
controlled trials with large numbers of participants are greatly needed. Evidence is still unclear as
to whether there are large differences in the effectiveness of various support surfaces (e.g., Group
II) to prevent pressure ulcers.
The role of protein-calorie malnutrition and pressure ulcer development remains understudied.
Moreover, research into dietary supplements (vitamins, minerals, etc.) in the absence of a dietary
deficiency is lacking. Additional nursing studies are needed to investigate whether the use of
dietary supplements have any effect on pressure ulcer prevention. Recent nursing studies
suggested that a comprehensive approach to prevention can lead to significant decreases in
pressure ulcer incidence. However, studies investigating methods to sustain these decreases in
pressure ulcer development are greatly needed. Additional research is also needed to further our
understanding of risk level and titration of preventive measures
Staging of pressure ulcers remains more of an art than a science. Additional nursing research
is needed to determine effective methods of classifying pressure ulcer depth with good validity and
reliability. There is also a dearth of nursing research on the optimal solution and frequency for
cleansing a pressure ulcer. Moreover, nursing research is needed to determine the optimal method
for removing devitalized tissue in a pressure ulcer. No randomized controlled trials could be found
that determined the best debridement method for healing pressure ulcers. Nursing research has
identified some clinical characteristics of infected pressure ulcers. However, additional research is
needed on the most effective method for treating an infected or contaminated pressure ulcer.
Numerous dressings are currently available to manage wound exudate. However, few
randomized controlled trials have been conducted to determine optimal dressings within a
classification (e.g., hydrocolloid, alginate). Many adjunctive therapies are currently being used,
but few have extensive research to substantiate their effectiveness in healing pressure ulcers.
Nursing research investigating the role of skin substitutes, growth factors, negative pressure
wound therapy, and electroceuticals in healing pressure ulcers is greatly needed. Finally, nursing
18
Pressure Ulcers and Patient Safety
research evaluating the cost effectiveness of adjunctive treatments in healing pressure ulcers is
warranted, given rising health care costs.
Conclusion
The prevention of pressure ulcers represents a marker of quality of care. Pressure ulcers are a
major nurse-sensitive outcome. Hence, nursing care has a major effect on pressure ulcer
development and prevention. Prevention of pressure ulcers often involves the use of low
technology, but vigilant care is required to address the most consistently reported risk factors for
development of pressure ulcers. The literature suggested that not all pressure ulcers can be
prevented, but the use of comprehensive pressure ulcer programs can prevent the majority of
pressure ulcers. When the pressure ulcer develops, the goals of healing or preventing deterioration
and infection are paramount. Randomized controlled trials are needed to determine optimal
management strategies dependent on stage and comorbidities/severity of illness. Nursing remains
at the forefront of protecting and safeguarding the patient from pressure ulcers.
Search Strategy
The electronic databases MEDLINE® (1980–2007), CINAHL® (1982–2007), and EI
Compedex*Plus (1980–2007) were selected for the searches. Evaluations of previous review
articles and seminal studies that were published before 1966 were also included. Research
conducted worldwide and published in English between the years 1930 and 2007 was included for
review. Moreover, studies using descriptive, correlational, longitudinal, and randomized
controlled trials were included.
Author Affiliations
Courtney H. Lyder, N.D., G.N.P., F.A.A.N., professor of nursing and professor of internal
medicine, University of Virginia; e-mail: [email protected].
Elizabeth A. Ayello, Ph.D., R.N., A.P.R.N., B.C., C.W.O.C.N., F.A.P.W.C.A., F.A.A.N.,
clinical associate editor, Advances in Skin and Wound Care; e-mail: [email protected].
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http://www.npuap.org/NPUAP_S3I_TD.pdf
Accessed January, 2008. 79. Lam DG, Rastomjee D, Dynan Y. Wound irigation:
a simple, reproducible device. Ann R Coll Surg Engl
67. Agostini JV, Baker DI, Bogardus ST. Prevention of 2000;82(5):346-7.
Pressure Ulcers in Older Patients. In: Making Health
Care Safer: A Critical Analysis of Patient Safety 80. Hellwell TB, Major PA, Foresman PA, et al. A
Practices. Evidence Report/Technology Assessment, cytotoxicity evaluation of antimicrobial wound
No. 43 Chapter 27.(Prepared by University of cleansers. Wounds 1997;9:15-20.
California at San Francisco-Stanford University
Evidence-based Practice Center under Contract No. 81. Schultz GS, Sibbald RG, Falanga V, et al. Wound
290-97-0013). Rockville MD: Agency for bed preparation: a systemic approach to wound
Healthcare Research and Quality, July 2001. AHRQ management. Wound Repair and Regen
Publication No. 01-E058. 2003;11:1-28.
http://www.ahrq.gov/clinic/ptsafety/chap27.htm.
Accessed November, 2006.
22
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82. Ayello EA, Baranoski S, Salati, D. A survey of 96. O’Brien, M. Exploring methods of wound
nurses’ wound care knowledge. Adv Skin Wound debridement. Br J Community Nurs 2002; Dec:
Care 2005;18(5):268-75. 10-8.
83. European Pressure Ulcer Advisory Panel. The 97. Barr JE, Day AL, Weaver VA, et al. Assessing
EPUAP Guide To Pressure Ulcer Grading clinical efficacy of a hydrocolloid/alginate dressing
http://www.epuap.org/grading.html Accessed April, on full-thickness pressure ulcers. Ostomy Wound
2007. Manage 1995;41(3):28-30, 32, 34-6 passim.
84. The National Pressure Ulcer Advisory Panel. 98. Sinclair RD, Ryan TJ. Proteolytic enzymes in wound
http://www.npuap.org/pr2.htm Accessed January , healing: the role of enzymatic debridement.
2008. Australas J Dermatol 1994;35(1):35-41.
85. Shea JD. Pressure sores: classification and 99. Wollina U, Liebold K, Schmidt, et al. Biosurgery
management. Clin Orthop Relat Res supports granulation and debridement in chronic
1975;112:89-100. wounds—clinical data and remittance spectroscopy
measurement. Int J Dermatol 2002;41(10):635-9.
86. Minimum Data Set (MDS)—Version 2.0 for nursing
home resident assessment and care screening
100. Dow G, Browne A, Sibbald RG. Infection in chronic
http://www.cms.hhs.gov/NursingHomeQualityInits/
wounds: controversies in diagnosis and treatment.
downloads/MDS20MDSAllforms.pdf. Accessed
Ostomy Wound Manage 1999;45(8):23-40.
April, 2007.
87. National Pressure Ulcer Advisory Panel. Updated 101. Robson MC, Heggers JP. Bacterial quantification of
staging system. http://www.npuap.org/pr2.htm. open wounds. Mil Med 1969;134(1):19-24.
Accessed April, 2007.
102. Robson MC. Lessons gleaned from the sport of
88. Rosen J, Mittal V, Degenholtz H, et al. wound watching. Wound Repair Regen
Organizational change and quality improvement in 1999;7(1):2-5.
nursing homes: approaching success. J Healthc Qual
2005;27(6): 6-14, 21, 44, (41 ref). 103. Heggers JP. Defining infection in chronic wounds:
Does it matter? J Wound Care 1998;7(8):452-6.
89. Dyson M. Lyder C. Wound management—physical
dalities. In: Morsion, M. ed. The prevention and 104. Bergin SM, Wraight P. Silver based wound
treatment of pressure ulcers. Edinburgh, UK: dressings and topical agents for treating diabetic foot
Harcourt Brace/Mosby International. P. 177-94. ulcers. Cochrane Database Syst Rev
2006;1:CD005082.
90. Quintavalle PR, Lyder CH, Mertz PJ, et al. Use of
high-resolution, high-frequency diagnostic 105. Cutting KF, Cardiff KG. Criteria for identifing
ultrasound to investigate the pathogenesis of wound infection. J Wound Care 1994;3(4):198-201.
pressure ulcer development. Adv Skin Wound Care
2006;19(9):498-505. 106. Gardner SE, Frantz RA, Doebbeling BN. The
validity of the clinical signs and symptoms used to
91. Robson MC, Heggers JP. Bacterial quantification of identify localized chronic wound infection. Wound
open wounds. Mil Med 1969;134(1):19-24. Repair Regen 2001;9:178-86.
92. Falanga V. Classification of wound bed preparation 107. Romanelli M, Magliaro A, Mastronicola D, et al.
and stimulation of chronic wounds. Wound Repair Systemic antimicrobial therapies for pressure ulcers.
Regen 2000;8:347-52. Ostomy Wound Manage 2003;49(5A Suppl):25-9.
93. Falanga V. Wound bed preparation and the role of 108. Meaume S, Vallet D, Morere MN, et al. Evaluation
enzymes: a case for multiple actions of therapeutic of a silver-releasing hydroalginate dressing in
agents. Wounds: A Compendium of Clinical chronic wounds with signs of local infection. J
Research and Practice 2002;14(2):47-57. Wound Care 2005;14:411-9.
94. Falabella A. Dedridement of wounds. Wounds: A 109. Thomas S, McCubbin P. A comparison of the
Compendium of Clinical Research and Pratice antimicrobial effects of four silver-containing
1998;10(Suplement C):1C-9C. dressings on three organisms. J Wound Care
2003;12(3):101-7.
95. Leaper D. Sharp technique for wound debridement.
World Wide Wounds 2002;5. 110. Vermeulen H, van Hattem JM, Storm-Versloot MN,
et al. Topical silver for treating infected wounds
(Review). The Cochrane Collaboration 2007;1:1-36.
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
111. McKenna P, Lehr GS, Leist P, et al. Antiseptic 125. Bartolucci AA, Thomas DR. Using principal
effectiveness with fibroblast preservation. Ann component analysis to describe wound status. Adv
Plastic Surg 1991;27:265-68. Wound Care 1997;10(5):93-5.
112. Lineaweaver W, Howard R. Topical antimicrobial 126. Stotts NA, Rodeheaver GT, Thomas DR, et al. An
toxcity. Arch Surg 1985;120:267-70. instrument to measure healing in pressure ulcers:
development and validation of the Pressure Ulcer
113. Ovington L. Dressings and adjunctive therapies: Scale for Healing (PUSH). J Gerontol A Biol Sci
AHCPR guidelines revisited. Ostomy Wound Med Sci 2001;56A(12): M795-9.
Manage 1999;45:94S-106S.
127. Bates-Jensen BM, Vredevoe DL, Brecht M. Validity
114. Colwell J, Foreman MD, Trotter JP. A comparision and reliability of the pressure sore status tool.
of the efficacy and cost-effectiveness of two Decubitus 1992;5(6):20-8.
methods of managing pressure ulcers. Decubitus
1993;6(4):28-36. 128. Bates-Jensen BM. The Pressure Sore Status Tool a
few thousand assessments later.
115. Kerstein MD, Gemmen E, van Rijswijk L et al. Cost Adv Wound Care. 1997 Sep;10(5):65-73.
and cost effectiveness of venous and pressure ulcer
protocols of care. Dis Manage Health Outcomes 129. Kloth L, Feeder J. Acceleration of wound healing
2001;46(8):651-63. with high voltage, monophasic, pulsed current. Phys
Ther 1988;68:503-8.
116. Xakellis G, Chrischilles EA. Hydrocolloid versus
saline-gauze dressings in treating pressure ulcers: a
cost effective analysis. Arch Phys Med Rehabil
1992;73:463-69.
24
Pressure Ulcers and Patient Safety
25
Evidence Table. Pressure Ulcers—Risk, Assessment, and Prevention
prevention improvement cohort study beneficiaries pressure ulcer prevention guidelines varied greatly
research (Level 9), pressure prevention for daily skin assessment (94%),
ulcer incidence guidelines risk identification (22.6%), use of
pressure-reducing devices (7.5%),
nutritional consult (34.3%), and
repositioning patient every 2 hours
(66.2%).
Lyder 200251 Pressure ulcer Retrospective and Pressure ulcer Two long-term care Pressure ulcer An 87% decrease in pressure ulcers
prevention prospective quasi- prevention facilities (A = 150 prevention in facility A (13.2% to 1.7%) and a
experimental program beds, B = 110 beds) program 76% decrease in pressure ulcers in
facility B (15% to 3.5%).
Lyder 20047 Pressure ulcer Quality Retrospective Hospitals, Medicare Implement Statistically significant increases in
prevention improvement cohort study beneficiaries systematic risk the identification of high-risk
research (Level 9), pressure assessment, patients, repositioning of bed-bound
ulcer development repositioning, or chair-bound patients, nutritional
support consults in malnourished patients,
surfaces and staging of acquired Stage II
pressure ulcers from baseline and
followup medical record
abstractions.
108
Meaume 2005 Silver in chronic Prospective cohort Randomized 13 centers with 99 Silver- The study suggests that treating
wounds study (stratification participants releasing wounds with a high risk of infection
according to hydroalginate with silver-releasing hydroalginate
Source Safety Issue Design Type Study Design & Study Setting & Study Key Finding(s)
Related to Study Outcome Study Intervention
Clinical Measure(s) Population
Practice
wound type) dressing dressing had a favorable influence
opened label on wound prognosis.
multicenter
comparative
two-arm
parallel-group
Ooka 199568 Support surfaces Prospective cohort A new-product Surgical intensive Dynamic and All three mattresses were
study evaluation with care unit static comparable in effectiveness.
convenience mattresses
sampling
Pang 199836 Pressure ulcer Prospective cohort Prospective cohort Hospital, 21 years Pressure ulcer Both the Norton and Waterlow
risk identification study study, validity of and older, pressure prediction scales had relatively high sensitivity
pressure ulcer ulcer free scales (81% and 95%, respectively),
prediction scales whereas the Braden Scale had both
high sensitivity (91%) and specificity
(62%). All three scales had relatively
high negative predictive values
31
Background
Home health care is a system of care provided by skilled practitioners to patients in their
homes under the direction of a physician. Home health care services include nursing care;
physical, occupational, and speech-language therapy; and medical social services.1 The goals of
home health care services are to help individuals to improve function and live with greater
independence; to promote the client’s optimal level of well-being; and to assist the patient to
remain at home, avoiding hospitalization or admission to long-term care institutions.2–4
Physicians may refer patients for home health care services, or the services may be requested by
family members or patients.
The Centers for Medicare and Medicaid Services (CMS) estimates that 8,090 home health
care agencies in the United States provide care for more than 2.4 million elderly and disabled
people annually.5 To be eligible for Medicare reimbursement, home health care services must be
deemed medically necessary by a physician and provided to a home-bound patient. In addition,
the care must be provided on an intermittent and noncontinuous basis.5 Medicare beneficiaries
who are in poor health, have low incomes, and are 85 years of age or older have relatively high
rates of home health care use.6 Common diagnoses among home health care patients include
circulatory disease (31 percent of patients), heart disease (16 percent), injury and poisoning (15.9
percent), musculoskeletal and connective tissue disease (14.1 percent), and respiratory disease
(11.6 percent).7
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
choose to take the medication at irregular times, despite advice about the importance of a regular
medication schedule. Thus, interventions to promote patient safety and quality care must account
for the fact that patients will sometimes choose to act in ways that are inconsistent with the
relevant evidence, and the clinician’s best efforts may not result in desired outcomes.
In addition to deliberate choices made by informed and capable patients regarding their care,
individual patient variables may also influence home-based outcomes in ways that are different
from those patients who are hospitalized. Ellenbecker and colleagues10, 11 reported that reading
skill, cognitive ability, and financial resources all affect the ability of home health care patients
to safely manage their medication regimens. Yet, none of these variables may play a meaningful
role in the safe administration of medications to hospitalized patients.
In addition to self-care, some home-bound patients receive assistance from family members
or other informal caregivers. Professional clinicians have no authority over these caregivers.
Further, the home environment and the intermittent nature of professional home health care
services may limit the clinician’s ability to observe the quality of care that informal caregivers
deliver—unlike in the hospital, where care given by support staff may more easily be observed
and evaluated. For example, because of limited access to transportation, a husband may decide
not to purchase diabetic supplies for his dependent wife. This behavior may not come to the
clinician’s attention until an adverse event has occurred. Evidence-based interventions are
predicated on careful assessment. However, limited opportunity to directly observe the patient
and informal caregivers may hinder efforts to quickly determine the etiology of an adverse event.
If a home health care patient is found with bruises that the patient can’t explain, is the cause a
fall, physical abuse, or a blood dyscrasia? In both self-care by patients and care by informal
caregivers, safety and quality standards may not be understood or achieved.
Another distinctive characteristic of home health care is that clinicians provide care to each
patient in a unique setting. There may be situational variables that present risks to patients that
may be difficult or impossible for the clinician to eliminate. Hospitals may have environmental
safety departments to monitor air quality and designers/engineers to ensure that the height of
stair risers is safe. Home health care clinicians are not likely to have the training or resources to
assess and ameliorate such risks to patient safety in the patient’s home.
Finally, given the large number of elderly persons who receive care from Medicare-certified
home health care agencies, it is reasonable to anticipate that some patients will be in a trajectory
of decline. Due to both normal aging and pathological processes that occur more frequently with
advancing age, some elderly persons will experience decreasing ability to carry out activities of
daily living (ADLs), even when high-quality home health care is provided. Thus, an implicit goal
of home health care is to facilitate a supported decline. That is, patients who do not show clinical
signs of improvement may nonetheless receive quality care that results in a decelerated decline
or increased quality of life. This is consistent with the American Nurses Association’s assertion
that promoting the patient’s optimal level of well-being is a legitimate goal of home health care.3
2
Patient Safety, Quality in Home Care
Pay for performance, a mechanism that ties a portion of an agency’s reimbursement to the
delivery of care, is another CMS quality initiative anticipated in the near future.12 In preparation,
quality-improvement organizations and providers are working to identify and develop a set of
performance measures proven effective in home care. A 2006 Medicare Payment Advisory
Commission report to Congress identified patient safety as an important component of quality
and the need to expand quality measures to include process and structural measures. An
expanded approach to quality measurement should accomplish the following goals: broaden the
patient population being evaluated, expand the types of quality measures, capture aspects of care
directly under providers’ control, reduce variations in practice, and improve information
technology.13
In January 2007, the home health community, health care leaders, and quality-improvement
organizations launched the Home Health Quality Improvement National Campaign 2007. The
campaign focuses on improving the quality of patient care in the home health care setting by
providing agencies with monthly best practice intervention tools. The goal is to prevent
avoidable hospitalizations for home health care patients. The Home Health Quality Improvement
National Campaign uses a multidisciplinary approach to quality improvement that includes key
home health, hospital, and physician stakeholders.14
Research Evidence
In many respects, home health care clinicians and clinicians working in other settings have
similar concerns about patient safety and care quality. For example, patient falls occur both in
homes and in hospitals, and some measures aimed at preventing falls are equally applicable to
both settings. However, the significant differences between home health care and other types of
health care often require interventions tailored to the home health care setting.
This chapter includes an analysis of the evidence on promoting patient safety and health care
quality in relation to problems frequently seen in home health care. The following six areas were
selected for review:
• Medication management
• Fall prevention
• Unplanned hospital admissions
• Nurse work environment
• Functional outcomes and quality of life
• Wound and pressure ulcer management
Adverse events in these areas could jeopardize achievement of one or more home health care
goals.
Medication Management
Nearly one-third of older home health care patients have a potential medication problem or
are taking a drug considered inappropriate for older people.15 Elderly home health care patients
are especially vulnerable to adverse events from medication errors; they often take multiple
medications for a variety of comorbidities that have been prescribed by more than one provider.
The majority of older home health care patients routinely take more than five prescription drugs,
and many patients deviate from their prescribed medication regime.11 The potential of
medication errors among the home health care population is greater than in other health care
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
settings because of the unstructured environment and unique communication challenges in the
home health care system.11
A search of the literature identified only three studies testing interventions to improve
medication management and adherence in home health care patients.16–18 The studies are
summarized in Table 1. All three studies used a controlled experimental design, with random
assignment of patients to one or two treatment groups and a control group of usual care. The
populations studied were elderly Medicare patients receiving home health care, ranging from 41
to 259 patients.
The interventions tested were patient education delivered by telephone or videophone with
nurse followup, education tailored to individual patients, and medication review and
collaboration among providers (e.g., nurse, pharmacist, physician) and patient. Specific
outcomes included identifying unnecessary and duplicate medication, improving the use of
specific categories of medication such as cardiovascular or psychotropic drugs, and identifying
the extent of use of nonsteroidal anti-inflammatory drugs (NSAIDs). The effectiveness of the
interventions was measured by improved medication management and adherence to drug
protocols. Adherence was estimated objectively from medication refill history and medication
event monitoring, and subjectively from patient self-report scores on pre- and postintervention
questionnaires testing knowledge, understanding of disease, and adherence.
Evidence from these studies suggests that all of the interventions tested were at least
somewhat effective. Medication use improved for patients receiving the intervention, while
control groups had a significant decline in adherence to drug protocols. The educational
interventions were most successful when individually tailored to patients’ learning abilities. The
interventions were most effective in preventing therapeutic duplication and improving the use of
cardiovascular medications, less effective for patients taking psychotropic medication or
NSAIDs. Generally, as knowledge scores improved, adherence improved. When more than one
intervention was tested, there was generally no difference between the two intervention groups.
Research Implications
More effective methods are needed to improve medication use in the home health care
population. Research should continue to expand the knowledge of factors that contribute to
medication errors in home health care and determine what interventions are the most effective in
improving medication management in the home.
4
Table 1. Summary of Evidence Related to Medication Management
16
2002 improvement controlled controlled trial: health care program to intervention patients and 38% of control
trial Outcomes: patients, more identify potential patients (P = .051).
unnecessary than 65 years of med problems Intervention effect greatest for therapeutic
therapeutic age with at least and duplication (P = .003), and
duplication and one medication collaboration intervention group improved in use of
inappropriate problem, from with clinical cardiovascular meds (P = .017).
cardiovascular, 2 large urban pharmacist and There were no differences in the groups
psychotropic, and home care nurse for psychotropic medication or NSAID
NSAIDs agencies; 2. Control: usual problems.
Fall Prevention
Emergent care for injury caused by falls or accidents at home is one of the most frequently
occurring adverse events reported for patients receiving skilled home health care services.19
Thirty percent of people age 65 and older living in the community fall each year. One in five of
these fall incidents requires medical attention.20 Falls are the leading cause of injury-related death
for this population.21 Among the elderly, Stevens22 reported direct medical costs in 2000 totaled
$179 million for fatal fall-related injuries and $19 billion for nonfatal injuries due to falls.
Although there is strong evidence of effective fall-prevention interventions for the general
over-65 population,20, 23, 24 knowledge of fall prevention in home health care is limited. For the
general older population living in the community, evidence suggests that individualized home
programs of muscle strengthening and balance retraining; complex multidisciplinary,
multifactorial, health/environmental risk factor screening and intervention; home hazard
assessment and modification; and medication review and adjustment can all reduce the incidence
of falls.20 However, patients in home health care are often older, sicker, and frailer than the
average community-residing older adult, and it is not known if knowledge from other settings is
transferable to home health care.
Research studies specific to home health care are predominantly retrospective, descriptive,
correlational designs in single agencies, using matched control or randomized control groups to
explore patient characteristics and other factors contributing to patient falls.25–27 Findings suggest
that factors related to falls for home health care patients are previous falls, primary diagnosis of
depression or anhedonia, use of antipsychotic phenothiazines and tricyclic antidepressants,
secondary diagnoses of neurological or cardiovascular disorders, balance problems, frailty, and
absence of handrails.25-27
A literature review located only three studies testing interventions to prevent falls.28–30 The
studies are summarized in Table 2. All three interventions were quality-improvement programs
in single agencies. The findings suggest that risk factor screening and intervention using a valid
and reliable instrument and physical therapy aimed at improvement in gait and balance may
reduce injury and emergent care for falls. Unfortunately, there is no evidence that the number of
falls incurred by the home health care population can be reduced. It may be that improved
provider assessments increased the number of falls reported and documented.
Research Implications
There are several limitations in the current evidence on falls in home health care. Most of the
research is descriptive, and there are no randomized controlled studies. Findings from small,
single-agency quality-improvement projects cannot be generalized. It is not known if predictors
for falls in home health care patients are the same as those for other community dwellers over
6
Patient Safety, Quality in Home Care
age 65. Research is needed to expand the knowledge of factors that contribute to falls in this
population and to develop effective interventions. Research is also needed to explore factors to
prevent injury from falls, as it is likely that the incidence of falls in this population cannot be
completely eliminated.
7
Table 2. Summary of Evidence Related to Fall Prevention
Yuan and Fall prevention/risk Quality Observational Unknown Fall prevention Number of patient falls remained
Kelly and injury improvement study without number of at- program, relatively stable, but fewer patients
29
2006 reduction project/research controls. Outcome: risk patients for multidisciplinary risk were injured in falls.
rate of falls, injury falls from 1 assessment with
from falls. hospital-based Morse scale,
home care evidence-based
agency. guidelines.
Patient Safety, Quality in Home Care
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Implications
The available evidence suggests that in addition to the use of APNs for care of complex
cases, traditional home health care professionals, individually or through interdisciplinary
practice, may be effective in preventing unplanned hospital admissions with targeted
interventions. Although numerous strategies have been recommended by researchers and other
home care experts, most interventions have not been empirically tested. Costs and benefits of the
various interventions also need further exploration. The measurement of intervention costs and
cost savings from prevented hospitalizations are not well understood. Some patient populations,
due to the nature and complexity of advanced disease process, may require more intense and
specialized home health care services that will not result in cost savings. On the other hand, use
of seemingly more expensive transitional resources, such as APNs, have been proven cost
effective, although adoption of such research-based best practices may be impeded by lack of
reimbursement and incentives.48 Research is needed to understand the impact of shifting care and
cost to home health care on patient outcomes and home health care industry fiscal status.
10
Table 3. Summary of Evidence Related to Unplanned Hospital Admission
Hospital relationships:
Discharge staff and EM staff
Telehealth.
Successful agencies
intentionally used one or
more of these strategies.
Most strategies did not
involve extra expense.
Daly 200544 Hospital Randomized Randomized Chronically ill, long- 1. Disease Intervention group had
admission controlled trial controlled trial. term mechanically management significantly fewer mean days
Berg 1998 nonskilled nursing cohort study study with or older who had rehabilitation additional home health care
facility admission controls. acute hospitalization discharge with services (27.2%) were less
Outcomes: for hip fracture and additional home care likely to be hospitalized than
hospitalization and were discharged to services those who received
any nonskilled home after inpatient 2. Inpatient rehabilitation only (31.1%);
nursing facility rehabilitation rehabilitation with no they were also less likely to
admission. additional home care have a nonskilled nursing
facility admission (11.3% vs.
23.3%), and more likely to
survive the year with no
subsequent Medicare claims
(65.6% vs. 55%).
Table 3. Summary of Evidence Related to Unplanned Hospital Admission (continued)
difference in all-cause
readmissions between
groups.
Naylor Hospitalization Randomized Randomized Patients age 65 and 1. APN transitional First time to readmission was
200440 controlled trial controlled trial. older from 6 care from hospital to longer for intervention (P =
(See also Table 5) Outcomes: time to academic and home care .026); intervention group had
first community 2. Routine care fewer readmissions at 52
hospitalization, hospitals, n = 118 (58% received weeks (104 vs. 162, P = .047)
number of intervention and n = skilled home care and lower mean cost ($7,636
hospitalizations, 121 control services) vs. $12,481, P = .002).
Research Implications
It is not known what characteristics of the home health care nursing work environment are
related to patient safety and quality. Home health care research is needed to investigate the
relationship of work environment characteristics, nurse satisfaction, and patient outcomes.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Table 4. Summary of Evidence Related to Nurse Work Environment
Feldman Adverse events Prospective Observational 51,560 patient 86 home care 7% of the 51,560 episodes had an
2001– cohort study study with care episodes teams adverse event.
200556 controls. from the Staff perception Adverse events were lower for teams with
Outcomes: largest U.S. of work higher volume of patient care episodes (P
team-attributable home care environment, ≤. 05), higher concentration of visits
patient adverse agency with especially among staff (P ≤ .10), fewer weekend
events. average age aspects of admissions (P ≤ .01), more weekend visits
of patient 71 organizational (P ≤ .01), in noncongregate care setting
years and team (P ≤ .10), and more care provided by
culture climate nurses without bachelor’s or higher
education (P ≤ .10).
16
17
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
with usual care) the number of post-hospitalization visits by patients with knee and hip
replacements and added one preoperative home visit. No differences in functional ability, quality
of life, or level of satisfaction between those patients receiving usual care (more visits) and those
receiving the intervention (fewer postoperative visits and one preoperative visit) were found.
Several studies have examined the use of technology in patient functioning and independence.
Johnston and colleagues69 tested real-time video nursing visits and found no difference in patient
outcomes or level of satisfaction with usual care or care enhanced by video technology.
A number of randomized controlled trials have tested the outcomes of interventions based on
the specialty of the provider combined with different models of care management, or
interventions based solely on different models of care management.44, 46, 65, 70, 71 Research
examining the effect of APN providers on the quality of patient care suggests they have a
positive effect. In two studies testing the transitional care model, APN-directed teams delivered
care to patients with COPD46 and CHF70 and found improvements in the group in the transitional
care model. Patients experienced fewer depressive symptoms and an increase in functional
abilities when compared with patients receiving usual care.46, 70 Patients in these studies also
needed fewer nursing visits, had fewer unplanned hospital admissions, and had fewer acute care
visits. A nurse practitioner’s urinary incontinence behavioral therapy was effective in decreasing
the number of patients’ urinary incontinence accidents.65 The Veterans Affairs Team-Managed
Home-Based Primary Care was an add-on to care routinely provided in the Veterans Affairs
Home-Based Primary Care program.44 The added component emphasized continuity of care and
team management with a primary care manager, 24-hour on-call nursing availability for patients,
prior approval of hospital admissions, and team participation in discharge planning. The
investigators found significant improvements in quality of life, functioning, pain management,
and general health outcomes for terminally ill patients in this study, and an increase in
satisfaction for nonterminally ill patients and family caregivers.
However, mixed results have been obtained from the research to date on the effectiveness of
models of care management.66, 68 Some intervention models have been less effective than others.
The interventions are usually an add-on to routine care, and their effectiveness has been
determined by a comparison to a control group of usual or routine home health care. An
intervention model that does not appear to be effective is the Health Outcomes Management and
Evaluation model tested by Feldman and colleagues66 This model adds a consumer-oriented
patient self-care guide and training to improve nurses’ teaching and support skills. Study results
showed no difference in patient quality of life or satisfaction. Tinetti and colleagues68 compared
the outcomes of a systematic, multicomponent rehabilitation program, including therapies for
physical and functional impairments, to the outcomes from usual home-based rehabilitation care.
No differences were found between the two groups.
18
Patient Safety, Quality in Home Care
remote technology to substitute for some in-person visits can improve access to home health care
staff for patients and caregivers.69
Specific patient interventions can be helpful in improving patient health and quality of life.
Interventions of individualized education and disease-specific programs, such as a behavioral
management program for urinary incontinence or educational programs for foot care, should be
incorporated into practice. The rate of a patient’s functional decline can be slowed and costs
reduced through a systematic approach to providing assistive technology and environmental
interventions to frail elderly patients in their homes. A patient’s need for these interventions can
be determined with a comprehensive assessment and continued monitoring.
Research Implications
Evidence of the outcomes of health care provided in the home is limited; there are very few
controlled experiments on which providers can base their practice. Research is limited in the
areas of composition, duration, and amount of home health care services needed to ensure patient
safety and quality. Research is needed to determine effective interventions to improve, maintain,
or slow the decline of functioning in the home health care population.
More research is also needed to determine mechanisms to keep nurses informed and
supported. Providing communication and support is a challenge when providers are
geographically dispersed and spend most of their time in the field. Remote technology has the
potential to reduce costs: it can substitute for some in-person visits, and it can improve access to
home health care staff for patients and caregivers.
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Table 5. Summary of Evidence Related to Functional Outcomes and Quality of Life
Source Safety Issue Design Type Study Design & Study Setting Study Key Finding(s)
Related to Clinical Study Outcome & Study Intervention
Practice Measure(s) Population
Archbold Family Quasi- Nonrandom trial. Caregiver 1. Nursing Intervention (PREP) group one standard
58
1995 preparedness experimental Outcomes: families interventions, deviation higher than the control group (P
retrospective care referred to designed to < .05), rated their assistance from PREP
without a effectiveness home care increase nurses significantly higher (P < .01); had
control group scale, indicating agency: n = 11 preparedness lower mean hospital costs ($2,775)
greater intervention (PR), enrichment versus comparison group ($6,929).
preparedness, and n = 11 (E), and
enrichment, and standard home predictability (P)
predictability. care in families
providing care to
older people.
2. Comparison
20
Corbett Diabetic foot care Randomized Randomized 40 home care 1. Intervention: The educational intervention improved
200363 controlled controlled trial patients with individualized patient’s knowledge, confidence, and
trial, pre/post- pre/post test. diabetes from 1 education about reported foot care behaviors.
test Outcomes: home care proper foot care
patient self- agency, 2 2. Control
report groups
knowledge.
Dougherty Urinary incontinence Randomized 1.Behavior
Randomized 218 older Intervention group incontinence severity
200264 controlled management
controlled trial women from 7 decreased by 61%.
trial program—self-
Outcomes: rural counties in
monitoring and
severity and north Florida Control group incontinence severity
bladder training
episodes of urine increased by 184%.
2. Control
loss—
frequency,
interval, and
quality of life.
Table 5. Summary of Evidence Related to Functional Outcomes and Quality of Life (continued)
Source Safety Issue Design Type Study Design Study Setting Study Key Finding(s)
Related to Clinical & Study & Study Intervention
Practice Outcome Population
Measure(s)
Feldman Quality of life and Randomized Random 371 patients 1. Formal nurse No difference in physician visit, patient
200466 patient satisfaction controlled assignment of with CHF and protocol of mortality, quality of life, or patient
with care trial nurses. 205 nurses from “Health satisfaction.
Outcomes: a large, urban, Outcomes
service use nonprofit home Management &
and quality of care agency Evaluation,”
life, satisfaction patient self-care
with care. guide, and nurse
training in
teaching and
support skills
2. Usual care
Feldman Functional status, Randomized Randomized 1,242 patients 1. Nurse e-mails Both intervention groups demonstrated
60
21
2005 quality of life, and controlled controlled trial from a large, highlighting improved patient clinical and functional
service use (see trial Outcome: urban, nonprofit clinical recom- outcomes (symptoms, physical
also Table 3) clinical, home care mendations limitations, quality of life, and social
functional, and agency: 2 Augmented: limitations) (P < .05).
quality of life 390 basic e-mails and Both intervention groups demonstrated
status. 404 augmented additional better management of medications (P <
448 control clinician and .05)
patient resources Intervention group 1 scored higher on
3. Usual care quality of life relative to control (P < .05).
Source Safety Issue Design Type Study Design Study Setting Study Key Finding(s)
Related to Clinical & Study & Study Intervention
Practice Outcome Population
Measure(s)
Mann Functional ability Randomized Randomized Frail elderly 1.Usual care, Both groups showed significant decline in
199967 (independence), controlled controlled trial. persons assistive functional motor score, with a
quality of life (pain trial Functioning referred from technology, significantly greater decline for the
reduction), and costs and pain, community (canes, walkers, control group.
measured with agencies, etc.), and Pain scores were significantly higher for
valid and hospitals, and environmental the control group.
reliable home care interventions Treatment group expended more costs
instruments; agencies in (ramps, removal than the control group.
health care New York State: of rugs, etc.) Control group had significantly more
costs. n = 52 2. Usual care expenditures for institutional care and
intervention, control significantly greater expenditures for
n = 52 control nurse visits and case manager visits.
McDonald Quality of life (pain Randomized Randomized Nurses, from a 1. Basic group – Patients in augmented intervention
59
23
2005 management) controlled controlled trial. large, urban, nurse e-mails improved significantly over the control in
through trial Outcome nonprofit home highlighting ratings of pain intensity at its worse (P =
provider behavior measure: care agency: clinical recom- 0.05).
change Estimate of n = 121 basic, n mendations Patients in basic intervention had better
treatment = 97 2 Augmented ratings of pain intensity on average (P <
effect on augmented, and group – 0.05).
nurse- n = 118 control additional In both intervention groups, evidence of
documented clinician and nurse assessment increased.
care practices patient resources
and patient’s 3. Usual care
pain
Source Safety Issue Design Type Study Design & Study Setting Study Key Finding(s)
Related to Study Outcome & Study Intervention
Clinical Practice Measure(s) Population
Tinetti Functional status Randomized Randomized 304 persons 1. Systematic There was no significant difference in the
68
1999 – self-care ADLs controlled trial controlled trial. age 65 who had multicomponent proportion of participants in the two
Outcomes: undergone rehabilitation groups who recovered to prefracture
a battery of self- surgical repair strategy levels in self-care ADL at 6 months (71%
report and of a hip fracture addressing both vs. 75%) or 12 months (74% in both
performance- at two hospitals modifiable groups), or in home management ADL at
based measures in New Haven, physical 6 months (35% vs. 44%) or 12 months
of physical and CT, from 27 impairments (44% vs. 48%). There also was no
social function. home care (physical difference between the two groups in
agencies therapy) and ADL social activity levels, two timed mobility
disabilities tasks, balance, or lower extremity
(functional strength at either 6 or 12 months.
therapy) Compared with participants who received
2. Usual care usual care, those in the multicomponent
rehabilitation program showed slightly
25
Wound Management
Over a third of home health care patients require treatment for wounds, and nearly 42 percent
of those with wounds have multiple wounds. Over 60 percent of wounds seen in home health
care are surgical, while just under one-quarter are vascular leg ulcers and another one-quarter are
pressure ulcers.71 Most home health care nurses can accurately identify wound bed and
periwound characteristics; the majority (88 percent) of wound treatments have been found to be
appropriate.72 The appropriateness of wound treatments in home health care is significantly
related to wound healing. Patients with healing wounds had shorter home health care visits and
shorter home health care lengths of stay.71
A literature review identified seven studies that tested interventions to improve wound care
management in home health care.73–79 Findings are summarized in Table 6. Three compared
effectiveness of various wound treatments. Capasso and Munro74 found no significant difference
in wound closure between amorphous hydrogel dressings and wet-to-dry saline dressings, but
costs were found to be significantly higher for the saline dressings due to the need for more
nursing visits. Kerstein and Gahtan76 found the percentage of venous leg ulcers healed using
hydrocolloidal dressings was six times higher than with saline gauze dressings and nearly four
times greater using an Unna boot; the hydrocolloidal dressings were most cost-effective. Use of
negative pressure wound therapy resulted in successful closure of 43 percent of wounds that
failed to respond to previous treatment.78
Four studies reported positive outcomes from interventions to improve and support home
health care nurse practice.73, 75, 77, 79 Use of telemedicine to provide consultation with wound
management experts resulted in improved healing rates, decreased healing time, and decreased
home visits and hospitalizations related to wounds.73, 77 Fellows and Crestodina75 studied the rate
of bacterial contamination of normal saline solutions prepared from distilled water and table salt,
a practice common for wound care in the home, and found refrigerated solutions essentially
growth-free at 4 weeks. A quality improvement project reported a reduction in adverse events
through structured nurse education, introduction of protocols, and competency review.79
27
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
ulcers and 14 percent of those at risk were receiving appropriate pressure-reducing treatment.81
Incontinence, limitations in ADLs, mobility impairment, skin drainage, recent fractures, anemia,
use of oxygen, and recent institutional discharge were associated with pressure ulcer
development.81, 82 Guidelines from the Wound, Ostomy and Continence Nurses Society83 call for
an initial risk assessment for pressure ulcers of all patients on admission to home health care, and
reassessment every visit thereafter, using a validated risk assessment tool. However, one study
found that only 21 percent of agencies used a validated tool such as the Braden Scale84 to
identify patients at risk, nearly 8 percent performed no assessments on admission, and only 33
percent used risk prediction or pressure ulcer prevention protocols.85 Just over half of agencies
reported routine skin inspections by nurses of at-risk patients.
A literature review resulted in identification of five studies relating to pressure ulcer
management in home health care. The findings are summarized in Table 7. Three studies were
randomized controlled trials testing interventions to improve pressure ulcer healing.86–88 One
intervention tested the use of air-fluidized bed therapy with services of a nurse specialist;87 a
second intervention used noncontact normothermic wound therapy.88 Both resulted in significant
improvement in wound healing compared to conventional moist dressings. Overall healing rates
were similar for polymer hydrogel and hydrocolloidal dressings, although debridement
performance of the hydrogel dressing resulted in more favorable clinical evaluation.86
The remaining two studies evaluated the use of the Braden Scale for prediction of pressure
ulcer risk in home health care patients, with mixed results. Ramundo89 reported that the Braden
Scale had validity in identifying at-risk patients, but limited predictive ability, while Bergquist82
found that the summative score of the scale was significantly associated with pressure ulcer
development. All subscale scores except nutrition were significantly and negatively associated
with pressure ulcer development.
Research Implications
Relatively little is known about the most effective practices for wound care in the home
health care setting. Although studies have compared different treatments for wounds, the most
efficacious treatments for different wounds are unknown in the presence of various risk factors
found in the home health care setting. Randomized controlled clinical trials exist comparing
different pressure ulcer treatments in the home, with the exception of care of other types of
wounds. Promising findings from studies with small sample sizes should be replicated with
larger samples and diverse populations.
28
Table 6. Summary of Evidence Related to Wound Management
Safety Issue Study Design & Study Setting & Study Intervention
Source Related to Clinical Design Type Study Outcome Study Population Key Finding(s)
Practice Measure(s)
Capasso and Wound Retrospective Observational Patients 25 years 1. Amorphous No significant difference
Munro management, cohort study study with control of age or more hydrogel dressings found in the rate of wound
200374 treatment, and cost (Level 4) with superficial 2. Control wet-to- closure between the two
Outcomes: wound wounds without dry normal saline types of dressings (P = .66).
size, predominant undermined areas: gauze dressings
tissue type, type of 1. Arterial surgical Costs were significantly
exudates; cost of wound dehiscence higher (P= .006) for control
treatment. or 2. Nonhealing ($3,774) than for the
arterial or diabetic intervention dressings
ulcerations ($2,634) due to significantly
In 3 home care higher numbers of required
agencies, n = 25 nursing visits (P = .003).
intervention, n = There was no significant
25 control difference in the cost of
29
Study Design
Safety Issue Related Design Type & Study Study Setting Study
Source to Clinical Practice Outcome & Study Intervention Key Finding(s)
Measure(s) Population
Berquist Pressure ulcer Retrospective Retrospective 1,684 patients None Braden Scale summative scores were
82
2001 management, cohort study. cohort study age 60 years or significantly lower for subjects who
prediction without older without developed pressure ulcers than subjects
controls. pressure ulcers remaining free of pressure ulcers (P <
Outcome on admission, .01).
measure: with All subscale scores except nutrition were
development of documented significantly and negatively associated
Stage I to IV Braden Scale with pressure ulcer development (P <
pressure ulcers scores, one .01), but only the summative score
or no ulcer large remained significantly associated on
development. Midwestern completion of a backward stepwise
urban home procedure (P < .001).
32
care agency
Motta Pressure ulcer Randomized Randomized Home care 1. Polymer The overall healing rate for the two groups
86
1999 management, controlled controlled trial. patients with hydrogel was similar.
treatment trial Outcomes: Stage II or III dressing Intervention 1 had more favorable overall
healing rate, pressure ulcer, 2. Hydrocolloidal clinical evaluation based largely on its
debridement in home care dressing autolytic debridement effect.
using Bates- setting:
Jensen n=5
Pressure Sore intervention
Status Tool (group 1), n = 5
intervention
(group 2)
Ramundo Pressure ulcer Prospective Observational 48 newly None 7 patients (17%) developed pressure
199589 management, cohort study study with admitted ulcers; Braden Scale scores ranged from
prediction control. patients free of 11 to 22. At a score of 18, sensitivity of
Outcomes: skin breakdown the tool was 100%; however, specificity
Braden Scale who were was only 34%, indicating that the scale
scores, unable to leave has validity in identifying patients at risk,
development of bed or chair, but has limited predictive ability in home
pressure ulcers one suburban, health care.
community-
based home
health care
agency
Table 7. Summary of Evidence Related to Pressure Ulcer Management (continued)
Study Design
Safety Issue Related Design Type & Study Study Setting Study
Source to Clinical Practice Outcome & Study Intervention Key Finding(s)
Measure(s) Population
Strauss Pressure ulcer Randomized Randomized Patients with 36 weeks of A higher proportion of intervention
87
1991 management, controlled controlled trial. Stage III or IV treatment, either patients were classified as improved
treatment trial Outcomes: pressure ulcers 1. Air-fluidized without statistical significance.
wound status, and severely bed therapy with Intervention patients spent significantly
inpatient limited mobility, services of a fewer days in the hospital (11.4 vs. 25.5
hospital days, in home care visiting nurse days, P < .01) and used significantly fewer
inpatient setting: n = 47 specialist, or total inpatient resources (P < .05). Total
hospital intervention, n = 2. Control – inpatient and outpatient resource
charges, 50 control conventional utilization was lower, but not significant.
Medicare DRG, therapies
and physician
payments.
Whitney Pressure ulcer Randomized Randomized Patients, age 18 1. Noncontact The intervention group healed significantly
88
33
2001 management, controlled controlled trial. or older with normothermic faster (P =.01), and average periwound
treatment trial Outcomes: Stage III or IV wound therapy temperature increased significantly (P =
wound healing pressure ulcers 2. Control – .001).
and periwound in primary care, moist dressings
temperature home care,
changes, acute care, or
measured long-term care
using valid, facilities: n = 15
reliable intervention,
instruments. n = 14 control
Conclusion
Home health care clinicians seek to provide high quality, safe care in ways that honor patient
autonomy and accommodate the individual characteristics of each patient’s home and family.
Falls, declining functional abilities, pressure ulcers and nonhealing wounds, and adverse events
related to medication administration all have the potential to result in unplanned hospital
admissions. Such hospitalizations undermine the achievement of important home health care
goals: keeping patients at home and promoting optimal well-being. Nevertheless, the unique
characteristics of home health care may make it difficult to use—or necessary to alter—
interventions that have been shown to be effective in other settings. Therefore, research on
effective practices, conducted in home health care settings, is necessary to support excellent and
evidence-based care.
In reviewing the extant studies, the authors of this chapter found useful evidence in all
selected areas. However, the number of studies was few and many questions remain.
Replications of investigations originally conducted in health care settings other than the home,
and studies considering home health care-specific issues are needed to support evidence-based
clinical decisions. The available evidence suggests that the work environment in which home
health care nurses practice may indirectly influence patient outcomes in many areas, and that
technology can be used to support positive patient outcomes. Thus, studies that link nurse-related
variables to improved care safety and quality are needed, as well as studies that focus directly on
patients. The demographics of an aging society will sustain the trend toward home-based care.
Home health care practices grounded in careful research will sustain the patients and the
clinicians who serve them. Given the focused review of evidence-based studies comprising this
chapter, many informative sources of use to the practicing home health care nurse are omitted.
Table 8 lists additional key resources.
34
Table 8. Additional Resources
Search Strategy
The literature review for this chapter focused on identifying evidence-based practices that
supported the goals of home health care: to promote independent functioning; to remain at home,
avoiding hospital or nursing home admission; and to achieve optimal well-being. The search was
conducted using multiple variations of key terms informed by the characteristics of home health
care described at the beginning of this chapter, adverse events used in the OBQM,5 goals of the
Home Health Quality Improvement National Campaign 2007,14 and the nurse-sensitive quality
indicators developed by the American Nurses Association.15 The Cumulative Index to Nursing &
Allied Health, Cochrane Library, Medline, and ProQuest Nursing & Allied Health databases
were searched, as well as the grey literature and government Web sites, including the CMS and
Agency for Healthcare Research and Quality. Hand searches were conducted of the reference
lists of retrieved articles. Search limitations were English language, United States or Canada,
peer-reviewed journals or scholarly literature, published between 1990 and the first quarter of
2007. Studies cited in the evidence table were accepted for review using the following inclusion
criteria:
• The study was published between 1990 and the first quarter of 2007, inclusive.
• The research was conducted in the United States or Canada.
• The study included an intervention that directly or indirectly influenced a patient
outcome.
• The intervention took place under the auspices of a home health care agency.
• Subjects in the study had to be home health care patients (not community-residing or
outpatient ambulatory) and 18 years of age or greater.
Author Affiliations
Carol Hall Ellenbecker, Ph.D., R.N., professor, University of Massachusetts, Boston. E-mail:
[email protected].
Linda Samia, Ph.D., R.N., program manager, Healthy Choices for ME, MaineHealth’s
Partnership for Healthy Aging. E-mail: [email protected].
Margaret J. Cushman, Ph.D.(c), R.N., F.H.H.C., F.A.A.N., research associate, University of
Massachusetts, Boston. E-mail:[email protected].
Kristine Alster, Ed.D., R.N., associate provost, University of Massachusetts, Boston. E-mail:
[email protected].
36
Patient Safety, Quality in Home Care
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client satisfaction, nursing perception of outcomes,
and organizational variables. Home Healthc Nurse 69. Johnston B, Wheeler L, Deuser J, et al. Outcomes of
2006;24(2):87-94. the Kaiser Permanente tele-home health research
project. Arch Fam Med 2000;9(1):40-5.
58. Archbold PG, Stewart BJ, Miller LL, et al. The PREP
system of nursing interventions: a pilot test with 70. Naylor MD. A decade of transitional care research
families caring for older members. Preparedness with vulnerable elders. J Cardiovas Nurs
(PR), enrichment (E) and predictability (P). Res Nurs 2000;14(3):1-14.
Health 1995;18(1):3-16.
71. Weaver FM, Hughes SL, Almagor O, et al.
59. McDonald MV, Pezzin LE, Feldman PH, et al. Can Comparison of two home health care protocols for
just-in-time, evidence-based "reminders" improve total joint replacement. J Am Geriatr Soc
pain management among home health care nurses 2003;51(4):523-8.
and their patients? J Pain Symptom Manage
2005;29(5):474-88.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
72. Center for Medicare & Medicaid Services. Outcome 81. Ferrell BA, Josephson K, Norvid P, et al. Pressure
based quality improvement (OBQI) manual. ulcers among patients admitted to home health care. J
http://www.cms.hhs.gov/HomeHealthQualityInits/16 Am Geriatr Soc 2000;48(9):1042-7.
_HHQIOASISOBQI.asp#TopOfPage. Accessed
February 27, 2006. 82. Bergquist S. Subscales, subscores, or summative
score: evaluating the contribution of Braden Scale
73. Bolton L, McNees P, van Rijswijk L, et al. Wound- items for predicting pressure ulcer risk in older adults
healing outcomes using standardized assessment and receiving home health care. J Wound Ostomy
care in clinical practice. J Wound Ostomy Continence Nurs 2001;28(6):279-89.
Continence Nurs 2004;31(2):65-71.
83. Wound Ostomy and Continence Nurses Society.
74. Capasso VA, Munro BH. The cost and efficacy of Guideline for prevention and management of
two wound treatments. AORN J 2003;77(5):984-92, pressure ulcers.
995-87, 1000-4. http://www.guideline.gov/summary/summary.aspx?d
oc_id=3860&nbr=003071&string=
75. Fellows J, Crestodina L. Home-prepared saline: a pressure+AND+ulcers. Accessed February 23, 2006.
safe, cost-effective alternative for wound cleansing in
home care. J Wound Ostomy Continence Nurs 84. Bergstrom N, Braden BJ. Predictive validity of the
2006;33:606-9. Braden Scale among Black and White subjects. Nurs
Res 2002; 51(6):398-403.
76. Kerstein MD, Gahtan V. Outcomes of venous ulcer
care: results of a longitudinal study. Ostomy Wound 85. Bergquist S. The quality of pressure ulcer prediction
Manage 2000;46(6):22-6, 28-9. and prevention in home health care. Applied Nurs
Res 2005;18(3):148-54.
77. Kobza L, Scheurich A. The impact of telemedicine
on outcomes of chronic wounds in the home health 86. Motta G, Dunham L, Dye T, et al. Clinical efficacy
care setting. Ostomy Wound Manage and cost-effectiveness of a new synthetic polymer
2000;46(10):48-53. sheet wound dressing. Ostomy Wound Manage
1999;45(10):41, 44-6, 48-9.
78. Philbeck TE Jr, Whittington KT, Millsap MH, et al.
The clinical and cost effectiveness of externally 87. Strauss MJ, Gong J, Gary BD, et al. The cost of home
applied negative pressure wound therapy in the air-fluidized therapy for pressure sores. A
treatment of wounds in home health care Medicare randomized controlled trial. J Fam Pract
patients. Ostomy Wound Manage 1999;45(11):41-50. 1991;33(1):52-9.
79. Sturkey EN, Linker S, Keith DD, et al. Improving 88. Whitney JD, Salvadalena G, Higa L, et al. Treatment
wound care outcomes in the home setting. J Nurs of pressure ulcers with noncontact normothermic
Care Qual 2005;20(4):349-55. wound therapy: healing and warming effects. J
Wound Ostomy Continence Nurs 2001;28(5):244-52.
80. Rodrigues I, Megie MF. Prevalence of chronic
wounds in Quebec home care: an exploratory study. 89. Ramundo JM. Reliability and validity of the Braden
Ostomy Wound Manage May 2006;52(5):46-8, 50, Scale in the home health care setting. J Wound
52-7. Ostomy Continence Nurs 1995;22(3):128-34.
40
Chapter 14. Supporting Family Caregivers in
Providing Care
Susan C. Reinhard, Barbara Given, Nirvana Huhtala Petlick, Ann Bemis
Background
Most patients have families that are providing some level of care and support. In the case of
older adults and people with chronic disabilities of all ages, this “informal care” can be
substantial in scope, intensity, and duration. Family caregiving raises safety issues in two ways
that should concern nurses in all settings. First, caregivers are sometimes referred to as
“secondary patients,” who need and deserve protection and guidance. Research supporting this
caregiver-as-client perspective focuses on ways to protect family caregivers’ health and safety,
because their caregiving demands place them at high risk for injury and adverse events. Second,
family caregivers are unpaid providers who often need help to learn how to become competent,
safe volunteer workers who can better protect their family members (i.e., the care recipients)
from harm.
This chapter summarizes patient safety and quality evidence from both of these perspectives.
The focus is on the adult caregiver who provides care and support primarily for adults with
chronic illnesses and chronic health problems. The focus is not on those with developmental
disabilities. In the first section, we discuss the evidence for protecting the caregiver from harm.
The second section addresses research aimed at protecting the care recipient from an ill-prepared
family caregiver.
Caregivers as Clients
For centuries, family members have provided care and support to each other during times of
illness. What makes a family member a “family caregiver”? Who are these family caregivers,
what do they do, and what harm do they face? What does the research tell us about ways to
assess the needs of these hidden patients and evidence-based interventions to prevent or reduce
potential injury and harm? This section answers these questions and highlights the need for
nurses to proactively approach family caregivers as clients who need their support in their own
right.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and 1994.4 These male caregivers are becoming more involved in complex tasks like managing
finances and arranging care, as well as direct assistance with more personal care.5 Nurses are
likely to see many of these caregivers, although many of them will not identify themselves as a
caregiver.
Those caring for someone 50 years or older are 47 years old—on average—and working at
least part-time.1 If they are providing care to an elder who is 65 years or older, they are, on
average, 63 years old themselves and caring for a spouse; one-third of these caregivers are in fair
to poor health themselves.6 In many cases, they are alone in this work. About two out of three
older care recipients get help from only one unpaid caregiver.7 In the last decade, the proportion
of older persons with disabilities who rely solely on family care has increased dramatically—
nearly two-thirds of older adults who need help get no help from formal sources.4
Caregiver Responsibilities
Caregivers spend a substantial amount of time interacting with their care recipients, while
providing care in a wide range of activities. Nurses have a limited view of this interaction.
Caregiving can last for a short period of postacute care, especially after a hospitalization, to more
than 40 years of ongoing care for a person with chronic care needs. On average, informal
caregivers devote 4.3 years to this work.8 Four out of 10 caregivers spend 5 or more years
providing support, and 2 out of 10 have spent a decade or more of their lives caring for their
family member.9 This is a day-in, day-out responsibility. More than half of family caregivers
provide 8 hours of care or more every week, and one in five provides more than 40 hours per
week.1
Most researchers in the caregiving field conceptualize the care that family members give as
assistance with activities of daily living (ADLs) and instrumental activities of daily living
(IADLs). But those concepts do not adequately capture the complexity and stressfulness of
caregiving.9 Assistance with bathing does not capture bathing a person who is resisting a bath.10,
11
Helping with medications does not adequately capture the hassles of medication
administration,12 especially when the care recipient is receiving multiple medications several
times a day, including injections, inhalers, eye drops, and crushed tablets. The need to make
decisions on behalf of family members who are unable to do so is stressful, as this is contrary to
the caregivers’ normal role, and they are concerned that the decisions are correct. Supervising
people with dementia and observing for early signs of problems, such as medication side effects,
are serious responsibilities as family members are often unable to interpret the meaning or the
urgency. The medical technology that is now part of home care and the frustrations of navigating
the health care system for help of any kind is not even part of the ADL/IADL measures.13 Being
responsible for medical and nursing procedures like managing urinary catheters, skin care around
a central line, gastrostomy tube feedings, and ventilators is anxiety provoking for the novice
nursing student, but is becoming routine family care of persons with chronic illnesses living at
home.
Family caregivers often feel unprepared to provide care, have inadequate knowledge to
deliver proper care, and receive little guidance from the formal health care providers.14-16 Nurses
and family caregivers rarely agree about specific needs or problems during hospital admission or
discharge,17 in part because nurses are often unaware of the strengths and weaknesses of both the
patient and caregiver. Due to inadequate knowledge and skill, family caregivers may be
unfamiliar with the type of care they must provide or the amount of care needed. Family
caregivers may not know when they need community resources, and then may not know how to
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Family Caregiving & Caregiver Assessment
access and best utilize available resources.18 As a result, caregivers often neglect their own health
care needs in order to assist their family member, causing deterioration in the caregiver’s health
and well-being.19-21
Caregivers get very little help from health care professionals in managing their tasks and the
emotional demands of caregiving. Among the greatest challenges for family caregivers is
interacting with nurses and other professionals in the hospital setting, and a rough crossing back
home, as the patient is “discharged to family.”22 Naylor’s review23 of nearly 100 studies
published between 1985 and 2001 confirms that breakdowns in care during the transition from
hospital to home result in negative outcomes. Health professionals in emergency departments
and inpatient hospital settings do not adequately determine the after-care needs of older patients
when they are being discharged.
Effective discharge planning is impeded by gaps in communication between the hospital and
community interface, such as illegible discharge summaries and delays in sending information to
the physician.24 Focus groups of caregivers found that they experience their family member’s
discharge from the hospital as an abrupt and upsetting event because the hospital staff did not
prepare them for the technical and emotional challenges ahead of them. Many caregivers felt
abandoned at a critical time, and none of the focus group participants had been referred by any
health care professional in the hospital to community-based organizations for emotional
support—or any other kind of support.22
Hazards of Caregiving
Health professionals’ lack of explicit attention to caregivers is a serious gap in health care in
light of the more than two decades of research that documents the potential hazards of family
caregiving. Caregivers are hidden patients themselves, with serious adverse physical and mental
health consequences from their physically and emotionally demanding work as caregivers and
reduced attention to their own health and health care.
Declines in physical health and premature death among caregivers in general have been
reported.21, 25 Given and colleagues18, 19 and Kurtz and colleagues26 found that family caregivers
experience significant negative physical consequences as the patient’s illness progresses. Elderly
spouses who experience stressful caregiving demands have a 63 percent higher mortality rate
than their noncaregiver age-peers.21 Most recently, research documents that elderly husbands and
wives caring for spouses who have been hospitalized for serious illnesses face an increased risk
of dying prematurely themselves.27
Declines in caregiver health have been particularly associated with caregivers who perceive
themselves as burdened.21 Caregiver burden and strain have been related to the caregiver’s own
poor health status, increased health-risk behaviors (such as smoking), and higher use of
prescription drugs.28 Researchers have reported that caregivers are at risk for fatigue and sleep
disturbances,29 lower immune functioning,30, 31 altered response to influenza shots,32 slower
wound healing,33 increased insulin levels and blood pressure,34, 35 altered lipid profiles,36 and
higher risks for cardiovascular disease.37
Burton and colleagues38 examined the relationships between provision of care by family
members and their health behaviors and health maintenance. These researchers found that, with a
high level of caregiving activities, the odds of the caregiver not getting rest, not having time to
exercise, and actually not recuperating from illness were also high. In addition, caregivers were
more likely to forget to take their prescriptions for their own chronic illnesses. Providing care
poses a threat to the overall health of caregivers, which can compromise their ability to continue
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
to be caregivers. If caregivers are to continue to be able to provide care, relief from the distress
and demands of maintaining the required care must be considered.
Both highly negative and highly positive consequences of providing care may exist
simultaneously.39 It is plausible that positive consequences, such as rewards and satisfaction,
may buffer the negative effects of caregiving. Positive aspects of caregiving are important,40-42
some researchers are now using a caregiver rewards scale to better understand caregivers’
experiences.41, 42 Other researchers are exploring the positive aspects of care as the mutuality
between the patient and caregiver develops.40 Archbold and colleagues40 demonstrated that
mutuality and preparedness did reduce some of the strain on the caregiver. Picot and
colleagues41, 42 worked primarily with African American caregivers and found that the rewards
perceived by caregivers were more important than coping. A specific Picot Caregiver Reward
Scale of 25 items exists and has been widely used to show that both rewards and costs can exist
in the same care situation.
Caregivers who attempt to balance caregiving with their other activities, such as work,
family, and leisure, may find it difficult to focus on the positive aspects of caregiving and often
experience more negative reactions, such as an increased sense of burden.43-45 Regardless of
amount of care provided, caregivers may become increasingly more distressed if they are unable
to participate in valued activities and interests.46 More than half of adult children who provide
parent care are employed.7 Caregiving responsibilities can have a negative effect on work roles
as caregivers adapt employment obligations to manage and meet care demands.47, 48 Caregivers
who are employed report missed days, interruptions at work, leaves of absence, and reduced
productivity because of their caregiving obligations. They have difficulty maintaining work roles
while assisting family members.46 On the other hand, employment provides some caregivers
respite from ongoing care activities and serves as a buffer to distress.49-51
Low personal and household incomes and limited financial resources can result in increased
caregiver risk for negative outcomes, particularly if there are substantial out-of-pocket costs for
care recipient needs.45 Caregivers who are unemployed or have low incomes may experience
more distress because they may have fewer resources to meet care demands. Overall, financial
concerns cause particular distress for caregivers during long treatment periods,52, 53 as resources
become depleted. Higher-income families, with greater financial resources to purchase needed
care, might not become as distressed or burdened as those with limited resources.54
Caregiver burden and depressive symptoms are the most common negative outcomes of
providing care for the elderly and chronically ill.20, 55, 56 Caregiver burden is defined as the
negative reaction to the impact of providing care on the caregiver’s social, occupational, and
personal roles57 and appears to be a precursor to depressive symptoms.58 Whether the caregiver
develops negative outcomes seems to be directly related to the care recipient’s inability to
perform ADLs, either due to physical limitations or cognitive status.51 If the care recipient
wanders (associated with Alzheimer’s disease) or displays unsafe behavior, the caregiver has to
be alert and on call for supervision 24 hours per day. The constant concern for managing
disruptive behaviors (such as turning on stoves, walking into the street, taking too many pills,
yelling, screaming, or cursing) also affects the caregivers negatively.
Care recipients’ functional, cognitive, and emotional status predicts caregiver burden and
depression,58-62 which may be manifested in feelings of loneliness and isolation, fearfulness, and
being easily bothered, as the demands of caregiving limit their personal time.58 Care recipient
behavior such as screaming, yelling, swearing, and threatening are associated with increased
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Family Caregiving & Caregiver Assessment
caregiver clinical depression.63 Caregiver depression may also have a somatic component, such
as anorexia, fatigue, exhaustion, and insomnia.64
Caregivers may suffer severe fluctuations in sleep patterns over time, which may affect
depression65 and exacerbate symptoms of chronic illnesses. Pain management is an intractable
problem for caregivers that results in substantial caregiver distress, as caregivers assist with both
nonpharmacologic and pharmacologic pain-management strategies.66-68
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Zarit and colleagues79 used a quasi-experimental design to demonstrate that caregivers who
used adult day care services for their relatives with dementia had significantly lower levels of
caregiver stress, anger, and depression after 3 months of this respite care than a control group of
similar caregivers who did not obtain this intervention. Sorenson and colleagues72 also found that
respite/day care interventions effectively reduced caregiver depression and increased well-being.
Caregivers as Providers
Twenty-five years of research have documented that the work of family caregiving can be
stressful. That stress can adversely harm both the caregiver and the care recipient. This section
addresses research aimed at protecting the care recipient from an ill-prepared or emotionally
stressed family caregiver. It describes the link between the work of caregiving and patient harm,
and examines interventions that aim to make the caregiver a better worker and less likely to harm
the patient.
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Family Caregiving & Caregiver Assessment
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Neglect is more common when the caregiver is depressed or distressed. It interferes with the
person’s ability to make observations and to identify needs or provide social stimulation for their
ill family member. When caregivers themselves are distressed, burdened, or depressed, they
might leave elders alone for long periods of time, ignore them, or fail to provide any
companionship or interaction.86 Annerstedt and colleagues report on the breaking point of
caregivers providing care for patients with dementia.59 When caregivers have a high level of
burden, care becomes inadequate. The amount of care demands and time per week, impaired
sense of own identity, clinical fluctuations in the patient, and nocturnal deterioration in the
patient predict the caregiver breaking point.
When there is family conflict, there is less assistance to the patient. Bourgeois and
colleagues94 looked at the consequences of disagreement between primary and secondary
caregivers and found divergence in perceptions. There was, however, more agreement on patient
behaviors and caregiver strain. Primary caregivers with pessimistic secondary caregivers were
less distressed than those with optimistic ones. Given and Given18 found that secondary
caregivers left the care situation over time and only returned with increased physical care needs.
Caregivers may also relinquish caregiving when they are unsuccessful in maintaining a
relationship or when the care becomes difficult, such as when the care recipient loses cognitive
function. Conflicts can also occur with unfulfilled or mismatched aid. Negative interactions with
kin include despairing comments on caregiving, caregiver health status, and criticisms of care
decisions.95, 96
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Family Caregiving & Caregiver Assessment
Caregivers require knowledge, skills, and judgment to carry out the tasks of care for patients,
and research has shown that caregivers who feel prepared to deliver care (i.e., have the
knowledge and skills needed) have less burden.15 Providing care takes into account the following
dimensions: (a) the nature of the tasks; (b) the frequency with which tasks are performed; (c) the
hours of care provided each day; (d) the skills, knowledge, and abilities of caregivers to perform
tasks; (e) the extent to which tasks can be made routine, and thus incorporated into daily
schedules; and (f) the support received from other family members. Caring for patients ranges
from providing direct care, performing complex monitoring tasks (e.g., monitoring blood sugar,
titrating narcotic dosages for pain), interpreting patient symptoms (e.g., determining the fever
level to report to a health care provider), assisting with decisionmaking, and providing emotional
support and comfort. Each type of involvement demands different skills and knowledge,
organizational capacities (e.g., obtaining needed community services or ordering the best
wheelchair), role demands, and social and psychological strengths from family members.16, 104,
105
Each of these is a potential area of concern for patient safety and caregiver distress.
Psycho-Educational Interventions
The majority of intervention studies for caregivers have utilized a psycho-educational
intervention. That is, the intervention emphasizes both the provision of information and a
psychological/counseling approach to decrease caregiver distress. Although not explicated as
such, these interventions aim to address caregivers as both clients and providers.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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Family Caregiving & Caregiver Assessment
flexibility to adjust the frequency and timing of paid and unpaid services. Benjamin and
colleagues examined the services of low-income Medicaid beneficiaries under agency-directed
and community-directed services. People who directed their own services had positive outcomes.
They were more satisfied with services and had fewer unmet needs.121 Foster and colleagues122
assessed the impact of consumer direction on caregiver burden in Arkansas and found that
caregivers had greater satisfaction with the care recipient’s care and were less worried about
safety. Caregivers in the study reported less physical, emotional, and financial strain compared to
the control group receiving traditional agency services. Primary informal caregivers who became
paid caregivers reported substantial benefit compared to the group receiving agency services.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Providing Information
Nurses need to communicate effectively with clients and caregivers to develop cost-effective
plans of care and achieve positive client outcomes.129 Communication is crucial across settings.
The emergency room and hospital discharge planning processes, assisted living facility
admission process, skilled nursing facility discharge process, and the home health care admission
and discharge process are all critical points of interaction where health care professionals,
patients, and family caregivers can benefit from respectful, high-quality communication.130 In the
managed care environment, providing concrete care information along with emotional support
can help spouses of frail older adults better manage their caregiving situation.118
At all points in the patient’s disease trajectory, caregivers need information to deal with the
patient’s care and treatment demands. Nurses and other health care providers should not expect
caregivers to be responsible for sorting out relevant information and applying it to the care
requirements for their family members. Research documents that caregivers have difficulty
obtaining information from health care professionals, particularly physicians and nurses.131-133
Professionals should be more responsive to patients’ and family members’ information needs.
It is important to provide information in a clear, understandable way through verbal, written,
and electronic methods. Caregivers want concrete information about medications, tests,
treatments, and resources. They also want time to have their questions answered. Nurses can
provide anticipatory guidance for what the caregiver can expect.134 This kind of information can
relieve caregivers’ distress arising from uncertainties about their ill family members’ disease and
treatment status and the care they may need.135, 136 For example, teaching caregivers how to
manage pain and other symptoms benefits both the patient and the caregiver. Caregivers who
report more confidence in managing symptoms report less depression, anxiety, and fatigue.137
Caregiver Assessment
Given caregivers’ essential role in caring for their family members and the hazards they face
in doing so, their needs and capacities to provide care should be carefully assessed.138 This
assessment should focus on the caregiver as both client and provider before health professionals
can assume caregivers are able to provide competent care without harming themselves or their
family member.
Assessing the home and family care situation is important in identifying risk factors for elder
abuse and neglect. Heath and colleagues87 found that in-home geriatric assessments are needed to
determine the risk for and occurrence of elder care recipient mistreatment. Fulmer’s research86
documents the need for interdisciplinary teams in emergency rooms to screen for elder neglect,
with attention to risk factors associated with caregiver and elder vulnerability, such as the elder’s
cognitive and functional status and depression. Health care professionals who conduct detailed
assessments of the caregiving situation through separate conversations with the patient and the
caregiver are better prepared to provide guidance and collaborate with the family to prevent
abuse and neglect.
Assessing the needs of older people living in the community is a prerequisite for helping
caregivers find resources and adhere to a comprehensive plan of care. Outpatient geriatric
evaluation and management can reduce caregiver burden, particularly for those who are less
experienced caregivers.139
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Family Caregiving & Caregiver Assessment
Research Implications
Taken as a whole, interventions to improve caregiver outcomes have been varied.
Intervention studies have typically been descriptive in nature, used small convenience samples,
and have not included comparison groups. In addition, many studies have limited their samples
to patients with only a single diagnosis. In the future, randomized trials are needed to
substantiate the role of similar programs in enhancing caregiver skills and minimizing caregiver
distress.
The majority of studies have focused on a single construct of the care situation (i.e.,
examining the correlation between the caregiver-patient relationship and caregiver burden).
Researchers have given limited attention to the nature of the knowledge and skills of the
caregiver, and to personality factors or dispositions of caregivers.144, 145 Most of the intervention
studies did not consider potential confounding or risk variables, such as prior family
relationships, cultural variation, caregiver health status, stage of disease, hours of care, or
competing caregiver role demands. In addition, little detail was provided about the intervention
design. Finally, few studies described the nature of care tasks of the caregiver, so we are unaware
whether caregivers were effectively managing symptoms, providing emotional support,
providing direct care, monitoring patient status, or performing a combination of these tasks.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
or care demands. Further studies should take into consideration other time points that may better
reflect the disease trajectory, such as time of initial diagnosis, protocols alterations, and points of
disease exacerbation or decline. A special focus on safety, risk for negative outcomes, and
adverse effects for both the caregiver and care recipient should be noted.
Key variables to include in these studies are the type and stage of the disease and the
treatments because they will be related to the types of continuing therapy. These various
therapies will be related to the needs of the patient and assistance with self-care, as well as the
patient’s ability to perform other customary daily activities. Are the demands on the caregiver
such that they jeopardize his or her health? We also need larger population-based studies so we
can have heterogeneous samples related to diagnosis, stage of disease, caregiver distress, care
provided, patient impairment, and duration of care as they relate to caregivers’ ability to provide
safe care without jeopardizing their own well-being.
Research that uses carefully selected inception cohorts is needed so that variation in care
demands can be understood. We will be in a far better position to describe how the course of the
disease and associated treatment influence caregivers’ responses if we start with inception
cohorts of those caregivers beginning with initial treatment and proceeding through palliative
care. Adverse patient care and caregiver situations, such as medication errors, falls, and
subsequent hospitalizations, can be noted over time.
We need studies that target caregivers that are from minority and economically
disadvantaged groups if we are to better understand their own needs and interventions to support
them in providing safe care. Furthermore, focus on variations or adaptations needed to minimize
caregiver distress related to ethnic, racial, cultural, or socioeconomic diversity is needed. We
know very little about the distress and resource limitations of various vulnerable groups and the
acceptability of various types of interventions to ethnically and racially diverse populations.
We need to investigate the interplay between the formal and informal systems of care for the
ongoing needs of patients as well as caregivers. More research needs to be conducted that
focuses on how family influences care-related decisions and the impact to clinically significant
processes of care and/or client outcomes. There is very little research to suggest how variations
in caregiver contact with the formal health care system interacts with the amount and types of
responsibilities faced by family caregivers. Can prepared caregivers contribute to the quality of
patient clinical outcomes as well as patient safety? What does competent and appropriate family
care contribute to patient clinical outcomes? How does it affect cost and care utilization?
Future research should identify and test patient- and family-directed interventions and chart
their impact upon the quality of care outcomes for patients. In addition, interventions should
report the cost of care, as well as the cost of utilization of services. What are the costs of negative
outcomes that result when safety and neglect or abuse are involved?
Interventions that can demonstrate improved patient outcomes are particularly essential to
building a high-quality system of continuing care. Caregivers who face conflicts in competing
demands related to caring for children, spouse, or parent and to maintaining their work roles are
particularly threatened by and vulnerable to the demands for continuing home care. More
appropriate home care and home care support (resulting in caregivers who are prepared to care
and have adequate formal support) may lead to fewer patient or caregiver hospital readmissions,
fewer interruptions in treatment cycles, shorter periods of work loss, and better patient and
caregiver mental health. Quality of care and patient safety are concerns.
We need to design and test interventions to assist patients and their families to increase their
preparedness to deal with the overall care process, to deal with both the direct and indirect care
14
Family Caregiving & Caregiver Assessment
demands. How do we increase their sense of control and mastery of their care situation? Future
intervention studies should utilize multidisciplinary, randomized clinical trials (including
physicians) to determine the unique contribution of educational programs versus social support
versus psychological support on caregiver outcomes and patient outcomes.
Future studies should explore whether health care professionals can assist the caregiver to
build effective buffers against being overwhelmed and distressed. Interventions that assist the
caregiver to engage in activities that promote their own health should be carried out to identify
strategies of health promotion. Research questions should address whether or not caregiver
distress (i.e., depression and burden) affects caregiver decisionmaking and judgment about
patient care, and to examine caregiver behavior and choices and the subsequent quality of care.
Do these have a negative impact on the patient or on themselves?
Examining caregiver distress as it relates to quality of care is absent from the literature.
Research is needed to understand the quality of care that family members provide and then
determine how that care impacts the overall therapeutic plan and patient clinical outcomes.
Longitudinal studies of caregivers are needed to explore the complex interactions of
caregiver physical health and mental health, and how self-care and health-promotion practices of
the caregiver are altered. Exploration is needed of which self-care practices (i.e., nutrition,
exercise, sleep, stress management, preventive and promotive health care) can influence
caregiver distress and physical health status so that caregivers can continue to provide quality
and positive care.
To better understand the effects of care on family caregivers and on patient outcomes,
caregiver roles, responsibilities, knowledge, and skills need to be more rigorously explored and
defined. For instance, what do caregivers do well? What do caregivers not do well? In what areas
are the patient outcomes most likely to be compromised? In what areas is patient safety most in
jeopardy? What areas cause caregivers more distress? Once these questions are answered, we can
target interventions at those who are at risk and intervene early in the care situation, rather than
late.
Finally, interventions must recognize professional or formal caregivers and family caregivers
as partners in health care—partners who offer unique and vital skills and resources—and engage
them in the entire plan of care. Such interventions are critical as we increase the focus on
outcomes of care and as providers are paid for outcomes performance. Family members as
partners are critical.
Conclusion
Family caregivers are critical partners in the plan of care for patients with chronic illnesses.
Nurses should be concerned with several issues that affect patient safety and quality of care as
the reliance on family caregiving grows. Improvement can be obtained through communication
and caregiver support to strengthen caregiver competency and teach caregivers new skills that
will enhance patient safety. Previous interventions and studies have shown improved caregiver
outcomes when nurses are involved, but more research is needed. There is more to be learned
about the effect of family caregivers on patient outcomes and areas of concern for patient safety.
Nurses continue to play an important role in helping family caregivers become more confident
and competent providers as they engage in the health care process.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Search Strategy
The research cited is a comprehensive but not exhaustive review of the caregiver literature.
The literature search for this paper was done in the databases MEDLINE, CINAHL,
and PsycINFO using variations of the terms “caregiver” and “long-term care” or “home care
services,” combined with other terms relating to patient safety and nursing practice. Other terms
employed included “case management,” “education and training,” “medication,” and “risk
management.” The search was limited to articles written in English, but not limited to the United
States.
The search terms applied were usually kept very broad, and keyword searches were
frequently employed more often than searches that relied upon the use of controlled descriptors,
as the topics of patient and caregiver safety, which are often intertwined, are difficult to isolate
through clearly defined identifiers. As a result, search results were large, and relevance was
frequently determined through the reading and review of abstracts of large sets of retrieved
publications. Relevant articles for this review were not always indexed using terms relating to
nursing; the potential involvement of the nurse as a contributor to improved patient and caregiver
safety was a determinant for inclusion. Some articles discussed the professional health care team
in general terms, while others focused on the specific role of a nurse serving as a factor in safe
family caregiving. The broad search strategies delivered high retrieval levels and the need to
distill relevant evidence.
Author Affiliations
Susan C. Reinhard, Ph.D., M.S.N., F.A.A.N. Professor and Co-Director, Center for State
Health Policy, Rutgers, The State University of New Jersey. E-mail: [email protected].
Barbara Given, Ph.D., R.N., F.A.A.N. Professor, Michigan State University College of
Nursing. E-mail: [email protected].
Nirvana Huhtala Petlick. Research Project Assistant, Center for State Health Policy, Rutgers,
The State University of New Jersey. E-mail: [email protected].
Ann Bemis, M.L.S. Research Analyst, Center for State Health Policy, Rutgers, The State
University of New Jersey. E-mail: [email protected].
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158. Schumacher KL, Stewart BJ, Archbold PG.
145 Moen P, Robinson J, Fields V. Women’s work and Conceptualization and measurement of doing family
caregiving roles: A life course approach. J Gerontol: caregiving well. J Nurs Scholarsh 1998;30(1):63-9.
Psych Sci 1994;49(Suppl.):176-86.
159. Silver HJ, Wellman NS, Galindo-Ciocon, et
146. Bowles KH, Foust JB Naylor MD et al. Hospital al. Family caregivers of older adults on home enteral
discharge referral decision making: A nutrition have multiple unmet task-related traing
multidisciplinary perspective. Appl Nurs Res needs and low overall preparedness for caregiving.
2003;16(3):134-43. J AM Diet Assoc. 2004;104(1):43-50.
147. Fulmer T, Paveza G, VandeWeerd C, et al. Dyadic 160. Smeenk WJM, van Haastregt JC, et al. Care process
vulernability and risk profiling for elder neglect. and satisfaction of a transmural home care program.
Gerontologist 2005;45(4):525-34. Int J Nurs Stud 1998;35:146-54.
148. Steffen AN, McKibbin C , Zeiss Am and Gallagher- 161. Steffen AM. Anger management for dementia
Thompson D The Revised Scale for Caregiving Self caregivers: A preliminary study using video and
Efficacy: Reliability and Validity studies . J Geront telephone interventions. Behav Therap
Psychol Scie 2002;57B(1):74-86. 2000;31(2):281-99.
149. Park CL , CohenLH and Murch RL Assessment and 162. Teng J, Mayo NE, Latimer E, et al. Costs and
prediction of stress related growth. J Personality l996 caregiver consequences of early supported discharge
Mar;64( 1):71-105. for stroke patients. Stroke 2003;34:528-36.
22
Family Caregiving & Caregiver Assessment
163. Williamson GM, Shaffer DR. Relationship quality 164. Zarit SH, Todd PA, Zarit JM. Subjective burden of
and potentially harmful behaviors by spousal husband and wives as caregivers: A longitudinal
caregivers: How we were then, how we are now. The study. Gerontologist 1986;26(3):260-6.
Family Relationships in Late Life Project. Psychol
Aging 2001;16 (2):217-26.
23
Evidence Table: Supporting Family Caregivers in Providing Care
Austrom Nonpharmacologic Randomized Randomized controlled Minority Alzheimer’s All participants receive Study is ongoing. Preliminary
2004114
24
methods, such as controlled trial (Level 2). patients, who were less Alzheimer caregiver data indicate that program is
this collaborative trial likely to visit specialty guides, educational well received by patients,
stepped-care Questionnaires were clinics, may find interventions, and caregivers, and primary care
management periodically interventions more specific protocols for physicians. Subjects are
intervention administered to accessible if they were common behavioral attending voluntary meetings
program, are the evaluate frequency of delivered through disturbances. Treatment more frequently than those
intervention of behavioral disturbances primary care clinics. group then received not in the program.
choice for in patients as well as a Intervention of three treatment
behavioral measure of the basic components: (1) recommendations for
disturbances, which caregiver’s reaction comprehensive specific behavioral
can add to (Memory and Behavior screening and diagnosis disturbances from a
caregiver burden Problems Checklist), protocol, (2) clinical treatment team
and affect quality and measure of severity multidisciplinary team of geriatric nurse
of care. of the caregivers approach to care practitioner, social
depression (Patient coordinated by a psychologist,
Health Questionaire-9). geriatric nurse geriatrician, geriatric
(Level 3) practitioner, and (3) psychiatrist.
proactive longitudinal
tracking system.
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Beach 200563 Threatening Convenience Structured interviews 265 caregiver/care None Harmful caregivers were
behavior, verbal sample (Level 5) recipient dyads associated with greater
abuse (descriptive) recipient ADL needs;
Care recipients reports spouse’s greater caregiver
of harmful caregiver cognitive physical symptoms;
behavior, screaming, caregiver at risk for clinical
yelling swearing, depression.
threatening (Level 3)
Bowles 2003146 Home care referral Noncompara- Interviews with content Patients discharged None Three themes describe why
can lead to better tive analysis (Level 5) without home care patients may not receive
care referrals were presented referrals: (1) patient
Identify patterns as case studies to characteristics, (2) workload,
clinicians used when nurses, social workers, and (3) staffing, educational
gathering information, physicians, and issues.
determine information discharge planners.
essential to discharge Observations were
25
recipients' willingness to
incorporate receiving family
care into their lives.
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Christakis The hospitalization Retrospective Cohort compiled from 518,240 couples who None Serious spousal illness and
200627 of a spouse with a cohort data in Medicare claims were enrolled in spousal death appear to be
serious illness may forms. (Level 4) Medicare in 1993, 65 independently associated with
be associated with years of age or older the risk of death of the
an increase in the Two statistical methods partner. Hospitalization for
risk of death of a were applied (Cox various diseases may
partner. regression and fixed- differentially affect partners.
effects) to estimate the Implications: training and
relationship between assistance of spouses who
the hospitalization of a serve as caregivers can lower
spouse and the costs and improve the health
subsequent death of the of patients and partners. Such
partner, while interventions might decrease
controlling for all mortality among partners.
constant characteristics Interventions may be more
of the spouses and their useful in certain diseases,
environment. (Level 1) such as stroke or dementia.
31
Dalton 2005129 Quality of care can Non- Observation, recording, 12 client-caregiver- None Coalitions (two members of a
be improved when comparative and transcription of nurse triads admitted triad acting together) form
client-caregiver- (ethnographic, triad interactions. for the first time to during triadic interactions; of
psycho-educational pretest and caregiver-recipient recipient dyads were and in-home groups caregiver burden and distress
interventions may post-test dyads received 12 recruited from geriatric were trained in was observed in those
provide relief from (repeated weekly sessions of clinics and home care problem-solving, receiving only friendly phone
the burden, distress, measures training by in-home agencies in central caregiver appraisal of calls, possibly because the
and depression design with contacts; training by Alabama, and were behavior problems, calls provided caregiver
suffered by randomization telephone contacts; and randomized into three written behavioral respite. Only the in-home
caregivers who are to treatment friendly, socially groups. programs for managing training group experienced
not able to, or do group) supportive phone calls. specific problems, and significant burden and
not wish to, seek (Level 2) strategies for handling caregiver distress reduction.
help from sources affective responses to Caregiver groups did not
that require that Caregiver self-reported difficult caregiving differ significantly on
they leave their outcome measures: strategies. caregiver depression. Despite
home. burden, distress, differences in contact time
depression, social with the three different
support, and life groups, they were all similar
satisfaction. (Level 4) in satisfaction levels.
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Dunnion & Improvements in Cross- Standardized Emergency department None Findings added support to
Kelly 200524 planned discharge sectional questionnaires (Level in a 320-bed rural others that found that in
strategies (a (interviews) 3) general hospital in the general, health professionals
multidisciplinary of 5 groups of Republic of Ireland. in the emergency department
approach to health care Quantitative data were Purposeful sample do not adequately determine
developing referral professionals analyzed with SPSS, (excluded psychiatric the aftercare needs of older
guidelines, staff and qualitative data nurses, social workers, patients when they are being
training, and were content analyzed. physiotherapists) of discharged. Effective
dissemination of (Level 4) nursing and medical discharge planning is
information) of staff in the emergency impeded by gaps in
elders from room, totaling 222. 135 communication between the
emergency room to questionnaires were hospital and community
home can lead to returned and 131 were interface, such as illegible
improved quality analyzed. discharge summaries and
and continuity of delays in sending information
care for the older to the general practice
person. physician. There is a lack of
33
Fortinsky The quality of Systematic Literature review None None Interactions in medical
2001130 interaction in the literature (Level 1) encounters involving
health care triad is review dementia care are not optimal
likely to influence Summarization of from the perspectives of
health-related knowledge base (Level family caregivers or
34
neglect (Level 3)
Gitlin 2001100 Upset family Randomized Intervention RCT 171 families of Focusing on education Spouses reported reduced
Gitlin 2005107 Negative behavior Randomized Randomized controlled 127 caregivers, 6 Skill building, Decreased days assisting with
in patients with controlled trial (Level 2) months education, problem- ADLs at 6 months, no
dementia trial solving, and technical difference at 12 months.
Behavior problem skills. Active—five 90- Decreased upset with
checklist, Says ADL, minute home visits and memory-related behaviors at
task management affect one phone session over 6 months, no difference at 12
(Level 4) 6 months. months. Improved affect at 6
Maintenance—one months, none at 12 months.
home visit and three Decreased memory
phone sessions over the behavioral occurrences in
next 6 months. patients at 6 and 12 months.
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Glueckauf Caregivers of Single-group Telephone interviews 21 caregivers of Series of six 45-minute Moderate support was
2004116 persons with pretest-post- with caregivers to individuals with interactive (PC- or obtained for the effectiveness
dementia typically test assess effects of the progressive dementia telephone-based) of AlzOnline's Positive
experience Positive Caregiving who had completed the Positive Caregiving Caregiving classes;
emotional, classes (Level 5) AlzOnline's Positive sessions, every 2-3 significant increases in self-
physical, and Caregiving program weeks over a 16-week efficacy, concomitant
psychosocial Survey instruments for period decreases in subjective
deterioration due to dependent measures caregiving burden, little or no
the extreme were: Steffen et al.'s change in stress-related
demands of Caregiver Self-Efficacy growth and positive
providing home scale,148 Parke et al.'s caregiving appraisals, or
care without Stress-Related Growth perceptions of time burden in
support. Scale,149 Lawton et al.'s providing caregiving
Caregiver Appraisal assistance.
Inventory150 (Level 3)
Grant 2002108 Caregiver Randomized Randomized 3-group 45 stroke caregivers Problem-solving: (1) 3- Improved problem-solving
37
depression and controlled design (Level 2) hour home visit with skills, preparedness, vitality,
burden trial RN, (2) weekly phone social functioning, mental
Social problem-solving calls by RN for 1 health, and role limitations
(Level 4) month, (3) phone calls related to emotional
illness.
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Griffiths Persons over 65 Pretest-post- Survey (Level 3) 111 participants over Various interventions, After invention, participants
2004109 years old represent test with a age 65, taking oral including client showed improvement in their
a significant cross- Participants living at medications and having education, referral ability to manage medications
percentage of sectional home and receiving regular community paths to physicians and (alteration in use of
medication-related survey community nursing nursing visits, were pharmacists, provision compliance aids) and
admissions to care were assessed for surveyed. Recruited of administrative demonstrated increased
hospitals. knowledge of and from case-load of support systems. knowledge about their
Community nurses ability to manage Australian community medications. Clients showed
can play a role in medication regimes. A nurses. A subgroup of significant improvement in
managing the nurse-initiated 24 participants with the ability to correctly name
administration of intervention was diminished knowledge their medications and
medicines and the developed that included of medications were schedules correctly; clients
monitoring of their referral pathways to administered a did not experience reduction
effects on patients. physicians and/or followup in-depth in the complexity of the
Community nurses pharmacist medication survey. regimes. Community nurses
can play a unique review. (Level 3) can successfully work within
role in the the boundaries of a
39
variables. Descriptive
statistical analysis.
(Level 3)
provided CO,
depression (Level 3)
Metlay 200590 In the outpatient Cross- Prospective cohort 4,955 Pennsylvania None Almost one-third of subjects
setting, patients and sectional study (Level 4) Pharmacy Assistance reported not receiving any
their caregivers Contract for the Elderly instructions on the use of their
play a critical role Telephone interviews. (PACE) members (65 medications. Approximately
in ensuring the safe Demographic years and older) who 40% used no organizational
use of medical characteristics of were taking warfarin, system to adhere to
therapies. survey participants digoxin, and phenytoin medication regimens. A
Knowledge of the were compared to (half of whom lived substantial proportion of older
causes of characteristics of home alone) adults on high-risk
48
Naylor 2000155 An effective Systematic Systematic review None None This program of research has
hospital discharge literature (Level 1) increased an understanding of
49
Roth 200577 Caregiver Randomized Randomized controlled 406 spouses, caregivers Individual and family Improved number of support
depression controlled trial (Level 2) of dementia patients counseling; five 90- persons, satisfaction with
53
may decrease trial intervention or usual services and had a rehabilitation and for those with greater
hospital costs care (Level 2) caregiver at home. nursing services. functional limitations than for
without having a those with less. Caregivers in
negative effect on the early supported discharger
patient outcomes. Interviews ascertained group scored lower on the
self-rated physical Burden Index than caregivers
health; costs estimated with usual care.
for acute-care
hospitalization,
outpatient care, and in-
home care; caregiver
stress (Level 3)
Source Safety Issue Design Type Study Design and Study Setting & Study Study Intervention Key Finding(s)
Related to Clinical Outcome Measures Population
Practice
Toseland Health education Randomized Two-level randomized Caregivers of spouse Multicomponent Caregivers reported that by
2004118 programs can help controlled controlled trial (Level with chronic illness psycho-educational end of 1 year, they felt the
caregivers reduce trial 2) who was a member of a health education health education program
depression, staff model HMO. program. Consisted of helped them learn about
increase knowledge General Health Minimum score of 7 on 8 weekly sessions, community resources and
of community Questionnaire, Medical Caregiver Strain Index. followed by 10 monthly how to access them.
services and how to Outcome Short Form Care recipients with at sessions.
access them, Health Survey, Social least two impairments
change caregivers Provisions Scale, in ADLs. Total of 105
feelings of psychological well- caregiver-care recipient
competence and being, perceived social dyads.
how they respond support, subjective
to the caregiver burden (Level 3)
situation.
Travis 200012 Improving Noncompara- Semistructured, face-to- 23 family caregivers None Primary care providers must
understanding of tive face interviews (Level providing 122 separate continually reevaluate and
59
Background
Pediatric inpatient safety and quality of care are dynamic and complex phenomena. Our
intent is to inform the reader about efforts underway by pediatric stakeholders and specialty
groups and to understand where credible information can be accessed pertaining to patient safety
and quality in the provision of care for the hospitalized child. Over the past several years,
pediatric groups have partnered to improve general understanding, reporting, process
improvement methodologies, and quality of pediatric inpatient care. These collaborations have
created a robust program of projects, benchmarking efforts, and research.
This chapter discusses general findings about safety and quality; major initiatives by
agencies, groups, and collaborations; a guide to synthesis documents surrounding quality care
and evidence-based practice for specific areas of pediatric care; and recommendations about how
we can move pediatric safety and quality forward in practice and in the policy arena.
Patient safety literature and associated findings on adverse events for pediatric patients have
been widely disseminated.1–9 Much of the focus has centered on medication errors—the most
frequently reported adverse event for both adult and pediatric patients. Indeed, the Institute of
Medicine (IOM) reported that medication errors are the most common, yet preventable, type of
harm that can occur within the pediatric population,10 and Bates11 reported that when pediatric
medication errors occur, these patients have a higher rate of death associated with the error than
adult patients.
Medication errors, however, are only one potential adverse event for hospitalized children.
Slonim and colleagues4 found 1.86–2.96 medical errors per 100 discharges of hospitalized
children. Four distinct challenges confront those conducting research and caring for children.12
These four related issues are each problematic, but in concert they create a high-risk environment
for hospitalized children. Following are the four issues for pediatric patients, summarized from
Beal and colleagues:12
• Development: As children mature both cognitively and physically, their needs as
consumers of health care goods and services change. Therefore, planning a unified
approach to pediatric safety and quality is affected by the fluid nature of childhood
development.
• Dependency: Hospitalized children, especially those who are very young and/or
nonverbal, are dependent on caregivers, parents, or other surrogates to convey key
information associated with patient encounters. Even when children can accurately
express their needs, they are unlikely to receive the same acknowledgment accorded adult
patients. In addition, because children are dependent on their caregivers, their care must
be approved by parents or surrogates during all encounters.
• Different epidemiology: Most hospitalized children require acute episodic care, not care
for chronic conditions as with adult patients. Planning safety and quality initiatives within
a framework of “wellness, interrupted by acute conditions or exacerbations,” presents
distinct challenges and requires a new way of thinking.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• Demographics: Children are more likely than other groups to live in poverty and
experience racial and ethnic disparities in health care. Children are more dependent on
public insurance, such as State Children’s Health Insurance Program (SCHIP) and
Medicaid.
All quality research is challenged to standardize frameworks and language under which all
care providers operate. Each population has unique language and focused areas with no current
common language across all specialty areas. Pediatric safety and quality efforts are further
challenged as most of the work on patient safety to date has focused on adult patients. There is
no standard nomenclature for pediatric patient safety that is widely used. However, a standard
framework for classifying pediatric adverse events that offers flexibility has been introduced.13
The model, seen in Figure 1, allows for analysis and depicts the relationships and interactions of
the elements of an event.
Contributing
Child/Patient Specific Medical Level of
Event Type Outcome Harm
Factors
2
Pediatric Safety & Quality
The Agency for Healthcare Research and Quality (AHRQ) is the Federal authority for patient
safety and quality of care. AHRQ has been a leader in funding safety and quality improvement
efforts, synthesizing and disseminating findings to clinicians and the public for more than two
decades to stimulate both scientific and policy dialogue. AHRQ has been a leader in pediatric
quality and safety. Within the agency, the Children’s Health Advisory Group is a resource for
AHRQ’s senior leaders that helps focus work in key topic areas as the state of the science
changes. A focus of AHRQ funding is translational research, which moves scientific findings to
health care settings across the care continuum. Projects funded by AHRQ help determine where
gaps in safety and quality exist.14
AHRQ also sponsors the Health Cost and Utilization Project (HCUP), a family of databases
supported by a Federal-State-industry partnership. One of the databases is the Kids Inpatient
Database (KID). HCUP is the largest information source of patient encounters in both inpatient
and outpatient settings. All HCUP databases contain more than 100 variables linked to patient
care, including both clinical and charge data. All patient identifiers are removed to protect
patients’ confidentiality. The HCUP databases are used by clinicians and health services
researchers to investigate care delivery and discover trends in outcomes and costs. They are also
used internally at AHRQ for special projects, such as the development of pediatric indicators
outlined in the next section.
The initial AHRQ work on pediatric patient safety was conducted by investigators from
Johns Hopkins, using the KID database for the year 1997.4 However, Miller, Elixhauser, and
Zhan5 conducted a more recent review of potential pediatric safety issues by using the previously
defined adult indicators. They found that hospitalized children who experienced a patient safety
incident, compared with those who did not, had
• Length of stay 2- to 6-fold longer
• Hospital mortality 2- to 18-fold greater
• Hospital charges 2- to 20-fold higher
Another key finding in this initial work demonstrated that severity of illness and type of
hospital are directly associated with patient safety incidents, except for birth trauma. Birth
trauma was directly associated with African American and Hispanic race, but not type of
hospital.
Subsequently, AHRQ sought to develop pediatric quality indicators with the goal to
“highlight areas of quality concern and to target areas for further analysis.”15 Nominated peer
reviewers from 44 professional clinical organizations joined this effort. Each had to spend the
majority of his or her time in direct clinical practice. Development of the PedQIs is the result of
Phase I of this work. The complete report, Measures of Patient Safety Based on Administrative
Data: The Patient Safety Indicators, was published in February 2006.
After rigorous review, 18 pediatric quality indicators were recommended for inclusion in the
AHRQ quality measure modules, based on expert input, risk adjustment, and other
considerations. Thirteen inpatient indicators are recommended for use at the hospital level, and
five are designated area indicators. Inpatient indicators are treatments or conditions with the
greatest potential of an adverse event for hospitalized children. Area-level indicators are intended
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
to measure access to care and have the potential to reduce hospitalization and subsequent
untoward events. Table 1 presents the AHRQ pediatric quality indicators.
Phase II of this project will extend the work to include indicators of neonatal care quality. In
addition, methodological issues associated with risk adjustment require refinement to reduce
variation in coding patient care for future comparison studies. Possible additions to the dataset
will address the patient’s condition on admission and increase the understanding of how
laboratory and pharmacy utilization impact patient outcomes. AHRQ will continue to work with
health care providers to refine the area-level indicators to improve outcomes for children
receiving outpatient care and reduce the incidence of hospitalization for those defined conditions.
The findings of AHRQ-funded research provide Congress with critical information about
patient safety and quality of care for the American people. This work will influence Federal
funding for projects related to improving health care safety and quality for children. (See
AHRQs’ Web site, www.ahrq.gov, for more information.)
Numerous groups are actively engaged in improving pediatric care, quality and safety. Each
of these groups has a unique mission and membership. Several recent efforts have these groups
4
Pediatric Safety & Quality
working on joint projects to move things forward within their respective spheres of influence.
Table 2 details these groups’ missions and how to access their Web sites.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
of research, education, and quality improvement projects.21 Currently, the Neonatal Intensive
Care/Quality collaborative has three primary goals:
1. Achieve measurable improvements in the quality, safety, and efficiency of neonatal
intensive care.
2. Develop new resources, tools, and knowledge for quality improvement in neonatal
intensive care units.
3. Disseminate this improvement knowledge to the neonatal community.
CHCA, NACHRI, and the National Initiative for Children’s Healthcare Quality are
partnering to bring resources to the children’s health care community as part of the Institute for
Healthcare Improvement 100,000 Lives Campaign. The Pediatric Node of the 100,000 Lives
Campaign was launched in December 2004.23 The objective of the campaign was to save
100,000 pediatric lives within 18 months by improving strategies in key areas of care: preventing
surgical site and central line infections, preventing ventilator-associated pneumonia, deploying
rapid response teams for inpatient settings, and medication reconciliation. A target of 1,600
participating institutions was set, and as of April 2006 there were more than 2,200 organizations
engaged in this work.
The Pediatric Intensive Care Measures collaborative is a joint effort of NACHRI; Medical
Management Planning, a benchmarking service; and CHCA to develop pediatric core
measures.24 In February 2004, the Pediatric Intensive Care Measures collaborative issued a
national call for measures from hospitals and received 51 measures from a variety of sources. An
expert panel was created representing a variety of expertise and care models, with panelists from
all parts of the Nation. The panel’s charge was to rigorously review the measures submitted and
determine which should move forward for consideration as standard measures for generalized
use.
6
Pediatric Safety & Quality
A key issue that arose immediately was the need for a standardized risk-adjustment
methodology that would meet the Joint Commission (formerly the Joint Commission on
Accreditation of Healthcare Organizations or JCAHO) requirement to be in the public domain,
but that also had been validated in the United States pediatric population. The panel did not
identify any single tool to meet these criteria, but noted that risk adjustment was a critical
component of any core measure set for pediatric intensive care units (PICUs).
After several months of work by the expert panel, by additional experts who worked in
subgroups, and after voting by the children’s hospitals, the following potential PICU core
measures were identified:
• PICU standardized mortality ratio
• PICU severity-adjusted length of stay
• PICU unplanned readmission rate and review of unplanned readmissions
• PICU pain assessment on admission and PICU periodic pain assessment
• PICU medication safety practice adoption
• PICU central line infection prevention practice adoption
Next steps are continued discussions with all stakeholders to pilot test these measures in a
respectable number of PICU settings followed by modification of these measures, if necessary.
Because the Joint Commission uses only measures endorsed by the National Quality Forum,
discussed in other chapters and below, advocates will seek this endorsement. Ultimately, PICUs
would embed these measures in their overall quality improvement programs with institutional
improvement strategies.
The mission of the National Quality Forum is to improve the lives of patients by building
consensus for quality measurement and reporting. The majority of this work has been done with
adult patients. A vigorous collaboration with NACHRI and CHCA was launched to create
pediatric measures. This partnership has identified the Children’s Asthma Core, which is made
up of the following core measures for asthma patients:25
1. Return to hospital (i.e., emergency department, observation status, or inpatient
admission) with same asthma diagnosis within 7 days following inpatient discharge
2. Return to hospital with same asthma diagnosis within 30 days following inpatient
discharge
3. Return to hospital with same asthma diagnosis within 7 days following emergency
department or observation stay
4. Use of relievers (drugs used to control exacerbations) for inpatient asthma
5. Use of systemic corticosteroids for inpatient asthma
6. Risk-adjusted length of stay
7. Home management plan of care discussed with patient/caregiver
Development and national pilot testing of these children’s asthma core measures was
conducted and, as of October 2007, three were selected for inclusion as performance measures
for accreditation by the Joint Commission: use of relievers, use of systemic corticosteroids, and
home management plan of care.
Resources and dedication are needed to conduct and sustain this level of inquiry. Hospitals
are committed to this level of disease-specific investigation and reporting. However, the Joint
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Palliative Care
Over the last few decades, a significant body of research has contributed to the science of
palliative care. Two key groups have developed best practices and guidelines for individuals and
institutions that provide care to dying children: the Initiative for Pediatric Palliative Care (IPPC)
and the End-of-Life Nursing Education Consortium.27, 28
IPPC is both an education and a quality improvement effort, aimed at enhancing family-
centered care for children living with life-threatening conditions. IPPC’s comprehensive,
interdisciplinary curriculum addresses knowledge, attitudes, and skills that health care
professionals need to better serve children and families.
IPPC is a project of the Center for Applied Ethics and Professional Practice, a division of
Education Development Center, Inc. The Education Development Center is a nonprofit
organization with more than 600 professional staff, working on 300 educational projects
throughout the United States and in 27 other countries. Education Development Center is the
lead organization in this initiative, working in close collaboration with NACHRI, the Society of
Pediatric Nurses (SPN), the Association of Medical Schools Pediatric Department Chairs, and
the New York Academy of Medicine.
The IPPC team is composed of nationally renowned educators and clinicians with expertise
in pediatric palliative care. IPPC is a broad-based collaborative effort that includes children’s
hospitals, pediatric units in general hospitals, and hospice or home care programs that serve
children living with life-threatening conditions and their families.
The End-of-Life Nursing Education Consortium project is a national education initiative to
improve end-of-life care in the United States. The project provides undergraduate and graduate
nursing faculty, continuing education providers, staff development educators, pediatric and
oncology specialty nurses, and other nurses with training in end-of-life care so they can teach
this essential information to nursing students and practicing nurses.
8
Pediatric Safety & Quality
violence.31 However, most of the research linking nursing workload and outcomes for either
patients or nurses has been conducted with adult patients and the nurses who care for them. The
following section covers only pediatric patients and nurses.
The American Nurses Association’s National Center for Nursing Quality collects data about
nursing care quality reported by nursing units to the National Database of Nursing Quality
Indicators.32 The database provides a data repository for hospitals participating in a national
effort to address nursing care safety and quality. The National Database of Nursing Quality
Indicators has collected data about nursing care quality for adult patients since 1998. Indicators
of pediatric nursing care quality were developed and pilot tested in 2004. Since the fourth quarter
of 2004, data about the pain assessment, intervention, and reassessment cycle and peripheral
intravenous infiltration have been collected from a national sample of pediatric units and
children’s hospitals.
These two indicators of pediatric nursing care quality are sensitive measures of nursing care.
That is, the presence or absence of registered nurses (RNs) impacts the outcome for pediatric
patients requiring pain management and/or peripheral administration of intravenous fluids and/or
medications. Professional nurses play a key role in successful pain management, especially
among pediatric patients unable to verbally describe pain. Astute assessment skills are required
to intervene successfully and relieve discomfort.33 Maintenance of a patient’s intravenous access
is a clear nursing responsibility. Pediatric patients are at increased risk for intravenous infiltration
and for significant complications of infiltration, should it occur.34, 35
The characteristics of effective indicators of pediatric nursing care quality include the
following:
• Scalable. The indicators are applicable to pediatric patients across a broad range of units
and hospitals, in both intensive care and general care settings.
• Feasible. Data collection does not pose undue burden on staff of participating units as the
data is available from existing sources, such as the medical record or a quality
improvement database, and can be collected in real time.
• Valid and reliable. Indicator measurement within and across participating sites is accurate
and consistent over time.
In 2003, Stratton36 studied the link between pediatric outcomes of interest and nurse staffing.
She used administrative data from seven academic, not-for-profit children’s hospitals, which
included 17 medical/surgical, 5 oncology, and 12 intensive care units, to analyze the correlation
between staffing and 5 indicators of quality care identified in the literature as nurse sensitive.
Stratton controlled for unit type and patient characteristics. The five indicators were medication
administration errors, central line infections, bloodstream infections, intravenous infiltrates, and
parent/family complaints. Key findings supported a strong inverse relationship between the
proportion of hours of pediatric nursing care delivered on patient care units by RNs and the rate
of occurrence of central line and bloodstream infections. Other significant findings included the
following:
• A higher percentage of nursing overtime hours was associated with lower parent/family
complaint rates.
• A higher percentage of nursing overtime hours and a lower percentage of hours of care
from float/agency/traveler RNs were associated with lower bloodstream infection rates.
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
This work applies nurse staffing to outcomes among pediatric patients and also expands the
context of nurse staffing to include “float/travel/agency” nurses and the complex issue of
overtime into the research questions. Since maximizing the capability of the nursing workforce is
a strategy employed in high-reliability organizations, this work makes an important contribution
to pediatric nursing.
The California Nursing Outcomes Coalition Database Project, the statewide database that
links patient outcomes and nurse staffing, is actively conducting data collection and unit-based
benchmarking for pediatric units across the State (N. Donaldson, co-principal investigator,
Carolyn Aydin, co-investigator, California Nursing Outcomes Coalition Pediatric Pilot Project,
personal communication, July 2006).To date, 66 diverse pediatric units have joined this database.
No formal reports have been generated, as this work is in process.
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Pediatric Safety & Quality
attention to errors. Cost-containment efforts resulting from managed care may reduce staffing to
dangerous levels, divert resources from error prevention, or both.38
Hospitals are making progress toward adopting strategies that improve patient safety,
McFadden, Stock, and Gowen report.39 Though continued progress is needed, most U.S.
hospitals have begun to implement some of the evidence-based practices that research has
demonstrated are efficacious in reducing hospital errors.
Nurses caring for hospitalized children face similar challenges as nurses in all hospital
settings. There is a substantial gap between evidence and practice, as many nurses do not
understand or value research and have had little training that helps them find evidence on which
to base their practice.36, 40 Most nurses practice based on what they learned in nursing school and
from their subsequent experiences with patient care.41 When practice questions arise, nurses are
most likely to ask peers for information and advice.37
Common challenges to nurses learning about and putting into practice guidelines based on
the systematic identification and synthesis of the best available scientific evidence persist in all
settings. For example, nurses’ knowledge and competence with the recommended technique for
endotracheal suctioning is inadequate, especially with regard to the instillation of normal
saline.42, 43 Bridging the gap between scientific evidence for practice and the application of the
evidence in the clinical care of patients continues to challenge practicing nurses, nursing
educators, nurse experts, and nursing administrators.
The following personal and organizational barriers to the use of research and the
implementation of evidence-based practices among nurses have been identified:37, 40, 41, 44–46
• Perceived low usefulness of research in clinical decisionmaking
• Lack of time to access, read, and evaluate research
• Lack of access to the tools needed to search for evidence
• Inadequate skills to conduct information searches
• Real or perceived lack of assistance with information seeking
• Difficulty understanding research articles
• Belief that change will produce minimal benefits
• Perceived lack of authority
• Low management and staff support
• Lack of physician collaboration and buy-in
• Costs of resourcing the development of evidence-based practices
Unique challenges in nursing care for children. Some authors suggest that pediatric
nursing, rooted deeply in tradition and ritual, is particularly resistant to evidence-based practice
changes.47, 48 Pain management in infants and children is an example of the influence of tradition,
personal bias, the persistence of myths, and resistance to change.48 However, it is important to
note that SPN has recognized that evidence-based practice represents a shift in clinical
decisionmaking and provides a more complete and comprehensive understanding of “best”
clinical practice. Its position and recommendations are as follows:49
1. SPN endorses clinical practice based on “best evidence” from evidence-based practice
sources and patient and family preferences.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
2. SPN supports clinically based nurses who use an evidence-based practice approach to
maximize clinical outcomes for pediatric patients and their families.
3. SPN supports advanced practice nurses in the roles of evidence-based practice mentors
for clinically based nurses.
4. SPN supports nursing research that generates new knowledge of best practice based on
measurable, improved patient outcomes.
5. The SPN Listserv provides an opportunity for best practice discussions among its
members.
6. SPN supports nursing higher education that trains all levels of nurses in the application
and dissemination of evidence-based practice.
7. SPN supports institutions’ efforts to create a culture and resource infrastructure that
incorporates evidence-based practice in all aspects of patient care delivery, including
collaboration and sharing of ideas and information among other nursing institutions and
agencies.
The Journal of Pediatric Nursing includes an evidence-based practice section in each issue,
focusing on the search for and critique of the best evidence to answer challenging clinical
questions so that the highest quality, up-to-date care can be provided children and their families.
The American Academy of Pediatrics Steering Committee on Quality Improvement and
Management develops and classifies clinical practice guidelines “intended to improve clinical
care by reducing inappropriate variations, producing optimal outcomes for patients, minimizing
harm, and promoting cost-effective practices”50 (p. 874). The committee uses a three-step
process in developing clinical practice guidelines:
1. Determination of the quality of the evidence in support of a proposed practice
recommendation
2. Evaluation of the anticipated balance between benefits and harm when the
recommendation is carried out
3. Designation of the recommendation’s strength (strong recommendation,
recommendation, option, or no recommendation).
Clearly, leadership exists for overcoming barriers to implementing evidence-based pediatric
practice.
The challenges of family-centered care. Family-centered nursing of children places the
concerns, needs, strengths, and capabilities of the family at the center of a hospitalized child’s
care. Rush and Harr48 suggest family-centered care and evidence-based practices might be at
odds at the bedside and recommend a “marriage” of the two to assure that the best care is
achieved. More recent definitions of evidence-based practice include patient preference, but
pediatric nurses will have an opportunity to lead efforts to include existing evidence-based
strategies for family-centered care, as well as lead the further development of practice guidelines
that include the perspective of the family in care. Several examples of evidence-based, family-
centered care follow.
Nearly two decades ago, Martha Curley demonstrated that the nursing mutual-participation
model of care diminished distress for parents of children in the pediatric intensive care unit.51, 52
When nurses assisted parents of critically ill children to continue specific parenting activities
with their children in the intensive care unit, parents reported less stress.
Bernadette Melnyk and colleagues53–55 tested the effects of the Creating Opportunities for
Parent Empowerment program with mothers of young children in the pediatric intensive care
unit. Study participants were provided written and audiotaped information describing young
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Pediatric Safety & Quality
children’s typical responses to critical illness and intensive care and parental-role information,
which suggested strategies the parents could use to facilitate their children’s adjustment. These
parents, compared to the control group, reported less negative mood and parental stress, provided
more support to their children during intrusive procedures, participated more in their children’s
care, and reported fewer posttraumatic stress symptoms after discharge.
A strategy to prepare parents for their child’s transfer from the pediatric intensive care unit
was tested for its impact on parental anxiety.56 Study parents received written information
explaining the transfer procedure and the level of care on the general pediatric unit, reinforcing
the positive aspects of their child’s transfer. The information was provided 24 to 48 hours prior
to the transfer. Findings indicated that experimental group parents had lower levels of anxiety
following transfer.
In 2004, Melnyk, Small, and Carno57 critically appraised these five studies of parent-focused
interventions aimed at improving coping and mental health outcomes for children and their
parents. Despite what is known about the potential adverse effects of critical illness and intensive
care for children and their families, interventions with proven effectiveness are not in place in
pediatric critical care units across the United States. Clinical practice guidelines that incorporate
evidence-based interventions are needed if they are to become the standard of care.
IPPC27 is a consortium of seven academic children’s hospitals, Education Development
Center, NACHRI, the New York Academy of Medicine, SPN, and the Association of Medical
School Pediatric Department Chairs. The group has both education and quality improvement
objectives that address the growing empirical evidence that U.S. health care systems fail to meet
the needs of children with life-threatening conditions and their families.
A commitment to culturally respectful, family-centered care of children with life-threatening
conditions is evidenced as support of the family unit and involvement of the child and family in
communication. Decisionmaking and care planning are two of six quality domains in the
program. Evidence-based practice guides discovering what matters to families and incorporating
the perspectives of children and families in care planning and implementation.58
The American Heart Association issued guidelines in 2000 that recommended, for the first
time, that family members be given the option to be with their loved ones during resuscitation
efforts, whenever possible.59 Pediatric Advanced Life Support guidelines also endorse family
presence during resuscitation of children.60 However, clinicians in many settings have resisted
following the guidelines, citing the belief that the family will suffer undue trauma and may not
understand what is happening to their loved one, and concern that family presence may lead to
litigation.61 A literature review for evidence-based practice guideline development at the
Children’s Hospital, Denver, found that families want to have a choice about being present
during resuscitation efforts, refuting previous beliefs that family presence is detrimental to
family members or institutions. The review led to development of an evidence-based practice
policy that may guide others to provide compassionate, family-centered care that respects family
choice and supports their presence during resuscitation efforts.62
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
is significant. In fact, the IOM identifies it as a “quality chasm.”63 In July 2003, the National
Quality Forum released 30 safe practices for better health care, calling it a road map for safety.
The practices identified are supported by “evidence so clear that if they were universally
implemented, they would significantly improve the situation with regards to medical errors and
patient safety”64 (p. 12). More than two-thirds of the 30 safe practices are related to Joint
Commission national patient safety goals or other Joint Commission initiatives, and they are
applicable to the care of hospitalized children. In addition, pediatric quality indicators proposed
by AHRQ and those proposed by the IOM inform and direct efforts to improve the safety and
quality of care for hospitalized children. The section that follows presents progress toward
evidence-based clinical practice guidelines for pediatric care addressing national patient safety
and quality objectives.
Pressure ulcers do occur in acutely ill children. However, there are differences among
pediatric patients, such as between premature neonates and older infants or children; between all
pediatric patients and those in at-risk groups, such as those with spina bifida and those who are
critically ill; and in the distribution of pressure ulcers between infants, children, and adults.
Risk factors for pressure ulcer development are not different among pediatric patients or
between children and adults. The factors include (1) decreased mobility, activity, and sensory
perception; (2) increased moisture, friction, and shear forces; and (3) intrinsic factors that
influence tissue tolerance associated with age, nutrition, and tissue perfusion.
The incidence of pressure ulcers among hospitalized children is consistent across studies.
There is a 17 percent incidence in children in the intensive care unit following cardiac surgery,65
19 percent among infants in a neonatal intensive care unit,66 26 percent among children in a
multidisciplinary pediatric intensive care unit,67 27 percent in a prospective, multicenter study of
pediatric intensive care unit patients,68, 69 and 23 percent in a recently reported study that
included pediatric intensive care and general pediatric care patients.70
Prevention of skin breakdown begins with accurate prediction of pressure ulcer risk. The
Braden Skin Risk Scale score, the gold standard for predicting pressure ulcer risk in adult
patients, has been adapted for use with pediatric patients to reflect the unique needs of children.71
A multicenter study of the Braden Q Scale demonstrated that its performance is similar in a
pediatric intensive care population and in adult patients. The modified Braden Q, which is
shorter, is comparable.68 The Starkid Skin Scale used the Braden Q as the basis for developing a
shorter, simpler tool to measure risk of skin breakdown. While it has high interrater reliability
and high specificity, the initial study of its use found its sensitivity low.70 It is, however, the only
tool evaluated in general pediatric patient care.
Risk factors for the development of pressure ulcers include white race; younger age;
diarrhea; use of medical devices, especially mechanical ventilation; and higher severity of
illness, hallmarked by hypotension and prescription of vasoactive medication infusions. Lower
Braden Q or Starkid Scale scores were predictive of risk for skin breakdown.
The location of pressure ulcers in pediatric patients is different than it is in adults. The most
common location in pediatric intensive care patients was the head (occiput and ears). Acutely ill
pediatric patients in the intensive care unit also developed lower-body pressure ulcers, with their
heels most frequently affected.68 In general care pediatrics, skin breakdown on the buttocks or
perineum is most commonly related to diaper dermatitis.70
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Pediatric Safety & Quality
Most children in all studies had Stage I pressure ulcers and developed them early in
hospitalization—likely when they were most ill. Prevention and treatment strategies have not
been studied in children, but those recommended in the AHRQ evidence-based review of
practices known to prevent pressure-related injury are logically applicable in pediatric patients.
Evidence supports the use of pressure-reducing devices to distribute weight over a larger surface
area, head-of-bed elevation to the lowest degree consistent with the patient’s condition to
minimize sheer-related injuries, elevation of the heels off the bed, and a turning schedule to
provide pressure relief.72 In addition, injuries from medical devices such as oximeter probes,
endotracheal and tracheostomy tubes, BiPAP masks, catheters, and splints—which were not
included in pressure ulcer data in the studies—warrant efforts at prevention from vigilant
pediatric care providers. “Excellent skin care is a hallmark of quality nursing care.”70
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Catheter site dressing changes. Recommendations for catheter site dressing changes are
extrapolated to pediatrics from adult studies.78 Central catheter dressings should be either sterile
gauze or sterile, transparent, semipermeable dressing that covers the insertion site. The choice of
dressing is a matter of preference, as no differences for CRBSI have been found between the
two.85 Gauze may be preferred in patients who are diaphoretic or who have oozing or bleeding at
the insertion site. Dressings should be changed using aseptic technique at least weekly or if the
dressing becomes damp, loosened, or visibly soiled.75
The longstanding practice of intermittent application of topical antibiotic ointment to the
catheter insertion site is no longer endorsed by the CDC.75 Application of antibiotic ointment
increases the rate of catheter colonization with Candida species, promotes emergence of resistant
bacteria, may compromise the integrity of the catheter, and has not consistently been shown to
decrease the rate of CRBSI.
Replacement of intravenous administration sets. The optimal interval for routine replacement
of administration sets has been well studied. Data reveal that replacing administration sets no
more frequently than every 72 hours is safe and cost effective.86, 87 Data from a more recent
study demonstrated that phlebitis rates were no different when administration sets were left in
place for 96 hours compared with 72 hours.88 Data from an additional recent study with adults
support delaying replacement of administration sets up to 7 days if the patient is not receiving
total parenteral nutrition, blood transfusion, or interleukin-2 via the intravenous tubing.89
Implementing the recommendations. Multifaceted interventions are necessary to assure
that evidence-based infection control guidelines to prevent CRBSI are followed. In a recent study
in an adult surgical intensive care unit, CRBSI was nearly eliminated when five interventions
were put in place to improve adherence with infection control guidelines during central venous
catheter insertion.90 The interventions were as follows:
1. An educational intervention to increase provider awareness of evidence-based infection
control practices
2. Creation of a central catheter insertion cart to assure that needed equipment and supplies
to provide asepsis during central venous catheter insertion or exchange were accessible in
one location
3. Asking providers daily in interdisciplinary rounds about removal of central catheters to
reduce risk from prolonged, but unnecessary exposure
4. Implementation of a checklist of items that assure compliance with evidence-based
infection control guidelines, completed by the bedside nurse during central venous
catheter insertion or exchange
5. Nurse empowerment to stop procedures if guidelines are not followed
The study authors report sustained improvement years following the initial implementation
of the five interventions. Between January 2003 and April 2004, there were two CRBSIs in this
surgical intensive care unit or 0.54/1,000 catheter days. No infections had occurred in more than
9 months. By their estimate, 43 CRBSIs and eight deaths may be prevented per year, saving
nearly $2 million in additional costs annually.
The authors report the following important lessons learned from this initiative: (1) relatively
simple and inexpensive interventions produced significant improvement; (2) processes that
reduce steps in workflow are more likely to succeed than those that require more steps; (3)
creating redundancy through the use of a checklist, as in aviation, is an effective technique to
improve patient care safety; and (4) a culture of safety requires teamwork and collaboration.
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Health care errors and poor quality of care are consequences of a variety of workplace
systems and processes. Care of hospitalized patients across the lifespan is provided in complex
environments where limited time, parallel tasking, interdependence, and the need for
decisionmaking despite uncertainty create unique demands. The importance of effective
communication with patients and their families as well as between interdisciplinary teams is
recognized as key to reducing errors and improving quality in a number of industries. Analysis of
2,455 sentinel events reported to the Joint Commission revealed that the primary root cause in
more than 70 percent was communication failure. The seriousness of these failures is evident:
approximately 75 percent of these patients died.91
Relational coordination. The concept of relational coordination was developed and
validated in the commercial aviation business.92 When team members and team relationships are
well coordinated, there is frequent, timely, accurate communication, as well as problem-solving,
shared goals, shared knowledge, and mutual respect. The impact of team relationships on
outcomes for patients has been demonstrated in a number of studies.
The impact of relational coordination in health care was tested in a study of orthopedic
surgery patients undergoing total joint replacement at nine hospitals in three U.S. cities.93 Quality
of care, postoperative pain and functioning, and length of stay were the outcome measures for
this study. Patients evaluated the quality of care by completing a questionnaire that measured the
patients’ reported confidence and trust in their physicians, nurses, physical therapists, or case
managers; knowledge of the identity of the physician, nurse, physical therapist, or case manager
in charge of their care; belief that providers were aware of their medical history; belief that
providers were aware of their condition and needs; belief that their providers supplied consistent
information; belief that their providers worked well together; belief that they were treated with
respect and dignity; satisfaction with their overall care; and finally, intent to recommend the
hospital to others. Providers, including physicians, nurses, physical therapists, social workers,
and case managers, assessed four communication dimensions (frequent, timely, accurate, and
problem-solving communication) and relationship dimensions (shared goals, shared knowledge,
and mutual respect) between each respondent and each of the five core disciplines involved in
the care of joint replacement patients.
The study found that relational coordination varied significantly between the hospital sites.
Quality of care was significantly improved by relational coordination and each of its dimensions.
Postoperative pain was significantly reduced by relational coordination, whereas postoperative
functioning was significantly improved by several dimensions of relational coordination,
including the frequency of communication, the strength of shared goals, and the degree of mutual
respect among care providers. Length of stay was significantly shortened by relational
coordination and each of its dimensions.
Improving communication and teamwork. The Kaiser Permanente health care system has
adopted standardized tools and behaviors from commercial aviation and has demonstrated their
effectiveness in enhancing teamwork and reducing risk of patient harm.94 Crew resource
management training was provided to team members from a variety of clinical domains,
including the operating room, the intensive care unit, obstetrics and perinatal care, and a cardiac
treadmill unit. The teams each worked on a clinical project in which crew resource management
techniques could be applied to improve the quality and safety of patient care, supported with site
visits and educational sessions. The tools and behaviors to improve communication effectiveness
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
in this study were briefings using the SBAR (situation, background, assessment,
recommendation) format, appropriate assertion, clear language, situational awareness, and
debriefing. This work is explicated in the section on communication of this book.
Briefings. Brief, concise communication of critically important information transmitted in a
predictable format has been adopted in the perinatal unit by nurses, midwives, and physicians to
improve the team response to fetal distress. A common language is used to optimize problem
recognition. Simple and effective rules are activated when a problem is recognized: the
identifying person has 1 minute to look at it independently, 2 minutes to look at it with a
colleague, and by minute 3 should be physically correcting the problem.
Perioperative briefings by surgical teams have virtually eliminated wrong-site surgeries and
improved nursing turnover in the operating room by 16 percent. Employee satisfaction has risen;
perception of safety in the operating room is judged “outstanding”; and significant improvements
in teamwork, communication, responsibility for patient safety, and handling errors have been
measured.94
Appropriate assertion and critical language. Creating environments where people will
express their concerns and speak up is a key factor in safety. The hierarchy of caregivers in
hospitals and differences in communication styles between nurses, physicians, and others often
interfere with adequate communication. The common practice of indirect communication
between nurses and physicians is risky. In assertive communication there is a series of steps to
clearly communicate what is needed and reach a decision:
1. Get the person’s attention.
2. Express concern.
3. State the problem.
4. Propose action.
5. Reach a decision.
Nurses have license to say “I need you to come now and see this patient.” They need not
provide an objective argument to convince a physician to see a patient. It is acceptable for nurses
to say “Something is wrong, I’m not sure what it is, but I need you here now.” Recently,
emergency medical teams from Australia demonstrated that in-hospital cardiac arrests were
reduced 65 percent by early intervention.95 The number one criterion to call for help was a staff
member who “was worried” about a patient.
Sharing goals. Patients in the intensive care unit at Johns Hopkins University Medical
Center are cared for by intensivist-led teams, which include the intensive care unit attending
physician, critical care fellows, anesthesia and surgery residents, nurse practitioners, nurses,
respiratory therapists, and a pharmacist. During daily rounds, the intensive care unit team
develops a plan of care for the day, spending 20 to 25 minutes at each patient’s bedside. One
attending physician questioned that rounds failed to clarify explicit patient care goals, prompting
the team to measure their impact on team communication.96
When measured, less than 10 percent of residents and nurses understood the goals of care for
the day. To improve communication among providers, the team developed and implemented a
daily goals form, based on crew resource management principles, which outlines the tasks to be
completed, the plan of care, and the plan for communication with the patient and family
members. The following are discussed in rounds and noted:
1. What needs to be done for the patient to be discharged from the intensive care unit?
2. What is this patient’s greatest safety risk? How can we reduce that risk?
3. Pain and sedation management
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Pediatric Safety & Quality
4. Cardiac/volume status
5. Pulmonary/ventilator management
6. Mobilization
7. Infection, cultures, drug levels
8. GI/nutrition status
9. Medication changes (Can any be discontinued?)
10. Tests and procedures
11. Scheduled labs, morning labs, chest x-ray
12. Consultations
13. Communication with primary service
14. Family communication
15. Can lines/catheters/tubes be removed?
16. Is this patient receiving DVT/peptic ulcer disease prophylaxis?
The daily goals form is completed for each patient during rounds, signed by the fellow or
attending physician, and handed to each patient’s nurse. The goals are reviewed at least three
times each day by all providers, who initial the form to indicate their review. The form is
updated if the goals of care change.
To evaluate the impact of the daily goals form on patient outcomes, intensive care unit length
of stay was measured for 1 year following pilot testing, revision, and implementation. After
implementing the goals form, the percentage of residents and nurses who understood their
patient’s daily goals increased to more than 95 percent. Intensive care unit length of stay
decreased significantly from a mean of 2.2 days to 1.1 days. With a decrease in length of stay,
the intensive care unit was able to admit 670 additional patients in the study year. In addition, the
use of the goals form may have prevented complications such as CRBSI (by prompting removal
of central venous catheters when no longer needed for therapy) and ventilator-associated
pneumonia (by assuring head-of-bed elevation, peptic ulcer disease prophylaxis, and assuring
patients were assessed for readiness for extubation).
The team learned that using an interdisciplinary communication tool is more important than
the specific statements on the form. As its use has spread to other intensive care units in the
Johns Hopkins system and to other hospitals, the structure and content of the form have changed.
Other hospitals are invited to modify the form to meet their needs and are cautioned to expect
frequent revisions in the beginning.
Interdisciplinary collaboration. Nurse-physician relationships have been characterized
negatively for more than a century. The “doctor-nurse game,” first described in 1967, is a
stereotypical pattern of interaction in which nurses learn to show initiative and offer advice,
while appearing to passively defer to physicians’ authority.97 The game has been replayed and
revisited in the decades since, though a recent literature review suggests that this pattern of
interaction is decreasing in frequency in contemporary health care settings.98 The importance of
managing the doctor-nurse game is illustrated in an analysis of nurse-physician collaboration in
pain management practices and underscores the need to draw on nursing practice and knowledge
to effectively challenge issues of power and status.99
Patient outcomes are linked to healthy professional relationships. A descriptive study with
nurses at 14 hospitals that had achieved Magnet status (see section on the Magnet Recognition
Program below) suggests that collaborative relationships between nurses and physicians
contributes to lower mortality at magnet hospitals, compared with mortality at hospitals without
the designation.100 Nurses participating in the study described relationships with physicians along
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Pediatric Safety & Quality
Mechanical ventilation is often required when treating critically ill newborns, especially
those who are preterm. A systematic review of randomized controlled trials that compared the
impact of several body positions during mechanical ventilation of sick newborns was conducted
by the Cochrane Collaboration and reported in 2003.108 Ten trials involving 164 infants were
included in the review. The trials compared several positions: prone versus supine, prone versus
lateral right, lateral right versus supine, lateral left versus supine, lateral right versus lateral left,
and good lung dependent versus good lung uppermost. In all the trials, stable infants were
selected for the intervention.
Only the prone position was more efficacious than supine positioning. Placing infants prone
for short periods of time improved oxygenation. However, evidence that prone positioning
produces sustained improvements in oxygenation was not reported.
None of the trials reported complications of repositioning infants who were receiving
mechanical ventilation. However, accidents such as inadvertent extubation or umbilical catheter
dislodgement are easily imagined. Infants who require prolonged mechanical ventilation may be
at risk for the development of pressure ulcers if maintained in one position and would benefit
from repositioning.
The review suggests that large controlled clinical trials are needed to determine the various
benefits or problems from different positions. Studies that look at medium and long-term
outcomes—duration of mechanical ventilation, skin integrity, hospital length of stay, and
mortality—are necessary. In addition, reexamination of positioning interventions with infants
who are less stable may help to clarify whether there are subgroups of infants with different
disease severity who may benefit. Finally, questions about the effects of lateral positioning,
especially in infants with asymmetrical pulmonary pathology, still need answers.
Smoking Cessation
Smoking and other tobacco-product use by adolescents is a major public health problem
recognized by the World Health Organization (WHO). Data from 1999–2005 found that nearly
20 percent of adolescents report current tobacco use.109 Tobacco cessation programs must
address this significant public health problem. In addition, both adolescents and younger children
may be exposed to second-hand smoke. Nurses who care for pediatric patients have an
opportunity to address the health risks of smoking with both pediatric patients and their families.
The Joint Commission recommends that smoking cessation advice be given to pediatric patients
who are hospitalized with community-acquired pneumonia or asthma and their families. Indeed,
Turner-Henson and colleagues110 have urged nurses to consider assessment of smoking status as
part of taking vital signs for all pediatric admissions and in outpatient settings.
A recent meta-analysis of the effects of nursing-delivered smoking cessation interventions
with adults found nursing efforts to modestly increase the odds of quitting.111 There was
evidence that interventions were most effective for patients hospitalized with cardiovascular
disease, and interventions with nonhospitalized adults were also beneficial. Studies of smoking
cessation efforts with adolescents and during pregnancy were not included in the meta-analysis.
However, it is not unreasonable to generalize from the findings that smoking cessation
interventions with hospitalized patients were most effective. Patients in the hospital may be more
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
amenable to the intervention. Certainly, the opportunity to offer cessation advice and resources
to pediatric or family tobacco users should not be missed.
A study of adolescent smokers’ attitudes toward quitting and their beliefs about their parents’
opinion about smoking included more than 4,500 U.S. high school students who had smoked
within the previous 30 days.111 All adolescent smokers were asked, “Have you ever seriously
thought about quitting smoking?” Those who had seriously considered quitting were questioned
about past attempts and how recent their last attempt was. Those who had not seriously thought
about quitting were asked if they thought they would ever want to quit. Regardless of whether
their parents smoked, adolescents who placed value on their parents’ opinions were more likely
to think seriously about quitting and to have tried to quit in the past 6 months. Recalling a
parent’s expressed desire that their child not smoke was associated with significant increases in
the likelihood of seriously thinking about quitting, even among those adolescents whose parents
smoked. Agreeing with the statement, “When I’m older, my parents won’t mind that I smoke,”
was significantly associated with decreased odds of seriously thinking about quitting and
recently attempting to quit. This study demonstrates that parents, both those who smoke and
those who do not, may have a significant role in influencing young smokers’ desire to quit
smoking. Nurses need to exploit this information with families of adolescent patients.
A recent randomized clinical trial compared an Internet-based smoking cessation intervention
(Stomp Out Smokes—SOS) developed at the University of Wisconsin with brief individual
counseling sessions for adolescent smokers.113 The smoking abstinence rate for teens who
received individual counseling was twice that of those who accessed the Internet-based
intervention at 30 days, 24 weeks, and 36 weeks. In fact, the SOS intervention participants
accessed the site an average of only 7 days and 11 total logins. Likely, they did not have an
adequate “dose” of treatment. More structured, personal, and proactive patient education
delivered in person or by telephone or e-mail is recommended for intervention with adolescent
smokers.
This section has presented a sample of the evidence-based practices that have implications
for national safety and quality aims and the care of infants and children in hospitals. Nurses who
care for pediatric patients must be actively involved in the development, testing, implementation,
and evaluation of evidence-guided best practices.
Poverty and disparities in health care, two overarching issues for children in this country,
impact their care within the community and the inpatient setting. In most cases they are
inextricably intertwined. In 2003, an estimated 35.9 million Americans (12.9 percent) lived in
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poverty, 4.3 million newly poor since 2000. Approximately 733,000 American children lived in
poverty.114 This is a fluid statistic as third-party payers for children’s health care are often public
programs, which fill the gaps created by reductions in employer-based health plans. These State
and Federal programs are subject to review and reduction at any time, when other financial
issues or crises take priority.
Childhood Obesity
Childhood obesity is at epidemic proportions. One in every six children in the United States
is obese or overweight.115 Obesity is not only an adverse social stigma and a threat to quality of
life; significant health issues are associated with it. Obese individuals are at greater risk for
diabetes, cardiovascular diseases, and poor mental health than persons who are not obese.
Children are not an exception. These chronic conditions increase the cost of care over a lifetime
and can lead to serious disability.114
Poverty, disparities in health care, and childhood obesity present unique challenges for the
health care system at large. Long-range planning must address these issues and tangential issues
for our children to live healthy, productive lives.
Adolescents (children ages 13–20 years) have unique health care needs, distinct from those
of younger children and nonelderly adults. Their physiologic and social characteristics differ
from those of younger children and adults. Adolescents require reproductive health care; care for
sexually transmitted diseases; mental health care for depression, substance abuse, and other
disorders; trauma care; and care for chronic diseases—asthma being the most common.116
Recent data reveal unique patient safety problems when adolescents are hospitalized. The
incidence of adverse events in the Colorado and Utah Medical Practice Study found 2.74 percent
more adverse events among adolescents than younger children.117 In this study, more than three-
quarters of adverse events for hospitalized adolescents occurred with diagnostic, medication, and
pregnancy and delivery-related services.
There are racial disparities in the incidence of asthma, a leading cause of chronic illness in
children and adolescents. African Americans have a higher prevalence of asthma and are four
times more likely to be hospitalized and five times more likely to die of asthma than non-African
Americans.118, 119 Despite much attention on improving asthma care and asthma disparities, a
2003 IOM report still identified the quality of asthma treatment as one of 20 priority areas for
national action.120 Priorities in research to reduce asthma disparities were published by the
National Heart, Lung, and Blood Institute in 2002.121
Pediatric nurse scientists have actively engaged in scientific inquiry from the bench to the
bedside for many decades. There have been rich contributions associated with nurse-patient
interactions that focus on the patient in a holistic manner. Recommendations from Sue Thomas
Hegyvary, editor of the Journal for Nursing Scholarship, might frame the future of pediatric
nursing research. She proposed research that will
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
1. Attend to morbidity, mortality, and contributing factors at the micro and macro levels of
society.
2. Support programs of study that are longitudinal, sequential, and comparative and that
continue to examine phenomena from small to larger contexts.
3. Move from reviews of the literature, concept analyses, and proposals for investigation
toward new knowledge in the field.
4. Focus on the interventions and outcomes of a study, rather than debate superior or
inferior methodologies.
5. Synthesize the aforementioned recommendations to generate research beyond the
theoretical and small-scale application.
6. Draw evidence-based conclusions based on scientific findings. In other words, only
conclusions based on empirical findings should be promulgated as nursing science.122
Participation in national benchmarking and quality work can pose a significant expense for
involved institutions. It is difficult, therefore, for some organizations to participate in this
valuable work. Institutions should not face economic barriers to participation. Perhaps
organizations that demonstrate need could be federally funded to join these efforts.
Funding for scientific work in pediatrics must be increased. However, appropriation
discussions for Federal funding are highly competitive. Children are disadvantaged as they are
not voting members of society. Although there are strong advocates for funding children’s
research, their voices can be muted by other specialty groups with voting power. It is critical that
nurses, health care providers, and other pediatric stakeholders continue their efforts to speak for
children in the halls of Congress.
A well-funded national strategy for organizing, analyzing, and reporting patient safety and
quality data would accelerate progress in pediatric safety and quality improvement. The KID
HCUP, the Kids Inpatient Database developed as part of the Healthcare Cost and Utilization
Project, forms a sound basis for this work; however, not all States report these data, as
participation is voluntary. No mandate for participation appears likely. Currently, 36 States
report discharge data to AHRQ for inclusion in the KID HCUP database. Even when States do
report, missing data can be a significant problem. For instance, reporting race is still optional.
Lack of consistency in reporting makes it difficult to control for confounding variables when
analyzing the data to answer research questions.
Despite its imperfections, the KID HCUP database is a rich source for health services
researchers and practitioners to mine. It would be an even stronger tool if all States reported data
and if uniformity and consistency were assured.
National Institute of Nursing Research. The National Institute of Nursing Research
(www.ninr.nih.gov), established in 1993, began as the National Center for Nursing Research in
1985. It has been a leader in funding for nursing research in key areas (see Table 3). Part of the
National Institute of Nursing Research mission is to identify and fund research in areas of
science unique to nursing and vulnerable patients, including children. A full complement of
funding is available, from intramural awards that support onsite education and training to
develop young investigators, to extramural funding for investigator-initiated research and for
centers that conduct and disseminate research for special populations.
24
Pediatric Safety & Quality
Chronic illness & long-term care Health promotion & risk reduction in Cardiopulmonary health & critical care
adults
Neurofunction & sensory conditions Immune responses & oncology Reproductive health & child health promotion
End-of-life & environmental contexts
In the past decade, the Magnet Recognition Program, the seal of approval for professional
nursing practice environments, has gained considerable momentum across the country. One of
the hallmarks of this prestigious certification is that direct care nurses have clinical experts who
help create an environment of scientific inquiry. Practice based on evidence is critical to both a
culture that contributes to nursing satisfaction and to quality care for patients. Magnet
momentum (www.nursingworld.org/ancc/magnet) continues to grow each year and can only
advance the use of evidence-based nursing practices. Children and their families will reap the
benefits of professional nursing practice driven by science, not tradition—valuable and worthy
goals for us all.
Conclusions
Pediatric care is complex due to developmental and dependency issues associated with
children. How these factors impact the specific processes of care is an area of science in which
little is known. We are only beginning to understand the relationship between nurse staffing and
adverse events in hospitalized children; effects that may be compounded by inadequate numbers
of pediatric nurses. Throughout health care providing safe and high quality patient care continues
to provide significant challenges. Efforts to improve the safety and quality of care are resource
intensive and take continued commitment not only by those who deliver care, but by agencies
and foundations that fund this work. Advocates for children’s health care must be at the table
when key policy and regulatory issues are discussed. Only then will the voice of our most
vulnerable groups of health care consumers be heard.
25
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Author Affiliations
Susan R. Lacey, R.N., Ph.D., director, Nursing Workforce and Systems Analysis, Children’s
Mercy Hospitals and Clinics, Kansas City, Missouri; e-mail: [email protected].
Janis B. Smith, R.N., M.S.N., director, Clinical Informatics Transformation, Children’s
Mercy Hospitals and Clinics, Kansas City, Missouri; e-mail: [email protected].
Karen Cox, R.N., Ph.D., C.N.A.A., F.A.A.N., executive vice president and co-chief operating
officer, Children’s Mercy Hospitals and Clinics, Kansas City, Missouri; e-mail: [email protected].
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30
Chapter 16. Prevention—Safety and Quality
Carol Loveland-Cherry
Background
To date, the preponderance of research on patient safety and the transformation of the work
environment has focused on inpatient, acute care settings. Institute of Medicine (IOM) reports1, 2
clearly recommend that work be done on “studies and development of methods to better
describe, both qualitatively and quantitatively, the work nurses perform in different care
settings”2 (p. 325). Specifically, the recommendation is that research on patient safety needs to
be addressed across care settings. Preventive services, primary care, and ambulatory care settings
are areas in which there is a more limited body of work related to patient safety. Yet, these
nonacute care settings constitute growing loci of health care services. This chapter will review
the extant research on patient safety in preventive services, primary care, and ambulatory care
settings. Preventive services, broadly defined, include screening, counseling, and
chemoprophylaxis. This chapter will not focus on prevention of adverse events in ambulatory
care or inpatient settings.
The Surgeon General’s report3 and subsequent plans for ensuring the health of the nation4, 5
emphasize the role of prevention in addressing the leading causes of morbidity and mortality.
Clinicians play important roles in both primary and secondary prevention.6 Primary prevention is
directed at measures to avoid or prevent the onset of disease or adverse condition. Secondary
prevention focuses on the identification and treatment of asymptomatic individuals who have
identified risk factors to prevent the development of active disease and/or reduce morbidity and
mortality. Preventive services encompass health care provided in primary care settings, such as
office-based practices and clinics, and in community-based settings. Preventive services are less
regulated and controlled than health care services provided in institutions such as hospitals, long-
term care facilities, and nursing homes. Not only have preventive services increased and become
a central component of primary health care, these services also have become a focus of scrutiny
in terms of quality and safety6 (p. 13). Screening, counseling, preventive medications, skill
building, and behavioral change strategies comprise the major foci of preventive services.
Two national task forces have been charged with the evaluation of preventive services. The
Agency for Healthcare Research and Quality (AHRQ) convened the United States Preventive
Services Task Force (USPSTF), an independent body of experts, to evaluate and make
recommendations for clinical preventive services. The Centers for Disease Control and
Prevention (CDC) established the Community Task Force to evaluate public health prevention
programs.7 Both task forces focus on establishing the efficacy of prevention strategies and also
consider the relative harms and benefits of preventive services. The recommendations of these
two task forces are available in print and online (http://www.ahrq.gov/clinic/prevenix.htm;
http://www.thecommunityguide.org/) and will not be reviewed in this chapter.
Several IOM reports have emphasized the need to address not only the efficacy and
effectiveness of health care strategies, but also patient safety.8 The report To Err is Human:
Building a Safer Health System8 defines important terms. Safety is defined as “freedom from
accidental injury” (p. 4) and error as “failure of a planned action to be completed as intended or
the use of a wrong plan to achieve an aim” (p. 28). Error can occur in either the planning or
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
execution of health care services. In preventive services, the challenges are defining and tracking
safety issues or adverse events. Thus, identification of literature related to patient safety and
quality of care in preventive services is difficult. Further, with few exceptions, the studies are of
medical errors. The studies of medical errors and adverse events cover doctors and other primary
health care providers, such as nurse practitioners.
The research evidence for patient safety in preventive services falls into five distinct groups:
identification and classification of errors in primary care, harms of screening, harms of
information technology, errors arising from language in preventive services, and potential
interventions to prevent errors and adverse events. The evidence in each of the first four groups
will be summarized and assessed in this chapter; the potential interventions will be included
within each of the relevant categories.
Research Evidence
Errors in Preventive Services/Primary Care
In the United States, the literature on patient safety has focused primarily on the inpatient,
acute care setting. In contrast, a growing literature in the United Kingdom focuses on identifying,
tracking, and assessing errors in primary care. Seven manuscripts describe some aspect of errors
in preventive services, primary care, or ambulatory services. The first priority for promoting
patient safety in primary care was to identify the most common errors that occur in primary
care.9
Researchers have used several different methodologies to identify errors in primary care. The
approaches include observational prospective studies,10, 11 review of malpractice claims,12 reports
from physicians,13, 14 and interviews with adult patients.15 One systematic review has
summarized literature in this area published between 1965 and 2001.16 The different
methodologies, including study length and modes of data collection, make it difficult to compare
rates of errors or adverse events. The number of events reported were
• 117 errors for 15 physicians in 83 visits across 7 offices over 3 half-day sessions11
• 221 incidents from interviews with 38 patients asking them to recall events that occurred
at any time in the past15
• 344 incidents from 42 physicians over 20 weeks13
• 940 incidents over 2 weeks across 10 practices14
• 805 incidents occurring between October 1993 and June 1995 from 324 physicians10
• 5,921 incidents from claims data for over a 15-year period12
• 1,223 incidents from 4 articles published 1995-200216
Regardless of the methodology, similar categories of errors and events were identified and
patterns emerged that provided the basis for development of classification systems. Dovey and
colleagues13 developed a taxonomy based on the identified types of errors and sources of errors.
The most general groupings of errors resulted in two major categories: process errors, and
knowledge and skills errors. Each of the two categories had three additional levels of specificity.
For example, a process error in investigating a patient’s condition, specifically in the process of
laboratory investigations, might involve a wrong test being ordered or a test not ordered when
appropriate. Bhasale and colleagues10 classified incidents as pharmacological (e.g., inappropriate
drug), nonpharmacological (e.g., treatment omitted/delayed), diagnostic (e.g., missed), or
equipment (e.g., malfunction/ineffective). Preventable harms identified by patients were
2
Prevention—Safety & Quality
classified as psychological (e.g., personal worth), physical (e.g., pain) or economic/other (e.g.,
avoidable personal medical expense).15 Elder and colleagues11 described office administration
errors (i.e., charting, general office administration), physician-related errors, patient
communication errors, and preventable adverse events. Rubin and colleagues14 noted six
categories of errors: prescriptions, communication, equipment, appointments, clinical, and
others. Elder and Dovey16 identified three categories: diagnosis—related to symptoms or
prevention with either missed or delayed diagnosis; treatment—either drug or nondrug as
incorrect/inappropriate, delayed or omitted; and preventive services—inappropriate, delayed,
omitted, or procedural complication. In addition to classifying types of errors, Elder and Dovey
identified related factors, such as clinician factors (clinical judgment and procedural skills error),
communication factors (clinician–patient, clinician–clinician/health care system personnel),
administration factors (clinician, pharmacy, ancillary providers, office setting), and blunt-end
factors (personal and family issues of clinicians and staff, insurance company regulations,
government regulations, funding and employers, physical size and location of practice, general
health care system).16 Kuzel and colleagues15 offered a similar list of access breakdown,
communication breakdown, relationship breakdown, technical error, and inefficiency of care.
Bhasale and colleagues10 also identified differences in individuals involved in preventable
incidents. The incidents involved slightly more females (58 percent) than males and more older
individuals 25 years and older (around 85 percent) than younger ones. Overall, infants and
females older than 75 years were overrepresented in the incidents. The same study described
factors that mitigated the outcomes of adverse events: early intervention by reporting physician,
patients, patient’s relative, another provider; plain good fortune; patient’s good physical or
psychological condition; prior experience or training; reliability of professional backup; skilled
assistant; high awareness via quality assurance activities; and reliability of equipment.
The data from this group of studies, regardless of the methodology, provide both
identification of errors or adverse events in preventive services or primary or ambulatory care
and direction for interventions. Dovey and colleagues’13 major classifications of process and
knowledge and skills errors provide major conceptual groupings within which to examine the
specific error identified in the schema. Combined with Bhasale and colleagues’10 identification
of mitigating factors, this group of studies provides direction for both identifying errors and
adverse events and for proposing interventions to address them. The findings specific to
preventive services imply that errors or adverse events result from screening, counseling, or
chemoprophylaxis being inappropriate, delayed, or omitted, or involve procedural complications.
These errors or adverse events may arise from either process errors or knowledge and skill
errors. Process errors are defined as resulting from some aspect of care delivery systems.111333
Examples of process errors include care that was provided but not documented in the patient’s
chart (e.g., a mammogram performed but not recorded) or a medication not being dispensed as
ordered. Knowledge and skill errors are related to providers’ clinical skills and knowledge (e.g.,
a wrong or missed diagnosis or a wrong treatment based on lack of clinician knowledge).
The next section examines two groups of studies that represent specific instances of areas
with potential harms: medication errors and screening activities.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
4
Prevention—Safety & Quality
colon cancer, and cervical cancer in elderly individuals. Volk and colleagues39 evaluated a
patient-educational approach to shared decisionmaking for prostate cancer screening that
included both potential benefits and harms of screening. The results of the randomized clinical
trial indicated positive outcomes in terms of increased knowledge and more informed decisions
regarding prostate cancer screening. Walter and Covinsky40 advocated including potential harms
in their framework for individual decisionmaking in cancer screening in elderly individuals.
In summary, harms of various cancer screening procedures have been identified. However, it
is important to evaluate the potential harms for each procedure relative to the benefits for
specific age groups and other individual considerations. Thus, the USPSTF recommends routine
screening mammography for women ages 40 years and older; routine screening for cervical
cancer in women who have been sexually active and have a cervix, but against routine screening
for women older than 65; and routine colorectal cancer screening for men and women 50 years
and older. However, the USPSTF is currently updating recommendations for screening for
colorectal, cervical, and breast cancer. The USPSTF currently recommends against routine
screening for pancreatic cancer or ovarian cancer. The task force concluded that there was
insufficient evidence to recommend for or against routine screening for prostate cancer, skin
cancer, oral cancer, or lung cancer.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
[American Academy of Pediatrics]”41 (p. 257). Further, infants whose parents reported that
English was not their primary language were half as likely to receive recommended preventive
care. When confounding factors were considered, results indicated that Asian-American infants
were less likely to experience disparities in preventive care associated with primary language
than White, Hispanic, and African-American infants.
While the evidence is limited, the results of these two studies support the potential for
adverse events resulting from language barriers. An obvious strategy would be to reduce the
language barriers. A systematic review of the impact of medical interpreter services on the
quality of health care43 indicated that health care was compromised for patients not proficient in
English; they were less likely to receive preventive screening, more likely to have a greater
number of tests done at higher costs; and were less satisfied with care. Additionally, the quality
of care is further compromised when untrained or ad hoc interpreters, especially children, are
used. However, availability of trained interpreters was positively associated with obtaining
preventive screening, such as mammograms. In light of the changing demographics and diversity
of the U.S. population, this small but growing body of literature on language as a barrier or factor
in adverse events in preventive services provides another challenge for the health care systems.
6
Prevention—Safety & Quality
Based on results from separate qualitative studies, Ash, Berg, and Coiera47 presented
evidence that implementation of electronic patient care information systems (PCISs) in many
instances appears to promote rather than limit errors. They argued that factors, including the
complexity of PCISs and the physical space and other system characteristics, contributed to the
occurrence of “unintended consequences”47 (p. 104). The authors identified errors in two general
areas: process of entering and retrieving information, and communication and coordination
processes. They attributed errors in entry and retrieval of information to the high level of
interruption and “cognitive overload” related to practice environments. Further, the authors
proposed that errors in communication and coordination were related to the assumptions of a
linear workflow and communication as information transfer. They advocated for educating
health care providers to have a critical approach to PCISs, that developers and vendors of PCISs
be clearer about the limitations of the systems, and that clinicians be supported in continuing
interactions that are part of monitoring the safety of clinical systems.
Research that evaluates the ability of IT systems to promote patient safety and reduce errors
is limited but growing,45 especially in preventive services. Five studies48–52 examined the use of
an electronic health record system to generate physician, telephone, and letter reminders for
patients to obtain preventive services. Results indicated that all three types of reminders were
effective. There is evidence supporting the reduction of medication errors and adverse events
through the use of computerized physician order entry and online decision support.53 Bakken and
colleagues54 advocated the use of informatics to address errors associated with impaired access
to information through the use of personal digital assistants, to address communication failures
associated with adverse events, to promote the use of standardized practice patterns, and to
provide automated surveillance to detect and prevent real-time errors. The proposed approaches
have direct application in preventive care settings.
Research Implications
The greatest challenge in patient safety and quality in preventive care is the lack of a strong
body of evidence on which to base our understanding of errors and adverse events in prevention
and, more broadly, in ambulatory and primary care settings. Research in preventive care is
limited relative to that in acute care, inpatient settings, and home care. The focus has been on
research evaluating the efficacy of preventive services, which includes an evaluation of the
potential and actual harms of the services in order to determine the net benefit. While there is a
growing body of evidence for safety and quality in health care in primary and ambulatory
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
settings, there is very limited literature on harms or adverse events in preventive care and how to
avoid them. Additionally, much of the research is observational and descriptive, with few
interventions being tested. The research on identifying and describing errors in primary and
ambulatory care has relevance for preventive care. However, there is a need for research directed
at explicating errors and adverse events in preventive care.
Once the types of errors and adverse events have been identified and described, then research
describing the factors associated with these events is needed. Further, there is limited evidence
on basic questions, such as when to begin or discontinue screening, chemoprophylaxis, or
counseling and implications for adverse events or potential harms. Only then can nurses and
other health care professionals develop and test strategies to reduce risk related to preventive
services. For example, the evaluation of the use of IT to decrease risks and adverse events is a
major focus in acute care, ambulatory care, and primary care settings. Would the use of IT
approaches be appropriate in preventive services? How can the human factor principles of
standardization, simplification, and use of protocols and checklists55 be facilitated by the use of
IT in prevention? Finally, the difficulties inherent in research on preventive services present
significant challenges, including timing of services and consideration of contextual factors (age,
culture, race/ethnicity, gender, setting, etc.).
Thus far, the evidence presented attempts to answer the following: (1) How do errors and
adverse events in prevention differ from those for other types of health care services? (2) How do
contextual factors contribute to potential errors and adverse events in prevention? and (3) What
are potential areas of research for nursing that would contribute to addressing patient safety in
prevention? The following areas are the critical research gaps:
• Descriptive data on errors and adverse events in preventive services
• Data on factors related to errors and adverse events in preventive services
• Evaluation of interventions to reduce errors and adverse events in preventive services.
Conclusion
The limited body of evidence on errors and adverse events in preventive services, especially
from a nursing perspective, supports the need for additional research to move ahead in the area
of patient safety. It is likely that some of the evidence from studies in ambulatory and primary
care will provide direction for research and subsequent evidence-based practice in preventive
care. However, there may be unique errors and adverse events associated with preventive
services. It is clear that there is potential for errors and adverse events in preventive services, but
additional evidence is needed to explicate what they are. The evidence that is available is largely
from either descriptive studies or from randomized controlled trials (RCTs) examining the
efficacy of preventive services, specifically in cancer screening. There is less systematic
evaluation of counseling interventions for prevention. The nature of preventive services and their
outcomes and where they are delivered increase the complexity of both establishing an evidence
base and implications for practice. The continued evaluation of using information technology to
address risks and adverse events is a promising area for study and practice.
The focus in safety and quality research in health care has been on preventable events rather
than on preventive services. Screening, counseling, and chemoprophylaxis are the key elements
of preventive services. The evidence base on errors and adverse events in preventive services is
limited and needs to be developed to provide direction for practice.
8
Prevention—Safety & Quality
Search Strategy
A search of the CINAHL®, Ovid MEDLINE®, Cochrane Database of Systematic Reviews
electronic databases, and the AHRQ Web site from 1990 to 2006 was conducted using the
following search terms: patient safety, safety, quality, preventive services. The search was
further limited to research studies and reviews. A total of 115 references were identified and the
abstracts reviewed. The criteria for inclusion in the review for this chapter were (1) systematic
review of published research; (2) nonsystematic review of published research; and (3) published
research that used randomized control, comparison, and pretest–post-test no control designs.
Based on the review of the abstracts using these criteria, 6 reviews, 10 commentary or
background articles, and 32 studies were selected for inclusion in the review.
Author Affiliation
Carol J. Loveland-Cherry, Ph.D., R.N., F.A.A.N., professor and executive associate dean,
University of Michigan School of Nursing. E-mail: [email protected].
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25. Hicks RW, Becker SC, Cousins DD. Harmful
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from the USP’s MEDMARX® program. J Ped Nurs, controlled trial of shared decision making for prostate
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42. Woloshin S, Schwartz L, Katz SJ, et al. Is language a 50. Rosser WW, Hutchinson BG, McDowell I, et al. Use
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11
Evidence Table. Prevention—safety and quality
happened, that
was not
anticipated, and
that makes you
say ‘that should
not happen in my
practice and I
don’t want it to
happen again’”
(1).
Source Safety Issue Design Type Study Design, Study Setting and Study Key Finding(s)
Related to Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Elder Errors and Systematic literature Systematic Seven studies from Classification of Limited number of small studies;
16
2002 preventable review review of original family practice, preventable classification of three main
adverse event research (7 ambulatory care, adverse events categories of PAEs – diagnosis
from medical studies); process primary health care (PAE) and (misdiagnosis related to symptoms
care in outpatient errors and process errors in or prevention) treatment (drug or
primary care preventable primary care nondrug), and preventive services
settings adverse events (inappropriate, delayed, omitted,
(1). procedural complications);
attributable to four groups of process
errors: clinician factors (clinical
judgment, procedural skills error),
communication factors (clinician-
patient, clinician-clinician, or health
care system personnel),
administration factors (clinician,
pharmacy, ancillary providers, office
setting), blunt-end factors (personal
and family issues of clinicians and
17
events/1,000person-years. Errors
occurred most often at stages of
prescribing (58.4 percent) and
monitoring (60.8 percent); 21.1
percent of errors involved patient
adherence. Most common
medication categories were
cardiovascular (24.5 percent),
diuretics (22.1 percent), nonopioid
analgesics (15.4 percent),
hypoglycemics (10.9 percent),
consumers to
engage in
actions.
Hicks Medication errors Retrospective cohort Observational Data from voluntary None 816 harmful outcomes involving 242
25
2006 in children study study without medication error medications; 11 medications
controls (5). reporting system accounted for 34.5 percent of errors;
Harmful (MEDMARX®) over 5 wrong dosing and omission errors
medication errors years for individuals common; associated with opioid
in children (1). <17 years old analgesics (11 percent),
antimicrobials (7.5 percent),
antidiabetic agents (4.5 percent),
fluids and electrolytes (4.4 percent).
Source Safety Issue Design Type Study Design, Study Setting and Study Key Finding(s)
Related to Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Kerlikowske Cost Noncomparative Decision analysis General population of Outcomes of Continuing screening to age 79 with
35
1999 effectiveness and study and cost- women 65 and older screening bone mineral density in top 3
impact on life effectiveness mammography quartiles prevent 9.4 deaths and add
expectancy of analysis using a based on three ~2.1 days to life expectancy with
mammography Markov model screening incremental cost of $66,773 /year of
screening in (4). strategies life saved; continuing screening in all
women 70–79 Deaths due to women to age 79 prevents 1.4
years breast cancer additional breast cancer deaths and
averted, life adds 7.2 hours to life expectancy
expectancy, cost with incremental cost of
effectiveness (2). $117,689/year of life saved. Goal is
to prevent deaths from breast cancer
at reasonable cost and minimize
harms of screening healthy women.
Incidence of DCIS increases with
age with 25 percent of cancer being
DCIS in elderly women; increases
rate of surgical treatment of
23
obtain national
estimates (5),
adoption of HIT in
two markets:
Boston and
Denver (4).
Quaid Psychological Literature review, Nonsystematic Nonsystematic None Risks include misunderstanding of
199329 and ethical nonsystematic review (6). literature review of test results, misdiagnosis, labeling,
considerations in Potential harms potential risks of stigmatization, and decreased
screening for of screening (2). screening for disease psychological well-being; results
disease may be misused by industry or
insurance companies; screening
should not be implemented until
certain safeguards in place;
clinicians and public should be
educated about potential risks and
benefits; use accurate, reliable,
valid, and sensitive screening tests;
obtain informed consent; followup
surveillance; procedures to protect
right to privacy should be
implemented.
Source Safety Issue Design Type Study Design, Study Setting and Study Key Finding(s)
Related to Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Rich 200038 Screening for Cross-sectional study Model days of life Randomized trial Stopping Start age of 50 years, maximum
breast, cervical, lost by stopping data, model using life screening at potential life expectancy benefit of
and colon cancer screening at tables to calculate life various ages 43 days for breast cancer, 28 days
various ages expectancy at various for colon cancer. Start at age 20,
using SEER data ages for stopping maximum potential benefit of 47
(5). screen and for days; 80 percent of benefit is
Days of life lost continuing until death achieved before age 75 for breast
by stopping for breast, cervical, cancer, 80 years for colon cancer,
screening at and colon cancer and 65 years for cervical cancer.
various ages (1). Small benefit may be outweighed by
harms of anxiety, additional testing,
and unnecessary treatment.
Rosser Reminders for Prospective Prospective 8,502 patients 15 During 1 year All three reminder systems improved
199152 preventive randomized randomized years or older not in a patients in active delivery of preventive services
procedures controlled study controlled study hospital or institution; reminder groups completion rates – 42 percent for
(2). 5,883 randomly received a letter reminder, 33.7 percent for
Completion of assigned by family to telephone or physician reminder, 14.1 percent in
preventive a control, physician letter reminder of control group; reminders were
29
2004 cancer screening controlled trial breast cancer women ages 40–74 screening associated with screening in women
by age screening (2). with 13-year followup 40–74 after 13 years, 34 percent in
Mortality (1). of 2,467 cancers women 50–74, and 13 percent for
women 40–49; reduced effect on
mortality in women 40–49 due to
prognostic factors of tumor size,
lymph node status, and histologic
type.
Triller Prevalence of Retrospective cohort Observational Data on 10 risk None Data on 4,250 discharges; risk
21
2005 risk factors for study study without characteristics of characteristics varied across three
sample of households
Background
At some point in life, virtually everyone experiences some type of pain. Pain is often
classified as acute or chronic. Acute pain, such as postoperative pain, subsides as healing takes
place. Chronic pain is persistent and is subdivided into cancer-related pain and nonmalignant
pain, such as arthritis, low-back pain, and peripheral neuropathy. These authors will draw from
the body of knowledge related to chronic pain; however, this chapter will focus on the evidence
supporting management of acute pain experienced by hospitalized adults.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Poorly managing pain may put clinicians at risk for legal action. Current standards for pain
management, such as the national standards outlined by the Joint Commission (formerly known
as the Joint Commission on Accreditation of Healthcare Organizations, JCAHO),5 require that
pain is promptly addressed and managed. Having standards of care in place increases the risk of
legal action against clinicians and institutions for poor pain management,6 and there are instances
of law suits filed for poor pain management by physicians.7 Nurses, as part of the collaborative
team responsible for managing pain during hospitalization, also may be liable for legal action.
Hospitals stand to lose reputation as well as profit if pain is poorly managed. Patient
satisfaction with care is strongly tied to their experiences with pain during hospitalization.
Evidence indicates that higher levels of pain and depression are linked to poor satisfaction with
care in ambulatory settings.8 With the advent of transparent health care, report cards for hospitals
are becoming more prevalent, and performance on pain management is likely to be one of the
indicators reported.
Undertreatment of Pain
The undertreatment of pain was first documented in a landmark study by Marks and Sachar
in 1973.9 These researchers found that 73 percent of hospitalized medical patients had moderate
to severe pain. The undertreatment of pain continues. Thirty years later in 2003, Apfelbaum and
others2 found that 80 percent of surgical patients experienced acute pain after surgery, and 86
percent of those had moderate to extreme pain. Of 1,308 outpatients with metastatic cancer from
54 cancer treatment centers, 67 percent reported pain.10 Of those who had pain, 62 percent had
pain severe enough to impair their ability to function, and 42 percent were not given adequate
analgesic therapy. It is estimated that 45 percent to 80 percent of elderly patients in nursing
homes have substantial pain that is undertreated.11 These studies and others suggested that when
patients had moderate to severe pain, they had only about a 50 percent chance of obtaining
adequate pain relief.12
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Symptom Management—Pain
demand. Aggressive pain control is required to reduce these effects and prevent thromboembolic
complications. Cardiac morbidity is the primary cause of death after anesthesia and surgery.13, 15
Since the stress response causes an increase in sympathetic nervous system activity, intestinal
secretions and smooth muscle sphincter tone increase, and gastric emptying and intestinal
motility decrease. This response can cause temporary impairment of gastrointestinal function and
increase the risk of ileus.13, 15
Unrelieved pain may be especially harmful for patients with metastatic cancers. Stress and
pain can suppress immune functions, including the natural killer (NK) cells that play a role in
preventing tumor growth and controlling metastasis.13, 16 Further, management of perioperative
pain is probably a critical factor in preventing surgery-induced decrease in resistance against
metastasis.17
Unrelieved acute pain can result in chronic pain at a later date. Thus, pain now can cause
pain later. If acute shingles pain is not treated aggressively, it is believed to increase the risk of
postherpetic neuralgia.18, 19 A survey of patients having undergone surgery found a high
prevalence of chronic postsurgical pain in patients whose acute postsurgical pain was
inadequately managed.20
Assessment of Pain
Assessment of pain is a critical step to providing good pain management. In a sample of
physicians and nurses, Anderson and colleagues21 found lack of pain assessment was one of the
most problematic barriers to achieving good pain control. There are many recommendations and
guidelines for what constitutes an adequate pain assessment; however, many recommendations
seem impractical in acute care practice. Nurses working with hospitalized patients with acute
pain must select the appropriate elements of assessment for the current clinical situation. The
most critical aspect of pain assessment is that it is done on a regular basis (e.g., once a shift,
every 2 hours) using a standard format.5 The assessment parameters should be explicitly directed
by hospital or unit policies and procedures.5, 22, 23 To meet the patients’ needs, pain should be
reassessed after each intervention to evaluate the effect and determine whether modification is
needed. The time frame for reassessment also should be directed by hospital or unit policies and
procedures.5
An early Clinical Practice Guideline on Acute Pain Management released by the Agency for
Health Care Policy and Research addressed assessment and management of acute pain.22 This
guideline outlines a comprehensive pain evaluation that would be most useful when obtained
prior to the surgical procedure. In the pain history, the nurse identifies the patient’s attitudes,
beliefs, level of knowledge, and previous experiences with pain. Expectations of patient and
family members for pain control postsurgically will uncover unrealistic expectations that can be
addressed before surgery. This comprehensive pain history lays the foundation for the plan for
pain management following surgery, which is completed collaboratively by the clinicians
(physician and nurse), the patient, and his or her family.
Pain History
The pain history should include the following:
• Significant previous and/or ongoing instances of pain and its effect on the patient
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• Previously used methods for pain control that the patient has found either helpful or
unhelpful
• The patient's attitude toward and use of opioids, anxiolytics, or other medications,
including any history of substance abuse
• The patient's typical coping response for stress or pain, including the presence or absence
of psychiatric disorders such as depression, anxiety, or psychosis
• Family expectations and beliefs concerning pain, stress, and postoperative course
• Ways the patient describes or shows pain
• The patient's knowledge of, expectations about, and preferences for pain management
methods and for receiving information about pain management22 (p. 7–8)
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Symptom Management—Pain
Pain interferes with many daily activities, and one of the goals of acute pain management is
to reduce the affect of pain on patient function and quality of life.24 The ability to resume
activity, maintain a positive affect or mood, and sleep are relevant functions for patients
following surgery. The Brief Pain Inventory10, 29 includes four items that may be useful in
assessing this aspect of the pain experience. Using an NRS format, assessment of interference
with ability to walk, general activity, mood, and sleep during the recovery period will assist in
selecting interventions to enhance function and quality of life.
The final elements of pain perceptions involve determining current aggravating and
alleviating factors.22, 24 Aggravating factors may be as simple as patient position, a full bladder,
or temperature of the room. Alleviating factors include the interventions used (e.g., analgesics)
and cognitive strategies used to control pain. Examples of such strategies are distraction, positive
self-talk, and pleasant imagery. The pain history will provide insight into the coping strategies
previously used by the patient and their effectiveness with previous painful episodes.
In addition to self-reported pain perceptions, a comprehensive assessment of pain following
surgery includes both physiological responses and behavioral responses to pain22 (p. 11).
Physiological responses of sympathetic activation (tachycardia, increased respiratory rate, and
hypertension) may indicate pain is present. Behaviors that may indicate pain include splinting,
grimacing, moaning or grunting, distorted posture, and reluctance to move. While these
nonverbal methods of assessment provide useful information, self-report of pain is the most
accurate. A lack of physiological responses or an absence of behaviors indicating pain may not
mean the patient is not experiencing pain. (Go to section “Tools to Assess Pain Intensity in the
Cognitively Impaired,” below, for more detail.)
Adequate pain management requires an interdisciplinary approach.22, 24 Documentation of
pain assessment and the effect of interventions are essential to allow communication among
clinicians about the current status of the patient’s pain and responses to the plan of care. The
Joint Commission requires documentation of pain to facilitate reassessment and followup. The
American Pain Society suggests that pain be the fifth vital sign as a means of prompting nurses
to reassess and document pain whenever vital signs are obtained.30 Documentation also is
important as a means of monitoring the quality of pain management within the institution.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Patient Satisfaction
Although satisfaction with pain management currently is used as a measure of institutional
quality, satisfaction with pain management is no longer recommended as a quality indicator for
pain control.24, 32 This is because patient satisfaction findings are difficult to interpret. In their
review of 20 quality improvement studies conducted between 1992 and 2001, Gordon and
colleagues32 noted 15 studies reported high satisfaction with pain management despite many
6
Symptom Management—Pain
patients experiencing moderate to severe pain during hospitalization. Thus, patient satisfaction
data should be cautiously interpreted and, if used, used in conjunction with other quality
indicators. Because of the current focus on report cards for health care organizations, patient
satisfaction data are routinely collected and easily obtained for review.
Many institutions use commercial patient satisfaction surveys to monitor satisfaction with
care. Most of these surveys have at least one item on satisfaction with pain management.
Institutions also may use generic health status or quality of life surveys, such as the Medical
Outcomes Study Short From-36, to monitor patient outcomes; most of these surveys include one
or more questions on pain experienced. Regular review of these patient satisfaction data can be
used as a quick measure of quality of pain care. If satisfaction scores on pain management dip, a
more thorough investigation of pain management processes is warranted.
Use of an interdisciplinary team to monitor current pain practice, identify areas for
improvement, and oversee quality improvement plans is consistently recommended in the
guidelines.5, 22, 24 To effectively monitor pain practice within a hospital, electronic systems are
needed to capture and collate data on the indicators in a readily available form. One method of
changing clinician behavior is through the use of feedback on performance; thus the reports
generated for interdisciplinary committee review also may be used to assist clinicians to review
and adjust their performance.
Current Guidelines
Many State and professional organizations have developed clinical practice guidelines to
direct health care providers in adequate management of acute pain. The 1992 Acute Pain Clinical
Practice Guideline22 lays the foundation for the more current guidelines. Listed below is a
sample of current guidelines available from the National Guideline Clearing House.
• Pain management guideline; developed by the Health Care Association of New Jersey;
released July 2006. This guideline includes definitions of pain (acute and chronic); clear
direction for assessment and treatment with pharmacological and nonpharmacological
interventions (including physical and occupational therapy); policies for pain education
for staff, patients, and families; and direction for quality monitoring. The guideline is
applicable to pain management in acute care and long-term care nursing facilities. Web
site: http://www.guidelines.gov/summary/summary.aspx?doc_id=5526&nbr=003757&
string=pain+and+assessment+and+nursing
• “Pain Management”; written for the 2nd edition of Geriatric Nursing Protocols for Best
Practice; published in 2003. This guideline addresses pain in the elderly, assessment
strategies, and nursing interventions to control pain. Pharmacological and
nonpharmacological interventions are included in the guideline. Web site:
http://www.guidelines.gov/summary/summary.aspx?doc_id=3514&nbr=002740&string=
pain+and+assessment+and+nursing
• ASPAN Pain and Comfort Clinical Guideline; developed by American Society of
Perianesthesia Nurses; released August 2003. This guideline provides direction for
assessment, interventions, and expected outcomes for the preoperative and postoperative
phases of treatment. Use of pharmacological and nonpharmacological interventions is
endorsed. Web site: http://www.guidelines.gov/summary/summary.aspx?doc_id=5526&
nbr=003757&string=pain+and+assessment+and+nursing
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• Clinical Practice Guideline for the Management of Postoperative Pain; developed by the
Veterans Health Administration; released May 2002. This guideline is organized into two
main algorithms, one for the preoperative phase and the other for the postoperative phase.
The pain management plan is set within the context of comprehensive pre- and
postsurgical care and includes discharge planning. A patient-focused objective is
provided for each step of the pain management plan. Emphasis is placed upon
reassessment and modification of the treatment plan. Clear descriptions of common
opioid side effects and interventions to reduce them are included in the guideline. Web
site: http://www.guidelines.gov/summary/summary.aspx?doc_id=3284&nbr=002510&
string=pain+and+assessment+and+nursing
• The American Society of Pain Management Nursing has published two position
statements on pain management issues that pose difficulty ethically and in practice.
Practice recommendations based upon research and clinical expertise are included in both
position statements.
Herr et al. Pain assessment in the nonverbal patient: Position statement with clinical
practice recommendations. Pain Management Nursing 2006;7(2):44-52.
American Society for Pain Management Nursing. ASPMN position statement: pain
management in patients with addictive disease. Journal of Vascular Nursing
2004;17(3):99-101.
• With the implementation of the Joint Commission standards for pain management, the
requirements for “as needed” (PRN) orders were altered. The American Society of Pain
Management Nursing and the American Pain Society developed a consensus statement
on the use of PRN range orders to guide nursing practice.
Gordon et al. Use of “as needed” range orders for opioid analgesics in the
management of acute pain. Home Healthcare Nurse, 2005;23(6):388-96.
Research Evidence
Analgesics, particularly opioids, are the primary treatment for acute pain. It is estimated that
up to 90 percent of cancer pain can be adequately managed with analgesics using the World
Health Organization (WHO) analgesic ladder.33, 34 Although no evidence exists to estimate the
likelihood of adequately managing acute pain, it is reasonable to infer that the vast majority of
postsurgical pain can be well managed with the appropriate use of analgesics. While there are
many factors that contribute to poor pain management—lack of assessment and inadequate or
inapposite use of analgesics are primary, and modifiable, factors.35 Thus, it is the responsibility
of clinicians to be knowledgeable about the analgesics used to treat pain, including onset, peak
action, and duration of the drug(s) administered; common side effects, and methods of managing
those side effects.36 Easy access to an equianalgesic table assists in providing good pain control
when switching from one opioid to another and from one route to another. This approach is
particularly important when preparing the postsurgical patient for discharge with an oral
analgesic.
The objective for postsurgical and procedural pain is to prevent and control pain.22, 24 This
does not mean that patients will be pain free, a misconception that some patients and families
have when entering the hospital. This misconception is best addressed during the preoperative
pain assessment by collaboratively setting goals for pain control and function. A multimodal
approach (balanced analgesia), which includes opioids, nonopioids such as nonsteroidal anti-
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Symptom Management—Pain
Opioid Analgesics
A series of three systematic reviews have been published in the past 5 years examining the
efficacy, safety, and side effect profile of opioids used to manage postsurgical pain.2, 37, 38 The
first review3 concluded that patient-controlled analgesia (PCA) and epidural routes of
administration were superior to intramuscular (IM) injections when pain intensity and relief were
considered. The safety of opioids used to control postsurgical pain was examined for
hypotension and respiratory depression; observed rates were less than 5 percent for hypotension
and less than 1 percent for respiratory depression.37 The most common opioid side effects
included 25 percent nausea, 20 percent vomiting, 23.9 percent mild sedation, 2.6 percent
excessive sedation, 14.7 percent pruritis, and 23 percent urinary retention. The use of intravenous
PCA was associated with the highest levels of nausea and sedation, whereas epidural analgesia
was associated with the highest rate of urinary retention.38 This series of systematic reviews
suggests the IM route of administration produces the poorest outcomes. Approximately one in
every four patients will experience common opioid side effects; however, the rate of excessive
sedation, respiratory depression, and hypotension related to opioids are low in the postsurgical
population.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
implemented during the presurgical clinic visit or during admission pain assessment. The
essential elements of pain education include telling the patient the following:
• Preventing and controlling pain is important to your care.
• There are many interventions available to manage pain; analgesics (opioid and
nonopioid) are the most effective in managing acute pain.
• Some people are afraid of using opioids because of the side effects and risk of addiction.
Side effects can be managed effectively with medication. The risk of addiction when
using opioids to control acute pain is extremely low.
• Your responsibility in achieving good pain control is to tell us when you are experiencing
pain or when the nature or level of pain changes.
• Complete pain relief usually is not achievable; however, we will work with you to keep
pain at a level that allows you to engage in activities necessary to recover and return
home.
This last comment flows directly into a discussion about goals for pain management during
the hospitalization. This goal is set in light of the functional requirements (e.g., when ambulation
will begin, need for deep breathing) to promote recovery. Thus, the patient, family member(s),
and nurse collaboratively set a tolerable or satisfactory level of pain and function during the
hospitalization, which is documented either in the patient’s room or record so that all clinicians
are working toward the same goals for pain control. Shared goal setting is one dimension of
relational coordination associated with adequate postsurgical pain management.39 Information
obtained from the pain history (e.g., previous experience with pain and what helped or did not
help, typical coping strategies used) will assist in developing a plan of care that incorporates the
patient’s preferences into the plan.
Patient-Nurse Interactions
One of the earliest evidence-based protocols was developed as part of the Conduct and
Utilization of Research in Nursing (CURN) project. Pain: Deliberative Nursing Interventions40
describes an approach to a patient’s complaint of pain that includes skilled communication to
determine the patient’s needs. While administering analgesics may be the most appropriate way
to meet the patient’s needs, the nurse may uncover other factors contributing to discomfort, such
as uncomfortable position, thirst, or the need to urinate.40 Addressing these needs will improve
patient comfort and communicate the nurse’s desire to promote comfort. McCaffery35 suggested
that the time spent with the patient to communicate concern and caring may go a long way in
providing patient comfort. The content of this 5-minute conversation may include the following:
• Listening to patient concerns
• Communicating the desire to help the patient become more comfortable
• Determining strategies that might achieve more comfort35 (p. 78)
Communication with patients is one of the core dimensions of relational coordination, an
approach examined in the orthopedic surgical population.39 In a cross-sectional study of nine
hospitals, Gittell and colleagues39 found that the better the relational coordination, the better the
postsurgical pain relief. Of note, four dimensions (frequent communication, shared goals, shared
knowledge, and mutual respect among clinicians) were associated with this improvement in pain
control. Thus, this study suggested that communication, goal setting, and patient education
contributed to better pain outcome.
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Symptom Management—Pain
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and colleagues:49 synthesizer, harp, piano, orchestral, or slow jazz. The intervention is delivered
via audiotape and headphones. The duration is typically 20–30 minutes and may involve a single
or multiple exposures.
A recent meta-analysis of 51 studies examining the effect of music on pain concluded that
although music produced a significant reduction in pain intensity (0.5 units), this result may not
reflect a clinically important change.50 Gordon and colleagues24 suggest a 1.5 to 2.0 unit change
in pain intensity on a 0–10 scale constitutes a clinically important difference. Despite the large
number of studies included, approximately 50 percent were of low quality, leading to low
confidence in the results of the analysis. Contrary to previous meta-analyses,51 Cepeda and
colleagues50 did not find differences in pain reduction related to whether the music was patient-
or clinician-selected. Recently published studies, all conducted on patients undergoing
cardiovascular procedures, found significant short-term reductions in pain, distress, or anxiety
after exposure to music.52–54 In each of these studies, music was used during an episode of
increased pain (e.g., getting up from a chair). While these studies hold promise, currently the
evidence for the effectiveness of music in reducing acute pain is weak to moderate.
Massage. Massage is defined as the systematic manipulation of soft tissues by manual or
mechanical means.55 Nurses have used massage—a back rub—to improve circulation, promote
comfort, and enhance sleep. More recently investigators have examined hand and foot massage
as an alternative to back or body massage. The duration of massage varies from 5 to 20 minutes.
Wong and Keck56 suggested that 20 minutes of massage was required to achieve the desired
effect, but little evidence exists to substantiate this claim.
Reviews of the massage literature conclude it has a beneficial effect on anxiety and tension,
depression, and stress hormones (cortisol and catecholamines).57, 58 The evidence on the
beneficial effects of massage on reducing pain is positive, but involves few studies, so that firm
conclusions cannot be drawn. More recent studies produced inconsistent findings, particularly in
terms of the effect of massage on pain control.56, 59–62 As with the relaxation and music literature,
studies of the effect of massage suffer from methodological problems57 that produce unstable or
biased results.
Heat/cold therapy. The application of heat and ice to reduce pain or promote comfort has
been a common nursing intervention, which may require a physician’s order to implement.
Despite the use of heat and cold by nurses, there are few studies investigating the impact on
pain or function. A meta-analysis of heat and cold for low-back pain concluded that continued
use of heat (over a 5 day period) improved pain intensity and function.63 Only two studies on the
use of heat for postsurgical pain were found, and the findings from these were inconclusive.64
The application of ice/cold for low-back pain has limited evidence to support it’s use.63 Cold
therapy has been investigated in patients undergoing orthopedic surgeries (primarily total knee
arthroplasty) and has been found to improve pain, range of motion, and function.65 However, a
study by Smith and others66 found that pain was similar with the cryo pad (a new technology to
deliver cold therapy) and the compression bandage applied by the surgeon at the end of surgery;
in addition, the cold therapy increased the cost of care and took more nursing time. Thus, using
cold therapy via the cyro pad provides no benefit over compression bandages after knee
replacement and is less cost efficient.
Use of multiple nondrug therapies for pain management. Introduction to a variety of
nondrug techniques may be used to better meet patients’ needs. Two recent studies examined the
effect of providing multiple nondrug techniques (e.g., a cafeteria style) on postsurgical pain. In
both studies, the interventions were developed to allow the patient maximum control and require
12
Symptom Management—Pain
minimum nursing time. Common techniques used in both studies included relaxation, music, and
massage.42, 67 While it is too early to determine if providing a pain “tool kit” will have benefit to
postsurgical patients, Kshettry and colleagues67 demonstrated the feasibility of implementing
such a program in a busy intensive care unit (ICU).
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
perform necessary activities, such as ambulating after surgery or being able to concentrate on
job-related activities. Interventions are implemented to achieve and maintain this pain rating as
much of the time as possible.70
14
Symptom Management—Pain
checklists are useful in identifying the patient’s “pain signature,” that is, the pain behaviors
unique to the individual.73
An example of a pain behavior checklist is the Pain Assessment Checklist for Seniors with
Limited Ability to Communicate (PACSLAC).74 The PACSLAC evaluates 60 behaviors such as
facial expressions, activities, and mood. A check mark is made next to any behavior the patient
exhibits. The total number of behaviors may be scored, but again, this cannot be equated with a
pain intensity score. It is unknown if a high score represents more pain than a low score. In other
words, a patient who scores 10 out of 60 behaviors does not necessarily have less pain than a
patient who scores 20.71 However, in an individual patient, a change in the total pain score may
suggest more or less pain. A more comprehensive description of pain assessment tools for the
cognitively impaired are located at the following Web site in the education section of Pain in the
Elderly: http://www.cityofhope.org/PRC/.
Balanced Analgesia
Analgesics are usually divided into three categories: (1) nonopioids, which include
acetaminophen and NSAIDs; (2) opioids, which include morphine-like drugs; and (3) adjuvant
analgesics, which include local anesthetics and anticonvulsants. Using an analgesic from each
one of the three groups, referred to as balanced or multimodal analgesia, may improve the safety
of analgesic therapy. When more than one analgesic is used, the same level of pain relief may be
achieved with a lower dose of each analgesic. For example, use of a local anesthetic along with
an opioid usually allows reduction of the opioid dose needed for adequate pain control.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
can give a false sense of security.75–77 Further, decreased oxygen saturation is a later sign of
impending respiratory depression. Capnography may more accurately detect respiratory
depression and apnea;78 however, further research is required to recommend widespread use of
the method outside of the operating room or post-anesthesia care unit. The use of mechanical
monitoring is recommended if a patient has a preexisting condition that requires it, such as sleep
apnea or chronic obstructive pulmonary disease.76
Instructions for the safe use of naloxone to reverse clinically significant opioid-induced
respiratory depression are included in Box 1. Naloxone must be titrated carefully. Giving too
much naloxone or giving it too fast can precipitate severe pain and increase sympathetic activity
leading to hypertension, tachycardia, ventricular dysrhythmias, pulmonary edema, and cardiac
arrest.79
The IM route of administration is not recommended for pain management.76 It is painful, and
it has unreliable absorption with a 30–60 minute lag time to peak effect and a rapid drop in
action. In addition to being ineffective, the IM route is dangerous because patients are often
alone at the time of peak effect of the opioid administered, can become excessively sedated,
vomit, and aspirate. A better alternative is the intravenous (IV) route of administration. Points to
consider in the overall safe management of opioid naïve patients receiving IV or intraspinal
analgesia are in Box 2.
Unacceptable: Stop opioid. Notify anesthesia provider; very slowly administer dilute IV naloxone
(0.4 mg naloxone in 10 mL saline; 0.5 mL over 2-minute period); administer acetaminophen or
an NSAID, if not contraindicated, to control pain; monitor sedation and respiratory status closely
until sedation level is less than 3.
Source: Pasero C. Acute pain service: policy and procedure guideline manual. Los Angeles, CA: Academy Medical
Systems, 1994; Pasero C, Portenoy RK, McCaffery M. Opioid analgesics, In: McCaffery M, Pasero C. Pain: clinical
manual. 2nd ed. St. Louis, MO: Mosby; 1999. p. 161-299. Copyright Chris Pasero, 1994. Used with permission.
16
Symptom Management—Pain
Box 2: Safe Care of the Opioid Naïve Patient Receiving Opioids by IV or Intraspinal Routes
o Opioid prescription
o Monitoring parameters
o Activity, ambulation
o IV access if indicated
o When to notify anesthesia or primary care provider (e.g., unrelieved pain, excessive adverse
effects)
• Monitor sedation and respiratory status every 1 to 2 hours for the first 24 hours after opioid therapy is
initiated, then every 4 hours until IV or intraspinal opioid therapy is discontinued, then routine in
stable patients (see Sedation Scale, Box 1).
• Monitor other vitals signs every 4 hours until IV or intraspinal opioid therapy is discontinued, then per
routine in stable patients (evaluate need to monitor blood pressure more often in some patients).
• When possible, avoid sedating drugs for treatment of opioid-induced adverse effects, such as
antihistamines for pruritus and antiemetics for nausea.
• Teach patients, family members, and visitors about the proper use of PCA and the dangers of
anyone other than the patient or an authorized person pressing the button.
Source: Pasero C, McCaffery M. Authorized and unauthorized use of PCA. Am. J. Nurs. 2005;105(7):30,31, 33;
Pasero C, Portenoy RK, McCaffery M. Opioid analgesics, In: McCaffery M, Pasero C. Pain: clinical manual. 2nd ed.
St. Louis, MO: Mosby; 1999 p. 161-299. Copyright Chris Pasero, 2005. Used with permission.
Research Implications
The evidence base supporting the use of analgesics to manage acute pain is strong and
clear—to date, analgesics, particularly opioids, are effective in controlling acute pain.
Undertreatment of acute pain, however, remains prevalent despite the availability of analgesics
and guidelines. Undertreatment is attributed to clinician behaviors—lack of adequate pain
assessment and inadequate prescription and administration of analgesics—that are modifiable.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Thus, the research in this area needs to be directed toward effective strategies for changing
clinician attitudes and behaviors that will result in better pain management for patients.
The evidence base for the use of nondrug therapies to manage acute pain requires further
development; the current knowledge does not support achieving consistent outcomes from these
therapies. Lack of standardization of nondrug therapies is one of the drawbacks of the current
literature. Using standard relaxation or massage techniques with a determined duration (i.e.,
dose) and frequency (i.e., interval) would improve our ability to summarize the literature and
determine the effectiveness of these therapies for pain control.
Conclusion
Education about safe pain management will help prevent undertreatment of pain and the
resulting harmful effects. Safety includes the use of appropriate tools for assessing pain in
cognitively intact adults and cognitively impaired adults. Otherwise pain may be unrecognized or
underestimated. Use of analgesics, particularly opioids, is the foundation of treatment for most
types of pain. Safe use of analgesics is promoted by utilizing a multimodal approach, that is,
using more than one type of analgesic to treat the individual’s pain. Opioid use is often avoided
or inadequate for fear of causing life-threatening respiratory depression. Nurse monitoring of
sedation levels when opioids are initiated is one way to assure safety. While nondrug techniques
pose minimal safety issues, the current evidence does not support that these techniques produce
consistent, predictable pain management outcomes.
Search Strategy
The terms “pain assessment” and “pain management” were used in the literature search. The
research was limited to the English language, published in the last 10 years, meta-analyses,
practice guidelines, literature reviews, clinical trials, and randomized clinical trials (RCTs). The
literature for nondrug techniques was searched using the key terms “relaxation,” “music,”
“massage,” “heat and cold,” and “pain.” The nondrug literature was limited to the English
language, meta-analysis, and literature reviews.
Author Affiliations
Nancy Wells, D.N.Sc., R.N., F.A.A.N., director of nursing research, Vanderbilt Medical
Center, and research professor, Vanderbilt University School of Nursing; e-mail:
[email protected].
Chris Pasero, R.N., pain management consultant; e-mail: [email protected].
Margo McCaffery, R.N., F.A.A.N., pain management consultant; e-mail:
[email protected].
18
Symptom Management—Pain
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43. Anderson KO, Cohen M, Mendoza TR, et al. Brief
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33. Mercadante S. Pain treatment and outcomes for 46. Kwekkeboom KL, Gretarsdottir E. Systematic review
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48. Good M, Anderson GC, Ahn S, Cong X, Stanton-
35. McCaffery M. What is the role of nondrug methods Hicks M. Relaxation and music reduce pain after
in the nursing care of patients with acute pain? Pain intestinal surgery. Res Nurs Health. 2005;28:240-
Manage Nurs. 2002;3(3):77-80. 251.
36. American Pain Society. Principles of analgesic use in 49. Good M, Stanton-Hicks M, Grass JA, et al. Relief of
the treatment of acute pain and cancer pain. Chicago, postoperative pain with jaw relaxation, music and
IL, American Pain Society. 2003. their combination. Pain. 1999;81:163-172.
37. Cashman NJ, Dolin SJ. Respiratory and 50. Cepeda MS, Carr DB, Lau J, Alvarez H. Music for
haemodynamic effects of acute post-operative pain pain relief. Cochrane Database of Systematic
management: Evidence from published data. Br J Reviews. 2007;(2):1-45.
Anaesthia. 2004;93(2):212-223.
51. Standley JM. Effectiveness of music therapy
38. Dolin SJ, Cashman JN. Tolerability of acute procedures: Documentation of research and clinical
postoperative pain management: nausea, vomiting, practice. In: Music research in medical treatment 3rd
sedation, pruritis, and urinary retention. Evidence ed. Silver Spring MD: American Music Therapy
from published data. Br J Anaesthesia. Association; 2000. p. 1-64.
2005;95(5):584-591.
52. Voss JA, Good M, Yates B, et al. Sedative music
39. Gittell JH, Fairfield K, Bierbaum B, et al. Impact of reduces anxiety and pain during chair rest after open-
relational coordination on quality of care, heart surgery. Pain. 2004;112:197-203.
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53. Sendelbach SE, Halm M, Doran K, et al. Effects of knee replacement surgery. Orthopaedic Nurs.
music therapy on physiological and psychological 2002;21(2):61, 62, 64, 66.
outcomes for patients undergoing cardiac surgery. J
Cardiovasc Nurs. 2006;21(3):194-200. 67. Kshettry VR, Carole LF, Henly SJ, et al.
Complementary alternative medical therapies for
54. Chan MF, Wong OC, Chan HL, et al. Effects of heart surgery patients: Feasibility, safety, and impact.
music therapy on patients undergoing a C-clamp Annals Thorac Surg. 2006;81:201-206.
procedure after percutaneous coronary interventions.
J Adv Nurs. 2006;53(6):660-679. 68. U.S.P., Patient controlled analgesia pumps can lead
to medication errors. Rockville, MD, U.S.
55. Beck ME. Milady's theory and practice of therapeutic Pharmacopeia The Standard of Quality, 2004.
massage. Albany NY: Milady Publishing; 1999.
69. Pasero C, Blesterowicz N, Primeau M, Couley C.
56. Wong HL, Keck JE. Foot and hand massage as an Registered nurse management and monitoring of
intervention for postoperative pain. Pain Manage analgesia by catheter techniques: Position statement.
Nurs. 2004; 5(2):59-65. Pain Manage Nurs. 2007;8(2):48-54.
57. Field TM. Massage therapy effect. American 70. McCaffery M, Pasero C. Assessment: underlying
Psychol. 1998;53:1270-1281. complexities, misconceptions, and practical tools. In:
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58. Richards KC, Gibson R, Overton-McCoy L. Effects ed. St. Louis, MO: Mosby; 1999. p. 35-102.
of massage in acute and critical care. AACN Clinical
Issues: Adv Prac Acute & Critical Care. 2000;11:77- 71. Pasero C, McCaffery M. No self-report means no
96. pain-intensity rating. Am J Nurs 2005;105(10):50-3.
59. Hulme J, Waterman H, Hillier V. The effect of foot 72. Payen J-F, Bru O, Bjosson J-L, et al. Assessing pain
massage on patients' perception of care following in critically ill sedated patients by using a behavioral
laprosocpic sterilization as day care patients. J Adv pain scale. Crit Care Med 2001;29:2258-63.
Nurs. 1999;30:460-468.
73. Herr K. Pain assessment in cognitively impaired
60. Hattan J, King L, Griffiths P. The impact of foot older adults. Am J Nurs 2002;105(10);50-3.
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surgery: A randomized controlled trial. J Adv Nurs. 74. Fuchs-Lacelle S, Hadjistavropoulos T. Development
2002;37: 99-207. and preliminary validation of the pain assessment
checklist for seniors with limited ability to
61. McRee LD, Noble S, Pasvogel A. Using massage and communicate (PACSLAC). Pain Manage Nurs
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AORN J. 2003;78(3):433-447.
75. Mulroy MF. Monitoring opioids. Reg Anesth
62. Taylor AG, Galper DI, Taylor P, et al. Effect of 1996;21:89-93.
adjunctive Swedish massage and vibration therapy on
short-term postoperative outcomes: A randomized, 76. Pasero C, Portenoy RK, McCaffery M. Opioid
controlled trial. J Complem and Alterna Med. analgesics. In: McCaffery M, Pasero C. Pain: clinical
2003;9(1):77-89. manual. 2nd ed. St. Louis, MO: Mosby; 1999. p. 161-
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63. French SD, Cameron M, Walker BF, et al.
Superficial heat or cold for low back pain. Cochrane 77. Institute for Safe Medication Practices. Safety issues
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Safety Alert! 2003;8:1-3.
64. Chandler A, Prece J, Lister S. Using heat therapy for
pain management. Nurs Standard. 2002;17(9):40-42. 78. Soto RG, Fu ES, Vila H, et al. Capnography
accurately detects apnea during monitored anesthesia
65. Kullenberg B, Ylipaa S, Soderlund K, Resch S. care. Anesth Analg 2004;99:379-82.
Postoperative cryotherapy after total knee
arthroplasty. J Arthroplasty. 2006;21:1175-1179. 79. Brimacombe J, Archdeacon J, Newell S, et al. Two
cases of naloxone-induced pulmonary oedemae—the
66. Smith J, Stevens J, Taylor M, Tibbey J. A possible use of phentolamine in management. Anesth
randomized, controlled trial comparing compression Inten Care 1991;19:578-80.
bandaging and cold therapy in postoperative total
21
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Evidence Table for Pain Assessment and Pain Management
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
Anderson Relaxation Randomized Pain intensity Cancer clinic Relaxation Significant pre-post reduction in pain
43
2006 controlled trial Quality of life, N = 57 chronic Distraction intensity using relaxation and distraction.
cancer specific cancer pain Positive mood No difference in outcome when adherence
Mood requiring opioids delivered via to intervention examined.
Symptom audiotape at No difference for positive mood on any
severity home outcomes.
Symptom 20 minute tape In poststudy interview, patients reported
interference used 5x/week for immediate relief with use of relaxation or
Self-efficacy 2 weeks distraction tape, but pain returned
Wait listed immediately after use.
control Some mismatch between patient
preference and type of technique randomly
22
assigned.
Pain reduction was short.
Cashman Respiratory and Systematic Respiratory Published Analgesic Respiratory depression defined differently
37
2004 hemodynamic adverse literature depression literature techniques across studies; incidence differed based
events related to review Hypotension 165 papers IM upon definition.
opioid analgesia > 20,000 PCA Incidence of respiratory depression as
patients Epidural measured by low ventilatory frequency < 1
percent.
Incidence of hypotension related to
analgesia < 5 percent .
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
Cepeda Music Meta-analysis Pain intensity 51 RCTs Music Studies of postsurgical pain showed a 0.5
200750 Pain relief reviewed reduction in intensity with music (14
Opioid use > 2,600 patients studies).
All types of pain Patient- versus provider-selected music
showed no benefit in pain intensity.
Patients exposed to music had 70 percent
greater likelihood of reporting > 50 percent
pain relief than those not exposed (4
studies).
Patients exposed to music required 57 mg
less of morphine in 1st 24 hours
postsurgery than those not exposed (5
studies).
No difference in medication side effects by
use of music (4 studies).
Clinical importance of benefit of music not
23
clear.
Chandler Heat/cold Literature 2 studies Limited evidence to support the use of heat
200264 review Acute pain for pain control in clinical settings.
Chang 200654 Music Randomized Pain intensity ICU in 2 acute Patient selected Significant difference in pain intensity after
controlled trial Heart rate (HR) care hospitals in music from 15 45 minutes of compression.
Resp rate (RR) Hong Kong selections of Patients exposed to music had significant
Blood pressure N = 43 soft, slow, reduction in pain.
(B/P) compression nonlyric music Patients in control group had significant
Oxygen with C-clamp Control: usual increase in pain.
saturation after care HR, RR, and SpO2 significantly lower with
(SpO2) percutaneous music at 30 and 45 minutes compared to
Symptom Management—Pain
Collected 15, cardiac control.
30, and 45 intervention Systolic B/P, HR, and RR declined with
minutes after music over time.
clamp applied Analysis controlled for multiple
comparisons.
Music has benefit during a painful
procedure in ICU.
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
De Jong Relaxation Systematic Pain intensity 11 studies Rhythmic Review sought to identify evidence for
200645 literature Pain distress reviewed breathing Simple simple relaxation techniques (e.g.,
review Postsurgical and relaxation breathing) on pain during burn wound care.
procedural (burn No research published with adults during
care) pain acute phase.
Most promising technique is rhythmic
breathing with jaw relaxation.
Dolin 20023 Efficacy of analgesic Systematic Pain intensity Published Analgesic Incidence of:
administration literature Pain relief literature techniques Moderate to severe pain: 29.7 percent
techniques review 165 papers IM Severe pain: 10.9 percent
> 20,000 PCA Poor pain relief: 3.9 percent
patients Epidural Fair-to-poor pain relief: 19.4 percent
Highest incidence with IM technique.
Significant decline in severe pain over time
(years of publication).
Dolin 200538 Adverse (side) effects Systematic Nausea Published Analgesic Incidence of adverse effects to opioids
24
French 200763 Heat/cold Systematic Pain intensity 9 papers Superficial Heat wrap produced a 17 percent reduction
literature Physical 1,117 patients heat/cold in pain after 5 days (2 studies).
review function Acute, subacute, Disability reduced with heat wrap after 4
Overall and chronic low- days (2 studies).
improvement back pain Heat produced adverse effect (pinkness of
Patient skin) in 6/128 patients.
satisfaction Limited evidence that cold therapy has an
Adverse effects effect on pain.
Good 200548 Relaxation Randomized Pain intensity 4 hospitals in Jaw relaxation 3 intervention groups reported significantly
controlled trial Pain distress United States Patient selected less pain than control group at rest and
Opioid use N = 167 music (5 types) before and after recovery from ambulation
Days 1 & 2 Intestinal Combined (16–40 percent less).
Secondary surgery relaxation + No difference among interneuron groups for
analysis of music pain intensity immediately after ambulation.
larger study Control: 15 Relaxation or music are effective in
25
included in lit minutes quiet reducing acute pain; the combination did
review on rest not improve effect.
music and
relaxation
Hattan 200260 Massage Randomized Psychological Teaching 20 minute foot No difference in physiologic measures pre-
controlled trial well-being hospital in massage post treatment.
(e.g., pain, United Kingdom 20 minute Significant difference in pre-post change in
anxiety, calm) N = 25 post- guided perception of calm; massage significantly
Heart rate (HR) CABG patients relaxation higher than control; no significant difference
Resp rate (RR) Delivered on day between relaxation and control.
Blood pressure 2 postsurgery No difference in change scores for pain,
Symptom Management—Pain
(B/P) Control: usual anxiety, relaxation, or rest.
care
Hulme 199959 Massage Randomized Pain intensity Day surgery unit 5 minute foot Significant decrease in pain during the early
controlled trial Analgesic use in United massage postsurgical period (both groups).
Quality of care Kingdom postsurgery No difference in pain intensity reported by
(satisfaction) N = 59 women Control: usual group.
day surgery for care Pattern over time showed patients who
sterilization received massage reported less pain than
controls.
No difference in analgesic use over the
early and postdischarge periods.
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
Hutchison IV PCA analgesia Literature Published None MEDMARX data on IV PCA errors identified
20074 review literature most common errors and reasons for those
errors.
Recommendations from report outlined for
prescription, administration, and
modification of PCA analgesia.
Kwekkeboom Relaxation Systematic Pain intensity 15 RCTs Relaxation, 5 8/15 studies had positive results for pain
200646 literature Pain distress published 1996– types intensity.
review Pain relief 2005 PMR 8/13 had positive results for pain relief.
Acute and Autogenic Pain relief improved significantly only when
chronic Systematic relaxation used multiple times; single-use
noncancer pain Jaw relaxation studies showed no difference.
Rhythmic Relaxation reduced distress (4/5 studies).
breathing Insufficient evidence to support broad
application of relaxation for pain control.
McRee 200361 Massage Randomized Anxiety Hospital in Swedish No difference among groups for pre- or post
26
controlled trial Heart rate (HR) United States massage anxiety, prolactin, cortisol, physiologic
Blood pressure N = 52 surgical Music (1 variables, or analgesic use.
(B/P) patients selection) Significant decline in anxiety, prolactin pre-
Cortisol Massage + post surgery for all groups.
Prolactin music None of the interventions demonstrated a
Analgesic use 30 minutes for beneficial effect on outcomes in early period
each group after surgery.
delivered
presurgery
Control: usual
care
Pellino 200542 Nondrug tool kits Randomized Pain intensity Hospital in Tool kit included Patients receiving tool kits used more
controlled trial Interference United States Tape player nondrug therapies postsurgically; control
Anxiety N = 65 Soothing music patients also reported using some nondrug
Control over Elective Relaxation tape techniques spontaneously.
pain orthopedic 9 PMR) No difference between groups on pain
Opioid use patients (total Massager (hand intensity, interference, control, or anxiety.
hip or knee) held, Patients with tool kits used significantly less
nonelectric) opioid on day 2 but not day 1.
Stress ball
Control: usual
care
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
Richards Massage Systematic Relaxation 22 studies Massage Consistent finding that massage decreased
200058 literature Comfort Published 1980– anxiety and/or tension (8/10 studies).
review Sleep 1999 Massage produced physiologic relaxation
(7/10 studies).
Massage has immediate benefit on pain
(3/3 studies; cancer pain).
Inconclusive findings of effect of massage
on sleep related to methodological
problems.
Roykulcharoen Relaxation Randomized Pain intensity Hospital in Systematic Relaxation significantly reduced pain
200447 controlled trial Pain distress Thailand relaxation for 15 intensity and distress pre-post intervention.
st
Anxiety N = 102 adults; minutes after 1 No difference in anxiety or opioid use.
Opioid use abdominal ambulation via
surgery audiotape
Control: 15
27
minutes quiet
rest
Kshettry Nondrug tool kits Randomized Pain intensity Hospital in Combination of Pain intensity and tension significantly lower
200667 controlled trial Tension United States preop for tool kit patients on days 1 & 2
Heart rate (HR) N = 104 CV Guided imagery postsurgery.
Blood pressure surgery in ICU relaxation + No differences noted in physiologic
(B/P) gentle touch or variables between groups.
Complications light massage No difference in complication rates.
and postop These nondrug techniques are safe and
music + gentle easy to use in an critical care area.
touch or light
Symptom Management—Pain
massage
Control: usual
care
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Study Design
& Study Study Setting &
Safety Issue Related Outcome Study Study
Source to Clinical Practice Design Type Measure(s) Population Intervention Key Finding(s)
Seers 199844 Relaxation Systematic Pain intensity 7 RCTs Relaxation 3/7 studies showed significant reduction in
literature Pain distress 352 patients, intensity and/or distress.
review Anxiety 150 received 4/7 showed no significant difference.
Analgesic relaxation No adverse effects reported.
consumption training Weak support for relaxation for acute pain
33 studies did control.
not meet
inclusion criteria
Surgical and
procedural pain
Sendelbach Music Randomized Pain intensity 3 hospitals in 20 minutes of Significant reduction in pain intensity and
200653 controlled trial Anxiety United States music twice/day anxiety pre-post treatment for patients
Heart rate (HR) N = 86 for 3 days exposed to music.
Blood pressure undergoing CV postsurgery No difference in physiologic variables
(B/P) surgery Patient selected between groups.
Opioid use 1/3 choices No difference in opioid use between groups.
28
Voss 200452 Music Randomized Pain intensity Hospital in Patient selected Significant reductions in pain intensity,
controlled trial Pain distress United States music (6 types) distress, and anxiety pre-post chair rest for
Anxiety N = 61 Scheduled rest music and rest groups.
CV surgery Control: usual Post hoc test indicated patients exposed to
patients care music reported significantly less pain
30 minutes intensity, distress, and anxiety than the rest
during chair rest or control patients.
Music reduced outcomes from 57–72
percent after 30 minutes of chair rest
compared to controls.
Wong 200456 Massage Pretest, post- Pain intensity Teaching 20 minute foot Significant decrease in pain intensity and
test Distress hospital in and hand distress pre-post massage.
Heart rate (HR) United States massage Significant decrease in HR and RR;
Resp rate (RR) Postsurgical No control differences small and not clinically
Blood pressure patients important.
(B/P) No difference in B/P pre- to postmassage.
29
Symptom Management—Pain
Chapter 18. Medication Management of the
Community-Dwelling Older Adult
Karen Dorman Marek, Lisa Antle
Background
For many older adults, the ability to remain independent in one’s home depends on the ability
to manage a complicated medication regimen. Nonadherence to medication regimens is a major
cause of nursing home placement of frail older adults.1 In the United States, an estimated 3
million older adults are admitted to nursing homes due to drug-related problems at an estimated
annual cost of more than $14 billion.2 Older adults are the largest users of prescription
medication, yet with advancing age they are more vulnerable to adverse reactions to the
medications they are taking. Approximately 30 percent of hospital admissions of older adults are
drug related, with more than 11 percent attributed to medication nonadherence and 10–17
percent related to adverse drug reactions (ADRs).3–5 Older adults discharged from the hospital on
more than five drugs are more likely to visit the emergency department (ED) and be
rehospitalized during the first 6 months after discharge.6 Nursing interventions that assist older
adults in managing their medications can help prevent unnecessary, costly nursing home
admissions, hospitalizations, and ED visits, as well as improve their quality of life.
The purpose of this review was to identify evidence-based interventions related to medication
management and the community-dwelling older adult. The focus of this review was interventions
that fall within the scope of practice of the registered nurse. The guidelines do not address the
specific intervention of medication prescribing. However, the interventions are applicable to
professional nurse providers whether they are prescribing or not. This chapter discusses risk
factors for problems in medication management followed by evidence-based interventions in
areas of medication reconciliation, medication procurement, medication knowledge, physical
ability, cognitive capacity, intentional nonadherence, and ongoing monitoring.
Risk Factors
There is a wide variety of factors that place the community-dwelling older adult at risk for
problems in medication management. The young-old (ages 66–74) have been found to be more
adherent to medication regimens than middle-aged older adults, but after age 75, older adults
present decreased comprehension of medication instructions and adherence.7–15 Living
arrangements influence the older person’s ability to manage medications, and older adults who
live alone were found to be more prone to medication errors.16–21 It is postulated that this is
related to the fact that there is no one to monitor, assist, or remind the older person about taking
their medications. Persons with chronic disease, especially depression, have a higher incidence
of nonadherence to their medication regimen.7, 10, 22–30 Many of the risk factors related to
inadequate medication management are items that are more prevalent in older adults living in the
community. Other factors that will be discussed in more detail later in the chapter are physical
impairments such as poor vision, grip strength, and cognitive decline.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Older adults are more prone to adverse events due to the clinical complexity of their care
rather than age-based discrimination.31 A study of older adult outpatients who took five or more
medications found that 35 percent experienced adverse drug events.32 In addition, individuals
with complex regimens had difficulty naming and explaining the purposes of medications and
appeared to be at high risk for nonadherence.33 The greater the medication complexity, the less
likely the older adult is to adhere to the medication regimen.34 The larger the number of
medications, the more likely the older adult will be nonadherent.3, 9, 13, 19, 28, 35–46 It is not only the
number of medications but also the number of doses per day and actions related to taking
medications that contribute to complexity of a medication regimen.34 In a study of medication
compliance, the compliance rate was 87 percent for daily dosing, 81 percent for twice a day, 77
percent for three times a day, and 39 percent for four times a day.47 In addition, a change in
prescribed drug regimen has been found to be a predictor of medication nonadherence in older
adults.9 Finally, the number of prescribing providers adds to the complexity of managing one’s
medications, and persons with more than one prescribing provider were found to be prone to
medication errors.16, 19
Research Evidence
Medication Reconciliation
Medication reconciliation is the first step in assisting older adults in the medication
management process. Multiple studies have demonstrated discrepancies from 30 percent to 66
percent in what medications were ordered by the prescribing provider and the actual medications
the older adult was taking.16, 48–52 Prescribing providers were often unaware of prescribed
medications their patients were taking,16, 53–55 and the larger the number of prescribing providers,
the greater the chance of medication discrepancies.3, 42, 56, 57 A study of elderly patients 2 days
after hospital discharge found 64 percent were taking at least one medication that was not
ordered, 73 percent failed to use at least one medication according to instructions, and 32 percent
were not taking all drugs ordered at discharge.58 Another challenge in reconciliation of
medications is determining exactly what medications older adults are taking in their home. One
study found 49 percent of community-based older adults kept stores of old medications from the
year before, and 6 percent admitted they self-prescribed medications on at least one occasion.59
Over the counter (OTC) medication use also needs to be assessed, because estimates of older
adults’ use of OTC drugs range from 32 percent to 86 percent.60–62 A recent study of older adults
with hypertension attending a blood pressure clinic found 86 percent reported two or more self-
medication practices using OTC drugs that could result in an adverse drug interaction.63
Multiple studies have demonstrated that 10–74 percent of medications prescribed for older
adults were inappropriate.48, 57, 64–74 A study of “brown bag” medication reviews, in which
patients bring all of their medications with them (often in a brown paper bag) to a medical or
pharmacy consultation, revealed that 12 percent of the patients had medication problems that
could potentially result in hospital admission.75 A review of ED visits of patients 65 years and
older found 10.6 percent of the visits were related to an adverse drug event, and 31 percent had at
least one potential adverse drug interaction in their medication regimen.
Pharmacy reviews have demonstrated a reduction in polypharmacy in older adults and
decreased adverse drug events in older patients.76–82 Beer’s set of criteria for potentially
inappropriate medication use in older adults is one example of criteria developed for pharmacy
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Medication Management
screening.83, 84 There are a variety of drug interaction programs that quickly identify adverse drug
interactions.
Also, patients who were given a medication card with a list of current medications were more
compliant with their medication regimen.85 Use of a medication list that is shared with the
patient’s primary care physician decreased patient rehospitalizations in one study.86
Medication Procurement
Not filling or refilling prescriptions is a common cause for medication nonadherence in older
adults.87–91 In a study of elderly patients at 15 days posthospitalization, 27 percent had not filled
their new prescriptions.92 Patients who participated in programs that provided pharmacy delivery
and refill reminders had fewer adverse drug events and higher compliance than those who did
not.78
If the cost of medication is viewed as high, older adults are more likely to not adhere to their
medication regimen and be hospitalized.3, 11, 56 Lack of funds, especially at the end of the month,
is one reason older adults delay filling prescriptions.93 In addition, chronically ill older adults are
more likely to experience financial burdens associated with covering out-of-pocket costs for their
prescription medications, cut back on medications due to cost, and use less medicines monthly.89,
93–98
A study of use of medications after an increase in the copayment found a reduction in use of
up to 45 percent in nonsteroidal anti-inflammatory drugs and 23 percent in antidiabetic drugs.99
Older adults who have insurance to cover medications have greater adherence.12, 14, 19, 100 In
one study, both adherence to medications and clinical outcomes improved while the number of
hospitalizations declined when cardiovascular drugs were provided to indigent patients who
could not afford to buy them.101
Medication Knowledge
Studies of older adults’ knowledge of medications have found more than 50 percent knew the
names and purpose of their medications; however, less than 25 percent knew the consequences
of drug omission or toxic side effects.9, 16, 54, 102 For example, one study of elderly patients with
congestive heart failure found that 30 days after a new medication was prescribed, only 64
percent of the patients could identify when they were supposed to take their medicine.103 Also,
older adults were found to have insufficient knowledge of inhaler technique and understanding
how medications can improve their asthma.104 Noncompliant patients on anticoagulant therapy
were more likely to report they did not know why their medication was prescribed.105 In a study
of OTC medication use, few older adults knew precautions related to the OTC drugs they were
taking.61 One study of older adult medication knowledge found that older adults understood
prescribed medications better than OTC drugs, especially nutritional supplements.106
Patient education is a key intervention to assist older adults with medication management.
Patient knowledge of drugs is positively associated with adherence.16, 21, 91, 105, 107–112 However,
older adults require specific educational methods. Learning is more effective in older adults if
information is explicit, organized in lists, and in logical order. Instructions that are compatible
with the older adults’ schema for taking medications are better remembered,113 and well-
organized prescription labels are more useful for older adults.114 Pictures are not helpful unless
the picture is clearly related to the content.115–118 A combination of both oral and written formats
was identified by older adults as most helpful.119 Medication schedules or charts in combination
with teaching or counseling enhances patient medication adherence.85, 86, 120–124 Four weeks after
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
starting a new medication for a chronic illness, patients identified a substantial need for further
information.125 Studies have demonstrated that patient education and counseling over several
home visits or with followup phone calls produces increased medication adherence in
recipients.126–141
Physical Ability
Poor vision and low manual dexterity are associated with poor medication self-
management.9,21,39,142–144 The inability to read medication labels has been associated with
nonadherence to long-term medications in the elderly.43,145 One study found 28 percent of
community-based older adults did not keep their medication bottles properly closed so that they
could open them, and 47 percent admitted that labels on their medications were unclear and they
could not read them due to poor eyesight, inability to read English, or small writing on the
label.59 Studies have demonstrated that from 31 percent to 64 percent of older adults living at
home have difficulty opening medication containers, with childproof containers presenting the
most difficulty.9,144,146 In studies of persons with chronic obstructive pulmonary disease (COPD),
38 percent used their inhaled medications with poor technique,89 and poor hand strength was
associated with nonadherence in inhaler use.147 In another study of COPD patients, more than 50
percent had difficulties with their inhalers.112
Medication-container modification is one area of intervention for older adults who have
difficulty opening or reading containers. Use of nonchildproof containers is one option for older
adults. However, blister packs or other variations of unit dose packaging have resulted in
increased compliance.148–150 In a recent study of older adults, 64 percent were unable to open
childproof containers, and 10 percent were unable to use blister packs.9 Also, different tablet
formations that increase the ease of breaking tablets have been found to increase patients’
abilities to comply with their medication regimen.151 Finally, talking medication containers and
large-print labels are modifications that can be useful for persons with visual impairment.
Cognitive Capacity
Poor cognition is associated with both over adherence and under adherence of a prescribed
medication regimen.9,14,18,28,37,38,142–144,152–155 A study of community-dwelling women found that
22 percent were unable to accurately perform a routine medication regimen; however, only 2
percent self-identified that they had difficulty with their medications.156 Forgetting is a major
reason medication doses are missed.9,78,88,89,157–162 The most prominent type of medication
noncompliance is dose omission, but overconsumption is a common mistake, especially in
persons on a once-daily dose schedule.163
There are a number of interventions to assist older adults with remembering to take their
medications. One simple method is the use of memory cues that prompt patients to take their
medications.148 Development of memory cues must be tailored to the patient’s lifestyle.90,164
Placing medication in a special place and use of a daily event such as meal time improve
medication adherence.91,106,165,166 A study that examined the most common ways older adults
remembered to take their medications found the following methods to be beneficial: (1) placing
containers in a particular location, (2) taking medications in association with meals/bedtime, (3)
using a timed pill box, (4) reminders from another person, and (5) using written directions or a
check-off list.159
4
Medication Management
Compliance aids such as pill box organizers have been found to increase medication
adherence.16,78 Medication schedules and calendars are helpful, especially in combination with
education and use of a pill box.38,40,78,120,150,167,168 In addition, electronic monitoring that provides
feedback to the user increases adherence.141,169–171 Older patients using a voice-reminder-
message medication dispenser were significantly more compliant than those using a pill box or
self-administering medications.172,173 Patients using topical pilocarpine were significantly more
compliant using an electronic medication alarm device.174 Programs that use daily telephone
reminder calls also have demonstrated increased medication compliance.155,175 Several studies
have demonstrated that dose simplification from two times a day to one time a day produces
higher compliance and improved patient outcomes.122,176–182
Intentional Nonadherence
One study of chronically ill persons who were starting a new medication found that almost a
third did not take their medication as prescribed, and half of the time it was deliberate.125 Older
adults’ perceptions of the seriousness of their illness and vulnerability to complications were
significantly related to medication adherence.13,46,90,91,97,166,183 In fact, low self-efficacy and
beliefs that others are responsible for one’s health care are predictors of medication
nonadherence.21,89,105,159,184–194
A major reason that older adults skip doses or stop taking their medications is related to
medication side effects.9,11,16,26,38,46,89,91,93,110,125,159,161,162,191,195–198 In a comparison of compliant
and noncompliant patients in fluvastatin treatment, the noncompliant patients were more likely to
experience side effects of the medication.199 Six months after discharge for acute coronary
syndrome, 8 percent of those taking aspirin,12 percent of those taking beta-blockers, 20 percent
of those taking ACE inhibitors, and 13 percent of those taking statins had discontinued taking
their medications.200
Use of commitment-based interventions has been found to increase self-efficacy and
medication compliance.201 Education that addresses patient involvement with decisionmaking,
such as focusing on appropriate versus inappropriate use of medication, can improve self-
efficacy.202 Patients with depression who participated in a program to enhance self-management
and prevent relapse had significantly greater long-term adherence to their medication regimen.203
Patients whose provider had an open, collaborative communication style also were more
adherent to their medication regimen.204
Ongoing Monitoring
Older adults have narrow therapeutic windows and require close monitoring, especially when
on multiple medications.205 Ongoing monitoring of the older adult’s medication management is
critical. A study of home care patients found 16 percent had skipped a medication in the last 24
hours, 6 percent were taking the wrong dose, and 5 percent were experiencing adverse effects
from their medication.87 In one study, symptomatic hypotension was identified in 13 percent of
community-based elderly.67 In another study, older adults treated for urinary tract infections and
sleeping disorders experienced a significantly higher risk of ADRs.206 A review of ED visits of
patients 65 years and older found 10.6 percent of the visits were related to an adverse drug event,
and 31 percent had at least one potential adverse drug interaction in their medication regimen.207
Pharmacist management of repeat prescriptions found 12.4 percent of patients had compliance
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
problems, side effects, ADRs, or drug interactions.208 A total of 35 percent of elderly ambulatory
patients reported at least one adverse event within the previous year.209
Monitoring medication adherence is an ongoing process. The longer people are on a
medication, the more likely they are to have difficulty following the medication regimen.179, 210
For example, in one study, only 31 percent of people with type 2 diabetes who were on oral
hypoglycemics adhered to their medication regimen.211 In another study, persons on oral
hypoglycemic medications were nonadherent an average of 64.7 days in one year.212 Since
adherence to medication regimen for type 2 diabetes is strongly associated with metabolic
control, interventions related to monitoring and improving adherence are critical.213
Patients taking Digoxin who are not adherent have an increased number and duration of
hospitalizations and twice the mortality rate than those who are adherent.214 Also, in a study of
long-term compliance of antihypertensive drugs, patients on ACE-inhibitors, beta-blockers,
calcium channel blockers, and diuretics were more likely to be noncompliant,215 as were persons
using bronchodilators and benzodiazepines.60
Medication Procurement
1. Assess the patient’s or caregiver’s ability to procure medications.87–92
a. Identify how and where the patient obtains and refills prescriptions.87–92
b. Assess how the patient pays for medications.3,11,56
c. Assess if medications doses are ever missed due to lack of funds.93
2. If the patient or caregiver has difficulty obtaining or refilling prescriptions, assist the
patient with creating a system to procure medications via
6
Medication Management
a. Pharmacy delivery.78
b. Refill reminders or automatic refill service.78
c. Scheduling family or friends to pick up medications.
3. If funds to purchase medication are a problem,89,93–98
a. Refer the patient to a social worker to obtain Medicare Part D coverage, other
insurance coverage, or participation in drug company programs.12,14,19,99,100
b. Consult with the pharmacist regarding use of generic drugs.
c. Consult the prescribing physician about availability of drug samples.101
Medication Knowledge
1. Assess the patient’s or caregiver’s knowledge of
a. Dose and frequency of medications taken.9,16,33,54,102,103
b. Special instructions related to medications, such as “take with food.”33
i. If the patient uses an inhaler, understanding of the correct inhaler
technique.104
c. Medication mode of action.9,16,54,102
d. Side effects to monitor and report.9,16,54,102
2. With each change in medication regimen (including OTC drugs), review medication
purpose, dosage, frequency, side effects to monitor and report, and other medication-
specific instructions.61
3. Interventions related to medication knowledge include16,21,91,105,107–112
a. Provide written instructions related to medications in large letters and bullet or list
format.115–119
b. Tailor instructions to how the patient takes his or her medicine.113
c. Group information starting with generalized information, followed by how to take
the medicine, and then the outcomes such as side effects to watch for and when to
call the doctor.114–118
d. Use medication schedules or charts to reinforce instructions.85,86,120–124
e. If the patient did not know important medication information at a previous
encounter, review dose, time, side effects to monitor and report, and special
instructions at the next visit.125–141
Physical Ability
1. Assess for decreased manual dexterity or vision impairment and its affect on the patient’s
ability to identify the correct medication, open medication containers, and prepare
medications (e.g., breaking tablets) for administration.9,21,39,43,142–145
a. Observe the patient opening medication containers.9,59,144,146
b. If the patient uses an inhaler, observe the use of the inhaler.89,112,147
c. If the patient is required to break tablets, assess his or her ability to do so.151
d. If the patient is unable to open or see the label and contents of each medication
container, provide one of the following:
i. Pill box or other easy-open container.150,172,217 If the patient is unable to
fill the pill box, identify someone who can assist him or her.
ii. Medication calendar with pill box.155,167,168,218
iii. Blister packs.138,149 Consult the pharmacy about the availability of the drug
in blister packs or nonchildproof containers.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
iv. If tablet breaking is required and the patient has difficulty doing it, consult
with the pharmacist about tablets that are easier to break or tablets that are
the correct dosage without requiring breaking.151
Cognitive Capacity
1. Assess the patient’s or caregiver’s cognitive capacity to organize and remember to
administer medication.106, 156
a. Assess when doses are taken.
b. Assess what cues the patient uses to remember to take medication.
c. Assess what dose is most difficult to remember.9,78,88,89,157–162
d. Assess how often a dose is missed or an extra dose is taken.9,14,18,28,37,38,142–144,152–
155
2. Teach the patient or caregiver the use of memory cues based on one of the following
methods:148,159
a. Clock time. Ask if the patient or caregiver is usually aware of the time of day or
keeps track of time through a watch or clock.
b. Meal time.90,91,106,164–166 Ask if the patient eats meals at a regular time.
c. Daily ritual, such as using the bathroom in the morning, shaving, or hair
combing.90,91,106,164–166
3. If the patient requires additional support,
a. Provide memory-enhancing methods or devices such as
i. Medication calendar or chart.38,40,78,120,150,167,168
ii. Electronic reminder or alarm.141,169–171,174
iii. Voice-message reminder.172,173
iv. Telephone reminder.155,175
v. Pill box.16,78 (If the patient is unable to fill a pill box, identify someone
who is willing to assist him or her.158)
vi. Electronic medication dispensing device.173
vii. Combine methods and devices when possible.38,40,78,120,150,167,168
b. Discuss dose simplification with the prescribing provider.122,176–182
Intentional Nonadherence
1. Assess if medication doses are missed intentionally.125
a. Drugs at high risk for intentional noncompliance include the following:
i. ACE-inhibitors200,215
ii. Beta-blockers200,215
iii. Calcium channel blockers200,215
iv. Diuretics215
v. Bronchodilators60
vi. Benzodiazepines60
b. If the patient intentionally misses doses, assess the reason(s).
i. Belief medication is not helping.13,46,90,91,97,166,183
ii. Fear of adverse side effects.13,46,90,91,97,166,183
iii. Side effects.9,11,16,26,38,46,89,91,93,110,125,159,161,162,191,195–198
8
Medication Management
Ongoing Monitoring
1. For all patients on a prescribed medication regimen, monitor the patient with each
encounter for the following:
a. Medication adherence
i. Monitor both under- and overadherence.87,179 Overconsumption occurs
frequently in a once-daily dose schedule.
ii. For persons using inhalers, assess
1. Inhaler emptying rate.89,104,147
2. Reported forgetfulness.104
3. Use of short-acting inhaler.89,104
b. Medication side effects67,205
i. If medication side effects present, notify the prescribing provider, as
appropriate.
c. Lab work, as appropriate, for prescribed medications216
i. Cockcroft-Gault Formula or other creatinine clearance measure at least
annually. If creatinine clearance <50 ml/min, notify the prescribing
provider.
d. Medication effectiveness205
i. If signs and symptoms of the problem the medication is treating are
present, notify the prescribing provider, as appropriate.
Research Implications
There is a large volume of research related to medication management and the elderly.
Medication management is a complex process that must be interdisciplinary in its approach.
Many of the evidence-based interventions discussed are not discipline specific. A team of
providers is needed to provide safe and therapeutic medication management.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
There is a large amount of research related to risk factors for medication nonadherence.
However, there is less evidence related to appropriate interventions to enhance adherence and
medication self-management. In addition, the most effective programs have multiple
interventions, so identifying the specific evidence for each intervention component is difficult.
For example, one study included a combination of interventions of medication review,
modification of containers, medication education, and a drug reminder chart.138 All are important
components of a medication program for older adults, yet it is difficult to identify the evidence
supporting each component. What is promising is the use of technology to assist in medication
management.173,219 This includes clinical screening software for adverse drug interaction and
potentially inappropriate prescribed medications, electronic adherence monitoring, and electronic
medication reminders. Much of this new technology is currently being tested.
Conclusion
Medication management is a complex process that consists of multiple activities. Factors
associated with problems in the performance of these activities include living alone, impaired
vision, impaired cognitive function, ages 75 and older, having three or more medications and/or
scheduled doses in one day, and more than one prescribing provider. Medication reconciliation is
a key first step in medication management. Multiple studies have demonstrated large
discrepancies in what medications are ordered by the prescribing provider and the actual
medications the older adult is taking. Evidence supports medication reconciliation interventions
that include a screen for inappropriate medications and adverse drug interactions, in addition to
verification of medications that are prescribed. Other areas of medication management include
assessment and interventions related to medication procurement, medication knowledge,
physical ability, cognitive capacity, and intentional nonadherence. Ongoing monitoring of these
areas is crucial.
Nurses play a pivotal role in the medication management process of older adults. Considering
the expense of prescription drugs in the current health care system, a small investment in
providing comprehensive assessment and interventions to assist older adults in accurate and safe
management of their medications will provide cost-effective care and increase the quality of life
of older adults struggling to manage their often-complex medication regimens.
Search Strategy
To conduct this review, a search was done in August 2005 of PubMed®, the Cumulative
Index to Nursing & Allied Health Literature, Cochrane Database of Systematic Reviews,
HealthStar, ISI Web of Science, Social Service Abstracts, Database of Abstracts of Reviews of
Effectiveness, and Internet searches for citations occurring from January 1990 to August 2005.
Key search terms used alone and in combination included medication adherence, compliance,
elderly; aged; outcomes; polypharmacy; medication management; chronic illness; chronic
disease; and individual types of chronic illnesses. All searches were limited to patients ages 65
and older and Web sites in the English language. The ISI Web of Science was used to track
citations to major works, and article references were reviewed for inclusion. Bibliographies of
retrieved articles also were searched for relevant articles not identified in the reference database
searches.
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Medication Management
Author Affiliations
Karen Dorman Marek, Ph.D., M.B.A., R.N., F.A.A.N., associate professor, University of
Wisconsin Milwaukee College of Nursing; e-mail: [email protected].
Lisa Antle, A.P.R.N., B.C., A.P.N.P, clinical assistant professor, University of Wisconsin
Milwaukee College of Nursing; e-mail: [email protected].
Acknowledgment
Development of the Medication Management of Community-Based Older Adult Guidelines
was partially funded by the Aurora-Cerner-University of Wisconsin Milwaukee (ACW)
Knowledge-Based Nursing Initiative. The authors would like to thank Lenore R. Wilkas, M.L.S.,
for her expert assistance.
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between appropriate and inappropriate utilization. 214. Miura T, Kojima R, Mizutani M, et al. Effect of
Patient Education Study Group. J Rheumatol digoxin noncompliance on hospitalization and
1999;26:1793-801. mortality in patients with heart failure in long-term
therapy: a prospective cohort study. Eur J Clin
203. Lin EH, Von Korff M, Ludman EJ, et al. Enhancing Pharmacol 2001;57(1):77-83.
adherence to prevent depression relapse in primary
care. Gen Hosp Psychiatry 2003;25(5):303-10. 215. Degli Esposti E, Sturani A, Di Martino M, et al.
Long-term persistence with antihypertensive drugs in
204. Bultman DC, Svarstad BL. Effects of physician new patients. J Hum Hypertens 2002;16(6):439-44.
communication style on client medication beliefs and
adherence with antidepressant treatment. Patient 216. Bergman-Evans B. Improving medication
Educ Couns 2000;40(2):173-85. management for older adult clients. Iowa City, IA:
University of Iowa Gerontological Nursing
205. Beers MH, Baran RW, Frenia K. Drugs and the Interventions Research Center;2004.
elderly, Part 1: The problems facing managed
care.Am J Manag Care 2000;6:1313-20. 217. Sturgess IK, McElnay JC, Hughes CM, et al.
Community pharmacy based provision of
206. Veehof LJ, Stewart RE, Meyboom-de Jong B, et al. pharmaceutical care to older patients. Pharm World
Adverse drug reactions and polypharmacy in the Sci 2003;25(5):218-26.
elderly in general practice. Eur J Clin Pharmacol
1999;55:533-6. 218. Park D, Morrell RW, Frieske D, et al. Cognitive
factors and the use of over-the-counter medication
207. Hohl CM, Dankoff J, Colacone A, et al. organizers by arthritis patients. Hum Factors
Polypharmacy, adverse drug-related events, and 1991;33(1):57-67.
potential adverse drug interactions in elderly patients
presenting to an emergency department. Ann Emerg 219. Durso S. Technological advances for improving
Med 2001;38:666-71. medication adherence in the elderly. Annals of Long-
Term Care 2001;9(4):43-8.
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
220. Allard J, Hebert R, Rioux M, et al. Efficacy of a and compliance with treatment in elderly patients.
clinical medication review on the number of BMJ 1995;310(6989): 1229-31.
potentially inappropriate prescriptions prescribed for
community-dwelling elderly people. CMAJ 2001 224. Malone DC, Carter BL, Billups SJ, et al. Can clinical
May 1;164(9):1291-6. pharmacists affect SF-36 scores in veterans at high
risk for medication-related problems? Med Care
221. Day RA, Moore KN, Hodgins M. The effects of 2001;39(2):113-22.
instruction and practice on medication knowledge
and compliance. Canadian J Rehabil 1998;12:15-24. 225. Pereles L, Romonko L, Murzyn T, et al. Evaluation of
a self-medication program. J Am Geriatr Soc
222. Hawe P, Higgins G. Can medication education 1996;44(2):161-5.
improve the drug compliance of the elderly?
Evaluation of an in hospital program. Patient Educ 226. Solomon DK, Portner TS, Bass GE, et al. Clinical and
Couns 1990;16(2):151-60. economic outcomes in the hypertension and COPD
arms of a multicenter outcomes study. J Am Pharm
223. Lowe CJ, Raynor DK, Courtney EA, et al. Effects of Assoc (Wash), 1998;38(5);574-85.
self medication programme on knowledge of drugs
20
Evidence Table. Medication Management of the Community-Dwelling Older Adult (Includes studies design level 4 and above)
Source Safety Issue Design Type Study Design, Study Setting and Study Study Intervention Key Finding(s)
Related to (level) Study Outcome Population
Clinical Measure(s)
Practice (level)
Allard 2001220 Inappropriate Randomized 1. RCT (Level 2) 1. Community-dwelling Medication review by Mean PIPs decreased in
prescribed Controlled 2. Error over time older adults, age > 70 nurse, pharmacist, and treatment group, but not
medication Trial (RCT) (Level 2) years and taking > 3 physician with monthly significant.
drugs nurse followup.
2. Treatment (n = 136) Potentially inappropriate
• Subgroup received prescriptions (PIPs)
case conference w/ reported to prescribing
intervention (n = 80) physician.
3. Control (n = 130)
Andrejak Medication RCT 1. RCT (Level 2) 1. Multicenter: 6 month Dose simplification: once Evidence suggests that daily
2000176 adherence 2. Clinical study, persons 18 and a day, group one; twice a dosing enhances daily
outcome (Level older with essential day, group two. compliance, missing fewer
1) HTN (diastolic BP,95- doses, and taking medications
115) on time as scheduled by the
21
Esposito Medication RCT 1. RCT (Level 2) 1. Age 65 and older at Medication schedule with Higher compliance rates were
1995167 adherence 2. Errors over hospital discharge verbal reinforcement. found in subjects who used
time (Level 2 ) 2. Four groups: medication schedule. Pilot,
• Group I – standard small study.
education (n = 11)
• Group II – standard
education and 30
minute verbal
instructions (n = 8)
• Group III – standard
education and
medication schedule
(n = 10)
• Group IV – standard
education,
medication schedule,
and 30 minute verbal
instructions (n = 14)
Source Safety Issue Design Type Study Design, Study Setting and Study Study Intervention Key Finding(s)
Related to (level) Study Outcome Population
Clinical Measure(s)
Practice (level)
Fillet 199976 Polypharmacy Noncom- 1. Observational 1. Medicare managed 1. Identification of 17% of patients informed their
parative study without care organization patients at risk for PCP about a new prescription
study controls (Level patients 65 and older polypharmacy. or nonprescription medication
5) on 5 or more 2. Empowerment letters they were taking. The review
2. Measurable medications, over 3 sent to patients with resulted in medication changes
outcomes with month period. brown bag to in 51% of the reviews. 29%
unestablished 2. 5,737 identified as high encourage a primary reported a decrease in
connection to risk and surveyed, with care provider (PCP) frequency of dosing, and 20%
outcome (Level 2,615 responding appointment for had a medication discontinued.
3) (response rate = 46%). medication review. 45% of the physicians reported
3. 275 primary care 3. All PCPs provided at least one medication
physicians surveyed, with practice change.
with 56 (20%) guidelines regarding
responding. polypharmacy and
patient-specific
medication
25
management reports.
Friedman Medication RCT 1. RCT (Level 2) 1. Persons age 60 and 1. Automated telephone Medication adherence was
132
1996 Adherence 2. Clinical older under treatment patient monitoring higher (P = 0.03) and diastolic
outcome (Level for hypertension from and counseling. blood pressure lower (P =
1) community sites such 2. Weekly-treatment 0.02) in the treatment group.
as senior centers with subjects reported self-
BP>160/90 measured BP,
2. Two groups: knowledge, and
• Treatment (n = 133) adherence to
• Control (n = 134) medications and side
effects.
• Control (n = 14)
Kimberlin Medication Non-RCT 1. Nonrandomized 1. Subject criteria Intervention pharmacists Subjects of intervention
199382 compliance trial (Level 3) • Age 60 or older participated in home pharmacists more likely to
and 2. Adverse events • Capable of self-care study and 1-day report pharmacists provided
knowledge (Level 1) • Taking four or more workshop on drug information and assessed for
medications or therapy for elderly problems than were control
medications from a patients. subjects. No significant
list of targeted drugs differences were found in
with narrow compliance or hospitalizations.
therapeutic ranges or However, the addition of each
likely to cause medication in the drug regimen
Lowe 2000138 Medication RCT 1. RCT (Level 2) 1. Community-dwelling Pharmacist-led Medication review, verification,
compliance 2. Errors over older adults, > 65, Intervention that included education, and modification of
29
150
1993 compliance 2. Errors over living in urban public single cup holding all higher with dose simplification
time (Level 2) housing for older adults meds to be taken at and unit-of-dose packaging (P
on at least three dosing time and BID = 0.017).
medications dosing
2. Three groups:
• Group 1 (n = 12):
conventional
packaging, varied
dosing
• Group 2 (n = 10):
conventional
Pereles Medication RCT 1. RCT (Level 2) 1. Geriatric rehabilitation Inpatient program that Treatment group at 1 month
225
1996 compliance 2. Errors over inpatients included three stages of had fewer self-medication
and time (Level 2) 2. Two groups: increasing responsibility errors than control (P < 0.001).
knowledge • Treatment (n = 51) to independently self- No difference between groups
• Control (n = 56) medicate. in knowledge, morale.
Source Safety Issue Design Type Study Design, Study Setting and Study Study Intervention Key Finding(s)
Related to (level) Study Outcome Population
Clinical Measure(s)
Practice (level)
Perri 1995170 Medication Non-RCT 1. Non-RCT 1. Community-dwelling Stimulant “counter cap” Subjects using the counter cap
compliance (Level 3) pharmacy customers prescription vile that had improved medication
2. Errors over taking a chronic indicates when cap was compliance (P = 0.0366).
time (Level 2) medication with a new last opened.
refill or prescription
2. Two groups:
• Intervention (n = 88)
• Control (n = 98)
Piette 2000129 Medication RCT 1. RCT (Level 2) 1. Adults receiving 1. Biweekly automated Intervention group monitored
adherence 2. Clinical diabetes treatment at a assessment and self- glucose, feet, and weight more
outcomes (level county health clinic care education frequently and had fewer
1) 2. Mean age 56 telephone calls problems with medication
3. Two groups: 2. Nurse educator adherence (P < 0.03). HbA1c
• Intervention (n = followup lower in intervention group (P
124) = 0.01).
• Control (n = 124)
33
Raynor Medication RCT 1. RCT 1. Inpatient adults taking 1. Counseling Groups that received reminder
1993120 compliance 2. Errors over 2–6 medications 2. Reminder chart or chart had higher medication
time (level 2) 2. Four groups: medication schedule compliance and medication
• Nurse standard knowledge than those that
counseling received counseling only (P <
• Nurse counseling 0.01).
and reminder chart
• Pharmacist
counseling
• Pharmacist
modification.
2. Treatment group
received six
telephone calls to
patient and six to
family member over
34 weeks.
Sturgess Medication Group RCT 1. Group RCT 1. Community-dwelling Intervention pharmacies Compliance greater (P < 0.05)
2003217 compliance (Level 2) older adults age 65 and received intensive and fewer problems with
2. Errors over older taking four or training related to medications (P < 0.05) in
time (Level 2) more medications and • Disease management intervention group when
• Control (n = 36)
Varma Medication RCT 1. RCT (Level 2) 1. Persons age 65 and 1. Pharmacist-led Treatment group had higher
124
1999 compliance 2. Clinical older with CHF who medication education knowledge of medications (P =
outcome were hospitalized or 2. Medication review 0.0026) and fewer hospital
(Level1) attended outpatient with dose admissions (P = 0.006). No
clinic simplification difference identified in quality
2. Two groups: of life between groups.
• Intervention (n = 42)
• Control (n = 41)
Ware 1991148 Medication RCT 1. RCT (Level 2) 1. Setting both inpatient 1. Webster-Pak Compliance was higher in
compliance 2. Errors over at a geriatric medication packaging subjects who used unit-dose
and time (Level 2) assessment and unit-dose system packaging system (P < 0.05).
medication rehabilitation unit and 2. Hospital practice prior
packaging postdischarge to discharge in both
2. Two groups: groups
• Treatment (n = 4)
• Control (n = 39)
Source Safety Issue Design Type Study Design, Study Setting and Study Study Intervention Key Finding(s)
Related to (level) Study Outcome Population
Clinical Measure(s)
Practice (level)
Weinberger Medication Group RCT 1. Group RCT 1. Pharmacy customers Tailored education by Treatment group had higher
2002130 Compliance (Level 2) who had COPD or pharmacist based on PEFRs compared to control
2. Clinical asthma as an active patient-specific data groups (P = 0.02), more
outcomes problem and received provided to the satisfaction with their
(Level 1) 70% or more of participating pharmacist (P = 0.001), and
medications from a pharmacists. more satisfied with their health
single drug store care at 6 months (P = 0.01)
2. Three groups: when compared to the control
• Intervention (n = groups. The asthma patients in
447) the pharmaceutical care group
• Control group with had more breathing-related ED
peak expiratory flow and hospital visits than the
rates (PEFR) usual care group (odds ratio,
monitoring (n = 363) 2.16 [CI 95% 1.76–2.63; P <
• Usual care control (n 0.001]); however, the mean
= 303) age for this group was 45,
37
Background
The organization of care delivery is determined by a variety of factors such as economic
issues, leadership beliefs, and the ability to recruit and retain staff. Ideally, evidence of the effect
of care models on quality and patient safety would also be a major factor in decisionmaking.
Historically, four traditional care models have dominated the organization of inpatient
nursing care. Functional and team nursing are task-oriented and use a mix of nursing personnel;
total patient care and primary nursing are patient-oriented and rely on registered nurses (RNs) to
deliver care.1, 2 In the late 1980s, a number of nontraditional nursing care delivery models
emerged that use various mixes of licensed and unlicensed nursing personnel.3–5
Care models do not exclusively pertain to the organization of nursing care, however, or the
inpatient setting. Models have been examined for medical housestaff,6 pharmacy services,7 and
social workers.8 They have been considered for ambulatory care,9–12 home care,13–15 and nursing
homes.16 Care models also exist for specific patient populations such as elderly patients,17–20
people with mental health needs,21 and individuals with chronic conditions22 to include disease
management models23, 24 and the use of technology.25
Research Evidence
Despite the interest in a variety of care models, it is difficult to discern which models work
best. Neither the traditional nor the nontraditional inpatient nursing care models have been
evaluated rigorously for their effects on patient safety.2, 4, 26 Emerging models from other care
disciplines, other settings, and particular patient populations are also lacking rigorous empirical
assessments of their relationship to patient safety.
A number of investigations examining care models addressed nurses’ perceptions of the care
model.1, 27–38 Only two investigations combined the nurses’ perceptions with patient safety
measures.39, 40
Several studies did not meet the criteria for inclusion in this review, largely due to weak
designs. Of these, some reported pilot data,6, 7, 13, 24, 41, 42 some were quality-improvement
projects,14, 17, 43 and others used qualitative methods.32, 36,44–48 Like the quantitative studies, the
rigor of the qualitative investigations varied. However, these qualitative studies illuminate
important aspects of care models not evident in quantitative investigations. For example,
Ingersoll32 and Redman and Jones36 were among the first investigators to assess the effects of
patient-centered care models on nurse managers. The data from both of these studies expose the
pressure and role confusion experienced by nurse managers. Subsequently, a quantitative
investigation found nurse managers experienced a high level of emotional exhaustion, a key
component of burnout.49
Among the quantitative studies of care models included in the evidence table, only one used
a design that combined systematic review and meta-analytic techniques.23 No randomized
controlled trials were identified. The remaining seven studies used Level 3 designs. In two of
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
these studies, large databases were used to examine different care models for home-based long-
term care15 and mental health services.21
All five studies of nursing care models meeting inclusion criteria focused on acute care work
redesigns in which the mix of nursing personnel was altered in some way. For each of these five
investigations, data were reported from only one hospital.39, 40, 50–52 Of these studies, one
evaluated changes in care delivery models at one university teaching hospital with two campuses
in the same city.39 The remaining studies were smaller in scale focusing data collection on
one,50, 51 two,52 or three units40 in the same facility. Most often, measurements were done at three
points in time—pre-implementation, and at 6 and 12 months after the model was
introduced.39, 40, 52
Research Implications
We actually know very little about the relationship between care models and patient safety.
Randomized controlled trials (RCTs) might contribute evidence that would help investigators,
administrators, and policy makers sort through the confusion. RCTs would be particularly
difficult to conduct, however, given the need to have longitudinal data. The rapidly changing
health care environment is not conducive to such endeavors.
2
Care Models
The most glaring need relates to clarifying the work that needs to be done for patients and
then determining which clinicians are best suited to provide it. Looking only at the work of
nurses, which has dominated studies of care models in acute care settings, fails to consider
nonnursing staff who are critical to the patient care mission.
We also know very little about care models that promote patient safety in outpatient settings,
home care, or long-term care. These are areas that remain to be explored.
Conclusion
Care delivery models range from traditional forms, such as team and primary nursing, to
emerging models. Even models with the same name may be operationalized in very different
ways. The rationale for selecting different care models ranges from economic considerations to
the availability of staff. What is glaring in its absence, however, is the limited research related to
care models. Even more sparse is research that examines the relationship between models of care
and patient safety. Ideally, future studies will not only fill this void, but the models tested will be
developed based on a comprehensive view of patient needs, taking the full complement of
individuals required to render quality care into account.
Search Strategy
Both MEDLINE® and CINAHL® databases were searched from 1995 to 2005 to identify
research-based articles published in the English language that were pertinent to this review.
Search terms were identified with the guidance of a reference librarian. The term “care models”
was not a search option in CINAHL®. Therefore the CINAHL® search terms included “care
delivery modules,” “nursing care delivery systems,” and “care modules.” The MEDLINE®
search was based on two terms, “care models” and “organizational models.” Together, these
searches yielded 549 citations, 55 in CINAHL® and 494 in MEDLINE®.
The abstracts for each of the 549 citations were reviewed. From this assessment it was
determined that 82 of the articles were sufficiently focused on nursing or patient care models and
should be considered further. Most of the 467 papers that were omitted used the word “model” in
their title, but the work was not related to care models per se. For example, articles about medical
management models were not used in this review. Additionally, a number of papers addressed
topics with no discernible connection to care models (e.g., life support decisions for extremely
premature infants).
The 82 articles were located and carefully read. As a result, 31 additional papers were
omitted from the actual analysis. Reasons for these omissions included the lack of sufficient
detail about the study, duplicate publications, and studies of advanced practice nurses. This left
51 articles for consideration in this review.
Author Affiliations
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N., colonel, U.S. Army (Retired), and health care
consultant; e-mail: [email protected].
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Acknowledgment
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library for their
considerable support of this work. They conducted the database searches and assisted in
acquiring numerous papers considered in this review.
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6
Table 1. Evidence Table for Care Models
Source Safety Issue Design Study Design, Study Setting & Study Study Intervention Key Finding(s)
Related to Type Study Outcome Population
Clinical Practice Measure(s)
Barkell 200250 Inpatient nursing Pretest (January– Design: Level 3 A surgical unit in a 508- Total patient care. In Pain scores for
work redesign June 1999) and Patient outcomes: bed teaching hospital in this intervention, the postoperative days 1
post-test pneumonia, urinary the Midwest, all patients ratio of RNs to and 2 were higher
(January–June tract infection (UTI), under DRGs 148 (major unlicensed assistive with total patient
2000) (6) postoperative pain small and large bowel personnel increased care (P = 0.017).
perception (Level 2), procedures with as compared to the Pneumonia and UTIs
patient satisfaction comorbidities or ratio in the previous occurred too
complications) & 149 model of team infrequently to
(bowel resection without nursing. The total analyze. There was
complications); 59 budgeted full-time no detectable
patients pre-, 37 employees statistical difference
patients post; 59% decreased with the in patient
female pre- and post total patient care satisfaction.
model.
Benjamin 200015 Home-based long- Cross-sectional Design: Level 3 In-Home Supportive Professional agency Both models had
7
term care (4) Patient outcomes: Services (IHSS) model vs. consumer- positive outcomes.
safety (physical and program in California; directed model Absolute differences
psychological risk, 1,095 IHSS Medicaid were small but
sense of security), beneficiaries with statistically
unmet needs (activities disabilities in significant for safety,
of daily living) (Level 2), professional agency unmet needs, and
patient satisfaction models (PAMs) and service satisfaction,
consumer-directed with the CDM scores
models (CDMs): about more positive.
half the recipients were
over age 65 (50% PAM,
54% CDM), most were
female (77% PAM, 70%
CDM); CDM recipients
had more functional
impairments
Care Models
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Design, Study Setting & Study Study Intervention Key Finding(s)
Related to Type Study Outcome Population
Clinical Practice Measure(s)
Greenberg Changed Nonrandomized Design: Level 3 139 Veterans Service-line Statistically
200321 organizational trial (3) Patient outcomes: Administration Medical organization significant effects
structure continuity of care, Centers; facility-level (interdisciplinary) v. were demonstrated
readmission (Level 2) data for patients profession-based in care continuity
receiving mental health leadership and readmission
services over a 6-year rates within 180 days
period during the first year
after implementing a
mental health
service line. A few
continuity effects
lasted 3 or more
years, but most
positive effects
lasted only 1 year.
Grillo-Peck and Inpatient nursing Pretest (January– Design: Level 3 A neuroscience unit in Nursing partnership The only statistically
8
51
Risner 1995 work redesign June 1992) and Patient outcomes: falls, an 800-bed not-for- model (fewer RNs, detectable
post-test medication errors, profit hospital in Ohio, more unlicensed differences related to
2
(January–June procedure errors, all patients under DRG assistive personnel) fewer falls (Χ =
1993) (6) nosocomial infections 14 (cerebrovascular 4.77, P < 0.05).
(Level 2), length of stay disease excluding
transient ischemic
attack): 71 patients
pre-, 85 patients post;
56% female
pre-, 55% post
Source Safety Issue Design Study Design, Study Setting & Study Study Intervention Key Finding(s)
Related to Type Study Outcome Population
Clinical Practice Measure(s)
Heinemann Inpatient nursing Nonrandomized Design: Level 3 A 518-bed private, not- Partners in patient Significant
199652 work redesign trial with the same Patient outcomes: falls, for-profit hospital in care (PIPC)— differences between
variables medication errors, Florida, all patients on experimental (pilot) the units were
measured at 3 intravenous (IV) two randomly selected unit; Total patient evident only when
points in time infections (Level 2), medical-surgical units; care—control unit. the ratio of events to
using different patient satisfaction pilot unit had 36 beds patient days was
patients (6 months for general surgery/ examined:
before the trauma patients (M medication errors (P
change, 6 and 12 patient days for a 6- = 0.008) and falls (P
months after the month period = 5,477), = 0.037), but not for
change) (3) control unit had 34-beds IV infections (P =
for orthopedic/trauma 0.309). Patient
patients (M patient days satisfaction scores
for a 6-month period = were higher on the
4,654). pilot unit.
Neumeyer- Models of care for Systematic review Design: Level 1 Only randomized Disease Relative risk (RR) for
23
Gromen 2004 patients with (11) and meta- Patient outcomes: controlled trials management the effect of DMP on
9
depression analysis (1) depression severity published from 1992 to programs (DMP) to depression severity
(Level 1), adherence to 2002; 10 studies met implement guideline- was 0.75 (95%
treatment regimen, the inclusion criteria; driven care confidence interval
(Level 2), patient patients had a mean [CI] = 0.70–0.81, P <
satisfaction age of 43 years, 71% 0.00001). The study
were women, and about with an ongoing
70% were white, 75% intervention over 2
were diagnosed with years showed a
major depression significant advantage
of DMP (RR = 0.44,
95% CI = 0.28–
0.67). Adherence to
medication for at
least 90 days
favored DMP (RR =
0.59, 95% CI =
0.46–0.75, P =
0.00001). The
overall effect for
Care Models
patient satisfaction
favored DMP (RR =
0.57, 95% CI=0.37–
0.87, P = 0.009).
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Design, Study Setting & Study Study Intervention Key Finding(s)
Related to Type Study Outcome Population
Clinical Practice Measure(s)
Seago 199939 Inpatient nursing Cross-sectional, Design: Level 3 A large university Change in care A statistically
work redesign same variables Patient outcomes: teaching hospital with model from primary significant decrease
measured at 3 medication errors, falls, two campuses: patient care to patient- was found only for
points in time pressure ulcers, (Level days—30,462 at time 1, focused care medication errors
using different 2), patient satisfaction 29,584 at time 2, (0.97% before the
patients (6 months 29,210 at time 3 change; 0.78% at 6
before the months, P = 0.016;
change, 6 and 12 0.80% at 12 months,
months after the P = 0.027).
change) (4)
Tourangeau Inpatient nursing Nonrandomized Design: Level 3 A 258-bed acute care Unlicensed assistive Adverse IV
199940 work redesign trial with the same Patient outcomes: IV community hospital in personnel (UAP)-RN outcomes decreased
variables therapy outcomes, falls, Toronto; all patients on partnership model on in all units; falls
measured at 3 medication incidents, three medical-surgical two experimental decreased initially on
10
points in time call bell usage units; the experimental units; Total patient the experimental
using different units had 57 beds care with an all-RN units and then
patients (6–7 (general staff on the control increased; falls
months before the medicine/surgery) and unit declined on the
change, 6 and 12 70 beds control unit at all
months after the (medicine/geriatric measurement points;
change) (3) rehabilitation); the on all units,
control unit had 38 beds medication incidents
(postcoronary) increased from
baseline to 6-months
and then decreased
below baseline; call
bell usage declined
dramatically at 6-
months then
increased to a rate
similar to baseline.
Chapter 20. Leadership
Bonnie M. Jennings, Joanne Disch, Laura Senn
Background
Reports from the Institute of Medicine (IOM) have emphasized that leadership is essential to
achieving goals related to quality care1 and patient safety.2 Leadership is expected from
individuals at all levels of an organization, from the executive suite to those working directly
with patients. Leadership is also expected regardless of where care is delivered—inpatient units,
clinics, settings for ambulatory procedures, long-term care facilities, or in the home.
Because of the breadth and complexity of the literature on leadership, the authors narrowed
the focus to leadership at two distinct levels of health care organizations. First, the literature on
executive leadership was reviewed, with a particular focus on the relationship between the chief
executive officer (CEO) and chief nurse officer (CNO), to examine leadership by individuals
responsible for setting the organization’s vision and direction related to quality of care and
patient safety. Second, an exploration of the literature related to the leadership exerted by nurses
and physicians as co-leaders of the patient care areas—that is, the type of leadership provided by
co-leaders who are responsible for actualizing the vision and creating the local environment in
which care is provided—was conducted.
A search of the relevant literature yielded little useful information on either of these
leadership topics. Studies relating to the CNO or the individual in an equivalent position focused
on hospital directors,3 nursing home administrators,4 CEOs and boards of directors,5 and
CNOs,6–29 with no empirical evidence regarding the CEO-CNO relationship. Thus, the focus on
the CNO shifted to reporting findings regarding the CNO’s leadership style and its impact on the
organization.
On the second level, that of nurse-physician co-leadership, there was a similar void in the
literature. Thus, this chapter describes the very few studies that have examined nurse-physician
co-leadership and reports findings from interventional studies on the broader context of nurse-
physician collaboration and its impact on quality and safety of patient care. Collaboration is
certainly a precursor to nurse-physician co-leadership.
Research Evidence
Executive Level
Only two investigations were found that linked CNO leadership to quality care and patient
safety. A case study was done to examine the influence of the CNO in revitalizing the flagship
hospital of a large, integrated health system.7 Features of patient safety were among the
outcomes evaluated at baseline, 18 months, and 36 months. Patient falls and nosocomial
bloodstream infections declined over time from baseline; patient satisfaction with nursing care
improved. The other investigation examined the relationship of both leadership and
communication to quality care in 15 nursing homes from four States.4 The nursing home
administrators were invited to participate, but the findings did not reflect how many actually
responded. Nonetheless, clinical staff (n = 656) provided important insights regarding what
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
promoted the best care possible. The top three responses regarding what facilitated good care and
what interfered with providing good care were communication, staffing, and leadership. The
study findings were not specific, however, as to whether the participants were addressing
executive leadership.
Studies involving CNOs frequently examined leadership styles and behaviors.
Transformational leadership captured the interest of several investigators.11–13, 21, 23, 24 Although
these studies were often framed to indicate a preference for a transformational style, the findings
reflected that leadership is complex and multidimensional. CNOs typically used combinations of
transformational, transactional, and laissez-faire leadership.13, 21, 23 Moreover, four homogeneous
leadership groupings were found among 84 CNOs based on combinations of high and low
transformational and transactional behaviors.11
The need for a comprehensive assessment of leadership was put into perspective in a study
involving a random sample of 477 CNOs who were members of the American Organization of
Nurse Executives (AONE).21 Both transformational and transactional leadership had a negative
relationship with alienative (unfavorable) organizational commitment among registered nurses
(RNs). However, transactional leadership demonstrated a stronger (r = –0.31; P < 0.01)
association with alienative organizational commitment than transformational leadership (r = –
0.24; P < 0.05).
Other styles of leadership were also assessed; however these findings could not be explicitly
linked to CNOs. Rather, the investigators considered leadership from nurse administrators,
allowing the possibility that participants may have reflected on leadership from nurse managers.
Nevertheless, authoritarian leadership interfered with work empowerment.20 Conversely,
connective leadership—which was largely composed of the elements of transformational
leadership—was predictive of empowerment.18 A study involving 6,526 RNs from Canada
illustrated the need to examine the full repertoire of leadership styles.30 A heretofore
unrecognized leadership style—resonant leadership—lessened the impact of restructuring.
Another approach to assessing CNO leadership was to compare how CNOs perceived their
leadership with how various other individuals perceived the CNO leadership style. These studies,
involving CNO direct reports,11 the individuals to whom CNOs reported (usually the chief
operating officer, COO),13 nurse managers (NMs),15, 19, 21 staff nurses,21 and influential
colleagues,14, 17 further verified the complexities of leadership. For example, although there were
discrepancies between CNOs and their direct reports regarding how often CNOs used
transformational leadership, the direct reports were more satisfied with the CNO leadership style
than the CNOs expected.13 Based on data from the same study, however, no differences in
ratings of work group effectiveness were found, among the three groups (CNOs, direct reports,
CNO supervisors).
NMs (n = 87) who agreed with their CNOs’ (n= 22) leadership style were more likely to be
satisfied with their jobs.15 In another study conducted in a 700-bed acute care setting during an
organizational transition, a rating scale and interviews were used to identify the executive
behaviors that were most important to NMs.19 Although it was not clear whether CNOs per se
were considered, communication and high visibility on work units were the top 2 of the 10 most
desired behaviors.
A study of nurse leadership in four hospitals—two with Magnet status and two without
Magnet status—found that leadership affected staff nurse job satisfaction.25 Based on survey
responses from 305 staff nurses and interviews with 16 nurse leaders, some of whom were
CNOs, the investigator concluded that staff nurses were more satisfied when nurse leaders were
2
Leadership
visible and responsive, when they supported autonomous decisionmaking, and when there was
adequate staffing.
Another group of studies examined skills essential to being a successful CNO, especially
given how the role is changing.8, 10, 17, 27, 28 For example, in a study conducted in one U.S. city
involving CNOs and female leaders in other fields, six categories of essential leadership skills
were identified: (a) personal integrity, (b) strategic vision/action orientation, (c) team
building/communication, (d) management and technical competence, (e) people skills, and (f)
personal survival skills.10 A Delphi study conducted in 22 European countries identified 16
relevant CNO qualities.17 Communication ranked first, followed by teamwork, leadership,
strategic thinking, political astuteness, professional credibility, integrity, personal qualities,
innovation, decisionmaking, promotion of nursing, research skills, physical characteristics,
information handling, good management, and conflict resolution. The rankings from a European
study differed from rankings derived from a U.S. study in which clinical knowledge ranked first
of 14 items, communication ranked eighth, and teamwork was not in the rankings.8 Attributes of
successful nurse leadership in acute care settings were compared between 16 leaders at Magnet
(n = 7) and non-Magnet hospitals (n = 9).27, 28
Additionally, researchers have found that organizational characteristics such as culture and
size may alter the expression of leadership.13, 27 Gender is another factor that has been assessed
regarding CNO leadership. In one study, gender was deemed irrelevant because of the effective
way in which the hospital leadership teams interacted.27
A final set of studies concerning CNOs provided evidence using qualitative
methods.6, 9, 16, 24, 26, 29 Some of these studies were conducted to delineate key executive
leadership characteristics.24, 26 For example, based on interviews with 10 CNOs, key
characteristics included knowing how to use power; being visible; having a vision for the
organization; motivating staff; empowering staff; and being open, honest, and personable.24
Similarly, 16 nurse leaders—some of whom were CNOs—from four acute care hospitals were
interviewed to identify effective leadership traits.26 The categories that emerged were (a) core
principles and value system guiding leadership (e.g., leading to serve, striving for excellence, a
passion for nursing); (b) use of quantitative data to influence decisionmaking; and (c)
collaborative teamwork among patient care staff to provide excellent care, and among
management to support one another and staff. Findings from other qualitative investigations
included a serendipitous finding about obstacles CNOs face in all aspects of their work;9
determining CNO leadership behaviors across three hierarchical domains of leadership: strategic,
organizational (administrative management), and production (creating goods and services);16
how the merger of business (managed care) and medicine widened the gender gap in health care
leadership;6 and thought processes used by expert CNOs in making decisions.29
Nurse-Physician Co-Leaders
While there is a growing body of research described later in this chapter on the impact of
collaboration between nurses and physicians who are caregivers,31–45 there is a notable absence
of research on the impact of a collaborative relationship between the nurse and physician co-
leaders of patient care units. Presented in this section is a brief history of the concept of partnered
leadership and a description of the one study found on this specific type of nurse-physician
relationship.
The importance of a focus on collaboration and partnered leadership between nurse and
physician is not a new concept, but rather one that has been in the literature for more than 25
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
years. In 1981, the National Commission on Nursing urged trustees and administrators to
“promote and support complementary practice between nurses and physicians” and to “examine
organizational structure to ensure that nurse administrators are part of the policymaking bodies
of the institution and have authority to collaborate on an equal footing with the medical leaders
in the institution”46 (p. 62). Similarly, the Joint Commission (formerly the Joint Commission on
Accreditation of Healthcare Organizations, JCAHO) required that activities of critical care units
be guided by a multidisciplinary approach, including nursing and medical input.47 Shortly
thereafter, the American Association of Critical Care Nurses and the Society of Critical Care
Medicine jointly developed a position statement outlining 10 principles for optimizing resources
in critical care units. While all of the principles reflect a commitment to medical and nursing co-
leaders, the following two are particularly relevant48 (p. 43).
• #1—Responsibility and accountability for effective functioning of a critical care unit
must be vested in physician and nurse directors who are on an equal decisionmaking
level.
• #10—Close collaboration between the directors is essential for successful management.
More recently, Gilmore49 has advanced the concept of productive pairs. He noted that as
organizations become increasingly complex with rapid change, leaders are less able to possess all
of the knowledge and expertise needed. Thus, a model of leadership that is based on a
partnership between two individuals who share common goals and come from different, yet
complementary, disciplines could be very effective.
Productive pairs possess several characteristics: separate, yet complementary, bodies of
knowledge; understanding and valuing each other’s areas of expertise; enough time or history
together to explore the interdependencies; trust of one another that enables direct, frank
exploration of issues; a commitment to the partnership and avoidance of efforts at triangulation;
and a shared passion for a common goal or vision.
One study that specifically examined how physician leaders and nurse administrators worked
together was by Tjosvold and MacPherson.50 Physician and nursing administrator pairs were
interviewed on how they worked together in managing areas within the hospital. Incidents they
used to describe their relationship were coded as cooperative, competitive, or independent, and
then related to outcomes.
Incidents in which goals were cooperative were ones in which physicians and nurse
administrators discussed their issues constructively, had positive effect, strengthened their
relationship, made progress on the task, promoted the organization’s effectiveness, developed
confidence in future work, and fostered quality care. Incidents in which goals were competitive
were negatively related to productive interaction and outcomes. When the partners felt
competitive, they were unable to exchange ideas openly, initiatives did not progress, and the
relationship and quality of care were compromised. Constructive controversy (open-minded
discussion, occurring within a strong cooperative context, or various perspectives that allow
disagreement and exploration in a respectful manner) enabled the pairs to discuss their views
productively and resulted in constructive outcomes. On the other hand, when constructive
controversy occurred in a competitive context, problems ensued, such as resistance, a close-
minded discussion of ideas, and an impaired working relationship.
4
Leadership
Nurse-Physician Collaboration
As a backdrop for considering collaboration between nurse and physician leaders of the team,
we examined the research on collaborative relationships between nurses and physicians.
Collaboration is the “process of joint decision making among independent parties involving
joint ownership of decisions and collective responsibility for outcomes. The essence of
collaboration involves working across professional boundaries”31 (p. 186). Assumptions have
been advanced that greater collaboration between nurses and physicians results in improved
quality of patient care.
One of the first, and most often cited, studies on collaboration was conducted by Knaus,
Draper, Wagner, and Zimmerman in 1986.32 These researchers analyzed patient outcomes in 13
intensive care units (ICUs) and found a significant relationship between the presence of excellent
interaction and coordination of care among nurses and physicians and improved patient
outcomes. In subsequent work, Shortell, Zimmerman, and Rousseau 38 looked at communication
and coordination in 42 ICUs, but they were unable to differentiate ICUs according to risk-
adjusted survival. However, these researchers noted that communication and coordination helped
decrease length of stay.
Baggs and others34, 35 investigated the perceptions of physician-nurse collaboration and either
negative outcomes (e.g., death or readmission to the ICU) or the transfer of patients from the
ICU to an area of less intensive care. In the first study of one ICU,34 these researchers found that
the more collaboration nurses reported, the lower the risk of a negative patient outcome. In the
second study in three different types of ICUs,35 reports of collaboration by nurses in the medical
ICU correlated significantly with patient outcomes: When the nurse reported full collaboration,
the patient’s risk of negative outcome was 3 percent; when the nurse reported no collaboration,
the patient’s risk increased to almost 14 percent. These findings were not observed in the surgical
ICU or the community hospital ICU. Interestingly, in both of the studies, the reports of
collaboration by attending physicians and residents were not associated with patient outcomes in
any site. Differences in perceptions about collaboration have been found by other researchers as
well, with physicians consistently perceiving higher levels of collaboration than nurses.33, 40, 43 A
study by Hojat and colleagues39 in Mexico, however, found the opposite.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Nurse-Physician Collaboration
On behalf of the Cochrane Collaboration, Zwarenstein and Bryant51 completed an
international review on collaboration and found several hundred studies on the topic. After
examining the abstracts, these colleagues reviewed the full text of 31 studies and found three
studies that were “methodologically adequate and evaluated relevant interventions”51 (p. 4),
although one study eventually had to be excluded because it was difficult to sort out the impact
of combined interventions.52 The first retained study by Curley and colleagues53 used a
randomized, controlled method to examine the impact of interdisciplinary rounds on aspects of
inpatient care. These researchers found a shorter length of stay (5.46 vs. 6.06 days) and lower
total charges ($6,681 vs. $8,090) for patients receiving care from the interdisciplinary team.
The second retained study at a Thai academic hospital54 compared average lengths of stay for
females in a control ward with those for females in a second ward in which frequent rounding
and weekly team case conferences occurred. There were no significant differences found,
although patients in the interventional ward had shorter lengths of stay, when patients who died
while in the hospital were excluded. These studies are reported in Evidence Table 2.
The inclusion criteria for the Cochrane Collaboration report were very restrictive and the
results do not provide health care leadership with enough relevant information to guide quality
improvement projects. However, a recent critical review55 was completed that incorporated a
wider range of methodological designs to help illuminate findings from experimental research on
the impact of nurse and physician collaboration on quality and safety of patient care.
The review was limited to outcome-based experimental studies completed in the United
States that focused on the acute care setting and nurse-physician collaboration. Seventeen studies
met the inclusion criteria,31, 37, 53, 56–69 and the findings from this review demonstrated that
outcomes could be grouped into three categories: professional outcomes, organizational
outcomes, and patient outcomes.
Professional outcomes were measured in several different ways, but the most frequent
evaluation was in communication skills. Other areas measured were teamwork, leadership, job
satisfaction, and collaboration. Organizational outcomes were very straightforward and consisted
of only three major types: length of stay (LOS), readmission rates, and hospital costs. Eight of
the studies that were reviewed focused on patient outcomes. Patient care outcomes ranged from
anxiety, depression, and pain to functional status, length of time on a ventilator, and diabetes
management. Usually the data collected were from medical records and interviews with patients
or their proxies and could be considered reasonably reliable.
The types of interventions used to improve collaboration had four basic threads:
interdisciplinary rounding, development of protocols, staff education of patient care guidelines,
and easier access to information at the patient’s bedside. These threads are closely related to the
attributes of collaboration: people working together, cooperation, sharing responsibility in
decisionmaking, communication, and coordination of care.
The studies that surveyed health care providers’ perceptions used a little broader spectrum of
interventions. Similarities were in the use of patient rounds, patient care guidelines, and
increased access to patient information. But these studies employed other interventions that
included such things as establishing contacts with key stakeholders to discuss roles and
responsibilities, appointing more physician helpers (NPs), appointing medical directors,
providing classes on the processes of communication and teamwork, and restructuring of the
organization to decentralize professionals. One study,61 which identified nine significant
6
Leadership
findings, employed a high-quality, randomized controlled design that used five interventions to
achieve its results: (1) daily review by medical director of medications and procedures; (2) daily
rounds by multidisciplinary teams; (3) daily assessments by nurses; (4) protocols to improve
patients’ self-care; and (5) early, ongoing emphasis on returning home. The design and
interventions of this complex study were well thought out, and the study subsequently
demonstrated significantly improved patient outcomes in very elderly (older than 70 years), frail
patients, as well as improvement in organizational outcomes. Details of the 17 studies are in
Evidence Tables 2 and 3.
It is apparent that there is a dearth of methodologically sound studies on nurse-physician
collaboration. While nurses and physicians universally acknowledge the importance of
collaboration, we actually know very little about what it is, how it works, and whether it makes a
difference. Furthermore, we have some evidence to suggest that nurses and physicians define
collaboration differently and use different criteria to assess whether it’s present.33, 40 To a large
extent, this is because collaboration is part of a complex set of related concepts, often defined
and operationalized very differently, e.g., as teamwork,36, 70, 71 collegiality,45, 72
communication,73–75 trust,31, 76 and coordination.32, 38
Additional challenges to establishing a strong evidence base include the following:
• Current studies focused on only one of several possible interconnecting factors. Without
adequate theoretical frameworks or sophisticated methodology, it is difficult to sort out
the contributions of individual factors in a complex situation.
• Studies typically focused on interventions within one or a few patient care areas, and
usually within one institution.
• Outcomes measured tended to be objective and easily quantifiable, such as length of
stay,53 cost,53 mortality,32, 34, 35, 38, 57 or readmission rates,34, 35 which are certainly
important. However, we also need more studies on some of the more qualitative
outcomes, such as patient satisfaction and morbidity, staff morale and retention, and
patient safety.
Findings indicated only one study that specifically targets the physician and nurse as co-
leaders,50 and this was a correlational study in British Columbia. A second study, by Boyle and
Kochinda,74 implemented a collaborative communication intervention to ICU nursing and
physician leaders, along with several other identified leaders such as the clinical nurse specialist,
in two diverse ICUs, using a pretest–post-test, repeated measures design. The intervention
included a series of educational and experiential modules, yielding improved communication
skills, leader satisfaction, and perceived problem-solving ability. Though this study included
nursing and physician leaders, several other individuals were included in the intervention and did
not target or emphasize the special role of the clinical co-leaders.
Why are there so few studies examining the relationships between and impact of co-leaders
in health care, given the extensive emphasis on leadership in health care today? Dougherty and
Larson77 noted that most research done on collaboration was conducted by nurses, and thus, the
idea of examining aspects of a partnership wasn’t equally valued. Fagin78 noted that physicians
are not interested in interprofessional relationships in general, and that health professions’
curricula do not include sufficient content in this area, although thoughts are changing as the
result of a number of national initiatives to promote interprofessional education and common
competencies.79–82 Two other factors that contribute to this gap are that (1) the role of medical
director as co-leader of a clinical area is not a widespread phenomenon and, if in place, is usually
seen in ICUs, emergency rooms, and other specialty areas; and (2) funding by the National
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Institutes of Health and other major funding agencies follows the biomedical model of health
care research.
Nurse-Physician Collaboration
While the impact of collaboration between nurses and physicians has been studied, we have
scant strong, empirical evidence that collaboration makes a difference. What is needed are
consistent definitions of the concept, use of tools with appropriate psychometric properties to
measure the concepts, interventional studies, and sampling from more than one or a few
organizations.
There is much work to be done, and there are a number of helpful resources for getting
started. The recent work of Gene Nelson, Paul Batalden, and their colleagues83–85 at Dartmouth
and elsewhere on clinical microsystems provides a framework for examining the role of
leadership in the patient care area. Ingersoll and Schmitt86 wrote a comprehensive review of the
literature on work groups and patient safety that highlights teamwork, collaboration,
communication, and other relevant concepts. Dougherty and Larson77 recently reviewed the
scope, psychometrics, and use of five instruments that have been used to measure nurse-
physician collaboration; while the instruments differ significantly from each other, the authors
concluded that they offer a good starting place for aiding future research.
A final comment and return to an original point: In addition to research needed on nurse-
physician collaboration, significant attention must be paid to examining the experience and
impact of nurses and physicians functioning as co-leaders of clinical areas. What are the factors
that enhance their ability to model collaboration and co-create healthy work environments that
benefit patients, families, and all members of the health care team? What are the barriers? What
are individual, institutional, and societal strategies that can be implemented to a healing
environment for patients, families, and all caregivers?
Acknowledgments
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library for their
considerable support of this work. They conducted the database searches and assisted in
acquiring numerous papers considered in the review of leadership at the executive level.
8
Leadership
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satisfaction of nurses in Magnet and Nonmagnet
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Adm 1995;25(7/8):24-31. 26. Upenieks VV. What constitutes successful nurse
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27. Upenieks VV. Nurse leaders’ perceptions of what 40. Rosenstein AH. Nurse-physician relationships: impact
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A controlled clinical trial of multidisciplinary team seamless service system from hospital to home: the
approach in the general medical wards of NICU training project. Infants Young Child
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12
Evidence Table 1. Findings on Impact of CNO Leadership Style
Source Safety DesignType Study Design, Study Setting & Study Study Key Finding(s)
Issue Outcome Population Intervention
Related to Measure(s)
Clinical
Practice
Dunham- Leadership Cross- Design: Level 3. National study from all States; Comparing There was a significant difference in
Taylor 200013 sectional (4) Outcomes: CNO 396 CNOs, at least 3 direct scores on how CNOs rated themselves and the
leadership style, reports for each CNO (N = leadership ratings from their direct reports for
work group 1,115), CNO’s boss (N = 360); styles, transformational, transactional, and
effectiveness. most CNOs were married workgroup laissez-faire leadership. No statistically
(77%) females ((93%) in their effectiveness. significant differences were found
40s (54%) with a master’s among CNOs, their direct reports, and
degree (61%). On average, CNO bosses in regard to work group
they had 24 years experience effectiveness. Staff were more satisfied
in nursing and 9 years in with the CNO leadership style than the
executive positions. Direct CNO expected. Organizational
reports and boss characteristics played a role with more
characteristics were not transformational CNOs in organizations
described except to note that that were participative.
most bosses were COOs.
13
Leadership
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety DesignType Study Design, Study Setting & Study Study Key Finding(s)
Issue Outcome Population Intervention
Related to Measure(s)
Clinical
Practice
Leach 200521 Leadership Cross- Design: Level 3. A national random sample of Leadership CNOs and NMs had a leadership
sectional (4) Outcomes: CNO AONE members working and nurses’ profile that illustrated elements of both
Organizational in hospitals and a convenience organizational transformational and transactional
commitment sample of NM (n = 148) who commitment. leadership. Both styles of leadership
which was reported to the CNO and 651 showed a negative and statistically
assessed staff nurses who reported to a significant relationship with alienative
according to 3 participating NM. CNOs from organizational commitment. Both
types-moral 35 States returned 102 usable leadership styles were positively and
(normative, surveys. All but one CNO were statistically significantly for CNOs and
internalized women. They had more than NMs. No relationship was found
identification), 15 years experience in nursing, between NM and staff nurse
calculative and 70% had more than 15 organizational commitment.
(remunerative or years experience in
compliance), management. Almost 80% had
and alienative master’s degrees. NMs were
(negative mostly women (95%). Most had
resistance). been in nursing for more than
14
Source Safety Issue Design Study Study Setting & Study Study Key Finding(s)
Related to Type Design, Population Intervention
Clinical Study Outcome
Practice Measure(s)
Curley 199853 Collaboration Randomized Variables Medical unit inpatients at Interdisciplinary Significant increase in provider
controlled measured were large county hospital rounds—MDs, satisfaction and perceived
trial–6 month length of stay affiliated with university; RN (patient care collaboration in the areas of
prospective (LOS), hospital used a 30-bed nursing unit; coordinator), understanding patient’s plan of care,
trial, with charges, each firm had 25 attending pharmacist, communication, and teamwork. Some
patients provider physicians and 25–30 nutritionist, and decreases in LOS, readmission rates,
randomly satisfaction, residents. social worker and hospital costs.
admitted to ancillary service 1,102- total number of daily rounding;
different doctor efficiency, patients: orders written
groups readmission 535 in control group during rounds;
(Firms). rates, and quality 567 in intervention group chart taken with
of patient care. MD on rounds.
Using hospital
billing system,
medical records,
15
and surveys.
Leadership
Evidence Table 3. Outcome-Based, Experimental Studies Focused on Increasing Collaboration between Nurses and Physicians
collaboration convenience monitoring; nutrition to a 16-bed ICU, study design, assessment, insulin
sample, repeated assessment; community organization, and management, and
measures done insulin management; hospital; implementation of hyperglycemia control.
quarterly; for 11- change to glucose 65 eligible a performance
month period. intolerance enteral formula 35 participants improvement
as recommended by who met criteria. initiative using the
protocol; Plan/Do/Check/Act
using medical records process: a group
review. formed; critical
blood glucose
levels defined;
interventions
defined.
Source Safety Issue Design Study Study Setting & Study
Related to Type Design, Study Intervention Key Finding(s)
Clinical Study Outcome Population
Practice Measure(s)
Lassen 199758 Nurse- Design – Variables measured were 350-bed tertiary Protocol Decrease in patient anxiety
physician retrospective and quality of patient care; hospital. development for and confusion; significant
collaboration prospective costs; length of stay (LOS), All children management of decrease in cost and LOS,
comparisons of number of antibiotics admitted with rule-out sepsis – and mixed results in
patient charts 1 received, and readmissions sepsis during Education of RNs readmission rates.
year prior to rates. study period. and MDs in the
intervention, right Using medical records nursery for 3
after intervention, review. months.
and then 1 year
after intervention,
for a 3-month
period of time
during each
interval.
Jordan-Marsh Nurse- Pre- and post- Variables measured were Patients on a Multifocal Decreased reports of pain by
200459 physician intervention data documentation of pain; pediatric ward in approach for QI- patients; increased evaluation
collaboration collection, total 14 evaluation of effectiveness; large urban Referral book; of effectiveness; and
quarters; 2–8 were improved pain hospital. resident experts; improvement of pain
17
Leadership
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Study Setting & Study
Related to Type Design, Study Intervention Key Finding(s)
Clinical Study Outcome Population
Practice Measure(s)
Kollef 199760 Nurse- Randomized Variables measured were In medical ICU Protocol-directed Significant decrease in
physician controlled trial duration on mechanical and surgical ICU weaning from duration on mechanical
collaboration during a 4-month ventilation; need for in 2 teaching mechanical ventilation; decreased costs
period; reintubation; hospitals; ventilation and LOS; and mixed results
stratification LOS; hospital mortality 4 units total. developed by with readmission rates.
according to ICU rate; and cost. 377 total medical director;
site. Using medical records 179 intervention education of
review. group (protocol nursing and
directed) respiratory staff
178 control group before
(physician implementation.
directed)
Landefeld, Nurse- Randomized 17 different measures >70 yr, admitted Daily review by Numerous quality of patient
199561 physician control trial – looking at ability to perform to general medical medical director of care outcomes were
collaboration randomly assigned ADLs – using different time unit meds and significant; also found a
to acute care frames, controlling for risk 651 total procedures; decrease in cost and LOS,
program for elderly factors; plus LOS and 327 intervention daily rounds by and a mixture of results for
or usual care. costs. group multidisciplinary readmission rates.
18
collaboration control and 1 NPs, RNs; communication; units; no of hospitalist had better communication
intervention unit; LOS; cost and readmission crossover medical director; only with NPs; MDs had
over a 2-year rates. between units institution of daily better communication with
period. Using surveys of nurses with MDs or RNs; multidisciplinary fellow MDs and NPs, and
(biannually); attending MD staffing and rounds–lasted 15 increased collaboration
(every 2 weeks), demographics of minutes per team. amongst themselves.) Some
and residents patients and decrease in LOS and hospital
(every month). nurses same costs; and mixed results for
between units. readmission rates.
House staff – 111
(58%)
Attending
physicians –
45 (69%)
Nurses –
123 (91%)
Leadership
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Study Setting & Study
Related to Type Design, Study Intervention Key Finding(s)
Clinical Study Outcome Population
Practice Measure(s)
Trey 199663 Nurse- Descriptive, Variable measured was Ambulatory care Clarification, Nurse manager reported that
physician retrospective clarity of roles. center of a large discussion, and intervention helped nurses
collaboration Using nurse manager’s teaching hospital. resolution of identify MD and RN
report. Nurses, surgeons ambiguous roles. responsibilities.
and anesthesia Job descriptions of
staff; no size nurse manager
given and medical
director were
written and
implemented.
Dechairo- Nurse- Pre- and post-test, Variables measured were RNs working on 3 Activities – Significant increase in
Marino 200164 physician intervention study perceived collaboration medical-surgical developed the perceived level of
collaboration – scores and satisfaction units and 2 ICUs; Operating collaboration and the nurses’
convenience with decisionmaking. 87 pretest obtained satisfaction with
sample. Using Bagg’s Collaboration 65 post-test; endorsement; decisionmaking process.
Surveyed at and Satisfaction about approx 50% incorporated
baseline and 1 Care Decisions response rate: principles into unit
month prior and 3 questionnaire (adapted 60% attendance activities; offered 4
20
Leadership
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Study Setting & Study
Related to Type Design, Study Intervention Key Finding(s)
Clinical Study Outcome Population
Practice Measure(s)
Narasimhan Nurse- Prospective, Variables measured were 16-bed medical Daily goals Increased perception of
200668 physician quasi- staff’s level of ICU, closed unit worksheet that collaboration (i.e.,
collaboration experimental, with understanding goals for the RNs – included consents, understanding patient goals
testing at baseline, day; communication; desire baseline – 21 tests, medications, and communication process)
1 week, 6 weeks, to continue to use 6 wk – 14 sedation, for both RNs and MDs.
9 months after worksheet; and belief the 9 mo – 18 analgesia
implementation of worksheet had a positive MDs – catheters,
intervention. effect on patient outcomes. baseline – 12 consults, nutrition,
Using surveys. 6 wk – 14 mobilization,
9 mo – 17 family discussions,
Response rate not and dispositions
given. (not part of the
Medical Record).
Lorenzi 199369 Nurse- Single group pre- Variables measured were 42 eligible Education Significant improvement in
physician and post-test job satisfaction; level of 18 participants program for collaboration with MDs, and
collaboration design, repeated nurse-physician 40% response nurses; 10 hours an increase in job satisfaction
measures at collaboration; broad rate of sickle-cell for RNs. Demographic
baseline, 3 knowledge base of sickle- disease process, variables were significant for
22
Leadership
Chapter 20a. [Vignette] Transforming Health Care for
Patient Safety: Nurses’ Moral Imperative To Lead
Diana J. Mason
Background
On July 16 and 17, 2004, the American Journal of Nursing, University of Pennsylvania
School of Nursing, Hospital at the University of Pennsylvania, and Infusion Nurses Society held
an invitational State of the Science Symposium on Safer Medication Administration in
Philadelphia. Funded by a small conference grant from the Agency for Healthcare Research and
Quality (AHRQ grant no. 1 R13 HS14836-01) and educational grants from industry, the meeting
brought together diverse health care professionals and groups —nurse clinicians, educators,
administrators, and researchers; pharmacists; physicians; industry representatives; consumers;
and professional organizations—to examine the current research on safe medication
administration, barriers to improving the integration of this research into practice, and
recommendations for overcoming these barriers.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
sometimes introduces errors, often because of factors such as inadequate training of the users of
the technology and poor communication.2–4 At a national nursing conference in 2003, some of
the companies that make bar-coding technology and advanced intravenous pumps (referred to as
“smart pumps” because of their ability to track and report data about their use) noted that nurses
often develop work-arounds when they believe that the technology is not efficient. For example,
one company representative said that some nurses using his company’s bar-coding technology
would print out a list of all of the unit’s patients with their bar-codes, then swipe these bar-
codes—instead of the one on the patient’s wristband—against the medication bar-codes, clearly
defeating the purpose of the bar-coding technology. In the nurses’ eyes, they were making more
efficient a process that they viewed as cumbersome and time consuming.
Technology’s absence from the research priorities and barriers also reflects the pressing
reality of working nurses: too many work in environments that give lip service to patient safety,
but seldom recognize that nurses are the key to quality and safety. Technology alone will not
make patients safer. We must focus on decisionmaking and communication if patients are to be
safer.
Defining “Error”
While companies work on developing cutting-edge technologies and health care facilities
focus on root-cause analyses and systems of care, Cook and colleagues5 found that health care
workers don’t even agree upon what constitutes an error. * In the landmark report, To Err Is
Human: Building a Safer Health System, error is defined as a “failure of a planned action to be
completed as intended or the use of a wrong plan to achieve an aim”6 (p. 3). But Cook and
colleagues found that nurses, physicians, pharmacists, and administrators don’t all embrace this
definition. Their findings suggested that the staff may “fail to appreciate complex, less easily
categorized” errors. Indeed, many reported that they were reluctant to identify diagnosis and
treatment errors as such. In fact, one glaring theme of this research was that nurses’ actions can
lead to errors, but physicians make “practice variances.” These “practice variances” were also
referred to as “suboptimal outcomes” or “differences in clinical judgment,” not errors. Some of
the practice variances or suboptimal outcomes included
• Delays in treatment
• Use of outmoded treatments
• Failure to employ necessary diagnostic tests
• Failure to act on the results of tests
• Errors in administration of treatment
• Failure to communicate with staff and patients
Note that this variance in the definition of error occurred despite respondents reporting that their
facilities were genuinely concerned about safety (90 percent of all respondents) and didn’t
punish people who reported safety discrepancies (94 percent).
2
[Vignette] Transforming Health Care
found that only 8 percent of physicians viewed nurses as key members of the decisionmaking
team in their institutions. And in their 2004 study, Cook and colleagues5 reported that 96 percent
of nurses and more than 90 percent of all others viewed nursing as having primary responsibility
for patient safety. How can nurses be responsible for patient safety if they don’t feel safe in
challenging a physician’s order?
Cook and colleagues5 found that nurses were reluctant to discuss physician “practice
variances” or errors with them because of nurses’ perceived lack of authority to question the
physician, a desire to maintain collegial relationships with physicians, prior experience with
being rebuffed by a physician when the nurse questioned a medical practice, and a lack of
support from administration when nurses do question or challenge physician practice.
The administrators’ views of the situation supported the nurses’ perceptions. Administrators
believed that administrators had a limited role in questioning medical practice because of their
own lack of clinical expertise. “According to many administrators, the responsibility for
determining that an error has occurred rests with the physician”5 (p. 36, 39). And pharmacists
concurred that, while they were confident in their ability to recognize errors, they acknowledged
that “differences among the four professions concerning definitions of error and scope of
practice limit their ability to record problems as errors or initiate procedural changes”5 (p. 39).
The participants in the study by Cook and colleagues5 acknowledged that a lack of consensus
about what constitutes an error leads to an underreporting of errors. As one nurse participant
noted, “The physician told me it’s not an error, so we don’t need to file an incident
report”5 (p. 40), illustrating the relationship between agreed-upon definitions of error and the
willingness to document, correct, or prevent errors. How can safe systems of care be developed
to avoid more complex errors involving diagnosis and treatment if physicians define such
mistakes as “practice variances” rather than errors, and others are not willing to correct this
misconception?
Communication
Interdisciplinary communication is crucial to patient safety. In 1986, Knaus and colleagues8
reported in the Annals of Internal Medicine that nurse-physician communication was the single
most important predictor of mortality rates in 13 intensive care units in academic medical
centers. But the study did little to prompt a concerted effort to improve such communications.
Rosenstein and O’Daniel9 reported on a convenience survey of 1,500 VHA † nurses and
physicians. The survey found that 75 percent of respondents had witnessed “disruptive behavior”
by physicians, and 68 percent had witnessed such behavior by nurses. Furthermore, 17 percent
reported that adverse events occurred as a result of the disruptive behaviors. Some of the
participating physicians said that nurses’ reports of the patients’ conditions are sometimes
frustratingly inadequate.9 On the other side, nurses reported that they will not call abusive
physicians about their patients. Consider the following quotes from nurses in this study”9 (p. 61-
62):
• Delay in patient receiving meds because RN was afraid to call the MD.
• Most nurses are afraid to call Dr. X when they need to, and frequently won’t call. Their
patients’ medical safety is always in jeopardy because of this.
• Adverse event related to med error because MD would not listen to the RN.
†
VHA, formerly Voluntary Hospital Association, is a national consortium of nonprofit hospitals and medical
practices.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• RN did not call MD about change in patient condition because he had a history of being
abusive when called. Patient suffered because of this.
• RN called MD multiple times re: deteriorating patient condition. MD upset with RN
calling. Patient eventually had to be intubated.
• Poor communication post-op because of disruptive reputation resulted in delayed
treatment, aspiration, and eventual demise.
4
[Vignette] Transforming Health Care
In April 2006, Trinkoff and colleagues11 reported on a work patterns survey of randomly
selected nurses in two States funded by the National Institute for Occupational Safety and
Health, adding to our understanding of the extent to which nurses are working unsafe hours and
schedules. A significant portion of the respondents worked more hours than has been
recommended by the Institute of Medicine: 28 percent worked 12 or more hours per day,
including 52 percent of hospital staff nurses; 33 percent worked more than 40 hours a week; and
17 percent worked mandatory overtime. Furthermore, 19 percent of respondents worked more
than one job. In this group, 37 percent worked 12 or more hours a day, 45 percent worked more
than 40 hours a week, and 18 percent worked 6 or 7 days a week.
The Institute for Women’s Policy Research12 notes that hospitals have resorted to unsafe
staffing practices (understaffing, overtime, use of contingency workers, and one-time bonuses for
new hires) instead of wage increases in response to their inability to recruit sufficient numbers of
nurses. Yet nurses who volunteer to work two jobs or extended work hours are associated with
fatigue and subsequent errors, compromising patient safety. Nurses must continue to push for
institutional and public policies that will support safer work environments, including adequate
staffing ratios (for example, through legislating minimum ratios or transparency in public
reporting of ratios, and through union contracts that set ratios or require that bedside nurses be
involved in staffing decisions), elimination of mandatory overtime, and whistle-blower
protections.
Conclusion
The current spotlight on patient safety provides nurses with an opportunity and the moral
responsibility to call for changes in health care facilities’ policies and operations that we know
are detrimental to the safety of patients. The challenge is for all nurses to seize this opportunity.
TCAB and other quality improvement initiatives provide nurses with the support and tools for
leading changes in their workplaces. Nurse administrators must model leadership behavior if
their staffs are to lead on the unit level. Nurses have a moral imperative to act on behalf of their
patients. Anything less violates the patient advocacy mantle that we claim as a core nursing role.
Author Affiliation
Diana J. Mason, R.N., Ph.D., F.A.A.N., editor-in-chief, American Journal of Nursing; e-
mail: [email protected]
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
References
1. Barnsteiner JH, Burke KG, Rich VL, eds. The state Institute of Medicine. Washington, DC: National
of the science on safer medication administration. Academy Press; 2000.
Am J Nur 2005 Mar;3 (Supplement):1-56.
7. Cook AF, Hoas H. Voices from the margins: a
2. Ash JS, Berg M, Coiera E. Some unintended context for developing bioethics-related resources in
consequences of information technology in health rural areas. Am J Bioeth 2001 Fall;1(4):W12.
care: the nature of patient care information system
related errors. J Am Med Inform Assoc 2004 Mar- 8. Knaus WA, Draper EA, Wagner DP, Zimmerman JE.
Apr;11(2):104-12. An evaluation of outcome from intensive care in
major medical centers. Ann Internal Med1986;
3. Miller RA, Gardner RM, Johnson KB, et al. Clinical 104(3):410-8.
decision support and electronic prescribing systems:
a time for responsible thought and action. J Am Med 9. Rosenstein A, O’Daniel M. Disruptive behavior and
Inform Assoc 2005 Jul-Aug;12(4):403-9. clinical outcomes: perceptions of nurses and
physicians. Am J Nur 2005;105:54-64, quiz 64-5.
4. Nelson NC, Evans RS, Samore MH, et al. Detection
and prevention of medication errors using real-time 10. Rogers AD, Hwang WT, Scott LD, et al. The
bedside nurse charting. J Am Med Inform Assoc working hours of hospital staff nurses and patient
2005 Jul-Aug;12:390-7. safety. Health Aff 2004 Jul-Aug;23(4):202-12.
5. Cook AF, Hoas H, Guttmannova K, et al. An error by 11. Trinkoff A, Geiger-Brown J, Brady B, et al. How
any other name. Am J Nur 2004 Jun;104(6):32- long and how much are nurses working? Am J Nurs
43;quiz 44. 2006;106(4):60-71, quiz 72.
6. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is 12. Lovell, V. Solving the nursing shortage through
human: building a safer health system. A report of higher wages. Washington, DC: Institute for
the Committee on Quality of Health Care in America, Women’s Policy Research; 2006.
6
Chapter 20b. [Vignette] Who Should Lead the Patient
Quality/Safety Journey?
Joanne Disch
Batalden and colleagues1 remind us that improving quality and safety for patients and
families requires leaders to lead—and that the words leader, leading, and leadership stem from
laitho or laithan, meaning “way,” “journey,” or “to travel.”2, 3 Much has been written about the
need for and characteristics of leadership for this journey.4–8 This section challenges Chief Nurse
Executives (CNEs) to lead the journey and highlights how patients, their families, and health
care organizations would benefit immeasurably if CNEs stepped forward and accepted this
leadership role. There are many examples across the country where this has been exquisitely
demonstrated.
The CNE should lead the journey because the nursing profession has been at the forefront of
assuring quality and safety. Before the first Institute of Medicine study,9 or the Chicago Tribune
article with the headline “Nursing Mistakes Kill Thousands,”10 or the National Patient Safety
Foundation, or the Institute for Healthcare Improvement, there were nurses at all levels in
hospitals and health care organizations concerned about patient safety and quality of care. For
decades, nursing leaders like Marie Zimmer and Norma Lang have developed and tested quality
indicators. For generations, nurses have taken seriously their Code of Ethics and their role as one
who “promotes, advocates for, and strives to protect the health, safety and rights of the
patient.”11 Florence Nightingale reminded us that “the very first requirement in a hospital [is]
that it should do the sick no harm”12—and proceeded to set up systems and practices that are still
being used today to enhance the quality and safety of patient care.
The CNE should lead the journey because nurses understand what the issues are. While many
physicians, administrators, policymakers, and others have come to realize only recently that
health care is frighteningly unsafe, nurses have been raising concerns for many years. Nurses do
not need to be alerted to the dangers of malfunctioning equipment, or the likelihood of
medication error when getting medications ready and being interrupted 16 times, or the safety
threat when orientation to the new computer system is inadequate, or the potential for serious
injury to the patient and self when struggling to lift a 287 pound patient. Nurses are there 24/7
and, through the nursing lens, recognize the system issues, dangerous shortcuts, work-arounds,
and waste.
The CNE should lead the journey because nurses have workable solutions. We recognize the
problems, and we also have solutions. We blend practical wisdom with scientific knowledge and
finely-honed interpersonal skills or, as a Boston cab driver once noted, we’re “caring, shrewd,
and a little bit crazy.” We see the big picture and the details—the interconnectedness among
departments and professions. We understand everything that needs to be done to complete the
job, whatever it is. We are holistic—whether it be caring for a patient in the context of family, or
coming up with a solution to a problem that incorporates the concerns of everyone involved. And
nurses are resourceful. Who else can coordinate the administration of three antibiotics, two units
of packed cells, and four units of platelets; cajole the pharmacist to bring up a missing drug; hunt
down the needed blood filter, extra IVAC, flexicare mattress, cardiac chair for a wife; and find a
nurse to work an extra 12-hour shift for nights—all within an 8-hour period?
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
As leaders within their organizations, CNEs have the background, perspective, and platform
to help their organizations seriously tackle safety issues that jeopardize patient care and that face
nurses and their colleagues daily. They can
• Create a healthy culture that promotes safety, inquiry, continuous learning, and
collaboration.
• Design systems and processes that help people do their best work and deliver quality care
(safe, timely, effective, efficient, equitable, patient-centered).
• Acquire and align resources to get the work done and achieve organizational goals.
• Assure the existence of a professional practice environment that values evidence as a
basis for decisionmaking and the ongoing development of everyone.
• Implement quality and safety programs that are effective, supported, embedded in the
culture, and get the job done.
2
[Vignette] Who Should Lead for Quality/Safety?
Author Affiliations
Joanne Disch, Ph.D., R.N., F.A.A.N., Clinical Professor and Director, Katharine J. Densford
International Center for Nursing Leadership and Katherine R. and C. Walton Lillehei Chair in
Nursing Leadership, University of Minnesota School of Nursing; e-mail: [email protected].
References
1. Batalden PM, Nelson EC, Mohr JJ, et al. 8. Barker AM, Sullivan DT, Emery MJ. Leadership
Microsystems in health care: Part 5. How leaders competencies for clinical managers. Sudbury,
are leading. Jt Comm J Qual and Safety MA: Jones & Bartlett; 2006.
2003:29(6);297-308.
9. Kohn LT, Corrigan JM, Donaldson MS, eds. To
2. Ayto J. Dictionary of word origins. New York: err is human: building a safer health system. A
Arcade-Little, Brown & Co.; 1990. report of the Committee on Quality of Health
Care in America, Institute of Medicine.
3. Barnhart R. Dictionary of etymology. New York: Washington, DC: National Academy Press; 2000.
Chambers; 2000.
10. Nursing mistakes kill, injure thousands. Chicago
4. Yoder-Wise PS. Leading and managing in Tribune, Sept 10, 2000, 1.
nursing, 3rd ed. St. Louis, MO: Elsevier, Mosby;
2003. 11. American Nurses Association. Code of ethics for
nurses with interpretative statements.
5. Dye CF, Garman AN. Exceptional leadership: 16 Washington, DC: ANA, 12.
critical competencies for healthcare executives.
Chicago: Health Administration Press; 2006. 12. Ulrich BT. Leadership and management
according to Florence Nightingale. Norwalk, CT:
6. Cashman K. Leadership from the inside out. Appleton and Lange, 1992, 22.
Provo, UT: Executive Excellence Publishing;
1998.
3
Chapter 20c. [Vignette] Creation of a Patient Safety
Culture: A Nurse Executive Leadership Imperative
Victoria L. Rich
Background
In 2004, the Healthcare Leadership Alliance, which includes the American Association of
Nurse Executives and other health care executives, identified a core set of competencies for
executive leaders in health care.1 The identified core competencies for nurse executives in health
care were: (a) leadership, (b) business skills and principles, (c) communication and relationship
management, (d) professionalism, and (e) knowledge of the health care environment. Patient
safety is identified as a key element of concern in the health care environment. Within the
context of the core five competencies listed above, seven imperatives were identified to develop
a patient safety culture: 1
• To support the development and implementation of an organization-wide patient safety
program
• To design safe clinical systems, processes, policies, and procedures
• To monitor clinical activities to identify both expected and unexpected risks
• To support a nonpunitive reporting environment and reward systems for reporting unsafe
practices
• To support safety surveys, responding and acting on safety recommendations
• To ensure staff is clinically competent and trained in their roles in patient safety
• To articulate and take action in support of the Joint Commission’s National Patient Safety
Goals
These imperatives are the necessary building blocks the nurse executive must communicate
to foster the development of a culture of proactive patient safety. This vignette will first review
the historical background of the evolution of a patient safety proponent. From lessons learned in
the redesign of an entire hospital culture, a model “Systemic Mindfulness Model of Proactive
Patient Safety” is presented. Using a corkscrew metaphor and systems theory, the model
suggests that all levels and professions of the health care culture must become aware and
responsible to achieve meaningful medical error reductions. Practical suggestions are then
offered, which derive directly from the model for achieving and maintaining a culture of
proactive error reduction. The skillful acquisition of the five core competencies and the
implementation of the seven patient safety imperatives are necessary for these practical
suggestions to be truly effective.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
of Betsy Lehman in Boston in the same year, ignited public and regulatory agencies to question
the safety of hospitals.2 In 1996, the Joint Commission (formerly the Joint Commission for
Accreditation of Healthcare Organizations) developed the Accreditation Watch and encouraged
the use of root-cause analysis.3 Subsequently, the Institute of Medicine’s 2000 report, To Err Is
Human, which estimated that 44,000 to 98,000 deaths in hospitals occurred each year due to
medical errors, forced the issue of patient safety into public awareness.
The organizational culture of UCH in 1996, 1 year following the Willie King tragedy, was
defensive and insular to any outside feedback or systems redesign. Nursing practice was
fragmented, and identifying and firing the one employee—usually a nurse—responsible for a
medical or nursing error was the way mistakes were handled.
Due to the negative publicity that the wrong-leg amputation created for the hospital, patients
were unsure of the care they would be given, and trust by local, State, and Federal health care
agencies was at an all-time low. Multiple inspections occurred by the Florida Agency for Health
Care Administration, Joint Commission, Health Care Finance Administration, and Federal Drug
Administration due to the numerous complaints and accusations. Malpractice claims increased
and hospital administrators became adept at giving legal depositions and writing corrective
action plans for the above-mentioned regulatory agencies.
Strong beliefs in patient advocacy and safety, in conjunction with a few visionary colleagues,
supported the work required to make necessary changes, relying on critical-thinking skills, strong
nursing educational background, personal tenacity, and self-reflection. It was not a time to
second-guess personal decisions to practice at UCH, but to become part of a culture of change.
Doctors, nurses, administrators, and all other employees at UCH seemed truly dedicated to
providing safe patient care. Due to the wrong-site event, the culture needed leaders unscathed by
the actual 1995 event to assist in reprioritizing basic patient care measures to reestablish the trust
of the community. The punitive treatment of the entire hospital community by the regulators and
media essentially destroyed the pride and self-confidence of the entire medical and hospital staffs.
To make matters worse, a nurse in the UCH emergency room administered a medication that
was contraindicated for a patient with an aspirin allergy, culminating in the patient’s death.
During this time, the Joint Commission encouraged the use of the root-cause analysis process;
hence, UCH was required to conduct one of the first root-cause analyses of a medical error. A
root-cause analysis was conducted with key pharmacy personnel and administrators, an approach
that was both overwhelming and enlightening. More questions than answers were discovered as a
result of the root-cause drill-down process. The Joint Commission provided further direction, and
the hospitals’ chief operating officer and chief nurse officer were invited to fly to Chicago to
discuss questions with the major creator of the root-cause analysis process, Dr. Richard Croteau.
Patient safety science is an important base of knowledge for nursing leadership. Patient
safety conferences where Dr. Lucian Leape, Don Berwick, and Michael Cohen and their book,
“New Look in Patient Safety,” provide important understanding of latent errors and system
dynamics in medical errors.4–7 An important insight into the most salient insight in the journey
was that the causes of medical errors were complex and did not occur in any predictable and
linear way. Rather, a systems approach to patient safety and the impact of leadership and
communication on the safety processes was needed—instead of focusing solely on the one
person who presumably made the error. Yet, the scarcity of nursing scholars and executives
assuming leadership in the development and design of patient safety science was evident; which
may be why physicians, pharmacists, quality officers, administrators, sociologists, and
information experts became the pioneers for this new frontier in health care.8
2
[Vignette] Nurse Executives and Safety Culture
The extensive experience gained by the entire UCH multidisciplinary team in the 3 years
from 1996 to 1999 culminated in a true success story. The 1999 Joint Commission triennial visit
resulted in UCH earning Accreditation with Accommodation with no citations. This achievement
remains a career hallmark.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Figure 1. Systemic Mindfulness Model of Proactive Patient Safety Using a Corkscrew Metaphor
Blunt End
Leadership
Culture
Communication
Healthcare Systems
Transactions
Clinician-Patient Transaction
Medication Administration
Sharp End
The Systemic Mindfulness Model of Proactive Patient Safety is complex and circular and
must constantly be evaluated. At the blunt end are executive nurse leaders. At the
sharp end are the nurses/clinicians who provide direct care to the patients. (Rich,2005)
Figure 1. Systemic Mindfulness Model of Proactive Patient Safety Using a Corkscrew Metaphor
The corkscrew metaphor (shown in Figure 1) also signifies that the journey to an error
reduction culture is never static, but constantly turning and twisting, and that a steady state of
patient safety can never be obtained without a systemic mindfulness value system that holds both
the sharp and blunt ends personally and professionally accountable for patient safety. As
mentioned, there are seven imperatives that the nurse leader must implement to develop a patient
4
[Vignette] Nurse Executives and Safety Culture
safety culture.1 These imperatives must be initiated by the nurse executive leadership and
communicated from top to bottom.
However, communication between the blunt and sharp ends of the system must be
bidirectional. If nurses feel comfortable reporting near misses in a nonpunitive environment, new
communication channels are developed and new practice procedures are put in place by
leadership. Moreover, decisions made at one level of the system affect all other levels. For
example, a decision to decrease staff made at the leadership level will necessarily affect health
care system transactions and nurse–patient interactions by increasing caseloads and
responsibilities, and thereby potentially increase medical error risk.21
Communication affects health care transactions among health care personnel. For example, it
is imperative that the list of a patient’s medications that is gathered at admission be
communicated effectively to subsequent providers as the patient is transferred between settings
and practitioners extending all the way to discharge.10
Croteau22 refers to the general principles of proactive risk reduction necessary at the sharp
end of care to mitigate error. Leadership involves staff in the development and implementation
of the following principles: (a) retraining and counseling, (b) redoing policies and changing
practices, (c) creating redundancy and double checks, (d) putting in fail-safe systems such as
backup systems, and (e) purchasing more technological solutions.
In summary, the premise behind the model is that each level identified in the spiral must be
addressed and managed to ensure patient safety. A generative culture of systemic mindfulness
and professional accountability is imperative at all levels of the system for system-wide
effectiveness. This infers that everyone’s job is patient safety in all health care system
transactions; this safety mission involves the entire health care team, from the nurse and
physician to the valet parking attendant.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
6
[Vignette] Nurse Executives and Safety Culture
b. Spread positive gossip and the rationale for the purchase of new safety equipment or
process changes that have been implemented. Include nurses in decisions. Celebrate
acquisition of new technologies and changes as key components to creating safe
environments for both the patient and nurse.
c. Develop a scorecard for each nursing unit, reporting clinical outcomes and adherence
to patient safety goals such as patient identification. Establish achievable targets to
share with all staff on a monthly basis.
d. Create evidence-based nurse safety practices that are unit-specific and review and
update on a yearly basis with staff.
e. Establish a communication officer for nursing and publish a monthly newsletter that
includes patient-nurse safety updates from both internal and external avenues.
Circulate to all nursing units the Institute for Safe Medication Practices (ISMP)
monthly newsletter.25
f. Expect new technology to create new, unexpected errors and perform a failure mode
and effects analysis prior to implementation or early on in the adoption phase.26, 27
g. Invite industry partners to open forum lunches with staff nurses to discuss design and
operative concerns of safety devices. Effectuate changes with health care vendors and
purchasing agents.
4. Develop clever reminders for nursing staff that validate their importance in safety, both
for their patients and themselves. An example is the following message attached to the
back of the employee identification badge:
Mindful Practice
It doesn’t matter how good we are if we are not paying attention.
• Stop—Stop and become focused on the task at hand.
• Look—Look and see the uniqueness of the patient.
• Listen—Listen to what you have been taught about safe
patient care.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
e. Keep informed on technology and innovations in patient safety and support them
vehemently if outcomes appear justified.
f. Emulate authentic leadership traits using skilled communication messages of truth,
trust, balance, respect, and confidentiality.29
6. Enable patients and their families to be part of patient safety improvements:
a. Invite preselected patients, families, and/or consumers to speak directly to nurses
about their perceptions of care given, as well as the lived experience of near misses or
medical errors.
b. Empower patients on admission by giving them safety information regarding issues
such as making sure identification bands have correct information, observing and
expecting clinicians to wash hands, mark surgery sites, etc.
c. Remember medical errors are always matters of the heart. Everyone is impacted, not
just the patient and family, but the nurse or clinician involved in the error—the
second victim.
The development of an informed patient safety culture has evolved since 1995 through the
passionate leadership of many stakeholders in both the public and private sectors, including the
Joint Commission and the development of its National Safety Goals.7, 8 However, the health care
industry still struggles to gain the trust of patients. Consumer groups are encouraging patients to
have a patient advocate accompany them to the hospital.30
The patient safety leadership skills identified by the Leadership Alliance for Nurse
Executives1 should be addressed by practicing the strategies described as necessary for creating a
generative culture at all levels of the health care system from leadership to the nurse-patient
transaction (see Figure 1). Patient safety is dependent upon the safe practices of nurses. Nurse
executives must be the moral conscience for the patient and assure that wherever nursing care is
practiced, it is practiced with a mindful approach. Nurses must have the time to think critically
and not be interrupted or easily distracted. Every newly designed system will never be fail-safe if
the nurse does not have time for that final safety net at the sharp end of the care delivery system.
The authentic executive nurse leader in the 21st century must lead in spite of contradictions and
complexity and build bridges to all stakeholders as we walk on them together.31
Research Implications
Despite the advances in the science of patient safety, a significant reduction in the frequency
of medical errors has yet to be accomplished.30 Process enhancements such as double checks,
redundancy, and fail-safe procedures, have not led to the elimination of administering the wrong
drug or the wrong dose. Research from the field of human factors has shown that attention,
perception, and cognition are all fallible. Reality is influenced by expectation. Routines and
similarities may result in not being able to recognize differences. Fatigue, stress, and strong
emotions such as anger and frustration, affect perceptions and thoughts. The next frontier in
patient safety is now researching how human factors affect performance. As such, mindfulness
may contribute to preventing common errors of attention and perception, but it is not known
whether mindfulness can be a learned skill. Each time a nurse administers a medication, an MRI
is performed, and the operating room personnel complete the sponge count, can they learn to
bring full awareness to their task?
Another set of questions involves new technology. How will the work of the future nurse be
redesigned to assure that barcoding, hand-held devices, bedside computerized documentation,
8
[Vignette] Nurse Executives and Safety Culture
computerized physician order entry, e-ICUs, smart infusion systems, and voice-activated
communication tools are all interconnected to result in a decrease in errors and better patient
outcomes? Paradoxically, these strategies may introduce new sources of error.
Conclusion
Well-publicized medical errors during the mid-1990s created a health care crisis involving
patient safety. As the public and the profession have become more cognizant of the problem,
demands for system redesign to significantly reduce medical errors have occurred. This vignette
suggests that it is imperative for all nurse leaders and the chief nurse executive, in particular, to
become prime architects in creating a culture of patient safety by employing the core
competencies of leadership, communication, professionalism, business skills, and knowledge of
the health care environment.
Personal experience in redesigning a hospital safety culture, following a significant medical
error, contributed to learning that the science of medical error reduction is complex and involves
multiple levels and systems of the health care environment. More specifically, reducing medical
errors is not a matter of finding and punishing the one person thought responsible for the error.
Rather, chief nurse executives must recognize that medical errors occur because of complex
reasons that are not entirely predictable. All departments of the hospital environment with direct
or indirect patient contact must be accountable if patient safety goals are to be achieved.
To assist in this process, the Systemic Mindfulness Model of Proactive Patient Safety model
suggests using a corkscrew metaphor where each multiple level of the health care system
interacts in complex ways to affect patient safety. Decisions made at one level can affect all
other levels and alter the dynamics of the patient safety culture. To be effective, all staff need to
be aware of their role in the patient safety process and how they can best promote and maintain a
patient safety culture.
Author Affiliation
Victoria L. Rich, Ph.D., R.N., F.A.A.N., Chief Nurse Executive, University of Pennsylvania
Health System; e-mail: [email protected].
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
References
1. American Organization of Nurse Executives. AONE 13. Langer, EJ. Mindfulness. Cambridge, MA: Perseus
nurse executive competencies. Nurse Leader 2005 Books; 1989.
Feb; 3(1): 15-21.
14. Kabat-Zinn J. Full catastrophe living: using the
2.. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is wisdom of your mind to face stress, pain and illness.
human: building a safer health system. A report of New York: Dell Publishing; 1990.
the Committee on Quality of Health Care in America,
Institute of Medicine. Washington, DC: National
15. Parasuraman R. The attentive brain. Cambridge, MA:
Academy Press; 2000.
MIT Press; 1998.
9. Rich VL. The handling of a catastrophic medical 23. Phillips J, Barnsteiner JH. Clinical alarms: improving
error event: A case study in the use of a systemic efficiency and effectiveness. Crit Care Nurs Q
approach to error reduction. In: Youngberg BJ, Hatlie 2005;48:317-23.
MJ, eds. Patient safety handbook. Sudbury, MA:
Jones and Bartlett; 2004. p. 507-20. 24. Will SB, Hennecke KP, Jacobs LS, et al. The
perinatal patient safety nurse: a new role to promote
10. Rich VL. How we think about medication errors? Am safe care for mothers and babies. J Obstet Gynecol
J Nurs 2005 March;105:10-1. Neonatal Nurs 2006;35(3):417-23.
11. Olsen E, Eoyang G. Facilitating organization change: 25. Cohen M. ISMP medication safety self-assessment.
lessons from complexity science. San Francisco: Huntingdon Valley, PA: Institute for Safe Medication
Jossey-Bass/Pfeiffer; 2001. Practices; 2000.
12. Gleick J. Chaos: the making of a new science. New 26. Koppel R, Metlay JP, Cohen A, et al. Computerized
York: Viking/Penguin; 1988. order entry systems can increase risk of medication
errors. JAMA 2005;293:1197-203.
10
[Vignette] Nurse Executives and Safety Culture
27. Joint Commission Perspectives on Patient Safety. healthy work environments. Aliso Viejo, CA:
Using FMEA to assess and reduce risk. Author 2001 American Association of Critical Care Nurses; 2005.
Nov;1(7):1-3.
30. Bleich S. Medical errors: Five years after the IOM
28. Berwick DM, Calkins DR, McCannon CJ, et al. The report. The Commonwealth Fund/John F. Kennedy
100,000 lives campaign: setting a goal and a deadline School of Government 2005 Bipartisan Health Policy
for improving health care quality. JAMA 2006;295 Conference. The Commonwealth Fund; July 2005.
(3):324-7.
31. Quinn RE. Deep change: Discovering the leader
29. American Association of Critical Care Nurses. within. San Francisco: Jossey-Bass; 1996.
AACN standards for establishing and sustaining
11
Chapter 21. Creating a Safe and High-Quality Health
Care Environment
Patricia W. Stone, Ronda Hughes, Maureen Dailey
Background
Maintaining a safe environment reflects a level of compassion and vigilance for patient
welfare that is as important as any other aspect of competent health care. The way to improve
safety is to learn about causes of error and use this knowledge to design systems of care to “…
make errors less common and less harmful when they do occur”1 (p.78). As a result, researchers,
policymakers, and providers have intensified their efforts to understand and change
organizational conditions, components, and processes of health care systems as they relate to
patient safety.
Health care is the second-fastest growing sector of the U.S. economy, and nursing is the
largest occupation within the industry, with more than 2.4 million jobs and the highest projected
growth.2 As noted in recent reports by the International Council of Nursing and the Institute of
Medicine, one of the reasons for the current and future shortages of nurses relates to the work
environment.3, 4 Improving the environment in which nurses work may attract new students to
nursing as well as engage current professionals in developing innovative models of care delivery
that will help retain and nurture future generations of nurses. Most important, improving the
work environment may also improve the quality and safety of patient care.
High turnover has been recognized as a problem in many service industries, including health
care.5 In U.S. hospitals, nursing turnover has been reported to range from 15 percent to 36
percent per year.6 These turnover rates are much higher than those for other health care
professionals, which are estimated to average 2.3 percent per year.7 Past estimates of the cost to
replace one medical-surgical registered nurse (RN) range between $30,000 and $50,000; and
replacement costs for critical care nurses are closer to $65,000.8 More recently, Jones9 estimated
the total turnover costs of one hospital-based RN to range from $62,000 to $67,000 depending on
the service line. While these cost estimates rely on nurse manager reports of decreased
productivity, clearly there are avoidable organizational monetary and human costs related to high
turnover of desirable employees. Using multiple databases in an academic medical center, other
analysts found the low-end estimate for the cost of employee turnover accounted for greater than
5 percent of the annual operating budget.10 Clearly, understanding organizational aspects that
promote a stable workforce is important.
Besides the obvious harm to patients, preventable adverse health care events related to
patient safety have major financial consequences for the patient, the provider, the insurer, and
often the family and/or caregivers. Using Agency for Healthcare Research and Quality (AHRQ)
patient safety indicators, researchers estimated the excess length of stay for postoperative sepsis
to be approximately 11 days at a cost of almost $60,000 per patient.11 While in some instances
there is extra payment made by insurers to hospitals for these adverse events, it has been
estimated to be considerably less than the total cost of the resources used.12 Furthermore, with
increased discussions about pay-for-performance and mandatory reporting of certain adverse
patient safety events, providers may have increased financial as well as other incentives to
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
improve patient safety.13 Therefore, understanding organizational aspects that promote patient
safety is also very important.
Throughout the body of patient safety and occupational health literature, authors refer to
concepts of organizational climate and culture as well as safety climate and culture. Culture
broadly relates to the norms, values, beliefs, and assumptions shared by members of an
organization or a distinctive subculture within an organization.14, 15 Organizational culture is
typically thought of as evolving over the course of time and difficult to change. Organizational
climate refers to members’ shared perceptions of organizational features like decisionmaking,
leadership, and norms about work, including opportunities for advancement and collaboration.16
Organizational climate has been likened to a weather pattern.17 For example, Clarke18 pointed out
that organizational climate refers to an atmosphere, which is a moveable set of perceptions
related to working and practice conditions, many of which can be directly influenced by
managers and organizational leaders. There are other microclimates; for example, safety climate
is the current landscape of employees’ perceptions and attitudes about safety, such as state of
current safety initiatives and safety behaviors.19
Additionally, a number of safety climate scales have been developed in the fields of
occupational health and patient safety. In occupational health, attributes of a safe climate in
hospitals have been found to include senior management support for safety programs, absences
of hindrances to safe work practices, availability of personal protective equipment, minimal
conflict, cleanliness of work site, good communication, and safety-related feedback.20 A positive
safety climate has been significantly correlated to reduced risk of work injury and exposure.20 In
patient safety, attributes of a safe hospital environment have been identified as a positive work
environment, supportive supervisor/manager, improved interdisciplinary communications, and
increased safety event reporting.21 Obviously these microclimates overlap. Additionally, they
should be synergistic and correlate with the overall organizational climate. Indeed, a positive
organizational climate is most likely an essential antecedent to the development of a strong
safety climate.
As part of AHRQ’s The Effect of Health Care Working Conditions on the Quality of Care
research portfolio (RFA HS-01-005), a team of interdisciplinary scholars developed a model
depicting aspects of organizational climate and their relationship to worker and patient
outcomes.22 These investigators tested the model in various settings (i.e., ambulatory care, home
health, long-term care, Veterans Health Administration facilities, and acute care hospitals) and
identified important organizational structures (leadership and infrastructure) and processes
(supervision, work design, group behavior, and quality/safety emphasis). Using this model as the
organizing framework, this chapter reviews the evidence examining the impact of organizational
climate on patient and employee outcomes. It is important to note that we are focusing on the
broad concept of organizational climate. Another chapter in this volume focuses specifically on
safety culture and climate. Based on the evidence on organizational climate and the relationships
with patient outcomes, job satisfaction, and turnover, we have developed a new conceptual
model of organizational attributes and outcomes.
Research Evidence
Overall 14 studies were reviewed. In four of the published studies, the researchers focused
only on patient outcomes,23–26 with one of the teams reporting the results related to worker
turnover and job satisfaction in other publications.27, 28 Two of the research teams published
2
Patient Safety and the Health Care Environment
results related to patient outcomes and worker outcomes in single manuscripts.29, 30 The majority
of the manuscripts reviewed focused on worker outcomes. In the following section, the studies
focusing on organizational climate and patient outcomes are synthesized, followed by a synthesis
of the evidence linking organizational climate with turnover and job satisfaction.
Table 1 describes the primary research (six studies) found investigating organizational
climate and patient safety outcomes. The attributes of organizational climate measured varied.
Some researchers focused on quality,23 measures of morale, and consensus of
depersonalization,24, 29 while others used a composite organizational climate measure, which
focused on nurses’ perceptions of the work environment.25 The patient outcomes were also
varied and specific to the setting. For example, in one study the measure of patient safety was
nurse-reported medication errors;24 another research team measured self-report service quality.29
All other research teams used some form of existing administrative data to measure patient safety
outcomes, with one team using clinical and laboratory data elements collected for participation in
the Centers for Disease Control and Prevention’s National Healthcare Safety Network.25 The
National Safety Network hospitals collect standardized nosocomial infection data. The settings
studied also varied across projects and were primary care sites, rural hospitals, outpatient social
services, specialized hospital settings (e.g., emergency departments and intensive care units) and
the Veterans Health Administration. All studies used cross-sectional designs with the exception
of one group reporting on the evaluation of a quality-improvement project.23 Despite these
varying measurement issues, settings and populations, and research designs, positive
organizational climates were generally found to improve patient safety.
Table 2 provides the results of the current evidence found examining the relationships among
organizational climate and worker outcomes (i.e., turnover and job satisfaction). Ten studies
were found, half of which included both job satisfaction and turnover. Again, the organizational
climate attributes varied from morale to composite measures of organizational climate.28, 30 The
study populations were mainly nurses (60 percent), but outpatient caseworkers and mental health
providers were also studied. Most studies (80 percent) were conducted in the United States, but
nurses employed in Australia,31 Begium,32 and Hong Kong33 were also studied. The majority of
the studies were cross-sectional, with only one pre-post test intervention study.34 All of the
researchers reported that positive organizational climates were related to increased worker
satisfaction. The results related to turnover were not quite as strong, and researchers in one study
found that job satisfaction mediated the effect of organizational climate on turnover.35
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
climate and patient safety outcomes was scant, with only six studies found, and only three of
those studies focused on patients in acute care settings. Despite these limitations, the consistency
of the findings point to the importance of organizational climate on patient and employee
outcomes.
Based on this review and our previous work,22 we developed the conceptual model displayed
in Figure 1. The structural characteristics of the setting may serve as enabling factors for
outcomes. These first and foremost include senior leadership. Other important enabling factors
are related to the infrastructure (such as technology available) and communication systems. We
call these enabling factors structural characteristics because they are not easily changed. These
enabling factors influence the settings’ microclimates, which may be grouped into three main
foci: employee/staff, patient, and organizational. It is important to understand these
microclimates are not conceptualized as mutually exclusive or independent. We believe these
microclimates interact with each other and are synergistic. For example, a setting that focuses on
occupational safety may also focus on evidence-based, patient-centered care; additionally,
collaboration and communication among providers and patients may be important shared
components of each microclimate. The microclimates influence the actions of the staff, patient,
and often the family and/or caregivers, which in turn have an impact on the outcomes. Again, the
outcomes are conceptualized at three different levels: the employee, the patient, and the
organization. The list of specific outcomes under each category is representative of the category,
but it is not exhaustive. For more complete lists of patient safety outcomes, the reader should
refer to AHRQ’s Patient Safety Indicators and the National Quality Forum’s consensus standards
for nursing-sensitive care.36, 37
Based on the literature reviewed and the conceptual model developed, there are a number of
practice recommendations at all levels of nursing (e.g., nursing leaders, nurse managers, staff
nurses, and educators). The existence of a relationship between a positive organizational climate
and both worker and patient outcomes means that facilities need to be aware of the importance of
assessing and periodically reassessing the climate within their organization. There are published
reviews of instruments used to assess organizational climate.38 Additionally, data regarding the
climate should be correlated with outcomes along all three of the foci (employee, patient, and
organizational).39 The recommended frequency of conducting these analyses is not clear, but
such assessment and reassessment should be part of a continuous quality-improvement process,
and it seems reasonable that employee surveys should be conducted at least annually. Nurse
educators need to develop and evaluate safety and leadership curriculum.40, 41 Additionally, as we
rapidly increase the information technology available in health care, we must ensure that this
infrastructure promotes patient safety, increases efficiency, and contributes to nursing
knowledge.42
Nursing leaders and managers need to be cognizant of the job satisfaction of all employees
on an ongoing basis, specifically as low satisfaction can be linked to burnout, intention to leave,
and even higher rates of job turnover or loss to the nursing profession (i.e., early retirement or
transfer to another career). With the high costs of nursing turnover, efforts to increase job
retention levels are likely to be financially beneficial.9, 10
Despite the scant evidence linking organizational climate—broadly defined—and patient
safety, the evidence supporting the significant relationship between a climate of safety—a
specific component of organizational climate—and patient safety is growing, given increased
utilization of safety climate surveys. (This is discussed further in the next chapter.) It is likely
then that development and utilization of readily available tools to assess organizational climate
4
Patient Safety and the Health Care Environment
will expand the evidence base and provide key information to leaders and managers to improve
job satisfaction, interdisciplinary teamwork, and retention, ultimately improving the quality of
health care delivery. Indeed, the usefulness of this information would likely be considerably
improved if it were linked with ongoing patient-safety monitoring and quality-improvement
activities within the organization. Organizational climate is more malleable and open to change
than the more-entrenched aspects of culture. Thus, data-driven leaders can be proactive by
assessing both worker perceptions and outcomes to ensure safety processes are adhered to more
consistently (i.e., less violations or work-arounds); this should improve all outcomes. For staff
and future staff, nurses’ job satisfaction is key to not only providing quality care, but to having
lower levels of occupational stress and higher levels of occupational safety, both of which are
discussed in other chapters within this book.
Research Implications
This review identified a number of gaps in the research evidence. First and foremost, as
interventions are developed to improve the organizational climate, rigorous research and
evaluation studies need to be conducted. It is important to note, however, that this type of
research will not often lend itself to randomized controlled trials. Other epidemiological designs
that control for confounding variables and ensure comparability between groups will most likely
be needed. Second, future research aimed at understanding the impact of human capital variables
(i.e., stability of the workforce, education, etc.) on patient outcomes and system efficiencies is
warranted. Furthermore, consistency in measurement tools would help advance the field and
assure that study results are more consistent and comparable.
Lastly, more cost analyses need to be conducted to make the business case for improving the
organizational climate in nurses’ work environment and improving patient, employee, and
organizational outcomes. The model provided presents various aspects of organizational climate
that may be measured in different research projects, across a research portfolio, and in various
settings. It is doubtful that any one study would include all aspects presented in this model.
Rather, the researcher may use this model to select the organizational aspects and outcomes most
appropriate to their research aims.
Organizational climate is one of the overarching aspects found in the work environment.
However, it is not the only aspect related to patient safety and worker satisfaction and turnover.
Other environmental aspects include actual workload, such as nurse-to-patient ratios in acute and
long-term care and caseloads in outpatient settings; scheduled work hours (e.g., shift length,
nights versus days); mandatory overtime; information systems for decision support to prevent
errors of commission and omission; and human factor engineering solutions. The impact of these
other aspects of the work environment is discussed elsewhere in this volume.
There are both strengths and limitations to this review. In our search for evidence we
attempted to be comprehensive. However, we may have missed some studies. Additionally, only
primary studies published in English after the year 2000 were audited.
Conclusion
Gradually, evidence is accumulating that links work environments to behavior, attitudes, and
motivations among clinicians. These behaviors and orientations can, in turn, affect quality
processes and outcomes. A growing number of studies in health care show that members of
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
organizations are more satisfied when they work in climates that have more supportive and
empowering leadership and organizational arrangements, along with more positive group
environments (often reflecting elements of group support and collaboration). Moreover, although
the research base is not as strong, there is emerging evidence that these same organizational
attributes impact employee turnover and, most important, patient safety. Improving the
organizational climate is likely to improve patient safety and decrease overall health care costs.
However, future research studying specific interventions and their cost effectiveness is needed.
Search Strategy
A systematic review of the literature was conducted focusing on relationships among
organizational climate and three outcomes: patient safety, nurse turnover, and job satisfaction.
Medline and AHRQ’s Patient Safety Network (PSNET: www.psnet.ahrq.gov) searches were
conducted using the key word “organizational climate,” then cross-referenced with “patient
safety” and “patient outcomes,” “satisfaction,” as well as “turnover” and “intention to leave.”
More than 200 titles were examined. Abstracts were examined by two nurse researchers if the
article was published in 2000 or after, written in English, and pertained to health care
organizations. Manuscripts were obtained and reviewed if they were primary reports of research
findings. Editorials were excluded. Reference lists were also reviewed for key articles.
Publications that presented primary research findings and had sample sizes of greater than 30
respondents were organized into two tables presenting evidence on the relationships between
organizational climate and (1) patient outcomes, and (2) worker satisfaction and retention of
workers. Each study was audited for the following elements: the organizational climate attributes
studied, the design type, the outcome measures (patient or worker), study setting and population,
study intervention, and key findings. All studies were reviewed by two authors. Following the
guidelines put forth by AHRQ, the study design types were categorized using the “type of
evidence” criteria.
Author Affiliations
Patricia W. Stone, Ph.D., M.P.H., R.N., assistant professor, Columbia University School of
Nursing; e-mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality; e-mail: [email protected].
Maureen Ann Dailey, R.N., M.S., doctoral student, Columbia University School of Nursing;
e-mail: [email protected].
6
Patient Safety and the Health Care Environment
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34. Glisson C, Dukes D, Green P The effects of the ARC nurses and other health sector workers. J Nurs Manag
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Adm Policy Ment Health 2006 May;33:289-301.
8
Evidence Table 1. Organizational Climate and Patient Outcomes
Source Organizational Design Patient Safety Study Setting & Study Intervention Key Finding(s)
Climate Attributes Type Outcome Study Population
Measure(s)
Cretin Importance of Quality Primary care U.S. Army Medical Integrated model Significant downward trend in the
200123 improving quality of improvement followup, Department: 4 guideline percentage of the patients referred to
care, current status projects/ physical therapy or facilities in the implementation physical therapy/chiropractic care
in quality research chiropractic care, Great Plains system: (10.7%–7.2%) at demonstration sites
improvement, specialist care Region served as Evidence-based as compared to comparison sites.
climate for demonstration practice guidelines,
guideline sites, and there education/training, No discernable reduction in specialty
implementation, were 5 toolkit, and care referrals or primary care followup
attitude toward comparison interdisciplinary visits at the demonstration sites as
practice guidelines, facilities. team approach compared to comparison sites.
and motivation for
guideline 31,273 new low-
implementation back pain patients
Fogarty & Workplace morale, Cross- Medication error 11 rural hospitals Not applicable Self-report medication errors positively
McKeon supervisor sectional index in Australia correlated to composite measure of
9
support, [COPD])
professional 2. Prevention Index
demands, and pay (PI): Summary of
satisfaction prevention care
delivery
(vaccination,
tobacco
prevention,
disease, and risk
factors screening)
3. Surgical
outcomes using
the National
Surgical Quality
Improvement
Program (NSQIP)
measures
postsurgical
morbidity and
mortality
Source Organizational Design Patient Safety Study Setting & Study Intervention Key Finding(s)
Climate Attributes Type Outcome Study Population
Measure(s)
Wright Fairness and Cross- Frequency of staff 1 general hospital Not applicable Workgroup cooperation and facilitation
43
2003 equity, role sectional members’ clinical emergency is positively associated (P < 0.05) with
ambiguity, study work with patients department (ED) frequency of clinical work with
role overload, role with psychiatric in a U.S. urban patients.
conflict, workgroup problems Midwest location
cooperation and
facilitation, growth 131 ED staff
and advancement, (medial, nursing,
job satisfaction, and psychiatric
emotional workers)
exhaustion,
personal
accomplishment,
and
depersonalization
11
professional
growth, goal
congruence,
workplace distress,
and excessive work
demands
Dunham- Transactional Staff satisfaction 396 nurse Not applicable Staff satisfaction in the workplace was
Taylor leadership, laissez- 4 executives and correlated with transformational
200045 faire leadership 1,115 staff who leadership (r = 0.79, P < 0.0001). Staff
report to them satisfaction decreased as staff rated the
leader as being more transactional (r =
0.37, P < 0.0001) or using a more
laissez-faire leadership style (r = 0.71, P
< 0.0001).
Glisson Depersonalization, 6 Turnover 235 caseworkers Availability, In hierarchical linear models analyses, it
200634 emotional and 26 case responsiveness, was found that the ARC intervention
exhaustion, role management teams and continuity reduced turnover by 2/3 and improved
conflict, and role that provide child (ARC) intervention organizational climate.
overload welfare and juvenile
justice services
Source Organizational Design Worker Outcome Study Setting & Study Key Finding(s)
Climate Attributes Type Measure(s) Study Population Intervention
Glisson & Employee Job satisfaction, 33 child welfare and Not applicable Case managers and teams with more
James consensus of 4 1 year turnover juvenile case constructive cultures experienced lower
200229 depersonalization, management teams turnover rates (P < 0.05); organizational
emotional in 30 counties (4 climate was not significantly related to
exhaustion, and urban and 26 rural) turnover. Organizational climate was
role conflict in 1 southeastern significantly positively related to job
State in the U.S. satisfaction.
Siu 200233 Organization, Job satisfaction Two separate Not applicable Findings were not consistent across
immediate upper 4 samples of Hong samples. In sample 1, environment was
level, coworkers, Kong nurses significantly correlated with satisfaction.
involvement, sample 1: 144 In sample 2, well-being was a significant
flexibility, work nurses predictor of job satisfaction.
environment, and sample 2: 114
well-being nurses
Stone Professional Intention to leave 2,323 registered Not applicable Organizational climate factors that had
200627 practice, 4 nurses from 66 an independent effect on ICU nurse
staffing/resource hospitals and 110 intention to leave due to working
adequacy, nurse critical care units conditions were professional practice,
management, nurse competence, and tenure (P <
13
handover shifts
Warren Organizational Intention to leave, 74,662 employees Not applicable Employee focus was most strongly
30
2007 climate as 4 job satisfaction from the Veterans associated with job satisfaction, and
measured by 4 Health support was negatively associated with
metafactors: Administration turnover intention (P < 0.05).
employee focus,
support,
professional
demands, and pay
satisfaction
Patient Safety and the Health Care Environment
Structural Characteristics
Enabling Factors: Leadership,
Technologies, Communication, Financial Resources
Microclimates
Employee/
Patient Organizational
Staff - Efficiency
- Workflow & workload - Patient-centered care
- Effectiveness
- Collaboration - Evidence-based care
- Quality improvement
- Occupational Safety
Outcomes
Employee/
Patient Organizational
Staff -Falls -Cost of care
-Job satisfaction - Health care - Staffing shortages
- Stress acquired infections - Reputation
- Occupational health
15
Chapter 22. Practice Implications of Keeping
Patients Safe
Ann E. K. Page
Background
Improving patient safety and other dimensions of health care quality requires change at all
four levels of the health care system: (1) the experience of patients during their interactions with
individual clinicians; (2) the functioning of small units (microsystems) of care delivery such as
surgical teams or nursing units; (3) the practices of organizations that house the microsystems;
and (4) the environments of policy, payment, regulation, accreditation, and other factors external
to the actual delivery of care that shape the context in which health care organizations deliver
care.1 Several groundbreaking Institute of Medicine (IOM) reports have spurred substantial
actions at each of these levels to bring about improvements in patient safety and overall quality.
These IOM reports began as the product of the unique Committee on the Quality of Health
Care in America created by the IOM in 1998 in response to the accumulating number of studies
documenting that the way in which health care has been delivered has not kept pace with the
advances in medical technology and our growing knowledge about diseases and how to
effectively treat them. The committee’s first report, To Err Is Human, was stunning. This report
documented that not only was health care often of poor quality, it was actually unsafe. The report
said that between 44,000 and 98,000 deaths every year (more than deaths from breast cancer,
AIDS, or motor vehicle accidents) were caused by problems in the way the health care system
was designed, not from “bad” doctors, nurses, or other health care workers.2
The report’s message and recommendations for building safer systems of care delivery across
the entire U.S. health care system primarily addressed the changes needed at the fourth level of
the health care system—where policy, payment, regulation, accreditation, and similar external
factors shape the delivery of health care. a Within weeks of the report’s release, the Senate
Committee on Appropriations began hearings on medical errors and patient safety.
As a result of those hearings, Congress directed the Agency for Healthcare Research and
Quality (AHRQ) to lead a national effort to combat medical errors and improve patient safety.
AHRQ subsequently established a research and demonstration program to fund research to
determine the causes of medical errors and to develop models that minimize the frequency and
severity of errors; mechanisms that encourage reporting, prompt review, and corrective action;
and methods to minimize paperwork.3
a
The Committee’s second report, Crossing the Quality Chasm—A New Health System for the 21st Century,
addressed health care quality in all its dimensions: effectiveness, timeliness, patient centeredness, efficiency, and
equity (in addition to safety). Crossing the Quality Chasm generally spoke to the first and second levels of the health
care systems—the experiences of patients with their individual clinicians and the microsystems of care delivery. To
Err Is Human and Crossing the Quality Chasm both directed less attention to the third level—health care
organizations.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Practice Implications
Keeping Patients Safe identifies eight overarching safeguards to protect patient safety that
need to be in place within all health care organizations in which nurses work: (1) organizational
governing boards that focus on safety; (2) the practice of evidence-based management and
leadership; (3) effective nursing leadership; (4) adequate staffing; (5) provision of ongoing
2
Practice Implications of Keeping Patients Safe
learning and clinical decisionmaking support to nursing staff; (6) mechanisms that promote
interdisciplinary collaboration; (7) work design practices that defend against fatigue and unsafe
work; and (8) a fair and just error reporting, analysis, and feedback system with training and
rewards for patient safety (see Table 1).
Adequate Staffing
• Is established by sound methodologies as determined by nursing staff.
• Provides mechanisms to accommodate unplanned variations in patient care workload.
• Enables nursing staff to regulate nursing unit workflow.
• Is consistent with best available evidence on safe staffing thresholds.
Source: Committee on the Work Environment for Nurses and Patient Safety, 20046: pages 16-17. Reprinted with Permission.
©2004 National Academy of Sciences.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
to individual nurses in clinical practice, the recommendations also can be used by nurses to
leverage improvements in patient safety. Specifically, the recommendations have corollary
questions (presented in Table 2) that nurses should ask of prospective and current employers.
Table 2. Questions Nurses Should Ask Prospective (and Current) Employers About Patient Safety
Adequate Staffing
9. What methods does the organization use to determine safe nurse staffing levels? Can you get a copy of
the methodology?
10. What input do clinical nurse staff have in reviewing and modifying the staffing methodology? How
frequently are the methodology and its assumptions reviewed?
11. Does the organization count admissions, discharges, and “less than full-day” patients (in
addition to a census of patients at a point in time) in its estimates of patient volume for
projecting staffing needs?
12. What mechanisms does the organization use to quickly secure additional staffing when need for nurse
staffing is higher than anticipated—e.g., an internal float pool, use of staff from external agencies, staffing
at higher levels to provide “slack” in the system, other mechanisms? Does the organization avoid use of
nurses from external agencies?
13. What roles does clinical nursing staff have in determining admissions and discharges to the unit?
14. What is the nurse turnover rate for the organization? How is this calculated?
15. If an acute care hospital, what are the nurse-patient staffing levels in the intensive care units (ICUs)?
16. If a long-term care facility, is there at least one RN in the facility around the clock, seven days a week?
4
Practice Implications of Keeping Patients Safe
b
Reprinted, with permission, from Keeping Patients Safe: Transforming the Work Environment of Nurses.6 ©2004
National Academy of Sciences.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Leadership will need to assure the effective use of practices that (1) balance the tension
between production efficiency and reliability (safety), (2) create and sustain trust throughout the
organization, (3) actively manage the process of change, (4) involve workers in decisionmaking
pertaining to work design and work flow, and (5) use knowledge management practices to
establish the organization as a “learning organization.” To this end, the committee makes the
following recommendations:
Recommendation 4-1. c HCOs should acquire nurse leaders for all levels of management
(e.g., at the organization-wide and patient care unit levels) who will:
• Participate in executive decisions within the HCO.
• Represent nursing staff to organization management and facilitate their mutual trust.
• Achieve effective communication between nursing and other clinical leadership.
• Facilitate input of direct-care nursing staff into operational decisionmaking and the
design of work processes and work flow.
• Be provided with organizational resources to support the acquisition, management,
and dissemination to nursing staff of the knowledge needed to support their clinical
decisionmaking and actions.
Recommendation 4-2. Leaders of HCOs should take action to identify and minimize the
potential adverse effects of their decisions on patient safety by:
• Educating board members and senior, midlevel, and line managers about the link
between management practices and safety.
• Emphasizing safety to the same extent as productivity and financial goals in internal
management planning and reports and in public reports to stakeholders.
Recommendation 4-3. HCOs should employ management structures and processes
throughout the organization that:
• Provide ongoing vigilance in balancing efficiency and safety.
• Demonstrate trust in workers and promote trust by workers.
• Actively manage the process of change.
• Engage workers in nonhierarchical decisionmaking and in the design of work
processes and work flow.
• Establish the organization as a “learning organization.”
Because HCOs vary in the extent to which they currently employ the above practices and in
their available resources, the committee also makes the following recommendation:
Recommendation 4-4. Professional associations, philanthropic organizations, and other
organizational leaders within the health care industry should sponsor collaboratives that
incorporate multiple academic and other research-based organizations to support HCOs
in the identification and adoption of evidence-based management practices.
c
For ease of reference, the committee’s recommendations are numbered according to the chapter of the main text in
which they appear.
6
Practice Implications of Keeping Patients Safe
knowledge and skills needed to carry out these interventions and the ability to effectively
communicate findings and coordinate care with the interventions of other members of the
patient’s health care team. Nurse staffing levels, the knowledge and skill level of nursing staff,
and the extent to which workers collaborate in sharing their knowledge and skills all affect
patient outcomes and safety.
Regulatory, internal HCO, and marketplace (consumer-driven) approaches are traditionally
advocated as methods to achieve appropriate staffing levels. The committee determined that each
of these approaches has limitations as well as strengths; their coordinated and combined use
holds the most promise for achieving safe staffing levels. The committee also took particular
note of the need for more accurate and reliable staffing data for hospitals and nursing homes to
help make these efforts more effective and to facilitate additional needed research on staffing.
Finally, the committee identified a need for more research on hospital staffing for specific types
of patient care units, such as medical-surgical and labor and delivery units. The committee
therefore makes the following recommendations:
Recommendation 5-1. The U.S. Department of Health and Human Services (DHHS)
should update existing regulations established in 1990 that specify minimum standards
for registered and licensed nurse staffing in nursing homes. Updated minimum standards
should:
• Require the presence of at least one RN within the facility at all times.
• Specify staffing levels that increase as the number of patients increase, and that are
based on the findings and recommendations of the DHHS report to Congress,
Appropriateness of Minimum Nurse Staffing Ratios in Nursing Homes – Phase II
Final Report.7
• Address staffing levels for nurse assistants, who provide the majority of patient care.
Recommendation 5-2. Hospitals and nursing homes should employ nurse staffing
practices that identify needed nurse staffing for each patient care unit per shift. These
practices should:
• Incorporate estimates of patient volume that count admissions, discharges, and “less
than full-day” patients in addition to a census of patients at a point in time.
• Involve direct-care nursing staff in determining and evaluating the approaches used to
determine appropriate unit staffing levels for each shift.
• Provide for staffing “elasticity” or “slack” within each shift’s scheduling to
accommodate unpredicted variations in patient volume and acuity and resulting
workload. Methods used to provide slack should give preference to scheduling excess
staff and creating cross-trained float pools within the HCO. Use of nurses from
external agencies should be avoided.
• Empower nursing unit staff to regulate unit work flow and set criteria for unit
closures to new admissions and transfers as nursing workload and staffing necessitate.
• Involve direct-care nursing staff in identifying the causes of nursing staff turnover
and in developing methods to improve nursing staff retention.
Recommendation 5-3. Hospitals and nursing homes should perform ongoing evaluation
of the effectiveness of their nurse staffing practices with respect to patient safety, and
increase internal oversight of their staffing methods, levels, and effects on patient safety
whenever staffing falls below the following levels for a 24-hour day:
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• In hospital ICUs—one licensed nurse for every two patients (12 hours of licensed
nursing staff per patient day).
• In nursing homes, for long-stay residents—one RN for every 32 patients (.75 hours
per resident day), one licensed nurse for every 18 patients (1.3 hours per resident
day), and one nurse assistant for every 8.5 patients (2.8 hours per resident day).
Recommendation 5-4. DHHS should implement a nationwide, publicly accessible
system for collecting and managing valid and reliable staffing and turnover data from
hospitals and nursing homes. Information on individual hospital and nursing home
staffing at the level of individual nursing units and the facility in the aggregate should be
disclosed routinely to the public.
• Federal and State nursing home report cards should include standardized, case-mix–
adjusted information on the average hours per patient day of RN, licensed, and nurse
assistant care provided to residents and a comparison with Federal and State
standards.
• During the next 3 years, public and private sponsors of the new hospital report card to
be located on the Federal government website should undertake an initiative—in
collaboration with experts in acute hospital care, nurse staffing, and consumer
information—to develop, test, and implement measures of hospital nurse staffing
levels for the public.
Moreover, the knowledge base on effective clinical care and new health care technologies is
increasing rapidly, making it impossible for nurses (and other clinicians) to incorporate this
information into their clinical decisionmaking and practice without organizational support.
Organizational studies and research on exemplary work environments indicate the importance of
investment in ongoing employee learning by employers. The committee therefore makes the
following recommendation:
Recommendation 5-5. HCOs should dedicate budgetary resources equal to a defined
percentage of nursing payroll to support nursing staff in their ongoing acquisition and
maintenance of knowledge and skills. These resources should be sufficient for and used
to implement policies and practices that:
• Assign experienced nursing staff to precept nurses newly practicing in a clinical area
to address knowledge and skill gaps.
• Annually ensure that each licensed nurse and nurse assistant has an individualized
plan and resources for educational development within health care.
• Provide education and training of staff as new technology or changes in the
workplace are introduced.
• Provide decision support technology identified with the active involvement of direct-
care nursing staff to enable point-of-care learning.
• Disseminate to individual staff organizational learning as captured in clinical tools,
algorithms, and pathways.
Finally, in response to evidence on inconsistent interprofessional collaboration among
nursing staff and other health care providers, the committee makes the following
recommendation:
Recommendation 5-6. HCOs should take action to support interdisciplinary
collaboration by adopting such interdisciplinary practice mechanisms as interdisciplinary
rounds, and by providing ongoing formal education and training in interdisciplinary
8
Practice Implications of Keeping Patients Safe
collaboration for all health care providers on a regularly scheduled, continuous basis
(e.g., monthly, quarterly, or semiannually).
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Recommendation 6-4. Regulators, leaders in health care; and experts in nursing, law,
informatics, and related disciplines should jointly convene to identify strategies for safely
reducing the burden associated with patient and work-related documentation.
10
Practice Implications of Keeping Patients Safe
Research Implications
Finally, the committee notes that changing health care delivery practices to increase patient
safety must be an ongoing process. Research findings and dissemination of practices that other
HCOs have found successful in improving patient safety will help HCOs as learning
organizations add to their repertoire of patient safety practices. This report calls attention to
several areas in which, at present, information is limited about how to design nurses’ work and
work environments to make them safer for patients. Research is needed to provide better
information on nursing-related errors, means of achieving safer work processes and workspace
design, a standardized approach to measuring patient acuity, information on safe staffing levels
for different types of patient care units, effective methods to help night shift workers compensate
for fatigue, information on what limits should be imposed on successive days of working
sustained work hours, and collaborative models of care. Accordingly, the committee makes the
following recommendation:
Recommendation 8-1. Federal agencies and private foundations should support research
in the following areas to provide HCOs with the additional information they need to
continue to strengthen nurse work environments for patient safety:
• Studies and development of methods to better describe, both qualitatively and
quantitatively, the work nurses perform in different care settings.
• Descriptive studies of nursing-related errors.
• Design, application, and evaluation (including financial costs and savings) of safer
and more efficient work processes and workspace, including the application of
information technology.
• Development and testing of a standardized approach to measuring patient acuity.
• Determination of safe staffing levels within different types of nursing units.
• Development and testing of methods to help night shift workers compensate for fatigue.
• Research on the effects of successive work days and sustained work hours on patient
safety.
• Development and evaluation of models of collaborative care, including care by
teams. d
d
This is the end of the copyrighted material reproduced, with permission, from the IOM report Keeping Patients Safe.
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Conclusion
Nurses are in a key position to improve patient safety, not just through their individual
patient care actions as clinicians, but by exercising their leverage as much-desired employees in
the labor marketplace. If nurses ask the above questions of their prospective employers, and
incorporate the responses they receive into their selection of their place of employment, they will
be able to exert significant influence within the health care system, as health care organizations
come to appreciate the ability to recruit nurses as an additional important reason for making the
types of organizational changes needed to provide safe patient care.
Author Affiliation
Ann E. K. Page, R.N., M.P.H., senior program officer, Institute of Medicine. E-mail:
[email protected].
References
1. Berwick D. A user’s manual for the IOM’s Quality http://www.bls.gov/oco/ocos102.htm. Accessed May
Chasm report. Health Aff 2002; 21(3):80–90. 14, 2003.
2. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is 5. American Hospital Association. Hospital statistics
human: building a safer health system. A report of 2002. Chicago, IL: Health Forum LLC; 2002.
the Committee on Quality of Health Care in America,
Institute of Medicine. Washington, DC: National 6. Committee on the Work Environment for Nurses and
Academy Press; 2000. Patient Safety, Board on Health Care Services, Page
A, ed. Keeping patients safe: transforming the work
3. Agency for Healthcare Research and Quality. environment of nurses. Washington, DC: National
AHRQ’s Patient Safety Initiative: building Academies Press; 2004.
foundations, reducing risk. 2002. Available at:
http://www.ahrq.gov/qual/pscongrpt/psinisum.htm. 7. Abt Associates. Appropriateness of minimum nurse
Accessed March 17, 2006. staffing ratios in nursing homes: report to Congress:
Phase II Final Report. (Contract No. 500-0062/
4. Bureau of Labor Statistics. Licensed practical and TO#3). Cambridge, MA: Abt Associates; 2001.
licensed vocational nurses. Occupational outlook Report No. 500-95-0062/TO 3.
handbook, 2002–03. Available at:
12
Chapter 23. Patient Acuity
Bonnie M. Jennings
Background
For more than 50 years, researchers have worked to develop staffing methodologies to
accurately indicate the number of nurses needed to give good care to patients.1 By the 1980s,
patient classification systems (PCSs) were in common use to predict patient requirements for
nursing care. These requirements, or patient acuity, could then be used to manage nursing
personnel resources, costs, and quality.2, 3
PCSs have numerous limitations, however. Paramount among these are (a) validity and
reliability are infrequently monitored;4, 5 (b) the tools are often complex and require considerable
time to complete;4 (c) they lack credibility among staff nurses and administrators;5, 6 (d) they are
not designed to detect census variability throughout the day from patient movement due to
admissions, discharges, transfers, and short-stays;7, 8 and (e) their focus on tasks shortchanges the
cognitive work and knowledge inherent to expert nursing care and sophisticated surveillance.9, 10
As restructuring and mergers escalated in the 1990s, issues of patient acuity once again
moved to the foreground. Patients were said to be sicker and leaving health care facilities more
quickly. Concerns about rising patient acuity continue into the new millennium because of the
relentless change that is now common in health care. Moreover, acuity is one of many elements
that comprise the often used but not yet well specified concept of workload.11, 12
Research Evidence
In assessing the research conducted between 1995 and 2005 about patient acuity, three things
stand out. First, most of the research reports are about developing or comparing instruments to
measure patient acuity. Unlike early PCSs that were designed for medical-surgical patients in
acute care facilities, these instruments are tapping into other care settings such as long-term
care,13–17 home care,18, 19 emergency departments (EDs),20–28 and neurological rehabilitation
centers,29–33 to name but a few. There is little evidence, however, regarding the extent to which
these tools are being used.
Second, most reports simply mention that patient acuity is increasing without supporting
data. Only four studies actually examined trends in patient acuity to empirically substantiate
perceptions that acuity is rising. Interestingly, these investigations were all conducted outside the
United States. PCS scores were compared over 3 months in 1996 and the same period in 1999 for
critical care patients in one Australian hospital.34 Acuity varied by shift (day, evening, night),
with the evening shift demonstrating the highest patient acuity. Although the PCS scores
followed similar patterns in 1996 and 1999, the PCS scores were higher for all shifts in 1999.
Monthly PCS data from 17 units in a Swedish hospital indicated that average scores in each
of four acuity categories increased from 1995 to 1996.35 The investigators concluded that
patients were sicker and their treatments more time consuming. However, they also demonstrated
discrepancies between actual and required staff, with the actual staff consistently lower than
required. This gap has also been observed in U.S. hospitals.6 In a Canadian study from Ontario,
case-mix data were examined for all acute care hospitals from 1997 to 2002.36 After controlling
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
for age, it was evident that the average inpatient case-mix index (CMI) increased by 17 percent
over the 5 years of data that were examined. The least complex patients declined by 24 percent,
and the most complex patients increased by 144 percent, representing an overall increase of 211
percent for the most complex patients. The fourth study examined care needs for long-term-care
(LTC) residents in Alberta, Canada, between 1988 and 1999.37 The data demonstrated an
increase in residents needing greater help with activities of daily living and more intervention for
difficult behaviors such as dementia.
Finally, studies were rarely designed to assess patient acuity in relation to patient outcomes.
Of those shown in Table 1, three evaluated heterogeneous groupings of patients in acute care
settings.38–40 An additional three studies examined acuity in more homogeneous patient
populations. One study focused exclusively on critical care patients,41 and another considered
only obstetrical care for teenagers.42 Acuity was also examined in relation to patient outcomes in
the ED.43
Research Implications
At present, very little is known about the relationship between acuity and outcomes. The lack
of a standardized approach to measuring acuity has broad research implications. For
investigations using PCSs, reports need to include information about the psychometric properties
of the tools. It would also be helpful to examine the relationship of PCS acuity to clinical
outcomes using more homogeneous patient groupings.
2
Patient Acuity
Perhaps the most important research issues concern greater clarity about the larger concept—
workload. There is an urgent need to develop a conceptual model illustrating the relationships of
the various elements comprising workload as well as a standardized definition of workload.
Empirical testing of the model might then better elucidate how acuity, as one aspect of workload,
relates to patient safety.
It would also be very helpful if U.S. studies were conducted to ascertain whether the
perceptions of increased acuity are verifiable. It would be most beneficial if these studies looked
not just at acuity in the aggregate, but also at acuity for homogeneous patient populations. This
could help clarify whether acuity for medical-surgical patients has escalated. Finally, it would be
useful to have a sense of acuity in the outpatient setting, given how patient care has shifted.
Although outpatient acuity is particularly difficult to capture, it remains a research challenge for
the future.
Conclusion
Patient acuity is a concept that is very important to patient safety. Presumably, as acuity rises,
more nursing resources are needed to provide safe care. Very little research has actually been
conducted, however, to verify this premise. Moreover, findings from the research that has been
conducted are largely inconsistent. Design issues account for these differences. In addition, it is
possible that factors other than patient acuity may contribute more to patient outcomes. It
remains important to derive a much better grasp of the relationship between patient acuity,
outcomes, and patient safety. At present, little can be said with confidence about this association.
Search Strategy
The literature for this review was identified by searching the MEDLINE® and CINAHL®
databases from 1995 to 2005 for research-based articles published in the English language. A
reference librarian assisted in choosing the search terms. In the CINAHL® search, the terms were
“patient acuity” or “patient classification.” This yielded 345 citations. The MEDLINE® search
was tried four times using various combinations of terms such as “patient acuity,” “patient
classification,” “severity of illness index,” “acute disease classification” and “diagnosis related
groups.” The combined efforts of the four searches resulted in identifying 98 references.
The abstracts for all 443 citations were reviewed. Of these, 104 were considered to be
potential candidates for use in this review. The references that were excluded from this
assessment included a wide array of topics that were irrelevant to patient acuity. The diversity of
these articles is too great to provide a complete view of them, but a few examples include quality
of life, menstrual cycle abnormalities, blood pressure variability, and fever management for
children.
After reading the 104 candidate articles in their entirety, an additional 72 papers were
omitted from the remainder of the analysis. Papers were excluded because they were more
tangentially related to patient acuity (e.g., indicators of patient dependency), they were reviews
of literature, or they did not focus on patients per se (e.g., a way to classify school-age children
with disabilities). As a result, this review was based on findings from 32 research reports.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Author Affiliation
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N., colonel, U.S. Army (Retired), and health care
consultant; e-mail: [email protected].
Acknowledgment
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library, Falls
Church, VA, for their considerable support of this work. They conducted the database searches
and assisted in acquiring numerous papers considered in this review.
References
1. Abdellah FG, Levine E. Work-sampling applied to the 12. Seago JA. The California experiment. Alternatives
study of nursing personnel. Nurs Res 1954;3(1):11-6. for minimum nurse-to-patient ratios. J Nurs Adm
2002;32(1):48-58.
2. Malloch K, Conovaloff A. Patient classification systems,
part 1: the third generation. J Nurs Adm 1999;29(7/8): 13. Adams-Wendling L. Clocking care hours with
49-56. workload measurement tools. Nurs Manage
2003;34(8):34-9.
3. Van Slyck A, Johnson KR. Using patient acuity data to
manage patient care outcomes and patient care costs. 14. Grando VT, Rantz MJ, Petroski GF, et al.
Outcomes Manage 2001;5(1):36-40. Prevalence and characteristics of nursing homes
residents requiring light-care. Res Nurse Health
4. DeGroot H. Patient classification system evaluation, part 2005;28:210-9.
I: essential system elements. J Nurs Adm 1989;19(6):30-
5. 15. Hendricks A, Whitford J, Nugent G. What would
VA nursing home care cost? Methods for estimating
5. Hlusko DL, Nichols BS. Can you depend on your patient private sector payments. Med Care 2003;41(6,
classification system? J Nurs Adm 1996;26(4):39-44. Suppl):II52-II60.
6. Minnick AF, Pabst MK. Improving the ability to detect 16. Mueller C. The RUG-III case mix classification
the impact of labor on patient outcomes. J Nurs Adm system for long-term care nursing facilities. Is it
1998;28(12):17-21. adequate for nurse staffing? J Nurs Adm
2000;30(11):535-43.
7. Budreau G, Balakrishnan R, Titler M, et al. Caregiver-
patient ratio: capturing census and staffing variability. 17. Swanson EA, Glick OJ. Reliability and validity of a
Nurs Econ 1999;17(6):317-24. new preadmission acuity tool for long-term care. J
Nurs Measure 1995;3(1):77-88.
8. Wagner C, Budreau G, Everett LQ. Analyzing
fluctuating unit census for timely staffing intervention. 18. Calver J, D’Arcy C, Homan J, et al. A preliminary
Nurs Econ 2005;23(2):85-90. casemix classification system for home and
community care clients in Western Australia. Aust
9. Ball C, Walker G, Harper P, et al. Moving on from Health Rev 2004;27(2):27-39.
‘patient dependency’ and ‘nursing workload’ to
managing risk in critical care. Intensive Crit Care Nurs 19. Santamaria N, Daly S, Addicott R, et al. The
2004;20:62-8. development, validity and reliability of the hospital
in the home dependency scale (HDS). Aust J Adv
10. Fulton TR, Wilden BM. Patient requirements for nursing Nurs 2001;19(4):8-14.
care: The development of an instrument. Can J Nurs
Adm 1998;11(1):31-51. 20. Eitel DR, Travers DA, Rosenau AM, et al. The
Emergency Severity Index triage algorithm. Version
11. Mark BA, Salyer J, Harless DW. What explains nurses’ 2 is reliable and valid. Acad Emerg Med
perceptions of staffing adequacy? J Nurs Adm 2003;10(10):1070-80.
2002;32(5):234-42.
4
Patient Acuity
21. Gorelick MH, Lee C, Cronan K, et al. Pediatric rehabilitations: a comparison of validity and
Emergency Assessment Tool (PEAT): a risk-adjustment sensitivity to change between the Northwick Park
measure for pediatric emergency patients. Acad Emerg Dependency Score and the Barthel Index. Clin
Med 2001;8(2):156-62. Rehab 2002;16:182-9.
22. Gorelick MH, Alpern ER, Alessandrini EA. A system for 33. Turner-Stokes L, Tonge P, Hyein K, et al. The
grouping presenting complaints: The pediatric Northwick Park Dependency Score (NPDS): a
emergency reason for visit clusters. Acad Emerg Med measure of nursing dependency in rehabilitation.
2005;12(8):723-31. Clin Rehab 1998;12:304-18.
23. Maldonado T, Avner JR. Triage of the pediatric patient 34. Donoghue J, Decker V, Mitten-Lewis S, et al.
in the emergency department: Are we all in agreement? Critical care dependency tool: monitoring the
Pediatrics 2004;114(2):356-60. changes. Austral Crit Care 2001;14(2):56-63.
24. Tanabe P, Gimbel R, Yarnold PR, et al. Reliability and 35. Levenstam AK, Bergsbom I. Changes in patients’
validity of scores on the Emergency Severity Index need of nursing care reflected in the Zebra system. J
Version 3. Acad Emerg Med 2004;11(1):59-65. Nurs Manage 2002;10:191-9.
25. Tanabe P, Gimbel R, Yarnold PR, et al. The Emergency 36. Preyra C. Coding response to a case-mix
Severity Index (version 3) 5-level triage system scores measurement system based on multiple diagnoses.
predict ED resource consumption. J Emerg Nurs Health Serv Res 2004;39(4,Pt1):1027-45.
2004;30(1):22-9.
37. Wilson DM, Truman CD. Long-term-care residents.
26. Tanabe P, Travers D, Gilboy N, et al. Refining Concerns identified by population and care trends.
Emergency Severity Index triage criteria. Acad Emerg Can J Pub Health 2004;95:382-6.
Med 2005;12(6):497-501.
38. Blegen MA, Goode CJ, Reed L. Nurse staffing and
27. Wollaston A, Fahey P, McKay M, et al. Reliability and patient outcomes. Nurs Res 1998;47(1):43-50.
validity of the Toowoomba adult trauma triage tool: a
Queensland, Australia study. Accident Emerg Nurs 39. Potter P, Barr N, McSweeney M, et al. Identifying
2004;12:230-7. nurse staffing and patient outcome relationships: a
guide for change in care delivery. Nurs Econ
28. Wuerz RC, Travers D, Gilboy N, et al. Implementation 2003;21(4):158-66.
and refinement of the Emergency Severity Index. Acad
Emerg Med 2001;8(2):170-6. 40. Reed L, Blegen MA, Goode CS. Adverse patient
occurrences as a measure of nursing care quality. J
29. Gross JC, Faulkner EA, Goodrich SW, et al. A patient Nurs Adm 1998;28(5):62-9.
acuity and staffing tool for stroke rehabilitation
inpatients based on the FIM™ instrument. Rehab Nurs 41. Tarnow-Mordi WO, Hau C, Warden A, et al.
2001;26(3):108-13. Hospital mortality in relation to staff workload: a 4-
year study in an adult intensive-care unit. Lancet
30. Gross JC, Goodrich SW, Kain ME, et al. Determining 2000;356(Jul 15):185-9.
stroke rehabilitation inpatients’ level of nursing care.
Clin Nurs Res 2001;10(1):40-51. 42. Hamilton P, Restrepo E. Weekend birth and higher
neonatal mortality: a problem of patient acuity or
31. Lowthian P, Disler P, Ma S, et al. The Australian quality of care? J Obstet Gyn Neonatal Nurs
national sub-acute and non-acute patient casemix 2003;32(6):724-33.
classification (AN-SNAP): its application and value in a
stroke rehabilitation programme. Clin Rehab 43. Boudreaux ED, Friedman J, Chansky ME, et al.
2000;14:532-7. Emergency department patient satisfaction:
Examining the role of acuity. Acad Emerg Med
32. Post MW, Visser-Meily MJ, Gispen LS. Measuring 2004;11(2):162-8.
nursing needs of stroke patients in clinical
5
Table 1. Evidence on Patient Acuity
Patient Acuity
indexes of self-care
symptom
management.
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source Safety Issue Design Study Design, Study Setting & Study Intervention Key Finding(s)
Related to Type Study Outcome Study Population
Clinical Practice Measure(s)
Reed 199840 Adverse occurrences Cross-sectional Design: Level 3 42 inpatient units in Deaths, pressure
among inpatients Patient outcomes: an 880-bed hospital ulcers, infections,
(acuity was measured deaths, pressure ulcers, during FY 1993 patient complaints
by an institutionally nosocomial infections, (prior to were positively
standardized medication restructuring). This intercorrelated and
measure; average administration errors was a secondary positively
daily acuity/month (Level 1), complaints data analysis of a correlated to
was used) mix of units: 5 patient acuity.
surgical; 10 medical; When patient
3 obstetrical; 8 acuity was
pediatric; 4 critical controlled, these
care; 4 psychiatric; 2 adverse outcomes
eye, ear, nose; 6 seemed to share a
orthopedic and common
neuroscience. underlying
characteristic
indicating
8
something other
than acuity, such
as the quality of
care.
Tarnow-Mordi Staff workload (after Prospective cohort Design: Level 3 1,050 patients Predicted mortality
200041 adjusting for risk Patient outcome: admitted to an adult was calculated
using the APACHE II; hospital mortality (Level ICU in Scotland using the APACHE
workload was defined 1) between January 1, II. The 337 hospital
by average nursing 1992, and deaths were 49
requirement per December 31, 1995. more than
occupied bed and Patients: Age, 16 to predicted by
peak occupancy) >70, with 43% of the APACHE II (95%
patients in the > 70 CI = 34–65).
age group58% male Adjusted mortality
was more than two
times higher (OR =
3.1, 95%CI = 1.9–
5.0) for patients
exposed to high
ICU workload.
Chapter 24. Restructuring and Mergers
Bonnie M. Jennings
Background
During the first half of the 20th century, there was a huge increase in the number of free-
standing general hospitals in the United States.1 At that time, registered nurses (RNs) typically
practiced in hospitals. Consequently, there are strong parallels between the evolution of the
nursing profession and the growth of hospitals as the central structure in the U.S. health care
system.2 By the 1980s, however, a variety of initiatives were implemented for the purpose of
curtailing the rapid rise in health care costs.3, 4 Based upon the assumption that hospital care was
very expensive, cutting inpatient care was a central strategy in the attempt to control the cost of
health care.5 Moreover, the focus on fiscal challenges shifted the health care industry into a
business mode that substantially altered the experiences of patients, as well as the roles of health
care personnel.6
Cost-cutting initiatives over the past 20-odd years contributed to tremendous turmoil in
health care. The initiatives were often introduced concurrently and without empirical evaluations
to determine their effectiveness. Among the early initiatives was a prospective payment system
based upon Diagnosis Related Groups (DRGs), which differed from the historical system of
retrospective payments that covered all services rendered. DRGs established fixed prices for care
based on set criteria, such as diagnosis, therapy, and discharge status. These fixed prices altered
hospital reimbursements, which in turn changed their incentives. As a result, for example,
lengths of stay were shortened. Patients with complex care needs moved through the inpatient
care setting much more rapidly than in the past, giving rise to the phrase “sicker and quicker” to
reflect this dramatic change. In addition, preauthorization was implemented to reduce hospital
use. Together, DRGs and preauthorization provided the impetus to shift care from the hospital to
the outpatient setting and the home.
Fewer inpatients required fewer staff. Reductions in hospital personnel helped to reduce
labor costs; they also raised concerns about the effects of staffing on quality of care and nurses’
job satisfaction.7 By the year 2000, although the hospital remained the primary place of
employment for RNs, 40 percent of RNs worked in other settings.8 This represented a significant
shift over 25 years.
Also contributing to the turmoil in health care during the 1980s was the rapid growth in
managed care. All types of managed care programs attempted to control costs by decreasing
unnecessary use of health care. To support this goal, primary care physicians assumed a more
dominant role in health care by becoming “gatekeepers,” allocating health care resources such as
referrals to specialists.
Managed care also prompted the integration of health services and providers. Through
horizontal integration, free-standing hospitals merged into multihospital systems owned by
central organizations (e.g., Humana), and physicians in private practices joined group practices.
Through vertical integration, a broad array of services covering the care continuum—from
ambulatory care to long-term care—were pulled together into comprehensive delivery systems.4
Ideally, these mergers helped to streamline functions, reduce administrative redundancy, and
negotiate reduced rates when purchasing supplies, equipment, and pharmaceutical products.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
These often radical changes proceeded, however, with little empirical evidence to guide
them. Evaluations were uncommon, and those that were conducted could not keep pace with the
speed of changes resulting from restructuring and mergers. A report from the Institute of
Medicine9 concluded that despite enormous organizational turmoil, little progress was made
toward restructuring health care systems in ways that meaningfully addressed quality and cost
concerns. Likewise, a critical review of restructuring studies found mixed signals about what was
accomplished through these organizational changes.3 According to Aiken and colleagues10 (p.
463), “What we know about changes in organization and structure and the potential for those
changes to affect patient outcomes pales by comparison to what we do not know.”
Assessments about how restructuring and mergers affected patients and staff are more a look
through the rearview mirror because they occurred after the fact. Nonetheless, the findings are
informative, especially when considered in the context of current changes such as recent growth
in hospital construction.11 Today, ongoing change, not stability, is the order of the day for health
care. Lessons from the past can be used as a platform for more proactive responses to future
changes.
Research Evidence
The findings from studies of restructuring can be grouped in numerous ways. A summary of
the findings is presented in Table 1. These studies represent work conducted internationally, but
predominantly in the United States and Canada. Most of the evidence came from assessments of
restructuring in acute care settings.10, 12–48 Although hospital restructuring altered care delivered
in other settings, little research was found that looked outside acute inpatient care. Exceptions
were assessments of outpatient care following restructuring in the Department of Veterans
Affairs (VA), 49, 50 an evaluation of increasing home care needs in Canada,51 and an examination
of overcrowding in an emergency department following restructuring.52
Studies typically addressed employee perceptions of restructuring. Overall, the changes that
occurred through restructuring processes were viewed unfavorably. Most studies considered the
effect of restructuring on staff nurses.10, 12–21, 23, 25–27, 29–31, 34, 35, 38–44, 47, 48 Other health care
professions such as physical therapists33 and social workers36 also explored how restructuring
affected their respective roles. A few investigations considered restructuring from the perspective
of nurses in administrative positions at the patient unit and executive levels.12, 22, 24, 32, 38, 43 One
investigation examined the views of top and middle managers from various disciplines at one
VA hospital, as well as physicians and patients.53 A pair of related investigations considered
restructuring as viewed by chief executive officers.45, 46 An important finding among these
studies was that although strong leadership is essential in times of change, staff nurses’
assessment of nurse managers’ abilities declined considerably between 1986 and 1998, as did the
perception of nurse executive power.10
Few studies explored ways to mitigate the deleterious effects of restructuring. There is
beginning evidence, however, that empowerment32 and leadership style20 may reduce burnout
and increase job satisfaction. One study explicitly examined rebuilding after restructuring.24
Staffing changes were central to the rebuilding efforts, especially increases in licensed personnel
and senior support staff, and decreases in part-time, temporary, agency, and contract nurses. In
three studies that examined cost, results reflected increased costs at both the unit level13 and the
hospital level45, 46 suggesting that restructuring did not achieve its intended purpose.
2
Restructuring & Mergers
The majority of studies examined the relationship between restructuring and job satisfaction.
Regardless of professional discipline, there was a decline in job satisfaction after
restructuring.13, 15, 18–21, 23, 30, 32, 33, 36, 45 Aspects of burnout were also frequently explored.19–21, 32, 48
Findings consistently showed burnout was increasing, particularly emotional exhaustion, which
is viewed as the core feature of burnout. Along with evaluating psychological health, studies
began to detect a relationship between restructuring and increased musculoskeletal
injuries.14, 29, 42
Restructuring can occur within a single institution, while mergers involve integrating two or
more institutions. A cluster of studies explicitly addressed various aspects of mergers.54–62
Findings from three studies verified that the success of mergers was enhanced by engaging staff
from the merging institutions in the process.54, 56, 57 Other investigations evaluated various
responses of nursing staff to mergers.58–60 In a merger involving three hospitals, for example,
Jones59 found that uncertainty about job status and feeling unappreciated minimized nurses’
organizational commitment. Other studies examined mergers from the standpoint of factors
effecting financial performance,61 midwifery practice,62 and the integration of two emergency
departments.55
A number of investigations relied exclusively on qualitative methods to explore restructuring
and mergers.16, 17, 25, 27–29, 32, 34, 40, 53, 54, 60, 62 Themes across these studies help to edify potential
sources of job dissatisfaction and burnout. For example, participants commented that
restructuring altered work relations in undesirable ways,16, 25, 27, 53, 62 including relations with
management,32 that contributed to staff distrust of the employing organization.25, 54 Participants
also identified changes in work life related to increased responsibilities, decreased resources, and
overall busyness.25, 27, 29, 32, 34, 62
In two studies, themes emerged indicating that staff viewed restructuring as detrimental to
the quality of care.27, 32 In another two investigations, in which both patients and health care
professionals were interviewed, findings indicated that patients had fewer complaints about the
changes than did the hospital staff.34, 53
A few studies considered the effects of restructuring on quantifiable patient
outcomes;10, 13, 18, 30, 37, 42, 49, 50 two of these investigations related to outpatient care.49, 50 The
paucity of studies exploring patient outcomes related to restructuring illustrates that staff
response has been the focus of most restructuring and merger studies. Although no causal
connections have been demonstrated, beliefs and assertions hold that staff characteristics do
affect patient outcomes. For example, recent findings show emotional exhaustion among nurses
is associated with higher patient morality.63
Nevertheless, the staff-focused studies do not help to inform patient care per se. Moreover,
the concerns addressed a decade ago by Ingersoll26 persist—many studies are reported in
journals geared to audiences that are more interested in application than scientific rigor. There is
a continued need for studies with more sophisticated designs to better inform the science of
patient safety. These needs expose the potential for better informing practice by combining
health services research techniques with nursing research inquiries.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Care setting • Most studies evaluated restructuring and mergers in acute care settings.
4
Restructuring & Mergers
Berlowitz49 led a study of pressure ulcers among residents of long-term care units at 150 VA
medical centers nationwide. This study illustrated that, as care shifted from a focus on hospital-
based specialty care to outpatient primary care, pressure ulcers increased, even after risk
adjustment. Conversely, in a study from a single VA facility in California, Rubenstein and
colleagues50 demonstrated that the shift to outpatient care yielded improvements in continuity of
care and preventive care related to smoking, exercise, detection of depression, and the number of
individuals with hypertension receiving treatment.
The final study involving a patient focus examined home care needs for patients after
hospitals closed beds.51 Not only did more patients need care after discharge, but service
intensity also increased. The intensity diminished in the second week after discharge. Although
findings from single studies do not warrant practice changes, the effects of restructuring on home
care needs remains an important consideration for patient safety.
The studies that evaluated various staff response to restructuring displayed a much clearer
pattern to their findings—restructuring was associated with negative effects on staff.21, 32, 48
Interested in mitigating these effects, Cummings and colleagues20 tested a model that examined
leadership style. Empathy was a critical leadership competency that served to offset the negative
effects of restructuring. It was characterized by individuals who listened and responded to
employee concerns.
Finally, Walston and colleagues46 evaluated changes in hospital costs during restructuring
efforts. They found that restructuring altered work processes by changing the workflow and job
responsibilities. This exerted a negative influence by increasing hospital costs relative to
competitors.
Research Implications
Given the current evidence, we know that reducing inpatient care as the central strategy for
controlling the cost of health care has not succeeded. We know that staff report being dissatisfied
with their job conditions. We also know there is no consistent pattern in the few studies that have
examined the effect of organizational change on patient outcomes. Furthermore, we know that
change in health care organizations is likely to continue.
Consequently, there are large gaps in knowledge about restructuring and mergers. It is not
feasible to provide a comprehensive list of areas for future study. However some general notions
can be outlined. A fundamental premise is that health care leaders must seriously consider which
changes to implement and the best processes for introducing changes into their organizations. In
addition, they need to evaluate changes—not just implement them. The evaluations need to be
sufficiently comprehensive so that organizational goals (e.g., costs) do not overshadow
examination of the effects of change on staff and patients. These studies also need to be
longitudinal, to track the effects of restructuring over time. This strategy will help to fill the void
about the effects of restructuring on patient safety.
Moreover, if existing care delivery structures are not effective, then a central question
concerns how best to organize care. For example, if the Institute of Medicine’s aims for the 21st-
century health care system are still appropriate,9 then what structures will lead to care that is safe,
effective, patient-centered, timely, efficient, and equitable? Continuity of care before and after
restructuring and mergers is an aspect of care that could benefit from in-depth exploration
because it could contribute to improvements in each of the desired aims. Acute care, outpatient
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
care, and home care have all been affected by restructuring. What mechanisms could be
introduced to enhance continuity from unit to unit and across the care continuum?
Many studies of restructuring follow a sociological view of organizations; a psychological
framework has been used less often. Human relations—among both staff and patients—are
central to caregiving organizations. Kahn64 asserts that interpersonal transactions are at the core
of caregiving organizations. He believes that resilient organizations have members who are able
to learn and grow, even in difficult environments. Resilient organizations are better able to
absorb stress and maintain the capacity to function effectively. Therefore, regardless of the
structure, health care organizations would benefit from investigations that examine interpersonal
conditions at work. Interventions could then be developed to help staff improve relationships
with one another and work together more effectively. To date, studies have not examined the
effects of restructuring on the dynamics among caregivers and between caregivers and patients.
In addition, leadership as a linchpin of relationships between staff and administrators begs to be
better understood.
From the perspective of patient outcomes, however, we know very little. There is no
discernible pattern in existing findings; there is no meaningful statement that can be made. The
impact of restructuring on patient safety remains unknown. Measurement and methods questions
are important considerations to enhance that understanding—which indicators to use, how they
are defined, how they are measured, what the unit of analysis is. Decreased resources, including
sufficient staff, surfaced as a concern in studies of restructuring. It would be beneficial to assess
different care structures, determine the work that needs to be done, determine who needs to do it,
provide the proper type and number of staff to do the work, and then assess which organizational
structures yield the best opportunity for providing safe care to patients.
It would also be extremely useful to pursue a series of qualitative studies to better depict the
current state of health care organizations. Data could be collected from staff at all levels of
individual organizations as well as vertically and horizontally integrated systems of care. Data
could also be collected from patients getting care in different venues, including the home. Family
member perspectives would be valuable, too. Such studies would be very complex and difficult,
but they could elucidate key issues and concerns. These could then be used to construct
interventions or guide future restructuring efforts.
This is just the beginning of an almost endless list of ideas that could be studied to advance
the understanding of restructuring and mergers. Future endeavors need to be more proactive in
assessing organizational change early in the change process. They also need to approach
questions over time, using a comprehensive set of variables, as well as sophisticated
methodological and statistical techniques, to truly advance the understanding of restructuring on
the staff as well as patient safety.
Conclusion
As reflected in the Table (see above), most studies of restructuring and mergers have been
conducted in acute care settings. Many of these studies have examined the effects of
restructuring and mergers on cost, staff nurses, and patient outcomes. In the aggregate,
restructuring and mergers did not achieve the desired reductions in cost. However the upheaval
accompanying restructuring efforts and mergers can be related to lower job satisfaction among
nurses and increased burnout. The effects of restructuring and mergers on patient care, however,
6
Restructuring & Mergers
are more difficult to understand because the evidence varies over time, by hospital or unit, and
by unit type.
There is convergence in findings about sources of job dissatisfaction and burnout related to
restructuring and mergers. Organizational and unit leaders would be wise to carefully assess
work relations, work responsibilities, and the availability of resources, all of which may be
sources of dissatisfaction and burnout. It would also behoove the leaders to consider the evidence
that illustrates ways to minimize the undesirable effects of restructuring and mergers. These
include empowerment, empathetic leadership, and staffing changes that increase the number of
licensed nurses who are employed by the institution.
Search Strategy
A reference librarian assisted in running database searches in both MEDLINE® and
CINAHL® to identify literature for this review. Both databases were searched from 1995 to
2005, using the same two MESH headings: hospital restructuring and health facility mergers.
The searches were limited to research reports published in the English language. A total of 149
potential publications were identified, 56 in MEDLINE® and 93 in CINAHL®. Based upon an
assessment of the abstracts, 67 of the publications were regarded as being suitable for inclusion
in this review. The 82 papers that were omitted were a combination of brief reports or abstracts,
topics not suitable to this review (i.e., mental health triage tools), and doctoral dissertations.
After reading the 67 publications in their entirety, 14 were omitted from further
consideration. Some of these papers, for example, were only tangentially related to restructuring
and mergers, a few were redundant publications, and others were about instrument development.
This review is therefore based on 53 research reports.
Acknowledgment
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library, Falls
Church, VA, for their considerable support of this work. They conducted the database searches
and assisted in acquiring numerous papers considered in this review.
Author Affiliations
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N.; Colonel, U.S. Army (Retired); and health care
consultant. E-mail: [email protected].
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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10
Evidence Table: Restructuring and Mergers
2001 care cohort Patient outcomes: Affairs (VA) long-term in 1995 to shift from a 1994), risk-adjusted rates of
risk-adjusted care units at about 150 hospital-based, specialty- PUs declined by 27%. Rates
development of VA medical centers focused system to one began increasing in 1997.
stage 3 or 4 nationwide between based on primary care By 1997 rates were similar
pressure ulcers 1990 and 1997; delivered in outpatient to those in 1990. The
(Level 1) 274,919 observations of settings proportion of new PUs that
103,499 VA residents were severe increased
who were without a significantly from 1995 to
pressure ulcer (PU) at 1997 (P = 0.01, average
an index assessment: 45%). 11 patient
97% were men, characteristics were
average age was 71 significantly associated with
years PU development (e.g.,
mobility, dependency on
transferring, toileting; P <
Cummings Leadership Cross-sectional Design: Level 3, 15 Acute care hospitals in Leadership styles: Hospital restructuring led to
20
2005 nursing outcomes: Alberta, Canada; resonant (visionary, reported increases in unmet
e.g., emotional 6,526 registered nurses coaching, affiliative, patient needs among all
health; physician- (53% response rate) democratic), dissonant nurses surveyed. Resonant
nurse (pace setting, leadership lessened the
teamwork; nurse commanding), mixed. intensity of the impact of
workgroup restructuring on unmet care
collaboration; needs, emotional
satisfaction with exhaustion, emotional
time to spend with health, and workgroup
patients, collaboration. Dissonant
supervision, leadership intensified the
financial rewards, effects of restructuring.
one’s job; Other causal relationships
perceived quality of were discovered among
care as measured nursing outcome variables
by unmet patient that were mitigated by
needs (Level 3) resonant leadership.
Safety Issue Study
Source Related to Design Design, Study Setting & Study Study Intervention Key Finding(s)
Clinical Type Study Outcome Population
Practice Measure(s)
Cummings Effects on Systematic Design: Level 1, Published research—84 Hospital restructuring Decreased job satisfaction
200321 nurses who literature review effects of papers were screened effects on nurses (RNs complicated recruiting and
remained restructuring on for inclusion criteria: 22 and LPNs) retaining nursing staff;
employed nurses remaining papers were included in increased emotional
while others employed in the review exhaustion and work
lost their jobs hospitals (Level 3) (18 of 24 quantitative absences; perceived and
papers and 4 of 9 actual increased workload;
qualitative papers) perceived increase in patient
acuity; impaired ability to
communicate important
patient information;
loss of work group cohesion.
Keller 200451 Hospital bed Cross-sectional Design: Level 4; Kingston, Ontario, Delivery of home care by Patients needed continued
closures outcomes: rate of Canada; closure of 134 registered nurses (RNs) care after discharge. Age-
home care, service acute care beds in 2 and registered practical gender standardized rates
intensity tertiary teaching nurses (RPNs) for home care showed a
hospitals in 1997; 10% increase between 1996
13
The importance of nurse staffing to the delivery of high-quality patient care was a principle
finding in the landmark report of the Institute of Medicine’s (IOM) Committee on the Adequacy
of Nurse Staffing in Hospitals and Nursing Homes: “Nursing is a critical factor in determining
the quality of care in hospitals and the nature of patient outcomes”1 (p. 92). Nurse staffing is a
crucial health policy issue on which there is a great deal of consensus on an abstract level (that
nurses are an important component of the health care delivery system and that nurse staffing has
impacts on safety), much less agreement on exactly what research data have and have not
established, and active disagreement about the appropriate policy directions to protect public
safety.
The purpose of this chapter is to summarize and discuss the state of the science examining
the impact of nurse staffing in hospitals and other health care organizations on patient care
quality, as well as safety-focused outcomes. To address some of the inconsistencies and
limitations in existing studies, design issues and limitations of current methods and measures will
be presented. The chapter concludes with a discussion of implications for future research, the
management of patient care and public policy.
Background
For several decades, health services researchers have reported associations between nurse
staffing and the outcomes of hospital care.2–4 However, in many of these studies, nursing care
and nurse staffing were primarily background variables and not the primary focus of study.5 In
the 1990s, the National Center for Nursing Research, the precursor to the National Institute of
Nursing Research, convened an invitational conference on patient outcomes research from the
perspective of the effectiveness of nursing practice.6 It was hoped that as methods for capturing
the quality of patient care quantitatively became more sophisticated, evidence linking the
structure of nurse staffing (i.e., hours of care, skill mix) to patient care quality and safety would
grow. However, 5 years later, the 1996 IOM report articulating the importance of nurses and
nurse staffing on outcomes concluded that, at that time, there was essentially no evidence that
staffing exerted an effect on acute care hospital patients’ outcomes and limited evidence of its
impact on long-term care outcomes.1
There has been remarkable growth in this body of literature since the 1996 IOM report. Over
the course of the last decade, hospital restructuring, spurred in part by a move to managed care
payment structures and development of market competition among health care delivery
organizations, led to aggressive cost cutting. Human resources, historically a major cost center
for hospitals, and nurse staffing in particular, were often the focus of work redesign and
workforce reduction efforts. Cuts in nursing staff led to heavier workloads, which heightened
concern about the adequacy of staffing levels in hospitals.7, 8 Concurrently, public and
professional concerns regarding the quality and safety of patient care were sparked by research
and policy reports (among them, the IOM’s To Err is Human9), and then fueled by the popular
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
media. A few years ago, reports began documenting a new, unprecedented shortage of nurses
linked to growing demand for services, as well as drops in both graduations from prelicensure
nursing education programs and workforce participation by licensed nurses, linked by at least
some researchers to deteriorating working conditions in hospitals.10, 11 These converging health
care finance, labor market, and professional and public policy forces stimulated a new focus of
study within health services research examining the impact of nurse staffing on the quality and
safety of patient care. An expected deepening of the shortage in coming years12 has increased the
urgency of understanding the staffing-outcomes relationship and offering nurses and health care
leaders evidence about the impacts of providing care under variable nurse staffing conditions.
This chapter includes a review of related literature from early 2007.
2
Staffing
among these.16 The ANA then funded six initial nursing quality report card indicator feasibility
studies, which developed and refined these first sets of measures, documenting the quality of
nursing care in acute care settings. The California Nursing Outcomes Coalition (CalNOC) was
among the first State-based feasibility projects conducted by the ANA that ultimately served as
the basis for the National Database for Nursing Quality Indicators (NDNQI) established in 1997.
Maintaining an informal collaboration with the NDNQI, CalNOC continues to function as a
regional nursing quality database, and more recently, CalNOC methods have been adapted by
both the emerging Military Nursing Outcomes Database and VA Nursing Outcomes Database
projects. All four groups currently collect and analyze unit-level data related to the associations
between nurse staffing and the quality and safety of patient care. Together, they have formed an
unofficial collaborative of nursing quality database projects.17–21
The most recent initiative in standardizing staffing and outcomes measures for quality
improvement and research purposes was undertaken by the National Quality Forum (NQF). The
mission of the NQF is to improve American health care through consensus-based standards for
quality measurement and public reporting related to whether health care services are safe, timely,
beneficial, patient centered, equitable, and efficient. To advance standardization of nurse-
sensitive quality measures and respond to authoritative recommendations from multiple IOM and
Federal reports,9, 15, 22 the NQF convened an expert panel and established a rigorous consensus
process to generate the Nation’s first panel of nursing-sensitive measures for public reporting.
The aim of the expert panel was to explicate and endorse national voluntary consensus standards
as a framework for measuring nursing-sensitive care and to inform related research. Potential
nursing-sensitive performance measures were subjected to a rigorous and systematic vetting
under the terms of the NQF Consensus Development Process, which included a thorough
examination of evidence substantiating each measure’s sensitivity to nursing factors, alignment
with existing requirements being made of providers, and validation/recommendations of
advisory bodies to Federal agencies. As illustrated in Figure 1, the resulting first 15 NQF
nursing-sensitive measurement standards were informed by earlier work by the NDNQI and
CalNOC, as well as measures arising from formal research studies.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Notes: CMS = Centers for Medicare and Medicaid Services; EHR = electronic health record; JCAHO = Joint
Commission on Accreditation of Healthcare Organizations, now known as the Joint Commission; OMB = Office of
Management and Budget.
These measures represent a first (but by no means final) attempt to make nurse-sensitive
outcomes visible to the broader community of payers and policymakers. The first 15 voluntary
consensus standards for nursing-sensitive care intended for use in public reporting and policy
initiatives included23
1. Failure to rescue
2. Pressure ulcer prevalence
3. Falls
4. Falls with injury
5. Restraint (vest and limb) prevalence
6. Urinary catheter-associated urinary tract infections (intensive care unit, ICU)
7. Central line catheter-associated bloodstream infections (ICU)
8. Ventilator-associated pneumonia (ICU)
9. Smoking cessation counseling for acute myocardial infarction
10. Smoking cessation counseling for pneumonia
11. Smoking cessation counseling for heart failure
12. Skill mix
13. Nursing hours per patient day
14. Practice Environment Scale-Nursing Work Index
15. Voluntary turnover
4
Staffing
• Staffing levels are set by administrators and are affected by forces that include budgetary
considerations and features of local nurse labor markets. Administrative practices result
in a structure of the nursing staff of an agency (nature of supervision) and staff or staff
hours assigned to different subunits in a facility. These practices also affect the mix and
characteristics of the nurse workforce, the model of care used in assigning staff and in
providing care, and a wide range of workplace environments that affect how nurses
practice. Other characteristics of the workplace environments noted in the literature
included the physical environment, communication systems and collaboration,
information systems, and relevant support services. All of these factors ultimately
influence the “dose” or quantity of nursing time, as well as the quality of nursing care.
• Variables included in the category of care needs of the patient include the acuity and
complexity of the patient’s health status, as well as the patient’s comorbid medical
conditions, functional status, family needs/resources, and capacity for self-care. The
vulnerabilities of patients for adverse events varies and changes over the course of a
hospital stay or episode of care.
• The quality of nursing care relates to the appropriate execution of assessments and
interventions intended to optimize patient outcomes and prevent adverse events. For
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
example, the extent to which nurses assess the risk for falls in hospital patients upon
admission, implement evidence-based fall-prevention protocols, and sustain such
preventive interventions could each be developed into measures of nursing care quality.
The quality of nursing care also includes attention to safety issues, for example, the
accuracy of medication administration. Safe care also entails consistent monitoring
tailored to patients’ conditions to guarantee early recognition of patient deterioration and,
if problems are identified, benefit from a rapid, appropriate interdisciplinary team
response to these issues.24
The quality of care that nurses provide is influenced by individual nurse characteristics such
as knowledge and experience, as well as human factors such as fatigue. The quality of care is
also influenced by the systems nurses work in, which involve not only staffing levels, but also
the needs of all the patients a nurse or nursing staff is responsible for, the availability and
organization of other staff and support services, and the climate and culture created by leaders in
that setting. The same nurse may provide care of differing quality to patients with similar needs
under variable staffing conditions and in different work environments.
• Safety outcomes include rates of errors in care as well as potentially preventable
complications in at-risk patients. Safe practices that avoid errors and foreseeable
complications of care can be thought of as either a basic element of or a precondition for
delivering high-quality care, but are generally thought of as only one component of
quality.
• Clinical outcomes (endpoints) of importance vary from patient to patient or by clinical
population and include mortality, length of stay, self-care ability, adherence to treatment
plans, and maintenance or improvement in functional status. Serious errors or
complications often lead to poor clinical outcomes. So far, very few positive clinical
outcomes have been studied by staffing-outcomes researchers, probably because of
limited measures and data sources.
The sheer number of variables and myriad linkages depicted suggest why precise evidence-
based formulas for deploying nursing staff to ensure safe, high-quality patient care are
impossible based on the knowledge on hand. In fact, such prescriptions may never be possible.
Certainly, evidence-based guidelines for allocating resources to ensure optimal outcomes in
acute care and other health care settings cannot be offered until working environments, staffing
(beyond head counts and skill mix), patient needs, processes, and outcomes of care can be
measured with precision.
Research investigating links between hospital nurse staffing and patient outcomes began with
studies examining patient mortality. Reviews now include research examining a broad range of
outcomes, including specific adverse events other than mortality. Although many studies support
a link between lower nurse staffing and higher rates of negative nurse-sensitive safety
outcomes,25–27 reviews of two decades of research revealed inconsistent results across studies.25–30
6
Staffing
second, linking the two types of variables to reach valid conclusions. As noted earlier in this
chapter, because of limitations in measures, data sources, and analytic methods, researchers
generally ask a different question in their studies (Is there a correlation between staffing and
patient care outcomes?) than the questions that are of primary concern to patients, clinicians,
managers, and policymakers (What staffing levels are safe under a specific set of
circumstances?).31 Nonetheless, researchers in this field deserve a great deal of credit for making
creative use of a variety of data sources not originally developed for research (or research on
staffing and outcomes) to generate a great deal of evidence that has fueled discussion in the
practice, management, and policy communities.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Important distinctions
• Level of measurement within the organization (whole
facility/department vs. unit)
• Roles of staff measured (such as staff involved in “direct
patient care” vs. all nursing staff)
• Time frame (shift/day/week/month/quarter/year)
Outcome • Patient records, discharge Occurrence of events suggestive of poor (or less commonly,
abstracts, incident reports, or high) quality of care or nurse work-related outcomes
other byproducts of care
delivery (including Level of measurement
reimbursement) • Individual patients/nurses
• Prospective surveillance for • Subunits (e.g., nursing units) of organizations
specific events (such as falls • Entire facilities
and pressure ulcers)
• Surveys of patients/families and
providers
Measurement of outcomes Were outcomes assessed in comparable ways across patients and across settings
(units or institutions or time periods)?
Does the outcome in question have a plausible association with nursing practice, or is
it primarily/entirely associated with factors outside the control of providers?
Risk adjustment Have the authors conducted fair comparisons between rates of adverse events across
hospitals units or time periods by considering potentially important differences in the
patients treated across those settings and/or over time?
8
Staffing
Are outcomes attributed to the locations of care where nursing services actually
influence the outcome, or do they also reflect the place where detection of the
outcome occurs?
Control for confounding Have other aspects of the environments in which patients are cared for that might
factors affect the outcomes been measured and analyzed?
E.g., availability of equipment/supplies, quality of physician care, other types of facility
personnel, hospital size, academic affiliation, rural-urban location
Statistical modeling If the study examines an outcome that is rare in the patient population, has this been
considered in any modeling? How is skewness of the data managed?
If the subjects of the study are grouped or nested within larger organizational units
(e.g., patients within nursing units within hospitals), has this been handled by the
analytic strategy?
Staffing
Staffing levels can be reported or calculated for an entire health care organization or for an
operational level within an organization (a specific unit, department, or division). Specific time
frames (at the shift level and as a daily, weekly, or yearly average) must be identified to ensure
common meaning among collectors of the data, those analyzing it, and individuals attempting to
interpret results of analyses.
In many cases, staffing measures are calculated for entire hospitals over a 1-year period. It is
fairly common to average (or aggregate) staffing across all shifts, for instance, or across all day
shifts in a month, quarter, or year and sometimes also across all the units of hospitals. The
resulting measures, while giving an imprecise idea of what specific conditions nurses and
patients experienced at particular points, are general indicators of facilities’ investments in
staffing. However, staffing levels on different units reflect differences in patient populations and
illness severity (the most striking of which are seen between general care and critical care units).
Furthermore, in practice, staffing is managed on a unit-by-unit, day-by-day, and shift-by-shift
basis, with budgeting obviously done on a longer time horizon. For these reasons, some
researchers argue that at least some research should be conducted where staffing is measured on
a shift-specific and unit-specific basis instead of on a yearly, hospitalwide basis. A distinct, but
growing, group of studies examined staffing conditions in subunits or microsystems of
organizations (such as nursing units within hospitals) over shorter periods of time (for example,
monthly or quarterly).17, 32–34
In addition to three sources of staffing data, there are also two basic types of staffing
measures or variables. The first type divides a volume of nurses or nursing services by a quantity
of patient care services. Common examples include patient-to-nurse ratios, hours of nursing care
delivered by various subtypes of personnel per patient day (HPPD), and full-time equivalent
(FTE) positions worked in relation to average patient census (ADC) over a particular time
period. Patient-to-nurse ratios, HPPD figures, or FTE:ADC measures have the potential to both
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
systematically overestimate or underestimate nurse workloads and the attention given to specific
patients in relation to those patients’ needs, conditions, and clinical trajectories across units or
institutions or over time.31
The second major type of measure examines the credentials or qualifications of those staff
members and expresses them as a proportion of staff with more versus less training (or vice-
versa). Commonly, the composition of the nursing staff employed on a unit or in a hospital in
terms of unlicensed personnel, practical or vocational nurses, and registered nurses (RNs) is
calculated. The specific types of educational preparation held by RNs (baccalaureate degrees
versus associate degrees and diplomas) have also begun to be studied. Additional staffing-related
characteristics studied include years of experience and professional certification. The incidence
of voluntary turnover and the extent to which contract or agency staff provide care have also
been studied. As will be discussed, the majority of the evidence related to hospital nurse staffing
focuses on RNs rather than other types of personnel.
For the most common measures, ratios and skill-mix, determining which staff members
should be included in the calculations is important, given the diversity of staffing models in
hospitals. Most researchers feel these statistics should reflect personnel who deliver direct care
relevant to the patient outcomes studied. Whether or not to count charge nurses, nurse educators
involved in bedside care, and nurses not assigned a patient load (but who nevertheless deliver
important clinical services) can present problems, if not in principle, then in the reality of data
that institutions actually collect. Outcomes research examining the use of advanced practice
nurses in acute care—for instance, nurse practitioners and nurse anesthetists—to provide types of
care traditionally delivered by medical staff and medical trainees has been done in a different
tradition (analyzing the experiences of individual patients cared for by specific providers) and
does not tend to focus on outcomes relevant to staff nurse practice; therefore these studies are not
reviewed here. No studies were found that examined advanced practice nurse-to-patient ratios or
skill mix in predicting acute care patient outcomes. There have been calls to examine advanced
practice nurses supporting frontline nurses in resource roles (for instance, clinical nurse
specialists who consult and assist in daily nursing care, staff development, and quality assurance)
and their potential impact on patient outcomes. No empirical evidence of this type was found.
Outcomes
Clearly, capturing data about patient outcomes prospectively (i.e., as care is delivered) is the
best option for obtaining precise, comprehensive, consistently collected data. This approach is
the most challenging because of practical, ethical, and financial considerations. However,
researchers can sometimes capitalize on prospective data collections already in progress. For
instance, hospital-associated pressure ulcer prevalence surveys and patient falls incidence are
commonly collected as part of standard patient care quality and safety activities at the level of
individual nursing units in many institutions.18, 32 Many, but by no means all, studies in this area
use secondary data not specifically intended for research purposes, such as patient medical
records. Outcomes researchers often use condensed or abstracted versions of hospital patients’
records in the form of discharge abstracts, which contain data extracted from health care records
about clinical diagnoses, comorbidities, procedures, and the disposition of patients at discharge.35
As there are concerns that the quality and reliability of clinical documentation varies widely,35
one author suggested that only a form of electronic medical record that forces contemporaneous
recording of assessment data and interventions will permit true performance measurement in
10
Staffing
health care.36 Wider application of information technology in health care settings, anticipated to
facilitate care delivery and improve quality and safety, is also expected to provide richer, higher-
quality data sources for strategic performance improvement that can be leveraged by outcomes
researchers.
Patients are not all at equal risk of experiencing negative outcomes. Elderly, chronically ill,
and physiologically unstable patients, as well as those undergoing lengthy or complex treatment,
are at much greater risk of experiencing various types of adverse events in care. For instance,
data on falls may be consistently collected for all hospitalized patients but may not be
particularly meaningful for obstetrical patients. Accurately interpreting differences in rates
across health care settings or over time requires understanding the baseline risks patients have for
various negative outcomes that are beyond the control of the health care providers. Ultimately
this understanding is incorporated into research and evaluation efforts through risk adjustment
methods, usually in two phases: (1) carefully defining the patient populations at risk—the
denominator in rates; and (2) gathering reliable and valid data about baseline risk factors and
analyzing them. Without sound risk adjustment, any associations between staffing and outcomes
may be spurious; what may appear to be favorable or unfavorable rates of outcomes in different
institutions may no longer seem so once the complexity or frailty of the patients being treated is
considered.35
The focus of this review is on staffing and safety outcomes. However, as was noted earlier,
quality of care and clinical outcomes (and by extension, the larger domain of nursing-sensitive
outcomes) include not only processes and outcomes related to avoiding negative health states,
but also a broad category of positive impacts of sound nursing care. Knowledge about positive
outcomes of care that are less likely to occur under low staffing conditions (or are more likely
under higher levels) is extremely limited. The findings linking functional status, psychosocial
adaptation to illness, and self-care capacities in acute care patients are at a very early stage37 but
eventually will become an important part of this literature and the business case for investments
in nurse staffing and care environments.
Linkage
In staffing-outcomes studies, researchers must match information from data sources about the
conditions under which patients were cared for with clinical outcomes data on a patient-by-
patient basis or in the form of an event rate for an organization or organizational subunit during a
specific period of time. Ideally, errors or omissions in care would be observed and accurately
tracked to a particular unit on a particular shift for which staffing data were also available. Most,
but not all, large-scale studies have been hospital-level analyses of staffing and outcomes on an
annual basis and have used large public data sources.
Linkages of staffing with outcomes data involve both a temporal (time) component and a
departmental or unit component. Many outcomes (endpoints) examined by staffing researchers
are believed to reflect compounded errors and/or omissions over time across different
departments of an institutions. These include some types of complications as well as patient
deaths. Attribution of outcomes is complicated by the reality that patients are often exposed to
more than one area of a hospital. For instance, they are sometimes initially treated in the
emergency department, undergo surgery, and either experience postanesthesia care on a
specialized unit or stay in an intensive care unit before receiving care on a general unit. If such a
patient develops a pressure ulcer, at what point did low staffing and/or poor care lead to the
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Evidence
Perhaps staffing and outcomes research has such importance and relevance for clinicians and
educators as well as for managers and policymakers, staffing-outcomes research is a frequently
reviewed area of literature. As was just detailed, a diversity of study designs, data sources, and
operational definitions of the key variables is characteristic of this literature, which makes
synthesis of results challenging. Many judgments must be made about which studies are
comparable, which findings (if any) contribute significantly to a conclusion about what this
literature says, and perhaps regarding how to transform similar measures collected differently so
they can be read side by side. The review of evidence here builds on a series of recent systematic
reviews with well-defined search criteria.25, 27, 30, 38 At least one group of researchers conducted a
formal meta-analysis that integrated the bulk of empirical findings in the hospital staffing
literature and summarized effect sizes for specific staffing measures, outcomes, and clinical
populations.30 This review was the most up-to-date identified within this search.
12
Staffing
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
In another analysis, Donaldson and colleagues39 traced daily, unit-level direct care nurse
staffing in 77 units across 25 hospitals over a 2-month period using data on staffing effectiveness
(the match between hours of care and hours provided). By law in California, each hospital unit
uses an institutionally selected, acuity-based workload measurement system to determine
required hours of care for each patient. For each patient-care unit, the ratio of actual to required
hours of care, was expressed as both a mean ratio and as a percentage of days on which required
hours exceeded actual hours over the 7 days prior to a pressure ulcer prevalence study. Using
Spearman rank correlations, the percentage of patients with hospital-associated pressure ulcers
was significantly associated with the mean actual/required hours ratio for the prior 7 days (r’s = -
0.25, 63 df, P < 0.05), and with the percent days with the actual/required ratio <100 percent for
the prior 7 days (r’s = 0.25, 63 df, P < 0.05). Larger actual/required ratios and actual/required
ratios closer to 100 percent were associated with a lower percentage of patients with hospital-
associated pressure ulcers. These analyses linked unit-level staffing and safety-related outcomes
data, and measured for time periods at the unit level closely and logically connected (staffing
measures relevant to conditions before the outcome occurred). The findings are intriguing and
suggest that the impact on patients of “short” staffing appeared a number of days later, as one
would expect given the pathophysiology of pressure ulcers (since it takes a number of days of
unrelieved pressure on a vulnerable area for tissue damage to occur). Both researchers and
research consumers need to reflect on the time frames involved in the evolution of various
outcomes when assessing the validity of data linkages across time and units. For instance, in
contrast to the lags between quality problems in care and evidence of their impact on outcomes
such as infections and pressure ulcers, practice conditions will tend to have more immediately
observable impacts on outcomes like falls with injury and most adverse drug reactions.
Recent legislation in California that introduced mandated nurse-to-patient ratios at the unit
level provides an interesting context for studying the association of staffing and outcomes.
CalNOC has reported early comparisons of staffing and outcomes in 268 medical-surgical and
step-down units in 68 California hospitals during two 6-month intervals (Q1 and Q2 of 2002 and
Q1 and Q2 of 2004) before and after introduction of the ratios. Data were stratified by hospital
size and unit type. On medical-surgical units, mean total RN hours per patient day increased by
20.8 percent, total nursing hours increased by 7.4 percent, the number of patients per licensed
nurse decreased by 16.0 percent, and the portion of nonlicensed nursing hours decreased by 20.8
percent. However, there were no statistically significant changes in the rate of patient falls or
pressure ulcers on these units.40 These early data suggested that the introduction of mandated
ratios may have led to changes in staffing metrics in California hospitals without yet attaining the
goal of improving patient outcomes.
14
Staffing
characteristics, affect outcomes since negative outcomes are relatively uncommon even at the
extremes of staffing and do not occur in every circumstance where staffing is low.
A critical mass of studies established that nurse staffing is one of a number of variables
worthy of attention in safety practice and research. There is little question that staffing influences
at least some patient outcomes under at least some circumstances. Future research will clarify
more subtle issues, such as the preferred methods for measuring staffing and the precise
mechanisms through which the staffing-outcomes relationship operates in practice.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
composition of hospital staffs may be a more cost-effective measure and could have a bigger
impact on outcomes than increasing hours of nursing care per patient day.41 Likewise, most
reports in the literature dealing with unlicensed assistive personnel (UAPs) either failed to find
associations with this type of staff or suggested worse outcomes in institutions with high levels
of such personnel. There is no direct evidence that it is unsafe to employ LPNs in acute care
settings,42, 43 nor is there empirical support that the use of unlicensed personnel is intrinsically
related to poor outcomes. Use of practical nurses and UAPs can be driven by any and all of the
factors outlined in Figure 2. Nonetheless, anecdotal evidence suggests that inadequately trained
and/or supervised personnel of all kinds at times provide unsafe care; that operational problems
having related, but distinct, causes and consequences can lead to substituting other types of
workers for RNs and to safety problems; and that the savings associated with using lesser-trained
workers sometimes prove to be false economies. The models of care under which LPNs and
unlicensed care providers are employed (i.e., the exact roles of non-RN personnel and degree of
oversight provided by RNs) has not been considered in research. While RNs have the broadest
scope of practice of frontline nursing workers, it is far from established that 100 percent RN
staffing is effective in all situations. Future research needs to identify the circumstances under
which LPNs and UAPs can be used safely. Until then (and even when it does), local labor market
realities, experience, and judgment will need to be used by leaders to establish skill mix and to
define the models of care under which RNs, LPNs, and UAPs work.
Early studies have offered early, tantalizing insights regarding a number of variables
conceptually close to staffing. These findings include the educational preparation of RN staff in
hospitals. Two recent studies44, 45 found that mortality in surgical and medical patients was lower
in hospitals where higher proportions of staff nurses held baccalaureate degrees. The AHRQ-
sponsored studies of California hospitals discussed above also suggested that a higher percentage
of nurses holding bachelor’s and higher degrees was associated with lower fall rates.
Additionally, in this latter work, units where higher percentages of RNs held specialty
certification had lower proportions of restrained patients. Should these findings be borne out in
future studies, there are important potential local and national policy implications. There is a
clear need for more research. Similarly, while many feel experience and specialty training have
logical associations with quality of care and patient safety, empirical data regarding their impact
are very limited at present.
Yet another area where data related to patient outcomes are thin relates to the impact of
specific types of work environments on nurse-sensitive outcomes, and in particular the impact of
the Magnet hospital model, which has been argued to produce superior patient outcomes (and
safer care).46, 47 Such connections would make intuitive sense, since current Magnet criteria
require adherence to many best practices in nursing management, including selection of a well-
articulated staffing model driven by data. To our knowledge, there are no studies yet to directly
support a connection between safety and specific managerial approaches or to link Magnet status
with patient outcomes in the current era of certification. However, early findings with respect to
questions around the outcomes of the program are expected in the coming years.
16
Staffing
challenges in using existing documentation and databases to measure outcomes in long-term care
facilities,48 some of which are shared with outcomes measurement in acute care. Long-term care
researchers face special issues, specifically with respect to data reliability and measure stability,
skewedness of measures, and selection and ascertainment bias (where types of patients at high
risk for poor outcomes or who are more closely observed are concentrated in certain nursing
homes).48
Despite these problems, a critical mass of studies suggests that long-term care facilities with
the lowest licensed and unlicensed staffing levels among their peers show disproportionately
worse patient outcomes. A study sponsored by the Centers for Medicare and Medicaid Services
(CMS) suggested that among short-stay patients, skilled nursing facilities with the lowest
staffing levels were 30 percent more likely to fall in the worst 10 percent of facilities for
transfers to acute care for acute heart failure, electrolyte imbalances, sepsis, respiratory infection,
and urinary tract infection. Facilities with staffing below thresholds of 2.78 hours of aide time
and 0.75 hours of RN time had greater probability of having the worst outcome rates for long-
stay patients, including pressure ulcers, skin trauma, and weight loss.49 Similar conclusions were
reached in a secondary analysis of data from a pressure ulcers study. In 1,376 residents of 82
long-term care facilities, patients in facilities with more direct RN time (30–40 minutes per
patient day and more) had fewer pressure ulcers, acute care hospitalizations, urinary tract
infections, and urinary catheters, and less deterioration in ability to perform activities of daily
living.50 In a national sample of nursing homes from 45 States, those that met CMS guidelines
for RN and unlicensed hours per patient-day had statistically lower rates of lawsuits after
controlling for a multitude of structural, market, and patient factors.51 Not all studies report such
findings. Rantz and colleagues’52 analysis of outcomes in 92 nursing homes found that staffing
levels did not predict facilities’ classification as having generally good, mediocre, or poor
outcomes and found that on average, costs were somewhat higher in poor-outcome facilities.
These researchers suggested that administrative practices other than staffing may play an
important role in determining long-term care quality.
Home health is a growing sector in U.S. health care. Staffing models fall somewhere between
acute care hospitals and long-term care in terms of the proportions of unlicensed personnel and
practical nurses. Allocation of nursing time to patients presumably influences quality and
thoroughness of nursing acts and assessments. There may be skill-mix issues as well. However,
to date there have been no studies of home health agency staffing models, nurse workloads, or
skill mix. OASIS (Outcomes Assessment and Information Set) data gathered by home health
providers by mandate from the Medicare program, skillfully analyzed and interpreted, will offer
opportunities to examine safety in home care in relation to staffing decisions.53 Similar
statements can be made about nurse staffing in most other ambulatory and community settings as
well.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
18
Staffing
have identified a number of organizational strategies that may constitute better practice in
managing the impact of nurse staffing on patient care quality and safety. For example, efforts to
optimize clinical, throughput flow and reduce practice variability may reduce threats to staff and
patients due to system and personnel overload.57 Managing supply and demand in health care
settings by smoothing peaks and valleys of patient flow,58 as well as staffing levels, may be
effective in modulating workflow extremes that cause staff distress and might pose risks to
patients. Implementing systems that enable staff to standardize high-volume common practices
(such as patient education, discharge planning, and risk assessments) may be expected to
increase efficiency, while enabling staff to customize these highly effective interventions to the
unique characteristics of the patient/family. Engaging staff in self-governance related to patient
flow has also been cited as a promising best practice. Considered key to safe staffing,
professional judgment as the gold standard establishes the threshold for safe patient care in a
given clinical setting,59 as nurses use a systematic decision matrix to determine if the staff on a
particular unit can accept responsibility for additional patients. Informed by understanding of
scientific conclusions linking staffing and patient outcomes in comparable settings, the self-
governing and administrative teams of the future may use internally generated data to support
decisions related to staffing adequacy and effectiveness.60 Through systematic microsystem
(unit) assessment, combined with concurrent measurement tracing structure, processes, and
outcomes of care, it is possible to calibrate the expertise and dose of the nurse and individualize
interventions to the unique characteristics and needs of the patient, optimizing patient care.61
As clinicians and administrators in clinical settings gain greater access to real-time data that
enable them to explore links between structure, process, and outcomes, increasingly
sophisticated tools such as virtual dashboards are promising.18 Despite a tradition in nursing that
has emphasized scientific inquiry as a fundamental source of evidence for practice, there is
growing awareness that data that emerge from practice and practitioners (particularly when
collected using systematic methods and with high-quality measures) may be a vital source of
material for research in this and other areas of policy-relevant inquiry.62
Research Implications
There are a great many questions in this field that are still unanswered. There is a clear need
to investigate processes of care that are specific to nursing that are associated with safer patient
care as well as safer, more efficient interdisciplinary team functioning. Data issues (a lack of
measures and of data sources) are a major barrier to work on care delivery. In a discussion of
nursing workload measurement tools, the International Council of Nurses noted that “existing
tools are unable to capture more than 40 percent of nursing work”63 (p. 16). Future research must
tackle the black box of nursing practice by acknowledging the complexity of nursing assessment,
planning, intervention, and evaluation. Addressing variance in the quality of patient care
performed by nurses is key to interpreting inconsistencies in the nurse staffing literature and
perhaps at the heart of efforts to improve patient care outcomes. Ultimately, it is a priority for
future research to explicate links between structure, process, and outcome in nursing practice and
patient care.64
As indicated before, study of models of care using non-RN staff in acute care, of the impacts
of high levels of staffing on health-promoting nursing interventions and nurse-sensitive
outcomes, and of staffing and outcomes in understudied specialties in acute care and in nonacute
care settings is vital. Ultimately, research in this area is on a track to assist in establishing
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Conclusion
From a research tradition in which nurse staffing factors were primarily background
variables, the study of nurse staffing and patient outcomes has emerged as a legitimate and
strategically crucial field of inquiry. However, despite significant growth in the number and
sophistication of studies responding to public policy and provider demand for these findings,
results have been inconsistent. This chapter highlights the methodologic challenges inherent in
this area of inquiry and explicates how the diversity in measures and units of analyses confound
literature synthesis. In the face of myriad pressures to adopt a position for or against mandated
nurse-to-patient ratios, the state of the young science does not permit precision in prescribing
safe ratios. In fact, it may be concluded that further research is crucial to tease out the nuances in
the staffing-outcomes equation. It is essential to advancing the field that future studies replicate,
extend, and refine the current body of knowledge, making explicit how characteristics of the
workforce, now barely considered (for example, years of experience or professional
certification), in addition to the “dose” of the nurse, are linked to processes of care that
ultimately result in clinical outcomes (both desirable and adverse). Until then, selected better
practices have been noted, with the potential to contribute to pragmatic efforts to improve patient
care quality and safety in hospitals.
Search Strategy
The literature on nurse staffing and patient safety is rapidly evolving, very heterogeneous in
terms of measures and methods, and equivocal in terms of many of its conclusions regarding
specific measures. Our aim was to describe broad trends in this literature, and to this end, we
based our work on four systematic, integrated reviews that contained detailed search criteria and
clearly-articulated inclusion criteria and provided detailed syntheses of findings. Three of these
four reviews were drawn from AHRQ publications, the most recent of which30 included articles
we had identified in our own searches of PubMed® and CINAHL® databases since 2002 and
2003 using the terms “nurse staffing,” “safety,” and “outcomes.”
Author Affiliations
Sean P. Clarke, R.N., Ph.D., C.R.N.P., F.A.A.N., associate professor, University of
Pennsylvania School of Nursing. E-mail: [email protected].
Nancy E. Donaldson, R.N., D.N.Sc., F.A.A.N., clinical professor, University of California,
San Francisco, School of Nursing. E-mail: [email protected].
20
Staffing
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Presentation at Critical linkages: nurse staffing, patient
safety and transforming care at the bedside. Joint
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Institutional outcomes:
Assaults on psychiatric units
Hospital financial outcomes
24
Staffing
25
Chapter 26. Work Stress and Burnout Among Nurses:
Role of the Work Environment and Working Conditions
Bonnie M. Jennings
Background
Stress has been categorized as an antecedent or stimulus, as a consequence or response, and
as an interaction. It has been studied from many different frameworks (or perspectives?). For
example, Selye1 proposed a physiological assessment that supports considering the association
between stress and illness. Conversely, Lazarus2 (p. 19) advocated a psychological view in which
stress is “a particular relationship between the person and the environment that is appraised by
the person as taxing or exceeding his or her resources and endangering his or her well-being.”
Stress is not inherently deleterious, however. Each individual’s cognitive appraisal, their
perceptions and interpretations, gives meaning to events and determines whether events are
viewed as threatening or positive.2 Personality traits also influence the stress equation because
what may be overtaxing to one person may be exhilarating to another.3
Nevertheless, stress has been regarded as an occupational hazard since the mid-1950s.4 In
fact, occupational stress has been cited as a significant health problem.5–7 Work stress in nursing
was first assessed in 1960 when Menzies8 identified four sources of anxiety among nurses:
patient care, decisionmaking, taking responsibility, and change. The nurse’s role has long been
regarded as stress-filled based upon the physical labor, human suffering, work hours, staffing,
and interpersonal relationships that are central to the work nurses do. Since the mid-1980s,
however, nurses’ work stress may be escalating due to the increasing use of technology,
continuing rises in health care costs,9 and turbulence within the work environment.10
In 1974, Freudenberger11 coined the term “burnout” to describe workers’ reactions to the
chronic stress common in occupations involving numerous direct interactions with people.
Burnout is typically conceptualized as a syndrome characterized by emotional exhaustion,
depersonalization, and reduced personal accomplishment.12 Work life, however, is not
independent from family life; these domains may even be in conflict.13, 14 Stress may result from
the combined responsibilities of work, marriage, and children.15–17 The effects of both work and
nonwork stress among nurses have been studied infrequently.18 And yet, nonwork stress may be
particularly salient to nursing, a predominantly female profession. Women continue to juggle
multiple roles, including those roles related to the home and family, for which the women may
have sole or major responsibility.
Nevertheless, work stress and burnout remain significant concerns in nursing, affecting both
individuals and organizations. For the individual nurse, regardless of whether stress is perceived
positively or negatively, the neuroendocrine response yields physiologic reactions that may
ultimately contribute to illness.1 In the health care organization, work stress may contribute to
absenteeism and turnover, both of which detract from the quality of care.9 Hospitals in particular
are facing a workforce crisis. The demand for acute care services is increasing concurrently with
changing career expectations among potential health care workers and growing dissatisfaction
among existing hospital staff.19 By turning toxic work environments into healthy workplaces,
researchers and nurse leaders believe that improvements can be realized in recruitment and
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
retention of nurses, job satisfaction for all health care staff, and patient outcomes—particularly
those related patient safety.20
Research Evidence
Work stress continues to interest researchers, as illustrated by studies identified in this review
that focused on occupations other than health care. For example, in a 3-year study of 14,337
middle-aged men, there was no strong evidence that job demands or job strain were predictors of
coronary heart disease (CHD).21 Findings did verify, however, that a supportive work
environment helped reduce CHD. The importance of work support was corroborated in a study
of 1,786 lower-ranking enlisted Army soldiers where support helped decrease psychological
strain from job demands.22 A study of 472 Air Force personnel illustrated high levels of work
stress in 26 percent of the respondents, with 15 percent claiming work-related emotional distress
and 8 percent noting work stress negatively affected their emotional health.23 Finally, in a sample
of 25,559 male and female German workers, the combined effects of exposure to work stress and
downsizing contributed to more symptoms than either experience alone.24
2
Work Stress & Burnout for Nurses
Shift length, 8-hour versus 12-hour, was explored in relation to both burnout95 and role
stress.60 In a random sample of Michigan nurses, RNs working 12-hour shifts (n = 105) reported
significantly higher levels of stress than RNs working 8-hour shifts (n = 99).60 However, when
differences in experience were controlled, stress was similar in both groups. Conversely, a study
from Poland illustrated that nurses working 12-hour shifts (n = 96) compared unfavorably in
several aspects to nurses working 8-hour shifts (n = 30).95 Although the type of nursing
personnel involved was unclear, the nurses on 12-hour shifts experienced significantly more
chronic fatigue, cognitive anxiety, and emotional exhaustion.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
workers, exposed to the same conditions, develop burnout or perceive stress. However, the
specific features of personality that affect the perception of stress or burnout remain unclear.
Neuroticism has been associated with exhaustion.41, 92 External locus of control has
demonstrated a positive relationship with burnout92 and stress.26 Findings are mixed for
hardiness.37, 50, 81 Evaluations of anxiety reflect a link with stress and burnout.49, 82 Anxiety is
viewed as having two components—state anxiety, the temporary component which manifests
when an individual perceives threatening demands or dangers, and trait anxiety, the more stable
component which may be regarded as a personality characteristic.105 In a study of intensive care
unit nurses, the investigators concluded that individuals high on state-anxiety were not only at
risk for burnout, but also for making medical errors.82 In another study, higher trait-anxiety
predicted psychological distress.49 In addition, relationships with other staff—coworkers,
physicians, head nurses, other departments—were also predictors of psychological distress.
Investigators have also examined the association between interpersonal relationships and
burnout and stress. The exact linkages are not yet understood. Problematic relationships among
team members were shown to increase burnout.93 Verbal abuse from physicians was noted to be
stressful for staff nurses.71 In a study of 260 RNs, conflict with physicians was found to be more
psychologically damaging than conflict within the nursing profession.59 However, a study
exploring verbal abuse among 213 nursing personnel (95 percent RNs) found the most frequent
source of abuse was other nurses (27 percent).88 Families were the second most frequent source
of abuse (25 percent), while physicians ranked third (22 percent).
Management Styles
Relationships between staff nurses and nurse managers are particularly important when
examining stress and burnout.49, 53, 65, 70, 89 Numeric ratings from a survey of 1,780 RNs indicated
that supervisor support and quality of supervision were lowest for nurse managers.53 Handwritten
comments from 509 (28.6 percent) of the RNs clarified these ratings by noting the following
problems: (a) inadequate unit leadership and the frequent turnover of nurse mangers, (b)
insufficient physical presence of the supervisor on the unit, (c) failure to address problems—too
much sweeping them aside or not even being aware they exist, and (d) modest awareness of
numerous staffing issues.
These ideas were corroborated in a study of 537 RNs from Canada.65 Using structural
equation modeling, the investigators substantiated the importance of manager behavior on
employee experiences. Similarly, in a qualitative study of 50 nurses conducted in England,
managers were identified as a direct cause of stress.89 Finally, responses from 611 RNs on 50
inpatient nursing units in four southeastern U.S. hospitals showed that group cohesion was
higher and job stress lower when nurse managers used a more participative management style.70
In addition to illustrating a likely connection between nurse managers and staff nurse
stressors, these studies also reflected the demanding role of today’s nurse managers who are
often responsible for multiple patient care areas. However, only two studies were identified
between 1995 and 2005 in which burnout was assessed in nurse managers and nurse
administrators. One study was conducted in the United States69 and the other study in Canada.66
Investigators for the Canadian study examined burnout in a random sample of nurses in first-line
(n = 202) and middle-management (n = 84) positions.66 Nurses in both groups reported high
levels of emotional exhaustion and average job satisfaction. In the U.S. study, the investigators
explored burnout among nurses (N = 78) from rural and urban hospitals in a southeastern State
4
Work Stress & Burnout for Nurses
who held positions in middle-management and higher.69 Almost half the respondents (49%)
reported high levels of emotional exhaustion.
Lessening Stress
Various studies were designed to evaluate ways to mitigate stress. Studies of social support
and empowerment dominated these investigations. Although social support is a multifaceted
construct, definitions and types of support were not typically found in these more recent
investigations. However, the importance of coworker support was verified in one study.39 In
another study, a general construct labeled “organizational support” exhibited the expected
negative relationship with work exhaustion.25 Similarly, social support from supervisors or
colleagues demonstrated a negative association with work stress.31, 72, 96 Stated differently, based
on another study, as nurses felt more stress, they relied more on social support.87 A cluster
analysis demonstrated that high social support was found only in the cluster with low burnout
and low stress.59 No buffering effects were discerned in the studies, but there was a direct and
beneficial effect of social support on workers’ psychological well-being and organizational
productivity.36 Although these findings do not clarify the mechanism for social support, they do
indicate that coworkers and supervisors at all levels would be wise to consider the importance of
reciprocal interpersonal exchanges that enhance security, mutual respect, and positive feelings.
All but two studies80, 96 of nurses and workplace empowerment were conducted by teams
involving Laschinger.57, 62, 64–68 Work empowerment showed a strong, negative association with
job tension and a strong positive relationship with perceived work effectiveness.62, 65 Similarly,
in other reports, structural empowerment in the workplace (e.g., opportunity, information,
support, resources, power) contributed to improved psychological empowerment (e.g., meaning,
confidence, autonomy, impact).64, 67, 68 Psychological empowerment, in turn, had a strong
positive effect on job satisfaction and a strong negative influence on job strain. Likewise, as
perceptions of empowerment increased, staff nurses reported less emotional exhaustion and
depersonalization along with a greater sense of personal accomplishment—the three components
of burnout.57 Empowerment was negatively associated with work stressors in another study as
well.96
Because empowerment is often viewed as a characteristic of how work environments are
structured, it has strong implications for nurse managers’ behaviors. However, one study
revealed an interpretive side to empowerment that derives from nurses’ perceptions of their
personal effectiveness and success.80 Additionally, there is beginning evidence that nurse
managers experience empowerment in a way that mirrors staff nurse experiences. That is, nurse
manager perceptions of structural empowerment influenced their sense of psychological
empowerment, which, in turn, affected the extent to which they experienced burnout.66
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
these studies were collected from nurses and patients throughout Pennsylvania.40 Data for the
other study were collected from nurses and patients at a single site.56 Some of the differences can
be accounted for by numerous methodological variations between the two studies. Other
differences might be attributed to the strong collective bargaining unit at the single-site study that
had negotiated staffing based on nurse-patient ratios that were adjusted for patient acuity.56
Moreover, fewer nurses from the single-site study reported being either dissatisfied or very
dissatisfied with their jobs, compared with the Pennsylvania study (8 percent versus 25 percent,
respectively).
Practice implications are also unclear regarding the effects of work stress on nursing staff.
The lack of clarity derives, in part, from the complexities of the work stress concept. In one
study, for example, nurses were grouped into one of four clusters based on their level of stress,
affective and physical symptoms, burnout, and unit social support.59 In another, the nurse ratings
of job strain placed them in four groups ranging from high to low strain.68 This heterogeneity
suggests that many dynamics are operational in relation to stress and burnout. The effects of shift
length on stress is one of the dynamics that is not yet understood.60, 95 Likewise, evidence about
how verbal abuse88 and generational differences77 operate in the stress equation is just beginning
to emerge. The role of personality, family-work conflict, and other features of stress require
further study.
Evidence is accruing about the utility of empowerment and social support in mitigating
stress. Some caution is warranted in regard to empowerment, however, because the work of one
investigator dominates the field.57, 62, 64–68 Findings related to social support indicated that
interpersonal exchanges with coworkers and supervisors may enhance security, mutual respect,
and positive feelings—which helped to reduce stress.31, 39, 72, 96 Overall, however, the assessments
of social support were often founded on weak conceptualization and relied upon
psychometrically weak instruments to measure the concept. Moreover, the analytical models did
not always consider the direct, indirect, and interactive effects of social support.
Although the evidence is sparse, the studies have practice implications for nurse managers.
First, managerial behaviors were linked to stress and burnout. Managerial support38 and
participative management70 helped to reduce stress. Similarly, burnout and work stress were
reduced when administrators created work environments that provided staff with access to
opportunity, information, resources, and support—the features of empowerment.64, 65 Second,
and studied even more infrequently, nurses in supervisory positions may encounter stress69 and
burnout66 themselves. There is no existing evidence, however, that empirically illustrates how
managerial stress affects staff stress or the manager’s ability to behave in a way that reduces staff
stress. Given the current emphasis on improving the work environment, there is an imperative to
carefully investigate both aspects of the nurse administrator in relation to stress and burnout.
Despite lacking absolute clarity, there is a body of research addressing work stress that spans
more than 50 years in the nursing profession. Stress is pervasive in nursing and health care.
Moreover, working conditions seem to be deteriorating at the same time that a severe and
protracted nursing shortage is occurring. Leaders of health care organizations can no longer
ignore these findings. Just as institutional leaders need to understand their financial standing,
they also need to assess how environmental stress is affecting patients and staff and take action
to alter unhealthy situations.
6
Work Stress & Burnout for Nurses
Research Implications
To derive a better understanding of stress and burnout in the workplace, solid
conceptualizations are needed that bring together the various pieces of the stress puzzle. At
present, research is often conducted absent a solid theoretical and conceptual base. A more
comprehensive blueprint of nurse stress and burnout in the work place needs to be developed.
Empirical studies could then be conducted to investigate these very complex relationships,
prospectively, over time. Once work stress is examined from a more solid theoretical and
conceptual basis, then intervention studies can be initiated to assess the most useful ways to
mitigate work stress.
Studies need to move beyond the tendency to use descriptive designs. There is sufficient
evidence to believe that work stress is a factor among health care personnel. What is less well
understood is the effect of stress on patient outcomes. Studies are needed to enhance the
understanding of stress and burnout on patient safety. Studies are also needed to better
understand stress beyond the acute care setting.
In addition, because nurse administrators are responsible for creating the environment in
which nursing is practiced and patient care is given,106 it is important to explore interventions
that will reduce the stress and burnout experienced by nurse administrators. Findings from
studies of this nature could have a threefold effect. By reducing the stressful nature of the nurse
administrator’s work, nurse administrators could be more satisfied in their positions. This role
satisfaction, in turn, could lead to enhancing those managerial behaviors that improve the work
environment for staff nurses. Finally, improved working conditions for nurse administrators
might make the role more appealing and help correct the serious dearth of individuals interested
in pursuing administrative positions.107
Conclusion
Stress and burnout are concepts that have sustained the interest of nurses and researchers for
several decades. These concepts are highly relevant to the workforce in general and nursing in
particular. Despite this interest and relevance, the effects of stress and burnout on patient
outcomes, patient safety, and quality care are not well defined by evidence. In fact, the link
between stress and burnout to patient outcomes has been explored in only four investigations.
There is a great need for comprehensive studies that will examine these dynamics in a way that
will yield more solid evidence on which to base practice.
Acknowledgments
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library for their
considerable support of this work. They conducted the database searches and assisted in
acquiring numerous papers considered in this review.
Author Affiliations
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N., colonel, U.S. Army (retired), health care
consultant. E-mail: [email protected].
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Search Strategy
Both MEDLINE® and CINAHL® databases were searched to locate literature for this review.
A reference librarian conducted the searches after working with the author to specify search
terms. The search terms for MEDLINE® were psychological stress, professional burnout, work
stress, and occupational health. The search terms for CINAHL® were occupational stress,
professional burnout, and nursing units. For both databases, the searches were limited to research
articles published in the English language between 1995 and 2005.
There were 1,145 articles identified in the CINAHL® search and 392 identified by the
MEDLINE® search, with some duplication in the citations identified by the two databases. All
1,537 abstracts were reviewed. Numerous abstracts were eliminated from further consideration.
For example, articles about instrument development, stress in specific populations (e.g., children,
adolescents, pregnant women, parents, caregivers) and occupations other than health care (e.g.,
the police force, fishermen, flight crews, farm workers) were omitted from this review. Likewise,
dissertations, literature reviews, concept analyses, and physiologic and immunologic studies of
stress in general were not included.
Once the unrelated articles were eliminated, 138 articles remained as candidates for this
review. A complete copy of each of these papers was acquired and read, following which an
additional 53 articles were removed from further consideration. Dominant among the reasons for
excluding these papers were that they were not research based or they were short reports that
were lacking essential details.
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12
Evidence Table
Source Safety Issue Design Study Design, Study Setting & Study Key Finding(s)
Related to Type Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Aiken 200240 Burnout Cross-sectional (4) Design: Level 4 Pennsylvania; 10,134 Staffing After adjusting for patient
Patient outcomes: RNs (survey data) and hospital characteristics:
30-day mortality, linked with discharge Nurse staffing effects on
failure to rescue data for 232,342 30-day mortality (odds ratio
(Level 1) surgical patients from [OR] = 1.07, 95%
Nurse outcomes: 168 hospitals. Nurses: confidence interval [CI] =
burnout 94% female; 40% 1.13–1.34, P < 0.001) and
BSN or higher; failure to rescue (OR =
average of 14 years 1.07, 95% CI = 1.02–1.11,
working as a nurse. P < 0.001) imply that
Patients: 44% male, decreases in mortality rates
average age 59, and failure to rescue could
general surgery be realized by increasing
(44%), orthopedic RN staffing. After adjusting
surgery (51%), for nurse and hospital
vascular surgery characteristics: Nurses who
13
tension (-0.29).
Laschinger Job strain Cross-sectional (4) Design: Level 3 Urban tertiary care Quality of work Nurse ratings of job strain
200167 Nurse outcomes: job hospitals in Ontario, life fell into Karasek’s four job
strain, quality of work Canada; 404 categories: high strain
life randomly selected (37%), active (33%),
staff nurses: 52% passive (21%), and low
female; on average, strain (10%). When
40 years old (SD = categories were collapsed
8.07), 16 years into high strain/low strain
nursing experience groups, 63% of the sample
(SD = 8.5), 8 years fell into the low strain
experience in current group. Comparisons of the
workplace (SD = 5.8); high strain and low strain
58% worked full time; groups revealed significant
15% had (P = 0.0001) differences for
baccalaureate both structural and
degrees, 85% were psychological
diploma graduates. empowerment as well as
organizational commitment.
Source Safety Issue Design Study Design, Study Setting & Study Key Finding(s)
Related to Type Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Lee 199669 Burnout Cross-sectional (4) Design: Level 3 Members of a State Commitment No significant differences
Nurse outcomes: organization of nurse were found for burnout or
stress, commitment, executives working at commitment among the
social support 134 rural and urban four groups of nurse
hospitals in the administrators. Phases of
southeastern U.S. 78 burnout were determined
nurse administrators: with most nurse
female (93%); ages administrators in the lowest
31–40 (35%); level (37%); 13% were at
positions—chief nurse the highest level. All
officers (CNOs) burnout scale scores and
(45%), assistant the organization
CNOs (19%), division commitment score were
or department heads related inversely (r = 0.472
(30%), nurses with – 0.515) and significantly (P
executive-level roles ≤0.001). Emotional
(6%); education— exhaustion and burnout
doctorate (3%), phase decreased as the
master’s (42%), coworker trust and support
17
Medical-surgical nurses
perceived higher job stress
than nurses on other units
such as intensive care.
Rowe 200588 Stress and verbal Cross-sectional (4) Design: Level 5 500-bed teaching None— 96% of the participating
abuse nurse-to- hospital in descriptive nurses reported they had
nurse Philadelphia. been spoken to in a
Nurses: 213 RNs and verbally aggressive
LPNs (69% response manner—79% indicated
interpersonal strain.
Simoni 200480 Stress Cross-sectional (4) Design: Level 3 Two hospitals in a Empowerment Two of the three individual
Nurse outcomes: mid-Atlantic State. styles of stress appraisal
empowerment Nurses (randomly were significantly correlated
selected, n = 142) with psychological
RNs with an average empowerment: skill
age of 35 years (SD = recognition (r = 0.52, P <
10.1), 48% had 0.001), and deficiency
baccalaureate focusing (r = -0.24, P <
degrees, most had 0.01). Together, these two
been working <5 interpretive styles explained
years since becoming 24% of the variance in
RNs (42%). empowerment.
Source Safety Issue Design Study Design, Study Setting & Study Key Finding(s)
Related to Type Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Vahey 200490 Burnout Cross-sectional (4) Design: Level 3 2 units each in 20 Patient After adjusting for patient
Patient outcomes: urban hospitals satisfaction characteristics (age,
satisfaction (Level 3) across the U.S. using gender, race, risk factors,
1991 data. and illness severity),
Nurses (n = 820— patients on units where
both RNs and LPNs): nurses reported higher-
93% male; on than-average levels of
average, 35 years old emotional exhaustion were
(SD = 10), 10 years in only half as likely to be
nursing (SD = 9), 4 satisfied with nursing care
years on present unit as compared to units where
(SD = 4). nurses reported lower-than-
Patients (with AIDS) average emotional
(n = 621): 88% male, exhaustion (OR =0.51, 95%
average age 37 years CI = 0.30–0.87, P < 0.05).
(SD = 8). Patients on units where
nurses reported higher-
than-average personal
accomplishment were twice
21
Background
The Institute of Medicine (IOM) report, Keeping Patients Safe: Transforming the Work
Environment of Nurses,1 determined that the use of temporary nursing staff or staff from
agencies external to the health care organization to provide care threatens patient safety.
Involving personnel with less knowledge of the nursing unit and larger organizational care
policies—and interrupting the continuity of patient care—increases the risk to patients’ safety. In
its report, the IOM recommended that health care organizations avoid using nurses from external
agencies.
In 2004, 2.3 percent of registered nurses (RNs) provided their services through a temporary
agency, as opposed to being employed by the organization or organizations through which they
delivered care.2 This was an increase from the 1.8 percent of RNs working in their principal
nursing position through a temporary employment service in 2000, which itself was a 36 percent
increase over that reported in 1996, reversing a declining trend between 1988 and 1996.3
Although this proportion continues to represent a minority of the nurse workforce, the increase
mirrors workforce trends occurring globally across many industries.4, 5 Temporary workers,
contract employees from external agencies, intermittent workers, “casual” workers, and other
types of workers without a standard employer-employee relationship with the organization in
which they provide services are together referred to in the United States as “contingent
workers.”6 In other counties, such arrangements are sometimes referred to as “precarious
employment,” the terminology used in the European Union, for example.
Although use of nurses from external agencies can increase the number of staff available for
patient care, threats to patient safety are theorized to arise, in part, because temporary staff are
less familiar with a nursing unit and a health care organization’s overall structure, policies,
practices, and personnel—including information systems, facility layout, critical pathways,
interdependency among work components, ways of coordinating and managing its work, and
other work elements.4, 7 This can be compounded when temporary workers do not receive the
same level of orientation and training from the organization in which they provide care as do the
organization’s employees. Studies in industries outside of health care have found that increased
use of contingent workers can result in higher accident rates and other adverse effects.4 The
International Atomic Energy Agency, for example, cites use of contract personnel to replace
traditionally hired employees as a symptom of incipient weakness in an organization’s safety
culture.8 Health care researchers find similar results.
Research Evidence
Searching health care literature for the effects of contingent nursing staff on patient safety
and other quality of care outcomes is difficult because of the various terminologies used to refer
to such workers: for example, temporary, float, casual nursing, contingent employment, or
precarious employment. Moreover, health care research, unlike research on the impact of
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
temporary employees across a variety of other industries, typically has not exclusively examined
the effects of temporary workers on patient safety and care quality. Findings are typically
embedded in studies of more comprehensive issues such as the effects of nurse staffing or health
care organization practices.
The search strategy (see below) resulted in finding seven observational studies; of which six
studies reported adverse patient outcomes associated with the use of contingent nurses7, 9–13 (see
evidence table). The seventh study, which did not find adverse patient outcomes,14 did not
measure patient outcome directly, but rather examined nurses’ documentation of their own
performance of activities related to patient safety and better quality of care—the lowest level of
outcome measured for all seven studies. The findings of the seventh study also were confounded
by the provision of specialized training in the legal ramifications of documentation to only two
of the three groups under study—the groups that subsequently performed at the highest level.
Although it is possible that the findings of six of seven studies showing adverse effects of
using agency nurses are a manifestation of reporting bias (i.e., multivariable studies that did not
find a difference in the use of contingent nurses might not report the finding of no difference),
the evidence cited in these studies does not support this possibility. Five of the seven studies
examined variables in addition to staffing composition and their effects on bloodstream
infection, 30-day mortality, medication errors, and violence committed by psychiatric patients.
All five of these identified and reported on variables for which “no difference” in patient care or
outcomes was found.
Research Implications
Research on temporary and agency nurses could benefit from a meta-analysis to determine
how strong the effect may be between using external nurses and patient safety and outcomes.
Additional research could be conducted to further build the evidence base pertaining to the effect
on patient care outcomes of using contingent nurses to meet staffing demands. However,
research is also needed to understand the reasons for the use of contingent workers in health care
in the first place. Such research can inform policy decisions by health care organizations and
2
Temporary & Agency Nurses
other entities affecting workforce deployment. Are contingent workers preferred by health care
organizations? If so, why? To what extent is increasing use of contingent nursing staff caused by
the same factors leading to increased use of contingent workers globally across myriad
industries, or are there unique factors at play in nursing? Do nurses employed by temporary
agencies prefer this type of employment? If so, why? Can these factors be replicated in health
care organizations to bring contingent workers into standard employer–employee relationships
with health care organizations? If nursing staff employed by temporary agencies do not prefer
this employment, why are nurses so employed in the face of a widely cited nursing shortage?
Conclusions
Whether temporary workers or float pools are used to meet staffing shortfalls, hospital
managers and leaders are challenged to ensure patient safety by matching the available skill mix
of nurses to the needs of patients. The flexibility offered by temporary workers may address
staffing gaps, but it is important to have effective communication, education, and orientation
mechanisms to enable comprehensive, safe patient care by outside nursing staff. More research is
needed on the effects of contingent nursing staff on patient safety and the reasons for the use of
contingent workers.
Search Strategy
A search of MEDLINE®, CINAHL®, the Cochrane Registry of Controlled Trials, and the
Cochrane data base of systematic reviews for the period January 1990–March of 2006 using the
search terms (temporary OR contingent) AND (staff OR personnel OR nurs$) in all fields for
human studies and English-language articles yielded 809 articles. Five of these titles or abstracts
described a research study that included measures of the effects of contingent nurses on patient
safety or clinical quality outcomes.7, 9–11, 14 A repeat of this search using (float OR casual) in
place of (temporary OR contingent) generated 181 references, which yielded an additional
research study with these variables.12 A similar search within PychoINFO yielded 178
references, of which one was a previously undetected research study examining use of temporary
nurse staffing and patient outcomes.13 All searches were mediated through the OVID search
engine. Studies measuring only nurse outcomes (e.g., occupational injuries, job satisfaction, or
features of work design) were excluded, although there is literature showing adverse outcomes in
these areas as well.
Author Affiliation
Ann E. K. Page, R.N., M.P.H., senior program officer, Institute of Medicine. E-mail:
[email protected].
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
References
1. Committee on the Work Environment for Nurses and bloodstream infections in intensive care units. Infect
Patient Safety, Board on Health Care Services, Page Control Hosp Epidemiol 2003 Dec; 24(12):916-25.
A, ed. Keeping patients safe: transforming the work
environment of nurses. Washington, DC: National 8. Carnino A. Management of safety, safety culture and
Academies Press; 2004. self assessment: international atomic energy agency.
Available at: http://www.iaea.org/ns/nusafe/publish/
2. U.S. Department of Health and Human Services. papers/mng_safe.htm. Accessed January 15, 2003.
Unpublished data from the 2004 National Sample
Survey of Registered Nurses. Rockville, MD: 9. Estabrooks C, Midodzi W, Cummings GG, et al. The
Author; 2006. impact of hospital nursing characteristics on 30-day
mortality. Nurs Res 2005; 54(2): 74-84.
3. Spratley E, Johnson A, Sochalski J, et al. The
registered nurse population March 2000: findings 10. Roseman C, Booker JM. Workload and
from the National Sample Survey of Registered environmental factors in hospital medication errors.
Nurses. Rockville, MD: Division of Nursing, Bureau Nurs Res 1995;44(4):226-30.
of Health Professions, Health Resources and Services
Administration; 2001. 11. Bourbonniere M, Zhanlian F, Intrator O, et al. The
use of contract licensed nursing staff in U.S. nursing
4. Quinlan M, Mayhew C, Bohle P. The global homes. Med Care Res Rev 2006 Feb;63:88-109.
expansion of precarious employment, work
disorganization, and consequences for occupational 12. Robert J, Fridkin SK, Blumberg HM, et al. The
health: a review of recent research. Int J Health Serv influence of the composition of the nursing staff on
2001;31(2):335-414. primary bloodstream infection rates in a surgical
intensive care unit. Infect Control Hosp Epidemiol
5. Connelly CE, Gallagher DG. Emerging trends in 2000 January;21(1):12-7.
contingent work research. J Manage 2004;30(6):959-
83. 13. James DV, Fineberg NA, Shah AK, et al. An increase
in violence on an acute psychiatric ward: a study of
6. Stagg S. The impact of contingent workers on the associated factors. Br J Psychiatry 1990 June; 156:
workplace. AAOHN J 2004 Sep;52: 412. 846-52.
7. Alonso-Echanove J, Edwards JR, Richards MJ, et al. 14. Strzalka A, Havens DS. Nursing care quality:
Effect of nurse staffing and antimicrobial- comparison of unit-hired, hospital float pool, and
impregnated central venous catheters on the risk for agency nurses. J Nurs Care Qual 1996 Jul;10(4):59-
65.
4
Evidence Table
Source Safety Issue Design Type Study Design, Study Setting & Study Intervention Key Finding(s)
Related to Study Study Population
Clinical Outcome
Practice Measure(s)
Alonso- Use of float Prospective Level 3 study 4,535 adult patients Observational study Of more than 60 potential risk
Echanove nurses – cohort design. admitted for at least – no intervention factors studied, portion of days
20037 agency nurses Level 1 24 hours in 1997– cared for by a float nurse was one of
or nurses from outcome 1999 to eight only six statistically significant (P
other hospital measure: Intensive care units at <.005) variables strongly associated
areas who had central venous six geographically with the development of CVC-BSIs
been working in catheter (CVC) distinct hospitals in patients.
the unit under bloodstream Risk of CVC-associated BSI was 2.6
study for less infections times higher for patients cared for by
than a year. (BSIs) float nurses more than 60% of the
time.
Bourbonniere Use of a high Cross-sectional, Level 4 study 15,717 freestanding Observational study Annually, facilities using 5 percent or
11
2006 proportion of time series design. nursing homes – no intervention more contract RNs and LPNs were
contract nurses Level 3 or (facilities) in urban disproportionately represented in the
5
(RNs and LPNs higher outcome and rural counties in top quartile of nursing facilities
combined) to fill measures; i.e., the United States ranked in each State according to
nurse staffing study measured between 1992 and health care deficiencies detected
positions. health care 2002. during annual State survey and
High proportion quality certification inspections.
was defined as deficiencies For each calendar year these
5 percent or detected in differences were statistically
more of total nursing homes significant(P < 0.05).
full-time as part of their
equivalent State ‘s annual
nursing survey and
positions. certification
inspection
Robert 200012 Use of nurses Case-control Level 4 study 28 patients with BSIs Observational study BSIs were significantly (P < 0.004)
from an study design. and 99 randomly – no intervention more frequent during the period of
external agency Level 1 selected controls in a high use of nurses from the external
or from a outcome 20-bed SICU in a agency or hospital float pool and low
hospital pool measure: 1,000 bed, university- use of permanently assigned
compared to nosocomial affiliated, inner-city, nursing staff.
nurses bloodstream public teaching The pool nurse-to-patient ratio was
permanently infections hospital. significantly higher for case patients
assigned to the (BSIs) Cases were any (P < 0.001) than for controls.
surgical patient hospitalized in Conversely, the regular nurse-to-
intensive care the SICU for 3 or patient ratio for the 3 days prior to
unit (SICU) more days from June infection was significantly lower for
1994 to June 1995 in case patients than control patients)
whom a primary BSI (P < 0.001).
was identified.
Source Safety Issue Design Type Study Design, Study Setting & Study Intervention Key Finding(s)
Related to Study Study Population
Clinical Outcome
Practice Measure(s)
Roseman Use of Cross-sectional Level 4 study All medication errors Observational study Number of shifts worked by
10
1995 temporary design. reported in a 140-bed – no intervention temporary staff was positively (and
nurses Level 2 acute care medical statistically significantly) associated
outcome center in Alaska from with medication errors (odds ratio =
measure: 1984 to1989. 1.15).
medication Errors decreased when permanent
errors nursing staff worked overtime (odds
ratio = 0.85).
Strzalka 199614 Use of nurses Prospective Level 4 study All agency nurses and Observational study Nursing groups’ documentation
from external cohort design. two randomly – no intervention varied from indicator to indicator,
agencies, Level 3 selected comparison with internal float pool nurses
compared to outcome groups of internal float generally documenting at the
internal float measure: and unit-hired nurses highest level and unit-hired nurses
pool nurses and Nurses’ providing care on one performing at the lowest, with
nurses hired by documentation nursing unit in a large agency nurses falling in between.
the organization that they teaching hospital in Differences were often minimal and
7
to staff a performed nine the United States over were statistically significant (at the P
specified activities an 8-month period. < 0.05 level) for only five of the nine
nursing unit determined by documentation activities.
under study the facility as Agency nurse reporting was
(unit-hired related to significantly lower than float pool
nurses) patient safety nurses on only two measurement
(e.g., side rails items.
raised,
assessment of
mental status,
vital signs, etc.)
and related to
Background
Recent attention in health care has been on the actual architectural design of a hospital
facility, including its technology and equipment, and its effect on patient safety. To address the
problems of errors in health care and serious safety issues, fundamental changes of health care
processes, culture, and the physical environment are necessary and need to be aligned, so that the
caregivers and the resources that support them are set up for enabling safe care. The facility
design of the hospital, with its equipment and technology, has not historically considered the
impact on the quality and safety of patients, yet billions of dollars are and will be invested
annually in health care facilities. This provides a unique opportunity to use current and emerging
evidence to improve the physical environment in which nurses and other caregivers work, and
thus improve both nurse and patient outcomes.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
patients, and families.6 In a review of more than 600 articles, researchers found that there was a
link between the physical environment (i.e., single-bed or multiple-bed patient rooms) and
patient (e.g., fewer adverse events and better health care quality) and staff outcomes (e.g.,
reduced stress and fatigue and increased effectiveness in delivering care).7 Efforts to improve
patient and staff outcomes can target latent conditions for clinicians by using evidence-based
designs to decrease distractions, standardize locations of equipment and supplies, and ensure
adequate space for documentation and work areas. The research done by Reason1 and Leape2
describes the value of practices based on principles designed to compensate for human cognitive
failings. Thus, when applied to the health care field, human factors research (i.e., an area of
research that includes human performance, technology design, and human-computer interaction;
this topic is covered in chapter 5, “A Human Factors Framework,” by Henriksen and colleagues),
which has emphasized the need for standardization, simplification, and use of protocols and
checklists, can be used to improve health care outcomes.
By targeting human factors through facility design and ensuring that latent conditions and
cognitive failures that lead to adverse events are minimized, patient safety will improve. This
requires a multifaceted approach, including developing a strong safety culture, redesigning
systems or facilities with their equipment and technology, focusing on eliminating the conditions
of cognitive errors, and helping caregivers correct/stop an error before it leads to harm or
mitigate it if it occurs.1, 2
2
Patient Safety & the “Built Environment”
• Efficiency, including
o standardizing room layout, location of supplies and medical equipment
o minimizing potential safety threats and improving patient satisfaction by
minimizing patient transfers with variable-acuity rooms
• Timeliness, by
o ensuring rapid response to patient needs
o eliminating inefficiencies in the processes of care delivery
o facilitating the clinical work of nurses
• Equity, by
o ensuring the size, layout, and functions of the structure meet the diverse care
needs of patients
There have been five other significant reviews of the literature relating to the physical
environment and patient outcomes. Nelson and colleagues10 identified the need to reduce noise
pollution and enhance factors that can shorten a patient’s length of stay (e.g., natural lighting,
care in new/remodeled units, and access to music and views of nature); according to their study,
patients can benefit from the skillful utilization of music and artwork. Ulrich and colleagues7
found research that demonstrated that the design of a hospital can significantly improve patient
safety by decreasing health care associated infections and medical errors. They also found that
facility design can have a direct impact on patient and staff satisfaction, a patient’s stress
experience, and organization performance metrics. Three other reviews found that hospital
design, particularly when single-bed rooms are employed, can enhance patient safety and create
environments that are healthier for patients, families, and staff by preventing injury from falls,
infections, and medical errors; minimizing environmental stressors associated with noise and
inefficient room and unit layout; and using nature, color, light, and sound to control potential
stressors.11–13
Nurse staffing levels. Preventable adverse events such as falls and complications have been
found to be related to both the design of health care facilities and nurse staffing levels. Patient
falls in acute care settings can result from slippery floors, poor placement of handrails,
inappropriate door openings, furniture heights,14 and inadequate nurse staffing.15, 16 Infection
rates have been found to be lower in patients, particularly critically ill patients, when there are
higher staffing levels.17, 18, 19 High rates of postoperative infections, especially related to wounds
among patients ages 65 to 70, have been found to be associated with facilities that were
overcrowded, had few private rooms, lacked individual bathrooms and toilets, had no isolation
facilities, and had deficient ventilation systems.16 Without effective ventilation systems, efforts
to avoid ventilator-associated pneumonia—such as patient positioning, oral health, and airway
management20, 21—have a greater potential of not being as beneficial. Then again, the greater risk
for health care associated infections may be associated with nurses not implementing evidence-
based practices,22 such as aseptic technique or washing hands appropriately18 to prevent
infections, as well as nurse understaffing;23–26 how much is not known. These are only some of
the examples that indicate that there are fewer adverse events when appropriate nurse staffing
levels are met, and operational costs are lower because the rates of adverse events are lowered.27
Thus, adequate staffing must be addressed to enable the benefits of well-designed health care
facilities.
Structural obstacles and the nature of work for nurses. Several factors have been
identified as physically being in the way of the work of nurses. An assessment of the
organization of nurses in medical and surgical units in hospitals in France found that the work of
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
nurses was dependent upon the spatial configuration of the unit. For purposes of this study,
nurses’ work areas were divided into four categories: the patients’ rooms, the nurses’ area, the
corridor, and other specialized areas such as a storage room. Nurses were found to have
generally followed three paths in their trips: different points of the nurses’ area, trips between the
patients’ rooms and nurses’ area, and trips between the patients’ rooms. Trips were organized
according to spatial and functional logic. The majority of the activities performed by nurses were
found to last less than 2 minutes. On the surgical unit, nurses during one shift were found to
perform 3,855 trips that lasted approximately 3 minutes and 25 seconds each; this was fewer than
the 4,521 trips performed by nurses on the medical units, each lasting approximately 3 minutes
and 9 seconds. The constant movement by nurses varied based on the spatial organization of the
unit as well as the temporal structure of the tasks. On the surgical unit, nurses were interrupted,
an average of once every 20 minutes; on the medical unit, nurses were interrupted an average of
once every 12 minutes.28
One approach to address these obstacles and to better meet patients’ needs is to not have one
central nursing station. Instead, there would be several decentralized nursing work stations
throughout the unit with supplies, linens, and equipment areas. Appropriately distributed supplies
and equipment could reduce fatigue and improve efficiency of nurses29 by minimizing the time
associated with finding supplies and equipment and moving from one location to another.
Patients could benefit from more time with nurses and increased surveillance opportunities that
require nurses to visually monitor patients—a benefit enhanced further by using single-bed
rooms in hospital design.30
Single-bed and variable-acuity rooms. Debate continues as to whether hospitals should
have single-bed rooms or semiprivate rooms for patients. Research over the past 10 years has
compared single to semiprivate rooms and, in so doing, has provided greater insight into cost
implications, patient satisfaction, and impact on patient care and outcomes. Several reviews of
the literature found that single-bed rooms were more conducive for infection control and patient
care,7, 31, 32 were associated with reduced stress and improved outcomes for patients,33 and
increased privacy and accessibility for patients and families.34 Noise levels and catheter-related
infections have been found to be lower for critically ill infants in single-bed rooms.35
Comparatively, environmental risk factors for patients in multiple occupancy include lack of
privacy36 and higher noise levels that can affect their comfort and recovery.37 Environmental
noise and light as well as patient interruptions can cause sleep disturbance,36 especially in
intensive care unit patients.38
Patients and families tend to be more satisfied with single-bed rooms. In one study, patient
satisfaction among low-risk maternity patients was found to be higher with single rooms because
of having their privacy respected; patients felt they were in a comfortable environment and felt
that they received more support and education.39 Clinicians have also been found to prefer single
rooms for maternity patients40 and neonatal intensive care patients.35
The availability of single-patient rooms has been found to control the spread of infection
from patients infected with methicillin-resistant Staphylococcus aureus,41–43 gram-negative
bacteremia in burn patients,44 and respiratory and enteric infections requiring contact isolation in
pediatric units.45 Single-bed isolation rooms, intended to prevent the spread of infectious agents
by using pressure differentials to contain them, are effective only if the room is tightly sealed.46
Thus, in terms of controlling infection in isolation rooms and other patient rooms, the greater risk
may be associated with nurses not implementing evidence-based practices regarding hand
washing and aseptic technique to prevent infections.18
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Patient Safety & the “Built Environment”
The design of a patient room that allows flexibility and can be adapted to meet changing
acuity and care needs of patients has been found in some institutions to contribute to decreased
medication errors and falls.47, 48 A well-designed patient room has also been found to be a factor
in improving care delivery processes for clinicians by providing more private patient
consultations,36 improving patient and clinician satisfaction,48 decreasing length of stay,29 and
facilitating continuity of care during a hospital stay.39
Traditionally, the bed charge has been higher for single rooms and the capital investment
greater. Yet research has found that single rooms and flexible/adaptable rooms for maternity care
and intermediate and intensive care offered cost savings, particularly because of shorter lengths
of stay and a decrease in the number of transfers within the hospital.40, 49 Such rooms are more
likely to be filled47 and can avoid the costs of transfers when the room is acuity adaptable.36
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
per month. Bronson Methodist Hospital in Michigan opened a new facility with private patient
rooms and increased patient access to nature (e.g., indoor gardens, natural light, and landscape
views) and decreased patient stress using of positive distractions such as music, water sounds,
artwork, and daylight. The Barbara Ann Karmanos Cancer Institute renovated several hospital
areas to be patient-centered and to provide a more pleasant environment, where patient rooms
were made larger and an emphasis was placed on lighting and acoustics. In doing so,
administrators and clinicians have seen a decrease in the use of pain medication and medication
errors on these units. Thus, by incorporating private rooms into their designs, these four hospitals
and patients they have served have experienced successful outcomes in their new and renovated
facilities.53
Research Evidence
There were 10 original articles that met the inclusion criteria for this review. Four articles
described investigations with nurses in relation to the work and built environment, five were
about patient’s perspectives, and two were about specific built environment projects; one study
investigated both staff and patient perceptions of the built environment.
Nurses’ Perspective
Four studies assessed hospital nurses’ perspectives on factors associated with the built
environment using cross-sectional surveys. Two surveys intended to assess the work
environment and challenges prior to moving forward with specific changes.54, 55 When asked
about performance obstacles, nurses reported: work environments; distractions from families;
hectic and crowded work environments; delays in getting medications from the pharmacy;
amount of time spent teaching families; equipment not being available; patient rooms not well
stocked; insufficient workspace for completing paperwork; time spent seeking supplies or
patients’ charts; receiving many phone calls from families; delays in seeing new medical orders;
and misplaced equipment.54 When asked about what physical changes were problematic in the
layout of the current unit, including patients’ rooms, pediatric nurses reported that they were not
satisfied with: the size of residents’ closets, showers, and activity room; the actual size,
aesthetics, and location of the break room and dining room; the available space for medical
equipment; the available space for charting; and the outdoor recreation area. Not only did nurses
share similar concerns with parents, the facility aesthetics and work environment were found to
be associated with higher satisfaction and better coworker relationships among nurses.55
The other two surveys assessed the perceptions of nurses about single versus multiple bed
rooms. A very small sample of nurse managers and unit directors (n = 7) in best-practice ICUs
reported the benefits of single-bed rooms as enhanced patient safety, ensured privacy for
patients, increased access to patient status information, and more space for family members.56
In the other survey, administrative and nursing staff (n = 77) reported that they favored single-
occupancy rooms because of their flexibility, being more appropriate for patient examination,
improved quality of patient monitoring and scope of patient surveillance, and improved patient
comfort level and patient recovery rate. Helpful characteristics of single-occupancy rooms were
reported as: the more favorable layout of the room, including the availability of extra space in the
room making arrangement of furniture easier and providing storage for clean and dirty supplies
in the room; better privacy for patients and more space for family members; and better lighting
6
Patient Safety & the “Built Environment”
and temperature control and lower noise levels. A little over half of the respondents believed that
health care acquired infections were low or very low in single-occupancy rooms, but that there
was no difference in the number of patient falls or the need for pain-reducing or sleep-inducing
medications between the two types of rooms. Conversely, helpful characteristics of double-
occupancy rooms included proximity to the nursing station. However, being able to see patients
for monitoring purposes was reported as problematic for both single and multiple occupancy
rooms.57
Acuity-Adaptable Rooms
One study investigated the impact of an evidence-based design of 56 new acuity-adaptable
rooms for a combined coronary critical care and step-down unit.62 Researchers found that two
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
different levels of acute care (intensive care and step-down care) could effectively be merged
together into a single patient room by making the room acuity adaptable to accommodate the
changing needs of patients. Once in the new single-bed acuity-adaptable unit, researchers found:
a large reduction in clinician handoffs and transfers; a 70 percent reduction in medication errors;
a reduction in patient falls; improvements in patient satisfaction; decreases in budgeted nursing
hours per patient day; and increases in available nursing time for direct care without additional
cost. Yet, clinicians felt more isolated by the increased size of the unit and with decentralized
nursing stations; then again, the “isolation” gave nurses greater opportunity for autonomous
decisionmaking.
Designed ICU
The implementation of a new neonatal intensive care unit, designed to have a more efficient
floor plan, provide space for supportive family-centered care, and to use of natural light, used
was assessed using multiple methods.63 On this new unit, the majority of nurses were positive
about the design features. Nurses reported the new unit as enabling efficiency, in part attributable
to being able to move about the unit at a greater velocity, enabling them to spend more time with
the infants and less time needed to walk about the unit in the course of their work. The nurses
also reported that the new unit was more comforting, clean and quieter, and the new lighting was
thought to have a positive impact on the patients. Additionally, nurses reported that they felt that
families were utilizing the majority of space designated to them.
8
Patient Safety & the “Built Environment”
Single-Patient Room
In many instances, including the need for patient isolation measures, double or multiple-
occupancy rooms were viewed as not being conducive to patient safety and quality care. The
floor plan shown in Figure 1 illustrates how a series of standardized single-patient rooms were
laid out on both sides of a hallway in St. Joseph’s Hospital. This perspective allows various
features of the room to be seen in relation to each other. There are two entrances to the room, one
from the hallway (along the lower edge of the picture), and one from the alcove on the right. In
that alcove, also entered from the hallway, a desk, computer, and chair are provided for use by
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
staff. The alcove also contains a standardized storage area, so staff can find everything they need
for the care of the patient adjacent to the patient room.
The interior of a single-patient room incorporates many of the recommendations relating to
latent conditions and active failures in the design for safety (see Figure 2). The family area of the
room is in the right corner of the room, by the window, and includes a couch/pull-out bed, chair,
desk with Internet connection, and good natural lighting. The treatment area of the room is on the
left side of the bed, with room all around the bed for patient care. It is intentional, also, that the
patient is on the nurses’ and other caregivers’ right as that person enters the room from either
door, so care can be more efficiently provided. Note that the bathroom is at the head of the
patient’s bed, allowing the patient to get to and from the bathroom without impediments, holding
onto a rail all the way if necessary. At the head of the bed is the headwall with connections for
various gases such as oxygen; on the wall to the left of the bed is a pull-down table the caregiver
can use when it is needed. Although it is not shown in the illustration, there will also be a
portable cart in each room, with a computer on it. Last but not least, in the lower right-hand
corner of the room, between the two doorways, easily visible to the patient, there is a sink—an
ever-present and convenient reminder to nurses, all staff, and visitors to wash their hands.
10
Patient Safety & the “Built Environment”
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
suction intensifies the transfer noise and vibration. In a truly standardized room, this does not
occur. In addition, the walls between rooms are separated and insulated with airspace,
minimizing transfer noise. This was designed into the structure early in the building design. In
addition, vibration noise between floors and within a floor was minimized through design. The
mechanical, electrical, and plumbing systems were designed to use the optimum materials for
minimizing noise. This included using vibration isolation/dampening devices wherever vibration
could be a factor.
The flooring in the patient room is rubber, second to carpet in sound reduction qualities. The
reason carpet was not chosen (it was mocked up and tested) is because spills and mishaps needed
to be cleaned up immediately. Carpet requires housekeeping to bring a carpet cleaner, which
could take time and also could be embarrassing for the patient. Carpet was chosen, however, for
the alcoves and hallways, with a low-nap, special carpet for hospital application. Special ceiling
tiles that absorb noise better than regular ceiling tiles were chosen. Triple glazed windows were
specified to minimize outside noises. No overhead paging system is used (except for public
emergencies such as a tornado warning), and nurse call systems use minimal tone with vibrating
features. As specific equipment and technologies were needed, manufacturers of that piece of
equipment or technology were contacted and asked how they reduced noise in their products.
That became one important criterion for selecting which company’s equipment to use.
Scalability, adaptability, flexibility: Many design and construction concepts can be applied
to achieve a scalable (e.g., the ability to expand or remodel easily) or adaptable (e.g., the ability
to adapt space for different or evolving services) health care facility. At St. Joseph’s, all rooms
have higher-than-normal ceilings to allow changes to be incorporated in the future. Space around
the bed is sized so procedures (e.g., colonoscopies) could be performed in the room in the future.
Visibility of patients to staff: The importance of being able to see patients is inherent to
nursing care, a concept that was recognized early by Florence Nightingale, who advocated the
design of open, long hospital wards to see all patients. The design of units and patient rooms
should allow caregivers to be in visual proximity to patients; a pod structure can allow close
proximity and enable quality care by improving efficiency and effectiveness. At St. Joseph’s,
each alcove door has a glass window with a blind so nurses can work in the alcoves and see the
patient or check on the patient. The nurse can also check on the patient in the evening without
opening the door and waking the patient. Each room is wired for cameras for observation. All
materials, such as medication, linens, IV poles, and a rough-in for icemakers, are delivered to the
alcove to allow nurses to spend more time with the patient. The chart will initially be in the
room, but shortly after the new hospital opens, it will be replaced by electronic medical records
with a workspace so nurses and other caregivers can spend more time with the patient.
Furthermore, visibility also means lighting to see the patient. Natural light is maximized by large
windows in every patient room. Light sources after hours are as close to natural light as can be
achieved cost effectively. Canned lights are located over the patient for assessment. A total of 15
lights are located in every room, including the bathroom and alcoves.
Involving patients in their care: The IOM9 found that many patients have expressed
frustration with their inability to participate in decisionmaking, to obtain information they need,
to be heard, and to participate in systems of care that are responsive to their needs. The
availability of information for patients increases their knowledge regarding their illness and
treatment options, and being informed gives patients the opportunity to participate in shared
decisionmaking with clinicians and may help patients better articulate their individual views and
preferences.69–71 This reflects several dimensions of patient-centered care, including respect for
12
Patient Safety & the “Built Environment”
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
14
Patient Safety & the “Built Environment”
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
error reduction. Private rooms with alcoves that include medical records allow nurses to
concentrate on one patient and document those efforts, before moving on to the next patient.
16
Patient Safety & the “Built Environment”
Practice Implications
The evidence base is growing in support of evidence-based design for renovations and new
building. The new field of evidence-based design has emerged at a time when there is a health
care construction boom.77 There are many factors in the workplace that impact care delivery and
work satisfaction, and they should be incorporated into designs. Based on the Gurses and
Carayon study,54 care processes will need to be modified to address inefficiencies caused by
distractions (e.g., by family members), overly busy working conditions, delays in getting access
to required resources (e.g., medications, patient medical records, supplies, and medical
equipment), delays in seeing new medical orders, and misplaced equipment.54
Nurses need to be involved and have an active role in evaluating, planning, and testing the
layout of patient units and patient rooms to ensure a healing and comfortable environment for
both patients and clinicians. Lessons learned should be shared with others to enable
improvements across the country, not just on one facility. Current laws and regulations will need
to be modified to support new hospital standards and building codes.10 As single-bed patient
rooms are now considered the minimum standard for maternity/postpartum and intensive care
units in general hospitals,78 nurses will need to be involved in planning for transitions and
assessing environmental and structural features that will improve the quality of care afforded
patient.
Research Implications
The impact of the built environment will most likely be magnified by concurrent efforts to
change organization culture and functionality as well as processes of care delivery, but future
research would need to so demonstrate. Since the majority of the research on the impact of the
built environment has been conducted in specific units in hospital settings, it will be important to
investigate whether similar effects can be realized in general medical-surgical units and
outpatient settings, including clinics and offices.
In a 2004 report commissioned by the Agency for Healthcare Research and Quality, The
Hospital Built Environment: What Role Might Funders of Health Services Research Play,10 the
following gaps in the literature were identified: What are the effects of the built environment on
the quality of communication and information sharing between clinicians, patients, and families?
What is the relationship between environmental factors and the working conditions for
clinicians? What are the best mechanisms and designs for facilitating effective hand washing?
What is the effect of elements in the built environment that reduce staff fatigue, distractions, and
stress? And what is the role of the built environment in decreasing infection rates across patient
types? Nurses can have a critical role in addressing these and other research gaps. In this
relatively new and exciting area of research in health care, nurses need to and should be actively
involved throughout the research and quality improvement processes involving the design of the
work environment space.
Conclusions
In the next few years, hospital leaders will be involved in new hospital construction projects
to meet the changing marketplace demands associated with the growing demand of an aging
population. Many clinicians, architects, and hospital administrators believe that the hospital built
17
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
environment can benefit the satisfaction of health care providers as well as patient satisfaction
and outcomes. There is some evidence that the built environment may influence patient and
family perceptions of the quality of and satisfaction with care received during a hospitalization.
There is also some evidence that nurse satisfaction with the built environment was related to
general well-being and job satisfaction, two factors that are critical because of their impact on
patient care.
The evidence-base is emerging to support the business case that designing for safety and
quality can improve patient outcomes and safety, promote healing, increase patient satisfaction,
and reduce costs. It is thought that the cost of building or remodeling projects based on design
evidence conducive to patient safety can result in organizational savings over time, without
adversely impacting revenues.8 Investigators with the Center for Health Design have been
assessing hospitals involved in the Pebbles Project, and have found that the financial incentive
for investing in evidence-based design using therapeutic design elements such as single-bed
rooms and decentralized nursing stations added close to $12 million in costs to hospital
reconstruction—but those costs would be recouped within one year of being operational.79
Those building new or remodeling current facilities should consider beginning with
transitioning to a culture of safety, then using a safe design as a matter of focusing on
maximizing the safety features without expending additional capital resources. While relatively
new, evidence is growing in objective assessments of the impact of built environments,
particularly around the issue of infection control. Some safety features will cost more than
traditionally designed facilities (e.g., HEPA filters and ultraviolet lighting to improve air quality)
while other safety features will cost less than a traditionally designed facility, most notably
standardization. In all, most of the safety features of a built environment involve a reordering of
functions in most “traditionally” designed facilities, minimally affecting capital costs, to improve
the quality of care and patient outcomes.
Search Strategy
PubMed® was searched to locate studies and related literature on the built environment. Most
of the articles identified in the literature search were primarily descriptive. Search terms included
“built,” “environment,” “hospital design and construction,” “interior design and furnishings,”
“patients’ rooms,” and “health care.” Excluded from the review were articles published before
1999, non-English language articles, expert opinions, case reports, and letters. Three hundred
abstracts were obtained. To be considered evidence in this review, the research had to involve
nurses or patients in clinical settings, reported findings related to patient safety, and not be
specific only to health information technology.
Author Affiliations
John Reiling, Ph.D., M.H.A., M.B.A., president and CEO, Synergy Health/St. Joseph’s
Hospital. E-mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
Mike R. Murphy, R.N., B.S.N., M.B.A., vice president administration and CNO, Synergy
Health/St. Joseph’s Hospital. E-mail: [email protected].
18
Patient Safety & the “Built Environment”
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75. Gaba DM, Howard SK. Fatigue among clinicians and 78. American Institute of Architects (AIA). Guidelines
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22
Evidence Table
Source Safety Issue Design Study Design, Study Setting & Study Key Finding(s)
Related to Type Study Outcome Study Population Intervention
Clinical Practice Measure(s)
Chaudhury Single-occupancy Cross- Survey of nurses 77 administrative None Nurses favor single-occupancy rooms
200657 rooms in acute sectional about patient care, and staff nurses in because of their flexibility, being more
care study management, and 3 hospitals in appropriate for patient examination, quality
infection control Washington and 1 of patient monitoring, improved patient
issues (Level 4). in Oregon comfort level, improved patient recovery
rate, and scope of patient surveillance.
57 percent believed that health care
acquired infections were low or very low in
single-occupancy rooms.
There was no difference in the number of
patient falls, need for pain-reducing or
sleep-inducing medications between the
two types of rooms.
Helpful characteristics of single-occupancy
rooms were layout of the room; availability
of space in the room; the arrangement of
furniture; privacy; space for family
23
rooms (Level 3). step-down medical new acuity- percent reduction in medication errors; a
unit at 1 hospital in adaptable reduction in patient falls; improvements in
Indiana rooms for the patient satisfaction; decrease in budgeted
combined nursing hours per patient day; increased
coronary critical available nursing time for direct care
care and step- without additional cost.
down unit.
Background
The health care environment was once regarded as safe and secure1 for patients and staff.
Turmoil and change have pervaded the U.S. health care system since the 1980s, contributing to a
state of chaos and instability.1 Today’s health care work environment can therefore be
characterized as turbulent—it is in a state of unrest, disturbance, agitation, or commotion.2
There are many sources of turbulence in 21st century health care. They can be grouped into
five categories:
• Hectic conditions in hospitals;
• The rapid growth of large health care corporations, which has altered organizational
structures and dynamics;
• Constantly changing health policies, such as those related to insurance—what is covered,
what is paid for out-of-pocket, how Medicare Part D really works;
• World events that have placed new demands on health care workers, such as concerns
related to bioterrorism; and
• An aging population that is seeking care for chronic conditions from a health care system
designed for acute care.
Although turbulence from all of these categories works to create challenges for health care
workers, it is turbulence on hospital units that has the most immediate effect on the nurses’ work
environment. Staff nurses are striving to meet complex patient needs that require rapid
decisionmaking, despite there being fewer resources and more interruptions and distractions.
The focus of this review is predominantly on studies that explored turbulence at the level of
the patient care unit. Although publications were located that addressed turbulence in health care,
no systematic conceptualizations were found delineating or describing the features of turbulence.
Moreover, there were indications of slippage between the terms turbulence and uncertainty.
Nevertheless, turbulence seems to capture key components of the dynamic and complex work
environment that add to the challenge of providing quality care and keeping patients safe.
Research Evidence
Perhaps because turbulence remains to be clarified conceptually, a number of studies relied
on qualitative methods. Although these investigations do not meet the criteria for inclusion
according to most evidence hierarchies, they provide a rich description of turbulence. The 11
qualitative studies that were identified through database searches examined the work environment
from the perspective of various health care personnel—Registered Nurses (RNs),3–11 physicians,12
and physical therapists.13
Although these studies varied in the rigor of their analytic approaches, five themes appeared
across them. In general, turbulence was viewed as a loss of control6, 11, 13 due to simultaneous
demands; new, difficult, or unfamiliar work; heavy patient loads; and excessive responsibility.6
Staff experienced the loss of control as a sense of chaos that infiltrated both their professional
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and personal lives.13 As the environment became more turbulent, noise escalated.3, 6 Problems
with equipment and supplies (e.g., malfunctioning, missing, calling for cumbersome processes to
acquire) were also addressed as elements of turbulence.3, 5, 11 Aspects of workload, particularly
variability associated with patient turnover—due to admissions, discharges, and transfers—were
mentioned as well.4, 7, 11, 13
2
Turbulence
Patient Turnover
The second grouping of quantitative studies considered census and staffing variability or
patient turnover related to admissions, discharges, and transfers, as well as observation
patients.17-23 The census variability from patient turnover demonstrates the need to replace
midnight census as an indicator of patient volume; it also contributes to turbulence in the
environment. The previously mentioned intervention study,17 for example, reduced patient
turnover from transfers by 90 percent through using acuity-adaptable rooms for coronary patients.
The importance of patient turnover is further illustrated in work by Houser,24 who used
structural equation modeling to assess features of the complex work environment on patient
outcomes. Although workload, measured by length of stay and midnight census, demonstrated a
negative relationship with patient outcomes, it was not a statistically significant predictor of
outcomes. Adding patient turnover to the workload measure may have yielded different findings.
Patient turnover was used in combination with other variables in an additional two studies.
The first19 illustrates the slippage between turbulence and uncertainty. The investigators
measured objective uncertainty—at times referred to as environmental turbulence—using patient
turnover divided by midnight census. Although objective uncertainty was predictive of emotional
exhaustion (P < 0.01) among staff nurses, the relationship was negative. The investigators
suggest this unexpected finding may reflect that patient census variability possibly mediates the
emotional effects of environmental turbulence because of the relief offered by occasional
decreases in patient turnover.
In the second study,21 path analysis was used to test a model to predict environmental and
personal characteristics affecting nurse performance. Similar to objective uncertainty, the
measure of turbulence included patient turnover. Although turbulence did not demonstrate direct
effects on nursing performance, it did have a direct negative relationship with interpersonal
relations and communication skills that was statistically significant (p < 0.01). These findings
begin to illustrate that more turbulent environments may exert undesirable effects on
communication with patients, families, and other staff.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
care communication mechanisms used by the RNs were similar regardless of the degree of
stability in the practice environment. The investigators suggested that quality could be better
sustained if nurses learned to adjust their communication according to demands in the practice
setting.
Communication was quantified and described in two studies. In observing eight emergency
department (ED) nurses and physicians for about 20 hours across all shifts, 831 distinct
communication events were identified.26 On average, each of the eight clinicians spent 89
percent of their time communicating; they experienced 42 communication events per hour.
Interruptions characterized one-third of the communication events, with each clinician
experiencing an average of 15 interruptions per hour.
In the second study,27 communication patterns were evaluated between the operating room
(OR) charge nurses and other OR staff members at four hospitals—two university and two
community. The OR suites ranged in size from 4 to 18 rooms. Observations and a data collection
tool were completed on 17 nonconsecutive days, for a total of 2,074 communication episodes
observed over about 100 hours. Communication episodes per hour ranged from 32 to 74, with
more communication episodes associated with the larger OR suites. Charge nurses most often
communicated with OR nurses (39 percent). The most common purpose of communication
related to equipment coordination. Most communication occurred face-to-face (69 percent), with
only 7 percent of the exchanges occurring via intercom. The duration of the communication
ranged from 10 seconds to 10 minutes, with a mean of 40 seconds and a median of 20 seconds.
Despite the overall brevity of most communication, the investigators did not assess interruptions.
The findings from this collection of qualitative and quantitative investigations have strong
implications for practice (see Table 1). Turbulence can be said to emanate from two major
sources—workload and communication. Reducing workload and improving communication,
with particular attention to minimizing interruptions, could have dramatic effects on stabilizing
the practice setting.
4
Turbulence
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
staff. The overall goal would be to reduce turbulence for the purpose of creating a safer, more
secure environment for both patients and staff.
Lastly, there is currently a gap in examining turbulence in long-term care, outpatient settings,
and the home. Along with advancing the understanding of turbulence in each of these care
settings, it would be useful to explore turbulence across the care continuum as it applies to
patient safety and quality care.
Conclusion
Turbulence is a concept that appropriately characterizes contemporary conditions
surrounding nurses’ work. Because this concept is more recent in its application to health care,
the literature about it in relation to quality care and patient safety is sparser. Nevertheless, as
indicated in Table 1, ideas related to turbulence cluster nicely within two themes—
communication and workload. Focusing efforts on improving communication and managing
workload could offer much needed help to the practicing nurse who is often found working in a
highly turbulent environment.
Search Strategy
Literature for this review was identified with the help of a reference librarian. Both
MEDLINE® and CINAHL® databases were searched from 1995 to 2005 with the goal of being
as inclusive as possible. The search terms were slightly different for each database because of
differences in MeSH® headings. The terms included: turbulence, work interruptions, attention/or
distractions, uncertainty, variability, unpredictability, workload or work overload, loss of control,
and work environment. Citations were limited to research reports published in the English
language.
The MEDLINE search identified 158 possible citations and the CINAHL search identified
1,324 possible citations. The abstracts for each of the 1,482 studies were reviewed. Based upon
information in the abstracts, all but 119 publications were eliminated from consideration.
Reasons for excluding papers were that they were not related to nurses in particular, health care
staff in general, quality, or patient safety. For example, some studies identified initially pertained
to memory assessments, environmental factors related to racial disparities, statistical tests, and
studies of particular patient populations. The remaining 119 articles were reviewed in their
entirety, 94 of which were eliminated from further consideration because they were not pertinent
to turbulence per se (i.e., they were related to other concepts such as stress or leadership), or
because they were simply short reports lacking in details.
Acknowledgments
Tremendous gratitude is expressed to the staff of the Armed Forces Medical Library, Falls
Church, VA, for their considerable support of this work. They conducted the database searches
and assisted in acquiring numerous papers considered in this review.
6
Turbulence
Author Affiliation
Bonnie M. Jennings, D.N.Sc., R.N., F.A.A.N., Colonel, U.S. Army (Retired), and Health
Care Consultant. E-mail: [email protected].
References
1. American Hospital Association Commission on clinical consultation: Qualitative study. Brit Med J
Workforce for Hospitals and Health Systems. In our 2005;330(Mar 5):511-5.
hands. How hospital leaders can build a thriving
workforce. Chicago, IL: American Hospital 13. Blau R, Bolus S, Carolan T, et al. The experience of
Association; 2002. providing physical therapy in a changing health care
environment. Physical Therapy 2002;82(7):648-57.
2. Merriam-Webster. Online dictionary. Available at
http://www.m-w.com/. Accessed March 26, 2006. 14. Miller GA. The magical number seven, plus or minus
two: Some limits on our capacity for processing
3. Beaudoin LE, Edgar L. Hassles: Their importance to information. Psych Rev 1956;63:81-97.
nurses’ quality of work life. Nurs Econ 2003;21(3):
106-13. 15. Grayson D, Boxerman S, Potter P, et al. Do transient
working conditions trigger medical errors? In:
4. Ebright PR, Urden L, Patterson E, et al. Themes Henrikson K, Battles JB, Marks ES, et al., eds.
surrounding novice nurse near-miss and adverse- Advances in patient safety: From research to
event situations. J Nurs Adm 2004;34(11):531-8. implementation. Vol 1, Research findings. Rockville,
MD: Agency for Healthcare Research & Quality;
5. Ebright PR, Patterson ES, Chalko BA, et al. 2005. p. 53-64. AHRQ Publication 05-0021-1.
Understanding the complexity of registered nurse
work in acute care settings. J Nurs Adm 16. Pape TM. Applying airline safety practices to
2003;33(12):630-8. medication administration. MEDSURG Nurs
2003;12(2):77-93.
6. Gaudine AP. What do nurses mean by workload and
work overload? Can J Nurs Leadersh 2000;13(2):22- 17. Hendrich AL, Fay J, Sorrels AK. Effects of acuity-
7. adaptable rooms on flow of patients and delivery of
care. Am J Crit Care 2004;13(1):35-45.
7. Geddes N, Salyer J, Mark BA. Nursing in the
nineties. Managing the uncertainty. J Nurs Adm 18. Budreau G, Balakrishnan R, Titler M, et al.
1999;29(5):40-8. Caregiver-patient ratio: Capturing census and staffing
variability. Nurs Econ 1999;17(6):317-24.
8. Hedberg B, Larsson US. Environmental elements
affecting the decision-making process in nursing 19. Garrett DK, McDaniel AM. A new look at nurse
practice. J Clin Nurs 2004;13:316-24. burnout. The effects of environmental uncertainty
and social climate. J Nurs Adm 2001;31(2):91-6.
9. Miller ET, Deets C, Miller RV. Nurse call systems:
Impact on nursing performance. J Nurs Care Qual 20. Jacobson AK, Seltzer JE, Dam EJ. New methodology
1997;11(3):36-43. for analyzing fluctuating unit activity. Nurs Econ
1999;17(1):55-9.
10. Potter P, Sledge J, Wolf L, et al. Understanding the
cognitive work of nursing in the acute care 21. Salyer J. Environmental turbulence. Impact on nurse
environment. J Nurs Adm 2005;35(7/8):327-35. performance. J Nurs Adm 1995;25(4):12-20.
11. Tillman HJ, Salyer J, Corely MC, et al. 22. Volpatti C, Leathley M, Walley KR, et al. Time-
Environmental turbulence staff nurse perspectives. J weighted nursing demand is a better predictor than
Nurs Adm 1997;27(11):15-22. midnight census of nursing supply in an intensive
care unit. J Crit Care 2000;15(4):147-50.
12. Griffiths F, Green E, Tsouroufli M. The nature of
medical evidence and its inherent uncertainty for the
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
23. Wagner C, Budreau G, Everett LQ. Analyzing 26. Spencer R, Coiera E, Logan P. Variation in
fluctuating unit census for timely staffing communication loads on clinical staff in the
intervention. Nurs Econ 2005;23(2):85-90. Emergency Department. Annals Emerg Med
2004;44(3):268-73.
24. Houser J. A model for evaluating the context of
nursing care delivery. J Nurs Adm 2003;33(1):39-47. 27. Moss J, Xiao Y. Improving operating room
coordination. Communication pattern assessment. J
25. Allred CA, Arford PH, Michel Y. Coordination as a Nurs Adm 2004;34(2):93-9.
critical element of managed care. J Nurs Adm
1995;25(12):21-8.
8
Evidence Table
sentinel events hospital, critical care in the same more than 200 intra-unit transfers each
(medication errors Patient transfers. setting. month; after the acuity-adaptable rooms
and falls) (Level 1), were introduced, transfers were reduced by
patient satisfaction 90%, the medication error index was
and financial reduced by 70%, the fall index was reduced
outcomes from an annual rate of about 6 to 2, and
patient dissatisfaction declined.
Turbulence
Safety Issue Study Design,
Background
The heavy workload of hospital nurses is a major problem for the American health care
system. Nurses are experiencing higher workloads than ever before due to four main reasons: (1)
increased demand for nurses, (2) inadequate supply of nurses, (3) reduced staffing and increased
overtime, and (4) reduction in patient length of stay.
First, the demand for nurses is increasing as a result of population aging. Between 2000 and
2020, the United States population is expected to grow by 18 percent (31 million), but the over-
65 population, with more health care needs, is expected to grow by 54 percent (19 million).1, 2
Second, the supply of nurses is not adequate to meet the current demand, and the shortage is
projected to grow more severe as future demand increases and nursing schools are not able to
keep up with the increasing educational demand.3, 4 When a nursing shortage occurs, the
workload increases for those who remain on the job.5 Third, in response to increasing health care
costs since the 1990s, hospitals reduced their nursing staffs and implemented mandatory
overtime policies to meet unexpectedly high demands, which significantly increased nursing
workloads. Fourth, increasing cost pressure forced health care organizations to reduce patient
length of stay. As a result, hospital nurses today take care of patients who are sicker than in the
past; therefore, their work is more intensive.6
There are several important consequences of high nursing workload. Research shows that a
heavy nursing workload adversely affects patient safety.7 Furthermore, it negatively affects
nursing job satisfaction and, as a result, contributes to high turnover and the nursing shortage.8 In
addition to the higher patient acuity, work system factors and expectations also contribute to the
nurses’ workload: nurses are expected to perform nonprofessional tasks such as delivering and
retrieving food trays; housekeeping duties; transporting patients; and ordering, coordinating, or
performing ancillary services.9 A 1998–1999 survey of more than 43,000 nurses in five countries
found that 17 percent to 39 percent of respondents planned to leave their job within a year
because of job demands.9 Heavy nursing workload increases burnout and job dissatisfaction,
which in turn contributes to high nurse turnover.10 This chapter focuses on the impact of nursing
workload on patient safety. We first present different concepts and models of nursing workload,
then discuss the impact of workload on patients and on nursing staff, presenting various
mechanisms of the relationship between nursing workload and patient safety. Finally, we
describe a human factors engineering approach on how work systems can be redesigned to
reduce nursing workload or to minimize the negative impact of a heavy nursing workload.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
workload is embedded in the unit-level workload. In a clinical unit, for example, numerous
nursing tasks need to be performed by a group of nurses during a specific shift (unit-level
workload). The type and amount of workload of nurses is partly determined by the type of unit
and specialty (e.g., intensive care unit [ICU] nurse versus general floor nurse), which is the job-
level workload. When performing their job, nurses encounter various situations and patients,
which are determinants of the situation- and patient-level workloads.
The most commonly used unit-level workload measure is the nurse-patient ratio. The nurse-
patient ratio can be used to compare units and their patient outcomes in relation to nursing
staffing. Previous research provides strong evidence that high nursing workloads at the unit level
have a negative impact on patient outcomes.7, 12, 13 These studies’ suggestions regarding
improving patient care are limited to increasing the number of nurses in a unit or decreasing the
number of patients assigned to each nurse. However, it may not be possible to follow these
suggestions due to costs and the nursing shortage. The major weakness of this type of research is
that it conceptualizes nursing workload at a macro level, ignoring the contextual and
organizational characteristics of a particular health care setting (e.g., physical layout, information
technology available) that may significantly affect workload. Research should examine the
impact on nursing workload of work factors in the health care microsystems.
According to this conceptualization, the level of workload depends on the type of nursing job
or specialty (ICU nurse versus operating room nurse). For instance, Schaufeli and LeBlanc14
used a job-level measure of workload to investigate the impact of workload on burnout and
performance among ICU nurses. Previous research linked job-level workload (a working
condition) to various nursing outcomes, such as stress15, 16 and job dissatisfaction.17 Workload
measures at the job level are appropriate to use when comparing workload levels of nurses with
different specialties or job titles (ICU nurses versus ward nurses).18 However, workload is a
complex, multidimensional construct, and there are several contextual factors in a nursing work
environment (e.g., performance obstacles and facilitators) other than job title that may affect
nursing workload.19 In other words, two medical ICU nurses may experience different levels of
workload due to the different contextual factors that exist in each ICU. The workload at the job-
level conceptualization fails to explain the difference in the workloads of these two nurses.
This conceptualization assumes that the main determinant of nursing workload is the clinical
condition of the patient. Several patient-level workload measures have been developed based on
the therapeutic variables related to the patient’s condition (e.g., Therapeutic Intervention Scoring
System)15, 20, 21 and have been extensively discussed in the nursing literature. However, recent
studies show that factors other than the patient’s clinical condition (e.g., ineffective
communication, supplies not well-stocked) may significantly affect nursing workload. As with
the previous two workload measures, patient-level workload measures have not been designed to
measure the impact of these contextual factors on nursing workload.
2
Workload for Nurses
Situation-Level Workload
To remedy the shortcomings of the three levels of measures explained above and
complement them, we have suggested using another way to conceptualize and measure nursing
workload based on the existing literature on workload in human factors engineering: situation-
level workload.11 In addition to the number of patients assigned to a nurse and the patient’s
clinical condition, situation-level workload can explain the workload experienced by a nurse due
to the design of the health care microsystem. In a previous study, we found that various
characteristics of an ICU microsystem (performance obstacles and facilitators)—such as a poor
physical work environment, supplies not well stocked, many family needs, and ineffective
communication among multidisciplinary team members—significantly affect situation-level
workload.22 For example, sometimes several members of the same family may call a nurse
separately and ask very similar questions regarding the same patient’s condition. Answering all
these different calls and repeating the same information about the patient’s status to different
members of the family is a performance obstacle that significantly increases the (situation-level)
workload of nurse.
It is important to note that the impact of this performance obstacle on nursing workload
would not be apparent if we used a unit-level or patient-level workload measure. Compared to
workload at the job level, situation-level workload is temporally bound: it explains the impact of
a specific performance obstacle or facilitator on nursing workload over a well-defined and
relatively short period of time (e.g., 12-hour shift), rather than using the overall experience of the
nurse in a given microsystem. Situation-level workload is multidimensional, that is, different
types of performance obstacles and facilitators affect different types of workload. Whereas the
distance between the patients’ rooms assigned to a nurse affects physical workload, the condition
of the work environment (noisy versus quiet, hectic versus calm) affects the overall effort spent
by the nurse to perform her job.23 No prior study investigated the impact of the microsystem
characteristics on situation-level nursing workload.19 In summary, by studying workload at the
situation level, researchers can identify the characteristics of a microsystem that affects
workload. This information is vital for reducing nursing workload by redesigning the
microsystem. In the last section of this chapter, a human factors engineering approach based on
the situation-level workload is described.
Research Evidence
Impact of Nursing Workload on Patients
A heavy nursing workload seems to be related to suboptimal patient care10, 24 and may lead to
reduced patient satisfaction.25 A 2004 report by the Agency for Healthcare Research and Quality
(AHRQ) describes several AHRQ-funded studies on the relationship between hospital nurse
staffing and quality of care (e.g., urinary tract infection, hospital-acquired pneumonia) and
patient safety outcomes (e.g., failure to rescue).26
Much of the research investigating the impact of nursing workload on patient safety focused
on linking nursing staffing levels with patient outcomes. There is strong evidence in the literature
that nurse staffing levels significantly affect several nursing-sensitive patient outcomes.13, 26, 27
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Several studies found a significant relation between lower nurse staffing levels and higher
rates of pneumonia.28-30 For example, a multisite study in California found that an increase of 1
hour worked by registered nurses (RNs) per patient day correlated with an 8.9 percent decrease
in the odds of pneumonia among surgical patients.28 Another study found a significant
relationship between full-time-equivalent RNs per adjusted inpatient day and rate of pneumonia:
the rate of pneumonia was higher with fewer nurses.31 However, other studies have not
confirmed these findings;31, 32 for example, the evidence regarding the impact of nurse staffing
levels on pneumonia is conflicting. As workload is affected by more than just staffing levels, a
deeper understanding of nursing workload is required to better assess the impact of workload on
patient outcomes. Later, a human factors engineering approach to nursing workload that can
provide this deeper understanding of nursing workload and its causes will be described, allowing
for the development and implementation of solutions aimed at reducing or dealing with
workload.
Nursing staffing levels have been shown to have a significant impact on nosocomial
infections. For example, Needleman and colleagues13 found that among medical patients, a
higher number of hours of care per day provided by RNs was related to lower urinary tract
infection rates. A retrospective cohort study in a neonatal ICU revealed that the incidence of E
cloacae infection in the unit was significantly higher when there was understaffing of nurses.33 A
prospective study in a pediatric cardiac ICU found a significant relation between the monthly
nosocomial infection rate in the unit and the nursing hours per patient day ratio: there were more
nosocomial infections when the number of nursing hours per patient day was lower.34
Although not as strong, some evidence exists regarding the impact of nurse staffing levels on
failure to rescue (death within 30 days among patients who had complications) and mortality. A
study using administrative data from 799 hospitals in 11 States revealed that a higher number of
hours of RN care per day was associated with lower failure to rescue rates.13 In a study of 168
nonfederal adult general hospitals in Pennsylvania, Aiken and colleagues10 found that each
additional patient per nurse was associated with a 7 percent increase in the likelihood of
mortality within 30 days of admission and in the likelihood of failure to rescue. An earlier study
found that hospitals that had more RNs per admission had lower mortality rates.35
There were four studies that found a relationship between nurse staffing and patient
outcomes. One study found that having a nurse-patient ratio of less than 1:2 during evening shifts
was associated with a 20 percent increase in length of stay in patients who had abdominal aortic
surgery in Maryland hospitals between 1994 and 1996.36 Researchers conducted studies in 1992
and 1994 using hospital cost reports and discharge data in New York and California, finding that
more nursing work hours were associated with reduced length of stay.37 Additionally, a critical
incident study of Australian ICUs revealed that insufficient nursing staff was linked to drug
administration or documentation problems, inadequate patient supervision, incorrect ventilator or
equipment setup, and self-extubation.38
A majority of the studies on nursing workload and patient safety used nurse-patient ratio as
the measure of nursing workload. According to research on workload in human factors
engineering (see section above), it is well known that workload is a complex construct, more
complex than the measure of nurse-patient ratio.11 It is unlikely that the multidimensional,
multifaceted structure of workload can be captured by one unique, representative measure.
Therefore, the belief is that researchers who use the nurse-patient ratio as a measure of workload
offer a limited contribution to understanding the impact of nursing workload and designing
solutions for reducing or mitigating nursing workload. One reason for the extensive use of the
4
Workload for Nurses
nurse-patient ratio may be that this measure is easy to use and is readily available in existing
databases. But tools used by human factors researchers can comprehensively assess workload,
facilitate the identification of the sources of excessive workload, and provide direction for
corrective interventions.11
According to the Systems Engineering Initiative for Patient Safety (SEIPS) model of work
system and patient safety,39, 40 structural/organizational characteristics of health care work
systems, such as nursing workload, can affect quality of care and patient safety. In this section, a
description of how nursing workload can affect patient safety will be offered (see Table 1). The
first five mechanisms describe the impact of a heavy workload experienced by one nurse on that
particular nurse. The last mechanism describes the systemic and organizational impact of a heavy
workload experienced by a nurse’s coworkers and team members.
Nursing workload and lack of time. Nursing workload definitely affects the time that a
nurse can allot to various tasks. Under a heavy workload, nurses may not have sufficient time to
perform tasks that can have a direct effect on patient safety. A heavy nursing workload can
influence the care provider’s decision to perform various procedures.41 A heavy workload may
also reduce the time spent by nurses collaborating and communicating with physicians, therefore
affecting the quality of nurse-physician collaboration.42 A heavy workload can lead to poor
nurse-patient communication.43, 44
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Nursing workload and deteriorated motivation. Several studies have shown the
relationship between nurses’ working conditions, such as high workload, and job
dissatisfaction.10, 45, 46 Job dissatisfaction of nurses can lead to low morale, absenteeism,
turnover, and poor job performance, and potentially threaten patient care quality and
organizational effectiveness.47 Researchers have found positive associations between job
satisfaction and job performance,48 and patient satisfaction and quality of care.49
Impact of workload on nursing stress and burnout. High workload is a key job stressor of
nurses in a variety of care settings, such as ICUs.15, 16, 50 A heavy nursing workload can lead to
distress (e.g., cynicism, anger, and emotional exhaustion)51 and burnout.10 Nurses experiencing
stress and burnout may not be able to perform efficiently and effectively because their physical
and cognitive resources may be reduced; this suboptimal performance may affect patient care
and its safety.
Nursing workload and errors. Workload can be a factor contributing to errors.52, 53 Errors
have been classified as (1) slips and lapses or execution errors, and (2) mistakes or knowledge
errors.52 High workload in the form of time pressure may reduce the attention devoted by a nurse
to safety-critical tasks, thus creating conditions for errors and unsafe patient care.
Nursing workload and violations or work-arounds. Violations are defined as deliberate
deviations from those practices (i.e., written rules, policies, instructions, or procedures) believed
necessary to maintain safe or secure operations.54 The literature on violations emphasizes the role
of the social and organizational context, where behavior is governed by operating procedures,
codes of practice, rules, and regulations.54, 55 This approach emphasizes factors in the work
system that can contribute to violations. The health care field has begun to explore caregivers’
violations of protocols.56 A survey describing medical practice was administered to 315 nurses,
doctors, and midwives and 350 members of the general public in the United Kingdom. The study
examined two factors manipulated within nine scenarios of surgery, anesthetics, and obstetrics.
The first factor, behavior, was described as an improvisation (no rule available), a violation of
clinical protocol, or compliance with a clinical protocol. The second factor, patient outcome, was
described as good, bad, or poor. Samples of health care providers and the general public were
asked to evaluate the nine scenarios with regard to the inappropriateness of the behavior, the
likelihood that they would take further action (i.e., reporting by health care provider and
complaining by the public), and responsibility for the outcome (e.g., the health care professional,
the patient, the protocol itself, the hospital). Results showed that violations of protocols and bad
outcomes were judged most harshly. Whether outcomes were good or bad, violations were
evaluated more negatively. The authors of the study warned against overreliance on procedures
(or protocols) as a form of organizational defense against accidents or claims. Procedures may
stifle innovation and make people less able to function in novel situations.
Alper and colleagues57 conducted a survey of 120 nurses (59 percent response rate) in three
units of a pediatric hospitals to assess self-reports of violations in the medication administration
process. Between 8 percent and 30 percent of the nurses reported violations in routine situations,
and between 32 percent and 53 percent of the nurses reported violations in emergency situations.
The most frequent violations or work-arounds occurred in matching the medication to the
medication administration record and checking the patient’s identification.
Further research is needed to understand the work system factors that lead to violations.
Violations occur more frequently when nurses are under time pressure or high workload because
of emergency situations. Under high workload, nurses may not have time to follow rules and
6
Workload for Nurses
guidelines for safe care, especially if following the rules and guidelines necessitate additional
time, such as hand washing.
Systemic, organizational impact of nursing workload. This final mechanism of the
relationship between nursing workload and patient safety is based on the systemic,
organizational impact of nursing workload: a heavy workload experienced by a nurse not only
affects this nurse, but can also affect other nurses and health care providers in the nurse’s work
system. Understaffing may reduce time nurses have to help other nurses. This lack of time may
also result in inadequate training or supervision of new nurses.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
support, practical support, affective support) can be provided to help nurses deal with negative
aspects of their work, such as workload.
Another key concept of the human factors engineering approach to nursing workload is the
work system: any change in one element of the work system can affect other elements of the
work system in negative and/or positive ways.60, 61 For instance, work hour limits for physicians
have affected nurse schedules. Nurses are often required to work increased overtime to
compensate for reduced physician hours.65 This is an example of how changing one element in
the work system of physicians can negatively affect the work system of nurses. Table 2
summarizes the research implications of the proposed human factors engineering approach to
nursing workload and patient safety.
Conclusion
Nursing workload is affected by staffing levels and the patients’ conditions, but also by the
design of the nurses’ work system. In this chapter, a description of different levels of workload,
including situational workload, was offered, and a proposal for a human factors engineering
approach aimed at reducing workload or at mitigating or balancing the impact of workload on
nurses and patient care was suggested.
Author Affiliation
Pascale Carayon, Ph.D., Department of Industrial and Systems Engineering, Center for
Quality and Productivity Improvement, University of Wisconsin–Madison. E-mail:
[email protected].
Ayse P. Gurses, Assistant Professor, Division of Health Policy and Management, School of
Public Health, University of Minnesota–Twin Cities. Email: [email protected].
8
Workload for Nurses
Acknowledgments
This chapter is partially based on a project funded by a Health Services Research Dissertation
Grant (# R03 HS14517-01) from the Agency for Healthcare Research and Quality.
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30. Kovner C, Mezey M, Harrington C. Research
priorities for staffing, case mix, and quality of care in 43. Davis S, Kristjanson LJ, Blight J. Communicating
U.S. nursing homes. J Nurs Sch 2000;32(1):77-80. with families of patients in an acute hospital with
advanced cancer: problems and strategies identified
31. Kovner C, Gergen PJ. Nurse staffing levels and by nurses. Cancer Nurs 2003;26:337-45.
adverse events following surgery in U.S. hospitals.
Image J Nurs Sch 1998;30(4):315-21. 44. Llenore E, Ogle KR. Nurse-patient communication in
the intensive care unit: a review of the literature. Aust
32. Unruh L. Licensed nurse staffing and adverse events Crit Care 1999;12(4):142-5.
in hospitals. Med Care 2003;41(1):142-52.
45. Bratton RL, Cody C. Telemedicine applications in
33. Harbarth S, Sudre P, Dharan S, et al. Outbreak of primary care: a geriatric patient pilot project. Mayo
Enterobacter cloacae related to understaffing, Clin Proc 2000;75:365-8.
overcrowding, and poor hygiene practices.Infect
Control Hosp Epidemiol 1999;20(9):598-603. 46. Darvas JA, Hawkins LG. What makes a good
intensive care unit: a nursing perspective. Aust Crit
34. Archibald LK, Manning ML, Bell LM, et al. Patient Care 2002;15(2):77-82.
density, nurse-to-patient ratio and nosocomial
infection risk in a pediatric cardiac intensive care 47. Cavanagh SJ. Job satisfaction of nursing staff
unit. Pediatr Infect Dis J 1997;16:1045-8. working in hospitals. J Adv Nurs 1992;17:704-11.
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48. McCloskey JC, McCain BE. Satisfaction, 58. Carayon P, Alvarado C. Workload and patient safety
commitment and professionalism of newly employed among critical care nurses. Crit Care Nurs Clin North
nurses. Image: J Nurs Sch 1987;19(1):20-4. Am 2007;8(5):395-428.
49. Tarnowski-Goodell T, Van Ess Coeling H. Outcomes 59. Carayon P, Hundt AS, Karsh BT, et al. Work system
of nurses' job satisfaction. J Nurs Adm design for patient safety: the SEIPS model. Qual Saf
1994;24(11):36-41. Health Care 2006;15(Suppl I):i50-8.
50. Oates RK, Oates P. Stress and mental health in 60. Carayon P, Smith MJ. Work organization and
neonatal intensive care units. Arch Dis Child ergonomics. Appl Ergon 2000;31:649-62.
1995;72:F107-10.
61. Smith MJ, Carayon-Sainfort P. A balance theory of
51. Greenglass ER, Burke RJ, Moore KA. Reactions to job design for stress reduction. Int J Ind Ergon
increased workload: effects on professional efficacy 1989;4:67-79.
of nurses. Appl Psychol: An International Review
2003;52(4):580-97. 62. Wilson JR, Corlett N. eds. Evaluation of human
work. 3rd ed. Boca Raton, FL: CRC Press; 2005.
52. Reason J. Human error. Cambridge, UK: Cambridge
University Press; 1990. 63. Carayon P, Wetterneck TB, Hundt AS, et al.
Evaluation of nurse interaction with bar code
53. Vincent C, Taylor-Adams S, Stanhope N. Framework medication administration technology in the work
for analysing risk and safety in clinical medicine. environment. J Patient Safety 2007;3(1):34-42.
BMJ 1998;316(7138):1154-7.
64. Carayon P, Alvarado CJ, Hundt AS, et al. Employee
54. Reason J, Manstead A, Stradling S, et al. Errors and questionnaire survey for assessing patient safety in
violations on the roads: a real distinction? outpatient surgery. In:. Henriksen K, Battles JB,
Ergonomics, 1990;33:1315-32. Marks E, et al., eds. Advances in patient safety: from
research to implementation. Vol. 4. Rockville, MD:
55. Lawton R. Not working to rule: understanding Agency for Healthcare Research and Quality; 2005.
procedural violations at work. Saf Sci 1998;28:77-95. pp. 461-73.
56. Parker D, Lawton R. Judging the use of clinical 65. Lundstrom T, Pugliese G, Bartley J, et al.
protocols by fellow professionals. Soc Sci Med Organizational and environmental factors that affect
2000;51:669-77. worker health and safety and patient outcomes. Am J
Infect Control 2002;30(2):93-106.
57. Alper SJ, Karsh B, Holden RJ, et al. Protocol
violations during medication administration in
pediatrics. In: The Human Factors and Ergonomics
Society, ed. Proceedings of the Human Factors and
Ergonomics Society 50th annual meeting. Santa
Monica, CA: The Human Factors and Ergonomics
Society; 2006. p. 1019-23.
11
Evidence Table. Nurse workload and patient safety
Archibald Nurse staffing Cross-sectional Rate of One pediatric cardiac Higher patient census was related to
199734 levels and patient study nosocomial intensive care unit; 782 higher rates of nosocomial infections.
census in ICU infections per admissions during one year There was an inverse correlation
1000 patient between the monthly nosocomial
days infection rates and the nurse/patient
ratio.
Beckmann Nursing staffing Noncomparative Incidents 89 nursing staff shortage Incidents involving nursing staff
199838 issues in incidents study associated incidents and 373 incidents shortage contributed primarily to
reported by ICU with nursing involving nursing staff problems in unit management (65%)
staff staff shortage shortage contributing factors and patient management (48%).
reported to the
Australian
Incident
Monitoring
Study-ICU
(AIMS-ICU)
project
Study Design
Safety Issue Design Type & Study Study Setting & Study
Source Related to Outcome Population Key Finding(s)
Clinical Practice Measure(s)
Keijsers Burnout (emotional Cross-sectional Standardized 576 nurses from 20 ICUs High burnout of ICU nurses is related
199524 exhaustion and study mortality ratio to poor perceived unit performance and
depersonalization) for each of the poor perceived personal performance.
20 participating Nurses in well-performing ICUs (as
ICUs; measured by the standardized mortality
perceived ratio) reported higher burnout than
personal nurses in poor-performing units.
performance;
perceived ICU
performance
Lichtig Nurse staffing Cross-sectional Adverse Hospital cost reports and Higher nurse staffing and higher
199937 study patient patient discharge data from proportion of RNs were related to lower
outcomes hospitals in the States of length of stay. Lower rates of adverse
(pressure California and New York outcomes were related to a higher
ulcers, proportion of RNs.
pneumonia,
13
UTIs,
postoperative
infections),
length of stay
Manheim Regional variation Cross-sectional Severity- 3,796 hospitals in nine US The percentage of RNs per adjusted
199235 in hospital mortality study adjusted Census regions admission was a negative predictor of
Medicare mortality rates.
hospital
mortality rate
Needleman Hours of nursing Cross-sectional Rates of Administrative data from A higher proportion of hours of nursing
200213 care per patient study urinary tract 1997 for 799 hospitals in 11 care was related to better quality of
infections, States care outcomes, such as lower rates of
rates of failure- urinary tract infections among surgical
Background
What Is Workflow?
Workflow, loosely defined, is the set of tasks—grouped chronologically into processes—and
the set of people or resources needed for those tasks, that are necessary to accomplish a given
goal. An organization’s workflow is comprised of the set of processes it needs to accomplish, the
set of people or other resources available to perform those processes, and the interactions among
them. Consider the following scenario:
On a slow Friday afternoon in the emergency room, as one nurse prepares to go
off shift, the clerk looks up from the desk and asks, “By the way, since you’re
passing by housekeeping on your way out, would you remind them that room 12
still needs to be cleaned?”
“No problem,” replies the nurse, and indeed, on a slow Friday afternoon, it is no
problem. The informal methods and processes that the hospital has developed
over the years to keep the enterprise humming work well, in general, and can
work very well in optimal times. It’s no trouble to remind housekeeping to come
up; it’s no trouble to run a special specimen down to the lab, and certainly no
trouble to catch the attending physician during rounds to get a quick signature.
Even if these small adjustments are forgotten, in due time the regular hospital
schedule will bring the right people to clean the room, to pick up the lab
specimen, to document the encounter.
These same methods that an organization uses to get work done, however, can begin to show
stress under trying circumstances. When the ward is full and it takes 12 hours for a room to be
readied for the next patient, that impact is felt throughout the organization. When the number of
small interruptions outweighs the amount of planned work done in a given hour, that impact is
felt in slower progress, lower job satisfaction, and potentially lower quality of care. In many
situations, it is very clear to all what needs to get done. Where organizations differ is in how they
do it. The examination of how an organization accomplishes its tasks often concerns the
organizations’ workflow.
In health care, as in other industries, some workflows are designed, while others arise
organically and evolve. The systems and methods by which organizations accomplish specific
goals differ dramatically. Some organizational workflows seem more straightforward than
others. Most often, when workflow processes are looked at in isolation, the processes appear
quite logical (and even efficient) in acting to accomplish the end goal. It is in the interaction
among the processes that complexities arise. Some of these interactions hide conflicts in the
priorities of different roles in an organization, for example, what the nursing team is accountable
to versus the physician team and its schedule. Organizations also adapt workflows to suit the
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
evolving environment. Over time, reflecting on organizational workflows may show that some
processes are no longer necessary, or can be updated and optimized.
Research Evidence
Health services researchers have explored workflow issues from several angles, including
mapping processes from other industries into health care. Literature about workflow can be
found in several different domains, such as quality improvement, technology implementation,
and process improvements. One common thread throughout the literature is the importance of
interdisciplinary involvement in all aspects of workflow analysis and implementation.
Reviewing the evidence to date, targeted studies of particular interventions and technologies
amply show that good workflow design has significant (expected and unexpected) impacts on
2
Workflow
care delivery.3 The literature also demonstrates a relative lack of sophistication in studies of the
field: whether researchers are initially concerned with the problem or whether it arises
organically from the results; whether the researchers have a theoretical framework to interpret
their findings; whether there is consistency in the outcomes of interest; whether the target(s) of
study are structural, cultural, and/or functional; and whether the researchers are able to
generalize from the findings in one setting to another. Many studies demonstrated significant
benefit from careful consideration of workflow, but few studies provided easily adaptable tools
and methods for immediate, consistent implementation.
Effect on Efficiency
Workflow analysis has often been used with the goal of improving efficiency. In response to
financial pressure and incentives driving provider organizations, minimizing slack time has
become important. Some of the studies discussed below demonstrated the power of analyzing
and changing workflow to improve efficiency.
Workflow analysis can be used to redesign existing processes. A classic study of this type is
Cendan and Good's4 analysis of the routine tasks of the various members of the operating room
(OR) team. They found that there was a wide variability in functions based on clinical and
organizational factors. They designed a new workflow based on the analysis and conducted a
pilot study. Part of their recommended solution involved defining functions in a more consistent
fashion. They were able to improve turnover and improve the mean number of cases handled in a
day. A significant factor in their success was their consideration of workflow from both the
physician and the nursing perspectives.
Efficiency can also be improved by carrying out processes in parallel, rather than improving
the efficiency of existing steps.5 Friedman and colleagues6 compared the impact of administering
anesthesia in the induction room versus in the OR for hernia repair patients. They found that the
OR time used by the surgeon decreased without significant impacts on patient satisfaction or
outcomes.6 Harders and colleagues7 employed a combination of approaches. They used parallel
processing and process redesign to improve workflow in a tertiary care center with multiple OR
suites. This combination of approaches allowed for a reduction in nonoperative time. Similarly,
in a study of trauma teams, Driscoll and Vincent8 modified task allocation so that standard tasks
performed during a trauma code were conducted in parallel rather than sequentially.
In each of these approaches, role definition played a critical role in the success of the efforts.
Each study found that nursing routines often included nonclinical tasks, such as tracking down
missing information or supplies.9 By defining roles and essential processes, it was possible to use
ancillary staff for these tasks. In order for the redesign to be successful, nursing involvement was
important from the beginning. An interdisciplinary approach provided the basis for the workflow
analysis and redesign; this was cited as a success factor in multiple studies.4, 6, 7
Common Issues
Workflow issues often arise in studies of technology. One well-studied domain area is
barcode medication administration (BCMA).10 BCMA is a technology that has been shown to
improve care quality by reducing reliance on memory, increasing access to information, and
increasing compliance with best practice. However, very simple inconveniences—such as the
need to access a patients’ wrist for the barcode strip—have led to workflow workarounds, such
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
as scanning barcodes off a key ring rather than the patient. In this case, the nurses’ adaptation to
make their work more efficient circumvents some of the intended benefits of the defined process.
More complex interactions have also been observed. Because many BCMA systems require
that the physician enter an order before the nurse can have access to the medication, some nurses
have, in critical situations, “borrowed” medication from one patient on the ward to give to
another until the medication for the second patient appears in the system. As a result, the nurse
cannot readily document the administration of the order until the order has been entered by the
physician. In some situations, a shadow system of informal paper documentation supplements,
duplicates, or confuses the documentation captured in an electronic system.
When technology does not adequately support the goals of the care team, it often causes
workaround workflows. These alternate workflows are a cause for concern because these
informal, evolutionary systems rely on the clinicians’ memories, and bypass decision-support
safeguards that the system may provide. Studies have documented other negative effects,11 such
as degraded coordination between nurses and physicians, nurses dropping activities during busy
periods, and decreased ability to deviate from routine sequences.
Information Transfer
Health care organizations provide valuable services that rely on large amounts of high quality
information. Information transfer is complicated because caring for one patient can involve many
providers and information sources. Thus, many errors occur at handoff or transition points.12
Dykes and colleagues13 found that many hospitals in the United States have dual paper and
electronic records, leading to redundancies and inefficiencies in information. Other information
tools include proprietary paper forms, the phone, the electronic record system, the whiteboard,
the pager, and schedules.14 In addition, informal meetings and verbal orders frequently also serve
as information transfer devices.15
One attempt to address this complexity is an electronic portal that provides access to systems
through one interface.16 Though this can mitigate the problem, it cannot fully address the
communication needs of a care team.
A common class of problems with information transfer and handoffs includes degradation of
information.17 If methods of transfer are informal and not documented, patient information may
not be passed on when staff members leave a unit. In addition, the lines of responsibility and
expectations are not always clear.17 Incorporating formalized information transfer tools and
protocols into workflow processes may help. Another problem complicating information transfer
is interruptions. These interruptions often cause a break in workflow, which can impact what
information is documented and passed on.18, 19
4
Workflow
Lamond23 reviewed the content of nursing intershift reports and found that more information
was documented in the patient notes than was given in the report. The report information tended
to be more overall assessments of patient care, which was not necessarily documented. Thus, it is
not clear if the detailed information was transferred in subsequent reports. Perrott24 found that
customizing data fields and having nurses involved from the beginning enhanced nursing
handoffs in the intensive care unit (ICU).
By understanding nursing workflow, barriers and facilitators for information transfer can be
discussed and improved upon.25 If handoff mechanisms are informal, then they might not be
documented in a workflow analysis.26 Health IT systems should not replace these handoffs, but
could be used to augment the process.27 However, when the processes are not well understood,
the technology may not be used and may even be a burden.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
system could also be accessed by other professionals.34 However, communication lines tend to
be separate and dependent on professionals, so it is not clear how much intraprofessional access
occurs. Patterson and colleagues35 studied handoff strategies in other industries and outlined
some common strategies for effective handoffs. Often, documentation was a supplement to the
handoff, rather than the sole mechanism for information transfer.
6
Workflow
Payne45 found that implementing CPOE had a profound impact on work patterns,
communication methods and roles. In analyzing workflow around electronic prescribing, the
range of tasks completed by the nonprescribers was outlined.46 After outlining the work
processes and information flows, they were able to adapt the system to accommodate the
necessary tasks. Similarly, Wright and colleagues47 found that physician-nurse communications
were impacted by the CPOE implementation. Paper-based order entry often relies on visual cues,
such as a folded piece of paper. If the loss of context and visual cues is not accounted for in the
CPOE implementation, then the nursing workflow is adversely impacted because of the
uncertainty around orders.
Piasecki and colleagues48 conducted a workflow analysis to look at the benefits of
implementing CPOE in an emergency department setting. These researchers developed a return-
on-investment tool to measure the outcomes of the implementation and found that many of the
savings did not make a direct impact on the bottom line of the organization. This was, in part,
because the changes in workflow were not fully understood until after implementation.
Though guidelines for analyzing workflow are few, the common factor was consideration of
all affected roles in the organization, not only those involved with entering data into the IT
system. Breslin and colleagues49 found that having an interdisciplinary team was important in the
success of a Vocera implementation. This team included clinical and nonclinical staff. By being
inclusive, they learned about workflow from a variety of perspectives and were able to
implement their tool in a fashion that would improve upon existing practices.
Practice Implications
The research findings for these studies of operational workflows have practice implications
for nurses and researchers. Throughout the literature, the importance of bringing multiple parties
to the table was emphasized. Because organizational workflows often cross the lines of
professional disciplines, workflow design from any single perspective runs the risk of sub-
optimizing against other constraints, priorities, and schedules.
Conscious workflow design has been shown to improve the efficiency of existing work
processes or enable parallelization of work. In designing such systems, researchers emphasize
the importance of clearly defining roles and responsibilities, preferably with multi-disciplinary
input. Designing workflow is of critical importance to all roles in a health care organization,
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
because the effects of decisions by an expert in one role may have downstream effects on others.
A workflow optimized to serve one role, such as the nurse, can be onerous or seem irrational to
another. Because each professional role deals with fairly complex, role-specific work processes,
it is often difficult for experts in one role to understand and envision how proposals will affect
other roles, even with the best intentions. Research on information transfer in organizational
settings demonstrates that adaptations to poor workflows can lead to increased interruptions,
workarounds, and informal or ill-defined communication. To improve the reliability of
workflows accomplishing their desired goals, and to reduce the risk to patient safety, researchers
recommend structured communications and clear agreements about roles and responsibilities in a
hand-off.
Health IT systems surface many of the long-standing issues around workflow. The
implementation of health IT systems can, at first glance, seem like a superficial intrusion into the
way things are done. For some, it feels like the addition of another documentation step in the
process of regular clinical care. This step can be disruptive and a burden, but it does not
dramatically change the way work is done. Yet there are many downstream effects on
communication and coordination within an organization. Analyzing workflow beforehand can
help prevent some of these unintended consequences. Technology does not necessarily improve
institutional efficiencies, but can bring opportunities for improvement to light.42 Sittig and
colleagues38 found that while considering that technology was important, it was also important to
consider organizational and workflow factors prior to implementation, or the benefits may not be
realized. In order to realize good outcomes, interdisciplinary consideration of process and
technology factors was important.57
In many organizations, the adoption of health IT is motivated by the desire to accomplish
goals that are difficult without a structured electronic system. These goals include reducing
medication errors through barcoding; improving clinical decisionmaking through decision
support, such as alerts and reminders; measuring clinical quality performance; proactively
reaching out to patients for population health management; or simply the ability to analyze
clinical information, for example, by charting a patients’ blood pressure based on nursing notes.
These additional expectations of a health IT system mean that the organization can expect
dramatic changes in workflow—the health IT implementation is a vehicle to trigger larger
improvement activities.
It is important to realize that health IT systems have a built-in sense of how things are done,
in fact, have an inherent workflow that may or may not map to the organizations’ workflow.
Consider the case of CPOE. Let’s describe the workflow process as a series of tasks, linked
chronologically, that require organizational resources. The logical model within a health IT
system usually goes something like this:
1. The provider enters an order.
2. The pharmacist verifies the order.
3. The order is delivered to the point of care.
4. The nurse administers the order.
There are two things to note about this perfectly reasonable assumption about how things are
done. The first is that the workflow is very linear. It will be very important to understand what
happens if that linearity is disrupted somehow. For example, if the pharmacist fails to verify the
order, will the system prevent the order from being “released” until this step is accomplished?
Flexibility within a linear workflow is very important to the smooth operation of a complex
service organization like a health care institution. Practitioners have a responsibility to check that
8
Workflow
a health IT system reacts gracefully to a change in workflow, lest patient care be compromised.
The second thing to note is that the workflow within the system only reflects one of the ways
health care is delivered in an organization. In many critical care settings, for example,
medications must be administered quickly, before any interaction with a CPOE system.
Practitioners should also ask whether the health IT systems they are implementing reflect all of
the main workflow processes within their organization.
When a new health IT system or a new technology fails to accommodate the real workflows
of an organization, interacting with the technology becomes a greater burden on the organization
than is required. In essence, there is “the way the world works” and then “the way the computer
thinks the world works,” and it is the constant responsibility of system users to reconcile the two
world views. In fact, implementing health IT systems within organizations poses such a
challenge that the Office of the National Coordinator for Health IT has estimated that as many as
30 percent of all implementations fail.58 Thoughtfully constructing the workflow inherent to the
technology can smooth technology acceptance.59, 60
Before implementing information technology in a health care environment, it is important to
have an understanding of processes and information flows. In addition, it is important to consider
various roles in the different departments, and to consider ideas from multiple sources.22 Each
department and role may have a different perspective of the encounter and its necessary
elements.36, 61 In addition, many organizations have a variety of tacit assumptions and
information exchanges which might not be documented in a traditional analysis. Thus, it is
important to consider multiple sources of data in order to develop a more complete
understanding of workflow and processes.36
In the United States, hospitals are generally organized by functions. Because of that,
workflow is also organized around these functions. Information systems were developed around
these functions and were designed to meet the needs of a particular department. However, patient
care takes place through a broader perspective. Thus, these functions need to be integrated.20 In
conducting a workflow assessment, it is important to consider how workflow currently functions
and how it might change to improve patient care and reduce errors throughout the system.20, 62 In
addition, this kind of analysis can help find flaws in the process for which information
technology can be leveraged.20
The truth is that many care teams do well even when workflow processes are designed
poorly. Health care practitioners understand the clinical needs of patients. Health care workers
often go to heroic lengths to make sure that the right thing gets done. When a problem arises,
most clinicians would not hesitate to pick up the phone, run the errand, or do what is necessary to
insure good care. Yet clinician resources are not unlimited. When nurses, like all people, get
tired, they may become forgetful When they are rushed, they may not remember to do everything
necessary.63 These issues may be exacerbated by a health IT system that seems not to understand
what the clinicians want to do—sometimes because the workflows in the health IT system do not
match those in the real organization. In the seminal work on clinical error, the health care
community acknowledged that most errors are the result of systematic deficiencies.64 Good
workflow processes are an aid to practitioners to insure that the system behaves to support high
quality care. Nurse informaticists can work with their counterparts to apply some of the
principles found in the literature to practice.
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Implications
Workflow design is a difficult endeavor because of the complexity of most health care
organizations and the division of labor into expert roles. Health care organizations are service
organizations that are very flexible and interdependent in response to dynamic patient needs. For
many work processes, the established workflow evolved over time in response to the kind of
tasks and resources available, and were not explicitly considered or designed. Changes to
organizational workflow are an opportunity to think through how the care team can provide good
patient care reliably under a variety of circumstances.
Research on workflow issues can be very rewarding because of its closeness to real-world
operational challenges. Study participants often experience a high level of frustration with their
current situation, and are eager to have assistance in thinking through complex organizational
effects. The research often starts with a theoretical model that helps define the problem space,
such as conceptualizing the structure, process, and outcomes65 or the tasks, actors, and
information.66 The model can be made operational through computer modeling, and used to
represent particular problems.
In support of workflow design activities, computer simulation tools have been developed to
help decisionmakers map their organizational roles and understand the impact of different
workflow choices.67-69 Models of workflow processes show the trajectories of the care providers,
patients, and information. By representing workflow in a manner which is easily accessible to
others, managers and researchers can identify where issues are likely to arise and develop tools
to prevent them. Modeling workflow also usefully defines roles and delineates how the care team
understands its job functions and work processes
For health IT, workflow design is especially difficult because many of the assumptions about
workflow are implicit. The designers of IT systems benefit from conversations with their users to
understand how clinical care is provided in the organization. Without the input of users, it is
tempting to apply the same workflows to different organizations. Many issues can be easily
resolved through small changes in user interface or clinical decision support rules—changes that
are very difficult to predict in advance. Although some issues can be resolved through
customizing the health IT system, others are more intractable. The health IT system may simply
reveal latent problems with the old workflow. As more organizations embark on large-scale
health IT implementations, a scalable method for incorporating workflow considerations is
urgently needed, so that new health IT systems do not cause harm.70 When issues have been
surfaced, through conversations, observation, modeling, and other methods, researchers have the
opportunity to bring to bear established quality improvement methods to workflow design.
Studies to date have relied on ad-hoc methods to effect improvement after studying workflow,
and there are opportunities to apply structured methods to assist an organization in responding to
workflow discoveries.
Many of the research articles reviewed involved a descriptive case study. Some studies
utilized a grounded theory approach. Few articles utilized a conceptual framework to frame the
results. While research on service organizations has been applied to health care organizations,
much work remains to be done in delineating how health care work differs from other industries,
in particular to understand whether results from inquiries in other fields, such as manufacturing,
can be generalized to health care. In addition, there is a need for research to demonstrate a link
between performance indicators and workflow.71 Nurse researchers have an opportunity to take
the research that has been done to date and apply it on a broader scale. Much of the work that has
10
Workflow
been done outlines specific implementation efforts or describes a single department. By taking a
systems approach to organizational workflow, coordination of patient care throughout the
trajectory of their stay can be improved.
Search Strategy
The search for workflow issues in delivering high quality nursing care is complicated
because workflow, by its nature, touches on many organizational issues and roles. Literature that
identifies specific problems in patient safety may allude to their greater systemic workflow
causes or effects. Even literature that specifically considers workflow may limit the analysis to
one organizational role. Thus, our literature search did not attempt to be a comprehensive search
of literature published on workflow, but rather a scan of areas in the medical and nursing
literature where relevant publications are likely to appear. There is also a longer history of
research literature in other fields, notably industrial engineering and management.
We looked at MEDLINE® and CINAHL® articles published in English. Because workflow is
not a standardized term in either database, we searched it as a keyword in its various
permutations. We did the same with handoffs, as we knew that this was a common study topic
where workflow issues surface. In addition, we did searches using combinations of related terms
in each database. The terms we used were in categories dealing with continuity of care, care
teams, information needs, information systems, and patient safety. We found that the keyword
search yielded more consistent information than the standardized terms, in part because the terms
were developed with specific purposes in mind. Studies of workflow are still fairly new, and it is
hoped that as the field matures, it will be easier to identify a unique body of work.
Author Affiliations
Carol H. Cain, Ph.D., practice leader, Incubation. Care Management Institute, Kaiser
Permanente. E-mail: [email protected].
Saira Haque, M.H.S.A., doctoral candidate at Syracuse University, School of Information
Studies. E-mail: [email protected].
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2. Laxmisan A, Hakimzada F, Sayan OR, et al. The 5. Sandberg WS, Daily B, Egan M, et al. Deliberate
multitasking clinician: decision-making and cognitive perioperative systems design improves operating
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15
Evidence Table
Ammenwerth User acceptance Pretest and post- Questionnaire: Nurses on four Questionnaire Previous acceptance of the nursing
73
2003 test 3 months before wards of a process and the previous amount of self
system hospital in confidence are two important factors
implementation, 3 Germany influencing acceptance of a new
months after, 9 computer based documentation system;
months after consider fit between nursing workflow
and functionality of system; some wards
adapted system to their needs and
others did not; some felt that it shows
what they do all day
16
Bahlman Workflow; OR; Pretest and Post- Reviewed OR Changed workflow Needed to review workflow processes
60
2005 Information test workflow processes first; figured out ideal systems and tried
transfer; processes for to have technology match them
Implementation redesign
Banet 200644 Workflow; ED; Pretest and Post- Looked at ER staff CPOE Nurse perception of effective use of
Information test implementation of implementation design is needed for successful
transfer; CPOE in ER and implementation of information system
implementation nurse perceptions changes; introducing CPOE into
workflow is complicated; documentation
time might not change
Bigelow Workflow; Pretest and Post- Case study Hospital Placed standards New format allows for changes in
75
2006 Standards test system in an accessible workflow because standards can be
document looked up from multiple locations.
repository reducing time spent searching for
information
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
Bowcutt Interprofessional Unpublished Roundtable NA NA Systems can enhance workflows, but
200329 communication; research discussion they need to meet user needs; there's
Information more information to sort through; data is
transfer not streamlined enough; if physicians
don't want to do CPOE, the nurse
suffers; clinical staff need to know that
their documentation impacts others'
workflow
Braswell Implementation Pretest and Post- Reviewed Nursing unit Added mobile Better teamwork with pharmacy;
200640 test workflow and time cabinets with improvement on workflow; better
spent before and barscanning for documentation because of bar scanning
after medications
implementation
Breslin 200449 Implementation Case–control Observation; Staff within Implemented Having the technology saved time; less
study, Pretest Documented units in a Vocera and overhead paging, more efficient
and post-test communication hospital in compared units workflow; time savings
17
Brixey 200619 Workflow; Noncomparative Observation; RNs and MDs NA Categorized activities and interruptions
Interruptions study Ethnography at a level 1 for doctors and nurses; layout can
trauma center cause break in workflow; unavailable
supplies or information can cause
interruptions; technologies can
contribute to more interruptions
Workflow
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Cendan 20064 Change; Pretest and Post- Analyzed and OR staff of a Workflow diagrams Turnover improved and the mean
Workflow; OR test improved tertiary care were redrawn; number of cases improved; looked at
workflow center critical moments interdisciplinary patterns
were identified
Chan 200678 Workflow; Pretest and Post- Interviews Nursing staff Changed nursing Some nursing work is formulated in a
Efficiency test delivery model task-oriented assembly-line approach;
allocate work assignments based on
skills; some routine activities are not
formalized
Christakis Continuity; Cross-sectional Survey Parents of Cross-sectional Importance of continuity of care to
79
2003 Information study patients at a survey of patients' promote coordination; greater objective
transfer pediatric clinic families compared measure of coordination was associated
who received to organizational with improved perceptions of care
care at multiple measures coordination; consistent provider contact
sites is associated with improved care
coordination
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
Clegg 200680 Workflow, Pretest and Post- Implementation of Elderly Implemented the Improved documentation helped with
Efficiency; test a single population in new process and sharing information; changed workflow
information assessment the UK changed workflow helped to make this information
transfer; process for elderly to enhance available to those who needed it,
Interprofessional patients information reducing redundant questioning of
communication transfer patient
Cunliffe Discharge; Noncomparative Description of Hospital in UK Developed a Communication and coordination help
200333 Communication; study rationale and standardized, with discharge planning; could be
Coordination processes for structured formal applied to other aspects of care;
developing a discharge information tools can be used for
nursing discharge summary multiple purposes
summary
19
Driscoll 19928 Coordination; Pretest and Post- Observation, Trauma teams Organizational When the structure of trauma team
Team structure test Survey in Hospitals changes were changed, complexity and distribution of
made during individual tasks came to light; hard to
resuscitations - get team members to work
task allocation and simultaneously; old habits occasionally
horizontal team recurred
organization
Dykes 200613 Information Pretest and Post- Survey, Interviews Health care Survey by HIMSS 95% of respondents had dual paper and
technology; test professionals nursing informatics electronic systems; nurses
Interprofessional in acute task force communicate and coordinate about care
communication settings both formally and informally; IT does not
reduce clinical thinking
Egan 200616 Information Noncomparative Reviewed a ICU and OR Determined who A dashboard with the data nurses need
transfer study dashboard of staff looks at what could help synthesize information,
relevant patient information and at across hospitals and within
information what stage of the departments; information availability can
process transform workflow; real-time data
Workflow
flowing from disparate devices into a
single interactive display
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Friedman Change; Case–control Reviewed time Patients Case group has Time decreased in case group; patient
6
2006 Workflow; OR study and workflow of undergoing anesthesia in the satisfaction similar; outcomes didn't
group with hernia repairs OR at the start of change; OR time used by the surgeon
standard versus under local surgery; control decreased by 1/3; roles were redefined
parallel anesthesia group had local and team cohesiveness improved
processing anesthesia in the
induction room
during turnover
time
Ghosh 200643 CPOE; Noncomparative Interviews, focus Chief Nursing How nurses impact Nurses are a primary success factor in
20
Implementation; study groups Officers and are impacted CPOE implementation; they have a
Interprofessional by CPOE critical role in communication,
communication coordination and knowledge sharing;
understanding communication
processes is key to CPOE
implementation
Guite 200622 Change; Pretest and Post- Ethnography, Level 1 trauma Documented each Use IT to help redesign process; found
Workflow; test interviews, center step of the current considerable duplicate documentation;
Implementation process modeling process with people have to spend time reconciling
detailed flow info; Consider a standardized language
diagrams; looked for shared data elements; need to
for opportunities integrate with workflow of various
for improvement departments
and implemented a
new process
Gurses 200614 Information Noncomparative Ethnography Case Information tools Information tools: bed management
transfer; study managers at a and processes bundle, phone, EMR, whiteboard, text
Coordination level 1 trauma pager, schedule
center
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
Gulliford Continuity; Unpublished Discussion NA NA Integration, coordination and sharing of
200683 Information research information across providers is
transfer important; need to think about patient
and provider perspective; continuity has
a relational, management and
informational component over time
Harders 20067 Change; Pretest and Post- Analyzed current OR in tertiary Redesigned Reduction in nonoperative time; roles
Workflow; OR test and new workflow care workflow were redesigned; need to think about
entire process with all team members
implementation
Joint Handoffs Unpublished Discussion of Handoffs aren't just between
Commission research JCAHO departments, can also be within a given
200584 expectations of department; need to discuss barriers
handoffs and facilitators for communication and
obtain team involvement
King 200485 IT; Workflow Unpublished Discussion NA NA Challenge to develop systems to satisfy
research multiple caregivers; think through
information needs and activities across
departments
Kinney 200762 IT; Workflow Unpublished Discussion NA NA Need to understand workflow of current
research system before implementing IT or
technology created new problems and
unearths existing ones
Kirkley 200359 Workflow Noncomparative Description Nursing NA IT can help streamline processes;
study implement IT as part of a larger effort to
reorganize workflow and processes;
Understanding goals; system should
Workflow
think like a nurse thinks
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
LaPenotiere Workflow; Changing Triage process Triage; ED ED expansion built Workflow changes described
61
2004 Process redesign practice design to fit desired
processes.
86
Lium 2006 Workflow Cross-sectional Survey Hospital Frequency of EMR Nurses reported more EMR use when
study use they changed their routine; clinicians
need to figure out how to include the
22
Lykowski CPOE; Workflow Noncomparative Description of Hospital Multidisciplinary team involvement and
200457 study CPOE incorporating process and technology
implementation led to good outcomes
process
Malhotra Workflow; Noncomparative Interviews and ICU in U.S. Completed models Communication, coordination,
200769 Modeling; ICU study observations to at various levels information needed; developed a model
document process of workflows in an ICU
and information
flows in ICU
Manias 200187 Rounds; Roles Noncomparative Ethnographic Critical care Description of Doctors use nurses to supplement
study study of 6 RNs; unit of a process information and provide extra details
Participant hospital in about patients; nurses discussed
observation, Australia nursing knowledge during shift change
journals,
interviews, focus
groups
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
McKnight Information Cross-sectional Surveys, focus Hospital Semi-structured Information needs and communications
200228 transfer; study groups survey about difficulties are common and can lead to
Interprofessional perceptions of errors; problems cited were difficulty in
communication information needs finding information, finding inaccurate or
and outdated information, limited time, not
communication knowing the system; difficulty in
difficulties; focus identifying and contacting other health
groups with care providers; limited time to lookup
physician and information; nurses mentioned patient
nurses education materials; physicians talked
about paging, inconsistent
communication at transfer of patient
care; need feedback on order status,
face to face communication where
mistrust or disagreement on care plans;
lack of communication leads to errors or
near-misses; people want to improve
their own efficiency without thinking of
23
system efficiency
Mekhjian CPOE; Workflow; Case–control Rapid system Inpatient units; Implemented Process breakdowns such as patient
200242 Implementation study evaluation; time academic CPOE on some safety issues, workflow interruptions and
and motion study; medical center; units inefficiencies; Technology may not
comparison of necessarily improve institutional
data between efficiency; incorporate safeguards for
areas with errors and interruptions; cultural change
differential needs to be considered
implementation of
systems
Workflow
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Payne 199945 CPOE; Noncomparative Description of first Hospital CPOE Implementing CPOE changed work
Implementation; study three months post implementation patterns, communication, roles
Interprofessional implementation
communication
Perrott 200424 Workflow; Noncomparative Ethnography, ICU nurses Nursing handovers Customization of data sets; nursing
Medication study Document review, in an ICU education; nurse involvement in
Interviews installation (from vendor and
organization) were all success factors
Philpin 200615 Information Unpublished Discussion of NA NA Nurses work with a number of other
transfer; ICU; research nursing role occupation groups; constant flow of
Interprofessional other people moving in and out;
communication discovered separate charts for
observations and recording of nursing
work; different providers have different
documentation requirements, which may
differ from organizational requirements
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
Piasecki CPOE Changing Review workflow Emergency CPOE Worked with business school to develop
200548 practice to determine time Department implementation a ROI tool to measure outcomes of
and FTE savings technology implementation; analyzed
before and after workflow before and after
CPOE implementation and found savings in
implementation time and money
Plsek 199936 Change; Unpublished Focus groups Clinical and NA Use a high-level flow chart to show a
Workflow research support staff of typical visit, but need to consider
a different perspectives; need to mentally
multispeciality escape from traditional rules of
clinic workflow; can use technology to help
with workflow and change how things
are done
Powell 200617 Information Unpublished Discussion about Problems identified: accountability of
transfer; research improving transition, transfer of information,
Handoffs; handoffs responsibility when communicating to
25
Price 200091 Workflow; Safety Literature review Discussion NA NA Problem based learning is done in the
classroom, but should be done on the
floor as part of workflow; need to think
about issues of patient safety and
competing demands on time
Workflow
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Riley 200631 Interprofessional Noncomparative Observational OR nurses Evaluated how Practices found: questioning judgment
communication; study fieldwork; they dealt with and timing, controlling speed, estimating
Information Individual and each other and surgeons' use of time, coping with
transfer group interviews physicians with different perceptions of time; knowledge
using 11 nurse respect to time and of individual surgeons was a source of
26
Sandberg Process redesign; Cross-sectional Analyzed current OR Staff Redesigned OR Changed the process to include parallel
5
2005 OR study workflow; activities and reorganized the space;
changed and improved throughput in the redesigned
evaluated new OR
workflow
Sandberg Change; Pretest and Post- Looked at Ambulatory Implementation of PACU nurses indicated that their
92
2006 Workflow, OR test recovery room laparascopic a pathway workload increased, but the data did not
flow sheets, time, chole- support that conclusion; data looked at
and nursing effort cystectomy interventions such as pain meds and iv
required patients fluids - but is not necessarily an
accurate capture of nursing workload
Scharnhorst Implementation; Noncomparative Workflow analysis Nursing staff Implementation of Collecting nursing data can help to
200339 Workflow study and usability handhelds define and articulate the role of nurses
testing in health care; handhelds can help with
reduction of redundancies
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Measures Population
Shefter 200693 Workflow; Unpublished Discussion Case Introduction of Workflow technology tools can help or
Implementation research management workflow tools hinder case management; integrate
patient level and organizational level
data to help with workflow; information
tools (databases, records) and workflow
tools can help with linkages; need to
consider not just training but ongoing
support
Sittig 200638 CPOE; Noncomparative Discussion of NA NA Need to consider related organizational
Medication; study CPOE and workflow factors (not just
Implementation implementation technology); CPOE and IT efforts can
alter workflow processes; we could
share experiences in an M&M format;
use opportunity to develop better
systems
Spear 200520 Change; Noncomparative Multiple case Hospitals NA Hospital care is organized around
Workflow study studies to functions, but there is not a reliable way
27
Stahl 200694 Change; Noncomparative Redesigned OR Suite Redesigned Increased patient throughput; added an
Workflow, OR study systems before processes additional nurse; considered multiple
making a new OR emphasizing disciplines and roles
parallel
processing; added
staff
Strople 200627 Information Noncomparative Reviewed shift Nursing staff at Analyzed content Use of electronic systems as an adjunct
transfer study report content, hospitals to the shift report can contribute to
Workflow
format and media patient care
Source Issue Related to Design Type Study Design Study Setting Study Key Findings
Practice and Outcome and Intervention
Waring 20069 Workflow; OR; Noncomparative Ethnography, OR in the UK; Analyzed routines Nursing staff often spent time
Information study Interviews Teaching and patterns of coordinating supplies, missing items,
transfer; hospital work; did some figuring out where the patient goes next;
Interprofessional interviews; looked each department seemed to be its own
communications at different roles hub with spokes going out to other
28
Wright 200695 CPOE Noncomparative Reviewed Hospitals CPOE CPOE impacts MD-nurse
study processes and implementation communications; found in
communications implementation that significant workflow
changes would be required; loss of
visual cues or physical presence to give
contextual information about orders;
paper reports are not accurate; people
know about order processes in their own
departments but not how it works
elsewhere or downstream impacts
* IT = information technology; EHR = electronic health record; EMR = electronic medical record; OR = operating room; ED = emergency department; CPOE = computerized
provider order entry; ICU = intensive care unit; RN = registered nurse; MD = physician; HIMSS = Health Information and Management Systems Society.
Chapter 32. Professional Communication
Jean Ann Seago
Background
Instructing nurses on communication is a bit like instructing birds on flying. All nurses have
been taught communication skills as a basic part of a prelicensure nursing program and then
retaught communication skills in postlicensure programs, continuing education programs,
workshops, and meetings. Some nurses would be insulted that anyone would even raise the issue
of communication since raising the issue implies that they are deficient in one of the most basic
aspects of nursing care. However, the problem with good communication is that it is, ironically,
easy to talk about but hard to put into practice. In the literature, there are numerous articles that
provide opinion, both expert and otherwise, about communication,1–7 but there is very little
evidence about communication practices that have demonstrated an impact upon patient
outcomes. The purposes of this chapter are to discuss evidence of professional communication
practices or strategies that have been tested empirically and have a relationship with patient
outcomes or patient safety, and to provide communication tools that might help practicing nurses
maintain and improve patient outcomes and patient safety.
This chapter will focus on communication strategies in hospitals and those related to
communication between nurses and physicians. Studies related to communication between
physicians and patients or nurses and patients were included if they were determined to be
sufficiently methodologically rigorous and had a direct relationship with patient outcomes or
patient safety. There is a large body of research on communication in other health care settings
and among other professionals, which was not included in this chapter.
Historical Context
The history of communication between doctors and nurses is well documented. A series of
publications begun in 1967 describing the “doctor-nurse game” provides insight into the way
nurses have historically made treatment recommendations to doctors without appearing to do so,
the way doctors have historically asked nurses for recommendations without appearing to do so,
and how both participants strive to avoid open disagreement.8–27 Although some nurses have
argued that much has changed—and improved—in the relationships between doctors and nurses
since that initial 1967 article, there is little evidence, although much wishful thinking, to support
that view.28–31 Additionally, over the years, the literature has contained descriptions of verbal
abuse of nurses by physicians,32–35 disruptive physician behavior,36, 37 and advice on how nurses
can better “handle” physicians.38–41 So, in spite of much discussion, communication between
doctors and nurses often remains contentious and obscure.
Theoretical Foundations
Many professional groups study communication among humans, and a wide range of theories
guides the work. For the purpose of this review, a sample of theories used to describe or study
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
nurse-physician communication will be presented in brief. Habermas’ critical theory has been
used to identify successful nurse-physician collaborative strategies, including a willingness to
move beyond basic information exchange and to challenge distortions and assumptions in the
relationships.42 Theories of Foucault and other poststructuralists that have guided concept
analysis of collaboration and explored the notion that the relationship between power and
knowledge (knowledge and power are not fixed, meaning not stable, and the idea that there is a
hidden or “real” discourse) help explain the relationships between nurses and doctors.43, 44
Various perspectives from the field of organizational behavior, including the structural (behavior
is rational) perspective, the human resource (human needs and motivation) perspective, the
political (competition for resources) perspective, and the cultural (organizational culture and
climate) perspective, have been used to guide activities to improve nurse-physician
communication.45
Feminists and scientists have used oppressed-group behavior theory to explain much of
nurses’ work and its structure in hospitals, including nurse-physician relationships.34, 46–54 Many
scientists and writers have evoked the issue of gender as it relates to the work of nurses and the
relationship between nurses and doctors. Early literature related to gender tends to emphasize
nurse image, and later work focuses more on nurse job satisfaction; job retention; and differences
in decisionmaking, attitudes, perceptions, and ethical or moral dilemmas.55–73 Mark and
colleagues argue for theory development related to nurse staffing and patient outcomes,
maintaining that one of the important and unexplored areas is the “why” of the nurse-physician
relationships and the hypothesis that “enhanced” nurse-physician communication would “result
in early recognition and intervention of potentially hazardous patient situations”74 (p. 13).
With the recent emphasis on patient safety, hospital error, and adverse events, some hospital
executives have embraced human factors science and training ideas taken from the aviation
industry (Crew Resource Management)75 to try to address the issue of patient safety and the lack
of collaboration or teamwork in hospital settings. One of the most intriguing recent ideas is the
use of the leader-member exchange theory76–88 to describe the interactions between nurses and
doctors in hospitals. Hughes and colleagues89, 90 used leader-member exchange theory to create a
nurse-physician exchange relationship scale and discussed the relationship between nurses and
doctors in terms of a supervisor-employee relationship. The physician can be thought of as being
the leader or supervisor of patient care, and the nurse can be thought of as being one of the
members or employees providing care. This conceptualization will undoubtedly be challenged by
nurses and nurse leaders who advocate for nurse autonomy or nurse independence, but Hughes
and colleagues make a compelling argument for viewing the hospital nurse-physician
relationship through this theoretical lens. There exists a long and varied history between nurses
and doctors, making it difficult to use only one theory to explain all the subtleties of the
relationships or to hold the key to improving those relationships.
Over the years, there have been repeated cries and admonitions for improving nurse-
physician communication and questioning why it is so difficult to achieve.1, 63, 91, 92 Some
research has shown that the lack of interpersonal and communication skills of physicians and
nurses is associated with errors, inefficiencies in the delivery of care, and frustration.93 There is
evidence, though conflicting, that links better collaboration with better patient outcomes,
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Professional Communication
Research Evidence
There is no shortage of manuscripts in the literature that advocate, based only on opinion, for
one or another method of building teamwork, collaboration, or communication, including
recognizing corporate culture,144 quality improvement,145 continuous assessment and regular
communication,146 and reducing conflict.147 Other publications detail the experience of one
institution or unit in improving communication or teamwork using strategies such as the
Comprehensive Unit-Based Safety Program developed at Hopkins,148 Surgical Morning
Meetings149 using daily goals in an intensive care unit,150 or interdisciplinary rounds.151 These
individual experience descriptions typically report varying outcomes or lack measured outcomes.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
This review found no randomized controlled trials (RCTs) that investigated communication
interventions between nurses and physicians that had a patient outcome as a measure of interest.
The RCTs included in the evidence table tested whether various communication training sessions
for physicians improved communication with patients.152–157 The evidence indicates that
communication training is effective in improving physician attitudes, beliefs, and communication
ability. There is also evidence that an intervention called peer leader education155 can result in
fewer symptom days, lower oral steroid rates, and reduced cost for children with asthma. In
general, longer training programs (2–3 days) had greater positive effects, and the effects were
longer lasting. Two RCTs tested the effect of training patients about care using information or
technology and found slight improvement in patient perceptions of care.158, 159
Four systematic literature reviews were found that evaluated aspects of communication. One
review of 14 studies measured the effect of communication training on physicians, using self-
rating of the training effects, but provided no evidence of a relationship between the training and
patient compliance or health status, and ambiguous effects on patient psychosocial health.160 The
second review of 26 studies concluded that various interventions had no effect on patient
expectations, had conflicting lung-function outcomes, improved systolic blood pressure with any
interaction, and decreased pain with improved patient-practitioner interaction.161 The third
review of 89 studies found no patient outcome changes (health status, disease incidence, cure
rates, mortality rates, complication rates) with implementation of interprofessional education
versus single-discipline education.162 The fourth review, covering two studies, concluded that
after communication training, team development meetings, or weekly rounds, there was no
difference in patient mortality rates; but staff satisfaction increased, and there were conflicting
results on length of stay.100
The literature search provided three nonrandomized controlled trials (NRCTs) with control
groups related to interventions aimed at improving effective communication.163–165 One study
described a communication training intervention, a second added personnel (nurse practitioners
and hospitalists) and multidisciplinary rounds to the environment, and the third used weekly
meetings to discuss role relationships. The first study improved hospital employee work
satisfaction and perception of opportunities and decreased information overload.163 The second
study improved physician perception of collaboration between nurses and doctors, but produced
no change in nurse perception of collaboration.164 The third study decreased consumers’ belief in
shared responsibility for care versus a physician-dominated responsibility for care, and increased
consumers’ belief that powerful individuals influence a consumer’s health status.165
Included in the evidence tables are seven quality improvement projects without a control or
comparison group. These projects are included as examples of the numerous studies in the
literature that essentially describe the experience of one or two institutions in implementing an
organizational change to improve doctor-nurse collaboration or communication. Dechairo-
Marino and colleagues166 report on a teamwork training program that produced no differences in
self-reported collaboration or satisfaction; McFerran and colleagues167 describe implementation
of a structured communication technique known as Situation-Background-Assessment-
Recommendation (SBAR), changing policies, debriefing, and multidisciplinary reports in four
Kaiser Permanente sites. No long-term measures are reported, and only the short-term
expectations for the “communication initiative” were met. Leonard and colleagues168 report on
4
Professional Communication
another Kaiser study of various groups in the organization trained in SBAR, assertion checklists,
and briefings. Reported outcomes associated with the intervention include reduced wrong-site
surgery, decreased nurse turnover, and improved employee satisfaction; however, no specifics on
the measurement of these outcomes are provided. Lassen and colleagues169 describe development
and education of a collaborative practice (primarily physician specialists) decisionmaking
protocol that was associated with a decrease in rule out sepsis diagnosis, use of antibiotics,
patient days, costs, and readmissions in one neonatal intensive care unit (NICU).
Dutton and colleagues170 reported that daily discharge multidisciplinary rounds were related
to decreased length of stay in the emergency department and emergency department closures in
one trauma center. Copnell and colleagues134 reported no difference in perception of doctor-
nurse collaboration after introduction of a nurse practitioner in two NICUs. Boyle4 reported an
increase in perceived doctor-nurse communication skills, nurse leadership skills, and problem-
solving, and a decrease in nurse stress after a six-module training session called Collaborative
Communication Intervention. The designs of these quality projects were too weak to allow any
sort of conclusions to be drawn.
Practice Implications
There is insufficient empirical evidence to recommend any specific communication strategy
or technology device to improve doctor-nurse communication. However, there is mixed or weak
evidence to support using some of the techniques described in the cited literature. It is likely that
focusing an organization on any strategy and persisting in that focus will be associated with, at
least temporarily, a change in doctor-nurse communication patterns (e.g., Hawthorne effect).
Given the paucity of available evidence, the following suggestions are offered for possible
consideration in efforts to improve professional communication:
• Carefully evaluate various strategies for doctor-nurse communication using measurable
outcomes that are important to your organization; plan to use a strategy that meets the
needs and culture of your organization.
• Select a strategy, focus training, and provide organizational support and sufficient
resources toward improving doctor-nurse communication.
• Slowly implement the change using sufficient resources and sufficient time.
• Do not implement multiple changes simultaneously.
• Persist in that strategy for an extended period of time (years, not weeks or months).
• Critically and rigorously evaluate the strategy using patient outcomes and worker
satisfaction.
• After allowing sufficient thought and time for implementation and evaluation, be willing
to publicly eliminate the strategy if it does not improve the outcomes.
Hospitals have used many communication tools such as written and verbal orders, reports,
rounds, and team meetings. As the United States shifted to the “business model” for hospitals,
organizations have tried to change culture or climate, create transformational leaders and
knowledge workers, implement continuous quality improvement or total quality management,
form quality circles, and train the one-minute manager. Some hospitals have used and are
currently using technology ranging from pencil and paper, medication rooms and carts, orange
vests for the medication nurse so she will have fewer interruptions, Pyxis or other automatic
medication dispensers, landline telephones, fax machines, beepers, e-mail, personal digital
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
assistants (PDAs), cellular telephones, wireless devices, direct information transfer, and Web
access.
Other recent technology includes mobile communication systems such as Vocera, electronic
medical records, computerized physician order entry, and bar-coding for medication
administration. A number of organizations are also trying SBAR, organizational support
structures such as Rapid Response Teams or techniques such as customer relationship
management from business or crew resource management from aviation. Other organizations are
trying systems such as Situation-Trajectory-Intent-Concern-Calibrate (STICC) using the Hands-
on Automated Nursing Data System Method from the University of Illinois at Chicago and
funded by AHRQ, or Gerontology Interdisciplinary Team Training from the Hartford Foundation
and the American Geriatrics Society. Few, if any, of these methods or devices have been
empirically tested. Without careful consideration and evaluation, efforts to improve
communication problems that exist in present-day hospitals may lead to implementation of
strategies that will be ineffective.
Research Implications
Based on the literature review, future research is needed to assess the following:
• What should be the communication competencies of physicians and nurses; and should
these competencies be assessed periodically?
• How can health information technologies be used to ensure effective communication
between physicians and nurses, across settings and among the various care delivery
models?
• What is the impact of effective communication strategies on hospitalized patient
outcomes and medical errors?
• What is the impact of effective communication strategies on nurse and physician job
satisfaction, and how does provider satisfaction relate to patient outcomes?
• How can communication skills training for practicing physicians and nurses have a
career-long impact on their communication skills?
Conclusion
Within health care, there have been and will continue to be many approaches to professional
communication. Unfortunately, the body of evidence is very limited, and the research findings to
support professional communication and the relationship with patient safety and quality are not
available at this time. There were limited studies that tested specific interventions aimed at
changing nurse-physician communication, and there is some evidence that focusing on a doctor-
nurse communication may have a positive effect. Health care organizations and providers will be
challenged as they seek to improve the effectiveness of professional communication, given all
the subtleties of the nurse-physician relationships.
Search Strategy
Search strategies employed included the use of the electronic databases PubMed®,
CINAHL®, the Cochrane Collection, and relevant AHRQ reports. Keywords included physician,
nurse, relationships, communication, coordination, collaboration, autonomy, teamwork, MD,
6
Professional Communication
RN, patient, outcome, safety, and adverse event. Reference lists of select publications were
investigated for potential manuscripts, and literature related to relevant measurement instruments
was sought.
Author Affiliation
Jean Ann Seago, Ph.D., R.N., associate professor, Department of Community Health
Systems, School of Nursing, University of California, San Francisco. E-mail:
[email protected].
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118. Watts RJ, Chmielewski C, Holland MT, et al. Nurse- 130. Goodman GR. How can nurses help patients work
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an exploratory study to assess what is said and what
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137. Pike AW. Moral outrage and moral discourse in 151. Halm MA, Gagner S, Goering M, et al.
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138. Patistea E, Vardaki Z. Clients' and nurses' 152. Jenkins V, Fallowfield L. Can communication skills
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153. Fallowfield L, Jenkins V, Farewell V, et al. Enduring
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154. Lozano P, Finkelstein JA, Carey VJ, et al. A multisite
140. Biancofiore G, Bindi ML, Romanelli AM, et al. randomized trial of the effects of physician education
Stress-inducing factors in ICUs: what liver transplant and organizational change in chronic-asthma care:
recipients experience and what caregivers perceive. health outcomes of the Pediatric Asthma Care Patient
Liver Transpl 2005;11:967-72. Outcomes Research Team II Study. Arch Pediatr
Adolesc Med 2004;158:875-83.
141. Florin J, Ehrenberg A, Ehnfors M. Patients' and
nurses' perceptions of nursing problems in an acute 155. Sullivan SD, Lee TA, Blough DK, et al. A multisite
care setting. J Adv Nurs 2005;51:140-9. randomized trial of the effects of physician education
and organizational change in chronic asthma care:
142. Mair FS, Goldstein P, May C, et al. Patient and cost-effectiveness analysis of the Pediatric Asthma
provider perspectives on home telecare: preliminary Care Patient Outcomes Research Team II (PAC-
results from a randomized controlled trial. J Telemed PORT II). Arch Pediatr Adolesc Med 2005;159:428-
Telecare 2005;11 Suppl 1:95-7. 34.
143. Young WB, Minnick AF, Marcantonio R. How wide 156. Levinson W, Roter D. The effects of two continuing
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patient and nurse perceptions of important aspects of of practicing primary care physicians. J Gen Intern
patient care. J Nurs Adm 1996;26:15-20. Med 1993;8:318-24.
144. Spicer J. Building teamwork by recognizing 157. Joos SK, Hickam DH, Gordon GH, et al. Effects of a
corporate cultures in the hospital. Trustee physician communication intervention on patient care
1991;44:14-5. outcomes. J Gen Intern Med 1996;11:147-55.
145. Eubanks P. Quality improvement key to changing 158. Tran TP, Schutte WP, Muelleman RL, et al.
nurse-MD relations. Hospitals 1991;65. Provision of clinically based information improves
patients' perceived length of stay and satisfaction
146. Blair PD. Continuous assessment and regular with EP. Am J Emerg Med 2002;20:506-9.
communication foster patient safety. Nurs Manage
2003;34:22-3, 60. 159. Ellison L, Pinto P, Kim F, et al. Telerounding and
patient satisfaction after surgery. J Am Coll Surg
147. Iacono M. Conflict, communication, and 2004;199:523-30.
collaboration: Improving interactions between nurses
and physicians. J Perianesth Nurs 2003;18:42-6. 160. Hulsman RL, Ros WJ, Winnubst JA, et al. Teaching
clinically experienced physicians communication
148. Ball M. Culture of safety. Advances for Nurses skills: a review of evaluation studies. Med Educ
2005;7:34-6. 1999;33:655-68.
149. Aston J, Shi E, Bullot H, et al. Qualitative evaluation 161. Di Blasi Z, Harkness E, Ernst E, et al. Health and
of regular morning meetings aimed at improving patient practitioner interactions: a systematic review.
interdisciplinary communication and patient York, UK: University of York, Department of Health
outcomes. Int J Nurs Pract 2005;11:206-13. Sciences and Clinical Evaluation; 1996.
150. Pronovost P, Berenholtz S, Dorman T, et al. 162. Zwarenstein M, Reeves S, Barr H, et al.
Improving communication in the ICU using daily Interprofessional education: effects on professional
goals. J Crit Care 2003;18:71-5. practice and health care outcomes. Cochrane
Database Syst Rev. 2001;(1):CD002213.
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163. Roberts K, Cerruti N, O'Reilly C. Changing 171. Aiken LH, Smith HL, Lake ET. Lower Medicare
perceptions of organizational communication: can mortality among a set of hospitals known for good
short-term intervention help? Nurs Res 1976;25:197- nursing care. Med Care 1994;32:771-87.
200.
172. Shortell SM, Rousseau DM, Gillies RR, et al.
164. Vazirani S, Hays RD, Shapiro MF, et al. Effect of a Organizational assessment in intensive care units
multidisciplinary intervention on communication and (ICUs): construct development, reliability, and
collaboration among physicians and nurses. Am J validity of the ICU nurse-physician questionnaire.
Crit Care 2005;14:71-7. Med Care 1991;29:709-26.
165. Weiss SJ. The influence of discourse on collaboration 173. Roberts K, O'Reillly C. Measuring organizational
among nurses, physicians, and consumers. Res Nurs communication. J Appl Psychol 1974;59:321-6.
Health 1985;8:49-59.
174. Choi J, Bakken S, Larson E, et al. Perceived nursing
166. Dechairo-Marino AE, Jordan-Marsh M, Traiger G, et work environment of critical care nurses. Nurs Res
al. Nurse/physician collaboration: action research and 2004;53:370-8.
the lessons learned. J Nurs Adm 2001;31:223-32.
175. Weiss SJ, Davis HP. Validity and reliability of the
167. McFerran S, Nunes J, Pucci D, et al. Perinatal Patient Collaborative Practice Scales. Nurs Res 1985;34:299-
Safety Project: a multicenter approach to improve 305.
performance reliability at Kaiser Permanente. J
Perinat Neonatal Nurs 2005;19:37-45. 176. Aiken LH, Patrician PA. Measuring organizational
traits of hospitals: the Revised Nursing Work Index.
168. Leonard M, Graham S, Bonacum D. The human Nurs Res 2000;49:146-53.
factor: the critical importance of effective teamwork
and communication in providing safe care. Qual Saf 177. Temkin-Greener H, Gross D, Kunitz S, et al.
Health Care 2004;13 Suppl 1:i85-90. Measuring interdisciplinary team performance in a
long-term care setting. Med Care 2004;42:472-81.
169. Lassen AA, Fosbinder DM, Minton S, et al.
Nurse/physician collaborative practice: improving 178. Baggs JG. Development of an instrument to measure
health care quality while decreasing cost. Nurs Econ collaboration and satisfaction about care decisions. J
1997;15:87-91, 104. Adv Nurs 1994;20:176-82.
170. Dutton R, Coooper C, Jones A, et al. Daily 179. Dougherty MB, Larson E. A review of instruments
multidisciplinary rounds shorten length of stay for measuring nurse-physician collaboration. J Nurs
trauma patients. J Trauma 2002;55:913-9. Adm 2005;35:244-53.
13
Evidence Table
interruptions, increased
summarizing; decline in
expressions of empathy.
Jenkins 2002152 MD/pt Design Type 2 At 3 months Oncology 3 day residential Improved attitudes and
(RCT)—P-P attitudes, empathy, MDs, UK communication beliefs toward psychosocial
videotape responses (Level 3) skills training issues compared to
(Level 2) course controls; increased
expressions of empathy;
open questions; appropriate
responses to patient cues
and psychosocial probing;
self-reported changes in
communication styles.
Study Design, Study
Source Communication Targets Design Type Study Outcome Setting & Study Key Finding(s)
Measure(s) Study Intervention
Population
Joos 1996157 MD/pt Design Type 2 Communication 42 MDs and 4.5 hours of Increased number of times
(RCT)—P-P skills 348 patients training MDs elicited patient and RN
questionnaire (Level 3), and with chronic concerns, increased patient
(Level 2) compliance and conditions perception of amount of
utilization information received, no
(Level 2) change in patient
compliance with
medications or
appointments; no change in
patient utilization.
Levinson 1993156 MD/pt Design Type2 Communication 53 A short CME Short program: no effect.
(RCT)—P-P skills community- program (4.5 Long program: more open-
audiotape (Level 3) based MDs hours) and a ended questions, asked
(Level 2) and 473 long CME patient opinions, gave more
patients program (2.5 biomedical information,
days) patients disclosed more
information, decrease in
15
Professional Communication
questionnaire costs 3 locations + nurse- incremental cost
(Level 2) (Level 1) mediated effectiveness ratio was
organizational $18/SFD gained for PLE
change (PACI) and $68/SFD gained for
PACI.
Study Design, Study
McFerran Perinatal RNs, certified Design Type 13 Long-term 4 Kaiser 4-hour human No long-term measures
167
2005 registered nurse anesthesists QI project-no measures: birth Permanente factors education reported;
and MDs control event data, medical- medical program, SBAR 4 sites met short-term
(Level 5) legal data, patient centers communication expectations for only
satisfaction data perinatal technique, communication initiatives.
(Levels 1 & 2); staff revising
short-term escalation policy,
measures: identifying safe
implementation of 2- communications,
3 interventions using debriefs after
human factors adverse events,
technique during 1 multidisciplinary
year (Level 3) reports,
Professional Communication
assertion, just
culture
statement
(Level 3)
Study Design, Study
Weiss 1985165 MD/RN/consumer Design Type 3— Belief regarding Recruited in Discussion of Decline in belief in shared
NRCT with 3 value of shared large urban role versus physician-dominated
groups, with 2 versus physician- area relationships, responsibility for health care
being matched dominated and problems for and increase in belief that
control groups responsibility for 2.5 hours 1 powerful individuals
(Level 3) health care and evening/month influence the consumer’s
beliefs that powerful for 20 months health status.
individuals influence
consumer health
status (Level 4)
18
Vazirani 2005164 Unit organization; RN, MD, Design Type 3— Collaboration, 1 hospital; 1 Added NP, Perception by MDs of
residents, hospitalist, NP NCRT 2 groups communication control unit hospitalist, daily greater collaboration
with 1 being (Level 3) and 1 multidisciplinary between physicians and
control (Level 3) intervention rounds nurses with largest effect
unit with residents, between
physicians and NPs, better
communication between
MDs; no difference in nurse
perception of
communication or
collaboration between
nurses and MDs, nurses
perceived better
communication with NPs
than MDs.
Study Design, Study
Source Communication Targets Design Type Study Outcome Setting & Study Key Finding(s)
Measure(s) Study Intervention
Population
Professional Communication
health. The other 4 studies
report no effects.
Study Design, Study
weekly case
conference
Descriptive
Aiken 1994171 MDs/RNs Design Type 4 Medicare mortality 39 Magnet None Magnet hospitals (higher
cross-sectional rates (Level 1) hospitals, autonomy, control, MD
(Level 5) 139 controls relationships, RN hours, skill
mix) had lower Medicare
mortality rates.
Aiken 199999 MDs/RNs Design Type 4 30-day mortality, 40 units in None Better nurse-patient ratios,
cross-sectional patient satisfaction, 20 lower mortality; higher nurse
(Level 5) nurse-patient ratios, hospitals; control, higher patient
control by bedside 1,205 satisfaction.
nurses; specialty patients and
physicians 820 nurses
(Levels 1, 3)
Alt-White MDs/RNs Design Type 4, 8 Nurse-physician 46 units, None Primary nurse, critical care
105
1983 cross-sectional no collaboration 446 nurses units, unit communication,
comparison group (Level 3) coordination, nurse
(Level 5) satisfaction associated with
better collaboration.
Study Design, Study
Source Communication Targets Design Type Study Outcome Setting & Study Key Finding(s)
Measure(s) Study Intervention
Population
Baggs 1997107 MDs/RNs Design Type 4, 8 Nurse/physician 3 ICUs in 3 None Collaboration was
cross-sectional no collaboration and hospital associated with satisfaction
comparison group satisfaction with for all but more strongly for
(Level 5) decisionmaking, nurses; nurse satisfaction
nurse retention with decisionmaking was
(Level 3) not associated with
retention.
Baggs 199995 MDs/RNs Design Type 4, 8 Mortality, ICU 3 ICUs in 3 None In the medical ICU, there
cross-sectional no readmission (Level hospitals was an association between
comparison group 1) nurse perception of
(Level 5) collaboration and lower risk
of patient death or ICU
readmission; MD reports of
collaboration were not
associated with patient
outcomes.
Estabrooks MDs/RNs Design Type 4, 8 30-day mortality 49 hospitals None Greater nurse-physician
21
Professional Communication
and 2
hospital
ships
Knaus 198697 MDs/RNs Design Type 4, 8 Actual and predicted 13 hospitals None Hospitals with less actual
cross-sectional mortality, mortality than predicted had
with no coordination of care better coordination of care
comparison group (Levels 1, 3) and communication
(Level 5) between RNs/MDs and
among MDs.
Study Design, Study
MDs/RNs Design Type 4, 8 LOS, nurse turnover, 42 ICUs None Higher scores on
cross-sectional no technical quality of leadership, coordination,
comparison group care, meeting family communication, conflict
(Level 5) needs (Levels 3, 4) management, associated
with shorter LOS, higher
technical quality of care,
greater ability to meet family
needs.
Thomas 200370 MDs/RNs Design Type 4, 8 Collaboration, 8 ICUs in 2 None Most MDs rated
cross-sectional no communication hospitals; collaboration and
comparison group (Level 3) 90 MDs, communication as high or
(Level 5) 230 RNs very high; most RNs rated it
as low or very low.
Zimmerman MDs/RNs Design Type 4, 8 ICU LOS, predicted 40 hospitals None Lower mortality associated
1991102 cross-sectional no hospital mortality with better technological
comparison group (Levels 1, 3) adequacy and work
(Level 5) environment; shorter LOS
associated with better
communication, culture,
coordination, conflict
management.
Appendix
Measurement Instruments
Shortell 1991172 ICU Nurse-Physician Questionnaire; 48 items selected Organizational culture, 48 items;
from the Organizational Culture Inventory (OCI) leadership, communication, 1–5 point Likert scale
coordination, problem-solving
Roberts 1974173 Organizational Communication Communication 35 items; 7–10 point Likert scale
Choi 2004174 Perceived Nursing Work Environment (PNWE) Nursing management, nursing 42 items; 4 point Likert scale
process, RN/MD collaboration, nursing
competence, scheduling climate
Weiss 1985175 Collaborative Practice Scales RN/MD interaction and influence on 9 items RN & 10 items MD; 6 point
patient care Likert scale
Aiken 2000176 Nursing Work Index-Revised (NWI-R) Autonomy, RN/MD relationships, 57 items; 4 point Likert scale
control of practice
Temkin-Greener PACE team performance questionnaire Interdisciplinary team performance 59 items; 5 point Likert scale
2004177
23
Baggs 1994178 Collaboration and Satisfaction About Care Decisions RN/MD collaboration 14 items; 7 point Likert scale
(CSACD)
Dougherty 2005179 A review of instruments measuring RN/MD collaboration RN/MD collaboration Collaborative Practice Scale,
Collaboration and Satisfaction About
Care Decisions, ICU Nurse-Physician
Questionnaire, Nurses Opinion
Questionnaire, and the Jefferson
Scale of Attitudes Toward Physician-
Nurse Collaboration
Professional Communication
Chapter 33. Professional Communication and Team
Collaboration
Michelle O’Daniel, Alan H. Rosenstein
Background
In today’s health care system, delivery processes involve numerous interfaces and patient
handoffs among multiple health care practitioners with varying levels of educational and
occupational training. During the course of a 4-day hospital stay, a patient may interact with 50
different employees, including physicians, nurses, technicians, and others. Effective clinical
practice thus involves many instances where critical information must be accurately
communicated. Team collaboration is essential. When health care professionals are not
communicating effectively, patient safety is at risk for several reasons: lack of critical
information, misinterpretation of information, unclear orders over the telephone, and
overlooked changes in status.1
Lack of communication creates situations where medical errors can occur. These errors
have the potential to cause severe injury or unexpected patient death. Medical errors,
especially those caused by a failure to communicate, are a pervasive problem in today’s health
care organizations. According to the Joint Commission (formerly the Joint Commission on
Accreditation of Healthcare Organizations, JCHAO), if medical errors appeared on the National
Center for Health Statistic’s list of the top 10 causes of death in the United States, they would
rank number 5—ahead of accidents, diabetes, and Alzheimer’s disease, as well as AIDS, breast
cancer, and gunshot wounds.1 The 1999 Institute of Medicine (IOM) report, To Err Is Human:
Building a Safer Health System, revealed that between 44,000 and 98,000 people die every year
in U.S. hospitals because of medical errors.2 Even more disturbing, communication failures are
the leading root cause of the sentinel events reported to the Joint Commission from 1995 to
2004. More specifically, the Joint Commission cites communication failures as the leading root
cause for medication errors, delays in treatment, and wrong-site surgeries, as well as the second
most frequently cited root cause for operative and postoperative events and fatal falls.1
Traditional medical education emphasizes the importance of error-free practice, utilizing
intense peer pressure to achieve perfection during both diagnosis and treatment. Errors are
therefore perceived normatively as an expression of failure. This atmosphere creates an
environment that precludes the fair, open discussion of mistakes required if organizational
learning is to take place. In the early 1990s, Donald Berwick wrote about patients needing an
open communication system instead of experiencing adverse events stemming from
communication failures.3 More than a decade later, this concept still has profound
implications on our method of health care delivery. As such, this chapter will review the
literature on the important role of communication and team collaboration in helping to
reduce medical errors and increase patient safety.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Evidence
What Are Communication and Team Collaboration?
Webster’s Dictionary defines communication as “the imparting or interchange of thoughts,
opinions, or information by speech, writing, or signs.” It is important to consider that
communication is not just verbal in form. One study states that 93 percent of communication is
more affected by body language, attitude, and tone, leaving only 7 percent of the meaning and
intent based on the actual words said.4 Whereas the spoken words contain the crucial content,
their meaning can be influenced by the style of delivery, which includes the way speakers stand,
speak, and look at a person.1 However, critical information is often transmitted via handwritten
notes, e-mails, or text messages, which can lead to serious consequences if there is
miscommunication.
Collaboration in health care is defined as health care professionals assuming complementary
roles and cooperatively working together, sharing responsibility for problem-solving and making
decisions to formulate and carry out plans for patient care.5, 6 Collaboration between physicians,
nurses, and other health care professionals increases team members’ awareness of each others’
type of knowledge and skills, leading to continued improvement in decisionmaking.7
Effective teams are characterized by trust, respect, and collaboration. Deming8 is one of
the greatest proponents of teamwork. Teamwork, he believes, is endemic to a system in which all
employees are working for the good of a goal, who have a common aim, and who work together
to achieve that aim. When considering a teamwork model in health care, an interdisciplinary
approach should be applied. Unlike a multidisciplinary approach, in which each team member is
responsible only for the activities related to his or her own discipline and formulates separate
goals for the patient, an interdisciplinary approach coalesces a joint effort on behalf of the patient
with a common goal from all disciplines involved in the care plan. The pooling of specialized
services leads to integrated interventions. The plan of care takes into account the multiple
assessments and treatment regimens, and it packages these services to create an individualized
care program that best addresses the needs of the patient. The patient finds that communication is
easier with the cohesive team, rather than with numerous professionals who do not know what
others are doing to mange the patient.9 Table 1 is a compilation of some of the components found
in the literature of a successful teamwork model.10–14
It is important to point out that fostering a team collaboration environment may have hurdles
to overcome: additional time; perceived loss of autonomy; lack of confidence or trust in
decisions of others; clashing perceptions; territorialism; and lack of awareness of one provider of
the education, knowledge, and skills held by colleagues from other disciplines and professions.15
However, most of these hurdles can be overcome with an open attitude and feelings of mutual
respect and trust. A study determined that improved teamwork and communication are described
by health care workers as among the most important factors in improving clinical effectiveness
and job satisfaction.16
2
Communication & Teamwork
• Respectful atmosphere
• Shared responsibility for team success
• Appropriate balance of member participation for the task at hand
• Acknowledgment and processing of conflict
• Clear specifications regarding authority and accountability
• Clear and known decisionmaking procedures
• Regular and routine communication and information sharing
• Enabling environment, including access to needed resources
• Mechanism to evaluate outcomes and adjust accordingly
Extensive review of the literature shows that communication, collaboration, and teamwork
do not always occur in clinical settings. For example, a study by Sutcliff, Lewton, and
Rosenthal17 reveals that social, relational, and organizational structures contribute to
communication failures that have been implicated as a large contributor to adverse clinical
events and outcomes. Another study shows that the priorities of patient care differed between
members of the health care team, and that verbal communication between team members was
inconsistent.16 Other evidence shows that more than one-fifth of patients hospitalized in the
United States reported hospital system problems, including staff providing conflicting
information and staff not knowing which physician is in charge of their care.18 Over the past
several years, we have been conducting original research on the impact of physician and nurse
disruptive behaviors (defined as any inappropriate behavior, confrontation, or conflict, ranging
from verbal abuse to physical or sexual harassment) and its effect on staff relationships, staff
satisfaction and turnover, and patient outcomes of care, including adverse events, medical errors,
compromises in patient safety, poor quality care, and links to preventable patient mortality.
Many of these unwanted effects can be traced back to poor communication and collaboration,
and ineffective teamwork.19–22
Unfortunately, many health care workers are used to poor communication and teamwork, as
a result of a culture of low expectations that has developed in many health care settings. This
culture, in which health care workers have come to expect faulty and incomplete exchange of
information, leads to errors because even conscientious professionals tend to ignore potential red
flags and clinical discrepancies. They view these warning signals as indicators of routine
repetitions of poor communication rather than unusual, worrisome indicators.23
Although poor communication can lead to tragic consequences, a review of the literature also
shows that effective communication can lead to the following positive outcomes: improved
information flow, more effective interventions, improved safety, enhanced employee morale,
increased patient and family satisfaction, and decreased lengths of stay.1, 24–26 Fuss and
colleagues27 and Gittell and others28 show that implementing systems to facilitate team
communication can substantially improve quality.
Effective communication among staff encourages effective teamwork and promotes
continuity and clarity within the patient care team. At its best, good communication encourages
collaboration, fosters teamwork, and helps prevent errors.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The barriers indicated in Table 2 can occur within disciplines, most notably between
physicians and residents, surgeons and anesthesiologists, and nurses and nurse managers.30, 31
However, most often the barriers manifest between nurses and physicians. Even though doctors
and nurses interact numerous times a day, they often have different perceptions of their roles and
responsibilities as to patient needs, and thus different goals for patient care. One barrier
compounding this issue is that because the United States is one of the most ethnically and
culturally diverse countries in the world, many clinicians come from a variety of cultural
backgrounds. In all interactions, cultural differences can exacerbate communication
problems.1 For example, in some cultures, individuals refrain from being assertive or
challenging opinions openly. As a result, it is very difficult for nurses from such cultures to
speak up if they see something wrong. In cultures such as these, nurses may communicate
their concern in very indirect ways. Culture barriers can also hinder nonverbal
communication. For example, some cultures ascribe specific meaning to eye contact,
certain facial expressions, touch, tone of voice, and nods of the head.
Issues around gender differences in communication styles, values, and expectations are
common in all workplace situations. In the health care industry, where most physicians are male
and most nurses are female, communication problems are further accentuated by gender
differences.32
A review of the organizational communication literature shows that a common barrier to
effective communication and collaboration is hierarchies.33–37 Sutcliff and colleagues’ research17
concurs that communication failures in the medical setting arise from vertical hierarchical
differences, concerns with upward influence, role conflict, and ambiguity and struggles with
interpersonal power and conflict. Communication is likely to be distorted or withheld in
situations where there are hierarchical differences between two communicators, particularly
4
Communication & Teamwork
when one person is concerned about appearing incompetent, does not want to offend the other, or
perceives that the other is not open to communication.
In health care environments characterized by a hierarchical culture, physicians are at the top
of that hierarchy. Consequently, they may feel that the environment is collaborative and that
communication is open while nurses and other direct care staff perceive communication
problems. Hierarchy differences can come into play and diminish the collaborative interactions
necessary to ensure that the proper treatments are delivered appropriately. When hierarchy
differences exist, people on the lower end of the hierarchy tend to be uncomfortable speaking up
about problems or concerns. Intimidating behavior by individuals at the top of a hierarchy can
hinder communication and give the impression that the individual is unapproachable.1, 38
Staff who witness poor performance in their peers may be hesitant to speak up because
of fear of retaliation or the impression that speaking up will not do any good. Relationships
between the individuals providing patient care can have a powerful influence on how and even if
important information is communicated. Research has shown that delays in patient care and
recurring problems from unresolved disputes are often the by-product of physician-nurse
disagreement.39 Our research has identified a common trend in which nurses are either reluctant
or refuse to call physicians, even in the face of a deteriorating status in patient care. Reasons for
this include intimidation, fear of getting into a confrontational or antagonistic discussion, lack of
confidentiality, fear of retaliation, and the fact that nothing ever seems to change. Many of these
issues have to deal more with personality and communication style.40 The major concern about
disruptive behaviors is how frequently they occur and the potential negative impact they can
have on patient care. Our research has shown that 17 percent of respondents to our survey
research in 2004-2006 knew of a specific adverse event that occurred as a result of disruptive
behavior. A quote from one of the respondents illustrates this point: “Poor communication post-
op because of disruptive reputation of physician resulted in delayed treatment, aspiration, and
eventual demise.”19
Leaders in both medicine and nursing have issued ongoing initiatives for the development of
a cooperative rather than a competitive agenda to benefit patient care.5, 39, 41, 42 A powerful
incentive for greater teamwork among professionals is created by directing attention to the areas
where changes are likely to result in measurable improvements for the patients they serve
together, rather than concentrating on what, on the surface, seem to be irreconcilable professional
differences. The fact that most health professionals have at least one characteristic in common, a
personal desire to learn, and that they have at least one shared value, to meet the needs of their
patients or clients, is a good place to start.
Practice Implications
Known Benefits of Communication and Team Collaboration
A large body of literature shows that because of the complexity of medical care, coupled with
the inherent limitations of human performance, it is critically important that clinicians have
standardized communication tools and create an environment in which individuals can speak up
and express concerns. This literature concurs that when a team needs to communicate complex
information in a short period of time, it is helpful to use structured communication
techniques to ensure accuracy. Structured communication techniques can serve the same
purpose that clinical practice guidelines do in assisting practitioners to make decisions and
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
take action. Research from aviation and wilderness firefighting is useful in health care because
they all involve settings where there is a huge variability in circumstances, the need to adapt
processes quickly, a quickly changing knowledge base, and highly trained professionals who
must use expert judgment in dynamic settings. Research shows that in these disciplines, the
adoption of standardized tools and behaviors is a very effective strategy in enhancing teamwork
and reducing risks.1, 17, 43–54, 60, 61
Crew Resource Management (Aviation). Experts in aviation have developed safety
training focused on effective team management, known as Crew Resource Management (CRM).
Improvements in the safety record of commercial aviation may be due, in part, to this training.
Realizing that 70 percent of commercial flight accidents stemmed from communication failures
among crew members, CRM sought to standardize communication and teamwork. The concept
originated in 1979, in response to a NASA workshop that examined the role that human error
plays in air crashes. CRM emphasizes the role of human factors in high-stress, high-risk
environments. John K. Lauber, a psychologist member of the National Transportation Safety
Board, deemed CRM as “using all available sources—information, equipment, and people—to
achieve safe and efficient flight operations.”44, 45 CRM encompasses team training as well as
simulation, interactive group debriefings, and measurement and improvement of aircrew
performance. This represents a major change in training, which had previously dealt with only
the technical aspects of flying. It considers human performance limiters (such as fatigue and
stress) and the nature of human error, and it defines behaviors that are countermeasures to error,
such as leadership, briefings, monitoring and cross-checking, decisionmaking, and review and
modification of plans. From a practical standpoint, CRM programs typically include educating
crews about the limitations of human performance. Trainees develop an understanding of
cognitive errors and how stressors (such as fatigue, emergencies, and work overload) contribute
to the occurrence of errors. Operational concepts stressed include inquiry, seeking relevant
operational information, advocacy, communicating proposed actions, conflict resolution, and
decisionmaking. CRM is now required for flight crews worldwide.
The development and implementation of CRM in aviation over the last 25 years offers
valuable lessons for medical care. Sexton and colleagues51 compared flight crews with operating
room personnel on several measures, including attitudes toward teamwork. This landmark study
included more than 30,000 cockpit crew members (captains, first officers, and second officers)
and 1,033 operating room personnel (attending surgeons, attending anesthesiologists, surgical
residents, anesthesia residents, surgical nurses, and anesthesia nurses). Questionnaires were sent
to crew members of major airlines around the world (over a 15-year period). The operating room
participants were mailed an analogous questionnaire, administered over a period of 3 years at 12
teaching and nonteaching hospitals in the United States, Italy, Germany, Switzerland, and Israel.
The Sexton study and other analyses suggest that safety-related behaviors that have been
applied and studied extensively in the aviation industry may also be relevant in health care.
Study results show successful CRM applications in several dynamic decisionmaking health care
environments: the operating room, labor and delivery, and the emergency room.26, 31, 55, 56 As with
aviation, the medical application of CRM has required tailoring of training approaches to mirror
the areas in which human factors contribute to mishaps. In anesthesiology, 65–70 percent of
safety problems (accidents or incidents) have been attributed at least in part to human error. In
response, several anesthesiologists from the Veterans Affairs Palo Alto Health Care System and
Stanford University developed Anesthesia Crisis Resource Management (ACRM), modeled
on CRM.55 Kaiser Permanente, a nonprofit American health care system providing care for 8.3
6
Communication & Teamwork
million patients, has also adopted CRM with successful results.54 In response to the occurrence
of a sentinel event—a medical error with serious consequences—Eglin U.S. Air Force (USAF)
Regional Hospital developed and implemented a patient safety program called Medical Team
Management (MTM) that was modeled on the aviation industry’s CRM program and focused on
communication, teamwork, and reporting to determine the impact of a patient safety program on
patterns of medical error reporting.57 This study was a retrospective review of 1,102 incident
reports filed at Eglin USAF Regional Hospital in Florida between 1997 and 2001. Collected data
from the comparison periods (1998 and 2001) were statistically analyzed using the chi-square
test. This study indicates that, since the implementation of MTM, there has been a statistically
significant increase in the number of reports filed at Eglin USAF Regional Hospital and a decline
in the severity of incidents. These findings suggest that since the implementation of MTM, there
have been changes in the patterns of error reporting, and with training, staff are able to prevent
more serious incidents. Table 3 highlights the application of a CRM model to medicine.
SBAR. Doctors and nurses often have different communication styles in part due to training.
Nurses are taught to be more descriptive of clinical situations, whereas physicians learn to be
very concise. Standardized communication tools are very effective in bridging this difference in
communication styles.
Michael Leonard, physician coordinator of clinical informatics at Kaiser Permanente, along
with colleagues, developed a technique called SBAR (Situation-Background-Assessment-
Recommendation). This technique has been implemented widely at health systems such as
Kaiser Permanente.1, 17, 58 Many other hospitals have embraced the SBAR communication tool or
a similar tool created by the Studer Group (see Table 4).59 For example, the Queen’s Medical
Center in Honolulu has incorporated the SBAR tool as a key component of its patient safety
program. The SBAR technique provides a framework for communication between members of
the health care team about a patient’s condition. SBAR is an easy-to-remember tool used to
create mechanisms useful for framing any conversation, especially critical ones, requiring a
clinician’s immediate attention and action. It allows for an easy and focused way to set
expectations between members of the team for what will be communicated and how, which is
essential for information transfer and cohesive teamwork. Not only is there familiarity in how
people communicate, but the SBAR structure helps develop desired critical-thinking skills. The
person initiating the communication knows that before they pick up the telephone, they need to
provide an assessment of the problem and what they think an appropriate solution is. Their
conclusion may not ultimately be the answer, but there is clearly value in defining the situation.
Table 5, Guidelines for Communicating with Physicians Using the SBAR Process explains how
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
to carry out the SBAR technique in detail. The guidelines use the physician team member as the
example; however, they can be adapted for use with all other health professionals.
STICC (Situation Task Intent Concern Calibrate) is another type of structured briefing
protocol used by the U.S. Forest Service to give direction to firefighters.1, 17, 60, 61 The
following five steps are involved:
• Situation: Here's what I think we face.
• Task: Here's what I think we should do.
• Intent: Here's why.
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Communication & Teamwork
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
white, or red light policy that addresses the issue in real time to prevent any further serious
consequences.59
Developing and implementing a standard set of behavior policies and procedures is vital.
These policies need to be consistent and universally applied. There should not be a separate
policy for any one particular discipline or service. For the medical staff, the policies should
become part of the medical staff bylaws with signed agreements to abide by these policies at the
time of appointment and recredentialing. Included in the policies should be a standardized
protocol outlining expected standards and the process for addressing disruptive behavior issues,
recommendations, followup plans, and actions to be taken in the face of individual resistance or
refusal to comply. Prior to implementation, make sure all employees are familiar with the
existence, purpose, and intent of the policies and procedures.
For the process to unfold, the organization needs to encourage its employees to report
disruptive behaviors. The organization needs to address issues related to confidentiality, fear of
retaliation, and the common feelings that there is a double standard and that nothing ever gets
done. Reporting mechanisms should be made easy and must be supported by the presence of a
nonpunitive environment. The ideal vehicle for reporting is to address the situation in real time,
but concerns about position, appropriateness, receptiveness, fear, hostility, and retaliation are
significant impediments.67 Appropriate vehicles for reporting may include reporting of the
incident to a superior, filing an incident report, using a complaint or suggestion box, or reporting
directly to a task force or interdisciplinary committee with assigned responsibilities for
addressing these issues.59 Besides maintaining confidentiality and reducing risks of retaliation,
one of the most crucial aspects of the reporting system is to give recognition and assurance that
the complaints will be addressed and actions will be taken. Responses should be timely,
appropriate, consistent, and provide necessary feedback and followup.
Taking action though appropriate intervention strategies is next. On one level, generic
educational programs can do a lot to spread the message and teach basic skills necessary to
promote effective communication. Appropriate topics should include sessions on team dynamics,
communication skills, phone etiquette, assertiveness training, diversity training, conflict
management, stress management, and any other courses necessary to foster more effective team
functioning and communication flow. Courses should be offered to all staff and employees at the
organization: physicians, physicians in training, nurses, nursing students, and all other staff who
have patient contact or play a role in the delivery of patient care. For individuals who have
consistently exhibited disruptive behavior, education may need to be supported by more focused
sessions and specific counseling. Another important strategy is to promote and assure
competency training at all levels of the health care team. This is a key factor affecting trust and
respect, which have such a strong influence on team collaboration.
Focused team training programs have been of particular value. One of the newer approaches
to improving team collaboration and patient safety is through the principles learned from the
aviation industry. Fostering an environment of trust and respect, accountability, situational
awareness, open communication, assertiveness, shared decisionmaking, feedback, and education,
interdisciplinary CRM training has brought significant improvements to communication flow in
the perioperative setting.52, 53
Having a clinical champion or early adopter who actively promotes the importance of
appropriate behavior, communication, and team collaboration can be an extremely valuable
asset. Champions can come from the executive ranks or through the voluntary interest and
enthusiasm of other staff members. Co-champions may be even more effective. Some
10
Communication & Teamwork
organizations have reported that having a nurse and physician (or other health care professional)
go through a joint training program will help foster mutual cooperation and collaboration
between the different disciplines.59 Followup and feedback bring closure to the process. It is
important to let people know that their input is welcomed, followup actions will be taken, and
appropriate feedback will be provided.
Research Implications
The existing literature adequately outlines structured communication techniques that will
help minimize medical errors. However, more research is needed on how to effectively deal
with miscommunication and barriers to communication in real-time crisis situations. Also, the
existing literature lacks concrete research confirming a cause-and-effect relationship between
human factors and clinical outcomes of care.
Conclusions
Effective clinical practice must not focus only on technological system issues, but also on the
human factor. As shown in this chapter, good communication encourages collaboration and helps
prevent errors. It is important for health care organizations to assess possible setups for poor
communication and be diligent about offering programs and outlets to help foster team
collaboration. By addressing this issue, health care organizations have an opportunity to greatly
enhance their clinical outcomes.
Author Affiliations
Michelle O’Daniel, M.H.A., M.S.G., director, member relations, VHA West Coast. E-mail:
[email protected].
Alan H. Rosenstein, M.D., M.B.A., vice president and medical director, VHA West Coast. E-
mail: [email protected].
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14
Chapter 34. Handoffs: Implications for Nurses
Mary Ann Friesen, Susan V. White, Jacqueline F. Byers
Background
The transfer of essential information and the responsibility for care of the patient from one
health care provider to another is an integral component of communication in health care. This
critical transfer point is known as a handoff.1–3 An effective handoff supports the transition of
critical information and continuity of care and treatment. However, the literature continues to
highlight the effects of ineffective handoffs: adverse events and patient safety risks.4–11 The
Institute of Medicine (IOM) reported that “it is in inadequate handoffs that safety often fails
first”12 (p. 45). This chapter presents an overview of handoffs, a summary of selected literature,
gaps in the knowledge, and suggestions for quality improvement initiatives and
recommendations for future research.
What Is a Handoff?
First one needs to recognize the term “handoff” and synonymous terms that are used in a
wide variety of contexts and clinical settings. There are a number of terms used to describe the
handoff process, such as handover,1, 13, 14 sign-out,15, 16 signover,17 cross-coverage,18, 19 and shift
report.20–22 For the purpose of this discussion, the term “handoff” will be used and defined as,
“The transfer of information (along with authority and responsibility) during transitions in care
across the continuum; to include an opportunity to ask questions, clarify and confirm”23 (p. 31).
The concept of a handoff is complex and “includes communication between the change of shift,
communication between care providers about patient care, handoff, records, and information
tools to assist in communication between care providers about patient care”1 (p. 1). The handoff
is also “a mechanism for transferring information, primary responsibility, and authority from one
or a set of caregivers, to oncoming staff”17 (p. 1). So, conceptually, the handoff must provide
critical information about the patient, include communication methods between sender and
receiver, transfer responsibility for care, and be performed within complex organizational
systems and cultures that impact patient safety. The complexity and nuance of the type of
information, communication methods, and various caregivers for each of these factors impact the
effectiveness and efficiency of the handoff as well as patient safety.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Our expanding knowledge base and technological advances in health care spawn additional
categories of health care providers and specialized units designed for specific diseases,
procedures, and phases of illness and/or rehabilitation. This dynamic, ever-increasing
specialization, while undertaken to improve patient outcomes and enhance health care delivery,
can contribute to serious risks in health care delivery and promote fragmentation of care and
problems with handoffs.3, 10, 29 It is ironic that as health care has become more sophisticated due
to advances in medical technology focused on saving lives and enhancing the quality of life, the
risks associated with the handoffs have garnered attention in the popular press30 and reports from
health care organizations and providers.3, 4, 6, 10, 31–35 The hazard that “fumbled handoffs”7, 10 pose
to patient safety and the delivery of quality health care cannot be ignored. Ineffective handoffs
can lead to a host of patient safety problems; research1 and development of strategies to reduce
these problems are required.33, 34
What contributes to fumbled handoffs? An examination of how communication breakdown
occurs among other disciplines may have implications for nurses. A study of incidents reported
by surgeons found communication breakdowns were a contributing factor in 43 percent of
incidents, and two-thirds of these communication issues were related to handoff issues.36 The use
of sign-out sheets for communication between physicians is a common practice, yet one study
found errors in 67 percent of the sheets.15 The errors included missing allergy and weight, and
incorrect medication information.15 In another study, focused on near misses and adverse events
involving novice nurses, the nurses identified handoffs as a concern, particularly related to
incomplete or missing information.37
Acute care hospitals have become organizationally complex; this contributes to difficulty
communicating with the appropriate health care provider. Due to the proliferation of specialties
and clinicians providing care to a single patient, nurses and doctors have reported difficulty in
even contacting the correct health care provider.38 One study found that only 23 percent of
physicians could correctly identify the primary nurse responsible for their patient, and only 42
percent of nurses could identify the physician responsible for the patient in their care.39 This
study highlights the potential gaps in communication among health care providers transferring
information about care and treatment.
A handoff is largely dependent on the interpersonal communication skills of the caregiver33
as well as the knowledge and experience level of the caregiver. There is reported variability in
quality,40 lack of structure in how handoffs usually occur,33 and variances in shift handoffs.22, 41–
43
Concern has been raised that the transition of care between providers during handoffs will
continue to be problematic as research indicates that “only 8 percent of medical schools teach
how to hand off patients in formal didactic session”3 (p. 1097), creating a large educational gap
in new professionals and persistence of traditional models. Physicians and nurses communicate
differently. Nurses are focused on the “big picture” with “broad and narrative”44 (p. i86)
descriptions of the situation, whereas physicians are focused on bullets of critical information.44
A technique that seeks to bridge the gap between the different communication styles of nurses
and physician is the situation, background, assessment, recommendation (SBAR) briefing
model44 that is being used successfully to enhance handoff communication.45
The issue of handoffs has become so prominent that the Joint Commission (formerly the
Joint Commission on Accreditation of Healthcare Organizations, JCAHO) introduced a national
patient safety goal on handoffs that became effective in January 2006.45 The national safety
goals, developed by the Joint Commission with input from the Sentinel Event Advisory Group,
identify new actions with the potential to protect patient safety.46 The patient safety goal requires
2
Handoffs—Implications for Nurses
Table 1. Joint Commission 2008 Hospital Patient Safety Goals Implementation Expectations for Handoffs
1. Interactive communications allowing for the opportunity for questioning
between the giver and receiver of patient information.
2. Up-to-date information regarding the patient’s care, treatment and
services, condition, and any recent or anticipated changes.
3. A process for verification of the received information, including repeat-back
or read-back, as appropriate.
4. An opportunity for the receiver of the handoff information to review relevant
patient historical data, which may include previous care, treatment, and services.
5. Interruptions during handoffs are limited to minimize the possibility that
information would fail to be conveyed or would be forgotten.
Source: Adapted from Joint Commission, National Patient Safety Goals Hospital Program.48
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
previous medication orders, including insulin. The nurse notifies the physician and
obtains correct and complete medication orders, thereby avoiding a potentially serious
medication error.
5. A nursing unit schedules staffing coverage to accommodate the shift change and
minimize the occurrence of interruptions during change-of-shift report. Ancillary staff
does not leave the nursing unit until report is completed to assure phones are answered
and timely responses to call lights are made so nurses can provide report effectively and
efficiently.
4
Table 2. Strategies to Improve Handoff Communication
Strategy Example
1. Use clear language and avoid use of abbreviations or During the reconciliation process, the nurse noted a medication that is usually administered
terms that can be misinterpreted. once daily being given every other day. The handwritten order for daily was written QD but read
as QOD. QD and QOD are on the Joint Commission official “Do Not Use” list.51 According to
the list, “daily” should be written instead of QD and QOD should be written as “every other
day.”51
2. Use effective communication techniques. Limit In the middle of a shift handoff, the unit clerk interrupts the nurse to inform her that a patient
interruptions. Implement and utilize read-backs or check- needs assistance to go to the bathroom. The nurse must leave report to assist the patient or
back techniques. find a nurse’s aide to help the patient. During this interruption, the offgoing nurse is in a rush to
leave and get her son from child care. Due to the need to leave quickly, the offgoing nurse
forgets to document and report to the oncoming nurse that a patient fell right before the shift
change. Efforts need to be made to ensure adequate staffing during shift report to minimize
interruptions.
3. Standardize reporting shift-to-shift and unit-to-unit. The surgical unit standardized shift-to-shift handoff report with a one-page tool that is used for
each patient, thereby providing a comprehensive, structured approach to providing the critical
information on new and recovering postoperative patients.
4. Assure smooth handoffs between settings. One of the busiest units in the hospital is the emergency department (ED). Patients must be
5
discharged or moved quickly out of the ED to an inpatient unit. To ensure rapid patient flow, a
new handoff process is established that includes a phone call to the receiving unit, the
assignment of an admission nurse so that there are no delays on the receiving unit, telephone
report so the receiving unit can prepare any special equipment, and then a final verbal handoff
between the two nurses while viewing the patient to verify the condition of the patient and
ensure no changes from one setting to another.
5. Use technology to enhance communication. Electronic The hospital has an electronic record and utilizes portable computers. Walking rounds are
records can support the timely and efficient transmission made by the offgoing and oncoming nurse using the portable computer and visiting each
of patient information. patient for introductions and quick visual assessment. The use of this technology allows the
Source: Adapted, in part, from Joint Commission International Center for Patient Safety. Strategies To Improve Hand -Off Communication: Implementing a
Process to Resolve Questions. 2005.34
Table 3. Nurse-to-Nurse Change-of-Shift Handoff Report
•
Verbal report at the • Allows face-to-face interaction.41 Confidentiality issues need to be • Monitor to assure confidentiality is
13, 41, 56 56, 57
patient’s bedside • Allows for clarification.41 addressed. protected, report in private setting.
• Nurses can assess patient together.41 • Not all patients wish to participate in • Introduce self to patient.57
52
•
6
• Allow the remedy of errors.41 bedside report. Encourage patient to participate, but not all
• Involve patient.41, 52, 56 • Terms (jargon) used by nurses in report patients will want or be able to participate
may pose a concern to patients if not and this needs to be respected.52
explained.52 • Develop protocol to guide the bedside
• Nurses may be interrupted.41 handover process.
57
Written report • Improvement in documentation.54 • Question and answer interaction must • Need to assure there is an opportunity to
47
• Effective management.54 be built into the process. ask questions about the report and interact
• Allows oncoming shift to review • May be missing essential information if between off going and oncoming shifts.47
• Information also provided verbally with
7
54 54
data. not documented.
• Quality of documentation may vary.54 written report.54
• Use standardized process to assure
34, 47
transmission of essential information.
It is important to understand the context in which care is provided and be cognizant of the
impact of the environmental processes on health care providers. The physical work environment
may not be conducive to effective handoffs as it may be noisy58, 59 and prone to interruptions,
(i.e., pagers, phone calls),60–63 and the handoff may be conducted under physical and emotional
pressures.11 A study examining communication patterns among physicians and nurses found
thirty one percent of communication exchanges involved interruption, translating into roughly 11
interruptions an hour for physicians and nurses.60 Spencer and colleagues62 found 15
interruptions per hour. Barriers to transmission of accurate information in a patient transfer
include incomplete medical record, lack of complete information provided by nurses, and the
omission of essential information.64 Handoffs are compromised if critical pieces of information
are omitted because of difficulties with data access4, 29 or if documentation is illegible31, 33 or not
transferred.55 Despite efforts to promote the use of electronic patient records, according to a 2002
survey, less than 10 percent of hospitals have complete access to electronic systems such as
computerized physician order entry (CPOE).65
The ever-increasing abundance of data requires that health care providers synthesize and
make decisions using large amounts of complex information. Unfortunately, data quickly
degrades; for example, critically ill patients have many clinical parameters that are being
monitored frequently.66 Decisions need to be based on trends in the data and current information,
which is essential to making informed decisions.66 Tremendous amounts of information are
constantly being generated, such as monitored clinical parameters, diagnostic tests, and
multidisciplinary assessments. When this large amount of information is combined with the
numerous individuals—clinical and nonclinical—who come in contact with a patient during a
treatment episode and data transmission, not all members of the health care team may be aware
of all the information pertinent to each patient.66
In an effort to compress information and make it manageable among health care providers,
handoffs may result in a “progressive loss of information known as funneling, as certain
information is missed, forgotten or otherwise not conveyed” 66 (p. 211). The omission of
information or lack of easy accessibility to vital information by health care providers can have
devastating consequences.4, 11 Such gaps in health care communication can cause discontinuity in
the provision of safe care67 and impede the therapeutic trajectory for a patient. These gaps
present major patient safety threats and can impact the quality of care delivered.
8
Handoffs—Implications for Nurses
• Shift-to-shift handoff
• Nursing unit-to-nursing unit handoff
• Nursing unit to diagnostic area.
• Special settings (operating room, emergency department).
• Discharge and interfacility transfer handoff
• Handoffs and medications
• Physician-to-physician handoffs
Shift-to-Shift Handoff
There are paradoxes in communication and handoffs, especially at shift changes.20 Many
human factors play a role. Human factors (ergonomics) focus on behavior and interaction
between human beings and their environment. Human factors engineering focuses on “how
humans interact with the world around them and the application of that knowledge to the design
of systems that are safe, efficient, and comfortable”76 (p. 3). The handoff poses numerous human
factors engineering implications. From the perspective of patient safety, the primary purpose of
the shift report or shift handoff is to convey essential patient care information,14, 43, 55, 78, 79
promote continuity of care13, 41, 77, 78, 80 to meet therapeutic goals, and assure the safe transfer of
care of the patient to a qualified and competent nurse. However, other reported purposes of shift
report include education,41, 78, 81 debriefing,14, 41 socialization,78, 82 planning and organization,78
enhancement of teamwork,81 and supportive functions.83
The intershift handoff is influenced by various factors, including the organizational culture.
An organization that promotes open communication and allows all levels of personnel to ask
questions and express concerns in a nonhierarchical fashion is congruent with an environment
that promotes a culture of safety.58 Interestingly, one study reported novice nurses seeking
information approached those seen as “less authoritarian.”84 The importance of facilitating
communication is critical in promoting patient safety. The shift-to-shift handoff is a multifaceted
activity.78, 85, 86 A poor shift report may contribute to an adverse outcome for a patient.55
Handoff intricacies. A phenomenon well known to nurses is the use of nurse-developed
notations, “cheat sheets” or “scraps” of information, while receiving or giving intershift reports.
A study of such note taking found scraps are used for a variety of purposes, including creating
to-do lists and recording specific information and perceptions about the patient and family.87
This approach presents some challenges, as no one else has easy access to the information;
therefore, continuity of care may be compromised during a meal break, for example, or if the
scrap or cheat sheet is misplaced.
Method of shift-to-shift handoff. Handoffs are given using various methods:13, 41, 88, 89
verbally,75, 77 with handwritten notes,80, 87 at the bedside,41, 52, 56, 57, 90, 92 by telephone,91 by
audiotape,41, 53 nonverbally,54 using electronic reports,92 computers printouts,14 and memory.14
The strength of the bedside report method is its effort to focus on and include the patient in the
report. There have been concerns regarding patient confidentiality,41, 52, 56, 90 which could be
compromised if not carefully addressed. A qualitative study focused on describing the
perceptions of patients who were present during a bedside report found some patients are in
favor of bedside handoff, while others are not.52 Patients also expressed concern regarding the
jargon used by nurses.52 One patient noted that including the patient in the handoff added another
level of safety as erroneous data could be addressed and corrected.52 Case studies indicate the
bedside handoff may be implemented for a number of reasons, including addressing specific
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
issues and improving care delivery.57, 92 A summary of the strengths and weaknesses of verbal,
bedside, written, and taped shift-to-shift reports is included in Table 3.
The challenge during handoffs across settings and times is to identify methods and
implement strategies that protect against information decay and funneling,66 contributing to the
loss of important clinical information. It is a challenge to develop a handoff process that is
efficient and comprehensive, as case studies illustrate.57, 88, 92, 93 Observation of shift handoffs
reveals that 84.6 percent of information presented in handoffs could be documented in the
medical record.42 A concern that emerged in this study was some handoff reports actually
“promote confusion,” and therefore the authors advocated improving the handoff process.42
Another concern with handoffs is the degree to which the report is actually congruent with
the patient’s condition. One study found 70 percent congruence between the shift report and the
patient’s actual condition, with an omission rate of 12 percent.22 A synthesized case example of a
psychiatric patient presents the adverse consequences for the patient if essential information is
not communicated.94 The importance of communicating objective descriptions of the patient
condition is highlighted.
A study focusing on assessing the effects of manipulating information in a shift handoff on
the receiving nurse’s care planning found in the different types of taped reports that the
information recalled ranged from 20 percent to 34 percent.95 Another study, by Pothier and
colleagues,55 examined different methods for transferring information during 5 consecutive
simulated handoffs of 12 fictional patients. Three methods of handoffs were analyzed; the
method demonstrating the greatest amount of information retention involved utilization of a
preprinted sheet containing patient information with verbal report, followed by note taking and
verbal report method, and lastly, only verbal report. The retained total data points for each style
of handoff varied considerably during the five handoffs. Over 96 percent to 100 percent of
information was retained using the preprinted sheet containing patient information and verbal
report. Only 31 percent to 58 percent of the data were retained using the note taking style and
verbal report.55 The verbal-only style demonstrated the greatest amount of information loss, with
retention ranging from 0 percent to 26 percent.55 None of the data was retained using the verbal-
only method for two handoff cycles. The insertion of incorrect information was observed in the
verbal-only method. The generation of incorrect data did not occur at all during the handoff with
the written or preprinted form style of report. This study55 supports the use of a consistent
preprinted form with relevant patient information during shift report, with less reliance on
verbal-only reports, in order to optimize communication.
10
Handoffs—Implications for Nurses
Special Settings
Operating room and postanesthesia. Several special handoff situations occur in certain
hospital settings. The operating room (OR) is considered “one of the most complex work
environments in health care”98 (p. 159), with a reported mean of 4.8 handoffs per case. Nursing
staff average 2.8 handoffs per case, with a range of one to seven handoffs.98
There have been at least 615 wrong-site surgeries reported to the Joint Commission between
1995 and 2007.99 To help prevent wrong-site surgery, the Joint Commission developed the
Universal Protocol for Preventing Wrong Site Surgery, Wrong Procedure, Wrong Person
SurgeryTM.100, 101 It is based on the consensus of experts and endorsed by more than 50
professional organizations.100 Effective interdisciplinary communication is critical. For example,
a health care organization using a perioperative briefing process reported that no wrong-site
surgeries have occurred since the adoption of the interdisciplinary briefings.44
Dierks suggests five categories for handoffs in the OR: (1) baseline metrics/benchmarks, (2)
most recent phase of care, (3) current status, (4) expectations for the next phase of care, and (5)
other issues such as “who is to be contacted for specific issues”102 (p. 10). The use of a team
checklist in the OR was pilot tested in another study and found to show “promise as a method for
improving the quality and safety of patient care in the OR”103 (p. 345).
A study focused on OR communication processes identified a number of patterns and found
the most common reason for communication in 2,074 episodes was coordination of equipment,
followed by “preparedness” for surgery.104 The authors recommend increasing the use of
automated processes to enhance process flow, especially related to “equipment management,”
thereby helping with transmission of information in a more efficient manner.104
Communication in handoffs is critical in all phases of care. However, a survey of 276
handoffs conducted in a postanesthesia care unit (PACU) revealed 20 percent of postoperative
instructions were either not documented or written illegibly.105 The nurses rated the handoffs
from anesthesia staff as “good” in 48 percent of cases, “satisfactory” in 28 percent, and “bad” in
24 percent.105 A number of suggestions for improving the quality of the postanesthesia care unit
handoff protocol were presented including the need to communicate information verbally to the
nurse.105
Emergency department. A study of five emergency departments (EDs) revealed that there
were differences in the characteristics of handoffs among the EDs studied, but “nearly universal”
attributes of handoffs were also noted.106 The researchers developed a conceptual framework for
addressing handoffs in the emergency setting. The handoffs were not one way communication
processes as both the offgoing and oncoming providers were engaged in interactive handoffs. 106
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
According to Behara and colleagues,106 8 of 21 handoff strategies used in other industries2 were
observed “consistently” in the ED setting, while four were used less often and nine were not or
rarely used. The handoff in the ED setting is viewed as a “rich source for adverse events”17 (p. 1).
There are inherent risks in handoffs, but it was also noted that the handoff can provide the
opportunity for two health care providers to assess the same situation and identify a “previously
unrecognized problem”17 (p. 2).
Studies focused on emergency nursing handoffs highlight unique aspects of this
process.107, 108 Currie reported in a survey of 28 ED nurses that the top three concerns nurses had
with handoffs were missing information, distractions, and lack of confidentiality.108
Recommendations included the development of guidelines to improve the handoff process in the
ED.
12
Handoffs—Implications for Nurses
preventable and ameliorable adverse events”119 (p. 166). The most frequent type of adverse event
was related to medications. The implications of this study indicate the need to enhance
communication in the handoff between the hospital and posthospital care. Suggested potential
strategies to improve the handoff include discharge planning and education of patients related to
medications prior to discharge.119
A number of contributors to a failed handoff in the discharge planning process have been
identified, including, lack of knowledge about the discharge process,117 lack of time,117 lack of
effective communication,119, 120 patient and family issues,117, 120 system issues,120 and staffing
issues.117, 120 Communication issues have emerged as a potential contributor to readmissions.121
An ineffective nursing handoff has been identified as a contributor to miscommunication within
the discharge process.122 The improvement of discharge planning requires that emphasis be
placed on collaboration and interdisciplinary communication.112 Well-orchestrated discharge
planning is recommended to help improve patient safety123 by controlling the risk of gaps
occurring in the discharge process and its inherent handoffs.
Physician-to-Physician Handoffs
Studies conducted to better understand physician-to-physician handoffs31, 33 may have
implications for nurses. Poor handoffs included omissions of essential information such as
medications, code status, and anticipated problems.31 Other issues contributing to failed
communication processes included lack of face-to-face interaction and illegible documentation.31
The weaknesses identified in another handoff study included incomplete and or illegible
information, difficulty accessing clinical information quickly, communication failures, and
difficulty contacting other doctors.33 Strategies to address handoff problems include providing
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
legible, accurate, relevant, comprehensive information and the use of a face-to-face report.31
Suggestions for improvement include development of a process to enhance transmission of
information, for example, the adoption of templates; use of technology; use of communication
processes such as SBAR, education, and evaluation of handoffs;31 and a standardized handoff
process.33
14
Handoffs—Implications for Nurses
computerized clinical documentation systems (CDS) in the nursing shift handoff. One study
reported nurses perceived shift-to-shift handoffs more positively after the implementation of the
CDS.140 Access to a physician computerized sign-out was rated positively by nurses and was
reported to improve communication.141
Human Factors
The study of human factors engineering is currently being used to improve patient safety,76
and there are an increasing number of strategies and tools that can be used to design systems in a
manner to decrease adverse outcomes. Designs to promote patient safety should include
integration with “forcing” functions to prevent errors. However, there needs to be testing of
proposed solutions to assure validity of these tools in the health care environment.76 Lessons
learned from other industries are fostering the adoption of human factors principles and
increasingly being used in health care.44, 137, 143–146
Studies of handoffs in other industries have been analyzed for possible implications for
health care. Patterson and colleagues2 analyzed data from four studies147–150 and described 21
handoff strategies. According to their findings, strategies that could be applied to shift handoff
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
included interactive questioning, face-to-face handoff, forcing functions such as passing a pager
to initiate handoff to the oncoming nurse to indicate an unambiguous transfer of responsibility,
flagging critical information, and reduction of interruptions.2 The researchers note a question
remains “if the strategies can be generalized to health care”2 (p. 132), and call for additional
research in this area.
Research Implications
Following are suggested questions for future research:
• What are the best systems designs to reduce unnecessary handoffs? How can they best be
implemented?
• What are best strategies for handoffs in various settings (i.e., nurse to nurse, unit to unit,
agency to agency, physician to nurse)?
• What are the most effective strategies, instruments, and tools to employ to assure
maximum transfer of and receipt of accurate, relevant, up-to-date information?
• How can electronic technology best be deployed to support and enhance effective
handoffs, decrease errors, and improve patient safety and patient outcomes?
• What are the best techniques for assuring critical information is forwarded and not
omitted or overlooked when received?
• How can handoff contributors to medication errors be addressed and decreased?
• What are the critical data elements that should be transferred by type of service, specialty,
profession, and setting?
Basic to the provision of quality health care is the ability to communicate with one another
and safely handoff patient care in a seamless manner so every patient can benefit from each
phase of care through a well-executed handoff. This is a process that is ubiquitous but also a
high-risk endeavor in many settings. More research is needed in this critical patient safety arena
to promote interdisciplinary approaches to patient safety throughout the continuum of care.
16
Table 4. Factors, Problems, and Strategies Cited in the Literature
External & internal Problem/barrier associated with patient Practice implications (strategies for reducing References
factors that contribute safety issues errors and improving safety)
to errors
Handoff Language problems may contribute to problems • Face-to-face handoff is preferred31, 35 to allow Arora 200531
communication during handoffs in several ways. Different verbal and nonverbal exchanges and interactive Barenfanger 200449
47, 48 45
dialects, accents, and nuances may be communication and questions. Haig 2006
misunderstood or misinterpreted by the nurse • Standardize forms, checklists, or tools (customized Hanna 200550
151
receiving report. Abbreviations and acronyms as agreed to by clinicians for specific practice ISMP 2005
that are unique to certain settings may be areas) so that all users will understand the Joint Commission47, 48
confusing to a nurse working in a different information from the same context.
34 Joint Commission
setting or specialty. Medications may have International Center for
• Allow opportunity for questions and clarification
similar sounding names, increasing risk for 2, 34, 47, 48 Patient Safety 200534
during the handoff.
confusion. Simpson 200535
• Use a “read back” “repeat back” to decrease Yates 2005136
communications errors.34, 47, 49
• Use phonetic and numeric clarifications.136
• Verify information.47
• Implement safe practice recommendations for
50
communicating critical test results
• Speak in simple, clear, straightforward manner and
34
be specific in description of patient and situation.
17
Written communication Trying to interpret illegible notes from another • Use electronic strategies to decrease problems Joint Commission
provider may create errors in communication. 159 International Center for
with illegibility.
• Use standardized processes (customized to a Patient Safety 200534
clinical area, practice setting) to assure critical Simpson 200535
159
information is communicated in handoff.34, 35 Upperman 2005
External & internal Problem/barrier associated with patient Practice implications (strategies for reducing References
factors that contribute safety issues errors and improving safety)
to errors
33
Variation in processes There may be wide variance in the way a • Adopt a standardized, consistent approach to the Bomba & Prakash 2005
handoff is conducted that may lead to omission 33,34
handoff to decrease errors.
of critical information and contribute to medical • Adopt and use behavior-based expectations to Joint Commission 2006132
and medication errors. reduce risks and promote patient safety. Tools to Joint Commission
use during handoffs include the 5 Ps for International Center for
Patient/Project, Plan, Purpose, Problems, Patient Safety 2005,
136
Precautions and Situation, Background, 200634
Assessment Recommendation (SBAR).34, 44, 45
Haig 200645
• Communicate essential patient care information.34 44
Leonard 2004
• Develop and implement a systematic process for Massachusetts Coalition
the reconciliation of patient’s medications to for the Prevention of
decrease risk associated with transfers and Medical Errors 2005131
130, 131, 132
transitions to other levels of care. USP 2005130
Yates 2005136
Organizational/system Problem/barrier associated with patient Practice implications ( strategies for reducing References
issues that contribute safety issues errors and improving safety)
to errors
Culture In a culture that lacks sufficient focus on safety • Institute of Medicine
Support the development of a culture of safety
and learning, staff may be reluctant to report where reporting of errors and problems is accepted 200458
133
problems or may not feel comfortable asking and encouraged.58, 133, 134 Marx 2001
questions. • Encourage the development of a “learning Reason 1997134
134 133, 134
culture” and a “just culture.”
28
Transfer of patients Increased number of transfers increases the • Consider health care delivery design models in Hendrich 2004
(within health care need for handoffs. which patient transfers are minimized.28 Institute of Medicine
organization) • Include nursing staff in the design of handoff 200458
processes.58
Physical space Environment may not be conducive to • Include health care providers in the design of work Institute of Medicine
limitations for handoffs conducting a handoff (interruptions, noisy). environments so adequate space requirement and 200458
configurations are identified.
Technology limitations Lack of technology may create voluminous • Ash 2003162
Design electronic systems that support the easy
and use of manual paper records (medication records, lab reports) .34, 141, 163 Joint Commission
retrieval of accurate and timely data
reports and records/ with multiple reports to be referenced for • Provide for adequate planning processes, International Center for
difficulty accessing handoffs to another unit, setting, or facility. infrastructure, human resources, and education to Patient Safety 200534
139
essential information successfully implement electronic support.139, 162 Karsh 2004
Sidlow & Katz-Sidlow
2006141
163
Van Eaton 2004
Different cultures or Organizations may have different goals, focus, • Davis 200573
Develop processes between sending and receiving
organizations and resources. organizations to assure both organizations are Leonard 200444
44, 73
aware of requirements for handoff.
• Plan resource allocation to meet the patient
44
needs.
Organizational/system Problem/barrier associated with patient Practice implications ( strategies for reducing References
issues that contribute safety issues errors and improving safety)
to errors
Intra- or extra-system Transfers to a setting/facility within a single • Anderson & Helms 1993
69
Seek to design systems, processes, and policies 68
transfers system may create fewer problems than a that allow for collaboration and efficient transfer of Anderson & Helms 2000
110
transfer to a different system/health care essential information between organizations during Coleman & Boult 2003
68, 69, 73, 111, 112, 115 114
provider in which different forms and handoff. Cortes 2004
73
technologies are used. Transfers require efforts • Davis 2005
Complete medication reconciliation process.129, 132 112
to assure continuity of care as the patient Hansen
• Remove barriers to communication.
transitions to another level of care. Institute for Safe
• Assure a bidirectional communication process Medication Practices
between health care providers.110 2005129
• Communication involves verbal, written, and Joint Commission
electronic means. International Center for
• Monitor process for opportunities for improvement.44 Patient Safety 2006
132
44
Leonard 2004
74
Nicholson 2003
111
Satzinger 2005
129
USP 2005
Wachter & Shojania
200411
Staffing limitations Staffing shortages may contribute to gaps in • Allocate adequate human resources to support Institute of Medicine
58
transmission of information in handoff. 58, 2004
21
Search Strategy
To retrieve pertinent literature on the topic of handoffs, the following databases were
reviewed: Academic Search Premier, CINAHL, Pre-CINAHL, EMBASE, Ovid’s Medline,
PubMed, and PsychInfo. The databases were searched for variants of the words “handover” and
“handoff,” “shift report,” and “changeover.” Additionally, the databases were searched for
groups of subject terms representing the concepts of patient transfer, communication, and
continuity of care. The use and combination of subject headings varied depending on the
characteristics of each database. Searches for the concept of patient transfer used the following
subject headings: transfer, discharge; transfer, intrahospital; patient discharge; transportation of
patients; and patient transfer. The concept of communication was represented by terms such as
“communication barriers,” “communication,” “communication skills,” “communication theory,”
and “interpersonal communication.” Subject headings focusing on the concept of overall health
care delivery or quality included quality of care, health care delivery, continuity of patient care,
patient safety, and medical care.
Acknowledgment
The authors wish to acknowledge Stephanie Narva Dennis, M.L.S., for support and
assistance in conducting the literature search.
Author Affiliations
Mary Ann Friesen, M.S.N., R.N., C.P.H.Q. Program Manager, Center for American Nurses,
Silver Spring, MD 20910-3492. E-mail: [email protected].
Susan V. White, Ph.D., R.N., C.P.H.Q., F.N.A.H.Q. Associate Chief Nurse, James A. Haley
Veterans’ Hospital, Tampa, FL 33612. E-mail: [email protected].
Jacqueline F. Byers, Ph.D., R.N., C.N.A.A., C.P.H.Q. Professor, College of Nursing,
University of Central Florida, Orlando, FL 32816-2210. E-mail: [email protected].
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Health Affairs 2004;23:202-212. 162. Ash JS, Stavri PZ, Kuperman GJ. A consensus
statement on considerations for a successful CPOE
155. Scott LD, Rogers A, Hwang W, et al. Effects of implementation. J Am Med Inform Assoc
critical care nurses’ work hours on vigilance and 2003;10(3):229-334.
patients’ safety. Am J Crit Care 2006;15(1):30-37.
163. Van Eaton, EG, Horvath, KD, Lober, WB, et al.
156. Reason J. Human error: Models and management. Organizing the transfer of patient care information:
BMJ 2000;320:768-770. The development of a computerized resident sign-out
system. Surgery 2004;136(1):5-13.
157. White SV. Improving patient safety using quality
tools and techniques. In: Byers JF, White SV, eds. 164. Goldstein MK. Agency for Healthcare Research and
Patient safety principles and practice. New York: Quality Web Morbidity and Mortality Rounds:
Springer Publishing Company; 2004. p 87-134. Deciphering the Code. 2006, February. Available at:
http://www.webmm.ahrq.gov/case.aspx?caseID=117.
158. Benner P. From novice to expert: Excellence and Accessed March 7, 2006.
power in clinical nursing practice. Menlo Park, CA:
Addison-Wesley; 1984. 165. Timonen L, Sihvonen M. Patient participation in
bedside reporting on surgical wards. J Clin Nurs
159. Upperman JS, Staley P, Friend K, et al. The impact 2000;9(4):542-548.
of hospitalwide computerized physician order entry
30
Evidence Table. Selected Sources on Handoffs—Nursing Handoffs, Quality Improvement Activities, Interdisciplinary Handoffs
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Anderson Handoff between Descriptive Inventory Referral Illinois, Iowa No intervention • Scores ranged from 7 to 35
& Helms hospital and home retrospective Information (IRI) 40 items completed
199369 health agency study items. Score 0–40 300 patient records • Hospital affiliated HHA
(HHA) Monitor type, amount 1988–1990 received more data than
of information the Referrals of nonaffiliated HHA
HHA received from 6 hospitals to 4 • More information transmitted
the hospital HHAs between hospital and HHA
when a standard form used
Australian Handoffs Literature review Retrieval of literature 777 papers reviewed Studies with • Quality of evidence on clinical
Council for that addresses Only 27 met interventions handoffs deemed “extremely
Safety and handover and safety inclusion criteria reviewed included poor” (p. 5).
Quality in in both health and 8 non-health care computerized • Majority are descriptive
Health nonhealth literature 19 health care documentation studies.
Care 20051 Another 21 papers system, • Three domains identified.
The literature review did not meet criteria interdisciplinary • System design factors: 17
report includes but were termed rounds, papers
Greaves Bedside handoff Qualitative Patients were Hospital No intervention • Four themes emerged from
199990 (patient interviewed and interviews and analysis of data
perceptions) asked questions Four patients 1. Access to information and
about the handoff a desire to be included in
process. Aspects Assess patient the handoff
explored included perceptions of 2. Confidentiality of patient
likes, dislikes, handoffs at the information
privacy, experience bedside 3. Continuity— the
with past handoffs, communication of
areas for information from one shift
improvement.
34
to another
4. Neglect— the staff need to
be available during a
handoff to care for patients
so patients are not at risk
for “neglect”
Haig Communication Quality Use of SBAR Bloomington, Illinois Effort to implement • SBAR use increased to 96% in
45
2006 Improvement situation, 2005.
Outcome Measures background, • Use of SBAR in discharge
Medication Medical center assessment and medication reconciliation
reconciliation recommendation increased from 53% to 89%.
(SBAR) • Adverse events decreased.
Adverse events communication
tool.
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Hardey Communication of Qualitative Communication England No intervention • Scraps are used for a variety
87
2000 information ethnographic process, specifically of purposes such as a ‘to do’
the use of “scraps” 5 wards (geriatric) list, and record information
examined. about the patient’s clinical
“Scraps” are Observation of status.
“personalized 23 handovers • Scraps were used by nurses to
recordings of Observation of augment documentation due to
information” (p. 209) interactions “perceived inadequacies.”
on paper or in • Three themes were identified
notebooks by nurses. Interviews with 34 related to the use of scraps:
Grounded theory nursing personnel construction and content of
analysis. scraps, role and use of scraps,
Written records confidentiality and disposal.
Hendrich Impact of acuity- Pre-post method 12 outcomes-based United States Use of acuity- Postimplementation
28
2004 adaptable rooms questions (seven adaptable rooms • 90% decrease in patient
on transfers, addressed in article). Hospital transports
medical errors, Outcomes studied: • 70% decrease in medication
satisfaction patient complications 2 years baseline errors
& mortality, sentinel data • Decrease in number of patient
35
Kennedy Nonverbal handoff Qualitative Study Pre Non-Verbal 28-bed ward The implementation Post nonverbal handoff:
199954 Handoff of a nonverbal • The documentation of
Quality Nonparticipant 41% (9) members of handoff system information addresses
improvement observation of nursing team reporting that one “didn’t hear
bedside handoff Stratified sample information in the handoff.
• Disadvantage: “forgetting” to
Post nonverbal Documentation document and quality of some
handoff reports.
Qualitative data • Team preferred the nonverbal
obtained via handoff
semistructured • However, interviews indicated
interview of staff, all nursing team members still
passed on information verbally
Eight months post in addition to the nonverbal
implementation of report.
nonverbal handoff an • Audit results indicate there was
audit of a 60% improvement in
documentation was documentation 8 months post-
conducted implementation of nonverbal
handoffs.
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Kerr 200278 Shift “handover” Qualitative The handoff was 2 pediatric units No intervention • Four main functions of handoff:
(handoff) observed by informational, social,
researchers. 20 handovers per organizational, educational
An interview guide unit • Three phases of handoff: pre-
was used and handover, intershift (meeting),
focused on three 12 individual per unit post-handover.
issues: practice and 2 group • A number of tensions were
(7 questions), interviews per unit identified inherent in the
functions (3 handoff process, including
questions), and Participants included tension between being
problems and nurses, support comprehensive versus
effectiveness (9 worker, students information overload;
questions). confidentiality issues versus
family-centered care.
Lally Intershift handoff Qualitative Research question: United Kingdom No intervention • The study of shift handoff
81
1999 To what extent does revealed 16 themes within 5
Observation the intershift One ward in a categories: nursing process,
37
surgical interventions.
management issues.
Liukkonen Handoff content Content analysis Identified type of 2 wards in 2 geriatric No intervention • Handoff reports lasted 30–90
77
1993 qualitative and information homes minutes.
quantitative discussed in the shift Audio recording of • Most of the content related to
handoff; a total of shift reports physical needs of the patients
28,891 statements Transcripts 1,034 followed by medical treatment.
were placed in 5 pages
content classes.
Manias & Communication Qualitative Focus on issues and Australia No intervention • First a “global” handoff was
Street practices of Critical activities related to presented to all nurses.
Menke Computerized One group Pre- and post-test Pediatric intensive Implementation of a • After implementation of a
2001140 clinical pretest–post-test time study of nursing care unit computerized CDS computerized CDS, no change
documentation design care /charting, in time for patient care or
system (CDS) medication delivery, documentation,
clinical Schedule and • Improved quality of
40
O’Connell Shift handover Qualitative Assess how nursing Teaching hospital No intervention • Strengths and limitations
& Penney Grounded theory care is identified for all 3 types of
200141 approach 1. determined 1.Semistructured handoff reports.
2. delivered interviews (n = 27) • Handoff is forum to
41
Patterson Continuity of care Descriptive 59-item survey of Medical Center No intervention 68% satisfied with information
199564 during patient nurses, addressing received.
transfers patient transfers 197 Nurses • 82% received patient
information via phone, but not
21 units all units use telephone report.
• Critically important content
items identified.
Patterson Handoffs in high- Qualitative Observation of 4 studies: No intervention • Handoffs were reported to be
20042 risk settings handoffs in four NASA mission interactive and face to face.
different settings control, • Commonalties in efforts to
based on previous nuclear power plant, improve handoffs’
research findings; railroad dispatch effectiveness were identified
21 handoff strategies center, ambulance across industries.
listed center • 19 handoff strategies were
observed
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Payne Handover Qualitative Observation of England No intervention
80
2000 Ethnographic information • Reports on 20–30 patients
exchanged in 5 wards in geriatric lasted about 20 minutes.
handover unit in hospital • Use of jargon and
abbreviations.
Audio taping of Observation 146 • Reports given quickly.
handovers hours • Student nurses reported
difficulty understanding
Interviewed staff, 23 handovers handover reports.
• Three levels of documentation
Review of 34 interviews with observed:
documentation nursing personnel 1. formal/public documents,
Kardex, and care plans
Written records; 2. Semiformal: ward diary
Kardex, care plans, 3. “Personal nursing
“scraps” records” ‘scraps’ “ (p.
282)
*Note: related study (Hardey,
200087)
43
Petersen Computerized Pre- and Post- Patient data included Urban teaching Computerized sign- Decrease in the rate of adverse
199816 sign-out Intervention sociodemographic, hospital outs events reported after the
severity of illness, Boston implementation of computerized
Quality comorbidity. sign-out program when compared
improvement Admissions: with the baseline information.
Outcome Measures: 3,146 baseline
adverse events. 1,874
Pre-intervention
Priest & Illustration of Qualitative Incomplete Synthesized case Nursing care • Several deficits in shift report
Holmberg ineffective shift Synthesized case assessment on study rendered is presented and analyzed.
200094 report study admission, ineffective examined and • Need for focus on the patient
shift report, adverse critiqued in and factual information during
drug reaction, and synthesized case a handoff.
the consequence for study.
patient in a
psychiatric setting
Safety issue Setting & study
Richard Congruence Descriptive Handoff study for Western U.S. No Intervention • Discrepancies were noted
198822 between patient incongruence, between the reported and
condition and shift omission, omission 19 medical surgical actual patient condition.
report resulting in units of an 800-bed • Overall congruence of 70%
incongruence hospital (range 68–72%) between the
patient’s condition and the shift
Data Collection of 11 report.
items 57 shift reports • Overall omission rate of
information was 12% (range 9–
584 patients 16%).
• Incongruence was 12% (range
2,952 11–14%).
entries • Significant relationship
between type of reports and
lack of congruence.
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Sexton Handover Qualitative Observation of Australia No intervention • Shift report lasted 15–50
42
2004 shift report handover minutes.
Analysis of data from 30-bed medical unit • Some of the handovers were
audiotaped in 200-bed hospital reported to “promote
handovers confusion.”
Compare handoff • Nurses usually did not use
information with 23 handovers care plans or other formal
documentation sources in the handover.
• 84.6% of information could be
Information in nursing communicated via
handover categorized documentation.
to where information
documented
Sidlow & Electronic sign-out Descriptive Surveyed nurses New York • Nurses given • Implementation of program
Katz- system regarding impact on access to rated positively by nurses.
Sidlow nursing care after General medical computerized • Nurses reported improved
2006141 implementation of unit, in medical sign-out used by communication between
sign-out program. center physicians nurses and physicians.
Likert scale survey • Training • Advantages cited integration of
with option for 19 nurses • Provided with
45
Sherlock Handover Qualitative Observation of 2 medical wards No intervention • Handovers lasted 10–61
43
1995 handovers and minutes.
interviews of nursing • Variance noted in the
described.
Strople & Intershift report Literature review Shift report purpose, Review spans 1988– Literature review • Analysis of deficiencies and
Ottani methods, formats 2005 problems with shift
200689 described. communication presented.
63 citations • Alternate methods of
communication, such as
computer technology, to
importance of patient safety
are discussed.
Safety issue Setting & study
Source related to Type Study outcome population Intervention Key findings
practice measures
Taylor Handover Qualitative Student nurses and Hospitals No intervention • All sought information from at
84
2002 RNs were observed least one source prior to
conducting patient Observation patient procedure.
care procedures. and interview • Sources of information
included: handoff,
Three groups documentation, knowledge of
students year 1 patient, other sources
Taped, transcribed students year 3 • Difference in how nursing
interviews were RNs students and expert nurses
analyzed and coded. accessed data
18 student (novice) • Problems that novices
nurses encounter during handoff are
15 RNs (expert) discussed.
nurses
Timonen & BedsideHandoff Descriptive Patient and nurses Finland No Intervention • Reports approximately three
Sihvonen perceptions of report minutes in length
2000165 Six hospitals • Differences in patient and
Participation by nurses of perceptions bedside
patients in report 118 nurses
47
report
74 patients • Patient reported various
Identification of reasons for not participating in
factors that influence 76 “bedside reports including tiredness,
patient participation reporting session” and not being encouraged to
participate
Webster Bedside handoff Action Research Questionnaire used Medical unit Change from 6 month evaluation:
56
1999 at 3 and 6 months traditional handover • 100% reported access to
Quality postimplementation. 3 months: to bedside resuscitation status
Background
This chapter examines reporting of health care errors (e.g., verbal, written, or other form of
communication and/or recording of near miss and patient safety events that generally involves
some form of reporting system) and these events’ disclosure (e.g., communication of errors to
patients and their families), including the ethical aspects of error-reporting mechanisms. The
potential benefits of intrainstitutional and Web-based databases might assist nurses and other
providers to prevent similar hazards and improve patient safety. Clinicians’ fears of lawsuits and
their self-perceptions of incompetence could be dispelled by organizational cultures emphasizing
safety rather than blame. This chapter focuses on the assertion that reporting errors that result in
patient harm as well as seemingly trivial errors and near misses has the potential to strengthen
processes of care and improve the quality of care afforded patients.
Reporting Errors
Reporting errors is fundamental to error prevention. The focus on medical errors that
followed the release of the Institute of Medicine’s (IOM) report To Err Is Human: Building a
Safer Health System1 centered on the suggestion that preventable adverse events in hospital were
a leading cause of death in the United States. This report emphasized findings from the Harvard
Medical Practice Study that found that more than 70 percent of errors resulting in adverse events
were considered to be secondary to negligence, and more than 90 percent were judged to be
preventable.2, 3 The IOM report also emphasized the importance of reporting errors, using
systems to “hold providers accountable for performance,” and “provide information that leads to
improved safety.” Conceptually these purposes are not incompatible, but in reality they can
prove difficult to satisfy simultaneously1 (p. 156). Nonetheless, reporting potentially harmful
errors that were intercepted before harm was done, errors that did not cause harm, and near-miss
errors is as important as reporting the ones that do harm patients. Patient safety initiatives target
systems-related failures that contribute to errors within the complex environment of health care.
Because many errors are never reported voluntarily or captured through other mechanisms, these
improvement efforts may fail.
Errors that occur either do or do not harm patients and reflect numerous problems in the
system,4 such as a culture not driven toward safety and the presence of unfavorable working
conditions for nurses. To effectively avoid future errors that can cause patient harm,
improvements must be made on the underlying, more-common and less-harmful systems
problems5 most often associated with near misses. Systems problems can be detected through
reports of errors that harm patients, errors that occur but do not result in patient harm, and errors
that could have caused harm but were mitigated in some manner before they ever reached the
patient. Reporting near misses (i.e., an event/occurrence where harm to the patient was avoided),
which can occur 300 times more frequently than adverse events, can provide invaluable
information for proactively reducing errors.6 Analysis of reported errors have revealed many
“hidden dangers” (near misses, dangerous situations, and deviations or variations) that point to
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
system vulnerabilities, not intentional acts of clinician performance that may eventually cause
patients harm.7
Opinions and experiences of hospital leaders about State reporting systems were solicited
from chief executive and chief operating officers of hospitals in six States with a variety of
reporting systems: mandatory, nonconfidential; mandatory, confidential; and voluntary systems.8
Questionnaires addressed perceptions of the effect of mandatory systems on error reporting,
since it was thought that they reduced the frequency of error reports. Items elicited perceptions
on the likelihood of lawsuits, overall patient safety, attitudes regarding release of incident reports
to the public, and likelihood of reporting incidents to the States or affected patients based on
hypothetical clinical vignettes varying in type and severity of patient injury. Safety was a high
priority across hospitals. Most hospital leaders reported that a mandatory, nonconfidential
reporting system run by the State deterred reporting of patient safety incidents to internal
reporting systems. The majority thought that a mandatory, nonconfidential system encouraged
lawsuits. Over half indicated that patients should learn details of errors on request by patients or
families. They preferred that individual practitioner and hospital names be kept confidential and
that incidents involving serious injury be reported to the State. Most indicated that the State
should not release information to patients under certain circumstances. Definitions of reportable
events varied by State, bringing hospital leaders to call for specific, national definitions of errors.
Just because an error did not result in a serious or potentially serious event does not negate
the fact that it was and still is an error. Since reporting both errors and near misses has been key
for many industries to improve safety,6 health care organizations and the patients they serve can
benefit from enabling reporting. Reporting sets up a process so that errors and near misses can be
communicated to key stakeholders. Once data are compiled, health care agencies can then
evaluate causes and revise and create processes to reduce the risk of errors. As such,
organizations have implemented strategies, such as staff education, elicitation of staff advice,
and budget appropriations, to ease the implementation of patient safety systems and to improve
internal (e.g., intrainstitutional) reporting and disclosure to patients and families.
The ramifications of errors that do cause patient harm can provide critical information to
inform the modification or creation of policies and procedures for averting similar errors from
harming future patients. The position taken by the Joint Commission is that once errors are
identified and the underlying factors/problems or “root causes” are identified, similar errors can
be reduced and patient safety increased. When both errors and near misses are reported, the
information can help organizations better understand exactly what happened, identify the
combination of factors that caused the error/near miss to occur, determine its frequency, and
predict whether it could happen again. Underreporting and failure to report errors and near
misses prevents efforts to avoid future errors and thwarts the organization’s and clinicians’
obligation to inform/disclose to patients about the error.
As patients become more aware of actual and potential errors, they not only want to be
informed, they want to know that quality improvement efforts supported by shared learning will
prevent similar future errors.9 Patients and the public support error reporting,10, 11 particularly
mandatory reporting,12 and want to know that clinicians and organizations acknowledge errors13
to leaders, managers, and peers, and that errors are reported as soon as they are detected.14
2
Error Reporting & Disclosure
Error-Reporting Mechanisms
Traditional mechanisms have utilized verbal reports and paper-based incident reports to
detect and document clinically significant medical errors; yet the correlation with actual errors
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
has been low.31 The benefits of these reports are dependent upon the design of the system, how
and what information is collected, and whether the information is used to inform a sophisticated
investigation of specific errors to understand the nature and magnitude of the problem.
Additionally, reports can reflect the clinician’s ability to recognize an error and willingness to
report it, whether through formal reporting mechanisms or documentation in patient records. A
consistent finding in the literature is that nurses and physicians can identify error events, but
nurses are more likely to submit written reports or use error-reporting systems than are
physicians.
Many types of errors that involve medications, health care acquired infections, and medical
devices have been targeted for reporting and dissemination mechanisms.32 In the case of
medication errors, errors made by nurses during the administration of medications to patients are
more likely to be reported in incident reports than are errors made by the prescribers (e.g.,
physicians) or distributors (e.g., pharmacists).33 That said, it is important to note that physicians
do not necessarily use incident-reporting systems.31
Error-reporting mechanisms may capture only a fraction of actual errors. Research has
approached potential errors using direct observation, which, while expensive and not necessarily
practical in all practice settings, generates more accurate error reports.34 More recent approaches
have been focusing on increasing and simplifying error reporting, and automating the detection
of errors, including creating Web-based forms or adapted standard spreadsheets to reveal
patterns of errors.35 Many of these efforts have focused on improving physician participation and
emphasize voluntary31 and confidential reporting.36 Most have encouraged reports of errors and
near misses and shared occurrences with risk managers, other agency leaders, and patient safety
specialists.37 Perhaps a combination of reporting mechanisms, both concurrent and retrospective,
might improve reporting and ideally result in safer processes.
Some of the challenges in using error-reporting mechanisms are associated with the lack of
standard definitions, gaining easy access to databases, and the associated cost of electronic
applications.38 The capability of health care organizations’ networks and hardware, the existing
policies and reporting processes, including reporting actual errors and near misses, and whether
the new system will provide error details to assist quality improvement initiatives must be
evaluated.
Patients can also be a source of information for reports about the occurrence of adverse
effects associated with medical interventions. In institutional settings, patients can provide
information on new symptoms that may not be readily detected by clinician observation or
testing. In outpatient settings, it could be argued that when there is no direct communication
between patients and their outpatient clinicians, some unplanned emergency department (ED)
visits and hospitalizations have been used to determine patients with significant, reportable, and
actionable adverse drug reactions (ADRs). Two studies of patients in an outpatient setting found
that patients reported more information about ADRs, the majority of which did not warrant an
ED visit or hospitalization, when specifically asked, providing clinicians the opportunity to make
changes in the patient’s medication therapy. Without the patient’s report of an ADR, clinicians
would not know about the majority of ADRs affecting patients.39, 40
4
Error Reporting & Disclosure
important information that might reduce future errors. However, there is concern that with
voluntary reporting, the true error frequency may be many times greater than what is actually
reported.42 Both of these types of reporting programs can be Web-based and nationally
representative. Mandatory and voluntary reporting systems differ in relation to the details
required in the information that is reported.
Mandatory reporting systems, usually enacted under State law, generally require reporting of
sentinel events, such as specific errors, adverse events causing patient harm, and unanticipated
outcomes (e.g., serious patient injury or death. It is estimated that less than half the States have
some form of mandatory reporting system for adverse events—a number that is expected to grow
in the next few years. One such State-mandated system is created by Pennsylvania’s Medical
Care Availability and Reduction of Error (MCARE) Act of 2002 (on the Web at
www.mcare.state.pa.us/mclf/lib/mclf/hb1802.pdf). Another example is the New York Patient
Occurrence Reporting and Tracking System (NYPORTS), a Web-based, external, confidential,
mandatory reporting system that has been in existence since 1998. The focus of NYPORTS is on
serious complications of acute disease, tests, and treatments. The system has 9 occurrence
categories (aspiration, embolic, burns/falls, intravascular catheter related, laparoscopic,
medication errors, perioperative/periprocedural, procedure related, and other statutory events)
and 54 specific event codes.43, 44
Sentinel events, such as serious medication errors resulting in deaths, are incidents that can
be voluntarily submitted to the Joint Commission in accordance with their Sentinel Event Policy
(accessible at www.jointcommission.org/SentinelEvents/PolicyandProcedures), which is based
on root-cause analyses. Root-cause analysis is a systematic investigation of the reported event to
discover the underlying causes. The Joint Commission’s position on mandatory reporting is that
providers who are forced to report errors may not describe the details of the event, since they are
motivated by a requirement. Nationally, the Joint Commission’s Sentinel Alerts provide
electronic access to selected sentinel events, identify common underlying causes, and
recommend steps to prevent future events. The alerts provide clinicians the opportunity to learn
about root causes of errors. Sentinel event statistics are available for clinicians to note error
trends and root causes.
An example of voluntary external reporting mechanisms, specifically a Web-based,
anonymous/confidential system, is the Medication Errors Reporting Program (MERP) of the
United States Pharmacopoeia and the Institute for Safe Medication Practices (assessable at
www.usp.org/hqi/patientSafety/mer). Reported errors make up the MEDMARX® database,
which subscribing hospitals and health care systems can use as part of their quality improvement
initiatives. Employees of subscriber organizations enter, review, and release data to a central data
repository that is then available for all subscribers to search. Comparisons can be made within
institutions of a single health care system and across participating health care systems. The
sharing of data allows medication error types, locations in agencies, level of staff involved,
products, and facts contributing to errors to be known and serves to alert clinicians to safety
hazards. Actual, intercepted, and potential errors are all included. MEDMARX® examines the
medication use process, systems, and technologies rather than individual blame and emphasizes
the Joint Commission’s framework for root-cause analysis.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
6
Error Reporting & Disclosure
Third, there is significant variation in how errors are defined, what information is reported,
and who should be involved in reporting and mitigating the effects of errors. Differing
definitions of errors and near misses and significant differences in reporting—among health care
providers working in the same institution and across health care systems—make it difficult to act
and prevent similar errors. One of the greatest challenges confronting the patient safety
movement is agreeing on standard definitions of what constitutes errors.67 Reporting near misses
can facilitate a blame-free approach (a hallmark of a culture of safety) and fewer cultural and
psychological barriers. Yet, clinicians who believe that an error or near miss was unimportant or
caused no harm, especially if intercepted, might decide that a report of a near miss is not
warranted;68–70 near misses are not frequently reported.71
Lastly, error reports are difficult to complete, and feedback about needed system changes to
improve safety is not commonly given.55 The lack of standardization in the information that is
reported and collected makes comparisons and trending as well as preventing future errors
difficult. Implementing and using standardized reports of error events, such as those available in
hospital databases, is just one example of an open communication strategy, benefiting both
clinicians and ultimately the patients they serve.72 However, the process for reviewing events is
not consistently applied nor conducted in matter conducive to providing feedback and improving
safety.73
These and other barriers to reporting and disclosing errors must be breached to accomplish
safer health care.25 Reporting errors and near misses through established systems provides
opportunities to prevent future similar, and perhaps even more serious, errors. Failure to report
and speak up about errors and near misses is unacceptable because the welfare of patients is at
stake. Investigations into the reporting behaviors of clinicians have found that clinicians are more
likely to report an error if the patient was not harmed.74 Clinicians would also be likely to report
an error made by a colleague regardless of patient harm.74
Several factors are necessary to increase error reporting: having leadership committed to
patient safety; eliminating a punitive culture and institutionalizing a culture of safety; increasing
reporting of near misses; providing timely feedback and followup actions and improvements to
avert future errors; and having a multidisciplinary approach to reporting.64, 65 Only through
reporting errors can nurses and other health care providers learn which system design and
operational failures contribute to human fallibilities and subsequently improve the quality of
care. Additionally, one study found that physicians, pharmacists, advanced practitioners, and
nurses considered the following to be modifiable barriers to reporting: lack of error reporting
system or forms, lack of information on how to report an error, and lack of feedback to the
reporter.75
Error Disclosure
Disclosure of health care errors is not only another type of error reporting, it is also an
account of a mistake. It involves an admission that a mistake was made and typically, but not
exclusively, refers to a provider telling a patient about mistakes or unanticipated outcomes.
Disclosure addresses the needs of the recipient of care (including patients and family members)
and is often delivered by attending physicians and chief nurse executives. However, while
physicians’ willingness to disclose errors may be stimulated by accountability, honesty, trust,
and reducing risk of malpractice, physicians may hesitate to disclose because of professional
repercussions, humiliation, guilt, and lack of anonymity.76
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Disclosure also sometimes calls for a formal verbal apology, in some institutions presented in
writing by patient safety officers. Often the providers involved in the error apologize. The central
element of disclosure is the trust relationship between patients (or residents of long-term care
facilities) and health care providers. Agency policies specify the disclosure approach and identify
the person—for example, the primary care provider or safety officer—who communicates the
error, adverse event, or unanticipated outcome to the patient or resident, or family member.
Some institutions make error disclosure mandatory, and some disclose errors on a voluntary
basis.
Providers were concerned about disclosure. They felt shame and fear about their mistakes.
“Medical missteps” were transformed into clinical mistakes after practice standards were
developed; next, malpractice suits followed. As a result, mistakes were subsequently hidden,
creating a negative cycle of events.72 Furthermore, physicians’ anxiety about malpractice
litigation and liability and their defensive behavior toward patients have blocked individual and
group strategies for preventing and reducing medical errors, thus hindering error reduction
attempts.22 Hiding errors at times resulted in providers being involved in litigation. The
association between hiding errors and reducing costs seemed less certain than formerly
believed.29
When patients’ concerns are not addressed, they are more unwilling to return for future care
needs77and follow medical advice, and are more likely to seek malpractice lawsuits.78–80 Several
surveys of patients and the general public have found that they believe health care to be only
moderately safe and that they are concerned about errors affecting them if the seek care in
hospitals.54, 81–84 Specifically, patients are concerned about misdiagnoses, physician errors,85
medication errors, nursing errors,77, 85 wrong test/procedure errors, 85 and problems with medical
equipment.77
Another dimension of reporting and disclosing errors is the role patients can have. Patients
can understand, perceive the risk of, and are concerned about health care errors. As more is
learned about errors, patients and clinicians have opportunities to improve health care quality.
Patients want full disclosure86 and to know everything about medical errors that impact them.
Disclosure can avert patients seeking another physician and can improve patient satisfaction,
trust, and positive emotional response to an error, as well as decrease the likelihood of patients
seeking legal advice following the error.87 Patients have the right to know; patients and the
public strongly desire disclosure.86, 87 Failure to disclose mistakes and unanticipated outcomes
limits opportunities for evaluation of systems and processes, and for sharing knowledge gained
by publishing safety alerts across organizations, conducting educational sessions, modifying
practice, and offering opportunities for improved performance.88 Disclosure is also an element
that contributes to the creation of a culture of safety89 and as such must be accepted as a strategy
in health care institutions interested in becoming high-reliability organizations, “those in which
error seldom occurs even in dangerous environments”90 (p. 121).
A significant barrier to disclosing errors is the clinicians’ willingness to do so. This may in
part be due to the lack of clarity as to exactly what should be disclosed, when the discussion
should take place, and who (e.g., a hospital administrator, physician, or nurse) should disclose
the error. When it comes to what should be disclosed, research has found that physicians and
nurses want to disclose only what had happened,81 but there are no universal rules for doing so.86
Decisions to disclose or not to disclose are complex and depend on how errors are defined and if
they are recognized or detected. Health care providers are heavily influenced by their perceived
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Error Reporting & Disclosure
professional responsibility, fears, and training, while patients are influenced by their desire for
information, their level of health care sophistication, and their rapport with their provider.91
Both health care providers and patients seem to agree that errors disclosure should take place
when patients are harmed and that corrective action should involve systems improvement.91
Other research has found that the likelihood of disclosure increased for physicians, nurses, and
emergency medical technicians (EMTs) as the severity of the error increased.92 Somewhat
conflicting with this is the assertion that patients would suffer additional harm when
“unnecessary” information was shared about a mistake.30 Unfortunately, this line of reasoning
has its roots in the dubious contention that patients might be more harmed when told the truth as
compared with disclosing the mistake.
Physicians have argued that they should be responsible for disclosing errors to the patient.93
This is borne out in some research that has shown that in practice, at least among emergency care
providers, nurses were less likely (23 percent to 54 percent) to disclose an error than were
physicians (71 percent to 74 percent).92, 94
Because there are instances when error disclosure has been followed by the “victims”
seeking further action, the disclosure of errors in practice may not reflect all errors that have
harmed patients,95–97 nor all those that could or should have been disclosed. In many instances,
patients may be less likely to seek legal action if the error is disclosed by the physician82, 83 and if
they do not suspect a cover-up.78 However, it is not known if there is a causal relationship
between disclosure of errors and adverse consequences such as litigation.87
Disclosure policies. Written policies on disclosing health care mistakes stand to benefit
institutions because they can reduce idiosyncratic responses of reporters.19 Specific policies and
systems of error disclosure are preferred over position statements.98, 99 This is because policies
stipulate health care personnel to be notified, patient care to be given following the mistake, and
the content of the disclosure notification. Plans to care for the patient are also included. “True
informed consent can only be as a result of discussion between a patient and
physician”19 (p. 155). Such a policy fits within a systemwide approach to quality and safety.
Underreporting may be addressed by a standardized patient safety event form, integration of
databases for event reporting, ongoing education to reinforce the need for providers to report,
and patient and family involvement in care delivery processes.100
A disclosure policy implemented by the Veterans Affairs (VA) Medical Center in Lexington,
Kentucky,91 resulted in liability payments that were more moderate than such payments at
similar facilities. The policy required disclosure to patients of unanticipated outcomes (accidents
or medical negligence).101 This developing, national VA initiative continued its focus on research
and policy related to health care error, error-reporting systems and analysis, and feedback
methods. Improving systems of care was the target of the ongoing initiative.102 The VA’s
disclosure policy included reporting details of incidents, expressing institutional regret, and
identifying corrective actions. Comparable liability payments resulted when contrasted with
other VA hospitals. Another solution instituted was the granting of a waiver for practitioners
who reported errors. Many voluntary adverse event/health care error-reporting systems created
for acute care hospitals have built on the VA reporting system.44 Nonetheless, many health care
organizations may not disclose errors to patients,53 although virtually all have traditionally
reported errors through paper incident reports that remained internal and confidential. Error-
communication strategies are changing, since several States have mandated that health care
institutions notify patients about unanticipated outcomes.103
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Policies can be supported by advisories, which have historically relied on relatively few
contributions from patients. Patients’ responses to drafts of advisories were explored best with
Medicare beneficiaries.104 While not specifying advisory content on disclosure of health care
errors, recommendations included the involvement of patients and providers. Discussions on
patient roles in safety enhancement and the development of protocols for inclusion in safety
advisories were encouraged.
The development and implementation of disclosure policies should be part of an
organization-wide effort predicated on cultural change that includes open communication, truth
telling, and no blame.20, 60 Debate regarding the assignment of blame has not negated the
importance of counseling some clinicians when policies are intentionally violated—or
prosecuted in the case of criminal behavior. Policies on disclosure, including apologies to
patients and families, have been justified; respect for patients and their autonomy prevails as a
source and support of patients’ right to information about health care errors. The aforementioned
changes for disclosure policies—for example, open communication, truth telling, and no
blame—apply to error-reporting systems as well.
Differences between reporting and disclosure. It is important to place health care error-
communication strategies, specifically definitions of reporting and disclosure, in context (see
Figure 1). The process of reporting errors is sometimes referred to as disclosure of errors,
causing confusion. A report of a health care error is defined as an account of the mistake that
conveys details of the occurrences, at times implicating health care providers, patients, or family
members in error events. Both clinicians and patients can detect and report errors.105 Each report
of a health care error can be communicated through established and informal systems existing in
health care agencies (internal) and outside organizations (external), and may be written (e.g.,
electronic or paper) or verbal, voluntary or mandatory (policy driven). The core value supporting
reporting is nonmaleficence, do no harm, or preventing the recurrence of errors.
An error report may be transmitted internally to health care agency administrators, managers,
physicians, nurses, pharmacists, laboratory technicians, other caregivers, and agency legal
counsel. Reporting is often directly related to risk management activities intended to prevent
actual or potential threats of harm. Intrainstitutional or internal reporting examples are incident
reports, nurses’ notes, safety committee reports, patient care rounds, and change-of-shift reports.
Intrainstitutional reports have increased since the initial IOM report and the elimination of the
culture of blame in many health care agencies. Of these, the most common means of reporting
serious errors for nurses has been through incident reports, a mechanism that has been criticized
as being subjective and ineffective in improving patient safety.106, 107
Extrainstitutional or external reporting systems include accounts submitted to agencies such
as the Medical Event Reporting System for Transfusion Medicine (MERS-TM), MERP, the Joint
Commission, and various State departments of health, as well databases such as United States
Pharmacopeia’s MEDMARX® Reporting System (U.S. Pharmacopeial Convention 2006), as
illustrated in Figure 1. Additional reporting methods have been called for, such as databases that
allow for analysis and communication of alerts to key stakeholders in single agencies and across
systems.
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Error Reporting & Disclosure
Mandatory, Voluntary
Intrainstitutional Extrainstitutional
(Nurses, physicians, pharmacists, (State, JCAHO,
other caregivers, managers, professional organizations,
administrators, risk, quality, and community, Nation, etc.)
safety officers, board of trustees,
other agency staff, etc.)
Reporting (providing accounts of mistakes) and disclosing (sharing with patients and
significant others) actual errors and near misses provide opportunities to reduce the effects of
errors and prevent the likelihood of future errors by, in effect, warning others about the potential
risk of harm. Reporting reduces the number of future errors, diminishing personal suffering108
and decreasing financial costs. In contrast, disclosure is thought to benefit patients and providers
by supplying them with immediate answers about errors and reducing lengthy litigation.109
Although clinicians and health care managers and administrators feel uncomfortable with
disclosure, disclosure is a duty.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
communicated. The investigators found that improved reporting systems may encourage
providers to report near misses. Once identified and shared with front-line providers, errors may
be prevented.111
Several Web-based systems have also been used in hospitals to improve error reporting. One
study investigated reported errors, intercepted errors, and data quality after a Web-based
software application was introduced for medication error event internal reporting. The reporting
system generated occurrence reports, documented anonymously submitted reports, and allowed
for the possibility of real-time reporting and more rapid investigation of contributing factors. The
investigators found that error reports increased as well as intercepted error threats (near misses),
and intercepted nurse, physician, and pharmacist medication errors increased. The details of
cause-of-error reporting also increased as did the participation of hospital leadership.112 In
another study, Wu and colleagues113 described the use of Web-based internal reporting in the
intensive care unit setting. The researchers found that analyzing and disseminating error and near
miss data, so that providers are alerted to safety risks, could reduce errors. Additionally, patient
safety would most likely improve when providers see the benefits of reporting through systems
improvements.113 One other project occurred when leaders at Baylor Medical Center at
Grapevine partnered with DoctorQuality to create a Web-based form for reporting errors.114 At
the same time, they implemented strategies to change the culture of the organization, supported
by education on the use of the reporting system, incident reporting, communication, and
feedback information about errors. Investigators found that event reporting doubled, suggesting
that even with increased reporting, the actual number of errors may not be identified. Proactive
risk management allowed for timely followup, the percentage of errors submitted increased after
implementation, and the average days from event to submission shortened.115
Using a voluntary, regional external reporting database and United States Pharmacopeia’s
MEDMARX® database increased medication error reports across critical access hospitals.116
Most errors reported to the regional database and MEDMARX® did not result in harm to
patients. However, significant differences existed in severity, phase, and types of error when
comparing the two external reporting systems. More error reports from the critical access
hospital database (Nebraska Center for Rural Health Research) reached patients than did
MEDMARX® errors. Increased reporting of potential and near-miss errors by nursing and
pharmacy personnel was associated with easily accessible pharmacist availability.
Another strategy to improve awareness of errors is the assessment of medical records to
detect errors that were not otherwise reported. Two prospective, cross-sectional studies
compared facilitated incident monitoring to retrospective review of patient medical records in
hospitals. The first117 compared medical record review to physician reporting prompts by daily
electronic reminders for 3,146 medical patients in an urban teaching hospital. The investigators
found that the physician reporting method identified nearly the same number (2.7 percent) of
adverse events as did the retrospective medical record review (2.8 percent), but the electronic
reminders detected more preventable adverse events (62.5 percent vs. 32.9 percent), was less
costly than the record review ($15,000 vs. $54,000), and could be integrated in the daily routine
through electronic health information technology. The second, smaller study118 compared
facilitated discussions to medical record review in one 12-bed intensive care unit (ICU) with 164
patients in an Australian hospital with an established incident reporting system. The investigators
found that facilitated discussions, in addition to the incident reporting system, identified more
preventable incidents than retrospective medical record review and was not as resource intensive
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Error Reporting & Disclosure
as medical record reviews (50 hours vs. 65 hours). However, medical record review detected
some incidents not captured by the incident reporting system.
Research Evidence
Over the past 11 years, research on the reporting of errors among nurses targeted four key
areas: (1) description of who reports errors and what errors are and perceived to be reported; (2)
barriers to error reporting; (3) disclosure preferences; and (4) reporting systems and frameworks,
including the development of effective reporting systems. The researchers used different
methods to assess reporting preferences and what was reported, including surveys,
retrospectively assessed error reports,116, 119–128 a 2-week journal,129 error scenarios,81, 92, 130 and
focus groups.91, 131, 132 One study used a mixture of methods.58 Most of the research included in
this analysis involved discussions of reporting involving health care providers using existing
systems, while 11 studies assessed the effects of new or revised error-reporting systems.
Who Is Reporting
Verbal, paper-based, electronic, and Web-based error-reporting mechanisms have been used
to capture, record, and communicate errors. Nurses were found to report the majority of errors.
The proportion of error report submitted by nurses ranged from 67.1 percent133 to 93.3
percent.124 Nurses reported 27 percent more errors than did physicians.134 Physicians submitted 2
percent135 to 23.1 percent, and 9.5 percent were submitted by others.133 Considering the 11
surveys included in this analysis that investigated who submitted error reports, all found that
nurses reported the majority of incident reports.36, 46, 106, 120, 123, 124, 133–137
Factors that have influenced the submission of error reports included believing it was
beneficial to do so131 and having quality management processes in place.138 Feeling comfortable
reporting, working in a climate of patient-centered care, job satisfaction, and the serious nature
of the error enabled error reporting.131 In terms of characteristics associated with those likely to
report errors, nurses with more than 5 years of experience were more likely to believe there was
no value in reporting near misses.106 This contradicts findings from another survey where the
frequency of error reporting was found to be higher among nurses with 5 to 10 years of
experience.139 Another finding that complicates this notion is that in one survey, nurse managers
reported more errors than did staff nurses,139 but this could have been associated with
organizational structure rather than ability of staff nurses. Additional characteristics were that
nurses providing direct patient care were more likely to report,140 and that pediatric nurses
reported medication errors more frequently than adult nurses.141
Compared to physicians, nurses seemed to have more knowledge/awareness of the reporting
process/system,106, 132 know what should be reported,69, 142 know when the error should be
reported,142 be more likely to have submitted an error/incident report, know how to use an
incident report form, and know where to submit the report.106 One survey found that while 98.3
percent of physicians and nurses knew about incident reporting systems within their
organizations, nurses were more likely to know how to submit an error report, have experience
with submitting an error report, and know where to submit the report.106 Another survey found
that 54 percent of residents and 97 percent of nurses knew about their hospital’s error-reporting
system, and 13 percent of residents and 72 percent of nurses were likely to use the reporting
system.143 Conversely, another survey found that less than 10 percent of physicians and nurses
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
were aware of their State’s mandatory reporting system, and only a small subset of the ones
familiar with the system (less than 50 percent of nurses and 20 percent of physicians) had
actually submitted a report using the mandatory system.144
Who reported was also be associated with their understanding of what should be reported.
One survey of medication administration errors found that nurses acknowledged differences in
how reportable errors were defined among staff.145 Similar findings were found in another survey
of nurses in Korea, where nurses were not clear as to what should be reported.139
Nurses tended to be more likely to report errors, considering it a professional obligation. One
survey of nurses in rural hospitals found that nurses believed they were responsible for reporting
errors, getting needed education, recommending changes in policies and procedures to prevent
future errors, and participating in investigations of the causes of errors.58 Another found that
physicians believed that nurses were responsible for reporting errors.144 Similar findings were
found using error scenarios, where nurses believed that error reporting was a professional
responsibility and that nurses should report the errors made by other nurses if they did not do so
themselves.130 However, another survey found that nurses were more comfortable reporting their
own errors than they were of those of colleagues.146 Another found that 54 percent of residents
and 91 percent of nurses believed that they would report their own error or someone else’s, and
25 percent of residents and 1 percent of nurses would report the errors of others if they did not
like the person who caused the error.143
What Is Reported
What is reported could depend upon the understanding of nurses as to what should be
reported, which is associated with how reportable errors and near misses are defined. If nurses,
nurse managers, and physicians question the value of reporting because they did not see
improved patient safety in practice and policies,132 few errors may be reported. If nurses did not
understand the definition of errors and near misses, they were not able to identify or differentiate
errors and near misses when they occurred. For example, one very small study gave four error
scenarios to 13 perioperative nurses to assess whether they could detect errors and their reporting
preferences. The investigators found that 58 percent of the theoretical errors were identified as
errors, but only 26.7 percent of them would have been reported.130 However, when nurses were
given definitions of errors and near misses, one study indicated that nurses reported 58 percent of
errors and 59 percent of near misses.129 Among the respondents, 61 percent reported one error
and 38 percent reported making between two and five errors during a 2-week period.
The severity of errors and who is doing the reporting influence which errors are reported.
One survey found that 58 percent of nurses did not report minor medication errors.69 Another
survey found that while nurses reported 27 percent more errors than physicians, physicians
reported more major events and nurses reported more minor events because they had a more
“inclusive view.” Both physicians and nurses reported near misses.134 Analysis of error reports in
Japan found similar differences in error reporting among different types of clinicians. One study
found that nurses and pharmacists submitted more reports of events that were considered minor,
while physicians submitted reports when errors were detected and prevented by nurses or
pharmacists.123 The other study of error reports submitted by physicians and nurses in a hospital
found that 99.5 percent of the reports—the majority of which were submitted by nurses—were
for what were considered minor incidents. Additionally, the lag time for reporting major events
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Error Reporting & Disclosure
was 18 percent shorter than it was for minor reports, but 75 percent longer when physicians
submitted the error report.124
Several surveys assessed whether errors that resulted in harm to patients were reported. One
survey of physicians and nurses in England found that error reporting was more likely if the error
harmed a patient, yet physicians were less likely to report errors than were nurses or midwives.
Clinicians were less likely to report errors made by senior colleagues, and physicians in
particular were unlikely to report violations of clinical protocols, whereas nurses and midwives
would.46 A review of error reports found that when an error harmed a patient, 34 percent of the
reports were submitted by physicians and 27 percent of the reports were submitted by nurses.
When errors did not harm patients, 31 percent of the reports were submitted by nurses and 17
percent were submitted by physicians.133 One survey found that nurses would report errors
whether they harmed the patient or not.140 A survey in Korea found that 67 percent of nurses
believed they always reported errors that harmed patients.139 A very small study found that
reporting errors that harmed patients was a secondary concern for nurses; nurses believed that
errors that fell outside the scope of the nurse’s practice should be reported by the responsible
individual (i.e., not the nurse).130 A related study found that errors resulting in either patient harm
or worker injury were underreported.138 Thus, events that may harm patients are at risk for not
being reported.
What is reported may also be associated with whether the reports are confidential or
anonymous. Informal reporting mechanisms were used by both nurses and physicians. One
survey found that nurses also informally reported to physicians when a dose was withheld or
omitted, but they were less likely to formally report the missed dose as an error.142 Nurses also
had a greater tendency to informally report errors to nurse colleagues.130 Reviewers found that
confidential reports were more complete than anonymous ones, but the types of patient harm did
not vary between anonymous and confidential reports.121 Since voluntary reporting depends on
health care professionals to report medication errors so that the more realistic frequency and type
of errors that happened can be known, several surveys encouraged anonymous responses to
identify the barriers to reporting medication administration errors.58, 69, 142, 147–149 While only brief
descriptions of the survey instruments were discussed in each of the studies, the surveys did
capture error reports that may not have been communicated or known otherwise.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
with fewer than 5 years experience were more likely to report deep vein thrombosis.106 Another
retrospective analysis of error reports in six Japanese hospitals found that reported error rates
were high for prevention of problematic behavior, patient suicide, patient falls, and subcutaneous
injections of insulin. A high number of error reports in some hospitals were associated with
maintenance of dialysis, endoscopy preparation and assistance, administration of preoperative
treatments, and blood transfusions. There were more reported errors in the elderly, hemodialysis
patients, and those with problematic types of behavior.125 Another study found that the major
types of errors reported were for unsafe conditions or near misses, adverse events that harmed
patients, medication/infusion errors, and patient falls.135 In yet another study, researchers found
that the majority of reports involved medication errors, surgical errors, falls, and problems with
procedures.127
Additionally, the type of errors reported can be associated with characteristics of the patient
population. For example, the findings from one survey indicated that medication error rates,
which were computed from actual occurrence reports, were higher on pediatric units than adult
units.141 Children’s vulnerability to adverse outcomes from medication errors was attributed to
weight-based drug dosing, dilution of stock solutions, and immature physiological buffering
systems, situations that are unique to children.
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Error Reporting & Disclosure
except near misses should be reported, less than half of medication administration errors were
reported. Intravenous medication errors were the highest percentage reported events; patient falls
were associated with major injuries. Not reporting medication errors was attributed to nurses’
concerns about administrative responses and personal fears such as imagining the poor opinion
of their coworkers. Sharps injuries, exposure to body fluids, and back injuries threatened nurse
safety. Some questioned hospitals’ quality management processes.
The perceived rates of error reporting may be associated with organizational characteristics.
For example, the perceived rates of medication administration error reporting were compared by
organizational cultures of hospitals and extent of applied continuous quality improvement (CQI)
philosophy and principles.151 As bed size increased, perceived rate of medication administration
error reporting decreased. Larger hospitals tended to be more hierarchical in nature. Group-
oriented hospital culture (norms and values associated with affiliation and trust, flexibility, a
people-oriented culture with concerned and supportive leadership) and higher levels of CQI
implementation were positively associated with the estimated overall percentage of medication
administration errors reported.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Table 1. Reasons why clinicians do not report and disclose errors and near misses
Reporting Barriers
Fear
Fear69, 138, 148, 150, 151
Fear of being blamed for negative patient outcome70, 147
Fear other providers will consider provider who made the error incompetent70, 138, 141, 142, 147
Fear of reprimand from physician(s)70, 147, 148
Fear patients will develop negative attitudes70, 147
Fear of legal liability, belief that disclosure of errors to patients results in lawsuits149
Fear of “telling” on someone else149
Fear of adverse consequences from reporting70, 141, 147, 148
Fear of reporting that is not anonymous149
Understanding
Confusion over definition of errors and near misses70
Disagreement with the organizations’ definition of error70, 148, 151
Providers unaware that errors occurred70, 142, 147
Providers’ bias about which incidents should be reported70, 149, 153
Some incidents, i.e., near misses, thought too trivial/unimportant to report106
No perceived benefit131, 149
Administrative/Management/Organizational
Administrative response138, 142, 148, 150, 151
Lack of feedback on reported errors70, 120, 147, 148
Persistence of the culture of blame/shame, blaming the individual70
Excessive emphasis on medication error rates as quality measure of care70, 147
Poor match of administrative response to errors with severity of errors70, 148
Burden of Effort148
Incident reports take too long to complete70, 131, 147, 149, 151
Verbal reports to physicians take too long or contacting the doctor takes too much time 70
Providers forget to make a report, too busy106, 131
Extra work involved in reporting149
Five studies provided additional information about reporting barriers for nurses. In a survey
of nurses in Taiwan, nurses did not vary in their concerns about the effects of reporting barriers
based on factors such as the age of the nurse, type of education, length of experiences, and length
of employment. Yet nurses who perceived more error reporting barriers also believed that errors
were over- or underreported, compared to nurses who reported that the error reporting rates were
accurate. In this study, factors that could thwart error reporting were positively correlated with
the power hierarchy and face-saving concern. On the other hand, the better the work
environment, quality management, and relationships with peers, the fewer the perceived barriers
for error reporting.147
Factors about the organization’s culture may be barriers to error reporting. In one survey of
clinicians in rural hospitals, the majority agreed that hospital administrators did not punish error
reporters. Most agreed that the hospital culture recognized that mistakes could be made (64
percent) and that error reporting could be done by all employees (86 percent). The majority felt
comfortable (65 percent) or somewhat comfortable (32 percent) discussing medical errors, and
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Error Reporting & Disclosure
have learned and would like to continue to learn from the mistakes of others. Attempts to
maintain collegiality and their belief about lacking authority prevented nurses from questioning
physicians. Nonphysicians attributed many errors to nursing practices. In fact, if an error
occurred, 96 percent of nurses and more than 90 percent of physicians, administrators, and
pharmacists would have assigned patient safety responsibility to nurses. Only 22 percent of
respondents believed that clinicians and administrators shared equal responsibility for patient
safety.58
Three studies by Wakefield and colleagues70, 150, 151 asked nurses about organizational and
leadership/management factors that could thwart error reporting. Staff nurses believed that
having an organizational culture that did not support error reporting70 and management practices
and beliefs (e.g., supervisors not viewing fear of an administrative response as a barrier to error
reporting)150 thwarted error reporting. Wakefield and colleagues151 found in another survey that
hospital culture types varied; smaller institutions tended to have group-oriented cultures while
larger institutions tended to be more hierarchal (which was negatively associated with error
reporting). They also found that the extent of CQI implementation increased with bed size of the
hospital, and perceived rate of medication administration error reporting decreased. Considered
together, the presence of a group-oriented culture and higher levels of CQI implementation were
positively but not significantly associated with reporting errors.
One study surveyed physicians and nurses about barriers that could be modified to enable
error reporting. The modifiable barriers they identified were the structure and processes for
reporting errors and the lack of education about errors. The least modifiable barriers they
reported were fear of lawsuits, fear of being blamed, and motivational issues.149
Error-Reporting Strategies
Thirteen studies investigated the effects of new and revised error-reporting systems on error
reporting. Investigators examined a clinical pharmacist on units;119 education, a revised reporting
system, and a call center;120 a voluntary reporting system;121, 122 a voluntary system for near
misses;154 a voluntary, paper-based reporting system;133, 136, 137 a confidential, electronic-based
reporting system;135 education enhanced by error report summaries;115 education of nurse case
managers;126 a Web-based anonymous reporting system;112 and confidential peer interviews.36
Only one study assessed the impact of mandatory error reporting.144
Three of the studies introduced an “expert” to assist providers in detecting errors. In one, a
clinical pharmacist was introduced on units to improve medication safety and increase
medication error reporting as well as error reporting generally. Error reports remained relatively
constant, yet error reports from physicians decreased. The severity of errors decreased over time,
and the reporting of near misses increased from 9 percent to 51 percent.119 Another study
introduced an “expert peer” to prompt assessment of patients, using confidential peer interviews
during morning rounds or via e-mail. Verbal reports of errors were confirmed with the patient
medical records, but only one incident report was submitted by a house officer for a patient fall.
Nurses submitted the majority of incident reports for errors involving patient slips and falls,
medication errors, and other events.36 In the third study, a hospital introduced nurse case
managers to review patient medications, detect adverse drug events (ADEs), and report detected
ADEs. Once the nurse case managers began reviewing medications and submitting ADE reports,
the majority of which were for serious ADEs and possible ADEs, the reports of ADEs nearly
doubled.126
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Researchers in one study provided error reporting education to staff, revised their current
reporting system, and introduced a call center. As a result, reporting increased throughout the
hospital—more physicians in the emergency department and more nurses in medical units
submitted error reports—and there were more anonymous reports compared to the hospital used
as a control. More reports were submitted using the one-page form than through the call center.
Nurses continued to submit the majority of reports.120
One study aimed to improve error reporting through educational initiatives in 10 critical
access hospitals. The investigators conducted several education workshops about the nature of
errors, the design of safety systems, and best practices in medication safety. Then they collected
error reports from all the hospitals and provided quarterly reports from the error reports to each
of the hospitals, including the results and averages from the group of hospitals. The investigators
found that most of the errors were not harmful and were associated with medication
administration, mostly for dose omissions. The reports helped hospitals identify and address
systems factors that were conducive to errors.116
Five studies tested the effects of new, voluntary error-reporting systems. One study assessed
the impact of introducing an error-reporting system in community, primary care research
networks. Investigators found that the number of reports increased, but the confidential reports
were more complete than the anonymous ones.121 Another study also found that error reports
increased after the introduction of a voluntary reporting system, that nurses submitted the
majority of the errors reports, followed by pharmacists, and physicians submitted an error report
only if the error was detected and prevented by the nurse.122 A teaching hospital in New York
implemented a new confidential, electronic-based error-reporting system along with an
educational program. Investigators found that error reporting increased, but reporting remained
low among physicians.135 Another study assessed the effects of introducing a new Web-based
anonymous reporting system. Investigators found that error reports, including those for
intercepted errors, increased, and errors attributed to physicians increased while those attributed
to nurses and pharmacists decreased.112 The last of these five studies assessed the impact of using
a voluntary reporting that called near misses, “close calls” and frequent feedback reports. The
investigators found that after six months, the number of error reports increased by 1,468
percent.154
The association between voluntary error reporting and the number of error reports submitted
was tested in two prospective, interrelated studies, using paper-based SAFE (Safety, Actions,
Focus, Everyone) cards. One tested these cards in the medical ICU,137 the other in the surgical
ICU.136 The SAFE report card was used over a period of 6 months to document types of events,
including errors in tests, treatments, and procedures; medication; equipment; blood products;
intravenous complications; behavioral/psychiatric; laboratory; surgery; and falls. This new
reporting system resulted in more reported events (232 events) than what was captured by the
existing hospitalwide database used to register errors and high-risk events (29 events before and
26 events during the intervention). The investigators believed that the system fostered reporting
by unit team members and could reduce events proactively through improved practice.136 The
second study used similar methodology and added an additional step: the cards were withdrawn
then reintroduced. The cards were reintroduced once the investigators assessed the significant
drop in error reporting. The initial use of the cards increased nurse and physician reporting. After
the cards were withdrawn, there was a decrease in reports by both nurses and physicians; instead,
there were an increased number of reports submitted to the hospital electronic reporting system
by nurses. The investigators found that a higher proportion of events reported by physicians were
20
Error Reporting & Disclosure
for events that resulted in patient harm, whereas the higher proportion for nurses was for events
that did not result in patient harm.136 In both studies, nurses submitted the majority of reports and
physician reporting increased.
Disclosure Preferences
Five studies investigated factors associated with disclosure preferences of nurses. Two
studies investigated disclosure preferences of patients and clinicians. In one of these studies,
which used surveys with error scenarios, patients reported wanting full disclose of errors, yet
physicians and nurses wanted to disclose only what happened.81 In the other study, which used
focus groups, patients and clinicians agreed that errors should be disclosed when the patient was
harmed. The degree of harm caused by errors and whether patients and others were aware of
errors were related to disclosure preferences. Institutional culture (perceived tolerance for error
and supportive infrastructure) was important to the disclosure decision. Relevant patient factors
were health care sophistication, desire for information, and rapport with provider. Provider
factors included fears of malpractice, reputation, job threat, and change in rapport with the
patient, as well as perceived professional responsibility, medical training, lack of confidence in
disclosure skills, and personal discomfort.91
Three studies used surveys to investigate disclosure preferences of EMTs, physicians, and
nurses. In one study that specifically asked only nurses, nurses reported that they were less likely
than physicians to want to disclose errors.81 Another survey found that 74 percent of physicians,
23 percent of nurses, and 19 percent of EMTs had disclosed errors.95 Physicians were also more
likely to disclose (71 percent) an error than were nurses (59 percent), but nurses (68 percent)
were more likely to report an error than were physicians (54 percent).92
Another survey found that 29 percent of physicians and 64 percent of nurses reported feeling
comfortable discussing mistakes. Also, 42 percent of physicians and 44 percent of nurses
reported feeling uncomfortable discussing errors with patients.143
21
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
safety practices begin with policy and procedure development and continue with the allocation of
resources for developing reporting systems and databases as well as educating caregivers.
New systems of reporting errors are generally developed in-house or purchased by health
care agencies. Electronic systems that are Web-based—that include easy reporting and standard
definitions of errors, near misses, and potential root causes as well as personnel responsible for
analyzing and sharing safety hazards—provide opportunities for data management and pattern
identification of unsafe practices. They also save time for providers as reports are entered into
databases and help to shorten the time from incident to report. Developing new systems of
reporting requires administrators to budget accordingly so that additional personnel and
electronic reporting systems as well as complementary software are financed. Periodic training
of personnel and upgrading reporting databases are necessary, as are systems improvements that
depend on error-report analysis.
Patients and families desire disclosure of health care errors by health care providers.
Providers have an ethical responsibility to disclose. Generally, organizations use verbal reports,
followed by written reports offered by patient safety officers, in consultation with agency
attorneys, in accord with institutional reporting and disclosure policies. Refusing to disclose
suggests fear and a need for provider control rather than patients’ and families’ need for honesty
about their care. Disclosure policies must be created with honesty and respect for patient
autonomy in mind; apologies must be required.
The emotional responses and perceptions of caregivers about errors are important barriers to
reporting. Providers consider themselves at risk when they report errors because many providers
carry the residue from previous experiences with mistakes. Anger from coworkers, shame, lack
of confidence, and the like combine with guilt about the suffering of patients and fear of
potential litigation to hinder reporting and disclosure. Nurses respond similarly to errors as
physicians. They feel vulnerable to disciplinary action and legal repercussions; thus errors go
underreported. Providers must experience changes in institutional culture, where systems
improvements are targeted rather than individual blame.
Teamwork training improves error reporting and reduces clinical errors. Teamwork
principles include increased communication among health care providers. One element of a
teamwork training program, cross-monitoring, might result in decreased errors as providers
observe each other, identify unsafe behaviors, and act to correct each others’ mistakes. Status
barriers must be penetrated. Cross-monitoring involves interdisciplinary/caregiver observations,
identifying unsafe behaviors, and acting to correct unsafe behaviors. The challenge is how this
team training element might be successfully initiated and consistently reinforced in acute care
hospitals, critical access hospitals, nursing homes, long-term care facilities, and other agencies.
Along these lines, nurse educators are challenged to include teamwork strategies and exercises
aimed at increasing safety practices in health care agencies in undergraduate and graduate
nursing courses, taking into account content on existing status issues among health care
providers.
Research Implications
The majority of the research on error reporting has occurred within the past 10 years. While
the studies included in this analysis provide important insight into what is being reported, they
were primarily descriptive and none were nonrandomized or randomized controlled trials. Thus,
additional well-designed studies are called for. Teamwork training holds promise as an
22
Error Reporting & Disclosure
intervention that might affect frequency and severity of reported errors. Emphasizing cross-
monitoring and increased communication as team training strategies might also affect outcomes.
Teamwork training could include scenarios that challenge clinicians to determine how and what
to report. Multisite team training programs should be investigated. The benefit of team training is
in the development of expertise in reporting and disclosure among front-line providers. However,
additional research is needed on the effect of team training on error frequency and reporting and
disclosure skills, especially among nurses. Examples of research questions might be, Are there
differences in patient and family member satisfaction when disclosure of errors is provided by
team-trained versus usual-approach health care providers? Does team training affect error and
near-miss reporting rates?
Additional studies could be conducted in which disclosure of errors to patients and families is
linked to differences in outcomes, for example, claims reports and monetary awards. More
research is needed on the impact of Web-based reporting systems on time used for reporting via
data entry, time from incident to report, time to systems improvement, as well as a classification
of systems improvement strategies and the effect of strategies on error outcomes. Examples of
research questions might be, Are there differences in severity scores following errors when Web-
based versus incident-report methods of reporting are used by health care providers? Are there
differences in frequency of error reports when Web-based versus incident reporting systems are
used? Comparisons also might be made between physician and administrator methods of
disclosure to patients and families in which simplicity or complexity of disclosure events are
examined. Examples of research questions might be, Are there differences in patient and family
satisfaction when physician/administrator disclosers are trained using standard, simple script
versus unscripted (usual) disclosure communication approaches? Are there differences in the
number of liability claims and monetary awards when mandatory versus voluntary disclosure
policies are used?
Notable in the reviewed literature was the dearth of studies on reporting and disclosure
regarding the variety of adverse events, for example, blood transfusion errors, device
malfunctions, health care acquired infections, and others. Most addressed were medication
errors. Data are needed across all settings; most research on reporting is hospital-based.
Community settings, nursing homes, free-standing short-procedure units, and primary care
offices also require additional study regarding error reporting and disclosure. Consequently,
there are many research opportunities for nurse investigators. Research is needed describing
initial patterns of errors across various settings and focusing on other events, including blood
transfusions, surgical incidents, device malfunctions, etc. Comparisons might also be made in
liability lawsuit statistics between institutions that have disseminated and acted on the no-blame
cultural approach versus those that have initially instituted this approach.
Conclusions
Sustained and collaborative efforts to reduce the occurrence and severity of health care errors
are required so that safer, higher quality care results. To improve safety, error-reporting
strategies should include identifying errors, admitting mistakes, correcting unsafe conditions, and
reporting systems improvements to stakeholders. The greater the number of actual errors and
near misses reported, the more reliable a health care organization or system could be, from a
safety viewpoint, when systems improvements are consistent with error patterns.
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Clinicians appreciate seeing the results of the reports they submitted transformed into
systems improvements. Understanding and communicating the root causes of errors and near
misses can decrease the risk of future errors, and support the concept that health care errors are
often systemic and multifactorial. Reporting errors and near misses may increase through
voluntary reporting systems, because voluntary systems provide additional evidence that the
blame/shame patterns are being eliminated in health care organizations and systems.
Electronic error-reporting systems can possibly make the time required to report shorter,
shorten the time for correcting unsafe conditions, and alert providers to emerging unsafe
patterns. Some systems can also facilitate quality improvement initiatives through enhanced
error-reporting systems. The benefits of Web-based health care reporting systems that clinicians
find easy to use and see the effects of their reporting in changes to systems might ultimately
reduce the incidence of serious errors, and significantly improve the safety and quality of health
care afforded patients.
Search Strategy
Various databases were searched to locate studies and related literature on reporting and
disclosing health care errors, including CINAHL®, PubMed®, and Psycharticles. Search terms
included “medical errors” and “medical error reports.” Published results in a non-English
language, expert opinions, case reports, and letters were excluded. Studies specifically assessing
rates, types, and causes of reported medication administration errors were excluded as well. To
be included in the analysis, each article had to involve nursing and report findings specific to
nurses. Most of the articles identified in the literature search were primarily descriptive.
Author Affiliations
Zane Robinson Wolf, Ph.D., R.N., F.A.A.N., dean and professor, La Salle University School
of Nursing and Health Sciences. E-mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
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health care safer: a critical analysis of patient safety 2007;64:1422-26.
practices. Evidence Report/Technology Assessment
No. 43 (Prepared by the University of California at 120. Evans SM, Smith BJ, Esterman A, et al. Evaluation
San Francisco–Stanford Evidence-based Practice of an intervention aimed at improving voluntary
Center under Contract No. 290-97-0013). AHRQ incident reporting in hospitals. Qual Saf Health Care
Publication No. 01-E058.Rockville, MD: Agency for 2007;16:169-75.
Health care Research and Quality. July 2001.
121. Fernald DH, Pace WD, Harris DM, et al. Event
111. Martin SK, Etchegaray JM, Simmons D, et al. reporting to a primary care patient safety reporting
Development and implementation of the University system: a report from the ASIPS collaborative. Ann
of Texas close call reporting system. In: Henriksen Fam Med 2004;2:327-32.
K, Battles JB, Marks ES, et al.,eds. Advances in
patient safety: from research to implementation: Vol. 122. France DJ, Miles P, Cartwright J, et al. A
2. Concepts and methodology, measurement and chemotherapy incidnet reporting and improvement
taxonomies. AHRQ Publication No. 05-0021- system. Jt Comm J Qual Saf 2003;29(4):171-80.
2.Rockville, MD: Agency for Healthcare Research
and Quality; Feb. 2005. p. 149-60. 123. Furukawa H, Bunko H, Tsuchiya F, et al. Voluntary
medication error reporting program in a Japanese
112. Rudman WJ, Bailey HH, Hope C, et al. The impact national university hospital. Ann Pharmacother
of a Web-based reporting system on the collection of 2003;37:1716-22.
medication error occurrence data. In: Henriksen K,
Battles JB, Marks ES, et al., eds. Advances in patient 124. Hirose M, Regenbogen SE, Lipsitz S, et al. Lap time
safety: from research to implementation: Vol. 3 in an incident reporting system at a university
Implementation issues. Surveillance. AHRQ hospital in Japan. Qual Saf Health Care 2007;16:101-
Publication No. 05-0021-3.Rockville, MD: Agency 4.
for Healthcare Research and Quality; Feb. 2005. p.
195-205.
125. Inoue K, Koizumi A. Application of human
reliability analysis to nursing errors in hospitals. Risk
113. Wu AW, Pronovost P, Morlock L. ICU incident Analysis 2004;24(6):1459-73.
reporting systems. J Crit Care 2002;17(2):86-94.
126. Lata PF, Mainhardt M, Johnson CA. Impact of nurse
114. Atherton T. Description and outcomes of the case manager-pharmacist collaboration on adverse-
DoctorQuality incident reporting system used at drug-event reporting. Am J Health-Syst Pharm
Baylor Medical Center at Grapevine. Proc (Bayl 2004;61:483-7.
Univ Med Cent) 2002;15(2):203-208; discussion
209-211.
127. Nuckols TK, Bell DS, Liu H, et al. Rates and types of
events reported to established incident reporting
115. Dixon JF, Wielgosz C, Pires ML. Description and systems in two US hospitals. Qual Saf Health
outcomes of a custom Web-based patient occurrence 2007;16:164-8.
reporting system developed for Baylor University
Medical Center and other system entities. Baylor
128. Yamagishi M, Kanda K, Takemura Y. Methods
Univ Med Cent Proc 2002;5(2):199-202.
developed to elucidate nursing related adverse events
in Japan. J Nurs Manag 2003;11:168-76.
116. Jones KJ, Cochran G, Hicks RW, et al. Translating
research into practice: voluntary reporting of
129. Balas MC, Scott LD, Rogers AE. The prevalence and
medication errors in critical access hospitals. J Rural
nature of errors and near errors reported by hospitals
Health 2004;20(4):335-43.
staff nurses. Appl Nurs Research 2004;17(4):224-30.
117. O’Neil AC, Petersen LA, Cook F, et al. Physician
130. Epsin S, Regehr G, Levinson W, et al. Factors
reporting compared with medical-record review to
influencing perioperative nurses’ error reporting
identify adverse medical events. Ann Intern Med
preferences. AORN J 2007;85:527-43.
1993;229:370-6.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
131. Elder NC, Graham D, Brandt E, et al. Barriers and 143. Wild D, Bradley EH. The gap between nurses and
motivators for making error reports from family residents in a community hospital’s error-reporting
medicine offices: a report from the American system. J Qual Patient Saf 2005;31(1):13-20.
Academy of Family Physicians National Research
network (AAFP NRN). J Am Board Fam Med 144. Harper ML, Helmreich RL. Identifying barriers to the
2007;20:115-23. success of a reporting system. In: Henriksen K,
Battles JB, Marks ES, et al., eds. Advances in patient
132. Jeffe DB, Dunagan WC, Garbutt J, et al. Using focus safety: from research to implementation: Vol. 3
groups to understand physicians’ and nurses’ Implementation issues. Surveillance. Rockville, MD:
perspectives on error reporting in hospitals. Joint Agency for Healthcare Research and Quality; Feb.
Comm J Qual Safe 2004;30(9):471-9. 2005. (p. 167-79). AHRQ Publication No. 05-0021-3.
133. Harris CB, Krauss MJ, Coopersmith CM, et al. 145. Vojir CP, Blegen MA, Vaughn T. Nursing staff as
Patient safety event reporting in critical care: a study estimators of unit medication error reporting.
of three intensive care units. Crit Care Med Commun Nurs Res 2003;36:202.
2007;35(4):1068-76.
146. Rathert C, May DR. Health care work environments,
134. Day S, Fox J, Reading T. Adverse event reporting: employee satisfaction, and patient safety: care
experience and education of trauma personnel at a providers perspectives. Health Care Manage Rev
level one trauma center. J Trauma Nurs 2007;31(1):2-11.
2004;11(4):137-43.
147. Chiang H, Pepper GA. Barriers to nurses’ reporting
135. Tuttle D, Holloway R, Baird T, et al. Electronic of medication administration errors in Taiwan. J Nurs
reporting to improve patient safety. Qual Saf Health Sch 2006;38(4):392-9.
Care 2004;13:281-6.
148. Wakefield BJ, Uden-Holman T, Wakefield DS.
136. Schuerer DJ, Nast PA, Harris CB, et al. A new safety Development and validation of the medication
event reporting system improves physician reporting administration error reporting survey. In: Henriksen
in the surgical intensive care unit. J Am Coll Surg K, Battles JB, Marks ES, et al., eds. Advances in
2006;202:881-7. patient safety: from research to implementation: Vol.
4. Programs, tools, and products. Surveys. AHRQ
137. Osmon S, Harris CB, Dunagan WC, et al. Reporting Publication No. 05-0021-4.Rockville, MD: Agency
of medical errors: an intensive care unit experience. for Healthcare Research and Quality; Feb. 2005. p.
Crit Care Med 2004;32:727-33. 475-88.
138. Blegen MA, Vaughn T, Pepper G, et al. Patient and 149. Uribe CL, Schweikhart SB, Pathak DS, et al.
staff safety: voluntary reporting. Amer J Med Qual Perceived barriers to medical-error reporting: an
2004;19(2):67-74. exploratory investigation. J Health Care Manag
2002;47(4):263-80.
139. Kim J, An K, Kim MK, et al. Nurses’ perception of
error reporting and patient safety culture in Korea. 150. Wakefield DS, Wakefield BJ, Borders T, et al.
West J Nurs Res Online 2007;1-18. Understanding and comparing differences in reported
medication administration error rates. Am J Med
140. Throckmorton T, Etchegaray J. Factors affecting Qual 1999;14(2):73-80.
incident reporting by registered nurses: the
relationship of perceptions of the environment for 151. Wakefield BJ, Blegen MA, Uden-Holman T, et al.
reporting errors, knowledge of the nursing practice Organizational culture, continuous quality
act, and demographics on intent to report errors. J improvement, and medication administration error
PeriAnesthesia Nursing 2007;22(6):400-12. reporting. Am J Med Qual 2001;16(4):128-34.
141. Stratton KM, Blegen MA, Pepper G, et al. Reporting 152. Wakefield BJ, Wakefield DS, Uden-Holman T, et al.
of medication errors by pediatric nurses. J Ped Nurs Nurses’ perceptions of why medication
2004;19(6):385-92. administration errors occur. Medsurg Nurs
1998;7(1):39-44.
142. Mayo AM, Duncan D. Nurse Perceptions of
Medication Errors: What We Need to Know for 153. King G III. Perceptions of intentional wrongdoing
Patient Safety. J Nurs Care Qual 2004;19(3):209-17. and peer reporting behavior among registered nurses.
J Bus Ethics 2001;34:1-13.
30
Error Reporting & Disclosure
154. Mick MJ, Wood GL, Massey RL. The good catch
pilot program: increasing potential error reporting.
JONA 2007;37(11):499-503.
31
Evidence Table
misses.
47% reported time and 27% reported fear of
punitive actions as the major barriers to
reporting.
Elder 2007131 Barriers to Cross-sectional Conducted focus Physicians, None Majority of reporting barriers were a lack of
error reporting study groups on errors related nurse time, forgetfulness, and confusion about
Reasons to to testing, issues practitioners, what to and who should report.
report errors involved in error physician Most common reported reason for reporting
reporting, and the assistants, office errors was a perceived benefit.
effects of error reporting staff, and nurses
on office systems (Level in 8 family
4) physicians
offices
Espin 200681 Error Cross-sectional Questionnaire using 4 9 surgeons, 9 None Patients want full disclosure, while
disclosure and study scenarios nurses, 10 physicians and nurses want to disclose only
reporting anesthesiologists what happened.
in operating Nurses (the only clinician type asked) were
rooms at 2 less likely to want to report errors than
teaching patients.
hospitals
Safety Issue Study Setting &
Source Related to Design Type Study Design, Study Study Study Key Finding(s)
Clinical Outcome Measure(s) Population Intervention
Practice
Espin 2007130 Error reporting Cross-sectional Administered 4 error 13 perioperative None 58% of theoretical errors were identified as
study scenarios to nurses nurses at 1 errors, only 26.7% of which would have
hospital in been reported by the nurses.
Canada Nurses perceived error reporting as a
profession-specific responsibility; nurses
should report errors made by nurses.
The presence of a negative outcome
appeared to be a secondary consideration
for nurse error reporting.
Nurses had a greater tendency to report
errors informally with a nurse colleague or
nurse manager.
Evans Barriers to Cross-sectional Anonymous survey of 70.7 response None 98.3% of physicians and nurses were aware
2006106 error reporting study physicians and nurses rate for of the incident reporting system.
about their knowledge physicians and Nurses were more likely to know how to
of their organizations’ 73.6% for nurses submit an error report (88.3%), to have
35
settings clinicians and staff, networks reporting and 13.6% with both medication and a
using a voluntary system diagnostic test; 70.8% of error reports were
reporting system associated with communication errors.
(Level 4) Confidential reports were more complete
than anonymous reports.
Reporting different types of patient harm did
not vary between anonymous and
confidential reports.
France Reporting Quality Assessed utilization of a 1 hospital in Implemented a Nurse reporting significantly decreased after
2003122 system improvement voluntary reporting Tennessee voluntary implementation, while pharmacy reporting
system and provider- reporting significantly increased.
initiated improvements system
(Level 4)
Furukawa Reporting Cross-sectional Errors reported using a Physicians, None Nurses reported 78% of errors, an average
123
2003 medication study Web-based system nurses, of 2.2 reports per nurse.
errors during a 2-year period pharmacists, The majority of error reports submitted by
(Level 4) technologists, nurses and pharmacists were considered
and others in 1 minor.
hospital in Japan Physicians were found to report errors only
when detected and prevented by nurses or
pharmacists.
Safety Issue Study Setting &
Source Related to Design Type Study Design, Study Study Study Key Finding(s)
Clinical Outcome Measure(s) Population Intervention
Practice
Harper Barriers to Cross-sectional Self-report survey 858 nurses and None Less than 10% of respondents had
2005144 error reporting study (Reporting Culture physicians (a knowledge of the mandatory reporting
Survey) on mandatory 41% response system, but less than half of nurses and
reporting system in rate) at 2 20% of physicians reported using the
hospitals transitioning to hospitals in system.
close-call reporting Texas Physicians and nurses were not positive
system: scaled and about the effectiveness of a hospital-based
open-ended items reporting system.
(Level 4) Physicians reported that nurses were
responsible for reporting errors.
40% of physicians and 30% of nurses were
concerned about the anonymity of reporters,
yet 86% of nurses and 81% of physicians
favored feedback on corrective action taken
in response to the report.
40% of physicians and 30% of nurses were
37
140
2007 study environment and 10% response associated with intent to report.
reasons why nurses do rate) licensed to Nurses providing direct care to patients were
not report errors (Level practice in Texas more likely to report.
4) Nurses would report both errors that harmed
patients and those that did not.
Tuttle 2004135 Error reporting Prospective Implementation of a 1 teaching Implemented Nurses reported 73% of the 2,843 safety
system cohort study voluntary, electronic hospital in New new events; physicians reported 2%.
reporting system (ERS) York confidential Of the events reported:
for safety events ERS for safety - 16% were unsafe conditions or
involving patients or events and near misses; 22% were adverse
visitors (Level 4) provided events where patient was harmed;
multifaceted and 39% were not reported
education correctly.
program to - 40% were medication/infusion
promote safety events, 30% were adverse clinical
awareness and events, and 24% were falls.
how to use the
ERS.
Safety Issue Study Setting &
Source Related to Design Type Study Design, Study Study Study Key Finding(s)
Clinical Outcome Measure(s) Population Intervention
Practice
Uribe 2002149 Barriers to Cross-sectional Survey on perceived 56 physicians None Major barriers to error reporting were time
reporting study barriers to reporting and and 66 nurses and work involved in documenting an error;
errors likelihood they could be (17.3% response not being able to report anonymously;
modified rate) in a thinking that errors with no negative
(Level 4) Midwest outcomes should not be reported; fear of
academic legal actions; and hesitancy to “tell” on
hospital someone else.
Modifiable barriers were identified as the
structure and processes for reporting errors
and education.
Least modifiable barriers were fear of
lawsuits, fear of being blamed, and
motivational issues.
Physicians identified twice as many barriers
to reporting than did nurses; both identified
time and extra work involved in documenting
45
Background
Surgery is one area of health care in which preventable medical errors and near misses can
occur. However, until the 1999 Institute of Medicine report, To Err Is Human,1 clinicians were
unaware of the number of surgery-associated injuries, deaths, and near misses because there was
no process for recognizing, reporting, and tracking these events.2 Of great concern is wrong-site
surgery (WSS), which encompasses surgery performed on the wrong side or site of the body,
wrong surgical procedure performed, and surgery performed on the wrong patient.3 This
definition also includes “any invasive procedure that exposes patients to more than minimal risk,
including procedures performed in settings other than the OR [operating room], such as a special
procedures unit, an endoscopy unit, and an interventional radiology suite”4 (p. 11). WSS is also
defined as a sentinel event (i.e., an unexpected occurrence involving death or serious physical or
psychological injures, or the risk thereof) by the Joint Commission (formerly called the Joint
Commission on Accreditation of Healthcare Organizations), which found WSSs to be the third-
highest-ranking event.5
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Commission issued two National Patient Safety Goals on January 1, 2003 to target wrong-site
surgery:
Goal 1—to improve the accuracy of patient identification by using two patient identifiers and
a “time-out” procedure before invasive procedures.
Goal 4—to eliminate wrong-site, wrong-patient, and wrong-procedure surgery using a
preoperative verification process to confirm documents, and to implement a process to mark
the surgical site and involve the patient/family.40
Both of these goals continue to be an ongoing priority for the Joint Commission. Yet with
many surgical procedures traditionally performed only in acute care settings now being
performed in freestanding surgical centers and physician offices—not necessarily all under the
purview of the Joint Commission—surgeons, surgical teams, and patients need to be vigilant
with all surgeries, particularly when the level of oversight and scrutiny may not be as high as in
hospitals.
WSS is generally caused by a lack of a formal system to verify the site of surgery or a
breakdown of the system that verifies the correct site of surgery.18 In using root-cause analysis, a
process that determines the underlying organizational causes or factors that contributed to an
event, the Joint Commission found the top root causes of WSS to be communication failure (70
percent), procedural noncompliance (64 percent), and leadership (46 percent).16 Other system
and process causes are listed in Table 1. Risk factors associated with WSS were identified as
emergency cases, multiple surgeons, multiple procedures, obesity, deformities, time pressures,
unusual equipment or setup, and room changes.17
5, 18, 19, 20
Table 1. Causes of Wrong-Site Surgeries
System Factors Process Factors
♦ Lack of institutional controls/formal system to ♦ Inadequate patient assessment
verify the correct site of surgery ♦ Inadequate care planning
♦ Lack of a checklist to make sure every check ♦ Inadequate medical record review
was performed ♦ Miscommunication among members of the
♦ Exclusion of certain surgical team members surgical team and the patient
♦ Reliance solely on the surgeon for determining ♦ More than one surgeon involved in the
the correct surgical site procedure
♦ Unusual time pressures (e.g., unplanned ♦ Multiple procedures on multiple parts of a
emergencies or large volume of procedures) patient performed during a single operation
♦ Pressures to reduce preoperative preparation ♦ Failure to include the patient and family or
time significant others when identifying the correct
♦ Procedures requiring unusual equipment or site
patient positioning ♦ Failure to mark or clearly mark the correct
♦ Team competency and credentialing operation site
♦ Availability of information ♦ Incomplete or inaccurate communication
♦ Organizational culture among members of the surgical team
♦ Orientation and training ♦ Noncompliance with procedures
♦ Staffing ♦ Failure to recheck patient information before
♦ Environmental safety/security starting the operation
♦ Continuum of care
♦ Patient characteristics, such as obesity or
unusual anatomy, that require alterations in the
usual positioning of the patient
2
Wrong-Site Surgery
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Text Box 1. The Joint Commission Universal Protocol for Preventing Wrong Site, Wrong
Procedure, Wrong Person Surgery™
Wrong site, wrong procedure, wrong person surgery can be prevented. This Universal Protocol is intended
to achieve that goal. It is based on the consensus of experts from the relevant clinical specialties and
professional disciplines and is endorsed by more than 40 professional medical associations and
organizations.
In concert with these principles, the following steps, taken together, comprise the Universal Protocol for
eliminating wrong site, wrong procedure, wrong person surgery:
• Preoperative verification process
o Purpose: To ensure that all of the relevant documents and studies are available prior to the
start of the procedure and that they have been reviewed and are consistent with each other
and with the patient's expectations and with the team's understanding of the intended
patient, procedure, site, and, as applicable, any implants. Missing information or
discrepancies must be addressed before starting the procedure.
o Process: An ongoing process of information gathering and verification, beginning with the
determination to do the procedure, continuing through all settings and interventions involved
in the preoperative preparation of the patient, up to and including the "time out" just before
the start of the procedure.
[Reprinted with permission from: Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.
Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations. 2003.20]
4
Wrong-Site Surgery
Text Box 2. Implementation Expectations for the Universal Protocol for Preventing Wrong Site,
Wrong Procedure, and Wrong Person Surgery™
These guidelines provide detailed implementation requirements, exemptions, and adaptations for special
situations.
• Verification of the correct person, procedure, and site should occur (as applicable):
o At the time the surgery/procedure is scheduled.
o At the time of admission or entry into the facility.
o Anytime the responsibility for care of the patient is transferred to another caregiver.
o With the patient involved, awake, and aware, if possible.
o Before the patient leaves the preoperative area or enters the procedure/surgical room.
• A preoperative verification checklist may be helpful to ensure availability and review of the
following, prior to the start of the procedure:
o Relevant documentation (e.g., history and physical, consent).
o Relevant images, properly labeled and displayed.
o Any required implants and special equipment.
• Make the mark at or near the incision site. Do NOT mark any nonoperative site(s) unless necessary
for some other aspect of care.
• The mark must be unambiguous (e.g., use initials or "YES" or a line representing the proposed
incision; consider that "X" may be ambiguous).
• The mark must be positioned to be visible after the patient is prepped and draped.
• The mark must be made using a marker that is sufficiently permanent to remain visible after
completion of the skin prep. Adhesive site markers should not be used as the sole means of
marking the site.
• The method of marking and type of mark should be consistent throughout the organization.
• At a minimum, mark all cases involving laterality, multiple structures (fingers, toes, lesions), or
multiple levels (spine). Note: In addition to preoperative skin marking of the general spinal region,
special intraoperative radiographic techniques are used for marking the exact vertebral level.
• The person performing the procedure should do the site marking.
• Marking must take place with the patient involved, awake, and aware, if possible.
• Final verification of the site mark must take place during the "time out."
• A defined procedure must be in place for patients who refuse site marking.
Exemptions
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The organization should have processes and systems in place for reconciling differences in staff responses
during the "time out."
• Site marking must be done for any procedure that involves laterality, multiple structures, or levels
(even if the procedure takes place outside of an OR).
• Verification, site marking, and "time out" procedures should be as consistent as possible
throughout the organization, including the OR and other locations where invasive procedures are
done.
• Exception: Cases in which the individual doing the procedure is in continuous attendance with the
patient from the time of decision to do the procedure and consent from the patient through to the
conduct of the procedure may be exempted from the site marking requirement. The requirement for
a "time out" final verification still applies.
[Reprinted with permission from: Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery.
Oakbrook Terrace, IL: Joint Commission on Accreditation of Healthcare Organizations. 2003.20]
The Association of periOperative Registered Nurses (AORN), realizing the importance of the
Universal Protocol for WSS, worked collaboratively with the Joint Commission to develop a
Correct Site Surgery Tool Kit. The tool kit, designed to assist health care providers to implement
the Universal Protocol for WSS in their facilities, was endorsed by the American College of
Surgeons, American Society of Anesthesiologists, American Society for Healthcare Risk
Management, American Hospital Association, and the American Association of Ambulatory
Surgery Centers.
The AORN Correct Site Surgery Tool Kit contains a variety of resources to educate health
care providers about the Universal Protocol for WSS and to assist them with its implementation.
The resources include (1) an educational program on CD-ROM; (2) a pocket reference card
outlining the steps necessary to promote patient identification, site marking, and the time out; (3)
a template to facilitate development of a facility policy to implement the Universal Protocol for
WSS; (4) a copy of the Universal Protocol for WSS and Guidelines for Implementing the
Universal Protocol; (5) frequently asked questions of the Joint Commission and AORN; (6)
letters to nurses, physicians, facility chief executive officers, and health care risk managers
encouraging standard implementation of the Universal Protocol across all facilities; and (7)
information for patients about the Universal Protocol for WSS and health care safety. This tool
kit is available from AORN at http://www.aorn.org/PracticeResources/ToolKits/
CorrectSiteSurgeryToolKit. In addition, AORN Standards, Recommended Practices, and
Guidelines has a position statement on Correct Site Surgery that has additional information on
preventing wrong site surgery.39
Several other organizations have set forth tools and policies to prevent WSS. The Veterans
Affairs National Center for Patient Safety put forth the Ensuring Correct Surgery and Invasive
Procedures directive, based on root-cause analysis, that adds two steps to the Joint Commission’s
6
Wrong-Site Surgery
Universal Protocol: ensuring the consent form is administered and used properly, and having two
members of the surgical team review patient information and radiological images prior to the
start of the surgery.26 The OR briefing tool used at Johns Hopkins Hospital expands the time-out
part of the Universal Protocol by prompting additional dialogue between the anesthesia care
team, nursing, and the surgical team.27 Additionally, the British National Patient Safety Agency
has introduced a risk management tool, setting forth a process for double-checking and
identifying who is accountable at each stage for ensuring surgical markings on the right site to
avoid WSS.28
Research Evidence
There is limited research on wrong-site surgery. The majority of studies have been
retrospective, chart reviews, case studies, and surveys of various professional organizations. The
evidence table summarizes the most recent evidence related to WSS, specifically the three
components of the Universal Protocol.
In two of the retrospective studies that investigated WSS broadly, Meinberg and Stern,7 in a
study relating to the Universal Protocol, found that nearly half of surgeons changed their
preoperative practices in response to the Sign Your Site campaign. Since the campaign targeted
orthopedic surgeons, they were more knowledgeable about the campaign and were more likely to
have changed their practices. Kwaan and colleagues6 identified 62 percent of WSS cases that
could have been prevented had providers adhered to the Universal Protocol. In this study, the
authors concluded that the Universal Protocol would not have prevented the remaining one-third
of WSS documented cases because of errors initiated in weeks before surgery (e.g., wrong
documentation, inaccurate labeling of radiological reports). In an analysis of quality
improvement efforts, similar findings also indicated implementation challenges associated with
staff nonadherence because the issue of laterality was not addressed in the policy and the process
was vulnerable to communication failures during handoffs.29
Preoperative Verification
In verifying that the right patient is to have the right surgery in the right location, one study
found that when discrepancies occurred among clinicians, a review of the patient’s information
could resolve the discrepancy.30 Published guidelines assert the need for a checklist to itemize
exactly what should be checked, but do not specify what should happen if a discrepancy
occurs.31
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
mark the right site after being given a set of instructions. They found that when patients (instead
of someone from the surgical team) were asked preoperatively to mark “no” on the wrong foot or
ankle, 60 percent of patients marked the site correctly.
The last study and quality improvement project assessed whether marking would cause other
errors, because of the permanence of the ink, thereby discouraging site marking. The study found
that marking the surgical site with a pen marker did not affect sterility or place a patient at a
higher risk for infection.34 The quality improvement project found that staff were not marking the
right site because the ink upset breast cancer patients and was indelible on premature infants, and
the policy did not address laterality.29
Time Out
Two studies found that the time out component can prevent the majority of WSS, but not
6, 13, 35
all. Another study found that when surgeons, anesthesiologists, and nurses were trained in
doing a standardized 2-minute briefing prior to surgery, there were specific improvements in
communication on the surgical site and side operated on.36
Research Implications
There is little empirical evidence regarding prevention of WSS or quantitative evaluation of
implementation of strategies to prevent WSS. Part of the problem with research in this area has
8
Wrong-Site Surgery
been that the medical-error data are not easy to extract, and error data are often transferred to
medical claims data and medical liability, further preventing the sharing of such data. Mandatory
reporting of these data has just recently been required in some States. Consequently, there are
gaps in the current evidence on wrong-site surgery. For example, there were no randomized
controlled studies to evaluate the effect of the Universal Protocol on WSS. Research is needed to
determine whether the patient’s risk for WSS is associated with the organization following the
Joint Commission’s Universal Protocol or other standardized process, or with the effectiveness
of the surgical team in communicating with each other. It is unknown how effective surgical
teams are in complying with the protocol on a daily basis, and it is unknown what factors or
barriers exist to implementing the Universal Protocol for WSS in facilities across the country.
Conclusion
The reported number of WSS cases continues to increase as health care organizations
become more transparent to medical error. Many health care organizations, drawing on error-
prevention theories and the experience of the aviation industry, recognize that through such
transparencies, systems can change and result in better patient outcomes. However, it is unlikely
that WSS will fully be reported because of industrywide report cards, fear of litigation, and
difference of opinions. Although absolute numbers of WSS may not be striking, the
consequences to the patient on whom it occurs are dire.
Search Strategy
Both PUBMED® and CINAHL® databases between 1990 and March 2007 were searched,
using wrong site surgery[keyword] OR wrong site surgery[subject heading]. This identified 239
citations. Citations were excluded for the following reasons: non-English, dealt only with
disclosing errors or patient preferences, opinion/editorial pieces, news articles, or
announcements. This left 68 articles for consideration in this review, 10 of which were
considered as evidence.
Author Affiliations
Deborah F. Mulloy, M.S.N., C.N.O.R., doctoral student, University of Massachusetts at
Boston School of Nursing. E-mail: [email protected].
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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system. A report of the Committee on
Quality of Health Care in America, Institute 13. Seiden SC, Barach P. Wrong-side/wrong-site, wrong-
of Medicine. Washington, DC: National procedure, and wrong-patient adverse events: are they
Academy Press; 2000. preventable? Arch Surg 2006; 141:931-9.
2. Agency for Healthcare Research and Quality. Medical 14. D’ambrosia R, Kilpatrick J. Medical errors and
errors: the scope of the problem. Fact sheet. wrong-site surgery. Orthopedics 2002; 25(3):288.
Publication No. AHRQ 00-P037. Available at:
http://www.ahrq.gov/qual/errback.htm. Accessed July 15. American Academy of Orthopaedic Surgeons. Report
18, 2005. of the task force on wrong-site surgery. Available at
http://www.aaos.org/wordhtml/meded/tasksite.htm.
3. Carayon P, Schultz K, Hundt AS. Righting wrong site Accessed July 18, 2005.
surgery. Jt Comm J Qual Saf 2004;30:405-10.
16. Joint Commission. Root causes of wrong site surgery.
4. Joint Commission. Special report! Helpful solutions Available at http://www.jointcommission.org/NR/
for meeting the 2006 National Patient Safety goals. rdonlyres/90B92D9B-9D55-4469-94B1-
Joint Commission Perspectives on Patient Safety 2005 DA64A8147F74/0/se_rc_wss.jpg.
August; 5(8):1-15. Accessed December 18, 2007.
5. Joint Commission on Accreditation of Healthcare 17. Joint Commission. Sentinel event statistics as of June
Organizations. A follow-up review of wrong site 30, 2007. Available at:
surgery. Sentinel Event Alert 2001;24. Available at: http://www.jointcommission.org/NR/rdonlyres/D7836
http://www.jointcommission.org/SentinelEvents/Senti 542-A372-4F93-8BD7-DDD11D43E484/0/se_stats_
nelEventAlert/sea_24.htm Accessed December 18, 063007.pdf. Accessed December 18, 2007.
2007.
18. Saufl NM. Universal protocol for preventing wrong
6. Kwaan MR, Studdert DM, Zinner MJ, et al. Incidence, site, wrong procedure, worng person surgery. J
patterns, and prevention of wrong-site surgery. Arch Perianesth Nurs 2004; 19: 348-51.
Surg 2006; 141:353-8.
19. The Association of Perioperative Registered
7. Meinberg EG, Stern PJ. Incidence of wrong-site Nurses.Position statement on correct surgery site.
surgery among hand surgeons. J Bone Joint Surg Am AORN February 2001. Available at:
2003; 85:193-7. http://www.aorn.org/PracticeResources/AORNPositio
nStatements/PositionCorrectSiteSurgery/. Accessed
8. Robeznieks A. Getting it right: Florida board cracking August 18, 2006.
down on wrong-site surgery. Mod Healthc 2005;
35(34):18, 20. 20. Joint Commission. Universal protocol for preventing
wrong site, wrong procedure, wrong person surgery.
9. Pairolero PC. Quality, safety, and transparency: a 2003. Available at http://www.jointcommission.org/
rising tide floats all boats. Ann Thorac Surg 2005; NR/rdonlyres/E3C600EB-043B-4E86-B04E-
80(2):387-95. CA4A89AD5433/0/universal_protocol.pdf. Accessed
December 18, 2007.
10. Weber P. Large loss indemnity payments and limits of
professional liability. Opthalmic Risk Management 21. American Academy of Orthopaedic Surgeons Council
Digest 1997. Available at: on Education. Report of the task force on wrong-site
http://www.omic.com/resources/risk_man/deskref/litig surgery. Rosemount, IL: American Academy of
ation/16.cfm. Accessed September 5, 2006. Orthopaedic Surgeons; 1998.
11. American Academy of Orthopaedic Surgeons. 22. American Academy of Orthopaedic Surgeons. Wrong
Advisory statement on wrong-site surgery. Available site surgery. Available at:
at: http://www.aaos.org/about/papers/advistmt/ http://www5.aaos.org/wrong/viewscrp.cfm. Accessed
1015.asp. Accessed September 5, 2006. August 18, 2006.
10
Wrong-Site Surgery
23. Perlow DL, Perlow SM. Incidence of wrong-site 31. Rogers ML, Cook RI, Bower R, et al. Barriers to
surgery among hand surgeons. J Bone Joint Surg implementing wrong site surgery guidelines: A
2003; 85A:1849. cognitive work analysis. IEEE Trans Syst Man
Cybern. 2004; 34(6):757-63.
24. Wong D, Mayer T, Watters W, et al. Prevention of
wrong site surgery: sign, mark and x-ray (SMaX). La 32. Giles SJ, Rhodes P, Clements G, et al. Experience of
Grange, IL: North American Spine Society; 2001. wrong site surgery and surgical marking practices
Available at: http://www.spine.org/smax.cfm. among clinicians in the UK. Qual Saf Health Care
Accessed September 5, 2006. 2006; 15:363-8.
25. Reason J. Managing the risks of organizational 33. DiGiovanni CW, Kang L, Manuel J. Patient
accidents. Burlington, VT: Ashgate Publishing compliance in avoiding wrong-site surgery. J Bone
Company; 1997. Joint Surg Am. 2003; 85(5):815-9.
26. Veterans Health Administration, Department of 34. Cronen G, Ringus V, Sigle G, et al. Sterility of
Veterans Affairs. VHA directive 2004-028: ensuring surgical site marking. J Bone Joint Surg Am 2005;
correct surgery and invasive procedures. Available at: 87(10):2193-5.
http://www.va.gov/ncps/SafetyTopics/CorrectSurgDir.
DOC. Accessed September 5, 2006. 35. Rothman G. Comment on Kwaan MR, Studdert DM,
Zinner MJ, et al. Incidence, patterns and prevention of
27. Makary MA, Holzmueller CG, Thompson DA, et al. wrong-site surgery. Arch Surg 2006; 141: 1049-50.
Operating room briefings: working on the same page.
Jt Comm J Qual Saf 2006; 32:351-5. 36. Makary MA, Mukherjee A, Sexton JB, et al.
Operating room briefings and wrong-site surgery. J
28. National Patient Safety Agency (NPSA), The Royal Am Coll Surg. 2007 Feb; 204(2):236-43. Epub 2006
Collage of Surgeons of England. Patient safety alert: Dec 8.
correct site surgery. Available at:
http://www.npsa.nhs.uk/site/media/documents/885_C 37. Watson D. Safety net: lessons learned from close calls
SS%20PSA06%20FINAL.pdf. Accessed September 5, in the OR. AORN J 2006; 84(Suppl 1):51-561.
2006.
38. Scheidt RC. Ensuring correct site surgery. AORN J
29. Mawji Z, Stillman P, Laskowski R, et al. First do no 2002; 76:770-7.
harm: integrating patient safety and quality
improvement. Jt Comm J Qual Improv 2002; 39. Conner R. AORN Standards, Recommended Practices,
28(7):373-86. and Guidelines. Denver, CO: AORN, Inc.; 2007.
30. Sexton JB, Makary MA, Tersigni AR, et al. 40. Joint Commission on Accreditation of Healthcare
Teamwork in the operating room: frontline Organizations. 2003 JCAHO National Patient Safety
perspectives among hospitals and operating room Goals. Available at: http://www.jcrinc.com/26813/
personnel. Anesthesiology 2006; 105:877-84. newsletters/3746/. Accessed December 20, 2007.
11
Evidence Table. Summary of Evidence Related to Wrong-Site Surgery
Wrong-Site Surgery
using the Plan- • Nature of marking was
Do-Study-Act problematic.
method.
• Laterality of markings
not included in policy.
Source Safety Issue Design Type Study Design & Study Setting & Study Intervention Key Finding(s)
preferred no hierarchies
(Sexton et al., 2000).
Wrong-Site Surgery
Chapter 37. Medication Administration Safety
Ronda G. Hughes, Mary A. Blegen
Background
The Institute of Medicine’s (IOM) first Quality Chasm report, To Err Is Human: Building a
Safer Health System,1 stated that medication-related errors (a subset of medical error) were a
significant cause of morbidity and mortality; they accounted “for one out of every 131 outpatient
deaths, and one out of 854 inpatient deaths”1 (p. 27). Medication errors were estimated to
account for more than 7,000 deaths annually.1 Building on this work and previous IOM reports,
the IOM put forth a report in 2007 on medication safety, Preventing Medication Errors.2 This
report emphasized the importance of severely reducing medication errors, improving
communication with patients, continually monitoring for errors, providing clinicians with
decision-support and information tools, and improving and standardizing medication labeling
and drug-related information.
With the growing reliance on medication therapy as the primary intervention for most
illnesses, patients receiving medication interventions are exposed to potential harm as well as
benefits. Benefits are effective management of the illness/disease, slowed progression of the
disease, and improved patient outcomes with few if any errors. Harm from medications can arise
from unintended consequences as well as medication error (wrong medication, wrong time,
wrong dose, etc.). With inadequate nursing education about patient safety and quality, excessive
workloads, staffing inadequacies, fatigue, illegible provider handwriting, flawed dispensing
systems, and problems with the labeling of drugs, nurses are continually challenged to ensure
that their patients receive the right medication at the right time. The purpose of this chapter is to
review the research regarding medication safety in relation to nursing care. We will show that
while we have an adequate and consistent knowledge base of medication error reporting and
distribution across phases of the medication process, the knowledge base to inform interventions
is very weak.
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Medication Errors
2
Medication Administration Safety
An adverse drug reaction is defined as “an undesirable response associated with use of a drug
that either compromises therapeutic efficacy, enhances toxicity, or both.”10 ADRs can be
manifested as diarrhea or constipation, rash, headache, or other nonspecific symptoms. One of
the challenges presented by ADRs is that prescribers may attribute the adverse effects to the
patient’s underlying condition and fail to recognize the patient’s age or number of medications as
a contributing factor.11 According to Bates and colleagues,12 more attention needs to be directed
to ADEs—including both ADRs and preventable ADEs—which range in severity from
insignificant to fatal.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The impact of medication errors on morbidity and mortality were assessed in a case-control
analysis of ADEs in hospitalized patients during a 3-year period.26 The investigators found
significant increases in (a) the cost of hospitalization from increased length of stay, ranging from
$677 to $9,022; (b) patient mortality (odds ratio = 1.88 with a 95% confidence interval); and (c)
postdischarge disability. The impact was less in male patients, younger patients, and patients
with less severe illnesses and in certain diagnosis-related groups.
Without an infrastructure to capture and assess all medication errors and near misses, the real
number is not known. These rates could be expected to be higher once patient safety
organizations begin to collect nationwide errors and health care clinicians become more
comfortable and skilled in recognizing and reporting all medication errors. The concern raised in
To Err Is Human1 about the potential prevalence and impact of ADEs—2 out of every 100
hospitalized patients—was just the beginning of our understanding of the potential magnitude of
the rates of medication errors. The concern continues, as is seen in the most recent IOM report,
Preventing Medication Errors,2 which states that “a hospital patient is subject to at least one
medication error per day, with considerable variation in error rates across facilities” (pp. 1–2).
Yet, despite numerous research findings, we cannot estimate the actual rates because they vary
by site, organization, and clinician; because not all medication errors are detected; and because
not all detected errors are reported.
Error-Prone Processes
There are five stages of the medication process: (a) ordering/prescribing, (b) transcribing and
verifying, (c) dispensing and delivering, (d) administering, and (e) monitoring and reporting.2
Monitoring and reporting is a newly identified stage about which there is little research. Some of
the most noted and early work on medication safety found hospitalized patients suffer
preventable injury or even death as a result of ADEs associated with errors made during the
prescribing, dispensing, and administering of medications to patients,12, 27–29 although the rates of
error in the stages of the medication process vary. A few studies have indicated that one of every
three medication errors could be attributed to either a lack of knowledge about the medication or
a lack of knowledge about the patient.30
Prescribing/ordering. Of the five stages, ordering/prescribing most often initiates a series of
errors resulting in a patient receiving the wrong dose or wrong medication. In this stage, the
wrong drug, dose, or route can be ordered, as can drugs to which the patient has known allergies.
Workload, knowledge about the prescribed drug, and attitude of the prescriber—especially if
there is a low perceived importance of prescribing compared with other responsibilities—are
significantly associated with ADEs.31, 32 Furthermore, if nurses or pharmacists question a
prescriber about an order, they can be confronted with aggressive behavior, which may inhibit
future questioning and seeking clarification.33 The proportion of medication errors attributable to
the ordering/prescribing stage range from 79 percent29 to 3 percent.34 Examples of the types of
errors committed in this stage include illegible and/or incomplete orders, orders for
contraindicated medications, and inappropriate doses. Similar results have been found in
mandatory adverse event reporting systems. An analysis of 108 reports associated with
significant harm or death reported to the State of New York noted that, when the error occurred
during the prescribing stage, written prescriptions accounted for 74 percent of the errors, and
verbal orders accounted for 15 percent.6
While the preponderance of the research focuses on physician prescribing, there is a brief
discussion about the role of advanced practice nurses in prescribing to ensure safety. One
4
Medication Administration Safety
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
the medication process has led to the formulation of the rights of nurses in the area of medication
administration. The essential environmental conditions conducive to safe medication practices
include (a) the right to complete and clearly written orders that clearly specify the drug, dose,
route, and frequency; (b) the right to have the correct drug route and dose dispensed from
pharmacies; (c) the right to have access to drug information; (d) the right to have policies on safe
medication administration; (e) the right to administer medications safely and to identify problems
in the system; and (f) the right to stop, think, and be vigilant when administering medications.42
6
Medication Administration Safety
errors.30, 50, 51 For example, Leape and colleagues27 found an association between the occurrence
of medication errors and the inability to access information and failure to follow policies and
guidelines. Also, research has found that health care clinicians should be aware of the repeated
patterns of medication errors and near misses to provide insight on how to avoid future errors.52
The system approach to safety emphasizes the human condition of fallibility and anticipates
that errors will occur, even in the best organizations with the best people working in them. This
approach focuses on identifying predisposing factors within the working environment or systems
that lead to errors.53 Reason’s53 model of accident causation describes three conditions that
predicate an error:
1. Latent conditions—Organizational processes, management decisions, and elements in the
system, such as staffing shortages, turnover, and medication administration protocols.
2. Error-producing conditions—Environmental, team, individual, or task factors that affect
performance, such as distractions and interruptions (e.g., delivering and receiving food
trays), transporting patients, and performing ancillary services (e.g., delivery of medical
supplies, blood products).49
3. Active failures—errors involving slips (actions in which there are recognition or selection
failures), lapses (failure of memory or attention), and mistakes (incorrect choice of
objective, or choice of an incorrect path to achieve it), compared to violation, where rules
of correct behavior are consciously ignored.
Threats to medication safety include miscommunication among health care providers, drug
information that is not accessible or up to date, confusing directions, poor technique, inadequate
patient information, lack of drug knowledge, incomplete patient medication history, lack of
redundant safety checks, lack of evidence-based protocols, and staff assuming roles for which
they are not prepared. An additional risk is a hospital without 24-hour pharmacy coverage,
especially when procedural barriers to offset the risk of accessing high-risk drugs are absent.6
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
determine system factors contributing to error; and ensuring positive incentives for MAE
reporting.
Incident reports, retrospective chart reviews, and direct observation are methods that have
been used to detect errors. Incident reports, which capture information on recognized errors, can
vary by type of unit and management activities;73 they represent only a few of the actual
medication errors, particularly when compared to a patient record review.74 Chart reviews have
been found to be most useful in detecting errors in ordering/prescribing, but not
administration.75, 76 Direct observation of administration with comparison to the medication
administration record detects most administration errors; however, it cannot detect ordering
errors and, in some systems, transcribing and dispensing errors. There were two studies that
compared detection methods. One of these studies of medication administration in 36 hospitals
and skilled nursing facilities found 373 errors made on 2,556 doses.77 The comparison of three
detection methods found that chart review detected 7 percent of the observed errors, and incident
reports detected only 1 percent. Direct observation was able to detect 80 percent of true
administration errors, far more than detected through other means. A second study compared
detection methods and found that more administration errors were detected by observation (a
31.1 percent error rate) than were documented in the patients’ medical records (a 23.5 percent
error rate).78 Therefore, no one method will do it all. When automated systems that use triggers
are not in place, multiple approaches such as incident reports, observation, patient record
reviews, and surveillance by pharmacist may be more successful.79
The wide variation in reported prevalence and etiology of medication errors is in part
attributable to the lack of a national reporting system or systems that collect both errors and near
misses. State-based and nationally focused efforts to better determine the incidence of
medication errors are also available and expanding (Patient Safety and Quality Improvement Act
of 2005). The FDA’s Adverse Event Reporting System (AERS), which is part of the FDAs’
MedWatch program (www.fda.gov/medwatch), U.S. Pharmacopeia’s (USP’s) MEDMARX®
database (www.medmarx.com), and the USP’s Medication Errors Reporting Program (MERP;
www.ismp.org/orderforms/reporterrortoISMP.asp), in cooperation with the ISMP, collect
voluntary reports on actual and potential medication errors, analyze the information, and publish
information on their findings.
Research reported to date clearly reveals that medication errors are a major threat to patient
safety, and that these errors can be attributed to all involved disciplines and to all stages of the
medication process. Unfortunately, the research also reveals that we have only weak knowledge
of the actual incidence of errors. Our information about ADEs (those detected, reported, and
treated) is better, but far from complete. With this knowledge of the strengths and limitations of
the research, this chapter will consider the evidence regarding nurses’ medication administration.
8
Medication Administration Safety
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
involved wrong dose. When the nurses delegated the drug administration to subordinate staff, the
majority of MAEs involved wrong drug or wrong concentration of a drug. Errors, which were
reported to the immediate supervisor, were also reported to the physician in 65 percent of cases.
The reported causes of MAEs were lack of administration protocols, failure to check orders,
ineffective nurse supervision when delegating administration, and inadequate documentation.
One study assessed medication errors using 31 medical records of patients discharged from a
psychiatric hospital and found a total of 2,194 errors.43 Of these, 997 were classified as MAEs
(4.7 percent of all doses, and 66 percent of all errors). Of these, 61.9 percent were due to
scheduled doses not documented as administered, 29.1 percent as drugs administered without an
order, 8 percent as missed doses because of late transcription, and 3 percent resulting from orders
not being correctly entered in the pharmacy computer.
10
Table 1. Comparison of the Incidence of Medication Administration Errors by Type Categories
Buckley Tang Balas Kopp Wolf Prot Handler Colen Tissot Flynn Kapborg
24
2007 200793 200684 200645 200644 200578 200492 200388 200391 200277 199980
n = 15 n = 72 n = 127 n = 132 n = 1,305 n = 538 n = 88 n = 1,077 n = 78 n = 457 n = 37
Percentages (%)
Deteriorated drug - - - - - 2 - - - - -
Maintenance 0 - - 2 - - - - - -
intravenous fluid/total
parenteral nutrition
Wrong concentration - - - - - - - - - - 8.1
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Information from these research studies forms a consistent picture of the most common types
of MAEs. These are wrong time, omissions, and wrong dose (including extra dose). Rates of
error derived from direct observation studies ranged narrowly between 20 and 27 percent
including wrong-time errors, and between 6 and 18 percent excluding wrong-time errors. The
alarming exception to this was the nearly 50 percent error rate in observation of intravenous
medication in ICUs in Europe.
14
Evidence Table 1. Types of Reported and Observed Medication Administration Errors (MAEs)
Source Safety Issue Design Type Study Design & Study Study Setting & Key Finding(s)
Related to Outcome Measure(s) Study
Clinical Practice Population
Balas Type of MAEs Cross- Voluntary, self-reported 393 full-time 37.8% of nurses reported medication errors and near errors;
200485 sectional recording of 14 days of registered nurses made on average between 2 and 5 errors.
study shift work, sleep, and (RNs) in hospitals Reported top types of medication errors were wrong time
errors using a journal responded to the (33.6%), wrong dose (24.1%), and wrong drug (17.2%),
survey. compared to the top three types of near errors, which were
wrong drug (29.3%), wrong dose (21.6%), and wrong patient
(19.0%).
Balas Types of MAEs or Cross- Voluntary, self-reported 502 RNs in Of the 224 errors and 350 near errors, 56.7% involved
84
2006 near errors sectional recording of 14 days of critical care units medications. Wrong time, omission, and wrong dose
study shift work, sleep, and throughout the accounted for 77.3% of MAEs, and wrong dose, wrong drug,
errors using a journal United States and wrong patient accounted for 77.8% of near misses.
Barker Types of MAEs Cross- Observation of 3,216 12 accredited 19% of doses were in error including wrong time, 11%
87
2002 sectional doses administered by hospitals, 12 excluding wrong time. The most frequent errors besides wrong
nurses in 36 randomly nonaccredited time were omissions and wrong dose in all three types of
15
and Welfare in
Sweden
Kopp Types of MAEs Prospective Direct observation over 1 16-bed Overall, 27% of doses were in error. Of the 132 ADEs, 42
200645 cohort study 6 months by 2 medical/surgical (32%) were attributed to medication administration. About half
pharmacy residents ICU in a tertiary of those (48%) were errors of omission. Other common error
specializing in critical care academic types were wrong dose, extra dose, and wrong technique.
care pharmacy. medical center in Thirty seven (34%) of ADEs attributed to medication
Pharmacy residents Arizona administration were considered potential ADEs, and only 3 of
would intervene if MAE those were intercepted.
would have resulted in
patient harm.
McCarthy Types of MAEs Cross- Voluntary, randomly 649 school 48.5% of respondents reported medication errors, and the
200086 sectional selected survey of nurses (64.9% majority of the types of errors were missed doses and
study members of the response rate) in undocumented doses.
National Association of the United States
School Nurses
Source Safety Issue Design Type Study Design & Study Study Setting & Key Finding(s)
Related to Outcome Measure(s) Study
Clinical Practice Population
Prot Types of MAEs Prospective Direct observation of 1,719 doses were 27% of doses were in error (538 MAEs). Wrong-time errors
78
2005 cohort study nurses administering observed on 4 were 36% of MAEs, wrong route was 19%, wrong dose was
medications to patients. units at a 15%, and unordered drug was 10%.
Observers would pediatric teaching The risk of an MAE increased if the medication was
intervene if MAE would hospital in Paris, administered by a nurse intern, a temporary staffing agency
have resulted in patient France. nurse, or a pool nurse (OR = 1.67, P = 0.03) and if the
harm. medication had been prepared by the pharmacy (OR = 1.66, P
= 0.02).
Schneider Frequency and Cross- Direct observation 275 doses were 26.9% of the doses were in error including wrong-time errors,
25
1998 types of MAEs sectional observed on a 18.2% excluding wrong-time errors. The other common error
pediatric ICU in types were wrong dose preparation and wrong administration
Switzerland technique.
Taxis Types of MAEs Cross- Ethnographic—direct 430 IV drug Overall error rate was 49%; wrong-time errors were not
89
2003 in Intravenous sectional observation of nurses doses were counted. Of the 212 errors observed, 38% involved
(IV) drug administering observed for administering a bolus dose too fast, and preparation errors
administration medications nurses working in accounted for 15%.
10 wards in 2 Majority of preparations errors by nurses involved doses
hospitals in the requiring multiple-step preparations, specifically preparing the
17
Medication safety for patients is dependent upon systems, process, and human factors, which
can vary significantly across health care settings. A review of the literature found 34 studies that
investigated some aspect of working conditions in relation to medication safety.
Systems factors. Systems factors that can influence medication administration include
staffing levels and RN skill mix (proportion of care given by RNs), shift length, patient acuity,
and organizational climate. There were 13 articles presenting research findings and three
literature reviews. The major systems/organizational factors included nurse staffing, workload,
organizational climate/favorable working conditions, policies and procedures, and technologies
enabling safety or contributing to MAEs.
Nurse staffing: Medication administration is a key responsibility of nurses in many settings,
and three studies assessed the relationship between nurse staffing, hours of nursing care in
hospitals, RN skill mix, and medication errors. Two studies associated the total hours of care and
the RN skill mix at a patient care unit to reported medication error rates in those units; one study
used 42 units in a large Midwestern hospital95 and the other used 39 units in 11 small hospitals.96
Rates of MAEs, when the number of doses was the denominator, were highest in medical-
surgical and obstetric units; when patient days were the denominator, the highest rate was in
ICUs. In both studies the type of unit was controlled and the rate of reported medication errors
declined as the RN skill mix increased up to an 87 percent mix. A third study of nurses in ICUs
in 10 hospitals found an inverse relationship between rates of medication errors and staffing
work hours per patient day in specific settings (e.g., cardiac ICUs and noncardiac intermediate
care settings). A little over 30 percent of the variance in medication error rates resulted from the
variance in staffing work hours per patient day.97
Other studies conducted prior to 1998 did not find a relationship between staffing and
medication errors. Three literature reviews,30, 39, 98 concluded that the direct evidence for a
relationship between staffing and MAE rates was inconsistent. Nurses’ perceptions of the impact
of staffing or workload on medication errors, however, is quite consistent.
Workloads: These findings are consistent with three studies and two literature reviews on the
impact of heavy workloads, a component of nurse staffing, on errors. In one survey of nurses in
11 hospitals, both pediatric and adult nurses reported staffing ratios and the number of
medications being administered as being the major reasons why medication errors occur.58 A
second survey found that nurses from Taiwan also indicated that workload was a major factor in
medication errors.93 Beyea, Hicks, and Becker81, 82 and Hicks and colleagues38 analyzed
MEDMARX data for medication errors in the operating room, postanesthesia, and in same-day-
surgery units. Most of these errors involved nurses (64–76 percent) and medication
administration (59–68 percent). In all three sets of error reports, workload increases and
insufficient staffing were noted to be causes of errors.
The effect of heavy workloads and inadequate numbers of nurses can also be manifested as
long workdays, providing patient care beyond the point of effective performance. In a national
survey by Rogers and colleagues,99 self-reported errors by nurses found that the likelihood of a
medication error increased by three times once the nurse worked more than 12.5 hours providing
direct patient care. Among nurses working more than 12.5 hours, the reported errors, 58 percent
of actual errors and 56 percent of near misses were associated with medication administration.
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Other findings support the importance of adequate nurse staffing and understanding the
impact of shift work in decreasing medication errors. A review of incident reports found that the
major contributing factors to errors were inexperienced staff, followed by insufficient staffing,
agency/temporary staffing, lack of access to patient information, emergency situation, poor
lighting, patient transfers, floating staff, no 24-hour pharmacy, and code situations.44 Certain
aspects of shift work can also impact medication safety, as shown in a review of research
conducted in the 1980s and early 1990s that indicated that there was a difference in the number
of errors by shift, but no difference in the number of hours worked (8 versus 12 hours). However,
there were more errors with nurses working rotating shifts.30
Organizational climate: Other systems/organizational issues include the presence of
favorable working conditions, effective systems, policies and procedures, and technologies that
enable safety or contribute to MAEs. An assessment of medication administration behaviors of
176 nurses in rural Australia, using structural equation modeling to test the association between
organizational climate and the administration behaviors of nurses, found that the variable
“violations” was the only variable with a direct contribution to MAEs, but there was no direct
linkage to actual errors. While it was not possible to determine the effect of organizational
climate on violations, distress was positively associated with violations, while quality of working
life, morale, and organizational climate had a negative association. The organizational climate
was found to be linked with safety behavior.100 Hofmann and Mark101 did find that the safety
climate on patient care units was linked to the rate of harm-producing medication errors in a
study using data collected from 82 units in 41 hospitals. Higher overall safety climate was related
to lower rates of medication errors and urinary tract infections.
Policies, procedures, and protocols: Lack of appropriate policies, procedures, and protocols
can impact medication safety, as seen in a few small studies. In a study of malpractice cases,
medication errors were associated with lack of administration protocols and ineffective nurse
supervision in delegating administration.80 However, even when policies are in place, they may
not necessarily improve safety. For example, a review of two studies in the literature found that
medication errors did not necessarily decrease with two nurses administering medications (e.g.,
double-checking).30 In addition, appropriate policies may not be followed. Double-checking
policies are commonly used as a strategy to ensure medication safety. When errors occurred
under such policies, failure to double-check doses by both pediatric and adult nurses 58 and
nurses in a Veterans Affairs (VA) hospital102 were reported. However, research presented in two
literature reviews offers somewhat conflicting information. In the first review of three studies,
following double-checking policies did not necessarily prevent errors.39 Yet in the other review,
failure to adhere to policies and procedures was associated with errors.30
Process factors. Process factors that influence medication administration include latent
failures that can instigate events resulting in errors, such as administrative processes,
technological processes, clinical processes, and factors such as interruptions and distractions.
These factors reflect the nature of the work, including “competing tasks and interruptions,
individual vs. teamwork, physical/cognitive requirements, treatment complexity, workflow.”103
A review of the literature found 18 studies and 2 literature reviews that contained process factors
and their association to medication errors by nurses.
Distractions and interruptions: Factors such as distractions and interruptions, during the
process of delivering care can have a significant impact on medication safety. Nine studies, four
with nationwide samples, and two literature reviews present information on the association
between MAEs and distractions and interruptions. One survey of nurses in three hospitals in
20
Medication Administration Safety
Taiwan found that they perceived distractions and interruptions as causes of errors.93 In three
other surveys in the United States, nurses ranked distractions as major causes for the majority of
medication errors.58, 61, 102 In a small, five-site observational study of medication administration
among 39 RNs, licensed practical nurses (LPNs) and certified medical technicians/assistants
(CMT/As), Scott-Cawiezell and colleagues104 found an increase in medication errors attributable
in part to interruptions, and when wrong-time errors were excluded, the error rate actually
increased during medication administration.
These finding are furthered by research concerning self-reported errors from a nationwide
sample of nurses.84 The nurses believed the cause of their reported medication errors and near
errors were interruptions and distractions. In a secondary analysis of the MEDMARX® data base,
distractions and interruptions were prominent contributing factors to medication errors.81–83
Furthermore, these findings are supported by three reviews of the literature: one found that
distractions and interruptions interfered with preparing and administering medication, potentially
causing errors;30 interruptions were perceived as causing medication errors in the second
review;98 and the third indicated that rapid turnover and changes as well as distractions and
interruptions contributed to errors.39
Documentation of the medication administration process: One small study investigated nurse
adherence to a hospital policy to document medications administered and their effects on
patients. From a sample of 12 nurses in one hospital, one-third of progress notes were found to
contain information about administered medications, yet only 30 percent of those progress notes
included medication name, dose, and time of administration, and only 10 percent documented
information about desired or adverse effects of medications. Medication education, outcomes of
administered medication, and assessment prior to administering were not documented in any
progress note. Only half of withheld medications were documented.105 In a review of records to
detect medication errors, Grasso and colleagues43 found that 62 percent did not document doses
as administered.
Communication: Five studies and one literature review assessed the relationship between
communication failures and medication errors. A small observational study of 12 nurses found
that they communicated with other nurses about information resources on medications, how to
troubleshoot equipment problems, clarification in medication orders, changes in medication
regimens, and patient assessment parameters when handing over patients.106 Nurses
communicated with physicians informally to exchange information, about the absence of other
physicians, and in both unstructured and structured ward rounds. Nurses also communicated with
pharmacists about information on medication administration and organizing medications for
patient discharge. Another direct observational study of medication administration found
opportunities for errors associated with incomplete or illegible prescriptions.91 This finding was
supported by two related literature reviews that indicated that illegible and poorly written drug
prescriptions and breakdowns in communication led to errors.30, 39 Another survey found that
nurses ranked difficult/illegible physician handwriting as a cause of the majority of medication
errors, but did not consider withholding a dose because a lab report was late or omitting a
medication while the patient was sleeping as something that should have been communicated to
physicians or others.61
A small survey of 39 nurses in three hospitals in Nova Scotia about communication failures
during patient transfers found that more than two-thirds of nurses reported difficulty in obtaining
an accurate medication history from patients when they were admitted; 82 percent reported
patients were unable to provide accurate medication histories. When patients were transferred
21
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
from across units, 85 percent of nurses reported that medication orders were rewritten at transfer,
92 percent that medication orders were checked against electronic medical records, 62 percent
that it was time consuming to clarify medication orders, 66 percent that the reasons for
medication changes were made at transfer, and 20 percent that blanket orders are often written as
transfer orders.107
Complexity: Three studies investigated the impact of complexity on medication safety. In a
small, five site observational study of medication administration of 39 RNs, LPNs and CMT/As
in long-term care settings, Scott-Cawiezell and colleagues104 found that even though RNs
administered fewer medications they had more MAEs, compared to LPNs and CMT/As. The
suggested explanation was that the mediations RN must administer in long-term care are those
with more complexity. Another survey of 284 RNs in 11 hospitals found that pediatric and adult
nurses reported numbers of medications being administered as a major reason on why
medication errors occur.58 Also, another survey of nurses found that they perceived that
complicated doctor-initiated orders (24 percent) and complicated prescription were the major
causes of MAEs related to the medication administration process.93
Equipment failure while administering medication: Three studies found that systems and
process factors can interfere with medication administration when equipment used in
administration does not perform properly, exposing the nurse and patient to safety risks. In two
ICU studies, infusion pump problems were involved in 6.7 percent of 58 MAEs in one study24
and 12 percent of the 42 MAEs in the other sutdy.45 Another investigation of smart pumps with
integrated decision-support software found that half of the ADEs were considered preventable
(2.12 of 100 patient-pump days), and 72 percent of preventable ADEs were serious or life-
threatening.108 Given the number of ADEs, the fact that the drug library was bypassed in 24
percent of the infusions, and the frequency of overriding alerts, the investigators concluded that
use of the smart pumps did not reduce the rate of serious medication errors—but possibly could
if certain process factors could be modified, such as not allowing overrides.
Monitoring and assessing: An essential component of the medication process related to the
administration of medications is monitoring and assessing the patient by the nurse. Only two
studies provided information in this area, offering scant evidence. In the first, based on a small
sample of nurses in one unit in one hospital, a qualitative analysis of observed medication
administration found that participants monitored patients before, during, and after medication
administration.109 Nurses assessed vital signs, lab values, ability to swallow, and patients’ self-
report of health. They also felt responsible for timing medication administration and providing
as-needed (e.g., PRN) medications. In the second study, where ICU nurses were surveyed, no
administration errors were found to be associated with inadequate monitoring or lack of patient
information.24
There are a wide range of system-related human factors that can impact medication
administration. These factors include characteristics of individual providers (e.g., training,
fatigue levels), the nature of the clinical work (e.g., need for attention to detail, time pressures),
equipment and technology interfaces (e.g., confusing or straight-forward to operate), the design
of the physical environment (e.g., designing rooms to reduce spread of infection and patient
falls), and even macro-level factors external to the institution (e.g., evidence base for safe
practices, public awareness of patient safety concerns).103 There were 10 studies that assessed the
22
Medication Administration Safety
association of human factors with MAEs. Four major themes emerged in the review: fatigue,
cognitive abilities, experience, and skills.
Effects of fatigue and sleep loss: Five studies assessed the association between fatigue and
sleep loss with MAE errors. The first specifically investigated the effects of fatigue and sleep
loss on errors using a national sample of nurses over a 2-week period. In this study, the rate of
errors increased after working 12.5 hours.99 A subpopulation of critical care nurses reported
forgetfulness, heavy workload, distractions, and high patient acuity as causes for their
medication errors or near errors.84 Fatigue and sleep loss was also a factor in a subpopulation of
ICU nurses, who reported errors with high-alert medications (e.g., morphine, chemotherapeautic
agents).85 The other two studies assessed fatigue along with other variables associated with
medication errors. In one of these, a survey of 57 nurses, respondents reported that the majority
of medication errors were attributable to fatigue.70 The other study, a survey of 25 nurses in one
hospital, found that one of the most frequently perceived causes of medication errors for nurses
was being tired and exhausted (33.3 percent).102
The thought processes of nurses during medication administration was assessed in two
studies. A semistructured, qualitative interview of 40 hospital nurses prior to implementation of a
bar-coding system explored the thinking processes of nurses associated with medication
administration.110 Their thought processes involved analyzing situations and seeking validation
or a solution when communicating about patients; using knowledge, experience, and
understanding of patients’ responses to anticipate problems; integrating their knowledge of lab
values and patterns of pathophysiological responses to determine possible need to change dosage
or administration timing; checking orders for validity and correctness; assessing patients’
responses for possible side effects and effectiveness of the drug; using cues from patients or
family members about need for explanations about drugs; bypassing protocols or procedures,
some taking a risk, to get drugs to patients or use time more efficiently; anticipating needs for
future problem solving; and applying professional knowledge during drug administration. The
other study of nurses, using direct observation in a medical and surgical unit in Australia, found
that participants used hypothetico-deductive reasoning to manage patient problems.111 Graduate
nurses used pattern recognition of patient characteristics and medications during decisionmaking.
Intuition and tacit knowledge was used in relation to changes in patients’ vital signs and to
objectively monitor patients.
Thought process can also be distorted by distractions and interruptions. One study employed
direct observation of medication administration to determine the effects of human factors on
MAEs.24 The investigators found that slips and memory lapses were associated with 46.7 percent
of MAEs. During both the prescribing and administration of medications, the causes of errors
were attributable to slips and memory lapses (23.1 percent during prescribing vs. 46.7 percent
during administration), lack of drug knowledge (46.2 percent during prescribing vs. 13.3 percent
during administration), and rule violations (30.8 percent during prescribing vs. 13.3 percent
during administration). Another study using direct observation found causes associated with
MAEs to include slips and memory lapses (40 percent), rule violations (26 percent), infusion
pump problems (12 percent), and lack of drug knowledge (10 percent).45
Experience and skills also impact thought processes. In one study of 40 student nurses and 6
nurses using a computerized program to assess the impact of dyslexia found that the greater the
tendency towards dyslexia, the poorer the potential cognitive ability to effectively provide the
skills associated with effective drug administration.112 Similarly, in two reviews of the literature,
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
a number of medications errors were found to be caused by poor mathematical skills,30 especially
if mathematical skills were needed to properly administer drugs.39
Lack of medication knowledge is a constant problem, and there is a need to continually gain
more knowledge about current and new medications.30 Nurses with more education and
experience may have greater knowledge of medications.39 However, experience has not been
found to mitigate the effect of poor mathematical skills nor frequency of MAEs.30 Those new to
a unit or profession may be at risk for errors.39 In a survey of nurses working in three hospitals in
Taiwan, nurses reported causes of MAEs as new staff (37.5 percent), unfamiliarity with
medication (31.9 percent), unfamiliarity with patient’s condition (22.2 percent), and insufficient
training (15.3 percent).93 Inexperience may also contribute to performance (human) deficit,
willingness to follow a procedure/protocol, and knowledge deficit. Of these reported contributing
factors, 78 percent were due to the inexperience of staff.44 Blegen, Vaughn, and Goode113 found
that medication errors rates were inversely related to the proportion of nurses on a unit with
greater experience, but were not related to the educational level of the staff on the unit.
24
Evidence Table 2. Working Conditions Associated With Medication Administration Errors and Adverse Drug Events
the patient care unit errors were positively correlated with falls
level (0.192).
Blegen System Factors: Cross- Analysis of event 39 units in 11 None Rates of MAEs by 10,000 doses were highest
199896 Staffing and RN sectional reports and nurse hospitals in medical-surgical and obstetric units; they
skill mix study staffing patterns for were highest by 1,000 days in ICUs.
10 quarters Units with RN proportions greater than 85%
had higher rates of MAEs per 10,000 doses.
Blegen Human Factors: Cross- Secondary data 80 units in 12 None MAEs were inversely related to RN
113
2001 RN education and sectional analysis hospitals experience but were not related to RN
Hofmann System Factors: Cross- Survey and None Increased safety climate scores associated
2006101 Safety climate sectional administrative data with lower rate of medication errors causing
study from 82 units in 41 harm.
hospitals
Kapborg Process Factors: Retrospective Analysis of 68 cases of None Reported causes of MAEs were lack of
80
1999 Policies and cohort study malpractice cases MAEs occurring administration protocols, failure to check
procedures and small interview in several types orders, ineffective nurse supervision in
Supervision survey with 8 nurses of home care delegating administration, and inadequate
Documentation of working in nursing and nursing documentation.
administration homes and home home settings
care setting using
semistructured
questions
Safety Issue Study Design & Study Setting
Source Related to Design Type Study Outcome & Study Study Key Finding(s)
Clinical Practice Measure(s) Population Intervention
Kopp 200645 Process Factors: Prospective Voluntary survey of 1 16-bed None 12% of the 42 MAEs were caused by infusion
Equipment cohort study nurses on the medical/surgical pump problems.
malfunction during medication use ICU in a tertiary Causes associated with MAEs included slips
medication process followed by care academic and memory lapses (40%), rule violations
administration direct observation medical center (26%), lack of drug knowledge (10%).
Human Factors: over 6 months by 2 in Arizona
Individual pharmacy residents
characteristics specializing in critical
associated with care pharmacy.
MAEs Pharmacy residents
would intervene if
MAE would have
resulted in patient
harm.
Manias Process Factors: Prospective Qualitative participant 12 graduate None To monitor patients before, during, and after
109
2004 Medication cohort study observation and nurses in medication administration, nurses assessed
management and questioning of nurses medical and vital signs, lab values, ability to swallow, and
patient monitoring during medication surgical units of patient self-report of health.
administration a university Participants felt responsible for timing
31
Osborne Process Factors: Cross- Self-reported 57 full-time and Main cause of medication errors was failure to
199970 Distractions sectional perception of nurses part-time RNs identify the right patient (35.1%), and 24.6%
Failure to comply study on medication errors, (a 62% indicated the effects of fatigue.
with procedures their causes, and response rate)
Human Factors: how medication in a medical-
Confusion errors should be surgical unit in a
Fatigue reported 700-bed
community
hospital in south
Florida
errors with and without hospital in support (i.e., library (24% of infusions) and overriding alerts
decision support Boston alerts, were frequent.
during 11 months. reminders, and Use of the smart pumps did not reduce the
unit-specific rate of serious medication errors.
drug rate limits)
used during
medication
administration
Scott- Process Factors: Prospective Naïve, direct 8 RNs, 12 None RNs administered 15.3% of observed doses,
Cawiezell Distractions and cohort observation of LPNs, 19 LPNs 23.3%, and CMT/As 61.43%. The MAE
2007104 interruptions medication CMT/As in 5 rate for RNs was 34.6%, LPNs 40.1%, and
Tissot System Factors: Prospective Direct observation of A geriatric unit None Opportunities for errors were associated with
91
2003 Workload cohort study nurses administering and a incomplete/illegible prescriptions and nurse
Process Factors: medications to cardiovascular- workload (OR = 2.44, 95% CI = 1.30–4.60; P
Incomplete/illegible patients by a thoracic surgery = 0.006).
orders pharmacist unit within a
hospital in
France
36
Ulanimo Process Factors: Cross- Survey on perceived 25 nurses (44% None The most frequent perceived causes of
2007102 Perceived causes sectional causes of medication response rate) medication errors for nurses were failing to
of MAEs study errors and in a VA hospital check patient name band with medication
Human Factors: percentage of all in Northern administration record (45.8%); being tired and
Distractions medication errors California exhausted (33.3%); miscalculating the dose
that are reported to (29.2%); confusion between 2 look-alike
the nurse manager, drugs (29.2%); distractions (25%); different
completing an infusion devices being used (25%); unclear
incident report. medication labeling/packaging (25%); and
wrong infusion device set up/adjustment
(24%).
Whitman System Factors: Prospective Secondary data 95 patient care None Rates of medication errors were inversely
200297 Nurse staffing cohort study analysis of a units in 10 adult associated to staffing work hours per patient
prospective, acute care day in cardiac ICU (r = -0.53) and noncardiac
observational cohort hospitals in an intermediate (r = -0.55) care settings.
study integrated 30.3% of the variance in medication error
health care rates resulted from the variance in staffing
system in the work hours per patient day.
eastern United
States
Safety Issue Study Design & Study Setting
Source Related to Design Type Study Outcome & Study Study Key Finding(s)
Clinical Practice Measure(s) Population Intervention
Wolf 200644 Process Factors: Retrospective Analysis of MAEs MAEs reported None The major contributing factors to MAEs were
Distractions cohort study reported January 1, by 1,305 inexperienced staff (78%) and distractions
Human Factors: 1999, to December nursing (20%).
Knowledge deficit 21, 2003, by nursing students in the The other, significantly fewer causes of errors
Inexperience students during the USP were insufficient staffing, agency/temporary
administration phase MEDMARX® staffing, lack of access to patient information,
program; 763 emergency situation, poor lighting, patient
reports included transfer, floating staff, no 24-hour pharmacy,
contributing and code situation.
factors. The major causes of MAEs were reported as
performance (human) deficit (51%),
procedure/protocol not followed (32%), and
knowledge deficit (27%).
37
Strategies to improve medication safety focused on acute care settings. Twenty-six studies
and descriptions of quality improvement projects were identified. Strategies used included
recommendations from a nationwide voluntary organization to improve safety, education of
nurses and other providers in safe practices, and system change and technology.
Nationwide voluntary efforts. Lucian Leape and colleagues116 reported on a 15-month
Institute for Healthcare Improvement Breakthrough Series Collaborative intended to reduce
ADEs. Eight types of strategies were successfully used, including documentation of allergies,
nonpunitive reporting, and standardizing medication administration times. Effective leadership
and appropriateness of intervention were associated with successful change implementation. The
converse was associated with failure, as were unclear aims, poorly designed interventions, lack
of focus on underlying system failures, unclear measures, too much focus on data collection,
involvement from only some stakeholders, opposition from physicians and nurses, and
conflicting time demands for team members. The findings were limited by the lack of an analysis
of the relationship between established safety policies and practices and the success of
implementing new strategies, as well as the relationship between the implementation and the
occurrence of ADEs.
A survey of 148 hospitals about the characteristics and barriers associated with adoption of
the National Quality Forums’ 30 safe practices was done by Rask and colleagues.117 These
practices included unit dosing, adopting computerized physician order entry (CPOE), and having
a culture of safety. Of the recommended practices, there was high adoption of standardized
labeling and storage of medications (90.5 percent), identification of high-alert medications (81
percent), and use of unit doses (81 percent). For-profit hospitals were more likely than not-for-
profit hospitals to have unit-dose medication distribution systems (93.1 percent vs. 78.2 percent)
and policies on reading back verbal orders (83.1 percent vs. 58.4 percent). There were greater
distractions affecting medication administration in large hospitals. Hospitals with 100–299 beds
were more likely to report using pharmacists to review and approve nonemergency orders prior
to dispensing; and, 69.4 percent of all hospitals used data analysis to drive patient safety quality
improvement efforts.
Nurses’ education and training. Educational strategies aimed to improve medication safety
and avert unnecessary medication errors. One randomized controlled study used an interactive
CD-ROM education program to improve the use of safe medication practices and decrease the
rate of MAEs.118 Direct observation of medication administration was used to assess the impact.
After the training, nurses’ use of safe administration practices increased, but preparation errors
did not decrease. There were too few actual medication errors to analyze pre-post differences.
Another approach used an 11 module Web-based educational strategy to improve drug safety
with a small sample of nurses.119 Direct observation of medication administration was used to
determine the outcome. After using these modules, rates of nonintravenous MAEs decreased
from 6.1 percent to 4.1 percent. Rates of errors in intravenous drug administration did not decline
as expected. Dennison120 reported the results of a medication safety training program for nurses.
Knowledge scores improved in this pre-post test study, but there was no significant change in
safety climate scores, labeling of intravenous infusion setups, or the number of self-reported
errors.
Attempts to improve basic and continuing education in medication safety have been reported,
but they have not assessed the impact on actual error rates. In a small pilot study, a problem-
38
Medication Administration Safety
based learning approach was found to enable students to use findings from topic-specific
research to develop and apply solutions for clinical problems. Papastrat and Wallace121 proposed
using problem-based learning and a systems approach to teach students how to prevent
medication errors and suggested content, but their approach was not compared to other teaching
methods. Another proposed educational strategy for practicing nurses was to use simulation of
medication administration and errors in a controlled setting to improve medication safety,
“duplicate the complexity of the nurse-patient interaction and related cognitive
thought”122 (p. 249). Simulations could be used to prepare nurses to recognize and manage
medication errors when and if they occur.
System change. Several attempts to change the system have been tested. Some of the
strategies addressed the thoroughness of error reporting, some the processes and events
surrounding medication administration, and some focused directly on reducing errors. Using a
hospitalwide performance improvement project that emphasized system factors, not individual
blame, error reporting increased from a rate of 14.3 percent to 72.5 percent.123 To address
intravenous infusion problems, a medication safety education program and medication
calculation worksheets were introduced, followed by ongoing Plan-Do-Study-Act cycles.124
Multiple system changes were also used to improve safety of intravenous drug infusion. These
included removing 90 to 95 percent of potassium chloride ampoules from the bedside;
developing preprinted labels for five common drug infusions; removing four-channel infusion
pumps the unit and replacing them with double-channel infusion pumps with a simple interface
design; standardizing administration of drugs given by bolus dose using a syringe pump;
decreasing missed doses of immunosupression drugs for transplant patients from 25 percent to 9
percent by incorporating them into the main drug chart; implementing standardized prefilter and
heparin-lock central venous catheters and heparin infusions into ICU protocol; redesigning drug
infusion administration practices throughout the hospital; eliminating burettes for IV drug
infusion; preparing standardized drug infusions for 36 drugs; and providing Intranet-based up-to-
date drug information.
A time study and focus groups were used to compare nurse efficiency during medication
administration using either medication carts with unit doses or a locked wall-mounted cupboard
in each patient room.125 After 12 weeks, the wall-mounted units were found to have decreased
medication administration time for nurses an average 23 minutes per 12-hour shift. Time saved
by not having to search for missing medications saved 0.38 full-time equivalent (FTE) annually.
Pharmacists spent an additional 0.05 FTE in stocking room cupboards. Nurses reported more
contact time with patients when using room cupboards and fewer interruptions by colleagues
during medication preparation and administration. Two small experimental studies attempted to
reduce distractions that frequently interrupt nurses during medication administration and thereby
introduce the potential for error.126, 127 In both studies a standardized protocol for safe
administration of medications was introduced to the nursing staff in the experimental group and
signage was used to remind others (physicians, patients, other staff) to not interrupt. The signage
in the first study was a vest that the nurse administering medication wore; in the second it was a
sign above the preparation area. Direct observation of the number and types of distractions
provided the outcome measures in the first study; a questionnaire completed by each nurse
administering medications provided the measure of distractions for the second. In both studies,
the number of distractions was significantly reduced. Medication error rates were not captured.
One randomized controlled trial compared the use of a dedicated nurse for medication
administration to nurses providing comprehensive care, including administering medications, to
39
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
their patients in two hospitals.128 MAEs were then assessed using direct observation. The
investigators found the error rates to be 15.7 percent at the intervention hospital and 14.9 percent
in the control hospital. The rate of MAEs was not significantly different between control and
experimental groups.
Involving patients in the administration of medications while in the hospital is another
system strategy that has been assessed. With this intervention, hospitalized patients have the
responsibility for administering their own medication under the supervision of nursing staff. A
literature review reported on 12 studies that described and evaluated a patient self-administration
program.129 This review found that the patients’ knowledge about their medications and the
prescribed dosing increased, but knowledge about the potential side effects of their medications
did not. Given the body of the reviewed literature, it appeared as though patients and families
make as many or more MAEs than do health care providers.
System change with technology. Another rapid-cycle implementation project over 6 months
used continuous quality improvement data before and after implementing a modular,
computerized, integrated infusion system.130 Most infusion error warnings occurred between 3
p.m. and 9 p.m., peaking at 6 p.m. Nurses responded to 12 percent of the infusion error warnings
by altering the setting and averting errors. The nature of the 88 percent of warnings not
responded to was not discussed. Risk scores associated with heparin infusion rates decreased
almost fourfold. Almost all nurses used the new software correctly.
Two studies focused on documentation of medication administration. One study introduced a
charting system with decision support and used a quasi-experimental design to determine the
effects.131 Researchers collected medication charting data for 8 weeks in both the control and
study units. Staff in the study unit received an educational intervention about error avoidance
through real-time bedside charting, followed by 12 weeks of monitoring and performance
feedback. After the 12 weeks, medication charting rates increased from 59 percent to 72 percent
in the intervention group. The second study used a computer-based “unreported meds followup”
to remind nurse staff about scheduled medications omitted or not documented.132 After charts
were prospectively reviewed, a mandatory medication error prevention seminar was given to
nurses, and a medication review report was created for nurses. Reported medication errors and
documentation of medication administration were reviewed, medication administration policies
were developed, and focus changed to the potential causes of errors. Documentation errors
decreased over the 3 years of the study, and reported error rates increased by 0.5 percent each
year.
Bar-coded medication administration (BCMA) is promoted as the most effective way to
reduce administration errors and is being implemented widely. Conceptually this technology
should catch nearly all errors, but rigorous evaluation of the impact of technology on error rates
has lagged behind implementation. The biggest challenge to determining the effectiveness of
BCMA or other interventions is the lack of valid measures of MAEs. Data from voluntary self-
reported medication errors are known to capture only a small portion (5 percent to 50 percent) of
actual errors, and the BCMA system itself greatly alters nurses’ awareness of errors, thereby
systematically affecting reported error rates. Many studies reporting analysis of the impact of
BCMA have used data collected by the system only after implementation.133–136 From these we
learn the types of errors intercepted by the system. Three other studies of the impact of BCMA
on administration errors reported very large reductions: 59–70 percent decrease,137 71 percent
and 79 percent drops.138 However, the sources of the data for determining these decreases are not
known.
40
Medication Administration Safety
41
Evidence Table 3. Strategies To Reduce Medication Administration Errors
chart.
Implemented standardized prefilter and
heparin-lock central venous catheters.
Eliminated burettes for IV drug infusion.
Standardized drug infusion protocols for
36 drugs and provided Intranet-based
up-to-date drug information.
Coyle 2005133 BCMA Quality Assessed process 161 medical Systemwide Acceptance of nurses and “marked
improvement centers in the change to decrease” in errors (data for this
project Veterans Health BCMA and decrease not described).
Greengold Medication Randomized Compared using a 2 hospitals Using a Generally, there were no significant
128
2003 administration controlled trial dedicated nurse for dedicated differences in MAEs between the 2
nurses medication nurse for types of interventions, but MAEs were
administration to medication lower in surgical units and higher in
nurses administration mixed medical and surgical units that
administering used dedicated nurse medication
medications to their administers.
patients
Larrabee 2003136 BCMA Quality Descriptive— 1 hospital BCMA Occurrence reports increased, analysis
improvement process and of systems data for prevented errors
respectively).
Success of change strategy was
associated with the commitment of the
collaborative team (i.e., leadership),
effective processes, and appropriate
choice of interventions.
Failure was attributed to lack of
leadership support; ineffective team
leadership; unclear aims; poorly
designed interventions; lack of focus on
underlying system failures; unclear
measures; too much focus on data
collection; involvement from only some
stakeholders; opposition from
physicians and nurses; and conflicting
time demands for team members.
Study Setting
Source Safety Issue Design Type Study Design & & Study Study Key Finding(s)
Related to Clinical Study Outcome Population Intervention
Practice Measure(s)
Mahoney 2007134 Integrated clinical Quality Examined Multihospital Included System decreased prescribing errors,
information improvement— medication errors, system CPOE, increased pharmacist interventions,
technology measures only turnaround time, electronic improved monitoring.
after decision-support record, BCMA, 73 administration errors for every
implementation overrides. decision 100,000 doses were intercepted after
support, and implementation.
drug
dispensing
Meadows 2002138 BCMA Review of Relates briefly the 2 hospitals BCMA The two hospitals had reductions in
BCMA system results of two medication error rates of 71% and 79%.
and effects system Data used to measure these not
interventions described.
Nelson 2005131 Decision support to Pretest and Collected Two 40-bed Educational Medication charting rate increased from
improve medication post-test medication charting surgical units in intervention 59% to 72% in the intervention group.
administration data for 8 weeks in one hospital in followed up
both the control Utah with real-time
and study units. feedback on
Staff in the study documentation.
47
unit received an
educational
intervention about
error avoidance
through real-time
bedside charting,
12 weeks of
monitoring, and
performance
feedback.
Paoletti 2007140 BCMA and Evaluation Used direct 3 units in one BCMA and Accuracy rate 86.5% before and 97%
Papastrat 2003121 Educational Changing Pilot testing of First-semester New teaching Problem-based learning enabled
interventions practice project problem-based baccalaureate method students to use findings from topic-
learning and nursing specific research to develop solutions
systems analysis students at for clinical problems.
methods for Thomas Students applied knowledge to clinical
medication Jefferson settings.
administration to University
undergraduate
nurses.
Pape 2003126 Reducing Quasi- Three groups: one One Protocol for Distractions were statistically
distractions during experiment control, one used medical/surgical safe significantly less in the intervention
medication protocol, one used unit in one medication groups, particularly the intervention
administration protocol and hospital, 24 administration. group using both protocol and signage.
signage. nurses Signage—
Outcomes nurse
measured by administering
observing medications
medication rounds wore vest
for distractions. asking others
not to interrupt.
Study Setting
Source Safety Issue Design Type Study Design & & Study Study Key Finding(s)
Related to Clinical Study Outcome Population Intervention
Practice Measure(s)
Pape 2005127 Reducing Process Interventions 5 units in one Protocol and Self-report of distractions from before
distractions during Improvement introduced after hospital, 20 checklist for and after signage was placed showed
medication observation of nurses safe decline in distractions from other
administration distractions. medication nurses, other personnel, external
Measured administration conversation, and loud noises.
distractions with introduced to
self-report tool. all nurses.
Signage
“STOP do not
disturb” placed
above med
prep area.
Rask 2007117 Medication safety Cross- Survey of hospitals 148 hospitals in None There was high adoption of
practices sectional study about adoption of the United standardized labeling and storage of
National Quality States medications (90.5%), identification of
Forum’s safe high-alert medications (81%), and use
practices and of unit doses (81%).
culture of safety For-profit hospitals were more likely
than not-for-profit hospitals to have unit-
49
of errors documented.
Charts were
prospectively
reviewed, a
mandatory
medication
error
prevention
seminar was
given to
nurses, and a
medication
review report
was created for
nurses.
Study Setting
Source Safety Issue Design Type Study Design & & Study Study Key Finding(s)
Related to Clinical Study Outcome Population Intervention
Practice Measure(s)
Schneider2006118 Educational Randomized Nurses were 30 nurses (10 Interactive Errors in administrative practices
interventions controlled trial randomly assigned at each site) medication decreased at a statistically significant
to use an with at least 1 administration level, errors in preparation increased
interactive year program slightly, and there were too few adverse
educational tool on experience, drug events to analyze.
medication working full-
administration. time for at least
Direct observation 6 months, at 3
of medication community
administration hospitals in the
before and after the Midwest within
educational tool. a large
nonprofit health
system
van Gijssel- Computerized Before-after Compared 1 internal Computerized Prescribing errors increased, mostly
Wiersma 2005141 medication charts study prescription errors medicine unit medication omitted name and date. Administration
by review and chart, updated errors decreased from 10.5% to 6.1%.
administration daily,
errors by direct compared to
51
52
Medication Administration Safety
and valid data available, and share the results through publications to make the knowledge
available to all.
Research Implications
The implications for research follow directly on the discussion of practice implications.
Research in this area is constrained by the need to carry out these projects “in the field.”
Secondary analysis of existing data sets cannot be used for most of the pertinent questions in this
area. Laboratory studies are equally impossible. The situations at the heart of medication safety
are complex, multifaceted, and multidisciplinary; knowledge about them must be produced with
studies conducted within that complex environment. This requires health care institutions to
simultaneously attempt to implement changes that will reduce the problem and evaluate the
impact. Essentially, this is quality improvement (QI) work.
The question is, should the results of QI projects be considered evidence and used as part of
the knowledge foundation for future evidence-based practice projects?142 QI is a set of activities
intended to improve some aspect of health care processes,143 a dynamic and changing package of
interventions,144 and identification of ways to implement effective change.145 For the most part,
definitions of QI do not include assessing the effectiveness of these activities or producing
knowledge. And yet, reports of QI projects are increasingly used as evidence for practice and
organizational change.
Health care institutions are responding to the crisis in quality and safety with frenetic
activities designed to bring about improvement. They desperately want evidence that will assist
them in knowing which of these activities to focus on. Massive amounts of money are being
invested in organizational changes to improve quality and safety with mostly expert advice and
hunches to go on. There is little doubt that these projects are well intentioned; many of them
suggest changes that are intuitive or reflect common sense. To move beyond the current state of
multiple projects targeting similar changes, the industry needs evidence of the effects of specific
changes: the direct and indirect effects, the intended and unintended effects, and the cost
effectiveness.
By their nature, QI efforts are local, attempt to minimize disruption to the organization, and
try to constrain costs of implementation. To justify the organization’s investment in the project,
there is a desire to show that the project had the intended effect. Further, the directors of the
project often want to capitalize on the QI activities by reporting the results publicly, preferably
through respected journals or presentations at professional meetings. As a result of these multiple
goals, the project usually has only low-cost, superficial evaluation efforts that are then reported
as evidence with an emphasis on outcomes supporting the intervention and omission of those that
did not. Many current QI studies have significant bias and can cause harm by disseminating
results that lead health care institutions to invest in activities that may not improve quality, while
ignoring others that could.146 But, there is no consensus on standards that can be applied to
improve this situation. As Mosser and Kane147 asked recently, What level of proof should we
require to conclude that improvement has been achieved? What level of proof is there that the
intervention was the cause of improvement?
The problem of bias inherent in local efforts to improve quality is crucial. When
organizations make decisions to invest large amounts of money in a QI project, there is
understandable reluctance to hear, let alone share, results that show no systematic effects on the
outcomes of care. Yet, to produce the science required for future QI efforts, reports of activities
53
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
that were ineffective and those that resulted in unintended and disruptive side effects must also
be shared with others. Most QI activities cannot be tested with rigorous and controlled research,
and we therefore need to develop a QI science to enhance the internal and external validity of the
results. We cannot accept poorly conducted studies of efforts to improve quality and safety—it is
too crucial to the future of health care. At the same time, we must recognize that the complexity
of projects taking place in the real world cannot be simplified and that analytic methods must
substitute for experimental controls in this work.148 Both the practitioners’ distrust of research
and its accompanying statistics and the researchers’ disdain of the messiness of QI activities
must be tempered with a better understanding.
Despite concerns about the rigor of QI, it is crucial that these activities be reported to
promote learning about implementation methods that worked and those that did not, and the
types of projects that produced desired results and those that did not. To maximize learning,
these reports must be thorough and include both the intended and unintended outcomes,
descriptions of the intervention and implementation must be candid, the robustness of the
measures must be clear, and the description of the organizational context must be adequate.
Recent guidelines for the publication of QI projects may assist in achieving this thoroughness
and transparency.149 Collaboration between the principals involved in the QI project and health
systems researchers would maximize the potential for producing evidence from these field
studies. It is unlikely that science will ever develop methods to study implementation and
evaluation of QI projects in their natural setting with a level of rigor similar to experiments or
clinical trials, and that makes the results of QI projects even more valuable. It is crucial that we
learn which QI activities work in which settings and which outcomes can most likely be
improved with organizational changes.
The specific issues most in need of research (QI activities) at this time are as follows:
• Bar-coding and other medication safety technology—widely recommended but little or
no valid research using before-and-after designs.
• Independent RN double-checks—logical and widely recommended, but no research has
been done describing, let alone testing, the effects of this policy.
• Relationship between nurse staffing and medication errors—a few descriptive studies and
studies asking RN perceptions of the problem suggest that staffing and workload are
major factors, but there are no research studies using valid and reliable data.
• Techniques to reduce distractions, interruptions, other risk factors for medication error
need to be tested.
• Methods of effective education in medication safety for nurses and all providers.
• Effectiveness of implementing new checklists, policies, and procedures.
• Understanding work-arounds.
• Methods and techniques for successful implementation of system and process change.
Despite the national emphasis on patient safety and quality care, very little is known about
effective medication safety strategies for nurses. The recent IOM report on medication safety 2
identified several areas needing future research, including the following:
• What are the most effective mechanisms to improve communication between patients and
clinicians regarding the safe use of medications?
• What are the most effective mechanisms to improve patient education about the safe use
of medications?
• Which self-management support strategies are effective in improving patient outcomes?
54
Medication Administration Safety
• How can information about specific medications be effectively used by patients? What is
the impact of that information on patients’ adherence and communication with clinicians?
• How can patient-centered approaches to medication safety decrease errors associated
with medications and improve patient outcomes?
• How can medication-related competencies become a core competency among the current
workforce?
• What is the impact of free samples on patient adherence and health outcomes?
Conclusion
There is a large and growing body of research addressing medication safety in health care.
This literature covers the extent of the problem of medication errors and adverse drug events, the
phases of the medication-use process vulnerable to error, and the threats all of this poses for
patients. As this body of literature is evaluated, the fact that there are crucial areas about which
we know little becomes apparent. Nurses are most involved at the medication administration
phase, although they provide a vital function in detecting and preventing errors that occurred in
the prescribing, transcribing, and dispensing stages. Administration errors comprise a significant
proportion of all errors and yet, beyond that fact, there isn’t much known about the causes or
about the effectiveness of proposed solutions. Research addressing the complex process of
medication use in hospitals is badly needed and requires a new approach to produce valid
knowledge from studies done in the field with few controls of confounding factors.
Search Strategy
A search of the literature was conducted using PubMed® and CINAL®. The key words
employed in the search included “adverse drug events,” “drug administration,” “medication
administration,” “medication administration errors,” “medication error reporting,” “medication
safety,” “nursing,” “patient safety,” and “work(ing) conditions.” This resulted in 1,400 abstracts,
which were narrowed as follows. Literature that addressed topics covered in this book on health
information technology, specifically computerized provider order entry with clinical decision-
support systems (for nurses and/or physicians) and bar-code medication administration systems,
children, and medication reconciliation were excluded from this review, as were studies with
only physicians and pharmacists as study subjects, those in home health care settings, and those
related only to prescribing medications or patient compliance. Additional exclusion criteria
included research not differentiating the nursing role in medication administration,
administration of medications to reverse adverse drug reactions (e.g., naloxone for opioid
overdose), prescribing and dispensing process of medications, and unique specifications
regarding specific medications. Reviewed articles were searched for references that we did not
already have, and PubMed® links were checked as additional articles were found. The final
review also excluded editorials, newsletters, single-case studies, medication safety outside
institutional settings (if dealing with patient self-management or adherence), and studies with
critically flawed methodology and inadequate reporting. The literature was then also limited to
reports written in English and research published in 1997 or later. A total of 70 articles were
identified as having met the inclusion criteria as evidence and were discussed in this chapter.
55
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Author Information
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
Mary A. Blegen, Ph.D., R.N., F.A.A.N., professor in community health system and director
of the Center for Patient Safety, School of Nursing, University of California, San Francisco.
E-mail: [email protected].
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120. Dennison RD. A medication safety education
107. Chevalier BA, Parker DS, MacKinnon NJ, et al. program to reduce the risk of harm caused by
Nurses’ perceptions of medication safety and medication errors. The J Contin Educ Nurs
medication reconciliation practices. Can J Nurs 2007;38(4):176-84.
Leadersh 2006;19(3):61-72.
121. Papastrat K, Wallace S. Teaching baccalaureate
108. Rothschild JM, Keohane CA, Cook F, et al. A nursing students to prevent medication errors using a
controlled trial of smart infusion pumps to improve problem-based learning approach. J Nurs Educ
medication safety in critically ill patients. Crit Care 2003;42(10):459-64.
Med 2005;33:533-40.
122. Paparella SF, Mariani BA, Layton K, et al. Patient
109. Manias E, Aitken R, Dunning T. Medication safety simulation: learning about safety never seemed
management by graduate nurses: before, during and more fun. J Nurses Staff Dev 2004;20(6):247-52.
following medication administration. Nurs Health Sci
2004;6:83-91. 123. Force MV, Deering L, Hubbe J, et al. Effective
strategies to increase reporting of medication errors
110. Eisenhauer LA, Hurley AC, Dolan N. Nurses’ in hospitals. J Nurs Admin 2006;36:34-41.
reported thinking during medication administration. J
Nurs Scholarsh 2007;39:82-7. 124. Burdeu G, Crawford R, van de Vreede M, et al.
Taking aim at infusion confusion. J Nurs Care Qual
111. Manias E, Aitken R, Dunning T. Decision-making 2006;21(2):151-9.
models used by graduate nurses managing patients’
medications. J Adv Nurs 2004;47:270-8. 125. Bennett J, Harper-Femson LA, Tone J, et al.
Improving medication administration systems: an
112. Millward LJ, Bryan K, Evaratt J, et al. Clinicians and evaluation study. Can Nurse 2006
dyslexia—a computer-based assessment of one of the October;102(8):35-9.
key cognitive skills involved in drug administration.
Int J Nurs Stud 2005;42:341-53. 126. Pape TM. Applying airline safety practices to
medication administration. MEDSURG Nurs
113. Blegen MA, Vaughn T, Goode CJ. Nurse experience 2003;12(2):77-94.
and education: effect on quality of care. J of Nurs
Admin 2001;31:33-9. 127. Pape, TM, Guerra DM, Muzquiz M, et al. Innovative
approaches to reducing nurses’ distractions during
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communication with health professionals managing 2005;36(3):108-16.
patients’ medications. J Clin Nurs 2005;14:354-62.
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128. Greengold NL, Shane R, Schneider P, et al. The 139. Franklin BD, O’Grady K, Donyai P, et al. The impact
impact of dedicated medication nurses on the of a closed loop electronic prescribing and
medication administration error rate. Arch Intern administration system on prescribing errors,
Med 2003;163:2359-67. administration errors, and staff time: a before-and-
after study. Qual Saf Health Care 2007;16:279-84.
129. Wright J, Emerson A, Stephens M, et al. Hospital
inpatient self-administration of medicine 140. Paoletti RD, Suiess TM, Lesko MG et al. Using bar-
programmes: a critical literature review. Pharm code technology and medication observation
World Sci. 2006;28(3):140-51. methodology for safer medication administration.
Am J Health Syst Pharm 2007;64(5):536-43.
130. Fields M, Peterman J. Intravenous medication safety
system averts high-risk medication errors and 141. van Gijssel-Wiersma DG, van den Bemt PM,
provides actionable data. Nurs Admin Q Walenbergh-van Veen MC. Influence of
2005;29(1):78-87. computerized medication charts on medication errors
in a hospital. Drug Saf 2005;28(12):1119-29.
131. Nelson NC, Evans RS, Samore MH, et al. Detection
and prevention of medication errors using real-time 142. Blegen MA. Knowledge from quality improvement
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2005 Jul-Aug;12(4):390-7
143. Nerenz DR, Stoltz PK, Jordan J. Quality
132. Schaubhut R, Jones C. A systems approach to improvement and the need for IRB review. Qual
medication error reduction. J Nurs Care Qual Manag Health Care 2003;1:159-70.
2000;14(3):13-27.
144. Lynn J. When does quality improvement count as
133. Coyle GA, Heinen M. Evolution of BCMA within research? Human subject protection and theories of
the Department of Veterans Affairs. Nurs Admin Q knowledge. Qual Saf Health Care 2004;13:67-70.
2005;29(1):32-8.
145. Baker GR. Strengthening the contribution of quality
134. Mahoney CD, Berard-Collins CM, Coleman R, et al. improvement research to evidence based health care.
Effects of an integrated clinical information system Qual Saf Health Care, 2006;15:150-1.
on medication safety in a multi-hospital setting. Am J
Health Syst Pharm 2007;64(18):1969-77. 146. Pronovost P, Wachter R. Proposed standards for
quality improvement research and publication: one
135. Sakowski J, Leonard T, Colburn S, et al. Using a bar- step forward and two steps back. Qual Saf Health
coded medication administration system to prevent Care 2006;15:152-3
medication errors in a community hospital network.
Am J Health Syst Pharm 2005;62:2619-25. 147. Mosser G, Kane RL. How do you prove quality
improvement? J Am Geriatr Soc 2007;55:1672-3.
136. Larrabee S, Brown MM. Recognizing the
institutional benefits of var-code point-of-care 148. Berwick DM. Broadening the view of evidence-based
technology. Jr Comm J Qual Saf 2003;29(7):345-53. medicine. Qual Saf Health Care 2005;14:315-6.
137. Anderson S, Wittwer W. Using bar-code point-of- 149. Davidoff F, Batalden, P. Toward stronger evidence
care technology for patient safety. J Healthc Qual on quality improvement. Draft publication
2004;26(6):5-11. guidelines: the beginning of a consensus project.
Qual Saf Health Care 2005;14:319-25.
138. Meadows G. Safeguarding patients again medication
errors. Nurs Econ 2002;20(4):192-4.
61
Chapter 38. Medication Reconciliation
Jane H. Barnsteiner
Background
According to the Institute of Medicine’s Preventing Medication Errors report,1 the average
hospitalized patient is subject to at least one medication error per day. This confirms previous
research findings that medication errors represent the most common patient safety error.2 More
than 40 percent of medication errors are believed to result from inadequate reconciliation in
handoffs during admission, transfer, and discharge of patients.3 Of these errors, about 20 percent
are believed to result in harm.3, 4 Many of these errors would be averted if medication
reconciliation processes were in place.
Medication reconciliation is a formal process for creating the most complete and accurate list
possible of a patient’s current medications and comparing the list to those in the patient record or
medication orders. According to the Joint Commission5 (p. 1),
Medication reconciliation is the process of comparing a patient's medication
orders to all of the medications that the patient has been taking. This reconciliation
is done to avoid medication errors such as omissions, duplications, dosing errors,
or drug interactions. It should be done at every transition of care in which new
medications are ordered or existing orders are rewritten. Transitions in care
include changes in setting, service, practitioner, or level of care. This process
comprises five steps: (1) develop a list of current medications; (2) develop a list of
medications to be prescribed; (3) compare the medications on the two lists; (4)
make clinical decisions based on the comparison; and (5) communicate the new
list to appropriate caregivers and to the patient.
Recognizing vulnerabilities for medication errors, numerous efforts are underway to
encourage all health care providers and organizations to perform a medication reconciliation
process at various patient care transitions. The intent is to avoid errors of omission, duplication,
incorrect doses or timing, and adverse drug-drug or drug-disease interactions. The Joint
Commission added medication reconciliation across the care continuum as a National Patient
Safety Goal in 2005.6 The Institute for Healthcare Improvement (IHI) has medication
reconciliation as part of its 100,000 Lives Campaign. This chapter reviews the evidence for
medication reconciliation and makes recommendations for nursing practice.
Medication Reconciliation
A comprehensive list of medications should include all prescription medications, herbals,
vitamins, nutritional supplements, over-the-counter drugs, vaccines, diagnostic and contrast
agents, radioactive medications, parenteral nutrition, blood derivatives, and intravenous solutions
(hereafter referred to collectively as medications).6 Over-the-counter drugs and dietary
supplements are not currently considered by many clinicians to be medications, and thus are
often not included in the medication record. As interactions can occur between prescribed
medication, over-the-counter medications, or dietary supplements, all medications and
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
supplements should be part of a patient’s medication history and included in the reconciliation
process.
The steps in medication reconciliation are seemingly straightforward.7 For a newly
hospitalized patient, the steps include obtaining and verifying the patient’s medication history,
documenting the patient’s medication history, writing orders for the hospital medication
regimen, and creating a medication administration record. At discharge, the steps include
determining the postdischarge medication regimen, developing discharge instructions for the
patient for home medications, educating the patient, and transmitting the medication list to the
followup physician. For patients in ambulatory settings, the main steps include documenting a
complete list of the current medications and then updating the list whenever medications are
added or changed.
However, the process of gathering, organizing, and communicating medication information
across the continuum of care is not straightforward. First, there is tremendous variation in the
process for gathering a patient’s medication history. Second, there are at least three disciplines
generally involved in the process—medicine, pharmacy, and nursing—with little agreement on
each profession’s role and responsibility for the reconciliation process. Third, there is often
duplication of data gathering with both nurses and physicians taking medication histories,
documenting them in different places in the chart, and rarely comparing and resolving any
discrepancies between the two histories.
Additionally, patient acuity may influence the process of reconciliation. For example, a
patient admitted for trauma may result in cursory data gathering about the medication history.
Alternatively, a patient with numerous comorbidities may stimulate gathering a more complete
list of current medications. In general, there is no standardization of the process of medication
reconciliation, which results in tremendous variation in the historical information gathered,
sources of information used, comprehensiveness of medication orders, and how information is
communicated to various providers across the continuum of care.7
2
Medication Reconciliation
In inpatient facilities, there are several situations where medication reconciliation is needed.
Generally, patients are admitted to the hospital for a specific procedure, such as surgery, or on an
urgent basis. When specialty health care providers are focused on the one component of care
related to the specific encounter and do not take a holistic view to other aspects of the patients’
health care needs and practices, it is easy to overlook medications that may cause an adverse
event when combined with new medications or different dosages. Some of the patient’s daily
medications may be discontinued during a hospital stay, and when there is a lack of a formal
reconciliation process on discharge, the need to restart medications upon discharge may be
overlooked. One example would be discontinuing an anticoagulant during a hospital stay and
neglecting to restart it upon discharge. Another example is when orders from one unit of care
(such as intensive care) are discontinued and new orders are written when the patient moves to
another unit of care (such as a general care unit). The policy necessitating the rewriting of orders
makes it easy for the prescriber to overlook medications that may need to be reordered when no
formal medication reconciliation process is in place. These factors combine to create an unsafe
medication environment in acute care settings.
Research Evidence
Medication reconciliation studies have focused on the accuracy of the medication history
during various transitions: ambulatory to acute care inpatient setting, skilled nursing facility to
acute care inpatient setting, inpatient acute care setting to skilled nursing facility, inpatient acute
care setting to discharge, inpatient floor to the intensive care unit (ICU), and ICU to discharge.
Little research has focused on outcomes related to the prevalence of errors resulting from a lack
of or an incomplete patient medication list.
Medication discrepancies in outpatient records were addressed in three studies. Ernst and
colleagues9 found discrepancies in 26.3 percent of charts of patients requesting prescription
renewal. Of the charts with discrepancies, 59 percent omitted medications from the electronic
medical record medication list. Miller and colleagues,10 upon examining patient records of an
ambulatory family practice, found that while 76 percent of patients had prescribed medications,
87 percent of charts had incomplete or no documentation of those medications. Three years
following institution of a reconciliation process, which included a form on the chart listing all
medications ordered for a patient, 82 percent of charts had complete prescription medication
documentation. Similar findings were noted in a study of cardiology and internal medicine
practices11 and in a group of patients receiving dialysis.12 Whether patients used the prescribed
medications as originally prescribed or if their medications were changed by another physician
was not reported. The reconciliation process requires verification with the patient regarding their
use of the prescribed medications.
Nine studies examined medication reconciliation in acute inpatient settings. Bayley and
colleagues7 identified that the common discrepancies in medication history from ambulatory to
inpatient care were omitted medication orders, altered doses, or incomplete allergy histories.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Vira and colleagues13 found a 38 percent discrepancy rate in their study of newly hospitalized
patients. Gleason and colleagues4 found more than half of the patients they studied had
discrepancies in medication histories or admission medication orders.
Among the most common medication discrepancies between what is in the patient’s history
and what is ordered upon admission to the hospital was omission of a medication that patients
reported taking prior to admission.13 These discrepancies result from incomplete documentation
of the patient’s medication history and a lack of time to search for the information. Nursing staff
have been noted spending in excess of an hour per patient admission or transfer trying to
accurately identify medications a patient has been receiving,3 including getting a list of
preadmission medications from the patient and filling in gaps through the pharmacy and primary
care physician.
Chevalier and colleagues14 examined nurses’ perceptions of medication reconciliation
practices. More than 60 percent of nurses reported that determining the medications a patient was
taking at home, clarifying medication orders at transfer, and ensuring accurate discharge
medication orders was a time-consuming process. Time requirements and staffing resources were
identified as a barrier to completing the process. Although implementing a medication
reconciliation process will likely consume more health care provider time initially, the process
may become more efficient once in place. A standardized reconciliation process has been
reported to reduce work and the rework associated with the management of medication orders.
Rozich and colleagues15 reported that implementing a systematic approach to reconciling
medications was found to decrease nursing time at transfer from the coronary care unit by 20
minutes per patient, and pharmacy time at hospital discharge by more than 40 minutes. Stover
and Somers16 reported that case managers performing the reconciliation process spent 5 to 10
minutes per day completing the process with new admissions, and each case manager typically
reviewed eight new admissions each day.
One challenge to having an accurate patient medication history is the lack of a standardized
location in the patient chart where the information may be found. A nurse may need to check the
nursing admission database, the medication administration record, the physician patient history
and progress notes, and the pharmacy database. Rozich and Resar15 found that prior to initiation
of a reconciliation process, details of the current medications in the inpatient chart were
nonexistent or incorrect 85 percent of the time. Similar findings were found in family practice.17
Nickerson and colleagues18 found that of the medication history discrepancies they identified, 83
percent had the potential for harm. Others reported that when a medication reconciliation process
was instituted, it reduced discrepancies from 70 percent to 15 percent.3, 19 Vira and colleagues13
reported that a medication reconciliation process prevented the potential for harm in 75 percent
of cases.
Transfers From Inpatient Floor to ICU and Discharge From the ICU
4
Medication Reconciliation
A study of medication changes during transfer from nursing home to hospital and hospital to
nursing home found inaccurate and incomplete reconciliation of medication regimens.22 The
mean number of medication orders altered per patient on admission to the hospital from a
nursing home was 3.1, and from the hospital to the nursing home was 1.4. Sixty-five percent of
the medication changes were discontinuations, 19 percent were dose changes, and 10 percent
were substitutions for medications with the same indications. The investigators estimated that 20
percent of the medication changes led to an adverse drug event.
Inpatient to Discharge
Four studies looked at the process of discharge from the hospital to home. Bayley and
colleagues,7 in a qualitative study including nurse, physician, and pharmacist informants,
reported that reconciliation failures at discharge stemmed from not resuming medications held
during the hospital stay, and insufficient patient education at discharge. These failures resulted
from incomplete gathering of the home medication regimen at admission and rushed discharges.
Moore and colleagues23 found that 42 percent of the patients they studied had one or more
errors in the discharge medication orders. Most often medications that should have been restarted
were not. The medications commonly involved were cardiovascular (36.4 percent),
gastrointestinal (27.3 percent), and pulmonary (13.6 percent). Sullivan and colleagues24 found
that 59 percent of discrepancies not corrected at discharge could have resulted in patient harm.
The use of a multipart paper prescription form for discharge medications was found to
improve accuracy. The form integrates admission medications, in-hospital changes, and
discharge medications. One part of the form is used as the prescription, the second is placed in
the chart, the third is given to the patient with instructions for home management, and the fourth
is sent to the primary care physician. Accuracy of medication prescriptions with the use of a
multipart form was 82 percent, as compared to 40 percent without the use of an integrated
process.25
The electronic health record is generally believed to contain more accurate information and
facilitate easier retrieval of information than paper-based medical records. Studies of medication
lists in electronic health records have found the data are only as accurate as what has been
entered. Wagner and Hogan26 found discrepancies between the number of medications patients
reported taking (5.67) and that listed in the electronic record (4.69). Data entry errors accounted
for 28 percent of the discrepancies, while 26 percent were related to failure of the clinician to
enter medication changes into the electronic record.
DeCarolis and colleagues27 found that a computerized medication profile was inaccurate in
71 percent of the patients they studied. They demonstrated that implementation of a standardized
medication reconciliation process reduced the number of patients with unintended discrepancies
by 43 percent, thereby significantly decreasing the potential for medication errors. However,
developing and implementing an electronic reconciliation process requires technical support.
Kramer and colleagues28 reported needing grant funding with hospital matching funds for
development and programming. Reprogramming is required anytime there are system upgrades.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Use of a computer order entry system can reduce errors at the time of discharge by
generating a list of medications used before and during the hospital admission. The medication
list with instructions can be printed and used for education and review with the patient.7 The
utility of such a system depends upon the prior implementation of an admission medication
reconciliation system. Some electronic discharge medication ordering systems allow for direct
transfer of the orders to the community pharmacy and to the primary care physician, as well as
keeping a permanent record on the electronic health record.
Clearly there is a need for patients, families, health care providers, and pharmacies to have a
single electronic medication record with everyone working from the same record and all
medications being reconciled against this record. Electronic systems make it easier to access
medication histories, but they need to be kept up to date, and information must be correlated with
patients’ actual medication use.
Electronic prescribing network systems are being developed that can instantaneously provide
a patient’s medication history to pharmacists, consumers, and health care providers, while
protecting patient privacy. Additionally, electronic prescribing allows for key fields such as drug
name, dose, route, and frequency. Electronic prescribing also allows for decision support such as
checking for allergies, double prescribing, and counteracting medications.
A first step in having an accurate listing of medications is defining the steps in obtaining a
complete medication history. IHI suggests three steps to the process: (1) verify by collecting the
list of medications, vitamins, nutritional supplements, over-the-counter drugs, and vaccines; (2)
clarify that the medications and dosages are appropriate; and (3) reconcile and document any
changes.29 Each health care setting needs to develop standards for who is responsible and how
the process will be completed. Whittington and Cohen reported that the accuracy of medication
lists went from 45 percent to 95 percent with the implementation of reconciliation standards.30
Health care professionals need to clearly identify team roles and responsibilities for
medication reconciliation. This needs to include evaluating existing processes; identifying a
standard location in the patient chart where the medication history is kept; and determining who
will put the medication history onto the agreed upon place in the chart, the time frame for
resolving variances, and how to document medication changes.31 These processes would
eliminate the duplication of history taking and documentation that currently exists in many
settings.
6
Medication Reconciliation
Many settings have found the use of a standardized medication form facilitates an accurate
list that is accessible and visible.32 Numerous examples are available on the IHI and Joint
Commission Web sites.
Many organizations have a process in place that calls for reviewing the patients’ medication
list at every primary care visit and within 24 hours of an inpatient admission. High-risk
medications such as antihypertensives, antiseizures, and antibiotics may need to be reconciled
sooner, for example, within 4 hours of admission.
Implement a reconciliation review of open and/or closed patient records. Assess adherence to
the process and identify the potential for and any actual harm associated with unreconciled
medications. Auditing tools such as the Improvement Tracker on the IHI Web site may assist
health care settings in tracking their findings over time. Share results with providers so they are
able to note progress over time.
Patient education needs to be a major focus in medication reconciliation. Patients may not be
accurate historians.32 Recognition that information is being gathered from laypeople needs to be
acknowledged and assistance needs to be offered to make the information as accurate as
possible. A number of approaches have been identified to assist patients and families—for
example, reconcile the medication list at every ambulatory visit.9 Establish a process where
patients bring their medications, including all over-the-counter preparations, to every health care
encounter.9, 33 Use of a universal patient medication form has shown promise in North Carolina;
the form can be found at www.scha.org. In addition, educating patients about their medications
allows them to keep better track of the medications they are taking.
Challenges
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Garnering executive leadership and support, obtaining physician and nurse understanding of the
need for medication reconciliation, and actively participating in the design and implementation
of programs may be difficult in many organizations where providers already feel burdened.
There is a time commitment in both obtaining the medication history and completing the
reconciliation process.
Research Implications
Research is needed on all aspects of the medication reconciliation process to provide an
evidence base for impacting the prevention of adverse drug events. The Institute of Medicine
report Preventing Medication Errors1 found that currently most of the studies reported in the
literature have small sample sizes and are single-site quality improvement projects. Multisite
studies across the continuum of care are needed to assess the scope of the problem. Intervention
studies using a variety of approaches, both paper based and electronic, are needed to determine
the accuracy, feasibility, and simplicity of maintaining accurate lists of a patient’s medication
history.
The medication reconciliation process takes time, initially an additional 30 to 60 minutes per
admission.15 If an inpatient unit has multiple discharges and admissions, this can translate to the
need for additional full-time staff. If nurses are responsible for the process, nursing hours per
patient day may need to increase. Study of how medication reconciliation processes change the
workflow and time associated with it are needed.
Busy clinicians are resistant to changing their workflow. Designing and testing streamlined
processes that will work across the continuum of care, from the ambulatory to the inpatient
setting, and having all stakeholders involved in the design will facilitate the process.
Studies of the sustainability of medication reconciliation processes need to be carried out.
What does it look like at 6, 12, and 24 months? Are improvements being maintained?
Patients need to be full partners and self-advocates in the medication reconciliation process.
Studies on systematic, multifaceted education programs regarding how to best maintain a current
and complete listing of all medications need to be undertaken, as recommended in Preventing
Medication Errors.1 Studies should also address what techniques (e.g., the use of a medication
card) work best to maintain an accurate list of medications.
Conclusion
There is some evidence to demonstrate how a medication reconciliation process is effective
at preventing adverse drug events. Few studies have been published demonstrating how to do the
process effectively or outlining the costs associated with design and implementation of
programs. Nonetheless, an effective medication reconciliation process across care settings—
where medications a patient is taking are compared to what is being ordered—is believed to
reduce errors. Comparing what is being taken in one setting with what is being prescribed in
another will avoid errors of omission, drug-drug interactions, drug-disease interactions, and other
discrepancies. Medication reconciliation is a major component of safe patient care in any
environment.
8
Medication Reconciliation
Search Strategy
Searches were carried out using the terms “medication reconciliation,” “medication
verification,” “medication safety” “medication systems,” and “medication errors.” OVID
databases for CINAHL®, MEDLINE®, and Google databases were searched. English-language
health care literature from 1965 through March 2007 was reviewed. Additional searches were
carried out on numerous patient safety Web sites, such as the Institute for Safe Medication
Practices, the National Patient Safety Foundation, the Joint Commission, and the Institute for
Healthcare Improvement. Reference lists from articles on medication reconciliation were also
used to identify additional publications.
Articles that describe various components of the reconciliation process were found. Studies
tended to be about one of the steps in the handoff process, such as admission from home to an
acute care facility. No studies were identified that described the reconciliation process along the
entire continuum of care from admission to an acute care facility, transfer from one level of care
to another (such as critical care to general care), and discharge back to the community to the
primary care practitioner or skilled care facility. The majority of articles were descriptive, and
published studies were primarily quality improvement projects with small sample sizes limited to
single clinical sites.
Author Affiliation
Jane H. Barnsteiner, Ph.D., R.N., F.A.A.N., professor of pediatric nursing, University of
Pennsylvania School of Nursing, and director of nursing translational research, Hospital of the
University of Pennsylvania. E-mail: [email protected].
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therapy problems, inconsistencies and omissions 13(1):53-59.
identified during a medication reconciliation and
seamless care service. Healthc Q 2005;8:65-72. 31. Barnsteiner JH. Medication reconciliation: transfer of
medication information across settings—keeping it
19. Rogers G, Alper E, Brunelle D, et al. Reconciling free from error. Am J Nurs 2005; 105(3 Suppl):31-6.
medications at admission: safe practice
recommendations and implementation strategies. Jt 32. Rodehaver C, Fearing D. Medication reconciliation in
Comm J Qual Saf 2006;32:37-50. acute care: ensuring an accurate drug regimen on
admission and discharge. Comm J Qual Saf
20. Pronovost P, Weast B, Schwarz M, et al. Medication 2005;31(7):406-13.
reconciliation: A practical tool to reduce the risk of
medication errors. J Crit Care 2003;18(4):201-5. 33. Jacobson J. Ensuring continuity of care and accuracy
of patients' medication history on hospital admission.
21. Pronovost P, Hobson DB, Earsing K, et al. A practical Am J Health Syst Pharm 2002;59:1054-5.
tool to reduce medication errors during patient transfer
from an intensive care unit. J Clin Outcomes Manag 34. Bates D, Miller EB, Cullen DJ, et al. Patient risk
2004 11:2633. factors for adverse drug events in hospitalized
patients. ADE Prevention Study Group. Arch Intern
22. Boockvar K, Fishman E, Kyriacou CK, et al. Adverse Med 1999;159(21):2553-2560.
events due to discontinuations in drug use and dose
changes in patients transferred between acute and 35. Winterstein AG, Hartzema AG, Johns TE, et al.
long-term care facilities. Arch Intern Med Medication safety infrastructure in critical-access
2004;164:545-50. hospitals in Florida. Am J Health Syst Pharm 2006;
63(5):442-450.
10
Evidence Table. Medication Reconciliation
Study Aim Design & Sample Site Outcome
Bates 199934 Assess strength of patient Nested case control 11 medical and Adverse drug events more frequent in
risk factors for adverse drug 4,108 admissions surgical units in 2 sicker patients with longer hospital stay.
events (ADEs) tertiary care Few risk factors emerged when
hospitals controlling for level of care and pre-event
length of stay. Prevention strategies
should focus on improving medications
systems.
Bayley 20057 Enhance understanding of Informant interviews One primary care Based on thematic analysis of qualitative
how patient handoffs are practice and four data, identified information barriers due
related to risk of adverse inpatient facilities to work processes, role definitions, and
medical events before and (one academic individual discretion which can assist in
after implementation of an medical center and designing effective technology solutions.
information technology three community
solution hospitals)
Bedell 200011 Examine frequency of Descriptive design 5 cardiology and 3 545 discrepancies among 239 patients
discrepancy between 312 medical records in internal medicine (76%)
medications prescribed and ambulatory setting practices 278 (51%) taking meds not recorded in
those taken and associated chart
causal factors. Compare 158 (29%) not taking recorded meds
11
Medication Reconciliation
route, and frequency of to medication changes occurred during
administration 14 (20%). Overall risk of ADE per drug
alteration (n=320) was 4.4% Most
medication changes (8/14) implicated in
causing ADEs occurred in the hospital,
most ADEs (12/14) occurred in the
nursing home after nursing home
readmission.
Study Aim Design & Sample Site Outcome
Gleason 20044 Identify type, frequency, and Convenience sample compared 725 bed tertiary Interviews took on average 13.4 minutes.
severity of medication 204 pharmacist conducted care academic Discrepancies in medication histories and
discrepancies in admission medication histories from medical center. admission medication orders identified in
12
orders. patients to medication and Direct admissions more than 50% of patients. 22% could
Assess whether pharmacist allergy history documented in to 12 adult medical- have been harmful if no intervention.
obtained admission med patient charts surgical units
histories decreased number
of med errors.
Kramer 200728 Establish feasibility of Pre-post electronic reconciliation 283 patients on Preimplementation RNs identified more
electronic system for process general medicine incomplete medication orders and
pharmacist and RN unit, 147 in dosage changes
admission and discharge preimplementation Post implementation greater numbers of
medication reconciliation and phase and 136 in allergies were identified, pharmacists
assess effect on patient postimplementation completed significantly more dosage
safety, cost, satisfaction phase. changes and patients reported higher
among providers and nurses level of agreement re discharge
medication instructions.
Lack of MD participation, 25% did not
complete electronic discharge report
Study Aim Design & Sample Site Outcome
Lau 20008 Compare medication history Prospective observational study General medical 61% of patients had discrepancy from
in hospital medical record of 304 patients units of 2 acute community pharmacy records to inpatient
with community pharmacy care hospitals medication history. 26% of prescription
records prior to admission medications in use prior to admission
were not listed in hospital medical
records.
Manley 200312 Determine rate of drug Prospective observational study Outpatient 60% of patients had drug record
record discrepancies in a of 63 patients hemodialysis discrepancies.
hemodialysis population center
Miller 199210 Improve family practice office Descriptive study of Ambulatory family Baseline: 51 patients (76%) had
chart documentation of implementation of duplicate practice prescribed medications with 87% of
prescribed medications prescription forms charts with incomplete or no
through use of duplicate Baseline chart review – 67 documentation
prescription forms charts 1 week: 83% of charts had complete
Duplicate prescription form: 1 prescription medication documentation
week = 50 charts; 40 months = 40 Months: 82% of charts had complete
60 charts prescription medication documentation
Moore 200323 Determine prevalence of Descriptive study of 86 patients 950 bed urban 42% of patients had at least 1 medication
medical errors from inpatient inpatient and ambulatory teaching hospital continuity error
to outpatient setting medical records and affiliated
primary care
13
practice
Nickerson 200518 Determine clinical impact on Randomized clinical trial with 6 2 inpatient family Pharmacist intervened in 481DTP with
drug therapy problems (DTP) month followup of 253 patients practice units average per patient of 3.49. Control
of pharmacist review of group retrospective chart review found
discharge medications at 56% had DTP
discharge
Paquette-Lamontagne Improve accuracy of patient Quasi experimental intervention Medical units in 3 82% of medication profiles in
200225 profile information in with 89 patients teaching hospitals experimental group were complete as
community pharmacies with compared to 40% in control group
use of discharge prescription
forms
Pronovost 200320 Reduce medication errors Intervention using paper Surgical ICU At baseline 94% of discharge orders
Medication Reconciliation
with a reconciliation process medication discharge form for were changed due to discrepancies. At
using paper form at ICU discharges Week 24 discharge error rate was 0
discharge fro surgical ICU
Pronovost 200421 Reduce medication errors Intervention using electronic 1,455 patients in 21% of patients required medication
with a reconciliation process medication discharge form for surgical ICU over 1 order change. 6% due to allergy
using an electronic form at ICU discharges year period discrepancy
discharge from surgical ICU
Study Aim Design & Sample Site Outcome
Background
The safety of nurses from workplace-induced injuries and illnesses is important to nurses
themselves as well as to the patients they serve. The presence of healthy and well-rested nurses is
critical to providing vigilant monitoring, empathic patient care, and vigorous advocacy. Many
workplace stressors that can produce diseases and injuries are present in nursing work
environments. These stressors include factors related to the immediate work context,
characteristics of the organization, and changes that are occurring external to the organization but
throughout the health care industry.1 Nurses experience significant physical and psychological
demands during their day, as well as a work safety climate that can be adverse. Pressures within
organizations to downsize, use nurses employed under alternative arrangements (pool and
traveling staff), and the turnaround time for patient care (early discharge, higher patient loads)
are examples of factors that are determined at an organizational level. The external context
within which nurses practice includes lean managed care contracts, increasing use of complex
technological innovations, an older nurse workforce, and increasing numbers of very sick elderly
patients (aging population). Factors at each of these levels can produce threats to nurses’ safety
while on the job.
The hazards of nursing work can impair health both acutely and in the long term. These
health outcomes include musculoskeletal injuries/disorders, other injuries, infections, changes in
mental health, and in the longer term, cardiovascular, metabolic, and neoplastic diseases. In this
chapter we will present major research findings that link common work stressors and hazards to
selected health outcomes. These stressors include aspects of the way work is organized in
nursing (e.g., shift work, long hours, and overtime) and psychological job demands, such as work
pace. In addition, aspects of direct care work that influence nurse safety will be discussed,
including the impact of physical job demands such as patient lifting and awkward postures,
protective devices to prevent needlesticks, chemical occupational exposures, and potential for
violence. Where possible, interventions that have demonstrated effectiveness to reduce the risk
of illness and injury will be presented, as well as gaps in knowledge that can spur new lines of
research inquiry.
Research Evidence
Shift Work and Long Work Hours
The relationship between work schedules and health and safety is complex and is influenced
by characteristics of the work schedule (time of shift, direction and speed of rotation, pattern of
days off, shift length, rest breaks), as well as characteristics of the job, the worker, and the work
environment.2 While the focus is on potential negative aspects, some workers experience benefits
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
from shift work and prefer it (e.g., incentive pay, reduced volume of activities and personnel
when compared with day shift).
Researchers theorize that shift work exerts adverse effects by disturbing circadian rhythms,
sleep, and family and social life.2, 3 Disturbances in circadian rhythms may lead to reductions in
the length and quality of sleep and may increase fatigue and sleepiness, as well as
gastrointestinal, psychological, and cardiovascular symptoms. In addition, working at unusual
times may make it difficult to interact with family and maintain other social contacts.4 Similarly,
long work hours may reduce the time available for sleep, leading to sleep deprivation or
disturbed sleep and incomplete recovery from work.5–7 This may adversely affect nervous,
cardiovascular, metabolic, and immune functioning. Family and social contacts may also be
reduced, which in turn may lead to physiological responses associated with stress. Long hours
may also increase exposure times to workplace hazards such as chemicals; infectious agents; and
physical, mental, and emotional demands. Long hours also may reduce time available for
exercise or nutritious meals, and added job stress can increase smoking, alcohol consumption,
and caffeine use.
Sleep, sleepiness, performance, safety. Drake and coworkers8 indicated that 32 percent of
night workers (majority of shift hours between 9 p.m. and 8 a.m.) and 26 percent of rotating shift
workers (shifts that change periodically from days to evenings or nights) experienced long-term
insomnia and excessive sleepiness and were unable to adapt their sleep adequately on these
shifts. Sleep loss makes people sleepier while awake, which may affect the shift worker’s ability
to perform activities safely and efficiently, both on and off the job. Increased sleepiness (or
decreased alertness) in shift workers on the job has been demonstrated with subjective reports,9
objective performance testing,10 and EEG recordings showing brief, on-the-job sleep episodes.11
Sleepiness is most apparent during the night shift, and poor daytime sleep appears to be a
contributing factor.12 A meta-analysis combining injury data from several studies indicated that
injury risk increased by 18 percent during the afternoon/evening shift and 34 percent during the
night shift compared to morning/day shift.13 These results are consistent with worksite
observations of increased subjective sleepiness and decreased reaction time during night shifts,
and progressive decreases in total sleep time from early to late in the workweek.14
Social and familial disruptions. Because shift workers often work in the evening and sleep
during the day, they frequently sacrifice participation in social and family activities.
Furthermore, shift workers in continuously operating organizations such as hospitals are
regularly required to work weekends and holidays, when much social and family interaction
occurs.15, 16 Consequently, too little time with family and friends is the most frequent and most
negatively rated complaint among shift workers. The extent to which such disruptions occur
depends both on the worker’s schedule, type of family, gender, presence of children, and the
degree of flexibility in the worker’s social contacts and leisure pursuits.15–17 For families, shift
work often conflicts with school activities and the times when formal child care services are
available, making arranging for the care of children more challenging,17 affecting both the
worker and the family’s social adjustments.
Long-term effects and vulnerable groups. Although the specific contribution of shift work
to other illnesses is not clear, several diseases have been associated with these work schedules.
Gastrointestinal (GI) complaints are common in shift workers and could be due to changes in
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Personal Safety for Nurses
circadian rhythms of GI function, sleep deprivation leading to stress response and changes in
immune function, or the types of foods that are available during these shifts.18, 19 Schernhammer
and colleagues20 reported an increased risk of colon cancer in nurses working 3 or more nights
per month for 15 or more years.
Psychological complaints are frequently reported, including depression and other mood
disturbances, personality changes, and relationship difficulties.21 A review of 17 studies suggests
that shift work increases risk for cardiovascular disease by 40 percent compared with day
workers.22 Possible mechanisms include decreased glucose tolerance, insulin resistance, elevated
cortisol levels, and increased sympathetic activity. A systematic review of reproductive outcome
studies concluded that shift work was associated with a modest increase in spontaneous abortion,
preterm birth, and reduced fertility in women.23 The effect on reproduction in men was not
analyzed due to an inadequate number of studies. A meta-analysis of 13 studies examining night
work and breast cancer reported that night work was associated with a moderately elevated risk
among women.24 The authors hypothesized that exposure to light at night reduces melatonin
levels, increasing risks for cancer.
Shift work also may exacerbate preexisting chronic diseases, making it difficult to control
symptoms and disease progression. Shift work interferes with treatment regimens that involve
regular sleep times, avoiding sleep deprivation, controlling amounts and times of meals and
exercise, or careful timing of medications that have circadian variations in effectiveness. Sood25
suggests several conditions that may be exacerbated by shift work: unstable angina or history of
myocardial infarction, hypertension, insulin-dependent diabetes, asthma, psychiatric illnesses,
substance abuse, GI diseases, sleep disorders, and epilepsy requiring medication. Costa26 adds to
this list chronic renal impairment, thyroid and suprarenal pathologies, malignant tumors, and
pregnancy. Aging is also associated with less tolerance of shift work, which may be due to age-
related changes in sleep that may make it more difficult for older people to initiate and maintain
sleep at different times of the day.27 These sleep changes may begin as early as the 30s and 40s,
so some workers who initially adapted well to shift work during their younger years may show
more symptoms as they grow older.
The number of studies examining long work hours is less extensive, but a growing number of
findings suggest possible adverse effects. A meta-analysis by Sparks and colleagues5 reports that
overtime was associated with small but significant increases in adverse physical and
psychological outcomes. A review by Spurgeon and colleagues6 concluded that the adverse
overtime effects were associated with greater than 50 hours of work per week, but little data are
available about schedules with fewer than 50 hours. An integrative review by Caruso and
colleagues28 reported that overtime was associated with poorer perceived general health,
increased injury rates, more illnesses, or increased mortality in 16 of 22 recently published
studies. Dembe and colleagues,29 examining data from the National Longitudinal Survey of
Youth, found a dose-response relationship, such that as the number of work hours increased,
injury rates increased correspondingly. Trinkoff and colleagues30, 31 found that long work hours
were related to the incidence of musculoskeletal injuries and needlesticks in nurses. Overall,
these studies indicate that caution is needed in implementing schedules with extended work
hours. Determining the number of work hours critically associated with risk for a specific job
would require examining how extended hours interact with other factors contributing to fatigue,
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
such as work load, competing responsibilities, and opportunities for rest and recovery.
Additional information on the effect of long work hours can be found elsewhere in this book.
Coping Strategies
Efforts to promote adaptation to (or ease the difficulties of coping with) shift work and long
work hours include strategies for employers and strategies for workers. Most suggestions to date
were written for shift work, but they may also be relevant for long work hours. A sampling of
strategies suggested in the literature for shift work include designing new work schedules and
rest breaks during work, altering circadian rhythms with bright light or blue light, optimally
timing physical activity or other work demands, improving physical conditioning, using caffeine,
planning dietary regimens, stress reduction, support groups, and family counseling.32–39 Caldwell
and Caldwell36 suggest using behavioral and administrative strategies fully before considering
pharmacologic aids since these stimulants and sedatives can be addictive and questions remain
about the safety and effectiveness of long-term use. Taking naps during work is another
intervention that has been associated with improvements in alertness40, 41 and is an accepted
practice in some Asian countries. More research is needed to determine the optimum length and
timing of the nap and a practical environment at work to take a nap. Empirical evaluations and
applications of the other techniques have begun and will be useful for some workers, but more
research is needed to develop strategies that can be easily applied by workers in a wide range of
demanding work schedule situations. Another type of strategy are work hour limits such as the
recent Institute of Medicine recommendation42 (p. 13) that work hours for nurses be limited to 60
hours per 7-day period and 12 hours per day.
Few industries in the United States have undergone more sweeping changes over the past
decade than the health care industry. Changes in health care, including restructuring and
redesign, have led to increasingly heavy demands on nurses and other health care workers.
Extended schedules and increased work pace, along with increased physical and psychological
demands, have been related to musculoskeletal injuries and disorders (MSD).43 These demands
have been found in laboratory and worker studies to increase the risk of musculoskeletal
pain/disorders.44–47
Definitions for MSD vary, though most include pain in the affected body region (e.g., back
or neck) for a specified duration or frequency,48 along with other related symptoms such
numbness and tingling.49 Measurement of MSD also varies from study to study, with many
studies relying on self-report and others requiring seeking care or obtaining testing or
clarification/diagnosis by a clinician.48 Researchers are careful to rule out nonwork-related MSD
from their studies.
Health care workers are at extremely high risk of MSD, especially for back injuries. Health
care workers are also overrepresented for upper extremity MSDs among workers’ compensation
(WC) claims.50 In 2001, U.S. registered nurses (RNs) had 108,000 work-related MSDs involving
lost work time, a rate similar to construction workers.51 In 2003, the incidence rate for nonfatal
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Personal Safety for Nurses
occupational injuries, many of which were MSDs, was 7.9 per 100 full time equivalents (FTEs)
for hospital workers.52
Studies have shown that MSDs lead to sick days, disability, and turnover. In a survey of
more than 43,000 nursing personnel in five countries, 17–39 percent planned to leave their job in
the next year due to physical and psychological demands.53 In previous research, the percentage
of nurses reporting job change due to MSD ranged from 6 percent to 11 percent, depending on
the body part injured (neck, shoulder, or back).54 Staffing has also been related to MSD, with
lower staffing complements related to increased injuries. Between 1990 and 1994, the Minnesota
Nurses Association collected injury and illness data from 12 hospitals in the Minneapolis-St.
Paul area. The researchers found that when RN positions in the hospitals decreased by 9.2
percent, the number of work-related injuries or illnesses among RNs increased by 65.2 percent.
Lower staffing ratios for nurses and higher patient loads have both been shown to result in
increased exposure to hazardous conditions and insufficient recovery time.55 In a review of
evidence, the Institute of Medicine indicated that there was strong relationship between nursing
home staffing and back injuries.56 In a recent study of the relationship of health care worker
injuries to staffing in nursing homes, researchers indicated that staffing levels were significantly
related to health care worker injury rates in nursing homes across three States.57
Physical/postural risk factors and MSD. Health care work is highly physically/posturally
demanding,54, 58, 59 and tasks requiring heavy lifting, bending and twisting, and other manual
handling have been implicated in health care worker back injuries.60 In one study, nurses were
found to be at particular risk of back injury during patient transfers, which require sudden
movements in nonneutral postures.61, 62 Patient transfers also require flexion and rotation,
increasing the injury risk due to a combination of compression, rotation, and shear forces.63–65
Highly demanding physical work was associated with 9–12 times the odds of having a neck,
shoulder, or back MSD among nurses.54 Hoogendoorn and colleagues,66 using video
observations and questionnaires in a 3-year study of health care workers, found that extreme
flexion and frequent heavy lifting had a strong impact on worker low-back pain. Other analyses
found that physical/postural risk factors were related to impaired sleep, pain medication use, and
absenteeism.59
Fewer studies have examined physical/postural risk factors in relation to health care worker
neck and shoulder MSDs. Risk factors related to neck and shoulder pain include body placement
in awkward postures that need to be maintained for long periods of time. Using direct
observation, Kant and colleagues58 found that surgeons had extensive static postures, along with
operating room nurses who were required to maintain tension on instruments, leading to
substantial musculoskeletal stress of the head, neck, and back. Lifting and stooping were
significantly associated with health care worker arm and neck complaints,67 whereas shoulder
complaints were associated with pushing and pulling motions.68, 69 Heavy lifting and actions with
arms above shoulder height were associated with shoulder pain or injury in health care workers
and in other occupational groups.70–72 The evidence indicates that preventive interventions for
MSD need to address physical/postural risk factors.
Work schedules and MSD. The work schedule can affect the sleep–wake cycle, and
working extended hours, such as 12+ hour shifts, can lead to MSD due to extended exposure to
physical/postural risk factors and insufficient recovery time.73, 74 As physical/postural demands
on the job increased for nurses, the likelihood of inadequate sleep also significantly increased.59
Workers on schedules requiring frequent shift rotation and long hours may also be at higher risk
for MSD.75–78 In a survey of 1,428 RNs, more than one-third had extended work schedules, and
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
such schedules were associated with an increased likelihood of MSD.79 A later study found that
long work hours were related to incident musculoskeletal injuries in nurses.30
In workers with employment-related myalgia, symptoms increased with each successive
workday, and remitted only by the second day off.80 These workers had shorter periods of
muscle rest, suggesting that continuous muscle tension was associated with musculoskeletal
symptoms. In a British study of doctors-in-training, the fewer hours they slept and the more
hours they worked, the more somatic symptoms, including MSD, they reported.81
Schedule components significantly related to MSD include long work hours, mandatory
overtime, working while sick or on days off, and having fewer than 10 hours between shifts.30
The new Institute of Medicine report, Keeping Patients Safe: Transforming the Work
Environment of Nurses,42 incorporated Wave 1 findings on nurse scheduling. More than one-
third of staff nurses typically worked 12 or more hours per day. Among those working 12+
hours, 37 percent rotated shifts. On-call requirements were also very common (41 percent of the
sample). Despite the long hours, few nurses took breaks; two-thirds typically took one or no
breaks during their shift.
Mitigating MSD risks. Although two decades of research have demonstrated the work-
relatedness of MSD, use of single-approach intervention methods to reduce MSD exposures
(e.g., engineering controls, administrative changes, or worker training only) has shown
inconsistent outcomes.82 This is likely due to the combination of factors related to MSD and the
need for broad organizational involvement to mitigate MSD problems.83 Despite these concerns,
important evidence-based successes have been demonstrated in reducing MSD, especially during
patient lifting and transfer.84, 85 Interventions incorporating participatory ergonomics have been
found to improve upon previous approaches by allowing for extensive worker input into the
design and adoption of preventive practices.86, 87 In a participatory ergonomics approach,
employees participate in the identification of ergonomic risk factors, brainstorm alternatives and
solutions, handle implementation of controls, and assess control effectiveness along with
symptom identification, ultimately becoming champions for ergonomics change.86 Participatory
ergonomics also has the potential for changing the culture of health care organizations, as
employees begin to use ergonomic principles to improve jobs and the workplace. Because
participatory interventions incorporate both management commitments to reducing injuries,
along with workers who are involved in developing solutions, positive and effective workplace
changes can occur.88
Interventions for MSD. Three common interventions used to prevent work-related
musculoskeletal injuries associated with patient handling are (1) classes in body mechanics, (2)
training in safe lifting techniques, and (3) back belts. Despite their wide spread use, these
strategies are based on tradition rather than scientific evidence; there is in fact strong evidence
these strategies are not effective.85, 89 Recently there has been a major paradigm shift away from
these approaches toward the following evidence-based practices: (1) patient handling
equipment/devices, (2) no-lift policies, (3) training on proper use of patient handling
equipment/devices, and (4) patient lift teams. Table 1 describes interventions and identifies
challenges that have been associated with their implementation.
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Personal Safety for Nurses
Promising new interventions that are still being tested include use of unit-based peer leaders,
clinical tools (algorithms and patient assessment protocols), and after-action reviews. Table 2
describes each intervention and identifies challenges associated with implementation.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
8
Personal Safety for Nurses
Needlesticks
Health care workers continue to be exposed to the serious and sometimes life-threatening risk
of blood-borne infections in a wide variety of occupations and health care settings. An estimated
600,000 to 800,000 needlestick injuries occur annually,133, 134 about half of which go
unreported.133, 135 It is estimated that each year more than 1,000 health care workers will contract
a serious infection, such as hepatitis B or C virus or HIV, from a needlestick injury. An estimated
50 to 247 health care workers are infected with hepatitis C virus (HCV) each year from work-
related needlesticks.136 At an average hospital, workers incur approximately 30 needlestick
injuries per 100 beds per year.133 Nursing staff incur most needlesticks—54 percent of reported
needlestick and sharp object injuries involve nurses.137
After a needlestick injury, the risk of developing occupationally acquired hepatitis B virus
(HBV) infection for the nonimmune health care worker ranges from 6 percent to 30 percent,
depending on the hepatitis B antigen status of the source patient. The risk of transmission from a
positive source for hepatitis C is between 0.4 percent and 1.8 percent, and the average risk of
transmission of HIV is 0.3 percent.138 Risk of transmission increases if one is injured by a device
visibly contaminated with blood, if the device is used to puncture the vascular system, or if the
stick causes a deep injury. Health care workers, laundry workers, and housekeeping workers are
often engaged in duties that expose them to high-risk needlestick injuries.
The number of occupationally acquired HIV infections is underestimated by the national case
surveillance system. This is related to the Centers for Disease Control and Prevention’s (CDC’s)
strict definition of a documented HIV seroconversion temporally associated with an occupational
HIV exposure and the fact that these are voluntary reports. CDC U.S. surveillance data over 20
years include 57 health care workers with documented occupationally acquired HIV infection.139
A total of 88 percent of these infections resulted from percutaneous injuries. Of these infections,
41 percent occurred after the procedure, 35 percent during a procedure, and 20 percent during
disposal.139 Recent State-based surveillance programs in California and Massachusetts will
provide more complete estimates of the incidents, devices involved, and circumstances
surrounding sharp exposures.140
Despite the promulgation of the original bloodborne pathogen (BBP) standard in 1991 by the
Occupational Safety and Health Administration (OSHA), percutaneous injuries continue to occur
in unacceptably high numbers in health care workers. The requirement under the BBP standard
that HBV vaccine be made available free of charge to health care workers has greatly reduced
the consequences of exposure to this pathogen. Advances in the treatment of HIV infection with
prophylaxis has improved the prognosis for those health care workers infected with HIV-
contaminated blood. Tragically, there is no vaccine or treatment for HCV, so nurses and other
health care workers exposed to HCV-contaminated blood suffer from the potential of contracting
a life-threatening illness. As such, it is imperative that all health care workers, not only those
working in the acute care setting or those who traditionally handle needles on a regular basis,
receive every available protection from occupational exposure to blood and body fluids.
The passage of the Federal Needlestick Safety and Prevention Act in 2000 has begun to
afford health care workers better protection from this unnecessary and deadly hazard. Not only
does the act amend the 1991 BBP standard to require that safer needles be made available, it also
requires employers to solicit the input of front-line health care workers when making safe needle
purchasing decisions.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Use of conventional needles in health care today has been compared with the use of
unguarded machinery decades ago in the industrial workplace. Safer needle devices have
integrated safety features designed into the product to prevent needlestick injuries. The term
“safer needle device” is broad and includes many different devices, from those with a protective
shield over the needle to those that are completely needle-free. Safer devices are categorized
from passive to active, with passive devices offering the greatest protection because the safety
feature is automatically triggered after use, without the need for health care workers to take any
additional steps. An example of a passive device is a spring-loaded retractable syringe or self-
blunting blood collection device. An example of an active safety mechanism is a sheathing
needle that requires the worker to manually engage the safety sheath, frequently using their
second hand and potentially resulting in more injuries.
A comparison of 1993 and 2001 percutaneous injury rates for nurses documented a 51
percent reduction in needlestick injuries, supporting the use of new technology in reducing
percutaneous injury risk.141 More recently, results from a number of intervention studies have
found the use of safer needles systems reduced injury.142–146 A study of safety needles at a
tertiary-care hospital in Manhattan found a statistically significant reduction in the mean annual
incidence of percutaneous injuries from 34.08 to14.25 per 1,000 FTE pre- versus
postintervention. The reductions were observed across occupations, activities, times of injury,
and devices.146 Other factors related to working conditions also may need to be addressed to
prevent and reduce needlesticks.31
While there has been widespread conversion to safer phlebotomy needles and intravenous
catheters, for other devices such as laboratory equipment and surgical instruments, relatively
small numbers of safer devices are in use.
There are thousands of chemicals and other toxic substances to which nurses are exposed in
practice. Hazardous chemical exposures can occur in a variety of forms—including aerosols,
gases, and skin contaminants—from medications used in practice. Exposures can occur on an
acute basis, up to chronic long-term exposures, depending upon practice sites and compounds
administered; primary exposure routes are pulmonary and dermal.147 Substances commonly used
in the health care setting can cause asthma or trigger asthma attacks, according to a recent
report.148 The report explores the scientific evidence linking 11 substances to asthma, including
cleaners and disinfectants, sterilants, latex, pesticides, volatile organic compounds (including
formaldehyde), and pharmaceuticals. An important criterion for the selection of the substances in
the report was the presence of safer alternative products or processes. The evidence is derived
from an array of peer-reviewed sources of scientific information, such as the National Academy
of Science Institute of Medicine. In this section, we will discuss some of the hazardous
substances currently in use and provide references to obtain evidence on others, as well as for
identifying safer alternatives.
Volatile organic compounds. Volatile organic compounds (VOCs) are chemicals that
readily evaporate at room temperature, thus allowing the chemicals to be easily inhaled.
Formaldehyde and artificial fragrances are two such sources that have a ubiquitous presence in
hospitals. A study of occupational exposure to artificial fragrances found that health care workers
had the highest rate of allergic sensitivity.149 The fragrances are typically contained in devices
that either aerosolize the chemicals into rooms or evaporate the fragrances from a solid form,
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Personal Safety for Nurses
thus producing VOCs. Although the Food and Drug Administration is responsible for regulating
fragrances and other chemicals in personal care products, the majority of these compounds have
not been tested for potential toxic human health effects.150 Strong odors, fumes, and perfumes are
also potent triggers of asthma.151 Formaldehyde, a known carcinogen,152 is used in pathology and
lab settings and is contained in bedding, drapes, carpets, acoustic ceiling tiles, and fabricated
furniture. Artificial fragrances are used to address unpleasant odors. Purchasing low- and no-
VOC products, which are readily available (e.g., no-VOC paint), is a key to addressing this
problem. Also ensuring adequate indoor air circulation, which can decrease the concentration of
VOCs in the air, effectively decreases the “dose” of the chemicals being inhaled.
Sterilants. As an example, ethylene oxide (EtO) and glutaraldehyde are commonly used in
medical settings for sterilization. Nurses and other medical staff are exposed while cleaning
equipment and work surfaces. Although both of these chemicals are powerful and effective, they
are associated with serious human health risks. Glutaraldehyde is associated with respiratory
irritation including asthma, skin irritation and dermatitis, and eye irritation and conjunctivitis.153
In fact, in a review of health effects of glutaraldehyde exposure, almost all case reports of
occupational asthma were of endoscopy nurses.154
The National Institute for Environmental Health Sciences152 produces a report on
carcinogens that summarizes the latest scientific evidence on the cancer-causing properties of
many chemicals, including EtO,155 formaldehyde, and others that are present in health care. In
this report, EtO is also listed as a known human carcinogen. EtO has been associated with
increased incidence of certain types of cancer in workers with long-term exposures.156
Additionally, EtO is an eye and skin irritant and also may damage the central nervous system,
liver, and kidneys.157
Medications. Many medications and compounds in use in personal care products have
known toxic effects. These have been comprehensively reviewed with a detailed summary of the
evidence of environmental and personal hazards associated with these compounds by Daughton
and Ternes.149 Although many medications can be hazardous to workers, those most commonly
identified as hazardous to health care workers include antineoplastics and anesthesia. Anesthetic
gases have been identified as particularly problematic, as gases escape into the air and can be
inhaled by workers. Methods of induction have been studied in terms of worker exposure,158 with
findings indicating that such exposures (measured by urinary metabolites) frequently exceed
National Institute for Occupational Safety and Health (NIOSH) recommended limits.159 Hasei
and colleagues160 found that intravenous induction posed a far lower risk of exposure to health
care workers.
There are also data to support the deleterious effects of exposure to antineoplastic drugs,
especially an increased risk of spontaneous abortions among health care workers.161
Cytotoxicity, genotoxicity, terotogenicity, and carcinogenicity are associated with such
exposures.152 For the past few decades, awareness of the risk of antineoplastic agents has been
available, including guidelines for handling them published by the Occupational Safety and
Health Administration.162 Nursing functions of particular risk, according to NIOSH, include
medication administration, handling contaminated linens, exposure to human wastes, handling
drug containers, cleaning drug preparation areas, being involved with special procedures, and
disposal of containers and other wastes.163 Other research indicates that antineoplastics and
cytostatics have been found in locations beyond the confines of the designated handling areas
such as air vents, desks, countertops, and floors.164, 165
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Pesticides. Pesticide use, both inside and outside of hospitals and health facilities, is
another cause for concern. Because of the special vulnerabilities of children and pregnant women
to pesticide exposures, control of pesticide use in health care settings is particularly important. In
a survey conducted by Health Care Without Harm, all hospitals surveyed reported some regular
applications of pesticides inside the hospital building, outside on the grounds, or both.166 This
report, Healthy Hospitals: Controlling Pests Without Harmful Pesticides, offers guidance on
reducing pesticides and implementing safer integrated pest management techniques. Integrated
pest management is a comprehensive approach to pest management that employs nontoxic and
least-toxic products and processes to control pests. Beyond Pesticides, a 25-year-old organization
that has been working with Health Care Without Harm on pesticide issues in the United States, is
currently orchestrating several hospital-based pilot programs in Maryland.167 They are working
with hospital environmental services to implement an integrated pest management approach that
will work for hospitals. These collaborations will result in a set of best practices for a range of
facility types—small community hospitals, inner-city university health centers, and others.
Latex exposure. Latex allergy due to exposure to natural proteins in rubber latex is also a
serious problem in health care workers. Diepgen168 estimated that the annual incidence rate
among all workers is 0.5 to 1.9 cases per 1,000 full-time workers per year. Symptoms may start
with contact dermatitis located in the glove area, and symptoms can become more severe, such
as asthma or anaphylaxis. The course of latex allergy as described by Amr and Bollinger169
involves progressive impairment of nurses from continued exposure to latex, leading to an
inability to continue working as nurses. In fact, the hazard from aerosolizing of latex particles
attached to powder in latex gloves or from latex balloons bursting is of great concern, as these
exposures can lead to occupational asthma.170 The American Nurses Association has issued a
position statement to suggest actions to protect patients and nurses from latex allergy in all health
care settings. These include use of low-allergen powder-free gloves and removal of latex-
containing products from the worksite throughout the facility to reduce the exposure at that
institution.171 Hospital environments that have gone latex-free need to ensure that they are not
allowing balloons into the facility. As balloons break they can contribute latex into the air that
remains for up to 5 hours.172
An awareness of the repercussions of exposure to chemicals and toxins has prompted action
to reduce such exposures in health care settings. Promotion of the availability of safer
alternatives has gained momentum as a means to reduce exposures. There are resources available
to assist advocates and decisionmakers. The Green Guide for Health Care is an extensive toolkit
providing recommendations for design, construction, renovation, operations, and management of
sustainable (causing reduced occupational and environmental effects) and healthier buildings.173
Also, a clearinghouse of nontoxic alternatives to various medical and health care products is
available from the Sustainable Hospitals Project.174 Green Link, a recently inaugurated
newsletter, promotes healthier buildings and sustainable hospitals for patients and health care
workers.175 In addition, the American Hospital Association and the Environmental Protection
Agency have partnered, forming Hospitals for a Healthy Environment, promoting purchasing of
environmentally preferable products.176 The focus on reducing chemical exposures will be
increasingly important over the next decade, especially as the benefits for patient and worker
health continue to be recognized.
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Personal Safety for Nurses
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Interventions to reduce work-related mental changes have focused on either changing the
organization of work to reduce the stressors, or changing the workers’ ability to cope with stress
by providing cognitive-behavioral interventions, relaxation techniques of various types, or
multimodal strategies.184, 206 Although several nationwide initiatives on the prevention of mental
disorders have emphasized the importance of addressing work organization factors,190, 194 only a
small number of studies have evaluated this approach, and results have not shown an overall
strong relationship.185 In nursing, Mimura and Griffiths206 conducted a systematic review of
interventions for nurses to reduce their work stress. Two of the reviewed studies used
organizational interventions (changing to individualized nursing care and primary nursing), and
only one of the two was deemed “potentially effective.” Seven studies of strategies to help nurses
manage their stress were presented; music, relaxation, exercise, humor, role-playing
assertiveness, social support education, and cognitive techniques were among the stress-reducing
strategies studied. The authors stated that no recommendations on the most effective approach
were possible due to the small number of studies. In a larger meta-analysis of both nurses and
other workers,183 a moderate effect for cognitive-behavioral interventions and multimodal
interventions was found, along with a small but significant overall effect for relaxation
techniques. Organizational interventions were not significant; however, the authors posit that
combining individual-level skills (e.g., cognitive-behavioral) with organizational changes may be
a fruitful area for future research.
Violence
From 1993 to1999, 1.7 million incidents of workplace violence occurred annually in the
United States, with 12 percent of all victims reporting physical injuries.207 Six percent of the
workplace crimes resulted in injury that required medical treatment. Yet, only about half (46
percent) of all incidents were reported to the police. The health care sector leads all other
industries, with 45 percent of all nonfatal assaults against workers resulting in lost workdays in
the United States, according to the U.S. Bureau of Labor Statistics (BLS).208 The BLS rate of
nonfatal assaults to workers in “nursing and personal care facilities” was 31.1 per 10,000, vs.
only 2.8 per 10,000 in the private sector as a whole.208 In two Washington State psychiatric
forensic facilities, 73 percent of staff surveyed had reported at least a minor injury related to an
assault by a patient during the previous year; only 43 percent of those reporting moderate,
severe, or disabling injuries related to such assaults had filed for WC. In these two facilities, the
survey found an assault incidence rate of 415 per 100 employees per year, compared to hospital
incident report rates of only 35 per 100.219
Environmental and organizational factors have been associated with patient and family
assaults on health care workers, including understaffing (especially during times of increased
activity such as meal times), poor workplace security, unrestricted movement by the public
around the facility, and transporting patients. The presence of security personnel reduces the rate
of assaults, while increased risk is associated with the perception that administrators consider
assaults to be part of the job, receiving assault prevention training, a high patient/personnel ratio,
working primarily with mental health patients, and working with patients who have long hospital
stays.
Emergency department personnel also face a significant risk of injuries from assaults by
patients or their families. Those carrying weapons in emergency departments create the
opportunity for severe or fatal injuries. California and Washington State have enacted standards
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Personal Safety for Nurses
requiring safeguards for emergency department workers. Although mental health and emergency
departments have been the focus of attention and research on the subject, no department within a
health care setting is immune from workplace violence. Consequently, violence prevention
programs would be useful for all departments.
The first report to the Nation on workplace violence underscores the lack of systematic
national data collection on workplace assaults, the paucity of data evaluating violence prevention
strategies, and the methodological flaws in published intervention research to date.210 As
background to this report, Runyan and colleagues211 reviewed the violence prevention
intervention literature and found five studies that evaluated violence prevention training
interventions,212–216 two that examined postincident psychological debriefing programs,217, 218
and two that evaluated administrative controls to prevent violence.220-221 Findings from the
studies were mixed, with six reporting a positive impact and three reporting no or a negative
impact. All were quasi-experimental and without a formal control group. Runyan and colleagues
criticized the design of published violence prevention interventions to date because of their lack
of systematic rigor in the evaluation. She calls for greater reliance on conceptual and theoretical
models to guide research as well as stronger evaluation designs. She further suggests that studies
must evaluate “process, impact and outcome measures.”211
Since Runyan’s review paper, Arnetz and Arnetz219 reported on a randomized controlled trial
of 47 health care workplaces examining a violence prevention intervention involving
“continuous registration” of violent events for 1 year with “structured feedback” from
supervisors. This study found that the intervention hospitals reported significantly more violence
incidents than the control hospitals. The authors attributed this finding to increased awareness of
the violence and improved supervisory support at the intervention facilities.
There is no Federal standard that requires workplace violence protections. California and
Washington State both have legislation addressing workplace violence in health care settings. In
1996, OSHA published Guidelines for Preventing Workplace Violence for Health Care and
Social Service Workers.222 The 1996 Federal guidelines provide a framework for addressing the
problem of workplace violence and include the basic elements of any proactive health and safety
program: management commitment and employee involvement, worksite analysis, hazard
prevention and control, and training and education. The OSHA guidelines provide an outline for
developing a violence prevention program, but since they are “performance based,” the challenge
of developing a specific process for implementing the guidelines in a manner that will yield
results is left to the employer.
Between 2000 and 2004, Lipscomb and colleagues223 conducted an intervention effectiveness
study to describe a comprehensive process for implementing the OSHA Violence Prevention
Guidelines and evaluate its impact in the mental health setting. Program impact was evaluated by
a combination of quantitative and qualitative assessments. A comparison of pre- and
postintervention survey data indicated an improvement in staff perception of the quality of the
facility’s violence prevention program as defined by the OSHA elements in both intervention
and comparison facilities over the course of the project. Results of the comparison of the change
in staff-reported physical assaults were equivocal.
Many psychiatric settings now require that all patient care providers receive annual training
in the management of aggressive patients, but few studies have examined the effectiveness of
such training. Those investigators that have done so have generally found improvement in
nurses’ knowledge, confidence, and safety after taking an aggressive behavior management
program. However, implementation of comprehensive violence prevention programs that go
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
beyond staff training will improve safety of the health care workplace for all workers. These
advanced programs include the use of currently available engineering and administrative controls
such as security alarm systems, adequate staffing, and training.
Research Implications
Challenges in Measuring Nursing Working Conditions and Nurse
Safety Outcomes
While there is increasing evidence linking nursing work environments to nurse health, much
more effort has focused on understanding how work influences satisfaction and performance.
Improving data and measures will allow better comparisons across studies and build evidence of
which relationships are most important. Varied approaches are used to compile data about the
nursing work environment. Measures of work characteristics have varied considerably and are
most often related to the particular discipline and study objectives. In occupational health, the
traditional assessments of exposure have expanded from obvious physical and chemical
exposures to include psychosocial demands, physical demands, and leadership quality.224 These
measures are used in individual studies or translated to a job exposure matrix where estimated
levels of exposure to an agent or stressor are assigned to an occupation or group of
occupations.225, 226 These approaches are more fully developed and utilized in Scandinavia and
Europe, although the O*NET database describes job requirements, worker attributes, and the
context of work (www.onetcenter.org).
A self-administered paper-and-pencil or electronic questionnaire is probably the most
common approach to gathering information from nurses. The advantages over observation or
interviews are obvious: they are generally less costly, can be administered over a broader
population, are more uniform and standardized, and confidentiality and anonymity can be more
efficiently assured. Yet, these same advantages can also be disadvantages: nurses have varying
motivations to respond, leading to response bias; questionnaires are often developed by
researchers based on particular study goals, limiting comparison across studies; and there is no
opportunity to clarify questions or solicit rich detail. The level of the data may also be unclear.
Some items may explicitly reflect the work group or organization, while others may reflect both.
Clarity is needed about how many respondents is optimum to represent a particular level of
analysis. Where multiple nurses’ perceptions are solicited, all responses may be used to form an
index or an average score.
Worker outcome data may be solicited from an individual through self-report interviews or
questionnaires. These data are subject to the same limitations noted above, although nurse
reports are more likely to yield detailed information about potential factors contributing to their
health. Measuring nurse health outcomes also is challenging. No matter how data are collected,
there can be some measurement error in assessing adverse health outcomes—and attributing
them to the work environment. Many of these issues have been discussed in the sections on
adverse health outcomes. For example, musculoskeletal injuries become chronic conditions and
may not be attributed to the work. Likewise, mental health and substance abuse may be
considered in isolation from the individual’s work experience.
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Personal Safety for Nurses
Another source that is rarely used is administrative data (e.g., incident reports, OSHA logs,
WC data).227 The Occupational Safety and Health Act (1970) requires employers to maintain
records of serious workplace injuries and illnesses (29 USC section 657 c[2]). Unfortunately,
these statistics may not reflect minor injuries requiring only first aid or injuries that can be
episodic and remitting, such as back injuries, majors concerns for nurses. Data sources include
logs maintained at the organizational level (OSHA Form 300), first reports of injury (FROI)
documenting details of the injury (OSHA Form 301), and WC claims, when filed. The FROI
may be used as the baseline data for entry into a WC system, although the two reports may be
distinct. The FROIs serve as a more complete source of potentially claimable injuries to health
care workers than WC data228 as they represent all reported injuries, even those that do not lead
to lost work time or a medical claim. Relying on WC claims data without using FROI data may
introduce systematic selection biases because studies have shown that WC claims are more likely
to be filed by workers who are unionized, working for a company too small to be self-insured, or
who are more severely injured.229 FROI data have been used to study injury in a population of
home health workers230 and to find that staffing was related to injuries in nursing home staff.57
Yet FROI data are often unavailable to researchers or may contain injuries of limited severity.
Somewhat distinct from the OSHA reporting requirements, employers are required to comply
with State WC regulations. WC is concerned with compensating injured or ill workers, while the
OSHA Occupational Injury and Illness Recording and Reporting Requirements Act is designed
to develop a database that can improve understanding of injury and illness, with the intent to
prevent them. Thus, certain injuries and illnesses may be reportable under both systems, while
others will be reportable under State WC law or under the OSHA recordkeeping rule. State WC
benefit requirements also vary, with some States not requiring lost time, but requiring that the
employee sought medical care. Other States require a certain number of days of lost time before
filing a FROI. Unfortunately, ascertainment of nursing health outcomes varies across these data.
Even when analyzing WC claims or FROI data with presumably broader inclusion, some injuries
will be missed. For example, injured workers may seek care from their regular health provider
and fail to mention the work-relatedness of the injury. In a cross-sectional study of unionized
autoworkers diagnosed with work-related MSDs, only 25 percent filed WC claims.231 In a
population-based telephone survey, only 10.6 percent of workers reporting work-related MSDs
had filed a WC claim.232
The need for standardization in data collection and measuring both work environment and
worker outcomes is not new. As noted by NIOSH,233 insufficient job data to link work factors to
health outcomes is a barrier to research. An international conference on linked employer-
employee data was held in 1998 to address issues of confidentiality, levels of analysis, and the
need for coordination across Federal and State agencies.234 The work in Europe and Scandinavia
builds upon international work and could become a model across many countries. Unfortunately,
data policy changes at the Federal and local levels are often slow to occur, as modifications to
existing systems require long and arduous lobbying, legislation, and procedure and policy
development before implementation. Moreover, the WC regulations are primarily State driven,
and this is unlikely to change.
Researchers are encouraged to use established instruments and items, with established
reliability and validity. If they are developing their own instruments, psychometric testing is
essential. Findings benchmarked with other similar populations are useful to determine variation
and explore sources of measurement error. When assessing work environments, the level of
17
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
analysis for the measure must be explicit (e.g., work group, organization, or system). Analytical
strategies should be used to account for the multilevel nature of the data.
Administrative data for worker injuries can be very useful. Many health care organizations
are implementing programs that are likely to affect both patient and worker safety, yet it may be
difficult to efficiently evaluate the effectiveness of these programs. Ohio, for example, has used
the claims data to support issuance and evaluation of safety grants used in lifting and other
mechanical equipment purchases to reduce employee injuries.235
Conclusion
In this chapter, we have focused on the major injury and safety issues for working nurses.
Some of these issues have been thoroughly researched, with extensive evidence-based findings
available for epidemiology and prevention, whereas others remain to be studied and explained.
As indicated, there is great potential for preventing nurse injury, even though many risk factors
have yet to be addressed. The benefits of improvements to nurse safety are great, both for
retaining nurses and attracting new nurses into the profession. For example, work hours that are
excessive adversely affect nurses’ health and thus can in turn adversely impact patient care. As
many facilities are making important financial investments and system-level improvements to
promote patient safety, it is important to leverage these efforts to improve worker safety as well.
In the long run, these improvements will also benefit patients, as measures that are taken to
improve safety for nurses should lead to a healthier and more effective workforce.
Search Strategy
Relevant papers for this review were identified from Pubmed,® CINHAL,® as well as from
cited literature, and from NIOSH publications up through 2007. Searches were also performed
examining journals such as the American Journal of Industrial Medicine, American Journal of
Public Health, and Scandinavian Journal of Work and Environmental Health. As our chapter
encompassed multiple outcomes, search terms varied depending on the category, and included
but were not limited to, e.g., occupational health, organization of work, shiftwork, back injuries,
musculoskeletal disorders, chemical exposures, mental health, work stress, and workplace
violence.
18
Personal Safety for Nurses
Author Affiliations *
Alison M. Trinkoff, Sc.D., R.N., F.A.A.N., professor, Work and Health Research Center,
University of Maryland School of Nursing. E-mail: [email protected].
Jeanne M. Geiger-Brown, Ph.D., R.N., assistant professor, Work and Health Research
Center, University of Maryland School of Nursing. E-mail: [email protected].
Claire C. Caruso, Ph.D., R.N., research health scientist, U.S. Department of Health and
Human Services, Public Health Service, Centers for Disease Control and Prevention, National
Institute for Occupational Safety and Health, Division of Applied Research and Technology. E-
mail: [email protected].
Jane A. Lipscomb, Ph.D., R.N., F.A.A.N., professor and director, Work and Health Research
Center, University of Maryland School of Nursing. E-mail: [email protected].
Meg Johantgen, Ph.D., R.N., associate professor, Work and Health Research Center,
University of Maryland School of Nursing. E-mail: [email protected].
Audrey L. Nelson, Ph.D., R.N., F.A.A.N., director, Patient Safety Center of Inquiry, James
A. Haley VAMC, Tampa, FL. E-mail: [email protected].
Barbara A. Sattler, R.N., Dr.P.H., F.A.A.N., professor, Environmental Health Education
Center, University of Maryland School of Nursing. E-mail: [email protected].
Victoria L. Selby, R.N., B.S.N., research assistant, Work and Health Research Center,
University of Maryland School of Nursing. E-mail: [email protected].
*
Disclaimer: The findings and conclusions in this chapter are those of the authors and do not necessarily represent
the views of the National Institute for Occupational Safety and Health.
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
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200. Jamal M. Burnout, stress and health of employees on 213. Goodridge D, Johnston P, Thomson M. Impact of a
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201. Stansfeld SA, North FM, White I, et al. Work
characteristics and psychiatric disorder in civil 214. Infantino JA Jr, Musingo SY. Assaults and injuries
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202. Zammuner VL, Galli C. Wellbeing: causes and
consequences of emotion regulation in work settings. 215. Lehmann L, Padilla M, Clark S, et al. Training
Int Rev Psychiatry 2005;17(5):355-364. personnel in the prevention and management of
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effectiveness in a medium secure psychiatric unit.
204. White K, Wilkes L, Cooper K, et al. The impact of Am J Forensic Psychiatry 1996;7(3):525-34.
unrelieved patient suffering on palliative care nurses.
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Replicated declines in assault rates after
205. Jezuit D. Personalization as it relates to nurse implementation of the assaulted staff action program.
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evaluation of a practical intervention programme for
207. Duhart D. Violence in the workplace 1993-1996: dealing with violence towards health care workers. J
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Washington, DC: U.S. Department of Justice, Office
of Justice Programs: 2001. National Crime 220. Drummond DJ, Sparr LF, Gordon GH. Hospital
Victimization Survey. Publication No. NCJ 190076. violence reduction among high-risk patients. JAMA
1989;261:2531-4.
208. Bureau of Labor Statistics. Nonfatal cases involving
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Available at: http://data.bls.gov/PDQ/servlet/ the reduction of inpatient violence and costs in a
SurveyOutputServlet;jsessionid=f030b1eee4ea$16$2 forensic psychiatric hospital. Psychiatr Serv
0E8. Accessed May 3, 2006. 1996;47:751-4.
209. Bensley L, Nelson N, Kaufman J, et al. Injuries due 222. U.S. Department of Labor, Occupational Safety and
to assault on psychiatric hospital employees in Health Administration. Guidelines for preventing
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workers. Washington, DC: Department of Labor,
210. University of Iowa Injury Prevention Research OSHA; 1996. Publication No. OSHA 3148.
Center. Workplace violence—a report to the nation.
Iowa City, IA: Author; 2001. 223. Lipscomb J, McPhaul K, Rosen J, et al. Violence
prevention in the mental health setting: The New
211. Runyan CW, Zakocs RC, Zwerling C. Administrative York State experience. Can J Nurs Res
and behavioral interventions for workplace violence 2006;36(4):29.
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1):116-27.
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Personal Safety for Nurses
224. Kristensen TS, Bjorner JB, Christensen KB, et al. and research directions. Cincinnati, OH: U.S.
The distinction between work pace and working Department of Health and Human Services; 2002.
hours in the measurement of quantitative demands at
work. Work and Stress 2004;16:305-22. 234. Haltiwanger J. Creating employee-employer data
sets. Mon Labor Rev 1998;121(7):49-51.
225. Johnson JV, Stewart W, Hall EM, et al. Long-term
psychosocial work environment and cardiovascular 235. Hamrick C. Ergonomics works: Success stories from
mortality among Swedish men. Am J Public Health Ohio’s Safety Grants Program. Applied Ergonomics
1996;86(3):324-31. Conference. Available at:
http://iienet2.org/uploadedfiles/ergo_community/case
226. Johnson JV, Stewart W. Measuring life course _studies/251.pdf Accessed October 1, 2007.
exposure to the psychosocial work environment with
a job exposure matrix. Scand J Work Environ Health 236. Fredriksson K, Alfredsson L, Ahlberg G, et al. Work
1993;19:21-8. environment and neck and shoulder pain: the
influence of exposure time. Results from a population
227. Johantgen ME, Trinkoff A, Gray-Siracusa K, et al. based case-control study. Occup Environ Med
Using state administrative data to study nonfatal 2002;59(3):182-8.
worker injuries: challenges and opportunities. J
Safety Res 2004, 35(3): 309-315. 237. Maul I, Laubli T, Klipstein A, et al. Course of low
back pain among nurses: a longitudinal study across
228. Wickizer TM, Franklin G, Plaeger-Brockway R, et al. eight years. Occup Environ Med 2003;60:497-503.
Improving the quality of workers’ compensation
health care delivery: the Washington State 238. Punnett L, Wegman DH. Work-related
Occupational Health Services Project. Milbank Q musculoskeletal disorders: the epidemiologic
2001;79:5-33. evidence and the debate. J Electromyogr Kinesiol
2004;14(1):13-23.
229. Biddle J, Roberts K, Rosenman KD, et al. What
percentage of workers with work related illnesses 239. Rogers B. Report on study on ergonomics and
receive workers’ compensation benefits? Journal of nursing in hospital environments for the Robert
Occup Environ Med 1998;40:325-31. Wood Johnson Foundation. Chapel Hill, NC:
University of North Carolina; 2005. p. 36.
230. Meyer J, Muntaner C. Injuries in home health care
workers: an analysis of occupational morbidity from 240. Dement JM, Epling C, Ostbye T, et al. Blood and
a state compensation database. Am J Ind Med body fluids exposure risks among healthcare
1999;35:295-301. workers: results from the Duke Health and Safety
Surveillance System. Am J Ind Med 2004;46(6):637-
231. Rosenman KD, Gardiner JC, Wong J, et al. Why 48.
most workers with occupational repetitive trauma do
not file for workers’ compensation. J Occup Environ 241. Vaughn TE, McCoy KD, Beekman SE, et al. Factors
Med 2000;42:25-34. promoting consistent adherence to safe needle
precaution among hospital workers. Infect Control
232. Morse TF, Dillon C, Warren N, et al. The economic Hosp Epidemiol 2004; 25(7): 548-55.
and social consequences of work-related
musculoskeletal disorders: the Connecticut Upper- 242. Gerberich SG, Church TR, McGorern PM, et al. Risk
Extremity Surveillance Project (CUSP). Int J Occup factors for work-related assaults on nurses.
Environ Health 1998 Oct-Dec;4(4):209-16. Epidemiology 2005; 16(5):704-9.
233. National Institute for Occupational Safety and 243. Sattler B, Hall K. Healthy choices: transforming our
Health. The changing organization of work and the hospitals into environmentally healthy and safe
safety and health of working people: knowledge gap places. Online J Issues Nurs 2007;12(2).
The
29
Evidence Table
pain
Bernard 199748 Work activities An extensive Neck, shoulder, Variety of Summarized evidence for work relatedness of
related to review of upper extremity occupations MSD. Findings include strong causal evidence
musculoskeletal over 600 (wrist, arm, for awkward and static work postures related to
problems epidemiologic hand) and back back MSD and posture related to neck MSD.
studies MSDs Tendinitis, hand, elbow/wrist MSD strongly
related to repetition, force, and posture
combined. There is evidence for a causal
relationship between highly repetitive work and
neck and neck/shoulder MSDs, and for forceful
exertion and repetition in relation to shoulder
MSD.
Author, year Safety issue Design type Outcome Setting Intervention Findings reported by authors
measure population
Punnett and Work-related Review of MSDs Variety of Despite numerous studies on the relationship
Wegman 2004 238 MSDs studies with occupations between MSD and occupation, there continues
94 article to be debate. From a review of the
citations epidemiologic literature, the authors, along with
the Institute of Medicine and others
internationally, conclude there are adequate
data to support the impact of physical work
demands on MSD. Risk factors for MSD with
sufficient evidentiary support include repetitive
motion, forceful exertions, nonneutral postures,
and vibration. Nursing is noted as one of the
“high-risk sectors” for MSDs “with rates up to 3–
4 times higher than the overall frequency.”
Rogers 2005239 Work-related Literature Nurse MSD Hospital Evidence on MSD epidemiology and prevention
injuries review nurses in summarized, along with best practices for
Best North addressing many ergonomic hazards that lead
practices Carolina to nurse MSD.
Focus groups Preventive interventions proposed and
with hospital recommendations provided.
33
nurses
Observation
of hospital
ergonomic
hazards
Trinkoff 200630 Work schedule Three-wave Reported neck, 2,617 Hours/days per week were significantly related
including work longitudinal shoulder, and registered to increased MSD; working 13+ hours/day, on
hours, mandatory study back nurses days off/vacation days, mandatory overtime, on-
overtime and on- MSD cases working in call, with <10 hrs between shifts all significantly
call Nordic nursing in the related to increased MSD. This was largely due
questionnaire past year to exposure to physical demands of the work.
Needlesticks and sharps
Dement 2004240
Background
Although the words “fatigue” and “sleepiness” are often used interchangeably, they are
distinct phenomena. Sleepiness refers to a tendency to fall asleep, whereas fatigue refers to an
overwhelming sense of tiredness, lack of energy, and a feeling of exhaustion associated with
impaired physical and/or cognitive functioning.1 Sleepiness and fatigue often coexist as a
consequence of sleep deprivation.
Even though fatigue can be due to a variety of causes (e.g., illness, a vigorous workout, or a
period of prolonged concentration), this chapter will focus on the effects of fatigue associated
with insufficient sleep (see Key Terms and Definitions). The impact of extended work shifts and
the relationship of these work schedules to nurse and patient safety will also be explored. Several
practices that show demonstrable potential for reducing the adverse effects of fatigue on patient
safety will be reviewed at the end of the chapter.
Insufficient Sleep
Studies suggest that average sleep durations have decreased from 9 hours in 1910 to as little
as 6.9 hours on workdays in 2002.2–6 Objective measurements, however, suggest that mean sleep
times may actually be somewhat lower than are typically reported in surveys. For example, 273
randomly selected middle-aged residents of San Diego (40 to 64 years) reported sleeping
approximately 7 hours, an amount that appeared to correspond to their time in bed. Mean sleep
times obtained from wrist actigraphy, however, revealed that participants slept on average 6.22
hours, approximately 43 minutes less than their subjective reports.7
Sleeping longer on weekends and nonworkdays is also common,4, 6 suggesting that
individuals are obtaining insufficient sleep on workdays, then attempting to “catch up” on
weekends. Americans slept on average 36 minutes more on weekends in 2002,4 which is
somewhat longer than the 23 minutes reported by British adults.6 American nurses who
participated in a recent survey, however, obtained on average 84 minutes more sleep on
nonworkdays than work days (8.2 hours on nonworkdays compared to 6.8 hours on workdays),8
which is more than triple the amount reported by British adults and more than double that of
other Americans.
Individuals working nights and rotating shifts rarely obtain optimal amounts of sleep. In fact,
an early objective study showed that night shift workers obtain 1 to 4 hours less sleep than
normal when they were working nights.9 Sleep loss is cumulative and by the end of the
workweek, the sleep debt (sleep loss) may be significant enough to impair decisionmaking,
initiative, integration of information, planning and plan execution, and vigilance.10, 11 The effects
of sleep loss are insidious and until severe, are not usually recognized by the sleep-deprived
individual.12, 13
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Finally, it is not uncommon for nurses and other shift workers to acknowledge falling asleep
when working nights.8, 14, 15 Almost one-fifth of the nurses working permanent night shifts
reported struggling to stay awake while taking care of a patient at least once during the previous
month.15 Another survey found that the occurrence of falling asleep during the night shift
occurred at least once a week among 35.3 percent of the nurses who rotated shifts, 32.4 percent
of the nurses who worked nights, and 20.7 percent of the day/evening shift nurses who worked
occasional nights.16 Objective recordings using ambulatory polysomnographic recorders and
actigraphy have verified that nurses, air traffic controllers, and even commercial truck drivers
regularly fall asleep for brief periods during the night shift.17–19
2
Effects of Fatigue and Sleepiness
obtained significantly less sleep than nurses who did not report an error or near miss (6.3 ± 1.9
hours versus 6.8 ± 1.7 hours). Using techniques described in one of their papers,38 researchers
determined that there was a 3.4 percent chance of an error when nurses obtained 6 or fewer hours
of sleep in the prior 24 hours and 12 or fewer hours of sleep in the prior 48 hours (Dawson,
personal communication, 2005). Although a 3.4 percent risk of an error or near miss sounds
insignificant, it would translate to a probability of 34 events per day in an average teaching
hospital with 1,000 nursing shifts per day.
In addition to jeopardizing patient safety, nurses who fail to obtain adequate amounts of sleep
are also risking their own health and safety. According to the National Center for Sleep
Disorders Research and the National Highway Transportation Safety Administration Expert
Panel on Driver Fatigue and Sleepiness,39 sleep loss is the leading cause of drowsy driving and
sleep-related vehicle crashes. Drowsy drivers have slower reaction times,40 reduced
vigilance,41, 42 and information processing deficits,40 which make it difficult to detect hazards and
respond quickly and appropriately.39 Laboratory studies have shown that moderate levels of
prolonged wakefulness can produce performance impairments equivalent to or greater than
levels of intoxication deemed unacceptable for driving, working, and/or operating dangerous
equipment.43, 44 Dawson and his colleagues43, 44 were the first to report that prolonged periods of
wakefulness (i.e., 20 to 25 hours without sleep) can produce performance decrements equivalent
to a blood alcohol concentration of 0.01 percent, and numerous other studies have confirmed that
prolonged wakefulness significantly impairs speed and accuracy, hand-eye coordination,
decisionmaking, and memory.45–49 Although numerous studies have shown that night shift
workers report very high rates of drowsy driving and motor vehicle accidents when driving home
after work,50–52 the majority of research on drowsy driving among health care providers has
focused on the dangers of resident physicians driving home after a night of being on-call.
There is also a growing body of evidence that sleep duration is (1) linked to metabolism and
the regulation of appetite, and (2) decreased sleep times may be a contributing factor to the
growing epidemic of obesity in this country. Several large-scale studies have shown dose-
dependent relationships between sleep duration and obesity, with greater sleep deprivation
associated with a higher risk of obesity.53, 54 Glucose tolerance is altered by short-term sleep
restriction,55 and habitually short sleep durations have been shown to significantly increase the
risk of developing diabetes in women.56 Tightly controlled laboratory studies have also shown
that short sleep durations, e.g., 4 hours per night, can result in alterations of hormones involved
in the regulation of appetite (e.g., leptin, cortisol, and thyrotropin).57
Sleep is also believed to play a role in regulating immune function. Both human and animal
studies have shown that immunological challenges such as vaccinations and both experimentally
induced and spontaneous infections tend to increase sleep duration, often increasing the duration
and intensity of slow-wave sleep (deep sleep) and decreasing REM sleep (rapid eye movement
sleep or dream sleep).58, 59 Even though studies evaluating the effects of sleep deprivation on
immunity have shown a variety of effects,60–65 no study has been able to link these changes in
immune function with increased rates of infection or other adverse effects on health.
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
increased risk of errors.35 More recent studies, however, have shown that the 12-hour shifts
favored by many nurses and frequent overtime are associated with difficulties staying awake on
duty, reduced sleep times, and nearly triple the risk of making an error.14, 69, 70
Although the majority of hospital staff nurses (75 percent) now work 12-hour shifts, some
nurses report being scheduled to work for periods as long as 20 consecutive hours.14, 69 Data
collected on 11,387 shifts revealed that nurses left work at the end of their scheduled shift less
than once every six shifts (15.7 percent), and worked on average 49 to 55 minutes extra each
shift they worked.14, 69 Working overtime, whether at the end of a regularly scheduled shift (even
an 8-hour shift) or working more than 40 hours in a week, was associated with a statistically
significant increase in the risk of making an error.14, 69 The most significant elevations in the risk
of making an error occurred when nurses worked 12.5 hours or longer; the risk was unaffected
by whether the nurse was scheduled to work 12.5 hours or more, volunteered to work longer than
scheduled, or was mandated to work overtime.14, 69
A little over two-thirds of the nurses participating in the Staff Nurse Fatigue and Patient
Safety Study reported struggling to stay awake on duty, and 20 percent reported actually falling
asleep on duty.14, 71 In fact, critical care nurses reported struggling to stay awake almost once
every five shifts they worked. Not all of the difficulties remaining alert occurred at night (24:00–
06:00); 479 episodes of drowsiness (40 percent) occurred between 6 a.m. and midnight, and 40
episodes (23 percent) of actually falling asleep on duty were reported between 6 a.m. and
midnight.14 Nurses working 12.5 hours or longer were significantly more likely to report
difficulties remaining alert than nurses working fewer hours per day,14 and they obtained on
average 30 minutes less sleep.
Although the participants (n = 35) in Urgrovics and Wright’s 1990 study72 reported fewer
difficulties driving home after switching to 12 hour shifts, at least two recent studies contradict
their findings. All but two of the nurses (n = 45) who worked 12-hour night shifts in an intensive
care unit of a large tertiary care center reported having at least one motor vehicle accident or near
accident during the previous 12 months driving to or from work.73 More recently, over half of the
participants in the Staff Nurse Fatigue and Patient Safety Study (54 percent) reported struggling
to stay awake driving home from work during the 28-day data-gathering period.74 While
difficulties remaining alert driving home were common (drowsy driving was reported
approximately once every five shifts), critical care nurses reported difficulties remaining awake
driving home after working 12.5 consecutive hours or more approximately once out every three
shifts they worked. In fact, critical care nurses who worked 12-hour shifts had a 1.87 percent
greater risk of fighting sleep on their drive home from work than nurses working traditional 8-
hour shifts (95 percent confidence interval [CI] = 1.43–2.45, P < 0.0001).74
According to a recent report of the National Institute of Occupational Safety and Health
(NIOSH),75 working more than 40 hours per week (overtime), working extended shifts (more
than 8 hours), and working both extended shifts and overtime can have adverse effects on worker
health. Extended shifts have been associated with increased musculoskeletal injuries,76 more
cardiovascular symptoms,77–79 the development of hypertension,80 and higher risks for injury.81–
83
Working overtime has also been associated with poorer perceived health,84, 85 increased neck
and musculoskeletal discomfort,76, 86, 87 increased risk for preterm birth,88 diabetes,89, 90 and
cardiovascular disease,91–93 as well as increased morbidity and mortality94 and higher rates of
accidents.95, 96 Not all studies, however, suggest that overtime is associated with poorer perceived
health,97 increased risk of developing diabetes mellitus, or cardiovascular disease.98
4
Effects of Fatigue and Sleepiness
Studies have shown that accident rates increase during extended periods of work,96 with
accident rates rising after 9 hours, doubling after 12 consecutive hours,81, 83 and tripling by 16
consecutive hours of work.82 Data from the National Transportation Safety Board aircraft
accident investigations also show higher rates of error after 12 hours.99 Other studies show no
change in accident frequency or severity of accidents,100, 101 while one study showed that workers
on a 12-hour shift schedule had lower rates of injuries at work, but higher rates of more
significant injuries away from work.82 The combination of extended shifts and overtime, while
rarely studied, has been associated with high rates of motor vehicle accidents or near misses in
the prior year,73 more musculoskeletal pain, and cardiovascular symptoms.77
Consecutive Shifts
Fatigue can be exacerbated with increased numbers of shifts worked without a day off,102, 103
and working more than four consecutive 12-hour shifts is associated with excessive fatigue and
longer recovery times.104 Folkard and Tucker83 also suggested that the accumulation of fatigue
over successive work shifts might explain the rise in accident rates observed in their meta-
analysis. On average, risk of an accident was approximately 2 percent higher on the second
morning/day shift; 7 percent higher on the third morning/day shift, and 17 percent higher on the
fourth morning/day shift than on the first shift. Accident risks also increased over successive
night shifts (e.g., on average risk was 6 percent higher on the second night, 17 percent higher on
the third night, and 36 percent higher on the fourth night) and were significantly higher than on
day/morning shifts, a finding similar to that reported by Hanecke and colleagues several years
earlier.81
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
the starting times of shifts whenever possible to make schedules more compatible with circadian
rhythms; to avoid scheduling employees to work more than two or three consecutive night shifts;
and to provide adequate recovery time between shifts, especially when an employee is rotating
off night shift. Hours of service regulations, where applicable, are also considered in the
development of a fatigue management program.119
Only limited information about the efficacy of these programs is available to the public.
Although several specialized fatigue countermeasures programs have been developed and tested
by the U.S Coast Guard, the Crew Endurance Management System,113 and the Commercial
Mariner Endurance Management System,112 information about the efficacy of these programs
has not been disseminated. Private companies implementing Fatigue Countermeasures Programs
consider their use to be proprietary information. In fact, the only paper describing the efficacy of
a fatigue countermeasures program reported only equivocal results.116
6
Effects of Fatigue and Sleepiness
Stimulants. Caffeine is probably the most commonly used fatigue countermeasure.143 Its
effects have been studied alone,144 as well as in combination with rest breaks, naps, and other
stimulant medications.145–147 Generally, caffeine’s onset of action occurs approximately 15–30
minutes after ingestion and its effects last 3–4 hours. Although tolerance can develop, significant
increases in alertness and performance can be obtained with 200 mg of caffeine (approximately
the amount of caffeine in one to two cups of coffee), with positive effects occurring with doses
ranging from 100 mg to 600 mg.143, 145 Although caffeine alone improved alertness and
performance during a laboratory study, the combination of napping and caffeine was more
efficacious than just napping or just caffeine alone in a field study of evening and night shift
workers.146 Six hundred milligrams of caffeine was also as effective as 20 mg d-amphetamine
and 400 mg modafinil in producing short-term performance and alertness during prolonged sleep
loss.148 Modafinil has also been shown to be effective in increasing alertness on laboratory
measures of performance among workers diagnosed with shift work sleep disorder (see Table 1
for a description of the disorder),149–151 but produced mixed results when evaluated during a
randomized, double-blind cross-over study of sleep-deprived emergency room physicians. Even
though modafinil improved some aspects of cognitive functioning and perceived alertness,
participants had difficulties falling asleep when given an opportunity.152 Although other
compounds have been recommended (e.g., melatonin), their efficacy has not been
established.153, 154
Bright light. Although a number of studies have shown that bright lighting in control rooms,
work areas, and laboratory environments can increase alertness at night and facilitate
entrainment to night shift work,154–157 this strategy may not help nurses as much as other types of
workers. Protocols typically involve exposure to bright lights (approximately 2,500 lux) or
normal lighting (approximately 150 lux) while working at a desk for periods of 2 to 6 hours. No
one has evaluated the efficacy of intermittent exposure to bright lights or the effects of
alternating exposure to bright lights with the dim lighting typically found in patient rooms at
night.
Exercise. Exercise typically produces increased subjective alertness and improved cognitive
performance in both sleep-deprived and nonsleep-deprived subjects.158, 159 Exercising for 10
minutes, however, produces only transient (30–50 minutes) increases in subjective alertness. In
one study there were no effects on performance after exercise, but within 50 minutes there were
signs of increased drowsiness on electroencephalogram (EEG) recordings.160 As a result of this
finding, the authors of the study caution that people who use exercise as an intervention for
maintaining alertness during a period of sleep loss may end up sleepier than if they had not
exercised.
Research Evidence
There is a very large, strong body of evidence showing that insufficient sleep has adverse
effects on cognition, performance, and mood. These effects have been documented by at least
two meta-analyses22, 150 and several clinical trials,32, 161, 162 as well as by studies using somewhat
less robust designs including time series, cross-sectional, before-and-after designs, and
noncomparative descriptive studies.11, 30, 37, 163–167 The adverse effects of insufficient sleep have
also been documented in a variety of settings ranging from tightly controlled
laboratories11, 32, 162, 163, 166 to field studies, 30, 37, 164–167 and in a variety of occupational groups.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The studies demonstrating a relationship between adverse effects on health and obtaining less
than 7 hours sleep per night tend to use less robust designs (e.g., cross-sectional designs, time
series designs, comparative and noncomparative descriptive designs), but they often include
large numbers of participants. Although survey and cross-sectional designs may not be as
rigorous as controlled clinical trials, the number of recent studies suggesting similar relationships
between insufficient sleep, altered glucose metabolism,56, 168 and increased risks of developing
diabetes mellitus54, 169 and obesity53, 54 is powerful and convincing evidence that a relationship
exists between these variables. Longer sleep durations (e.g., more than 8 to 9 hours per night)
were also associated with greater risks of dying or developing a chronic illness such as DM or
cardiovascular disease,29, 56, 168 leading researchers to speculate that individuals who routinely
obtain higher than normal amounts of sleep may have preexisting health problems.29
The evidence regarding shift duration, however, is less clear-cut. Although some studies
suggest that reductions in the work hours of resident physicians and interns is associated with
fewer errors,35 other studies suggest that the implementation of work hour limitations has not
decreased the number of adverse events.169,170 Although there are numerous literature
reviews,171–173 descriptive and other comparative studies,14, 25, 26, 69, 174–176 there are no meta-
analyses and only one systematic review177 focusing on the impact of work hours on medical
errors or work performance. The strongest study, involving 20 critical care residents and interns
and direct observation of errors, found that traditional schedules were associated with 35 percent
more serious errors, and shortened workdays (16 hours) were associated with both fewer order-
writing errors and diagnostic errors.35 Unfortunately, this study has not been replicated outside of
the critical care setting or at any other institution.
The evidence demonstrating a relationship between working long hours and adverse effects
on health is stronger. Not only are there several large-scale studies documenting higher injury
rates when people worked overtime or extended shifts,82, 178, 179 there are several literature
reviews83, 170 and three meta-analyses examining the effects on worker health.78, 79, 83
Clinical trials that would provide more definitive answers to questions regarding shift
duration and adverse health effects have not been done, nor are they likely to be done because of
ethical issues.
Although more than 170,000 employees from a variety of industries (including aviation, rail,
trucking, maritime, health care, petrochemical, nuclear energy, and law enforcement) have been
exposed to fatigue countermeasures programs,115 there is very limited information about their
efficacy. Typical reports indicate that some aspects of a particular program were successful (e.g.,
employees slept longer at night,180 napping improved alertness on duty,129 and that participants
used most of the suggested strategies),116 but the reports rarely assess the efficacy of the program
as a whole for improving alertness on the job and reducing errors. The only published study
describing the outcomes of a fatigue countermeasures program for resident physicians involved a
very small sample (n = 6) and produced mixed results.116 Although participants reported
increased subjective alertness after using the suggested strategies for a month, there were no
improvements in their performance, mood, or the amount of sleep obtained when working the
night shift.
There is strong evidence that short naps can improve alertness during night shifts and
prolonged periods of wakefulness. Data obtained from several small clinical trials,134, 138, 140, 146
and a meta-analysis142 all support the use of this strategy for improving alertness at night. In
addition, there are several small clinical trials that suggest a short daytime nap can improve
alertness during the afternoon.181–184
8
Effects of Fatigue and Sleepiness
The effects of rest breaks were more variable. Study designs evaluating the efficacy of rest
breaks on performance and alertness also tended to be weaker, involving quasi-experimental
designs128, 130, 131, 133, 185 rather than randomized clinical trials129 or meta-analyses. Given that
almost all of the aforementioned studies were field studies conducted at actual worksites during
regular workhours, the choice of somewhat less rigorous designs is understandable.
There is strong evidence that use of caffeine, either alone or in combination with a nap, can
increase alertness. Although there are no meta-analyses evaluating the efficacy of caffeine, the
utility of caffeine for increasing alertness has been demonstrated through numerous clinical
trials,144, 145, 147 and its widespread use by adults. (Mean caffeine consumption in the United
States is estimated at 238 mg or slightly more than two cups of coffee per day per person.)186
Other measures to increase alertness, such as bright lighting and exercise, either lack sufficient
evidence or may not be practical for nurses.
Table 1. Adverse Effects of Restricted Sleep on Patient Safety and the Health of Nurses
Sleep Adverse Effects on Patient Safety Adverse Effects on Health
Duration in 24
Hour Period
< 7 hours More likely to report struggling to stay Increased risk of developing cardiovascular
14
awake during work shift disease and DM among nurses187
Increased risk of becoming obese over a 10-
year period53
≤ 6 hours Risk of making an error is 3.4% during a Increased prevalence of DM and altered
work shift among nurses who slept ≤ 6 glucose metabolism56, 168
hours in 24 hours prior to shift (Dawson, Risk of obesity is 23% greater than subjects
53
personal communication) sleeping 7–9 hours
< 5 hours Increased subjective and objective Increased risk of developing DM demonstrated
sleepiness, and reduced performance on in nurses187
22, 161
cognitive tasks Risk of obesity is 50% greater than among
53
subjects sleeping 7–9 hours
≤ 4 hours Altered levels of appetite-regulating hormones
(leptin, cortisol, and thyrotropin)57
Risk of obesity is 73% greater than among
subjects sleeping 7–9 hours53
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Younger nurses (e.g., those 20–30 years old) need to If you are younger than 30 years of age, adequate
be particularly careful about obtaining sufficient sleep, sleep is especially important for providing safe and
since their mood and performance may be more high-quality patient care.
adversely affected by insufficient sleep.
10
Effects of Fatigue and Sleepiness
The continued use of 12-hour shifts cannot be Nurse managers should not schedule nurses for 12-
recommended given the current working conditions, hour shifts and nurses should not request 12-hours
including the almost daily need for nurses to stay beyond shifts.
the end of their scheduled shift, the frequent absence of
breaks during the workday, and the higher risk of errors
14, 69, 126
associated with 12-hour shifts.
If nurses insist on continuing to work 12-hour shifts, If you are scheduled to work a 12-hour shift, (1) do not
several measures should be taken to reduce the risks to work more than three shifts without a day off; (2) insist
patients and nurses. These steps include reducing the that provisions are made for sufficient staffing to ensure
number of consecutive shifts to no more than three,83, 104 that you are able to be free of patient care
120, 195
providing adequate meal and rest breaks, revising responsibilities for 10 minutes every 2 hours and for 30
schedules to ensure that nurses have at least 10–12 minutes to eat a meal; and (3) insist that you have at
hours off between work shifts so that they have adequate least 10–12 hours off between shifts so that you can
time for sleep, commuting, and completing their domestic obtain sufficient sleep.
responsibilities, and requiring that nurses use their off-
duty time to get sufficient sleep.
The emphasis on maximizing opportunities for sleep is intentional. Because long workhours
are often associated with insufficient sleep,25, 36, 196 some authorities believe that fatigue on the
job is more likely to be associated with a lack of sleep than the number of hours spent
working.191, 197 Workers who report high workloads, stressful workweeks, or who score higher
on burnout indexes have shorter sleep times,198, 199 as well as more arousals, greater sleep
fragmentation, more wake time after sleep onset, lighter sleep, and less deep sleep.200, 201 Fatigue
and daytime sleepiness associated with stressful working conditions and burnout is believed to
be a result of insufficient sleep, rather than a direct result of stressful working conditions or
burnout.
Although employer support will be required to implement schedule changes, there are several
strategies that nurses can adopt to improve their ability to remain alert throughout their entire
shift. Even though the following three fatigue countermeasures were developed mainly for night
shift workers, the first two recommendations are also appropriate for nurses working other shifts.
2. Nurses should be allowed to nap during their break and meal periods. Naps should be short,
e.g., less than 45 minutes, to reduce the likelihood of awakening from deep sleep and
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
experiencing sleep inertia.143 Some nurses may prefer to take a shorter nap, and have a 15-
minute wake up period before they resume patient care.
3. Nurses, particularly those who start their shift at 11 p.m. or midnight, should consider
napping prior to starting their shift. Not only are nurses who work at night required to be
awake and vigilant when their body temperature is lowest and their sleep tendency is
greatest, they are typically awake longer before the beginning of their shift than workers on
other shifts.203
Finally, nurses should realize that most people are not accurate judges of how impaired they
are by fatigue or sleep loss.204, 205 Few adults can perform at high levels for more than 12
consecutive hours or function adequately with less than 6 hours sleep. Figure 1 illustrates the
risks associated with combining insufficient sleep with extended shifts and outlines strategies to
reduce fatigue-related errors.
12
Effects of Fatigue and Sleepiness
Figure 1. Risks Associated With Various Combinations of Sleep Duration, Shift Duration, and Shift
Time, and Strategies To Mitigate the Effects of Insufficient Sleep and Extended Work Shifts
Scheduled to
work day or Lowest Risk of
Yes, and am evening Errors.
scheduled to work
< 12-hour shift. Higher Risk of
Scheduled
to work the Errors.
night shift? Do the following:
Take regular breaks
from patient care.
Scheduled to work? Scheduled Nap during break(s)
to work the and use caffeine
Yes, and am day shift? therapeutically,
Y scheduled to work especially on the
a 12-hour shift. night shift.
Have you had at Scheduled
If have < 7 hours of
least 7 hours of to work the
sleep, take a nap
sleep in the night shift?
before starting the
24-hours prior to work shift.
starting your shift? Scheduled to Plus, use naps and
work day or caffeine to maintain
No, and am evening alertness.
scheduled to
work < 12-hour
shift. Scheduled
to work the
night shift?
Scheduled
No, and am
to work the Highest Risk of
scheduled to
day shift? Errors:
work a 12-hour
shift. Use all of the above
strategies to mitigate the
Scheduled
effects of sleep loss, plus
to work the
double check all work.
night shift?
Research Implications
More research is needed to understand the effects of fatigue on patient safety. Controlled
trials are needed to determine optimal work schedules in hospital settings and test fatigue
countermeasures. Since night shifts cannot be eliminated, the efficacy of fatigue
countermeasures, naps during break periods, therapeutic use of caffeine, and other measures
should be tested in hospital environments. Since the use of naps and caffeine have been shown to
increased alertness during prolonged sleep deprivation and during night shift work, these
measures should also be evaluated to determine if they would be effective for increasing
alertness on day and evening shifts.
Finally, there is no information about the sleep of nurses working outside of hospital
environments, and only limited information about the workhours of nurses in nursing homes and
extended-care facilities. Nor is there any information about the sleep and performance of nurses
who work 24-hour shifts (e.g., nurse-midwives and some advanced practice nurses) or who are
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
required to take call. These issues and others need to be examined to improve both the safety of
patients and the nurses who care for them.
Although many questions remain unanswered, “We do know enough,” according to L. G.
Olson and A. Ambrogetti, “to end the worse abuses of the human sleep-wake cycle, and we need
to see a shift by both hospital employers and the medical [nursing] * profession towards
addressing this issue”206 (p. 416). The service regulations written during the first two decades of
the 20th century recognized that people cannot work for long periods of time each day without
adequate time to sleep. Eighty years later, at the beginning of the 21st century, it is perhaps time
to acknowledge that nurses cannot provide safe care when they are fatigued, have worked for
more than 12 consecutive hours, and/or have not had at least 12 to 16 hours off between shifts.
*
Material in brackets added by author.
14
Table 5. Critical Research Questions
Will the risk of making an error decrease if shifts To determine if shorter work durations and Clinical trial, with one group assigned to shorter
are shortened to ≤ 10 hours and/or nurses get at obtaining adequate amounts of sleep reduce the shifts, the second group assigned to obtain at least
least 7 hours sleep? risk of making an error. 7 hours sleep, and the third group assigned to work
shorter shifts and obtain at least 7 hours sleep.
Since most nurses and managers favor 12-hour To determine what factors favor the continued use Qualitative approaches, in combination with rating
shifts despite their well-recognized hazards, how of 12-hour shifts and how to alter those factors to scales to assess unit culture and institutional
can the culture of individual nursing units be make shorter shifts more acceptable to staff nurses commitment to improving patient safety.
changed to discourage their use? and nurse managers.
What differentiates those nurses who always obtain To identify the characteristics of nurses who are Correlation studies and regression models.
at least 6 hours sleep prior to working from those most likely to obtain the minimum amount of sleep
who fail to get at least 6 hours sleep prior to necessary to provide care safely.
15
working?
Will fatigue countermeasures, e.g., naps during To evaluate the efficacy of fatigue Clinical trial comparing the alertness and risk of
break periods and therapeutic use of caffeine, countermeasures for increasing the alertness and errors in night shift nurses assigned to fatigue
increase the alertness of nurses working at night? decreasing the risk of errors when nurses work at countermeasures group to those who are not
Decrease the risk of making an error? night. assigned to the intervention group.
Will fatigue countermeasures, e.g., naps during To evaluate the efficacy of fatigue Clinical trial comparing the alertness and risk of
break periods and therapeutic use of caffeine, countermeasures for increasing the alertness and errors of nurses working 12-hours shifts assigned
Should nurse midwives and other advanced To determine if 24-hour shifts worked by nurse Observational study using methodology similar to
practice nurses be allowed to work 24-hour shifts? midwives and other advanced practice nurses are that used to evaluate the safety of 24-hr shifts
safe. worked by critical care residents.
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Conclusion
The evidence is overwhelming that nurses who work longer than 12 consecutive hours or
work when they have not obtained sufficient sleep are putting their patients’ health at risk; risk
damaging their own health; and if they drive home when they are drowsy, also put the health of
the general public at risk. Nurses, nurse managers, nursing administrators, and policymakers
need to work together to change the culture that not only allows, but often encourages nurses to
work long hours without obtaining sufficient sleep.
Search Strategy
Relevant papers for this review were identified from three databases (MEDLINE,®
CINHAL,® and PsychLit) using the period 1990–2006. Several older, classical works were also
cited. Hand searches were also performed examining journals such as the Journal of Sleep
Research and Sleep. Only those papers that focused on the effects of chronic partial or total sleep
deprivation for a single night, extended work shifts, and strategies to reduce fatigue-related
errors and accidents were included in this review. Search terms included “caffeine,” “chronic
partial sleep deprivation,” “fatigue,” “fatigue countermeasures,” “extended work shifts,”
“napping,” “overtime,” “performance,” “resident physicians,” “registered nurses,” “rest breaks,”
“sleep loss,” “sleep restriction,” “staff nurses,” “total sleep deprivation,” and “vigilance.”
Author Affiliations
Ann E. Rogers, Ph.D., R.N., F.A.A.N., associate professor, University of Pennsylvania
School of Nursing, and the Center for Sleep and Respiratory Neurobiology, University of
Pennsylvania School of Medicine. E-mail: [email protected].
16
Effects of Fatigue and Sleepiness
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25
Evidence Table 1. Effects of Insufficient Sleep on Patient Safety and Health of Individuals
Chronic sleep Cross-sectional Survey (5) Participants 1.1 million Mortality rates were highest
restriction study (4) were 30–100 years of participants from the among subjects who
age, sleep durations and American Cancer obtained ≥ 8-hr sleep or
morbidity and mortality Society’s Cancer less than 3.5–4.5 hr. The
rates over a 6-year Prevention II Study. lowest risks were found
period (1) among those who obtained
7 hours sleep.
Singh 200554 Sleep restriction Cross-sectional Survey (5), total sleep 3,158 randomly Overall prevalence of
study (4) time in the 2 weeks prior selected adults in obesity was 24.8% and
to survey, and body the metropolitan significantly higher in those
mass index (BMI) (3) area of Detroit, MI with lower amount s of
sleep. After controlling for
age, sex, loud snoring,
hypertension, DM, arthritis,
and alcohol intake, sleeping
less than 6 hours greatly
increased the risk of being
obese.
Evidence Table 2. Extended Work Hours
no micro-sleep events
during last 30 minutes of
flight or when landing
compared to 27 micro-sleep
events during the last 30
minutes of flight and
landing from the no-nap
group. Longer naps
produced longer periods of
alertness. Sleep inertia was
not observed in the 1-hour
period after the nap.
Safety Issued
Source Related to Design Type Study Design, Study Study Setting & Study Intervention Key Finding
Clinical Practice Outcome Measures Study Population
Sallinen Maintenance of Randomized Randomized controlled 14 experienced male Subjects randomly Naps improved ability to
1998138 Vigilance, napping controlled trial (2) trial (2), efficacy of naps shift workers, assigned to take respond to visual signals
during night shift during night shift simulated work shift either a 30-minute early in second half of night
evaluated using visual in laboratory or 50-minute nap at shift. Physiological
reaction times, subjective 1 a.m. or 4 a.m. sleepiness was improved
ratings of sleepiness, Control condition by the nap at 1 a.m., but
and physiological was a shift without not the nap at 4 a.m.
sleepiness (3) a nap. Subjective sleepiness
somewhat decreased by
the naps. Sleep inertia
lasted approximately 10–15
minutes.
Bonnet Maintenance of Systematic High-quality systematic 239 papers, most Recommend caffeine as
2005211 vigilance, sleep literature review literature review (1) were double-blind initial stimulant of choice
restriction, and use (11) related to the safety and clinical trials due to its availability in
of stimulants efficacy of five different multiple forms, widespread
stimulants use, limited abuse potential,
and little impact on sleep
35
Background
The occurrence and undesirable complications from health care–associated infections (HAIs)
have been well recognized in the literature for the last several decades. The occurrence of HAIs
continues to escalate at an alarming rate. HAIs originally referred to those infections associated
with admission in an acute-care hospital (formerly called a nosocomial infection), but the term
now applies to infections acquired in the continuum of settings where persons receive health care
(e.g., long-term care, home care, ambulatory care). These unanticipated infections develop
during the course of health care treatment and result in significant patient illnesses and deaths
(morbidity and mortality); prolong the duration of hospital stays; and necessitate additional
diagnostic and therapeutic interventions, which generate added costs to those already incurred by
the patient’s underlying disease. HAIs are considered an undesirable outcome, and as some are
preventable, they are considered an indicator of the quality of patient care, an adverse event, and
a patient safety issue.
Patient safety studies published in 1991 reveal the most frequent types of adverse events
affecting hospitalized patients are adverse drug events, nosocomial infections, and surgical
complications.1, 2 From these and other studies, the Institute of Medicine reported that adverse
events affect approximately 2 million patients each year in the United States, resulting in 90,000
deaths and an estimated $4.5–5.7 billion per year in additional costs for patient care.3 Recent
changes in medical management settings have shifted more medical treatment and services to
outpatient settings; fewer patients are admitted to hospitals. The disturbing fact is that the
average duration of inpatient admissions has decreased while the frequency of HAIs has
increased.4, 5 The true incidence of HAIs is likely to be underestimated as hospital stays may be
shorter than the incubation period of the infecting microorganism (a developing infection), and
symptoms may not manifest until days after patient discharge. For example, between 12 percent
and 84 percent of surgical site infections are detected after patients are discharged from the
hospital, and most become evident within 21 days after the surgical operation.6, 7 Patients
receiving followup care or routine care after a hospitalization may seek care in a nonacute care
facility. The reporting systems are not as well networked as those in acute care facilities, and
reporting mechanisms are not directly linked back to the acute care setting to document the
suspected origin of some infections.
Since the early 1980s HAI surveillance has monitored ongoing trends of infection in health
care facilities.8 With the application of published evidence-based infection control strategies, a
decreasing trend in certain intensive care unit (ICU) health care-associated infections has been
reported through national infection control surveillance9 over the last 10 years, although there has
also been an alarming increase of microorganism isolates with antimicrobial resistance. These
changing trends can be influenced by factors such as increasing inpatient acuity of illness,
inadequate nurse-patient staffing ratios, unavailability of system resources, and other demands
that have challenged health care providers to consistently apply evidence-based
recommendations to maximize prevention efforts. Despite these demands on health care workers
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and resources, reducing preventable HAIs remains an imperative mission and is a continuous
opportunity to improve and maximize patient safety.
Another factor emerging to motivate health care facilities to maximize HAI prevention
efforts is the growing public pressure on State legislators to enact laws requiring hospitals to
disclose hospital-specific morbidity and mortality rates. A recent Institute of Medicine report
identified HAIs as a patient safety concern and recommended immediate and strong mandatory
reporting of other adverse health events, suggesting that public monitoring may hold health care
facilities more accountable to improve the quality of medical care and to reduce the incidence of
infections.3 Since 2002, four States (Florida, Illinois, Missouri, and Pennsylvania) set legislation
mandating health care organizations to publicly disclose HAIs.10, 11 In 2006, the Association for
Professionals in Infection Control and Epidemiology (APIC) reported that 14 States have
mandatory public reporting, and 27 States have other related legislation under consideration.12
Participation in public reporting has not been regulated by the Federal sector at this time. Some
hospital reporting is intended for use solely by the State health department for generating
confidential reports that are returned to each facility for their internal quality improvement
efforts. Other intentions to utilize public reporting may be aimed at comparing rates of HAI and
subsequent morbidity and mortality outcomes between different hospitals. This approach is
problematic as there is currently a lack of scientifically validated methods for risk adjusting
multiple variations (e.g., differences in severity of illnesses in each population being treated) in
patients’ intrinsic and extrinsic risks for HAIs.13–15 Moreover, data on whether public reporting
systems have an effective role in reducing HAIs are lacking.
To assist with generating meaningful data, process and outcome measures for patient safety
practices have been proposed.13, 14, 16 Monitoring both process and outcome measures and
assessing their correlation is a model approach to establish that good processes lead to good
health care outcomes. Process measures should reflect common practices, apply to a variety of
health care settings, and have appropriate inclusion and exclusion criteria. Examples include
insertion practices for central intravenous catheters, appropriate timing of antibiotic prophylaxis
in surgical patients, and rates of influenza vaccination for health care workers and patients.
Outcome measures should be chosen based on the frequency, severity, and preventability of the
outcome events. Examples include intravascular catheter-related blood stream infection rates and
surgical-site infections in selected operations. Although these occur at relatively low frequency,
the severity is high—these infections are associated with substantial morbidity, mortality, and
excess health care costs—and there are evidence-based prevention strategies available.17, 18
2
Preventing Health Care–Associated Infections
Source of Microorganisms
During the delivery of health care, patients can be exposed to a variety of exogenous
microorganisms (bacteria, viruses, fungi, and protozoa) from other patients, health care
personnel, or visitors. Other reservoirs include the patient’s endogenous flora (e.g., residual
bacteria residing on the patient’s skin, mucous membranes, gastrointestinal tract, or respiratory
tract) which may be difficult to suppress and inanimate environmental surfaces or objects that
have become contaminated (e.g., patient room touch surfaces, equipment, medications). The
most common sources of infectious agents causing HAI, described in a scientific review of 1,022
outbreak investigations,20 are (listed in decreasing frequency) the individual patient, medical
equipment or devices, the hospital environment, the health care personnel, contaminated drugs,
contaminated food, and contaminated patient care equipment.
Host Susceptibility
Patients have varying susceptibility to develop an infection after exposure to a pathogenic
organism. Some people have innate protective mechanisms and will never develop symptomatic
disease because they can resist increasing microbial growth or have immunity to specific
microbial virulence properties. Others exposed to the same microorganism may establish a
commensal relationship and retain the organisms as an asymptomatic carrier (colonization) or
develop an active disease process.
Intrinsic risk factors predispose patients to HAIs. The higher likelihood of infection is
reflected in vulnerable patients who are immunocompromised because of age (neonate, elderly),
underlying diseases, severity of illness, immunosuppressive medications, or medical/surgical
treatments. Patients with alterations in cellular immune function, cellular phagocytosis, or
humoral immune response are at increased risk of infection and the ability to combat infection. A
person with a primary immunodeficiency (e.g., anemia or autoimmune disease) is likely to have
frequently recurring infections or more severe infections, such as recurrent pneumonia.21
Secondary immunodeficiencies (e.g., chemotherapy, corticosteroids, diabetes, leukemia) increase
patient susceptibility to infection from common, less virulent pathogenic bacteria, opportunistic
fungi, and viruses. Considering the severity of a patient’s illness in combination with multiple
risk factors, it is not unexpected that the highest infection rates are in ICU patients. HAI rates in
adult and pediatric ICUs are approximately three times higher than elsewhere in hospitals.22
Extrinsic risk factors include surgical or other invasive procedures, diagnostic or therapeutic
interventions (e.g., invasive devices, implanted foreign bodies, organ transplantations,
immunosuppressive medications), and personnel exposures. According to one review article, at
least 90 percent of infections were associated with invasive devices.23 Invasive medical devices
bypass the normal defense mechanism of the skin or mucous membranes and provide foci where
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
pathogens can flourish, internally shielded from the patient’s immune defenses. In addition to
providing a portal of entry for microbial colonization or infection, these devices also facilitate
transfer of pathogens from one part of the patient’s body to another, from health care worker to
patient, or from patient to health care worker to patient. Infection risk associated with these
extrinsic factors can be decreased with the knowledge and application of evidence-based
infection control practices. These will be discussed in further detail in Chapter 42, “Targeting
Health Care–Associated Infections: Evidence-Based Strategies.”
Prolonged hospitalization, due to a higher acuity of illness, contributes to host susceptibility
as there is more opportunity to utilize invasive devices and more time for exposure to exogenous
microorganisms. These patients are also more susceptible to rapid microbial colonization as a
consequence of the severity of the underlying disease, depending on the function of host
defenses and the presence of risk factors (e.g., age, extrinsic devices, extended length of stay).
Exposure to these colonizing microorganisms is from such sources as (1) endemic pathogens
from an endogenous source, (2) hospital flora in the health care environment, and (3) hands of
health care workers. A study related to length of hospitalization examining adverse events in
medical care indicated that the likelihood of experiencing an adverse event increased
approximately 6 percent for each day of hospital stay. The highest proportion of adverse events
(29.3 percent) was not related to surgical procedures but linked instead to the subsequent
monitoring and daily care lacking proper antisepsis steps.24
Means of Transmission
Among patients and health care personnel, microorganisms are spread to others through four
common routes of transmission: contact (direct and indirect), respiratory droplets, airborne
spread, and common vehicle. Vectorborne transmissions (from mosquitoes, fleas, and other
vermin) are atypical routes in U.S. hospitals and will not be covered in this text.
Contact transmission. This is the most important and frequent mode of transmission in the
health care setting. Organisms are transferred through direct contact between an infected or
colonized patient and a susceptible health care worker or another person. Patient organisms can
be transiently transferred to the intact skin of a health care worker (not causing infection) and
then transferred to a susceptible patient who develops an infection from that organism—this
demonstrates an indirect contact route of transmission from one patient to another. An infected
patient touching and contaminating a doorknob, which is subsequently touched by a health care
worker and carried to another patient, is another example of indirect contact. Microorganisms
that can be spread by contact include those associated with impetigo, abscess, diarrheal diseases,
scabies, and antibiotic-resistant organisms (e.g., methicillin-resistant Staphylococcus aureus
[MRSA] and vancomycin-resistant enterococci [VRE]).
Respiratory droplets. Droplet-size body fluids containing microorganisms can be generated
during coughing, sneezing, talking, suctioning, and bronchoscopy. They are propelled a short
distance before settling quickly onto a surface. They can cause infection by being deposited
directly onto a susceptible person’s mucosal surface (e.g., conjunctivae, mouth, or nose) or onto
nearby environmental surfaces, which can then be touched by a susceptible person who
autoinoculates their own mucosal surface. Examples of diseases where microorganisms can be
spread by droplet transmission are pharyngitis, meningitis, and pneumonia.
Airborne spread. When small-particle-size microorganisms (e.g., tubercle bacilli, varicella,
and rubeola virus) remain suspended in the air for long periods of time, they can spread to other
people. The CDC has described an approach to reduce transmission of microorganisms through
4
Preventing Health Care–Associated Infections
airborne spread in its Guideline for Isolation Precautions in Hospitals.25 Proper use of personal
protective equipment (e.g., gloves, masks, gowns), aseptic technique, hand hygiene, and
environmental infection control measures are primary methods to protect the patient from
transmission of microorganisms from another patient and from the health care worker. Personal
protective equipment also protects the health care worker from exposure to microorganisms in
the health care setting.
Common Vehicle. Common vehicle (common source) transmission applies when multiple
people are exposed to and become ill from a common inanimate vehicle of contaminated food,
water, medications, solutions, devices, or equipment. Bacteria can multiply in a common vehicle
but viral replication can not occur. Examples include improperly processed food items that
become contaminated with bacteria, waterborne shigellosis, bacteremia resulting from use of
intravenous fluids contaminated with a gram-negative organism, contaminated multi-dose
medication vials, or contaminated bronchoscopes. Common vehicle transmission is likely
associated with a unique outbreak setting and will not be discussed further in this document.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
and basic training courses offered by professional organizations or health care institutions.28, 29
The Certification Board of Infection Control offers certification that an ICP has the standard core
set of knowledge in infection control.30, 31, 32
Over time, the workload responsibilities of the ICP have significantly increased to
encompass additional administrative functions and regulatory compliance reporting, sometimes
covering prevention of infection activities in other facilities that belong to the health care system
(e.g., long-term care, home care, and outpatient settings). The expanding scope of ICP
responsibilities being performed with limited time and shrinking resources has created an
imbalance in meeting all tasks, leading to regular completion of only essential functions and
completing less essential functions when time permits. In a 2002 ICP survey examining resource
allocations, the activity consuming the greatest amount of mean estimated time was surveillance,
followed by education, prevention strategies to control transmission, infection control program
communication, and outbreak control. In examining the tasks and the time allocations necessary
to complete essential infection control responsibilities, a recent expert review panel
recommended new and safer staffing allocations: 1 full-time ICP for every 100 occupied beds.
Further staffing levels and recommendations are included for different types of health care
facilities by bed size.33 To maximize successful completion of current reporting requirements
and strategies for the prevention of infection and other adverse events associated with the
delivery of health care in the entire spectrum of health care settings, infection control personnel
and departments must be expanded.34
Nursing Responsibilities
Clinical care staff and other health care workers are the frontline defense for applying daily
infection control practices to prevent infections and transmission of organisms to other patients.
Although training in preventing bloodborne pathogen exposures is required annually by the
Occupational Safety and Health Administration, clinical nurses (registered nurses, licensed
practical nurses, and certified nursing assistants) and other health care staff should receive
additional infection control training and periodic evaluations of aseptic care as a planned patient
safety activity. Nurses have the unique opportunity to directly reduce health care–associated
infections through recognizing and applying evidence-based procedures to prevent HAIs among
patients and protecting the health of the staff. Clinical care nurses directly prevent infections by
performing, monitoring, and assuring compliance with aseptic work practices; providing
knowledgeable collaborative oversight on environmental decontamination to prevent
transmission of microorganisms from patient to patient; and serve as the primary resource to
identify and refer ill visitors or staff.
Prevention Strategies
Multiple factors influence the development of HAIs, including patient variables (e.g., acuity
of illness and overall health status), patient care variables (e.g., antibiotic use, invasive medical
device use), administrative variables (e.g., ratio of nurses to patients, level of nurse education,
permanent or temporary/float nurse), and variable use of aseptic techniques by health care staff.
Although HAIs are commonly attributed to patient variables and provider care, researchers have
also demonstrated that other institutional influences may contribute to adverse outcomes.35, 36 To
encompass overall prevention efforts, a list of strategies are reviewed that apply to the clinical
6
Preventing Health Care–Associated Infections
Hand Hygiene
…so they shall wash their hands and their feet, that they die not:
and it shall be a statute for ever to them…
Exodus 30:21 Revised Standard Version
Overview. For the last 160 years, we have had the scientific knowledge of how to reduce
hand contamination and thereby decrease patient infections from the seminal work on hand
washing by the Hungarian obstetrician, Ignaz Semmelweis. Epidemiologic studies continue to
demonstrate the favorable cost-benefit ratio and positive effects of simple hand washing for
preventing transmission of pathogens in health care facilities.37, 38 The use of antiseptic hand
soaps (i.e., ones containing chlorhexidine) and alcohol-based hand rubs also effectively reduce
bacterial counts on hands when used properly. Even though the clear benefits of hand washing
have been proven in multiple settings, the lack of consistent hand-washing practices remains a
worldwide issue. In a resource-poor area of Pakistan, a recent household hand-washing campaign
demonstrated a 50 percent lower incidence of pneumonia in children younger than 5 years
compared to households that did not practice hand washing. Children under 15 years in hand-
washing households had a 53 percent lower incidence of diarrhea and a 34 percent lower
incidence of impetigo. Hand washing with plain soap prevented the majority of illnesses causing
the largest number of childhood deaths globally.39 The World Alliance for Patient Safety, formed
by the World Health Organization, has adopted infection reduction programs—in both developed
and developing countries—as its first goal.40, 41 The World Alliance for Patient Safety advocates
a “clean care is safer care” program, in which health care leaders sign a pledge to take specific
steps to reduce HAIs in their facilities. Hand hygiene is the first focus in this worldwide initiative.
Understaffing and hand hygiene. Hospitals with low nurse staffing levels and patient
overcrowding leading to poor adherence to hand hygiene have been associated with higher
adverse outcome rates and hospital outbreak investigations.34, 42, 43 In an ICU setting,44 it was
demonstrated that understaffing of nurses can facilitate the spread of MRSA through relaxed
attention to basic infection control measures (e.g., hand hygiene). In a neonatal ICU outbreak,45
the daily census was above the maximum capacity (25 neonates in a unit designed for 15), and
the number of assigned staff members was fewer than the number necessitated by the workload,
which resulted in relaxed attention to basic infection-control measures (use of multidose vials
and hand hygiene). During the highest workload demands, staff washed their hands before
contacting devices only 25 percent of the time, but hand washing increased to 70 percent after
the end of the understaffing and overcrowding period. Ongoing surveillance determined that
being hospitalized during this period was associated with a fourfold increased risk of acquiring
an HAI. These studies illustrate an association between staffing workload, infections, and
microbial transmission from poor adherence to hand hygiene policies.
Time demands. A perceived obstacle is that time to complete patient care duties competes
with time needed for hand washing, particularly in technically intense settings such as an ICU.
Hospital observational studies demonstrate that the frequency of hand washing varies between
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
hospital wards and occurs an average of 5 to 30 times per shift, with more hand washing
opportunities in an ICU.46 With time limitations due to patient acuity demands or nurse-patient
ratios and limited availability of sinks, the use of waterless, alcohol-based hand rubs has been
shown to improve health care workers’ compliance with hand hygiene practices in the ICU.47
Hand washing behaviors. Observational studies have found that on average, health care
workers adhere to recommended hand hygiene procedures 40 percent of the time (with a range of
5 to 80 percent).44 These studies implemented various interventions to improve hand washing,
but summarized effects by measuring responses over a short time frame, without demonstrating
long-lasting behavioral improvements. Two studies demonstrated the use of multidisciplinary
interventions to change the organizational culture on frequency of hand washing that resulted in
sustained improvements during a longer followup time period.48, 49
Behavioral theories that examine the relationship of multiple factors affecting behavioral
choices have been applied to the complex issue of hand washing compliance. These theories
illustrate the influence of the individual intention to perform hand washing and organizational
influences that affect the outcome behavior. The Theory of Planned Behavior has been studied in
this context, acknowledging that the intention to wash hands involves a person’s (1) attitude
whether or not the behavior is beneficial to themselves, (2) perception of pressure from peers,
and (3) perceived control on the ease or difficulty in performing the behavior.50–53 These
perceptions are also influenced by the strength of the person’s beliefs about the significance of
the outcomes of the behavior; the normative beliefs, which involve the individual evaluation of
peer expectations; and control beliefs, which are based on a person’s perception of their ability to
overcome obstacles that obstruct their completion of the behavior.
Monitoring compliance. Although standards for hand hygiene practices have been
published with an evidence-based guideline44 and professional collaborations have produced the
How-to-Guide: Improving Hand Hygiene,54 there is no standardized method or tool for
measuring adherence to institutional policy. Varying quality improvement methodologies and a
lack of consensus on how to measure hand hygiene compliance have made it difficult to
determine the effectiveness of hand hygiene expectations within and across health care settings.
The Joint Commission has instituted a partnership with major infection control leadership
organizations in the United States and abroad to identify best approaches for measuring
compliance with hand hygiene guidelines in health care organizations though its Consensus
Measurement in Hand Hygiene (CMHH) project. The participating organizations include APIC,
CDC, the Society for Healthcare Epidemiology of America, the World Health Organization
World Alliance for Patient Safety, the Institute for Healthcare Improvement, and the National
Foundation for Infectious Diseases. The final product of this project, due to be completed in
early 2008, will be an educational monograph that recommends best practices for measuring
hand hygiene compliance.55
Summary. Hand hygiene adherence and promotion involve multiple factors at the individual
and system level to provide an institutional safety climate for patients and health care staff.
Methods used to promote improved hand hygiene require multidisciplinary participation to
identify individual beliefs, adherence factors, and perceived barriers. Program successes have
been summarized and should be reviewed to establish improved hand hygiene as a priority
program at your facility.44, 56, 57
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Preventing Health Care–Associated Infections
Environmental Cleanliness
The health care environment surrounding a patient contains a diverse population of
pathogenic microorganisms that arise from a patient’s normal, intact skin or from infected
wounds. Approximately 106 flat, keratinized, dead squamous epithelium cells containing
microorganisms are shed daily from normal skin,58 and patient gowns, bed linens, and bedside
furniture can easily become contaminated with patient flora. Surfaces in the patient care setting
can also be contaminated with pathogenic organisms (e.g., from a patient colonized or infected
with MRSA, VRE, or Clostridium difficile) and can harbor viable organisms for several days.
Contaminated surfaces, such as blood pressure cuffs, nursing uniforms, faucets, and computer
keyboards,59, 60 can serve as reservoirs of health care pathogens and vectors for cross-
contamination to patients. Studies have demonstrated that health care workers acquire
microorganisms on gloved hands without performing direct patient contact and when touching
surfaces near a colonized patient.59, 61 Another study determined that a health care worker’s hand
became contaminated after entering a regular patient’s room (one who was not on contact
precautions) and only touching common surfaces close to the patient (bed rails, bedside table),
without direct patient contact. The same hand contact was done by other personnel in unoccupied
rooms that had been terminally cleaned after patient discharge. Ungloved hands became
contaminated with low levels of pathogenic microorganisms more than 50 percent of the time,
even from surfaces in rooms that had been terminally cleaned after patient discharge.62 It is
important to consider this likelihood of hand contamination could occur (contamination would
also apply to the external surface of gloves, if worn) and to perform routine hand hygiene to bare
hands or ungloved hands to reduce hand contamination before touching clean, general-use
surfaces (e.g., computer keyboard, telephone, med cart, medical record, cleaning supplies, etc.).
Proper disinfection of common surfaces and proper hand hygiene procedures (after direct contact
to surfaces or contact with glove usage) is also critically important to reduce direct or indirect
routes of transmission.63 Persistence of environmental contamination after room disinfection can
occur and has been recently demonstrated to increase the risk of transmission to the next
susceptible room occupants.64–66
Thus, patients with known colonization or diseases with multi-drug-resistant organisms or
Clostridium difficile require Contact Precautions in addition to the Standard Precautions to
reduce the risk of transmission from the patient and the contaminated environment to others.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Nurses can ensure clean medical equipment is used between patients and can work with
environmental services personnel to maximize clean conditions in and around patient rooms. It is
necessary to consistently perform hand hygiene after routine patient care or contact with
environmental surfaces in the immediate vicinity of the patient. Infection control procedures are
recommended to reduce cross-contamination under the following situations:67
1. Use EPA-registered chemical germicides for standard cleaning and disinfection of
medical equipment that comes into contact with more than one patient.
2. If Clostridium difficile infection has been documented, use hypochlorite-based products
for surface disinfection as no EPA-registered products are specific for inactivating the
spore form of the organism.
3. Ensure compliance by housekeeping staff with cleaning and disinfection procedures,
particularly high-touch surfaces in patient care areas (e.g., bed rails, carts, charts, bedside
commodes, doorknobs, or faucet handles).
4. When contact precautions are indicated for patient care (e.g., MRSA, VRE, C. difficile,
abscess, diarrheal disease), use disposable patient care items (e.g., blood pressure cuffs)
wherever possible to minimize cross-contamination with multiple drug-resistant
microorganisms.
5. Advise families, visitors, and patients regarding the importance of hand hygiene to
minimize the spread of body substance contamination (e.g., respiratory secretions or fecal
matter) to surfaces.
A patient safety goal could be to adopt a personal or an institutional pledge, similar to the
following: I (or name of health care facility) am committed to ensuring that proper infection
control and environmental disinfection procedures are performed to reduce cross-contamination
and transmission so that a person admitted or visiting to this facility shall not become newly
colonized or infected with a bacterium derived from another patient or health care worker’s
microbial flora.
Leadership
Health care workers dedicate enormous effort to providing care for complex medical needs
of patients, to heal, to continuously follow science to improve the quality of care—all the while
consciously performing to the best of their ability to Primum non nocere (First, do no harm).
Though medical errors and adverse events do occur, many can be attributed to system problems
that have impacted processes used by the health care worker, leading to an undesired outcome.
Health care workers evaluate their professional impact based on outcomes that demonstrate that
medical and nursing orders are completed properly, that a sentinel event did not occur, clinical
judgment was properly utilized to improve patient care, and that most patients leave in stable or
better health than when they arrived. With all the complicated patient care administered, if the
patient did not acquire an infection during a hospitalization, is that an indication that all patient
care interactions were practiced aseptically? Or could the lack of infection be attributed to some
process interactions where the patient received a microbial exposure that was less than the
threshold needed to acquire an infection or, fortuitously, the patient had enough natural
immunity to ward off a potential infection? Although success is measured by an outcome with or
without infection, we should consistently practice in such a manner to reduce patient exposure to
exogenous microorganisms, which would consequently reduce the risk of infection.
Responsibility for risk reduction involves the institution administrators, directors, and
individual practitioners. It is clear that leaders drive values, values drive behaviors, and
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Preventing Health Care–Associated Infections
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
patient. Gloves may have small, unapparent defects or may be torn during use, and hands can
become contaminated during removal of gloves,72–75 thus hand hygiene is essential before
donning another pair of gloves.
Various types of masks, goggles, and face shields are worn alone or in combination to
provide barrier protection. A surgical mask protects a patient against microorganisms from the
wearer and protects the health care worker from large-particle droplet spatter that may be created
from a splash-generating procedure. When a mask becomes wet from exhaled moist air, the
resistance to airflow through the mask increases. This causes more airflow to pass around edges
of the mask. The mask should be changed between patients, and if at anytime the mask becomes
wet, it should be changed as soon as possible. Gowns are worn to prevent contamination of
clothing and to protect the skin of health care personnel from blood and body fluid exposures.
Gowns specially treated to make them impermeable to liquids, leg coverings, boots, or shoe
covers provide greater protection to the skin when splashes or large quantities of potentially
infective material are present or anticipated. Gowns are also worn during the care of patients
infected with epidemiologically important microorganisms to reduce the opportunity for
transmission of pathogens from patients or items in their environment to other patients or
environments. When gowns are worn, they must be removed before leaving the patient care area
and hand hygiene must be performed.
Improper use and removal of PPE can have adverse health consequences to the health care
worker. During the 2003 severe acute respiratory syndrome (SARS) outbreak in Canada, 44
percent of the probable SARS cases were in health care workers. After institutional
implementation of SARS-specific infection control precautions, 17 workers developed disease.
Fifteen were interviewed to determine their knowledge and work practices that could have
contributed to their infection. Only 9 (60 percent) reported they had received formal infection
control training; 13 (87 percent) were unsure of the proper order in which to don and remove
PPE; 6 (40 percent) reused items (e.g., stethoscopes, goggles, and cleaning equipment) elsewhere
on the ward after initial use in the room of a SARS patient; and 8 (54 percent) were personally
aware of a breach in infection control precautions. Fatigue and multiple consecutive shifts may
have contributed to the transmission.76
From the experiences observed during the SARS outbreak, CDC developed training materials
to increase the safety of the health care worker environment through improved use of PPE by
health care personnel. Posters (bilingual), slides, and video information are available on the CDC
Web site: http://www.cdc.gov/ncidod/dhqp/ppe.html.
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Preventing Health Care–Associated Infections
self-reported questionnaire demonstrated that although all health care providers knew the
appropriate protective barrier equipment required for a particular patient care interaction, their
reasons for nonadherence included perceived time constraints (64 percent), inconvenience (52
percent), and presumption that the patient was not infected (34 percent).79 The observed rate of
compliance was inversely related to the years of health care experience.
Translation of evidence-based guidelines into clinical practice may require more than
reliance on an individual practitioner’s knowledge and intentions. Organizational interventions
may be necessary to better understand the barriers that impede the process of effectively
reviewing and implementing evidenced-based practices into daily clinical practice.80–83 Standard
policies and standards of practice should be time specific, measurable, and should also define the
specific population of patients that will be affected. When the institution implements an
evidence-based guideline that updates the current policy, a multidisciplinary intervention should
be planned to ensure staff concurrence with the change; agreement that the new approach is
crucial; an assurance that there will be adequate staff, knowledge, and resources to implement
the change; and a method to evaluate the impact of the change.84
Antimicrobial-Resistance Campaign
“In theory, there is no difference between theory and practice. But in practice, there is.”
Jan L. A. van de Snepshceut, computer scientist and educator
Background. After the first use of penicillin in the 1950s, antibiotic resistance developed
rapidly in some bacteria such as Staphylococcus aureus. Over the last several decades, a shift in
the etiology of more easily treated pathogens has increased toward more antimicrobial-resistant
pathogens with fewer options for therapy. Infections from antimicrobial-resistant bacteria
increase the cost of health care, cause higher morbidity and mortality, and lengthen hospital stays
compared to infections from organisms susceptible to common, inexpensive antimicrobials.
Antimicrobial resistance has continued to emerge as a significant hospital problem affecting
patient outcomes by enhancing microbial virulence, causing a delay in the administration of
effective antibiotic therapy, and limiting options for available therapeutic agents. In a 2003
Institute of Medicine report, antimicrobial resistance was noted as a paramount microbial threat
of the 21st century.85
Burden of organisms. Rates of antimicrobial resistance among hospital and community
pathogens have increased considerably during the past decade. More than 70 percent of the
bacteria that cause hospital-associated infections are resistant to at least one of the drugs most
commonly used to treat these infections.86 According to 2003 National Nosocomial Infections
Surveillance System data from ICU patients, 60 percent of Staphylococcus aureus isolates were
resistant to methicillin, oxacillin, or nafcillin (MRSA)—an 11 percent increase from data
reported the year before.87 There was a nearly 50-percent increase in nonsusceptible Klebsiella
pneumoniae isolates to 3rd generation cephalosporins between 2002 and 2003. Although the rate
of vancomycin-resistant enterococcus (VRE) has shown a less drastic increase than previous
years, it still increased 12 percent in 2003 (for a total of 28.5 percent of all enterococci isolates).
Another recent national survey of antimicrobial resistance trends and outbreak frequency was
performed among U.S. hospitals (those hospitals having at least 50 beds, both general medical
and surgical services, and accreditation by the Joint Commission) using the American Hospital
Association annual survey data set.88 A total of 494 of the 670 hospital laboratories (74 percent)
responded. Antimicrobial resistance rates were highest for oxacillin-resistant Staphylococcus
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
aureus (ORSA, also referred to as MRSA) (36 percent); two-thirds of the hospitals reported
increasing MRSA rates, 4 percent reported decreasing rates, and 24 percent reported MRSA
outbreaks.
Mechanism of antibiotic resistance. The treatment of bacterial infections is not a
straightforward process. Bacterial microorganisms are initially susceptible to a new antibiotic,
but over time, as use of the antibiotic increases, new generations of the organism will selectively
adapt by developing antibiotic resistance. These organisms have the ability to undergo protective
spontaneous mutation within themselves or acquire an exogenous antibiotic-resistant gene
through genetic transfer from another organism, which enables it to inactivate an antibiotic or
nullify its killing activity. The human microbial population includes a combination of susceptible
bacteria and antibiotic-resistant bacteria. Antimicrobial usage changes the competitive balance of
the microbial population by decreasing the amount of susceptible bacteria, providing an
opportunity for resistant bacteria to flourish. Areas within hospitals such as ICUs that have high
rates of antimicrobial usage also have the highest rates of antimicrobial resistance.
Patients can acquire an antibiotic-resistant organism through other mechanisms. Increased
antibiotic treatments received in community settings can lead to the presence or colonization of
antimicrobial-resistant organisms in the community population, which can be introduced into the
hospital by patients on admission. These colonized organisms may not be detected if the patient
is admitted for noninfectious reasons. This underscores the need for routine hand hygiene after
all patient care, not just after care to patients on Contact Precautions. Often, it becomes apparent
that silent transmission has occurred when the newly discovered presence of a resistant organism
can be traced back to another patient who is later found to have been infected or colonized with
the resistant organism. More frequently, however, the exact source of resistant organisms or the
source of transmission within the institution remains undetermined.
Prevention of antibiotic-resistant organisms. Authors of evidence-based guidelines on the
increasing occurrence of multidrug-resistant organisms propose these interventions: stewardship
of antimicrobial use, an active system of surveillance for patients with antimicrobial-resistant
organisms, and an efficient infection control program to minimize secondary spread of
resistance.89–91 Antimicrobial stewardship includes not only limiting the use of inappropriate
agents, but also selecting the appropriate antibiotic, dosage, and duration of therapy to achieve
optimal efficacy in managing infections. A prospective study on hospital mortality due to
inadequate antimicrobial treatment demonstrated that the infection-related mortality rate for
patients receiving inadequate antimicrobial treatment (42 percent) was significantly greater than
the infection-related mortality rate of patients receiving adequate antimicrobial treatment (17.7
percent) in a medical or surgical ICU setting.92
Earlier guideline recommendations by professional organizations were published between
1995 and 1997 for the prevention of antimicrobial resistance in hospitals.93–95 To evaluate the
application of the recommendations, a cross-sectional survey was performed to determine what
types of antimicrobial-use programs were being used among 47 U.S. hospitals participating in
the ICU component of the CDC’s National Nosocomial Infections Surveillance System.96 All 47
hospitals had some established programs, although their practices did not meet all of the
published recommendations. For example, one programmatic practice was to consult with an
infectious disease physician or pharmacist (used 60–70 percent of the time) to discuss initial
antimicrobial options; however, only 40 percent reported a system to measure compliance with
administering the recommended antimicrobial agent. The Cochrane Collaboration reviewed 66
published papers to develop “interventions to improve antibiotic prescribing practices for
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Preventing Health Care–Associated Infections
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Precautions to prevent the transmission of all respiratory illnesses, including influenza, have
been developed.99 The following infection control measures should be implemented at the first
point of contact with a symptomatic or potentially infected person. Occupational health policies
should be in place to guide management of symptomatic health care workers.
1. Post visual alerts (in appropriate languages) at the entrance to outpatient facilities
instructing patients and escorts (e.g., family, friends) to notify health care personnel of
symptoms of a respiratory infection when they first register for care.
2. Patients and health care staff should consistently practice the following:
a. Cover the nose/mouth when coughing or sneezing.
b. Use tissues to contain respiratory secretions and dispose of them in the nearest waste
receptacle after use.
c. Perform hand hygiene after having contact with respiratory secretions and
contaminated objects or materials.
3. During periods of increased respiratory infection activity in the community or year-
round, offer masks to persons who are coughing. Either procedure masks (i.e., with ear
loops) or surgical masks (i.e., with ties) may be used to contain respiratory secretions.
Encourage coughing persons to sit at least 3 feet away from others in common waiting
areas.
4. Health care personnel should wear a surgical or procedure mask for close contact (and
gloves as needed) when examining a patient with symptoms of a respiratory infection.
Maintain precautions unless it is determined that the cause of symptoms is not an
infectious agent (e.g., allergies).
Evaluation
The ICP or a nurse on a specific patient care unit should design a periodic evaluation
program of infection control practices, including aseptic technique practices. Evaluation methods
include a self-assessment survey of intended practices, direct observational assessments by
another health care worker or a patient, and self-completion of checklists that review work
practices and identify opportunities for improvement within the health care operations. If
deficiencies or problems in the implementation of standardized infection control procedures are
identified, further evaluation activities (e.g., root-cause analysis) may be indicated to identify and
rectify the contributing factors to the problem.100
Most evaluation reviews are generated after a major, life-threatening error occurs, which
usually happens infrequently. Historically, when an evaluation determined that a process
completed by personnel was deficient, problem-solving efforts focused on the identification of
the specific individual(s) who “caused” the problem. Later, quality improvement efforts focused
on developing a culture of safety and recognized that additional contributions to errors were due
to complex, poorly designed systems. The advantage of an evaluation that reviews system
problems is that it encourages health care professionals to report adverse events and near misses
that might be preventable in the future, while balancing the identification of system problems
with holding individual providers responsible for their everyday practices. Improvement is
impossible without evaluation reports to provide data on the factors that contribute to mistakes
and lead to subsequent individual and system changes that support safer practices.101
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Preventing Health Care–Associated Infections
Research Implications *
1. Research and apply behavioral and management sciences to achieve implementation of
evidence-based clinical guidelines and compliance with infection prevention policies.
2. Develop methods to improve the appropriateness of antimicrobial use based on identified
antimicrobial control measures and institution microbial susceptibility patterns.
3. Collect data for the economic impact of HAIs and other adverse effects and resulting return
of investment for prevention methods.
4. Identify specific components of infection prevention and control programs and staffing in
health care institutions that are effective (and cost effective) in reducing rates of infection.
*
Adapted from Lynch et al. 2001104 and Aboelela et al. 2006.105
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
5. Improve health care institution information systems for seamless review of appropriateness
of infection control-related care based on patient diagnosis.
6. Determine standard indices for measurement of effectiveness and cost of infection control
measures.
7. Measure effect of staffing changes (reduced personnel, prolonged work hours, varying levels
of formal education) on patient outcomes related to infectious outcomes of morbidity and
mortality (e.g., colonization of microorganisms, postoperative wound infections, and
catheter-related infections).
8. Design studies so that independent effects of specific interventions can be identified.
9. Monitor the implementation of interventions in a multicenter study to examine a cause-and-
effect response and differentiate between efficacy and effectiveness.
10. Develop interdisciplinary research teams to improve the rigor and sophistication of studies
conducted.
Conclusions
It is the responsibility of all health care providers to enact principles of care to prevent health
care–associated infections, though not all infections can be prevented. Certain patient risk factors
such as advanced age, underlying disease and severity of illness, and sometimes the immune
status are not modifiable and directly contribute to a patient’s risk of infection. Depending on the
patient’s susceptibility, a patient can develop an infection due to the emergence of their own
endogenous organisms or by cross-contamination in the health care setting. Benefits of
antimicrobial therapy will alter the microbial flora by reducing one microbial presence but may
allow the emergence of another, causing a new infection (e.g., antibiotic-associated diarrhea).
Nurses can reduce the risk for infection and colonization using evidence-based aseptic work
practices that diminish the entry of endogenous or exogenous organisms via invasive medical
devices. Proper use of personal protective barriers and proper hand hygiene is paramount to
reducing the risk of exogenous transmission to a susceptible patient. For example,
microorganisms have been found in the environment surrounding a patient and on portable
medical equipment used in the room. Environmental surfaces around a patient infected or
colonized with a multidrug-resistant organism can also become contaminated. Health care
workers should be aware that they can pick up environmental contamination of microorganisms
on hands or gloves, even without performing direct patient care. Proper use and removal of PPE
followed by hand hygiene will reduce the transient microbial load that can be transmitted to self
or to others. Identified aseptic and infection control practices have been proven to reduce the
dissemination of organisms to a single patient, to prevent repeated transmissions that contribute
to an outbreak situation among multiple patients, or to become established in the health care
environment as endemic hospital flora.
Nursing has many complicated scopes of practice, which challenge time management,
priority setting, and efficiency of practice. Although system and administrative support is
beneficial to supporting aspects of nursing care, direct care is performed by individuals. Every
individual nurse focuses on making a difference throughout the daily workloads and enormous
responsibilities but changes in a patient’s medical condition can become overwhelming. One
nurse comes to mind who found the resolve to make significant strides within the patient ward
dealing with chronically overwhelming situations. She was administratively responsible for
18
Preventing Health Care–Associated Infections
directing and addressing the challenges of all patients’ chronic wound infections, ongoing cross-
contamination, lack of needed medical supplies and equipment, severe understaffing, working
extra shifts, and still finding time to provide care and comfort to patients. By her personal efforts
to improve wound care, aseptic practices, and hand hygiene among all nursing and medical staff,
mortality dropped in a dramatic decline from 33 percent to 2 percent within a 9-month period.102
These sustained and dedicated efforts to reduce patient infections and improve patient care in
light of overwhelming adversity set a standard of practice for all nurses to follow. That nurse was
Florence Nightingale, defining the art of nursing in the 1850s. Although medical care is more
advanced and technically more complex since that time, it was the dedication of a nurse (like you)
to ensure aseptic practices despite the significant nursing demands of patient care that makes the
difference for the patients—then and now.
National surveys of the public have repeatedly found nursing to be one of the most trusted
professions. The public trusts us to provide safe care and employ best practices by following
certain principles: (1) to not work while having an infectious illness, (2) to be knowledgeable
about the methods to protect our patients from transmission of disease, (3) to perform aseptic
practice and monitor patient infections, (4) to participate in quality improvement initiatives to
reduce infections, and (5) to provide care even if it means self-risk from infection. As nurses we
have an ethical obligation to meet that trust and uphold the highest standards for our patients and
the public, whether we are providing direct care, teaching about proper health care, or overseeing
nursing practice.103
It has been demonstrated that nursing and medical practices can pick up transient
microorganisms from intact patient skin and from environmental surfaces. Although the amount
of contamination is not quantified and the exact incidence is not apparent, it does occur. Hand
hygiene and aseptic practices before caring for a susceptible patient can reduce the transient
carriage and transfer of microorganisms. The protective benefits of infection control using
evidence-based practices are cost effective and numerous: they not only contribute to the best
individual patient care outcome, but also protect health care workers, increase public awareness
in all health care settings about infection control issues, and maintain the highest standards in
nursing, which positively contributes to our goal for the best possible patient and public health
outcomes.
Author Affiliation
Amy S. Collins, B.S., B.S.N., M.P.H., Centers for Disease Control and Prevention; Atlanta,
Georgia. E-mail: [email protected].
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24
Preventing Health Care–Associated Infections
Appendix 1. Resources
Federal Agencies
Centers for Disease Control and Prevention: CDC for Healthcare Providers
Health care infections, hepatitis, antimicrobial resistance, health care worker protection. Slide
presentations. Fact sheets. http://www.cdc.gov/CDCForYou/healthcare_providers.html
Guidelines http://www.cdc.gov/ncidod/dhqp
Prevention of Catheter-Associated Urinary Tract Infections, 1981
Environmental Infection Control in Healthcare Facilities, 2003
Hand Hygiene in Healthcare Settings, 2002
Preventing Healthcare-Associated Pneumonia, 2003
Guidelines for Infection Control in Health Care Personnel, 1998
Infection Prevention and Control in the Long-Term Care Facility, 1997
Guideline for Isolation Precautions in Hospitals, 1996
Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2002
Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006
Guideline for Prevention of Surgical-Site Infection, 1999
Public Health Service Guidelines on the Management of Exposure to HBV, HCV, and
HIV with PEP Recommendations, 2001
Updated U.S. Public Health Service Guidelines for the Management of Occupational
Exposures to HIV and Recommendations for Post-Exposure Prophylaxis, 2005
Guidelines for Preventing the Transmission of M. tuberculosis in Health Care Settings,
2005
25
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Professional Organizations
Journals, Articles
MedlinePlus Infection Control (National Library of Medicine)
http://www.nlm.nih.gov/medlineplus/infectioncontrol.html
26
Preventing Health Care–Associated Infections
27
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
28
Preventing Health Care–Associated Infections
29
Chapter 42. Targeting Health Care–Associated
Infections: Evidence-Based Strategies
Ruth M. Kleinpell, Cindy L. Munro, Karen K. Giuliano
Background
Hospitalization for an acute illness, trauma, chronic care, or other health care conditions is a
common occurrence. There were 39.2 million hospital discharges in 2005, with an average
length of stay of 4.6 days.1 Hospitalization brings associated risks, including risk of infection.
Nosocomial infections, or hospital-associated infections, are estimated to occur in 5 percent of
all acute care hospitalizations, or 2 million cases per year.2 Hospital-associated infections have
been identified as one of the most serious patient safety issues in health care.3
Infections that become clinically evident after 48 hours of hospitalization are considered
hospital-associated.2 Risks factors for hospital-associated infections are generally categorized
into three areas: iatrogenic, organizational, or patient-related. Iatrogenic risk factors include
invasive procedures (e.g., intubation, indwelling vascular lines, urine catheterization) and
antibiotic use and prophylaxis. Organizational risk factors include such things as contaminated
air-conditioning systems, contaminated water systems, staffing (e.g., nurse-to-patient ratio), and
physical layout of the facility (e.g., open beds close together). Examples of patient-related risk
factors include severity of illness, immunosuppression, and length of stay.2
Nosocomial infections more than double the mortality and morbidity risk for hospitalized
patients, resulting in an estimated 20,000 deaths a year.2 Nosocomial infections increase the costs
of hospitalization in addition to increasing morbidity and mortality risk. A meta-analysis of 55
studies examining nosocomial infections and infection control interventions determined that
attributable costs are significant; costs associated with bloodstream infections (mean = $38,703)
and methicillin-resistant Staphylococcus aureus infections (mean = $35,367) are the largest.3
Most infections in hospitalized patients are endogenous, meaning they are caused by bacteria
that have already colonized the patient’s digestive tract prior to infection.4 The majority (60
percent) of infections in patients hospitalized in an intensive care unit (ICU) setting are caused
by bacteria already colonizing the patient on admission (primary endogenous). A lesser amount
(23 percent) of infections result from bacteria acquired during the ICU stay, leading to
colonization before infection (secondary endogenous). A total of seventeen percent of infections
are caused by bacteria introduced from the ICU environment that lead to infection without prior
colonization (exogenous). Targeting hospital-associated infections is, therefore, a very important
aspect of providing quality health care.
This chapter reviews the evidence-based knowledge on health care–associated infections,
highlighting important information for nurses caring for hospitalized patients. The review
focuses on hospital-associated pneumonia, urinary tract infection, catheter-related bloodstream
infection, sepsis, and antibiotic-resistant infection. An evaluation of the literature, including
recent research, and evidence-based practices are presented.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Hospital-Associated Pneumonia
Pneumonia is the second most common hospital-associated infection (after urinary tract
infection).5 In critically ill patients, ventilator-associated pneumonia (VAP) is the most common
nosocomial infection. VAP doubles the risk of death, significantly increases ICU length of stay,
and adds more than $10,000 to each affected patient’s hospital costs.6
The current evidence-based recommendations by the Centers for Disease Control and
Prevention (CDC) for prevention of nosocomial pneumonia were published in 2004.5 Although
some of the interventions to reduce nosocomial pneumonia are the responsibility of physicians or
other health care workers, many of the interventions are the direct responsibility of nurses or can
be influenced by nurses. Nursing care can directly contribute to prevention of hospital-associated
pneumonia, particularly in patients who are most at risk due to advanced age, postoperative
status, or mechanical ventilation. The evidence shows that the most important contributions of
nursing care to prevention of hospital-associated pneumonia are in four areas: hand hygiene,
respiratory care, patient positioning, and education of staff.
Hand Hygiene
Hand hygiene is an essential component of hospital-associated pneumonia reduction.
Evidence-based guidelines have been published for general hand hygiene7, 8 as well as specific
hand hygiene measures related to respiratory care.6
Excellent evidence exists that alcohol hand rubs effectively reduce the transmission of
potential pathogens from health care workers’ hands to patients. For hands that are not visibly
soiled, alcohol hand rubs are more effective than hand washing with plain or antimicrobial
soap.8, 9 In the health care setting, the preferred method for cleaning visibly soiled hands is
washing with water and antimicrobial soap. Gloves should be worn for handling respiratory
secretions or any objects contaminated with respiratory secretions.5 If soiling from respiratory
secretions is anticipated, a gown should also be worn. Hand decontamination and glove changes
are required between contacts with different patients, as well as in an encounter with a single
patient between contacts with a contaminated body site and the respiratory tract or respiratory
equipment.
Respiratory Care
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Targeting Health Care–Associated Infections
Chumillas and colleagues12 randomized subjects who had upper abdominal surgery to a
breathing exercise program or to no breathing exercise. Postoperative pulmonary complications
were reduced in the deep-breathing group (7.5 percent versus 19.5 percent in the control group),
and the deep-breathing group had fewer postoperative chest radiograph abnormalities (P = 0.01).
In a study of 456 abdominal surgery patients, Hall and colleagues13 found that deep-breathing
exercises for low-risk patients, and incentive spirometry plus physiotherapy for high-risk
patients, was as effective for prevention of postoperative pulmonary complications as incentive
spirometry.
Deep breathing also appears to be effective after coronary artery bypass graft (CABG)
surgery. Westerdahl and colleagues14 randomly assigned subjects for the first 4 postoperative
days to hourly deep-breathing exercises during the daytime (n = 48) or to no breathing exercises
(n = 42). Compared to the control group, the deep-breathing group had smaller atelectasis on
spiral CT scan (P = 0.045 at the basal level and P = 0.01 at the apical level) and significantly
smaller postoperative reduction in lung function (forced vital capacity [FVC], P = 0.01; forced
expiratory volume [FEV1], P = 0.01). In contrast, a randomized study of 56 abdominal surgery
patients at high risk for postoperative pulmonary complications demonstrated beneficial results
of early postoperative mobilization; however, the study produced no statistically significant
difference in outcomes when deep breathing and coughing interventions were added to the early
mobilization.15 Based on current evidence, CDC guidelines encourage deep breathing for all
postoperative patients and use of incentive spirometry on postoperative patients who are at high
risk for pneumonia.5
The earliest CDC guidelines addressing nosocomial pneumonia, published in 1981, placed
great emphasis on standardization of practices related to care of respiratory equipment, and this
area has been a continued focus in subsequent reports. Recommendations related to procedures
for cleaning, sterilizing or disinfecting, and maintaining respiratory equipment now have a strong
evidence base, and those recommended procedures are presented in detail in the current CDC
report.5 Compliance with those procedures is primarily the responsibility of respiratory therapy,
but it requires the cooperation and support of nurses. Many unresolved issues remain regarding
optimal procedures for respiratory tract secretion suctioning, including whether sterile or clean
gloves should be used when performing endotracheal suctioning, and whether multiuse closed-
system suction catheters or single-use open-system suction catheters are more effective in
prevention of pneumonia.
Patient Positioning
Elevation of the head of the bed is believed to reduce the risk of gastroesophageal reflux and
aspiration of gastric secretions, and thus to reduce risk of hospital-associated pneumonia. Supine
position is an independent risk factor for mortality in mechanically ventilated patients16, 17 and in
all ICU patients.18 Torres and coworkers19 conducted a randomized crossover study of the effect
of semirecumbent versus supine position in 19 critically ill mechanically ventilated adults. After
radiolabeling gastric contents, the researchers found higher radioactive counts in endobronchial
aspirates when subjects were in a supine position than when in a semirecumbent position (P =
0.036). In a similar design, Orozco-Levi and coworkers20 introduced radio label through
nasogastric tubes in 15 mechanically ventilated subjects and obtained radioactive counts in
pharyngeal and endobronchial secretions over a 5-hour period in supine and semirecumbent
positions. Bronchial radioactive counts were higher at 5 hours in a supine position compared
with baseline (P < 0.05) and semirecumbency (P < 0.01); importantly, significant reflux
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
occurred by 5 hours even with semirecumbent positioning. These studies support a relationship
between head-of-bed position and aspiration of gastric secretions.
Two clinical trials have examined the effect of head-of-bed position on VAP. Prior to the
publication of the 2004 CDC guidelines, Drakulovic and coworkers21 conducted a randomized
clinical trial assigning 86 mechanically ventilated ICU subjects to semirecumbent (45 degree) or
supine (0 degrees) positions, with position documented once daily. The trial was stopped early
because significant findings at an interim analysis showed that the semirecumbent group had
lower frequency of clinically suspected pneumonia (P = 0.003) and microbiologically confirmed
pneumonia (P = 0.018) than the supine group. Both supine body position (P = 0.006) and enteral
nutrition (P = 0.013) were identified as independent risk factors for nosocomial pneumonia. A
second, larger multicenter trial by van Nieuwenhoven and colleagues22 was published in 2006.
Mechanically ventilated ICU patients were prospectively randomly assigned to a semirecumbent
position (45 degrees, n = 109) or standard care (10 degrees, n = 112). Because backrest elevation
was continuously electronically monitored during the first week of mechanical ventilation, the
researchers were able to document that subjects assigned to 45-degree elevation achieved the
target position only 15 percent of the study time, despite intensive efforts to ensure provider
compliance. Average elevations (28 degrees in the group assigned to 45-degree elevation, and 10
degrees in the standard-care group) were significantly different between groups (P < 0.001), but
differences in VAP were not demonstrated.
These two clinical trials of the effect of head-of-bed elevation on VAP differed in several
ways that may have affected study outcomes. Important differences existed in the comparison
groups, with Draculovic and colleagues assigning subjects to 0 degree elevation, while the
subjects assigned to usual care in the van Nieuwenhoven study had an average elevation of 10
degrees. The nosocomial pneumonia rate in the van Nieuwenhoven standard-care group was 6.5
percent, much lower than the 23 percent reported for the Draculovic control group (23 percent).
While current evidence and practice guidelines support the elevation of the head of bed to reduce
pneumonia risk, additional research is needed to further determine the optimal level for head-of-
bed elevation.
Grap and colleagues23 examined the relationship of backrest elevation to VAP in a
descriptive study of 66 subjects over a total of 276 patient days. Backrest elevation was
continuously monitored. Mean backrest elevation for the entire study period was 21.7 degrees,
but backrest elevations were less than 30 degrees 72 percent of the time, and less than 10 degrees
39 percent of the time. In a statistical model predicting pneumonia risk on study day 4, 81
percent of the variability (F = 7.31, P = 0.003) was accounted for by the pneumonia score on
study day 1, severity of illness, and percentage of time spent at less than 30 degrees in the first
24 hours. Thus, early initiation of elevated backrest may influence outcomes in patients who are
at highest risk.
Elevation of the head of the bed for patients at risk is a simple and inexpensive intervention
that has the potential to decrease nosocomial pneumonia. Adverse effects of elevating the head
of the bed have not been demonstrated in patients who do not have a medical contraindication.
However, most evidence suggests that this intervention is not widely used. The effectiveness of
turning or lateral rotation remains an unresolved issue. Additional research is needed to identify
optimal or sufficient head-of-bed elevation to prevent nosocomial pneumonia, to determine the
effects of turning, and to address barriers to implementation of optimal patient positioning.
The Institute for Healthcare Improvement (IHI) outlines a ventilator bundle, or care
strategies, to target VAP. A “bundle” is a group of interventions that when implemented
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Targeting Health Care–Associated Infections
together, produce better outcomes than when implemented individually.24 The ventilator bundle
incorporates evidence-based interventions aimed at reducing VAP incidence, including head-of-
bed elevation greater than 20 degrees, assessment of the need for continued mechanical
ventilation, and prophylaxis for stress ulcer disease and deep vein thrombosis.25
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
pneumonia that are appropriate to the worker’s level of responsibility. Table 1 outlines evidence-
based guidelines for hospital-associated pneumonia prevention and management, including
nursing-based care.
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Targeting Health Care–Associated Infections
catheter dislodgement, obstruction, and failed introduction—can occur. The review could not
substantiate the overall benefit of routine suprapubic catheterization.38
Antimicrobial Catheters
A variety of specialized urethral catheters have been designed to reduce the risk of catheter-
associated UTI. These include antiseptic-impregnated catheters and catheters coated with silver
alloy or nitrofurazone.36, 41 A Cochrane systematic review has examined 18 clinical trials to
assess the different types of urethral catheters for the management of short-term catheter use in
hospitalized patients.36 Silver oxide catheters were not associated with a statistically significant
reduction in bacteriuria, but the confidence intervals were wide (RR = 0.89, 95 percent CI =
0.68–1.15). Silver alloy catheters were found to significantly reduce the incidence of bacteriuria
(RR = 0.36, 95 percent CI = 0.24–0.52). The results of the review indicated advantages from
silver alloy catheters, including an economic benefit compared to standard catheter use. A
previous review of four clinical trials studies assessing silver alloy catheters also substantiated a
significant reduction in the development of catheter-associated bacteriuria.38
Another systematic review of antimicrobial urinary catheters in the prevention of catheter-
associated UTI in hospitalized patients analyzed 12 clinical trials of nitrofurazone-coated or
silver alloy-coated urinary catheters. Both nitrofurazone-coated and silver alloy-coated catheters
reduced the development of bacteriuria in comparison with latex or silicone control catheters.41
However data on comparative efficacy is lacking as no trial directly compared nitrofurazone-
coated and silver alloy-coated catheters. While evidence exists to support the use of
antimicrobial urinary catheters in preventing bacteriuria in hospitalized patients during short-
term catheterization, estimates on cost-effectiveness have not been established.41 Additional
strategies for preventing catheter-associated UTI—including hand-held bladder scanners,
computerized order/entry system prompts, and education on appropriate use of indwelling
urinary catheter—have also proved beneficial.43
Table 2 outlines evidence-based strategies for UTI prevention. Nursing-related care aspects
include thorough assessment to determine need for indwelling catheter use, aseptic insertion
technique, indwelling catheter care to minimize infection risk, and astute monitoring of patients
with urinary catheters for signs of UTI. All of these are important measures to decrease the risk
of catheter-associated UTI.
Central venous catheters (CVCs) are frequently used in hospitalized patients and they carry
associated risks, the most common being bloodstream infection (BSI). According to the CDC, up
to 250,000 hospital-associated catheter-related bloodstream infections (CR-BSIs) occur annually
in U.S. hospitals, with approximately 80,000 of these occurring in ICUs.44 CVCs of all types are
the most frequent cause of nosocomial BSIs.45
A CR-BSI is defined as the presence of bacteremia in a patient with an intravascular catheter
with at least one positive blood culture and clinical signs of infections (i.e., fever, chills, and/or
hypotension), with no apparent source for the BSI except the catheter. Specific criteria for CR-
BSI include either a positive culture with the same organism isolated from the catheter and
peripheral blood, simultaneous blood cultures with a > 5:1 ratio of catheter versus peripheral
culture, or a differential period of catheter culture versus peripheral blood culture positivity of >
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
2 hours.46 A BSI is considered to be associated with a central line if the line was in place during
the 48-hour period before development of the BSI.46 Although CVSs account for only a small
percentage of all intravenous lines, they cause most CR-BSIs.47 The most common mechanism
of CVC-BSI is migration of the organism from the insertion site along the surface of the catheter
and colonization of its distal part.48 CR-BSIs can also occur from contamination of the catheter
hub or infusate administered through the device.45
Several practices have been evaluated in an attempt to reduce the incidence of CVC-BSI.
These include the use of antimicrobial catheters, antimicrobial-impregnated dressings, and
interventions related to catheter insertion and maintenance.
CVC-BSIs often result from contamination of the catheter during insertion.52 Maximum
sterile barrier precautions during insertion are indicated to reduce the incidence of CVC-BSI.
Effective barrier precautions include the use of sterile gloves, long-sleeved gowns, full-size
drape, masks, and head covers by all personnel involved in the central line insertion procedure.52
In addition to maximal barrier precautions during insertions, the 2002 CDC guidelines for the
prevention of CVC infections outline other evidence-based practices, including the following:53
1. Use of a 2-percent chlorhexidine preparation as the preferred skin antiseptic prior to
insertion
2. Education and training of staff who insert and maintain intravenous lines
3. No routine replacement of central lines at scheduled intervals
Additional measures advocated for best practices for CVC care include hand hygiene by
washing hands with conventional antiseptic-containing soap and water or with waterless alcohol-
based gels or foam before and after palpating insertion sites; and before and after insertion,
replacing, accessing, or dressing a CVC.53 Avoidance of antibiotic ointment at insertion sites,
which can promote fungal infections and antibiotic resistance, and restricted use of stopcocks on
any tubing other than pressure tubing to minimize contamination are also recommended.53 Either
sterile gauze or transparent, semipermeable dressings can be used, as research has demonstrated
similar risks of CVC-BSI.53 Gauze dressings should be replaced every 2 days and transparent
dressings every 7 days or when the dressing becomes damp, loose, or soiled.53, 54
The IHI has also published a central line bundle to reduce CVC-BSI.55 The components of
the central line bundle include hand hygiene to prevent contamination of central lines, maximal
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Targeting Health Care–Associated Infections
barrier precautions and CHG antisepsis for central line insertion, optimal catheter site selection
with the subclavian vein as the preferred site for nontunneled catheters, and daily review of line
necessity with removal of unnecessary lines.55
Educational measures related to CVC insertion and maintenance have proven effective in
several studies.56–58 Focused aspects of education included proper insertion and maintenance, a
catheter insertion cart, a checklist to ensure adherence to evidence-based guidelines, and
empowering nurses to stop the catheter insertion procedure if a violation of guidelines is
observed. Table 3 outlines evidence-based strategies for CVC-BSI prevention. Nursing-related
care aspects include maximal barrier precaustings during CVC insertion; maintenance of central
line site to minimize infection risk; prevention of contamination of CVC ports during blood
sampling, infusion of intravenous fluids, or medication administration; maintenance of sterile
technique for dressing changes; intravenous tubing changes based on protocol guidelines; and
astute monitoring of patients with central lines for signs of infection.
Sepsis
Sepsis, or clinical manifestation of the systemic response to infection, represents a significant
condition that results in increased mortality for hospitalized patients. The incidence of sepsis is
increasing, with more than 750,000 cases occurring in the United States each year.59 Severe
sepsis, which occurs when sepsis progresses to involve acute organ dysfunction, results in more
than 200,000 annual fatalities, and the number of cases are projected to increase.59
Epidemiological studies indicate that between 11 percent and 27 percent of ICU admissions have
severe sepsis, with mortality rates ranging from 20 percent to more than 50 percent.59–62 As
infections can progress to sepsis, heightened monitoring of hospitalized patients for signs of
sepsis are indicated for any patient with a suspected or confirmed infection. Focal areas pertinent
to sepsis include monitoring, treatment, and prevention.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Treatment of Sepsis
The Surviving Sepsis Campaign evidence-based guidelines for the treatment of sepsis were
released in 2004 and have been promoted to improve outcomes for patients with severe
sepsis.24, 68 The guidelines outline recommendations for targeting treatment of patients at risk of
developing severe sepsis and septic shock. The guideline recommendations are aimed at
providing resuscitation for sepsis-induced hypoperfusion and enhancing perfusion, antibiotic
administration to combat infection, cultures to identify the source of infection, mechanical
ventilation to optimize oxygenation, and source control to contain the infection. Additional
treatment practices include glycemic control, steroid administration for adrenal insufficiency,
prophylaxis measures for deep vein thrombosis and stress ulcer prevention, renal replacement
therapies, administration of recombinant human activated protein C (rhAPC), blood product
administration, sedation and analgesia, and consideration for limitation of support in critically ill
patients.68 These evidence-based guidelines are outlined in Table 4.
Bundles are also established for recognition and treatment of severe sepsis. The severe sepsis
bundles are categorized into 6- and 24-hour bundles. The 6-hour bundle outlines the following
interventions, which should be implemented immediately and within the first 6 hours of
identification of severe sepsis:
1. Measure serum lactate.
2. Obtain blood cultures prior to antibiotics.
3. Administer broad-spectrum antibiotics within 3 hours from time of presentation in the
emergency room and 1 hour for nonemergency room ICU admissions.
4. For hypotension and/or lactate > 4 mmol/L,
a. Administer an initial minimum of 20 ml/kg of crystalloid (or colloid equivalent).
b. Administer vasopressor for hypotension not responding to initial fluid resuscitation to
maintain mean arterial pressure > 65 mm Hg.
5. With persistent hypotension despite fluid resuscitation and/or lactate > 4 mmol/L,
a. Achieve a central venous pressure (CVP) > 8 mm Hg.
b. Achieve a central venous oxygen saturation (SCVO2) of > 70 percent.
The 24-hour bundle outlines the following interventions, which should be implemented
immediately and within the first 24 hours of identification of severe sepsis:
1. Administer low-dose steroids for septic shock based on a standardized ICU policy.
2. Administer drotrecogin alfa (activated) based on a standardized ICU policy.
3. Maintain glucose control > lower limit of normal, but < 150 mg/dL.
4. Maintain inspiratory plateau pressures < 30 mm H20 for mechanically ventilated patients.
Implementation of the Surviving Sepsis Campaign guidelines, including the sepsis bundles,
can favorably influence the course of sepsis. Additional focused approaches to the management
of sepsis include early rapid-resuscitation shock protocols,69 comprehensive interdisciplinary
sepsis treatment protocols,70 and algorithm-based or goal-directed care.71
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Prevention of Sepsis
Nursing-related implications for early detection and treatment of sepsis include assessing
patients for signs of infection, obtaining cultures for suspected infection, providing medical
treatments for sepsis, and infection-prevention measures.72 Awareness of the risk factors, clinical
signs and symptoms, pathophysiology, and updates in the management of sepsis can enhance the
nursing care for patients with severe sepsis and promote best practices for sepsis care in the ICU.
Infection-prevention measures for sepsis include general infection control practices, hand-
washing principles, and measures to prevent nosocomial infections (oral care and proper
positioning to prevent nosocomial pneumonia, care of invasive catheters, skin care, wound care,
identifying patients at risk for infection, prioritizing cultures for patients with suspected
infection, and providing astute clinical assessment for early detection of sepsis).73 Table 5
outlines general infection-prevention measures, highlighting nursing care considerations. A
Cochrane systematic review is currently underway to assess the impact of the use of preoperative
bathing or showering with skin antiseptics in reducing surgical-site infections.74 Keeping up to
date with evidence-based and research practices aimed at preventing health care–associated
infections is an additional essential aspect of nursing care.
Antibiotic-Resistant Infections
Both the CDC and the World Health Organization have identified antibiotic resistance as an
important public health concern.75 The emergence of antimicrobial resistance in hospitals has
been attributed to antibiotic use patterns as well as the capability of bacterial strains to develop
resistance mechanisms through genetic alterations.76 It is estimated that up to 50 percent of
antibiotic use in hospitals is inappropriate.77 According to the CDC, more than 70 percent of the
bacteria that cause hospital-associated infections are resistant to at least one of the drugs most
commonly used to treat them.78
When compared to infections caused by susceptible bacteria, infections caused by multidrug-
resistant bacteria are associated with higher incidences of mortality, morbidity, and increased
hospital length of stay.77 Hospitalized patients who contract an infection with an antibiotic-
resistant organism also have more costly management and therapies, and encounter more
medical complications, than patients who do not acquire an infection or become infected with
sensitive organisms.79–80
Data from many sources, including the CDC, indicate that antibiotic resistance to all the
commonly used drug classes is increasing.79 For example, between 1998 and 2003, the following
increases in resistant organisms have occurred in critically ill patients: 11 percent increase in
methicillin-resistant Staphylococcus aureus (MRSA); 12 percent increase in vancomycin-
resistant enterococi (VRE); 47 percent increase in 3rd generation cephalosporin-resistant
Kliebsiella pneumoniae; and a 20 percent increase in 3rd generation cephalosporin-resistant
Pseudomonas aeruginosa.81 An additional nosocomial infection that has been linked to antibiotic
use in the hospital setting is Clostridium difficile (C. difficile). Although C. difficile is not an
antibiotic-resistant infection, increased incidences in hospitalized settings have heightened
awarenes.82
Because of the widespread increases in resistant organisms with the concomitant difficulties
associated with treatment and complications, addressing the issue of resistant organisms has
become one of the CDC’s major concerns. Several main areas of focus for the prevention of
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
antibiotic-resistant infections include control of antibiotic use, determining the right antibiotic,
and control of patient-to-patient spread.
Antibiotics are effective in treating infections because they kill or inhibit the growth of
susceptible bacteria; however, they are not effective against viral infections. In an ever-
increasing number of instances, one of more of the bacteria causing the infection are able to
survive. Those bacteria are then able to multiply and begin to proliferate a new strain of bacteria
that have developed the inherent ability to survive in the presence of the antibiotics that are
designed to eradicate them. The more exposure bacteria have to various antibiotics, the more
likely it is that resistant organisms develop.
According to the CDC, the biggest contribution to the development and continuing increase
in resistant organisms is the overuse of antibiotics. Therefore, decreasing inappropriate antibiotic
administration is the best way to control resistance. In 1995, the CDC83 launched a national
campaign to reduce antimicrobial resistance. The two major goals of this campaign are (1) to
reduce inappropriate antibiotic use, and (2) to reduce the spread of resistance to antibiotics.
Following are the three major CDC recommendations for supporting and achieving these goals:
• Prescribe antibiotic therapy only when it is likely to be beneficial.
• Use an agent that targets the likely pathogens.
• Order the antibiotic for the appropriate dose and duration.
To effectively reduce antimicrobial resistance, prescribing health care providers must keep
themselves informed about the most common infectious organisms present in the patient
populations that they treat. For example, both VAP and hospital-associated pneumonia due to
MRSA are becoming more common, and treatment strategies have emerged. Data compiled by
an expert panel of the American Thoracic Society26 support the following recommendations:
1. Apply early, appropriate, broad-spectrum antibiotic therapy at adequate doses; avoid
excessive antibiotics through appropriate antibiotic deescalation.
2. Empiric regimens should include agents from a different antibiotic class than the patient
has recently received.
3. Combination therapy should be used judiciously.
4. Linezolid may be an appropriate alternative to vancomycin.
5. Shorten antibiotic duration to the minimum effective period, and use short-course therapy
whenever possible.
6. Use local microbiologic data to adapt treatment recommendations to the clinical setting.
Research has demonstrated the benefit of focused interventions aimed at improving antibiotic
prescribing practices for hospital patients. A Cochrane systematic review of 66 studies revealed
that interventions to improve antibiotic prescribing, dosing, timing of first dose, and duration of
treatment are successful in reducing antimicrobial resistance.77 Specific interventions included
distribution of educational materials; reminders provided verbally, on paper, or by computer;
formulary restrictions; therapeutic substitutions; automatic stop orders; antibiotic policy change
strategies, including cycling, rotation, and crossover studies; computerized order entry; and Web-
based antimicrobial approval systems.77, 84 Other strategies, such as selective decontamination of
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Targeting Health Care–Associated Infections
the digestive tract and use of CHG for daily bathing of hospitalized patients, have demonstrated
efficacy in single-site controlled trials, but require further study.4, 85
Controlling the patient-to-patient spread of bacteria is one of the least expensive, most basic,
and effective means for controlling the spread of resistant organisms. Both MRSA and VRE, two
of the most troublesome resistant organisms, are spread primarily from person-to-person contact.
In hospitalized patients, this includes transmission by the hands of a health care provider caring
for an infected patient. Diligent hand washing is therefore of the utmost importance, and nurses
can have a major influence. Both MRSA and VRE can also survive on equipment and surfaces,
such as floors, sinks, and blood pressure cuffs.
Specific CDC recommendations to prevent the spread of antimicrobial-resistant infections in
hospitalized patients are outlined in Table 6. Focused measures include monitoring antimicrobial
resistance of both community and nosocomial isolates on a regular basis, monitoring use of
antimicrobials, increasing clinical staff awareness, and use of the CDC’s guidelines for isolation
precautions in hospitals.76, 78 Preventative nursing care measures are essential in minimizing
infection risk for hospitalized patients. Table 5 outlines additional essentials of infection-
prevention measures for reducing the risk of health care associated infection among hospitalized
patients.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Research Implications
Given the gaps in the current evidence base, additional research is needed in the following
areas:
1. Continuous aspiration of subglottic secretions for VAP prevention
2. Semirecumbent position for VAP prevention
3. Silver alloy-coated catheters to prevent hospital-associated UTI
4. Suprapubic catheters to prevent hospital-associated UTI
5. Strategies to ensure use of full barrier precautions (gowns and gloves, dedicated
equipment, dedicated personnel) during central line insertion
6. Tunneling short-term CVCs to decrease central line infections
7. Antibiotic limitations on hospital-associated infections due to antibiotic-resistant
organisms
8. Strategies to promote appropriate antibiotic administration in hospitals, including the
use of informatics technology (e.g., computer-assisted decision support) to assist in
point-of-care prescribing and patient-outcome monitoring
9. Source control measures such as chlorhexidine gluconate for bathing, oral care
protocols, and selective decontamination of the digestive tract
10. Strategies to improve hand-washing compliance (education/behavior change, sink
technology and placement) to reduce hospital-associated infections
Conclusion
A number of factors can lead to the development of health care–associated infections in the
hospital setting, including increasing patient acuity levels, chronically ill and acutely ill patients
who harbor antibiotic-resistant bacteria, and frequent use of broad-spectrum antibiotics. Health
care–associated infections can significantly impact patient outcomes, including morbidity and
mortality rates, length of hospital stay, and costs of care. Therefore, focusing on health care–
associated infections is an important aspect of providing quality health care.
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Targeting Health Care–Associated Infections
Author Affiliations
Ruth M. Kleinpell, Ph.D., R.N., F.A.A.N., professor, Rush University College of Nursing,
Chicago, Illinois. E-mail: [email protected].
Cindy L. Munro, R.N., A.N.P., Ph.D., F.A.A.N., professor, Virginia Commonwealth
University School of Nursing. E-mail: [email protected].
Karen K. Giuliano, R.N., Ph.D., F.A.A.N., clinical nurse specialist, Philips Medical Systems,
Andover, Massachusetts. E-mail: [email protected].
References
1. Levit K, Ryan K, Elixhauser A, et al. HCUP facts and 7. Healthcare Infection Control Practices Advisory
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Infect Control 2002; 30(3):145-52. 2002;23:S3-40.
15
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
11. Overend TJ, Anderson CM, Lucy SD, et al. The effect 23. Grap MJ, Munro CL, Hummel RS III, et al. Effect of
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Arch Phys Med Rehabil 1998;79:5-9. Intensive Care Medicine, and the International Sepsis
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13. Hall JC, Tarala RA, Tapper J, et al. Prevention of
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http://www.ihi.org/NR/rdonlyres/A448DDB1-E2A4-
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15. Mackay MR, Ellis E, Johnston C. Randomised clinical ventilator-associated, and healthcare-associated
trial of physiotherapy after open abdominal surgery in pneumonia. Am J Respir Crit Care Med 2005;17:388-
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17. Kollef MH. Ventilator-associated pneumonia. A 28. Mori H, Hirasawa H, Oda S, et al. Oral care reduces
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18. Kollef MH. The identification of ICU-specific
outcome predictors: a comparison of medical, surgical, 29. Cutler CJ, Davis N. Improving oral care in patients
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19. Torres A, Serra-Batlles J, Ros E, et al. Pulmonary 30. Schleder BJ, Stott K, Lloyd RC. The effect of a
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Respir Crit Care Med 1995;152:1387-90. 32. Fourrier F, Cau-Pottier E, Boutigny H, et al. Effects of
dental plaque antiseptic decontamination on bacterial
21. Drakulovic MB, Torres A, Bauer TT, et al. Supine colonization and nosocomial infections in critically ill
body position as a risk factor for nosocomial patients. Intensive Care Med 2000;26:1239-47.
pneumonia in mechanically ventilated patients: A
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intensive care unit: state of the science. Am J Crit
22. van Nieuwenhoven CA, Vandenbroucke-Grauls C, Care 2004;13:25-33.
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semirecumbent position to prevent ventilator- 34. Won SP, Chou HC, Hsieh WS, et al. Handwashing
associated pneumonia: a randomized study. Critical program for the prevention of nosocomial infections in
Care Meicine 2006;34:396-402. a neonatal intensive care unit. Infect Control Hosp
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35. Zack JE, Garrison T, Trovillion E, et al. Effect of an 46. Centers for Disease Control. Guidelines for the
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ventilator-associated pneumonia. Crit Care Med 2002.
2002;30:2407-12. http://www.cdc.gov/ncidod/dhqp/gl_intravascular.htm
l. Accessed February 18, 2006.
36. Brosnahan J, Jull A, Tracy C. Types of urethral
catheters for management of short-term voiding 47. Todd B. Preventing bloodstream infection. Am J Nurs
problems in hospitalized adults (Cochrane Review). 2006;106(1):29-30.
The Cochrane Database Syst Rev 2007;1.
48. Levy I, Katz J, Solter E, et al. Chlorhexidine-
37. Niel-Weise BS, van den Broek PJ. Antibiotic policies impregnated dressing for prevention of colonization of
for short-term catheter bladder drainage in adults. The central venous catheters in infants and children: a
Cochrane Database Syst Rev 2005;3. randomized controlled study. Pediatr Infect Dis J
2005;24:676-9.
38. Saint S. Prevention of nosocomial urinary tract
infection. In: Shojania KG, Duncan BW, McDonald 49. Mermel LA. Prevention of intravascular catheter-
KM, et al., eds. Making health care safer: a critical related infections. Ann Intern Med 2000;132:391-402.
analysis of patient safety practices. Evidence
Report/Technology Assessment No. 42. (Prepared by 50. Rupp ME, Lisco SJ, Lipsett PA, et al. Effect of a
the University of California at San Francisco-Stanford second-generation venous catheter impregnated with
Evidence-based Practice Center under Contract No. chlorhexidine and silver sulfadiazine on central
290-97-0013), Rockville, MD: Agency for Healthcare catheter-related infections: a randomized, controlled
Research and Quality; 2001. p. 149-61. AHRQ trial. Ann Intern Med 2005;143:570-80.
Publication No. 01-E058.
51. Veenstra DL, Saint S, Saha S, et al. Efficacy of
39. Bagshaw SM, Laupland KB. Epidemiology of antiseptic-impregnated central venous catheters in
intensive care unit-acquired urinary tract infections. preventing catheter-related bloodstream infection: a
Curr Opin Infect Dis 2006;19:67-71. meta-analysis. JAMA 1999;281:261-7.
40. Trautner BW, Hull RA, Darouiche RO. Prevention of 52. Saint S. Prevention of intravascular catheter-
catheter-associated urinary tract infection. Current associated infections. In: Shojania KG, Duncan BW,
Opinion in Infectious Diseases 2005;18;37-41. McDonald KM, et al., eds. Making health care safer: a
critical analysis of patient safety practices. Evidence
41. Johnson JR, Kuskowski MA, Wilt TJ. Systematic Report/Technology Assessment No. 42. (Prepared by
review: antimicrobial urinary catheters to prevent the University of California at San Francisco-Stanford
catheter-associated urinary tract infection in Evidence-based Practice Center under Contract No.
hospitalized patients. Ann Intern Med 2006;144:116- 290-97-0013), Rockville, MD: Agency for Healthcare
26. Research and Quality; 2001. p. 163-83.
42. Wong ES. Guideline for prevention of catheter- 53. O’Grady NP, Alexander M, Dellinger EP, et al.
associated urinary tract infections. 2005. Centers for Disease control and Prevention (CDC)
http://www.cdc.gov/ncidod/dhqp/gl_catheter_assoc.ht Hospital Infection Control Practices Advisory
ml. Accessed March 1, 2006. Committee. MMWR 2002;vol. 2000;1(RR10):1-26.
43. Topol J, Conklin S, Camp K, et al. Prevention of 54. Newell-Stokes G, Broughton S, Giuliano K, et al.
nosocomial catheter-associated urinary tract infections Developing an evidence-based practice procedure:
through computerized feedback to physicians and a maintenance of central venous catheters. Clin Nurse
nurse-directed protocol. Am J Med Qual 2005;20:121- Spec 2001;15:199-206.
6.
55. Institute for Healthcare Improvement. Getting Started
44. O’Grady NP, Alexander M, Dellinger EP, et al. kit: prevent central line infections. 2006.
Guidelines for the prevention of intravascular catheter- http://www.ihi.org/NR/rdonlyres/BF4CC102-C564-
related infections. MMWR Recomm Rep 4436-AC3A-0C57B1202872/0/
2002;51(RR-10):1-29. CentralLinesHowtoGuideFINAL720.pdf. Accessed
March 11, 2006.
45. Safdar N, Fine JP, Maki DG. Meta-analysis: methods
for diagnosing intravascular device-related 56. Coopersmith CM, Zack JE, Ward MR, et al. The
bloodstream infection. Ann Intern Med 2005;142:451- impact of bedside behavior on catheter-related
66. bacteremia in the intensive care unit. Arch Surg Feb
2004;139(2):131-6.
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57. Coopersmith CM, Rebmann TL, Zack JE, et al. Effect 71. Kortgen A. Niederprum P, Maure M. Implementation
of an education program on decreasing catheter- of an evidence-based “standard operating procedure”
related bloodstream infections in the surgical intensive and outcome in septic shock. Crit Care Med
care unit. Crit Care Med 2002;30:59-64. 2006;34:943-9.
58. Berenholtz S, Pronovost PJ, Lipsett PA, et al. 72. Kleinpell RM. The role of the critical care nurse in the
Eliminating catheter-related bloodstream infections in assessment and management of the patient with severe
the intensive care unit. Crit Care Med 2004;32:2014- sepsis. Crit Care Nurs Clin North Am 2003;15:27-34.
20.
73. Kleinpell RM. Advances in treating patients with
59. Angus DC, Linde-Zwirble WT, Lidicker J, et al. severe sepsis. Crit Care Nurs 2003;23:1-13.
Epidemiology of severe sepsis in the United States:
analysis of incidence, outcome and associated costs of 74. Webster J, Osborne S. Pre-operative bathing or
care. Crit Care Med 2001;29:1303-10. showering with skin antiseptics to reduce surgical site
infection.Cochrane Database Syst Rev 2006 Apr
60. Flaatten H. Epidemiology of sepsis in Norway in 19;(2):CD004985.
1999. Crit Care 2004;8:R180-4.
75. Centers for Disease Control. Background on antibiotic
61. Silva E, de Almeida Pedro M, Sogayar AC, et al. resistance. http://www.cdc.gov/drugresistance/
Brazilian sepsis epidemiological study (BASES community. Accessed March 8, 2006.
study). Crit Care 2004;8:R251-R260.
76. Shales DM, Gerding DN, John JF, et al. Society for
62. van Gestel A, Bakker J, Veraart CP, van Hout BA. healthcare epidemiology of the American and
Prevalence and incidence of severe sepsis in Dutch infectious disease society of American joint committee
intensive care units. Crit Care 2004, 8:R153-62. on prevention of antimicrobial resistence: guidelines
for prevention of antimicrobial resistance in hospitals.
63. Balk RA. Pathogenesis and management of multiple Infect Control Hosp Epidemiol 1997;18:275-91.
organ dysfunction or failure in severe sepsis and septic
shock. Crit Care Clin 2000;16;337-52. 77. Davey P, Brown E, Fenelon L, et al. Interventions to
improve antibiotic prescribing practices for hospital
64. Weycker D, Akhras KS, Edelsberg J, et al. Long-term inpatients. Cochrane Database of Syst Rev
mortality and medical care charges in patients with 2005;(4):CD003543.
severe sepsis. Crit Care Med 2003;31:2316-23.
78. Centers for Disease Control. Antimicrobial resistence
65. Wheeler AP, Bernard GR. Treating patients with in healthcare settings. 2005.
severe sepsis. N Engl J Med 1999;340:207-14. http://www.cdc.gov/ncidod/dhqp/ar.html. Accessed
February 20, 2006.
66. Angus DC, Wax RS. Epidemiology of sepsis: an
update. Crit Care Med 2001;29:S109-16. 79. Neiderman MS. Impact of antibiotic resistance on
clinical outcomes and the cost of care. Crit Care Med
67. Rivers E, Nguyen B, Havstad S, et al. Early goal- 2001;29, supplement: N114-20.
directed therapy in the treatment of severe sepsis and
septic shock. N Engl J Med 2001;345:1368-77. 80. Farr, BM, Salgado, CD, Karchmer, TB, et al. Can
antibiotic resistant nocomomial infections be
68. Dellinger RP, Carlet JM, Masur H, et al. Surviving controlled? Lancet 2001;1:38-45.
sepsis campaign guidelines for management of severe
sepsis and septic shock. Crit Care Med 2004;32:858- 81. Centers for Disease Control. National Nosocomial
72. Infections Surveillance System (NNIS) report, data
summary from January 1992 through June, 2004,
69. Sebat F, Johnson D, Musthafa AA, et al. A issued October, 2004. Am J Infect Control
multidisciplinary community hospital program for 2004;32(6):470-85.
early and rapid resuscitation of shock in nontrauma
patients. Chest 2005;127;1729-43. 82. Centers for Disease Control. Department of Health
and Human Services, Center for Disease Control and
70. Shapiro N, Howell MD, Talmor D, et al. Prevention, National Center for Infectious Diseases
Implementation and outcomes of the multiple urgent Hospital Infections Program.
sepsis therapies (MUST) protocol. Crit Care Med http://wonder.cdc.gov/wonder/prevguid/p0000107/p00
2006;34:1025-32. 00107.asp#head002000000000000. Accessed
February 26, 2006.
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Targeting Health Care–Associated Infections
83. Centers for Disease Control. A public health plan to on broad-spectrum cephalosporin use at a teaching
combat antimicrobial resistance. hospital. Med J Aust 2003;178(8):386-90.
http://www.cdc.gov/drugresistance/actionplan/html/int
ro.htm. 2006. Accessed February 10, 2006. 85. Vernon MO, Hayden MK, Trick WE, et al
Chlorhexidine gluconate to cleanse patients in a
84. Richards MJ, Robertson MB, Dartnell JG, et al. medical intensive care unit. Arch Intern Med
Impact of a web-based antimicrobial approval system 2006;166:306-12.
19
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Sources: Adapted from Institute for Healthcare Improvement. Getting Started Kit: Prevent Ventilator Associated Pneumonia,
2006, http://www.ihi.org/NR/rdonlyres/A448DDB1-E2A4-4D13-8F02-16417EC52990/0/VAPHowtoGuideFINAL.pdf (accessed
March 11, 2006); and the American Association of Critical Care Nurses practice alert: Ventilator-Associated Pneumonia,
http://www.aacn.org (accessed March 5, 2006).
• Indwelling urinary catheters should be inserted using aseptic technique and sterile equipment.
• Only hospital personnel who know the correct technique of aseptic insertion and maintenance of the catheter
should handle catheters.
• Hospital personnel should be provided with periodic in-service training stressing the correct techniques and
potential complications of urinary catheterization.
• Indwelling urinary catheters should be inserted only when necessary and left in place only for as long as
necessary.
• Other methods of urinary drainage such as condom catheter drainage, suprapubic catheterization, and
intermittent urethral catheterization should be considered as alternatives to indwelling urethral catheterization.
• Hand washing should be done immediately before and after any manipulation of the indwelling urinary catheter
site or apparatus.
• Indwelling catheters should be properly secured after insertion to prevent movement and urethral traction.
• A sterile, continuously closed drainage system should be maintained.
• The catheter and drainage tube should not be disconnected unless the catheter must be irrigated, and irrigation
should be used only for suspected obstruction.
• If breaks in aseptic technique, disconnection, or leakage occur, the collecting system should be replaced using
aseptic technique after disinfecting the catheter-tubing junction.
• Specimen collections should be obtained from the distal end of the catheter, preferably from the sampling port
after cleansing with a disinfectant and then the urine specimen aspirated with a sterile needle and syringe.
• Consider the use of antimicrobial catheters for indwelling urinary catheters.
Source: Adapted from Wong ES, Guideline for Prevention of Catheter-Associated Urinary Tract Infections.
http://www.cdc.gov/ncidod/dhqp/gl_catheter_assoc.html.
20
Targeting Health Care–Associated Infections
• Education and training should be provided for staff who insert and maintain intravenous lines.
• Maximal sterile barriers should be used during catheter insertion (cap, mask, sterile gown and gloves,
and a large sterile drape).
• A 2% chlorhexidine preparation is the preferred skin antiseptic, to be applied prior to insertion.
• Antiseptic- or antibiotic-impregnated catheters should be reserved for very high-risk patients or
situations in which catheter-related BSI rates are high despite careful attention to these
recommendations.
• Replace peripheral intravenous sites in the adult patient population at least every 96 hours but no
more frequently than every 72 hours. Peripheral venous catheters in children should be left in until the
intravenous therapy is completed, unless complications such as phlebitis or infiltration occur.
• Replace intravenous tubing at least every 96 hours but no more frequently than every 72 hours.
• Replace intravenous catheters as soon as possible when adherence to aseptic technique during
catheter insertion cannot be ensured (i.e., prehospital, code situation).
• Central lines should not routinely be replaced at scheduled intervals.
• Consider use of a central line insertion checklist to ensure all processes related to central line insertion
are executed for each line placement.
• Consider use of a central line insertion cart to avoid the difficulty of finding necessary equipment to
institute maximal barrier precautions.
• Replace central line dressings whenever damp, loose, or soiled or at a frequency of every 2 days for
gauze dressings and every 7 days for transparent dressings.
• Avoid use of antibiotic ointment at insertion sites because it can promote fungal infections and
antibiotic resistance.
• Include daily review of line necessity.
• Assess competency of staff who insert and care for intravascular catheters.
Sources: Adapted from: O’Grady NP, et al., Guidelines for the Prevention of Intravascular Catheter-Related Infections, Centers
for Disease Control and Prevention, MMWR Recomm Rep 2002;51(RR-10):1–29; Institute for Healthcare Improvement, Getting
Started Kit: Prevent Central Line Infections, 2006, available at: http://www.ihi.org/NR/rdonlyres/BF4CC102-C564-4436-AC3A-
0C57B1202872/0/CentralLinesHowtoGuideFINAL720.pdf (accessed March 11, 2006); and American Association of Critical
Care Nurses practice alert: Preventing Catheter-Related Bloodstream Infections, www.aacn.org (accessed March 5, 2006).
The Surviving Sepsis Campaign guidelines outline evidence-based recommendations for targeting
treatment of patients at risk of developing severe sepsis and septic shock.
The following grading system was used to classify the treatment recommendations:
A. Supported by at least two level I investigations (large, randomized trials with confident results)
B. Supported by one level I investigation
C. Supported by level II investigations only (small, randomized trials with uncertain results)
D. Supported by at least one level III investigation (nonrandomized study)
E. Supported by level IV (nonrandomized, historical controls, and expert opinion) or level V evidence
(case series, uncontrolled studies, and expert opinion)
21
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
b. Diagnosis
• Obtain cultures: at least two blood cultures with one drawn percutaneously and one drawn through
each vascular access device; cultures of other sites such as urine, wounds, respiratory secretions
should be obtained before antibiotic therapy is initiated—grade D
• Diagnostic studies (e.g., ultrasound, imaging studies)—grade E
c. Antibiotic therapy
• Empirical antibiotics—grade E
d. Source control
• Removal of potentially infected device, drainage of abscess, debridement of infected necrotic
tissue—grade E
e. Enhance perfusion
• Fluid therapy—grade C
• Vaspressors—grade E
• Inotropic therapy—grade E
f. Steroids
• For patients with relative adrenal insufficiency—grade C
i. Mechanical ventilation
• Lung protective ventilation for acute lung injury/acute respiratory distress syndrome—grade B
k. Glucose control
• To maintain blood glucose <150 mg/dL—grade D
l. Renal replacement
• For acute renal failure—grade B
m. Prophylaxis measures
• Deep vein thrombosis—grade A
• Stress ulcer—grade A
Source: Adapted from Dellinger et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock.
Crit Care Med 2004;32:858-72.
22
Targeting Health Care–Associated Infections
• Hand washing: after touching blood, body fluids, secretions, excretions, and contaminated items,
whether or not gloves are worn; after gloves are removed, between patient contacts, between
tasks and procedures
• Gloves: when touching blood, body fluids, secretions, excretions, and contaminated items; before
touching mucous membranes and nonintact skin; between tasks and procedures; after contact
with potentially contaminated material
• Mask, eye protection, face shield: to protect mucous membranes of the eyes, nose, and mouth
during procedures and patient-care activities with the potential to generate splashes or sprays of
blood, body fluids, secretions, and excretions
• Gown: to protect skin and prevent soiling of clothing during procedures and patient-care activities
with the potential to generate splashes or sprays of blood, body fluids, secretions, or excretions
• Patient care equipment: appropriate handling of used patient-care equipment soiled with blood,
body fluids, secretions, and excretions to prevent skin and mucous membrane exposures,
contamination of clothing, and transfer of microorganisms to other patients and environments; to
ensure that reusable equipment is not used until it has been cleaned and reprocessed
appropriately; to ensure that single-use items are discarded properly
• Environmental control: to ensure adherence with procedures for the routine care, cleaning, and
disinfection of environmental surfaces, beds, bedrails, bedside equipment, and other frequently
touched surfaces
• Linen: procedures for handling, transporting, and processing used linen soiled with blood, body
fluids, secretions, and excretions to prevent skin and mucous membrane exposures and
contamination of clothing; to avoid spread of microorganisms to other patients and environments
• Patient placement: placement of patients with the potential to contaminate the environment in a
private room
23
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Source: Adapted from Centers for Disease Control, Antimicrobial Resistence in Healthcare Settings, 2005.
http://www.cdc.gov/ncidod/dhqp/ar.html. Accessed February 20, 2006.
24
Chapter 43. Advanced Practice Registered Nurses:
The Impact on Patient Safety and Quality
Eileen T. O’Grady
Background
This chapter will define the role of advanced practice nurses (APNs), review a selected
sample of the literature regarding what we know about APNs and patient safety/quality, and
describe the research gaps and limitations. Advanced practice registered nurse is a term used to
encompass certified nurse-midwife (CNM), certified registered nurse anesthetist (CRNA),
clinical nurse specialist (CNS), and nurse practitioner (NP). Advanced practice nursing is
broadly defined as nursing interventions that influence health care outcomes, including the direct
care of individual patients, management of care for individuals and populations, administration
of nursing and health care organizations, and the development and implementation of health
policy.1 In 2004, the number of registered nurses (RNs) prepared to practice in at least one
advanced practice role was estimated to be 240,461, or 8.3 percent of the total RN population. As
noted in figure 1 below, the largest group among the APNs was NPs, followed by CNSs. The
APN movement has been growing exponentially with APNs employed in every health care
sector. According to the Bureau of Labor Statistics,2 the demand for APNs is expected to
continue to increase over the next decade and beyond, as the need and demand for effective
health care increases, especially in rural, inner-city, and other underserved areas.
Source: 2004 National Sample Survey of Registered Nurses, U.S. Department of Health and Human Services, Health Resources
and Services Administration. http://bhpr.hrsa.gov/healthworkforce/reports/rnpopulation/preliminaryfindings.htm.
Direct clinical practice is a core competency of any APN role, although the actual skill set
varies according to the needs of the patient population.3 APNs build on the competence of the
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
RN skill set and demonstrate a greater depth and breadth of knowledge, a greater synthesis of
data, increased complexity of skills and interventions, and significant role autonomy. The APN is
prepared to assume responsibility and accountability for health promotion and the assessment,
diagnosis, and management of patient problems, including the use and prescription of
pharmacologic and nonpharmacologic interventions.4
Research Evidence
Certified Nurse-Midwife
CNMs are licensed health care practitioners educated in the two disciplines of nursing and
midwifery. They provide primary health care to women of childbearing age, including prenatal
care, labor and delivery care, care after birth, gynecological exams, newborn care, assistance
with family planning decisions, preconception care, menopausal management, and counseling in
health maintenance and disease prevention. CNMs attend more than 10 percent of the births in
the United States; 96 percent of these are in hospitals.9
What we know. MacDorman and Singh10 used logistic regression models to examine
differences between CNMs and physician-delivered births in infant perinatal mortality on all
singleton vaginal births between 35 and 43 weeks gestation in the United States (n = 810,790) in
1991. After controlling for all social and health risk factors, the CNM risk of infant death was 19
percent lower, neonatal mortality was 3 percent lower, and low-birth-weight infants were 31
percent fewer than with the physician-delivered babies. The mean birth weight was 37 grams
heavier for the CNM-attended births. The researchers concluded that CNMs provide a safe and
viable alternative to maternity care in the United States, particularly for low- to moderate-risk
women. The retrospective study design could not address the inherent selection bias of mothers
who choose midwives versus mothers who choose physicians to assist with delivery.
Rosenblatt and colleagues11 compared a random sample of records of Washington State
obstetricians, family physicians, and CNMs for low-risk women over a 1-year period (n =
1,322). The researchers found that CNM patients were less likely to receive continuous fetal
monitoring and had lower rates of labor induction, epidural injections, and caesarean sections
2
Role & Impact of Nurse Practitioners
and overall used fewer resources. The researchers concluded that overall, in Washington State,
low-risk patients of CNMs received fewer obstetrical interventions than similar patients cared for
by family physicians or obstetricians, especially lower cesarean rates and resource use. There
was no controlling for maternal risk factors such as maternal age and birth weight in this study,
and the degree of selection bias in pregnant women choosing a CNM versus a physician could
have influenced these results.
Oakley and colleagues12 compared the pregnancy outcomes (n = 1,181) of low-risk pregnant
women cared for by either an obstetrician or a CNM. After controlling for maternal risk and
selection bias, the nurse-midwife group had statistically significant fewer infant abrasions,
perineal lacerations, and complications; higher satisfaction with care; and lower hospital and
professional fee charges. The researchers concluded that important significant differences were
found between the CNMs and obstetricians and that CNMs are contributing significantly to
lowering maternity care costs and improving maternal outcomes of low-risk women.
While most of the research on CNM quality covered low-risk women, Davidson13 explored
the effectiveness of CNM care for high-risk women. Outcomes of high-risk women cared for by
CNMs in an inner-city hospital (n = 803) were compared with all women who delivered in the
United States in 1994. The comparison suggests that CNMs can provide safe care to women with
high-risk conditions. The single site of the study sample and lack of a controlled pair group make
generalizability of these findings difficult.
Nurse Anesthetist
A CRNA is a registered nurse who is educationally prepared for and competent to engage in
the practice of nurse anesthesia. CRNAs administer approximately 27 million anesthetics in the
United States each year, practice in every setting where anesthesia is available, and are the sole
anesthesia providers in more than two-thirds of all rural hospitals.14 CNRAs can also administer
every type of anesthetic and provide care for every type of surgery or procedure, from open heart
to cataract to pain management. CRNAs are both responsible for and accountable to others for
their individual professional practices. In addition, CRNAs are capable of exercising independent
professional judgment within their scope of competence and licensure.3 CRNAs provide
anesthetics to patients in collaboration with surgeons, anesthesiologists, dentists, podiatrists, and
other qualified health care professionals. When anesthesia is administered by a nurse anesthetist,
it is recognized as the practice of nursing and is not a medically delegated act.14
What we know. In 1988, the Centers for Disease Control and Prevention (CDC)15 conducted
a pilot study to explore anesthesia outcomes. The study concluded that anesthesia-caused
mortality and severe morbidity were too low to warrant a broader study. The CDC found that
precise estimates would require studying 290 hospitals and would cost $15 million over 5 years,
which was not deemed feasible. According to the IOM,6 it is estimated that death occurs only
once for every 200,000–300,000 anesthetics administered. This low incidence of error makes
studying the safety of CRNAs as a distinct provider group extremely difficult as it would require
an enormous number of study subjects.
To answer questions about surgical patients’ safety with regard to CRNAs versus
anesthesiologists, Pine and colleagues16 studied 404,194 anesthesia cases across 22 States. Risk
adjustment was conducted for case mix, risk factors, hospital characteristics, geographic
location, and surgical procedure. The study found no statistically significant difference in the
mortality rate for CRNAs and anesthelogists working together versus working individually.
There was no statistically significant difference between hospitals staffed by CRNAs (without
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The CNS is an expert clinician in a specialized area of nursing practice. The specialty may be
a population (e.g., pediatrics), a setting (e.g., critical care), a disease (e.g., cardiovascular or
mental health), or a type of problem (e.g., wound or pain). CNSs are engaged in direct clinical
practice; function as consultants in their area of expertise; provide expert coaching and guidance;
interpret, evaluate, and participate in research; provide clinical and professional leadership;
collaborate; and employ ethical decisionmaking.3
What we know. In 2001, a randomized controlled clinical trial by Brooten, Youngblut, and
colleagues17 looked at prenatal, infant (194) and maternal (173) outcomes where half of the
prenatal care was delivered in the home by CNSs. Results found that the group cared for in the
home by CNSs experienced fewer fetal/infant deaths, fewer preterm infants, fewer prenatal
hospitalizations, and fewer rehospitalizations compared to the control group. Researchers
concluded that the CNS prenatal home care saved 750 hospital days or about $2.5 million
dollars.
Topp, Tucker, and Weber18 conducted a retrospective chart review on 491 hospitalized
congestive heart failure patients over a 12-month period. Results indicated that length of stay and
hospital charges were significantly less in patients who were case-managed by a CNS.
Naylor and colleagues19 conducted a randomized clinical control trial with 276 patients and
125 caregivers to show the effects of a comprehensive discharge planning protocol. The
discharge planning protocol was specifically designed for elderly medical and surgical patients
and implemented by a gerontological CNS. From the initial discharge until 6 weeks after
discharge, the medical intervention group had fewer readmissions, fewer total days of
rehosptilization, lower readmission charges, and lower charges for all health care services after
discharge compared to the control group and the surgical intervention group.
Brooten, Kumar, Brown, and colleagues20 conducted a randomized clinical trial on the
effectiveness of CNS home care on the early hospital discharge of very low-birth-weight infants
(n = 79). The researchers found that hospital costs were 27 percent less than for the control
group. The researchers concluded that early hospital discharge for very low-birth-weight infants
was safe with CNSs conducting home followup care.
4
Role & Impact of Nurse Practitioners
Nurse Practitioner
NPs are registered nurses who are prepared, through advanced education and clinical
training, to provide a wide range of preventive and acute health care services to individuals of all
ages. NPs take health histories and provide complete physical examinations; diagnose and treat
many common acute and chronic problems; interpret laboratory results and x-rays; prescribe and
manage medications and other therapies; provide health teaching and supportive counseling, with
an emphasis on prevention of illness and health maintenance; and refer patients to other health
professionals as needed.21 Hughes and colleagues22 have categorized the 40-year history of NP
research into succinct eras, chronicling the evidence base on NPs, by far the largest of all of the
four APN roles. The current era is characterized by strategies to combat rising costs and tension-
building between NPs and the medical profession. The authors provide keen insight into why
benchmarking NP care against physician care may have taken us to the end of that research road.
What we know. Lambing and colleagues23 sought to build the evidence base for NP
effectiveness in the acute care setting. They conducted a descriptive, comparative research
design on 100 randomly selected hospitalized geriatric patients and a sample of 17 professional
providers who staffed 3 hospital units over a 1-month period. The researchers found that the
patients of NPs were older and sicker at the time of discharge and that readmission and mortality
rates were similar amongst NPs and physicians. The researchers concluded that NPs provide
effective care to hospitalized geriatric patients, particularly to those who are older and sicker.
Mundinger, Kane, and colleagues24 conducted the most definitive research on NPs and
quality by exploring the outcomes of care in patients randomly assigned either to a physician or
to a nurse practitioner for primary care after an emergency or urgent care visit. The NP practice
had the same degree of independence as the physicians, making this study unique. Patient
interviews and health services utilization data were used on a total of 1,316 patients, and it was
determined that the health status of the NP patients and the physician patients were comparable
at initial visits, 6 months, and 12 months. A followup study conducted in 200425 showed that
patients 2 years later confirmed continued comparable outcomes for the two groups of patients.
No differences were identified in patient outcomes such as health status; physiologic measures;
satisfaction; and use of specialists, emergency room, or inpatient services. The researchers
concluded that NP care and physician care was comparable.
A study by Avorn and colleagues26 used a sample of 501 physicians and 298 NPs who
responded to a hypothetical scenario regarding a patient with epigastic pain (acute gastritis).
They were able to request additional information before recommending treatment. If adequate
history taking was performed, the provider would have learned that the patient ingested aspirin,
coffee, and alcohol, and was under a great deal of psychosocial stress. Compared to NPs, the
physician group was more likely to prescribe a medication without seeking the relevant history.
NPs, in contrast, asked more questions, obtained a complete history, and were less likely to
recommend prescription medication. This study suggests that NP-delivered care may be superior
to that of physicians when a diagnosis is history dependent.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
A selected sample of research on APNs and quality and safety was conducted because much
of the APN research lacked randomization, had sample sizes too small to be generalizable to the
national health care system, or was not relevant to quality or safety. The summary of the
preceding research samples suggests that APN * -delivered care, across settings, is at least
equivalent to that of physician-delivered care as regards safety and quality. In the case of the
CNSs, it appears that CNSs demonstrate competence and cost savings as case managers for
patients transitioning from acute care to home care. Overall, however, the study designs and
sample sizes are too limited to draw conclusions that are generalizable to the United States
population. Widely accepted methodological techniques and research best practices outlined in
the report of the Agency for Healthcare Research and Quality (AHRQ), Evidence Report to Rate
the Strength of Scientific Evidence27 (see Table 1), have not been applied to the emerging
research on APN practice and quality. Methodologic quality has been defined as the extent to
which all aspects of a study's design and conduct can be shown to protect against systematic bias,
nonsystematic bias, and inferential error. Not met were certain design elements in the preceding
APN research design, conduct, or analysis that have been shown through empirical work to
protect against bias or that are long-accepted practices in epidemiology and related research
fields. These research evaluation criteria include quality, quantity, and consistency that are well-
established variables for characterizing how confidently one can conclude that a body of
knowledge provides information on which clinicians or policymakers can act. As the research on
APN and quality evolves over time, the rigor of the research and its capacity to influence policy
will improve.
Table 1. Important Domains and Elements for Systems To Grade the Strength of Evidence
Quality: The aggregate of quality ratings for individual studies, predicated on the extent
to which bias was minimized.
Quantity: Magnitude of effect, numbers of studies, and sample size or power.
Consistency: For any given topic, the extent to which similar findings are reported using
similar and different study designs.
These studies are also limited in looking specifically at patient safety as a subset of health
care quality. According to Crossing the Quality Chasm,7 the American health care system is in
need of fundamental change because health care frequently harms and fails to deliver its
potential benefits. The preceding literature compared APNs to physicians within the context of a
health care system that is not necessarily patient safety focused. Comparing APN to physician
outcomes was an important validation of APN practice as these professions evolved. Given the
current mandate for fundamental system change, new research questions on APN practice as they
relate to patient safety have emerged. Most outcome studies to date have focused on acute care
*
No studies comparing CNSs to physicians have been conducted.
6
Role & Impact of Nurse Practitioners
nurse staffing and nursing-sensitive outcomes such as decubitus ulcers.28 The research to
measure APN outcomes with valid tools has yet to be developed.
While the summary of research related to the safety and quality of APNs validates them as
competent and comparable to physicians in many aspects, more research is needed to reduce
errors and enhance patient safety. Threshold improvement cannot be accomplished without
interdisciplinary practice approaches—which are going to require revolutionary change to flatten
the educational and cultural silos between medicine and nursing education.29 It is crucial that
APNs are separated out as distinct provider types in all interdisciplinary research and
administrative and clinical datasets. It has taken the nursing profession decades to untangle
nursing’s unique role and value within the hospital and decouple professional registered nursing
from the “hotel costs” of a hospital stay. RNs have historically been characterized as a cost
center rather than a highly valued revenue source within hospitals. If all professional nursing
activity was billed for separately, such as is done with physician care, nursing’s value would not
have to be debated. As the evidence base on interdisciplinary teams is built, APNs must not
become invisible on the health care team. Building a research portfolio on APN practice will
require adherence to methodological quality that explores APN practice within an
interdisciplinary context. Practice Implications—Barriers to APN Practice
Lack of Collaboration
Health professionals work together in small groups providing care, be it oncology, the
operating room, end of life, or primary care. These team members, however, are educated in their
health professional silo and likely have little knowledge of their team members’ skill sets. The
IOM report, To Err is Human,6 suggested that health professionals should be educated in teams
using evidenced-based methods employed in aviation such as simulation and checklists. People
make fewer errors when they work in teams because it forces processes to be planned and
standardized, forces team members to have a clear role and to look out for one another, noticing
errors before they become an accident. In an effective interdisciplinary team, members come to
trust one another’s judgments and attend to one another’s safety concerns.
In no uncertain terms, the IOM declares that most care delivered today is done by teams of
people, yet training often remains focused on individual responsibilities, leaving practitioners
inadequately prepared to enter complex settings. The silos created through training and
organization of care impede safety improvements.6
The Quality First report highlighted “… the need for clinicians to develop a broader systems
perspective. Specifically, the commission states that ‘… in health care organizations, much of the
learning is aimed at improving individual physicians learning to become better physicians,
nurses learning to become better nurses, rather than learning how the system as a whole can
improve.’”30 Irrespective of health care setting, there is a high premium placed on medical
autonomy and perfection and a historical lack of interprofesional cooperation and effective
communication.6
Learning and working in a true interdisciplinary context is a requirement for improved
patient safety, and the silo systems in place now are viewed as wholly inadequate. It is the space
between the disciplines that may create the most opportunity for patient safety improvement. The
following quote expresses the opportunity created in this interdisciplinary space as John Brown,
an information technology leader, discusses how his company lost the commercial market share
on the world’s first personal computer solely due to a lack of interdisciplinary collaboration:
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
The 50 States and the District of Columbia have vastly different laws governing APN
practice. The 51 nurse practice acts currently lack any clear framework or congruence amongst
each other.35 This high degree of variation suggests that the regulatory framework for APN
practice is not evidence-based and that States are not promulgating APN regulations with a
coherent patient safety orientation.
By way of example, some States employ a joint board of nursing-board of medicine to
regulate APNs, while others require physicians and APNs to be in collaborative or even
supervisory relationships with each other. Some States consider APN practice a medically
delegated act and require physician, dentist, or podiatrist supervision of APNs, while other States
require physicians to be in contact with the APN periodically throughout the week or to be
physically within a defined radius (defined in miles) of the NP. Some States require APNs with
doctorates to “hide” their doctoral degree credential from patients, and other States do not
require APNs to be nationally certified to practice. These practice acts vary even within States
8
Role & Impact of Nurse Practitioners
(urban or rural) and can specify the types of medical conditions APNs are permitted to treat. The
current APN regulatory environment has numerous issues that foster poor quality or impair
patient safety. Regulatory barriers that directly impact patient safety include onerous entry into
APN practice; cryptic scope of practice regulations; polices that restrict APN hospital and
prescriptive privileges and impede continuity of care, the capacity of NPs to serve as primary
care providers (NP empanelment), to receive third-party payment, or the pharmacist from
printing the prescribing APN name on the prescription bottle, making it difficult for pharmacists
or patients to contact the prescribing APN. The APRN Joint Dialogue Group36 of the National
Council of State Boards of Nursing (NCSBN) recommends sole board of nursing regulation for
APN practice and that APNs be independent practitioners with no regulatory requirement for
supervision from another discipline across all States. Standardizing nurse practice acts will
establish the groundwork necessary to move to a mutual recognition (interstate compact) for
APNs.
This high degree of variation across the States for APN regulation has spotlighted the need to
ensure that regulation serves the public, promotes public safety, and does not present
unnecessary barriers to patients’ access to care. Likewise, the regulatory bodies overseeing APN
practice are slow or unable to keep pace with changes in health care. Moreover, the Internet has
rendered geographic boundaries irrelevant, and as technology and national delivery systems
infiltrate care delivery, these practice acts will strangle innovation. The Crossing the Quality
Chasm report notes that State practice acts that limit nonphysician providers, e-health, and
multidisciplinary teams act as a barrier to innovative health care because these innovations can
help care for patients across settings and over time7 (p. 215). Crossing the Quality Chasm
recommends greater coordination and communication among professional boards, both within
and across States, as the patchwork of NP regulations are resolved over time.
The IOM’s Crossing the Quality Chasm recommends that regulators create an infrastructure
to support evidence-based practice, facilitate the use of information technology, align payment
incentives, and prepare the workforce to better serve patients in a world of expanding knowledge
and rapid change7 (p. 5). The report stresses that if innovative programs are to flourish,
regulatory environments will be required to foster innovation in organizational arrangements,
work relationships, and use of technology. The 21st century health care system described in
Crossing the Quality Chasm simply cannot be achieved in the current environment of regulation
and oversight. The report summarizes the current patchwork of regulatory frameworks as
inconsistent, contradictory, duplicative, outdated, and counter to best practices. Moving the
NCSBN’s vision for APN regulation into reality across all of the States is requisite to promote
APNs and patient safety.
APN Invisibility
Many polices have rendered APN practices “invisible” or established barriers that adversely
impact accurate measurement of quality-related data. By way of example, Medicare has a policy
that allows physician practices to bill Medicare for NP-provided services as “incident-to” the
physician. This allows medical practices to bill for NP care through a physician, creating
perverse incentives to make NPs invisible, as NPs are reimbursed 100 percent of the physician
rate when billing Medicare “incident-to.” When APNs bill Medicare directly, they bill at 85
percent of the physician rate. The cost savings of using a less expensive provider are passed onto
the physician practice, not the patient or the payer.
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Another startling example of APN invisibility is that the most comprehensive ambulatory
care data, the National Ambulatory Medical Care Survey (NAMCS) produced by the National
Center for Health Statistics, does not include APNs. This important national survey is conducted
annually on the provision and use of ambulatory medical care services in the United States.
Findings are based on a sample of visits to nonfederally employed office-based physicians who
are primarily engaged in direct patient care. Each physician is randomly assigned to a 1-week
reporting period. During this period, data for a systematic random sample of visits are recorded
by the physician or office staff on an encounter form provided for that purpose. Data are
obtained on patients’ symptoms, physicians’ diagnoses, and medications ordered or provided.
The survey also provides statistics on the demographic characteristics of patients and services
provided, including information on diagnostic procedures, patient management, and planned
future treatment. APNs practicing in ambulatory care are not surveyed or discussed in the 906
million visits to physician offices.37
In that same vein, the Center for Studying Health System Change (HSC), whose mission is
“to inform policy makers about how local and national changes in the financing and delivery of
health care affect people … strives to provide high-quality, timely and objective research and
analysis that leads to sound policy decisions, with the ultimate goal of improving the health of
the American public.”38 HSC employs rigorous surveys and in-depth case studies and chronicles
trends in the health care system; however, their provider surveys include only physicians. HSC
unquestionably influences decisionmakers on all sides of the issues and guides those crafting
health care policy in Government and private industry. More must be done to encourage thought
leaders to think about health system change more broadly.
APNs are also invisible in the basic county-specific Area Resource File (ARF), a database
containing more than 6,000 variables for each of the Nation's counties. ARF contains
information on health facilities; health professions; and measures of resource scarcity, health
status, economic activity, health training programs, and socioeconomic and environmental
characteristics. In addition, the basic file contains geographic codes and descriptors that enable it
to be linked to many other files and to aggregate counties in various geographic groupings. This
database is used to establish Health Professional Shortage Areas (HPSAs), using criteria of
population-to-clinician ratios. It is difficult to include APNs in the ratio as there is no uniform
data source at the ZIP Code level on APNs. HPSA designation is important to communities
because of the enormous funding priority they receive in more than 34 Federal programs that
depend on the shortage designation to determine eligibility.39 About 20 percent of the U.S.
population reside in primary medical care HPSAs, and APNs are not considered full-time
equivalent providers in the designation because of the lack of data. Fully counting APNs could
thus impact the distribution of Federal funds to counties.
The Federal requirement that CRNAs must be in a supervisory relationship with
anesthesiologists creates enormous barriers to adequate measuring of patient safety data, as the
CRNA may not be identified as a distinctive provider group, rendering CRNA-delivered
anesthesia invisible. This policy also has a detrimental effect on rural States that cannot staff
their hospitals with anesthesiologists; therefore, many States have opted out of the Federal
requirement for CRNA supervision in order to meet their patients’ needs.
These policies, in each of the preceding examples, remove or marginalize the APN from all
administrative and clinical data systems or survey designs. This lack of inclusion in these
national research endeavors makes it impossible to understand the full dimensions and value of
NP practice.
10
Role & Impact of Nurse Practitioners
Practice Implications
The intense drive to measure quality is a deep concern for payers, regulators, and
increasingly consumers. As data systems evolve and payers insist on “paying for performance,” a
level of accountability and transparency will be required regardless of provider type or health
care setting. As these quality measures are developed, the current focus seems to be entirely on
physician-delivered care. Quality data will be embedded with health information systems, so it
will be imperative that APNs are involved in both the development of quality measures and the
inclusion of APN practice as distinct from that of other providers. The database on nurse-
sensitive indicators is being built at the inpatient level of hospitals. As many APNs practice in
settings outside of the hospital, the need to create APN-sensitive measures cannot be
overemphasized. The Medicare objective to align quality incentives through payment creates
enormous opportunity for APNs. As Medicare gathers the evidence on effective strategies, it will
phase in new payment systems intended to promote transformational quality improvement in the
health care industry. This realignment will encourage innovation and efficiency and promote
coordination of care across time and settings.40 These activities are central to the APN function
and have historically been undervalued and invisible in the fee-for-service model.
Pay-for-performance initiatives are occurring outside of Government as well. Bridges to
Excellence (http://www.bridgestoexcellence.org/) is a multistate, multiemployer coalition
developed by employers, physicians, health care services researchers, and other experts. Its
mission is to reward quality across the health care system. In Bridges to Excellence’s three
program areas, physicians are targeted exclusively by certifying physicians in diabetes, cardiac
care, and electronic office systems. The physician receives a financial bonus of up to $180 per
year per patient treated. There are no other providers included in this program, despite the
claimed mission to improve health care across the health care system.
Over the last 20 years, the evolution of health services research (HSR), a distinct area of
scholarship, has grown dramatically in both resources and influence and is currently funded
publicly at $1.5 billion annually. HSR is important to APNs because it addresses questions that
require observational or quasi-experimental design. This form of research includes determining
the comparative effectiveness of interventions across a range of different settings, economic
evaluation of different financing and organizational decisions, and qualitative designs that help
us understand the how and why of social interactions.41 The HSR field is uniquely suited to
exploring APN practice because it provides a mixing bowl of interdisciplinary perspectives
working on similar problems. As HSR methods become increasingly more prestigious and
influential, APN research must be framed within a broader HSR and patient safety context.
Research Implications
The rapid growth and success of the APN movement has been described as a disruptive
innovation—in that APNs can in many ways provide the same care or better care than
physicians, at a lower cost in a more convenient setting. This disruption has contributed to
professional turf battles that do not promote quality and patient safety. Strong leadership to study
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
innovative models on interdisciplinary team approaches that foster patient safety, including how
to eliminate barriers to interdisciplinary education and practice, is required.
Turning the disruption of APNs toward improved patient safety will require a more robust
evidence base and laser beam focus by these professionals. APNs must demonstrate specific
clinical performance and patient outcomes. To develop this research agenda, stakeholders must
convene and map out a vigorous research agenda that distinguishes APNs in the context of
interdisciplinary practice. APN organizations along with the governmental and private research
enterprise must come together and build a strategic plan identifying the most critical research
questions. This research agenda would address strategies for APN inclusion in electronic
administrative and clinical data systems, quality measurement, cost containment, as well as
influential surveys such as the NAMCS and HSC. As pay-for-performance initiatives are
transformed into payment policy, it is essential that researchers include APNs in the quality
measurement process. This research agenda must be highly relevant to address today’s health
care problems and overcome APN invisibility; it must recognize APNs’ unique contribution and
discipline.
APN research must expand to an HSR orientation. This includes developing a research
agenda that has methodological dialogue with other disciplines and fits within a framework of
agreed-upon methods in the field of HSR. This research agenda must consistently and
systematically translate APN research into sound health policy. Applying randomized thinking to
nonrandomized problems is seldom useful to inform public policy because the researcher cannot
expose a randomized group to the policy on a qualitative problem. The research must help the
policymaker see the intended and unintended consequences that follow enactment of policies
over time.
The Agency for Healthcare Research and Quality (AHRQ) has emerged as the premier
funder for HSR, and this funding source should be explored to a far greater degree by APN
researchers. While the National Institutes of Health focus on the biomedical aspect of diseases,
AHRQ focuses on patient outcomes, cost, use of services, access disparities, quality of care, and
patient safety. The focus of AHRQ is becoming increasingly important as the delivery system
undergoes transformation, driven by transparency and quality. AHRQ’s goal is to ensure that the
knowledge gained through HSR is translated into measurable improvements in the health care
system and better care for patients.42 This goal could be shared by members of the APN
community by sharpening and aligning the APN research focus on systems of care.
There are a number of informational or empirical issues lacking in the current APN evidence
base. Future research must be independent, longitudinal, and directed to authoratitively answer
the most urgent policy-relevant questions concerning APNs. Following are some of the questions
that research into APN practice should address.
12
Role & Impact of Nurse Practitioners
Medicare
• What is the advantage to Medicare to include APNs in its pay-for-performance
initiatives? Do APNs, as central members of the health care team, demonstrate threshold
quality improvements? How do these findings inform Medicare’s Graduate Medical
Education program currently targeting primarily physicians?
• How can the cost savings on APN practice be passed onto consumers, Medicare, and
other payers?
Access
• What impact do APNs have on vulnerable segments of the population? How do they
impact the uninsured? Elderly? Children? Rural residents? How do APNs participate in
the safety net?
• How are access and quality of care impacted once a State has adopted NCSBNs
regulatory vision for APN practice, which eliminates barriers to APN practice?
• Does APN practice improve health care disparities? Do improvements benefit minority
populations preferentially?
Educational Issues
• How are APNs demonstrating interdisciplinary patient safety curricula with educational
simulation techniques for use early in professional schooling, continuing throughout
training, and at intervals during professional practice?
• How do APNs maintain continued competence throughout their career trajectory?
• What would be included in a curriculum that demonstrated competency in patient safety?
13
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• When do APNs enter the workforce, and when and how to they leave/retire?
• How should APNs be included in shortage designation methodologies?
• What would a national, integrated workforce planning initiative look like?
• What is the best way to communicate APN-related research to the public, policymakers,
payers, and media?
Conclusion
In addition to developing a robust APN research agenda, APN organizations must strategize
to have APNs appointed to Federal and private advisory commissions that oversee or develop
quality improvement measures. APN organizations must also identify key corporate boards and
develop long-term strategies and political capital to get APNs appointed to those influential
boards. This sector of the health policymaking process is increasingly influential as payers seek
to know more about what they are getting from their health care dollar vis-à-vis pay-for-
performance initiatives.
Findings from APN research must be published in journals outside of nursing to reach a
broader policymaking and public audience. Key policymakers as well as the public could be
made more aware of the contributions that APNs make in reducing health care costs and
improving access and quality of care. Achieving broader recognition, reducing APN invisibility,
and removing barriers to APN practice will be contingent on APNs communicating
methodologically sound APN research that produces results that are generalizable to the larger
delivery system.
Search Strategy
Both MEDLINE® and CINAHL® databases were searched to locate literature for this review.
The search terms were “advanced practice nursing,” “certified nurse midwives,” “certified
registered nurse anesthetists,” “clinical nurse specialists,” “nurse practitioners,” “quality,”
“safety,” and “outcomes.” For both databases, the searches were limited to research articles
published in the English language between 1991 and 2006 and restricted to research within the
United States.
There were 97 articles identified in the CINAHL search and 54 identified by the MEDLINE
search, with some duplication in the citations identified by the two databases. All abstracts were
reviewed and most were eliminated from further consideration because they were not evidence
based or there were methodology concerns. For example, articles about advanced practice roles,
delivery models, theoretical papers, educational and curriculum issues, international issues,
advanced practice nursing in defined specific populations (e.g., rural, emergency departments,
gerontological) or diseases (e.g., sexually transmitted infection, heart disease), and all meta-
analyses and studies with fewer than 70 subjects were omitted from this review. Once the
unrelated articles were eliminated, a complete copy of each of these papers was acquired and
read. Four professional associations were contacted to obtain the strongest research papers on the
four APN roles (American College of Nurse Midwives, American Association of Nurse
Anesthetists, the American Association of Clinical Nurse Specialists, and the American College
of Nurse Practitioners). Dominant among the reasons for excluding papers were that they were
not research based, they were short reports that were lacking essential details, or there were
methodological concerns.
14
Role & Impact of Nurse Practitioners
Author Affiliations
Eileen T. O’Grady, Ph.D., R.N., N.P., policy editor, Nurse Practitioner World News and The
American Journal for Nurse Practitioners. E-mail: [email protected].
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manager/clinical nurse specialist patients hospitilized
7. Institute of Medicine. Crossing the quality chasm: A with congestive heart failure. Nurs Case Manag 1998
new health system for the 21st century. Washington, 3(4):140-5.
DC: National Academy Press; 2001.
19. Naylor M, Brooten D, Jones R, et al. Comprehensive
8. Institute of Medicine. Health professions education: discharge planning for the hospitalized elderly. Ann
A bridge to quality. Washington, DC: National Inter Med 1994 120:999-1006.
Academies Press; 2003.
20. Brooten D, Kumar S, Brown LP, et al. A randomized
9. American College of Nurse Midwives. clinical trial of early hospital discharge and home
http://www.acnm.org/. Accessed February 15, 2007. follow up of very low birthweight infants. N Engl J
Med 1996 (315): 934-9.
10. MacDorman MF, Singh, GP. Midwifery care, social
and medical risk factors, and birth outcomes in the 21. American College of Nurse Practitioners. http://
USA. J Epidemiol Community Health 1998 www.acnpweb.org/. Accessed February 15, 2007.
May;52(5):310-7.
22. Hughes F, Clarke S, Sampson D, et al. Research in
11. Rosenblatt RA, Dobie, SA, Hart, LG, et al. support of nurse practitioners. In: Mezy, MD,
Interspecialty differences in the obstetric care of low- McGivern, DO, Sullivan-Marx, EM, eds. Nurse
risk women. Am J Public Health 1997 practitioners: evolution of advanced practice. 4th ed.
Mar;87(3):344-51. New York: Springer Publishing Company; 2003.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses
23. Lambing AY, Adams DL, Fox DH, et al. Nurse 33. Bodemheimer T, Wagner EH, Grumbach K.
practitioners and physicians’ care activities and Improving primary care for patients with chronic
clinical outcomes with an inpatient geriatric illness: The chronic care model part II. JAMA.
population. J Am Acad Nurse Pract 2004 16(8):343- 2002;288:1909-14.
52.
34. Cowan MS, Hays RD. The effect of a
24. Mundinger MO, Kane RI, Lenz ER, et al. Primary multidisciplinary hospitalist/physician and advanced
care outcomes in patients treated by nurse practice nurse collaboration on hospital costs. J Nurs
practitioners or physicians: A randomized trial. Adm 2006;36(2):79-85.
JAMA. 2000:283;59-68.
35. Pearson L. The Pearson report. A national overview
25. Lenz ER, Mundinger MO, Kane RI, et al. Primary of NP legislation and health care issues. Am J Nurse
care outcomes in patients treated by nurse Pract 2007;11(2):9-136.
practitioners or physicians: two-year follow up. Med
Care Res Rev 2004;61:332-51. 36. National Council of State Boards of Nursing. Joint
Dialogue Working Group. Activities Update.
26. Avorn L, Everitt DE, Baler MW. The neglected https://www.ncsbn.org/APRN_Joint_Dialogue_Grou
medical history and theraputic choices for abdominal p.ppt. Accessed November 8, 2007.
pain: a nationwide study of 799 physicians and
nurses. Arch Intern Med 1991; 141:694-98. 37. National Center for Health Statistics. National
ambulatory medical survey, The Centers for Disease
27. Agency for Healthcare Research and Quality. Control and Prevention. http://www.cdc.gov/nchs/
Systems to rate the strength of scientific evidence. about/major/ahcd/ahcd1.htm. Accessed February 20,
Evidence Report/Technology Assessment No. 47. 2007.
Rockville, MD: Author; 2002.
38. Center for Studying Health System Change (HSC).
28. American Nurses Association. Nursing-sensitive http://www.hschange.com/. Accessed February 14,
quality indicators for acute care settings and ANA’s 2007.
safety & quality initiative.
http://nursingworld.org/readroom/fssafe99.htm. 39. Health Resources and Services Administration.
Accessed February 15, 2007. Bureau of health professions, shortage designation
branch. http://bhpr.hrsa.gov/shortage/muaguide.htm.
29. Health Resources and Services Administration. Accessed February 14, 2007.
Collaborative education to ensure patient safety.
COGME/NACNEP. Rockville, MD: Health 40. Institute of Medicine. Rewarding provider
Resources and Services Administration; 2000. performance: aligning incentives in Medicare
(Pathways to Quality Health Care Series).
30. The President’s Advisory Commission on Consumer Washington, DC: National Academy Press; 2007.
Protection and Quality in the Health Care Industry.
Quality first: better health care for all Americans. 41. AcademyHealth. AcademyHealth Report, 2006 Dec;
Final report. Washington, DC; 1998. pp 201. 25
31. Schrage M. The debriefing: John Seely Brown. 2000. 42. Agency for Healthcare Research and Quality. AHRQ
Wired 2000 August 20; 4-7. Strategic Plan
http://www.ahrq.gov/about/strateix.htm. Accessed
32. Institute for Healthcare Improvement. Rapid response February 14, 2007.
team record. http://www.ihi.org/IHI/Topics/
CriticalCare/IntensiveCare/Tools/RapidResponseTea
mRRTRecord.htm. Accessed February 21, 2007.
16
Evidence Table. Advanced Practice Nurses: Impact on Safety and Quality of Care
Source Safety/Quality Study Design, Study Study Setting & Study Key Finding(s)
Issue Related to Outcome Measure(s) Study Population Intervention
Clinical Practice
Quality Evidence on CNMs
Davidson High-risk Level 3. Univariate High-risk mothers Risk factors 83% of the CNM deliveries were spontaneous
13
2002 obstetrical care analysis on vaginal who received care managed by vaginal births, compared to the national average of
births after cesarean, from an urban, mid- CNMs 79%. Seventy four percent of the CNM births after
forceps, and vacuum- Atlantic hospital- compared to cesarean births delivered vaginally, significantly
assisted deliveries, based OB clinic the national higher than the national average of 28%. Instrument
cesarean delivery, 5 during a 10-year population. delivery rates were considerably lower for the CNM
minute Apgar score, period from 1988 to group (4%) compared to the national average (9%).
maternal fever, and 1998, N = 803. Only 12% of the CNM group had cesarean sections,
meconium stained compared to the national average of 21%. The
amniotic fluid researcher concludes that CNMs provide high-
outcomes. quality care to high-risk women in an urban setting.
MacDorman Birth outcomes and Level 3. Logistic All singleton CNM care After controlling for medical and social risk factors,
10
1998 infant survival regression on infant, vaginal births at compared to the risk of experiencing an infant death was 19%
neonatal, post-neonatal 35–43 weeks physician- lower for CNM-attended than for physician-attended
17
mortality and risk of low gestation in the delivered births, the risk of neonatal mortality was 33% lower,
birth weights. United States in births. and risk of delivering a low-birth-weight infant was
1991, N = 810,790. 31% lower. National data demonstrate that CNMs
have excellent birth outcomes amongst low- to
moderate-risk women.
Oakley 199612 Pregnancy/ Level 3. Logistic At intake, all CNM care After controlling for social and health risk factors,
perinatal outcomes regression analyzed women qualified for compared to multivariate analysis found statistically significant (P
outcome measures: CNM care and a obstetrician ≤ 0.05) differences between obstetricians and CNMs
infant and maternal convenience care. on 7 outcome measures. Infant abrasion ( 7% OB
provider cholecystectomies, N = 404,194, from anesthetists mortality is not affected by whether the anesthesia
herniorrhaphies, 22 States from vs. nurse provider is a CRNA or an anesthesiologist.
mastectomies, 1995 to 1997. anesthetists.
hysterectomies,
prostatectomies, and
knee replacements.
Quality Evidence on CNSs
Brooten 200117 Prenatal, maternal, Level 1. Randomized 1-year study period Half of the Group cared for in the home had 2 fetal infant
and infant clinical trial n = 173 in one delivery study sample deaths compared to the control group (9); fewer
outcomes women and 194 infants. system of women received preterm infants, 78% of twin pregnancies carried to
at high risk for prenatal care term (9), control group = 33%); 4 prenatal
delivering low-birth- in the home by hospitalizations, 18 infant rehospitalizations (control
weight infants. CNS while group = 24). CNS home care saved 750 total
they received hospital days or about $2.5 million.
traditional
obstetrical
care.
Source Safety/Quality Study Design, Study Study Setting & Study Key Finding(s)
Issue Related to Outcome Measure(s) Study Population Intervention
Clinical Practice
Brooten 199620 Safety and cost Level 1. Randomized Very low-birth- Home care Mean hospital costs were 27% less than the control
effectiveness of clinical trial, n = 79 weight infants followup by group ($47,520 vs. $64,940, P < 0.01); the mean
care by CNSs. patients in one system. discharged from a CNS. physician charge was 22% (P < 0.01) less in the
Outcomes included hospital early. group cared for in the home by CNS. The mean cost
hospital costs, of home care was $576, yielding a net savings of
physician fees, home $18,560
followup care by CNSs.
Naylor 199419 Hospital transition Level 1. Randomized Medical and Comprehensiv The medical patient group had fewer hospital
to home for frail clinical trial; initial surgical patient and e CNS- readmissions, fewer total days of hospital
elderly hospital discharge until caregiver delivered readmission, lower readmission charges. The
6 weeks after posthospital discharge surgical intervention group showed no significant
discharge. discharge planning differences with the control group during the
outcomes and cost protocol. discharge period.
of care, N = 276
patients and 125
caregivers
Topp 199818 Effect of CNS case Level 4. Quasi- Chart review of 164 CNS case Patients in the units with CNSs received more
19
management experimental post-op total knee management nursing interventions, had shorter lengths of stay.
comparative, replacements in
correlational. Outcomes one delivery
included nursing system.
interventions, length of
stay, complication rate.
Quality Evidence on NPs
Avorn 199126 Treatment Level 4. Randomized 501 MDs and 298 Hypothetical More than one-third of the physicians chose to
comparisons selection of MDs and NPs were scenario initiate therapy without seeking a relevant history.
appointment and health academic medical MD process health services utilization after 6 months or 1 year.
services utilization. enter, outcomes. There were no differences in satisfaction ratings
N = 1,316. following the initial appointment. Satisfaction ratings
at 6 months differed for 1 of 4 dimensions measured
(provider attributes), with MD rates higher( 4.2 vs.
4.5 on a scale where 5 = excellent; P = 0.05).
Authors conclude that primary care outcomes of
NPs are comparable to MDs when NPs have the
same level of authority, responsibilities, productivity,
and administrative requirements.
Lenz 200425 2-year followup of Level 2. Randomized N = 406 adults Health status, Results consistent with 6-month findings (see
outcomes on clinical trial (of same disease- Mundinger, 2000). The body of evidence suggests
patients followed sample in Mundinger, specific that the quality of primary care delivered by NPs is
by NPs and MDs 2000) physiologic equivalent to that of MDs.
measures,
satisfaction or
use of
specialist,
emergency or
inpatient
services.
CNM = clinical nurse midwife; CRNA = clinical registered nurse anesthetist; CNS = clinical nurse specialist; NP = nurse practitioner.
Chapter 44. Tools and Strategies for Quality
Improvement and Patient Safety
Ronda G. Hughes
Background
The necessity for quality and safety improvement initiatives permeates health care.1, 2 Quality
health care is defined as “the degree to which health services for individuals and populations
increase the likelihood of desired health outcomes and are consistent with current professional
knowledge”3 (p. 1161). According to the Institute of Medicine (IOM) report, To Err Is Human,4
the majority of medical errors result from faulty systems and processes, not individuals.
Processes that are inefficient and variable, changing case mix of patients, health insurance,
differences in provider education and experience, and numerous other factors contribute to the
complexity of health care. With this in mind, the IOM also asserted that today’s health care
industry functions at a lower level than it can and should, and it put forth the following six aims
of health care: effective, safe, patient-centered, timely, efficient, and equitable.2 The aims of
effectiveness and safety are targeted through process-of-care measures, assessing whether
providers of health care perform processes that have been demonstrated to achieve the desired
aims and avoid those processes that are predisposed toward harm. The goals of measuring health
care quality are to determine the effects of health care on desired outcomes and to assess the
degree to which health care adheres to processes based on scientific evidence or agreed to by
professional consensus and is consistent with patient preferences.
Because errors are caused by system or process failures,5 it is important to adopt various
process-improvement techniques to identify inefficiencies, ineffective care, and preventable
errors to then influence changes associated with systems. Each of these techniques involves
assessing performance and using findings to inform change. This chapter will discuss strategies
and tools for quality improvement—including failure modes and effects analysis, Plan-Do-
Study-Act, Six Sigma, Lean, and root-cause analysis—that have been used to improve the
quality and safety of health care.
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has consequently not used the reports to the extent hoped to make informed decisions for higher-
quality care.13–15
The complexity of health care systems and delivery of services, the unpredictable nature of
health care, and the occupational differentiation and interdependence among clinicians and
systems16–19 make measuring quality difficult. One of the challenges in using measures in health
care is the attribution variability associated with high-level cognitive reasoning, discretionary
decisionmaking, problem-solving, and experiential knowledge.20–22 Another measurement
challenge is whether a near miss could have resulted in harm or whether an adverse event was a
rare aberration or likely to recur.23
The Agency for Healthcare Research and Quality (AHRQ), the National Quality Forum, the
Joint Commission, and many other national organizations endorse the use of valid and reliable
measures of quality and patient safety to improve health care. Many of these useful measures that
can be applied to the different settings of care and care processes can be found at AHRQ’s
National Quality Measures Clearinghouse (http://www.qualitymeasures.ahrq.gov) and the
National Quality Forum’s Web site (http://www.qualityforum.org). These measures are generally
developed through a process including an assessment of the scientific strength of the evidence
found in peer-reviewed literature, evaluating the validity and reliability of the measures and
sources of data, determining how best to use the measure (e.g., determine if and how risk
adjustment is needed), and actually testing the measure.24, 25
Measures of quality and safety can track the progress of quality improvement initiatives
using external benchmarks. Benchmarking in health care is defined as the continual and
collaborative discipline of measuring and comparing the results of key work processes with those
of the best performers26 in evaluating organizational performance. There are two types of
benchmarking that can be used to evaluate patient safety and quality performance. Internal
benchmarking is used to identify best practices within an organization, to compare best practices
within the organization, and to compare current practice over time. The information and data can
be plotted on a control chart with statistically derived upper and lower control limits. However,
using only internal benchmarking does not necessarily represent the best practices elsewhere.
Competitive or external benchmarking involves using comparative data between organizations to
judge performance and identify improvements that have proven to be successful in other
organizations. Comparative data are available from national organizations, such as AHRQ’s
annual National Health Care Quality Report1 and National Healthcare Disparities Report,9 as
well as several proprietary benchmarking companies or groups (e.g., the American Nurses
Association’s National Database of Nursing Quality Indicators).
2
Quality Methods, Benchmarking
Quality Management (TQM), promoted “constancy of purpose” and systematic analysis and
measurement of process steps in relation to capacity or outcomes. The TQM model is an
organizational approach involving organizational management, teamwork, defined processes,
systems thinking, and change to create an environment for improvement. This approach
incorporated the view that the entire organization must be committed to quality and improvement
to achieve the best results.29
In health care, continuous quality improvement (CQI) is used interchangeably with TQM.
CQI has been used as a means to develop clinical practice30 and is based on the principle that
there is an opportunity for improvement in every process and on every occasion.31 Many in-
hospital quality assurance (QA) programs generally focus on issues identified by regulatory or
accreditation organizations, such as checking documentation, reviewing the work of oversight
committees, and studying credentialing processes.32 There are several other strategies that have
been proposed for improving clinical practice. For example, Horn and colleagues discussed
clinical practice improvement (CPI) as a “multidimensional outcomes methodology that has
direct application to the clinical management of individual patients”33 (p. 160). CPI, an approach
lead by clinicians that attempts a comprehensive understanding of the complexity of health care
delivery, uses a team, determines a purpose, collects data, assesses findings, and then translates
those findings into practice changes. From these models, management and clinician commitment
and involvement have been found to be essential for the successful implementation of change.34–
36
From other quality improvement strategies, there has been particular emphasis on the need for
management to have faith in the project, communicate the purpose, and empower staff.37
In the past 20 years, quality improvement methods have “generally emphasize[d] the
importance of identifying a process with less-than-ideal outcomes, measuring the key
performance attributes, using careful analysis to devise a new approach, integrating the
redesigned approach with the process, and reassessing performance to determine if the change in
process is successful”38 (p. 9). Besides TQM, other quality improvement strategies have come
forth, including the International Organization for Standardization ISO 9000, Zero Defects, Six
Sigma, Baldridge, and Toyota Production System/Lean Production.6, 39, 40
Quality improvement is defined “as systematic, data-guided activities designed to bring about
immediate improvement in health care delivery in particular settings”41 (p. 667). A quality
improvement strategy is defined as “any intervention aimed at reducing the quality gap for a
group of patients representative of those encountered in routine practice”38 (p. 13). Shojania and
colleagues38 developed a taxonomy of quality improvement strategies (see Table 1), which infers
that the choice of the quality improvement strategy and methodology is dependent upon the
nature of the quality improvement project. Many other strategies and tools for quality
improvement can be accessed at AHRQ’s quality tools Web site (www.qualitytools.ahrq.gov)
and patient safety Web site (www.patientsafety.gov).
QI Strategy Examples
Provider reminder systems • Reminders in charts for providers
• Computer-based reminders for providers
• Computer-based decision support
Facilitated relay of clinical data to providers • Transmission of clinical data from outpatient specialty clinic
to primary care provider by means other than medical record
(e.g., phone call or fax)
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QI Strategy Examples
Audit and feedback • Feedback of performance to individual providers
• Quality indicators and reports
• National/State quality report cards
• Publicly released performance data
• Benchmarking – provision of outcomes data from top
performers for comparison with provider’s own data
Provider education • Workshops and conferences
• Educational outreach visits (e.g., academic detailing)
• Distributed educational materials
Patient education • Classes
• Parent and family education
• Patient pamphlets
• Intensive education strategies promoting self-management
of chronic conditions
Patient reminder systems • Materials and devices promoting self-management
Promotion of self-management • Postcards or calls to patients
Organizational change • Case management, disease management
• TQM, CQI techniques
• Multidisciplinary teams
• Change from paper to computer-based records
• Increased staffing
• Skill-mix changes
Financial incentives, regulation, and policy Provider directed:
• Financial incentives based on achievement of performance
goals
• Alternative reimbursement systems (e.g., fee-for-service,
capitated payments)
• Licensure requirements
Patient directed:
• Copayments for certain visit types
• Health insurance premiums, user fees
Health system directed:
• Initiatives by accreditation bodies (e.g., residency work hour
limits)
• Changes in reimbursement schemes (e.g., capitation,
prospective payment, salaried providers)
Note: Reprinted with permission from AHRQ38 (pp. 17–18).
Quality improvement projects and strategies differ from research: while research attempts to
assess and address problems that will produce generalizable results, quality improvement
projects can include small samples, frequent changes in interventions, and adoption of new
strategies that appear to be effective.6 In a review of the literature on the differences between
quality improvement and research, Reinhardt and Ray42 proposed four criteria that distinguish
the two: (1) quality improvement applies research into practice, while research develops new
interventions; (2) risk to participants is not present in quality improvement, while research could
pose risk to participants; (3) the primary audience for quality improvement is the organization,
and the information from analyses may be applicable only to that organization, while research is
intended to be generalizable to all similar organizations; and (4) data from quality improvement
is organization-specific, while research data are derived from multiple organizations.
The lack of scientific health services literature has inhibited the acceptance of quality
improvement methods in health care,43, 44 but new rigorous studies are emerging. It has been
asserted that a quality improvement project can be considered more like research when it
involves a change in practice, affects patients and assesses their outcomes, employs
4
Quality Methods, Benchmarking
Plan-Do-Study-Act (PDSA)
Quality improvement projects and studies aimed at making positive changes in health care
processes to effecting favorable outcomes can use the Plan-Do-Study-Act (PDSA) model. This is
a method that has been widely used by the Institute for Healthcare Improvement for rapid cycle
improvement.31, 49 One of the unique features of this model is the cyclical nature of impacting
and assessing change, most effectively accomplished through small and frequent PDSAs rather
than big and slow ones,50 before changes are made systemwide.31, 51
The purpose of PDSA quality improvement efforts is to establish a functional or causal
relationship between changes in processes (specifically behaviors and capabilities) and
outcomes. Langley and colleagues51 proposed three questions before using the PDSA cycles: (1)
What is the goal of the project? (2) How will it be known whether the goal was reached? and (3)
What will be done to reach the goal? The PDSA cycle starts with determining the nature and
scope of the problem, what changes can and should be made, a plan for a specific change, who
should be involved, what should be measured to understand the impact of change, and where the
strategy will be targeted. Change is then implemented and data and information are collected.
Results from the implementation study are assessed and interpreted by reviewing several key
measurements that indicate success or failure. Lastly, action is taken on the results by
implementing the change or beginning the process again.51
Six Sigma
Six Sigma, originally designed as a business strategy, involves improving, designing, and
monitoring process to minimize or eliminate waste while optimizing satisfaction and increasing
financial stability.52 The performance of a process—or the process capability—is used to
measure improvement by comparing the baseline process capability (before improvement) with
the process capability after piloting potential solutions for quality improvement.53 There are two
primary methods used with Six Sigma. One method inspects process outcome and counts the
defects, calculates a defect rate per million, and uses a statistical table to convert defect rate per
million to a σ (sigma) metric. This method is applicable to preanalytic and postanalytic processes
(a.k.a. pretest and post-test studies). The second method uses estimates of process variation to
predict process performance by calculating a σ metric from the defined tolerance limits and the
variation observed for the process. This method is suitable for analytic processes in which the
precision and accuracy can be determined by experimental procedures.
One component of Six Sigma uses a five-phased process that is structured, disciplined, and
rigorous, known as the define, measure, analyze, improve, and control (DMAIC) approach.53, 54
To begin, the project is identified, historical data are reviewed, and the scope of expectations is
defined. Next, continuous total quality performance standards are selected, performance
objectives are defined, and sources of variability are defined. As the new project is implemented,
data are collected to assess how well changes improved the process. To support this analysis,
validated measures are developed to determine the capability of the new process.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3
Six Sigma and PDSA are interrelated. The DMAIC methodology builds on Shewhart’s plan,
do, check, and act cycle.55 The key elements of Six Sigma is related to PDSA as follows: the plan
phase of PDSA is related to define core processes, key customers, and customer requirements of
Six Sigma; the do phase of PDSA is related to measure performance of Six Sigma; the study
phase of PDSA is related to analyze of Six Sigma; and the act phase of PDSA is related to
improve and integrate of Six Sigma.56
6
Quality Methods, Benchmarking
the root cause of most problems.2, 4 A similar procedure is critical incident technique, where after
an event occurs, information is collected on the causes and actions that led to the event.63
An RCA is a reactive assessment that begins after an event, retrospectively outlining the
sequence of events leading to that identified event, charting causal factors, and identifying root
causes to completely examine the event.66 Because it is a labor-intensive process, ideally a
multidisciplinary team trained in RCA triangulates or corroborates major findings and increases
the validity of findings.67 Taken one step further, the notion of aggregate RCA (used by the
Veterans Affairs (VA) Health System) is purported to use staff time efficiently and involves
several simultaneous RCAs that focus on assessing trends, rather than an in-depth case
assessment.68
Using a qualitative process, the aim of RCA is to uncover the underlying cause(s) of an error
by looking at enabling factors (e.g., lack of education), including latent conditions (e.g., not
checking the patient’s ID band) and situational factors (e.g., two patients in the hospital with the
same last name) that contributed to or enabled the adverse event (e.g., an adverse drug event).
Those involved in the investigation ask a series of key questions, including what happened, why
it happened, what were the most proximate factors causing it to happen, why those factors
occurred, and what systems and processes underlie those proximate factors. Answers to these
questions help identify ineffective safety barriers and causes of problems so similar problems can
be prevented in the future. Often, it is important to also consider events that occurred
immediately prior to the event in question because other remote factors may have contributed.68
The final step of a traditional RCA is developing recommendations for system and process
improvement(s), based on the findings of the investigation.68 The importance of this step is
supported by a review of the literature on root-cause analysis, where the authors conclude that
there is little evidence that RCA can improve patient safety by itself.69 A nontraditional strategy,
used by the VA, is aggregate RCA processes, where several simultaneous RCAs are used to
examine multiple cases in a single review for certain categories of events.68, 70
Due the breadth of types of adverse events and the large number of root causes of errors,
consideration should be given to how to differentiate system from process factors, without
focusing on individual blame. The notion has been put forth that it is a truly rare event for errors
to be associated with irresponsibility, personal neglect, or intention,71 a notion supported by the
IOM.4, 72 Yet efforts to categorize individual errors—such as the Taxonomy of Error Root Cause
Analysis of Practice Responsibility (TERCAP), which focuses on “lack of attentiveness, lack of
agency/fiduciary concern, inappropriate judgment, lack of intervention on the patient’s behalf,
lack of prevention, missed or mistaken MD/healthcare provider’s orders, and documentation
error”73 (p. 512)—may distract the team from investigating systems and process factors that can
be modified through subsequent interventions. Even the majority of individual factors can be
addressed through education, training, and installing forcing functions that make errors difficult
to commit.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3
proactively identify steps in a process that could reduce or eliminate future failures.77 The goal of
FMEA is to prevent errors by attempting to identifying all the ways a process could fail, estimate
the probability and consequences of each failure, and then take action to prevent the potential
failures from occurring. In health care, FMEA focuses on the system of care and uses a
multidisciplinary team to evaluate a process from a quality improvement perspective.
This method can be used to evaluate alternative processes or procedures as well as to monitor
change over time. To monitor change over time, well-defined measures are needed that can
provide objective information of the effectiveness of a process. In 2001, the Joint Commission
mandated that accredited health care providers conduct proactive risk management activities that
identify and predict system weaknesses and adopt changes to minimize patient harm on one or
two high-priority topics a year.78
HFMEA. Developed by the VA’s National Center for Patient Safety, the health failure
modes and effects analysis (HFMEA) tool is used for risk assessment. There are five steps in
HFMEA: (1) define the topic; (2) assemble the team; (3) develop a process map for the topic,
and consecutively number each step and substep of that process; (4) conduct a hazard analysis
(e.g., identify cause of failure modes, score each failure mode using the hazard scoring matrix,
and work through the decision tree analysis);79 and (5) develop actions and desired outcomes. In
conducting a hazard analysis, it is important to list all possible and potential failure modes for
each of the processes, to determine whether the failure modes warrant further action, and to list
all causes for each failure mode when the decision is to proceed further. After the hazard
analysis, it is important to consider the actions needed to be taken and outcome measures to
assess, including describing what will be eliminated or controlled and who will have
responsibility for each new action.79
Research Evidence
Fifty studies and quality improvement projects were included in this analysis. The findings
were categorized by type of quality method employed, including FMEA, RCA, Six Sigma, Lean,
and PDSA. Several common themes emerged: (1) what was needed to implement quality
improvement strategies, (2) what was learned from evaluating the impact of change
interventions, and (3) what is known about using quality improvement tools in health care.
8
Quality Methods, Benchmarking
underway to change practice, and that quality improvement needed to be incorporated into
systemwide leadership development.88 Leadership was needed to make patient safety a key
aspect of all meetings and strategies,85, 86 to create a formal process for identifying annual patient
safety goals for the organization, and to hold themselves accountable for patient safety
outcomes.85
Even with strong and committed leadership, some people within the organization may be
hesitant to participate in quality improvement efforts because previous attempts to create change
were hindered by various system factors,93 a lack of organization-wide commitment,94 poor
organizational relationships, and ineffective communication.89 However the impact of these
barriers were found to be lessened if the organization embraced the need for change,95 changed
the culture to enable change,90 and actively pursued institutionalizing a culture of safety and
quality improvement. Yet adopting a nonpunitive culture of change took time,61, 90 even to the
extent that the legal department in one hospital was engaged in the process to turn the focus to
systems, not individual-specific issues.96 Also, those staff members involved in the process felt
more at ease with improving processes, particularly when cost savings were realized and when
no layoff policies were put in place to protect job security even when efficiencies were
realized.84
The improvement process needed to engage97 and involve all stakeholders and gain their
understanding that the investment of resources in quality improvement could be recouped with
efficiency gains and fewer adverse events.86 Stakeholders were used to (1) prioritize which safe
practices to target by developing a consensus process among stakeholders86, 98 around issues that
were clinically important, i.e., hazards encountered in everyday practice that would make a
substantial impact on patient safety; (2) develop solutions to the problems that required
addressing fundamental issues of interdisciplinary communication and teamwork, which were
recognized as crucial aspects of a culture of safety; and (3) build upon the success of other
hospitals.86 In an initiative involving a number of rapid-cycle collaboratives, successful
collaboratives were found to have used stakeholders to determine the choice of subject, define
objectives, define roles and expectations, motivate teams, and use results from data analyses.86
Additionally, it was important to take into account the different perspectives of stakeholders.97
Because variation in opinion among stakeholders and team members was expected99 and
achieving buy-in from all stakeholders could have been difficult to achieve, efforts were made to
involve stakeholders early in the process, solicit feedback,100 and gain support for critical
changes in the process.101
Communication and sharing information with stakeholders and staff was critical to
specifying the purpose and strategy of the quality initiative;101 developing open channels of
communication across all disciplines and at all levels of leadership/staff, permitting the voicing
of concerns and observations throughout the process of creating change;88 ensuring that patients
and families were appropriately included in the dialogue; ensuring that everyone involved felt
that he or she was an integral part of the health care team and was responsible for patient safety;
sharing lessons learned from root-cause analysis; and capturing attention and soliciting buy-in by
sharing patient safety stories with staff and celebrating successes, no matter how small.85 Yet in
trying to keep everyone informed of the process and the data behind decisions, some staff had
difficulty accepting system changes made in response to the data.89
The successful work of these strategies was dependent upon having motivated80 and
empowered teams. There were many advantages to basing the work of the quality improvement
strategies on the teamwork of multidisciplinary teams that would review data and lead change.91
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These teams needed to be comprised of the right staff people,91, 92 include peers,102 engage all of
the right stakeholders (ranging from senior managers to staff), and be supported by senior-level
management/leadership.85, 86 Specific stakeholders (e.g., nurses and physicians) had to be
involved81 and supported to actually make the change, and to be the champions103 and problem-
solvers within departments59 for the interventions to succeed. Because implementing the quality
initiatives required substantial changes in the clinician’s daily work,86 consideration of the
attitude and willingness of front-line staff for making the specific improvements59, 88, 104 was
needed.
Other key factors to improvement success were implementing protocols that could be
adapted to the patient’s needs93 and to each unit, based on experience, training, and culture.88 It
was also important to define and test different approaches; different approaches can converge
and arrive at the same point.81 Mechanisms that facilitated staff buy-in was putting the types and
causes of errors in the forefront of providers’ minds, making errors visible,102 being involved in
the process of assessing work and looking for waste,59 providing insight as to whether the
improvement project would be feasible and its impact measurable,105 and presenting evidence-
based changes.100 Physicians were singled out as the one group of clinicians that needed to
lead106 or be actively involved in changes,86 especially when physician behaviors could create
inefficiencies.84 In one project, physicians were recruited as champions to help spread the word
to other physicians about the critical role of patient safety, to make patient safety a key aspect of
all leadership and medical management meetings and strategies.85
Team leaders and the composition of the team were also important. Team leaders that
emphasized efforts offline to help build and improve relationships were found to be necessary for
team success.83, 93 These teams needed a dedicated team leader who would have a significant
amount of time to put into the project.84 While the leader was not identified in the majority of
reports reviewed for this paper, the team on one project was co-chaired by a physician and an
administrator.83 Not only did the type and ability of team leaders affect outcomes, the visibility
of the initiative throughout the organization was dependent upon having visible champions.100
Multidisciplinary teams needed to understand the numerous steps involved in quality
improvement and that there were many opportunities for error, which essentially enabled teams
to prioritize the critical items to improve within a complex process and took out some of the
subjectivity from the analysis. The multidisciplinary structure of teams allowed members to
identify each step from their own professional practice perspective, anticipate and overcome
potential barriers, allowed the generation of diverse ideas, and allowed for good discussion and
deliberations, which together ultimately promoted team building.100, 107 In two of the studies,
FMEA/HFMEA was found to minimize group biases by benefiting from the diversity within
multidisciplinary composition of the team and enabling the team to focus on a structured outline
of the goals that needed to be accomplished.107, 108
Teams needed to be prepared and enabled to meet the demands of the quality initiatives with
ongoing education, weekly debriefings, review of problems solved and principles applied,84 and
ongoing monitoring and feedback opportunities.92, 95 Education and training of staff 95, 80, 95, 101, 104
and leadership 80 about the current problem, quality improvement tools, the planned change in
practice intervention, and updates as the project progressed were key strategies.92 Training was
an ongoing process 91 that needed to focus on skill deficits82 and needed to be revised as lessons
were learned and data was analyzed during the implementation of the project.109 The assumption
could not be made that senior staff or leadership would not need training.105 Furthermore, if the
team had no experience with the quality tools or successfully creating change, an additional
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Quality Methods, Benchmarking
resource could have been a consultant or someone to facilitate the advanced knowledge involved
in quality improvement techniques.106 Another consideration was using a model that intervened
at the hospital-community interface, coupled with an education program.97
The influence of teamwork processes enabled those within the team to improve relationships
across departments.89 Particular attention needed to be given to effective team building,110
actively following the impact of using the rapid-cycle (PDSA) model, meeting frequently, and
monitoring progress using outcome data analysis at least on a monthly basis.86 Effective
teamwork and communication, information transfer, coordination among multiple hospital
departments and caregivers, and changes to hospital organization culture were considered
essential elements of team effectiveness.86 Yet the impact of team members that had difficulty in
fully engaging in teamwork because of competing workloads (e.g., working double shifts) was
dampened.97 Better understanding of each other’s role is an important project outcome and
provides a basis for continuing the development of other practices to improve outcomes.97 The
work of teams was motivated through continual sharing of progress and success and celebration
of achievements.87
Teamwork can have many advantages, but only a few were discussed in the reports reviewed.
Teams were seen as being able to increase the scope of knowledge, improve communication
across disciplines, and facilitate learning about the problem.111 Teams were also found to be
proactive, 91 integrating tools that improve both the technical processes and organizational
relationships,83 and to work together to understand the current situation, define the problem,
pathways, tasks, and connections, as well as to develop a multidisciplinary action plan.59 But
teamwork was not necessarily an easy process. Group work was seen as difficult for some and
time consuming,111 and problems arose when everyone wanted their way,97 which delayed
convergence toward a consensus on actions. Team members needed to learn how to work with a
group and deal with group dynamics, confronting peers, conflict resolution, and addressing
behaviors that are detrimental.111
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3
assessment and management by using standardized metrics and assessment tools.80, 93, 100, 117 In
all of these initiatives, simplification and standardization were effective strategies.
Related to simplification and standardization is the potential benefit of using information
technology to implement checks, defaults, and automation to improve quality and reduce errors,
in large part to embedding forcing functions to remove the possibility of errors.96, 106 The effects
of human error could be mitigated by using necessary redundancy, such as double-checking for
certain types of errors; this was seen as engaging the knowledge and abilities of two skilled
practitioners 61, 101 and was used successfully to reduce errors associated with dosing.78
Information technology was successfully used to (1) decrease the opportunity for human error
through automation;61 (2) standardize medication concentrations78 and dosing using computer-
enabled calculations,115, 116 standardized protocols,101 and order clarity;116 (3) assist caregivers in
providing quality care using alerts and reminders; (4) improve medication safety (e.g.,
implementing bar coding and computerized provider order entry); and (5) track performance
through database integration and indicator monitoring. Often workflow and procedures needed to
be revised to keep pace with technology.78 Using technology implied that organizations were
committed to investing in technology to enable improvement,85 but for two initiatives, the lack of
adequate resources for data collection impacted analysis and evaluation of the initiative.93, 97
Data and information were needed to understand the root causes of errors and near errors,99
to understand the magnitude of adverse events,106 to track and monitor performance,84, 118 and to
assess the impact of the initiatives.61 Reporting of near misses, errors, and hazardous conditions
needs to be encouraged.96 In part, this is because error reporting is generally low and is
associated with organizational culture106 and can be biased, which will taint results.102
Organizations not prioritizing reporting or not strongly emphasizing a culture of safety may have
the tendency to not report errors that harm patients or near misses (see Chapter 35. “Evidence
Reporting and Disclosure”). Using and analyzing data was viewed as critical, yet some team
members and staff may have benefited from education on how to effectively analyze and display
findings.106 Giving staff feedback by having a transparent process39 of reporting findings82 was
viewed as a useful trigger that brought patient safety to the forefront of the hospital.107 It follows
then that not having data, whether because it was not reported or not collected, made statistical
analysis of the impact of the initiative115 or assessing its cost-benefit ratio not possible.108 As
such, multi-organizational collaboration should have a common database.98
The meaning of data can be better understood by using measures and benchmarks. Repeated
measurements were found to be useful for monitoring progress,118 but only when there was a
clear metric for measuring the degree of success.83 The use of measures could be used as a
strategy to involve more clinicians and deepened their interest, especially physicians. Using
objective, broader, and better measures was viewed as being important for marking progress, and
provided a basis for “a call to action” and celebration.106 When measures of care processes were
used, it was asserted that there was a need to demonstrate the relationship between specific
changes to care processes and outcomes.61
When multiple measures were used, along with better documentation of care, it was easier to
assess the impact of the initiative on patient outcomes.93 Investigators from one initiative put
forth the notion that hospital administrators should encourage more evaluations of initiatives and
that the evaluations should focus on comprehensive models that assess patient outcomes, patient
satisfaction, and cost effectiveness.114 The assessment of outcomes can be enhanced by setting
realistic goals, not unrealistic goals such as 100 percent change,119 and by comparing
organizational results to recognized State, regional, and national benchmarks.61, 88
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Quality Methods, Benchmarking
The cost of the initiative was an viewed as important factor in the potential for improvement,
even when the adverse effects of current processes were considered as necessitating rapid
change.106 Because of this, it is important to implement changes that are readily feasible106 and
can be implemented with minimal disruption of practice activities.99 It is also important to
consider the potential of replicating the initiative in other units or at other sites.99 One strategy to
improve the chances of replication is to standardize processes, which will most likely incur some
cost.106 In some respects, the faster small problems were resolved, the faster improvements could
be replicated throughout the entire system.84, 106 Recommendations that did not incur costs or had
low costs and could be demonstrated to be effective were implemented expeditiously.93, 107 A
couple of investigators stated that their interventions decreased costs and patients’ length of
stay,103 but did not present any data to verify those statements. It was also purported that the
costs associated with change will be recouped either in return on investment or in reduced patient
risk (and thus reduced liability costs).61
Ensuring that those implementing the initiative receive education is critical. There were
several examples of this. Two initiatives that targeted pain management found that educating
staff on pain management guidelines and protocols for improving chronic pain assessment and
management improved staff understanding, assessment and documentation, patient and family
satisfaction, and pain management.80, 93 Another initiative educated all staff nurses on
intravenous (IV) site care and assessment, as well as assessment of central lines, and realized
improved patient satisfaction and reduced complications and costs.109
Despite the benefits afforded by the initiatives, there were many challenges that were
identified in implementing the various initiatives:
• Lack of time and resources made it difficult to implement the initiative well.82
• Some physicians would not accept the new protocol and thwarted implementation until
they had confidence in the tool.103
• Clear expectations were lacking. 86
• Hospital leadership was not adequately engaged.86
• There was insufficient emphasis on importance and use of measures.86
• The number and type of collaborative staffing was insufficient.86
• The time required for nurses and other staff to implement the changes was
underestimated.120
• The extent to which differences in patient severity accounted for results could not be
evaluated because severity of illness was not measured.89
• Improvements associated with each individual PDSA cycle could not be evaluated.89
• The full impact on the costs of care, including fixed costs for overhead, could not be
evaluated.89
• Failure to consider the influence of factors such as fatigue, distraction, time pressures.82
• The Hawthorne effect may have caused improvements more so than the initiative.118
• Many factors were interrelated and correlated.96
• There was a lack of generalizability because of small sample size.93, 119
• Addressing some of the problems created others (e.g., implementing computerized
physician order entry (CPOE)).110
• Targets set (e.g., 100 percent of admissions) may have been too ambitious and were thus
always demanding and difficult-to-achieve service improvements.119
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3
Despite the aforementioned challenges, many investigators found that it was important to
persevere and stay focused because introducing new processes can be difficult, 84, 100 but the
reward of quality improvement is worth the effort.84 Implementing quality improvement
initiatives was considered time consuming, tedious, and difficult for people who are very action
oriented; it required an extensive investment of resources (i.e., time, money, and energy);94 and it
involved trial and error to improve the process.91 Given theses and other challenges, it was also
important to celebrate the victories.84
Other considerations were given to the desired objective of sustaining the changes after the
implementation phase of the initiative ended.105 Investigators asserted that improving quality
through initiatives needed to be considered as integral in the larger, organizationwide, ongoing
process of improvement. Influential factors attributed to the success of the initiatives were
effecting practice changes that could be easily used at the bedside;82 using simple
communication strategies; 88 maximizing project visibility, which could sustain the momentum
for change;100 establishing a culture of safety; and strengthening the organizational and
technological infrastructure.121 However, there were opposing viewpoints about the importance
of spreading the steps involved in creating specific changes (possibly by forcing changes into the
redesign of processes), rather than only relying on only adapting best practices.106, 121 Another
factor was the importance of generating enthusiasm about embracing change through a
combination of collaboration (both internally and externally)103 and healthy competition.
Collaboratives could also be a vehicle for encouraging the use of and learning from evidence-
based practice and rapid-cycle improvement as well as identifying and gaining consensus on
potentially better practices.86, 98
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Quality Methods, Benchmarking
became at implementing it and the more effective the results.84 Yet it was noted that to use this
strategy effectively, a substantial commitment of leadership time and resources was associated
with improved patient safety, lowered costs, and increased job satisfaction.84 Six Sigma was also
an important strategy for problem-solving and continuous improvement; communicating clearly
about the problem; guiding the implementation process; and producing results in a clear, concise,
and objective way.59
Plan-Do-Study-Act (PDSA) was used by the majority of initiatives included in this analysis
to implement initiatives gradually, while improving them as needed. The rapid-cycle aspect of
PDSA began with piloting a single new process, followed by examining results and responding
to what was learned by problem-solving and making adjustments, after which the next PDSA
cycle would be initiated. The majority of quality improvement efforts using PDSA found greater
success using a series of small and rapid cycles to achieve the goals for the intervention, because
implementing the initiative gradually allowed the team to make changes early in the process80
and not get distracted or sidetracked by every detail and too many unknowns.87, 119, 122 The ability
of the team to successfully use the PDSA process was improved by providing instruction and
training on the use of PDSA cycles, using feedback on the results of the baseline
measurements,118 meeting regularly,120 and increasing the team’s effectiveness by collaborating
with others, including patients and families,80 to achieve a common goal.87 Conversely, some
teams experienced difficulty in using rapid-cycle change, collecting data, and constructing run
charts,86 and one team reported that applying simple rules in PDSA cycles may have been more
successful in a complex system.93
Failure modes and effects analysis (FMEA) was used to avoid events and improve or
maintain the quality of care.123 FMEA was used prospectively to identify potential areas of
failure94 where experimental characterization of the process at the desired speed of change could
be assessed,115 and retrospectively to characterize the safety of a process by identifying potential
areas of failure, learning about the process from the staff’s point of view.94 Using a flow chart of
the process before beginning the analysis got the team to focus and work from the same
document.94 Information learned from FMEA was used to provide data for prioritizing
improvement strategies, serve as a benchmark for improvement efforts,116 educate and provide a
rationale for diffusion of these practice changes to other settings,115 and increase the ability of the
team to facilitate change across all services and departments within the hospital.124 Using FMEA
facilitated systematic error management, which was important to good clinical care in complex
processes and complex settings, and was dependent upon a multidisciplinary approach,
integrated incident and error reporting, decision support, standardization of terminology, and
education of caregivers.116
Health failure modes and effects analysis (HFMEA) was used to provide a more detailed
analysis of smaller processes, resulting in more specific recommendations, as well as larger
processes. HFEMA was viewed as a valid tool for proactive analysis in hospitals, facilitating a
very thorough analysis of vulnerabilities (i.e., failure modes) before adverse events occurred.108
This tool was considered valuable in identifying the multifactoral nature of most errors108 and the
potential risk for errors,111 but was seen as being time consuming.107 Initiatives that used
HFMEA could minimize group biases through the multidisciplinary composition of the
team78, 108, 115 and facilitate teamwork by providing a step-by-step process,107 but these initiatives
required a paradigm shift for many.111
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16
Quality Methods, Benchmarking
Research Implications
Given the complexity of health care, assessing quality improvement is a dynamic and
challenging area. The body of knowledge is slowly growing in this area, which could be due to
the continued dilemma as to whether a quality improvement initiative is just that or whether it
meets the definition of research and employs methodological rigor—even if it meets the
requirements for publication. Various quality improvement methods have been used since
Donabedian’s seminal publication in 1966,27 but only recently has health care quality
improvement used the Six Sigma methodology and published findings; when it has, it has been
used only on a single, somewhat isolated component of a larger system, making organizational
learning and generalizability difficult. Because of the long standing importance of quality
improvement, particularly driven by external sources (e.g., CMS and the Joint Commission) in
the past few years, many quality improvement efforts within organizations have taken place and
are currently in process, but may not have been published and therefore not captured in this
review, and may not have necessarily warranted publication in the peer-reviewed literature. With
this in mind, researchers, leaders and clinicians will need to define what should be considered
generalizable and publishable in the peer-reviewed literature to move the knowledge of quality
improvement methods and interventions forward.
While the impact of many of the quality improvement projects included in this analysis were
mentioned in terms of clinical outcomes, functional outcomes, patient satisfaction, staff
satisfaction, and readiness to change, cost and utilization outcomes and measurement is
important in quality improvement efforts, especially when variation occurs. There are many
unanswered questions. Some key areas are offered for consideration:
• How can quality improvement efforts recognize the needs of patients, insurers,
regulators, patients, and staff and be successful?
• What is the best method to identify priorities for improvement and meet the competing
needs of stakeholders?
• What is the threshold of variation that needs to be attained to produce regular desired
results?
• How can a bottom-up approach to changing clinical practice be successful if senior
leadership is not supportive or the organizational culture does not support change?
In planning quality improvement initiatives or research, researchers should use a conceptual
model to guide their work, which the aforementioned quality tools can facilitate. To generalize
empirical findings from quality improvement initiatives, more consideration should be given to
increasing sample size by collaborating with other organizations and providers. We need to have
a better understanding of what tools work the best, either alone or in conjunction with other
tools. It is likely that mixed methods, including nonresearch methods, will offer a better
understanding of the complexity of quality improvement science. We also know very little about
how tailoring implementation interventions contributes to process and patient outcomes, or what
the most effective steps are that cross intervention strategies. Lastly, we do not know what
strategies or combination of strategies work for whom and in what context, why they work in
some settings or cases and not others, and what the mechanism is by which these strategies or
combination of strategies work.
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Patient Safety and Quality: An Evidence-Based Handbook for Nurses: Vol. 3
Conclusions
Whatever the acronym of the method (e.g., TQM, CQI) or tool used (e.g., FMEA or Six
Sigma), the important component of quality improvement is a dynamic process that often
employs more than one quality improvement tool. Quality improvement requires five essential
elements for success: fostering and sustaining a culture of change and safety, developing and
clarifying an understanding of the problem, involving key stakeholders, testing change strategies,
and continuous monitoring of performance and reporting of findings to sustain the change.
Search Strategy
To identify quality improvement efforts for potential inclusion in this systematic review,
PubMed and CINAL were searched from 1997 to present. The following key words and terms
were used: “Failure Modes and Effects Analysis/FMEA,” “Root Cause Analysis/RCA,” “Six
Sigma,” “Toyota Production System/Lean,” and “Plan Do Study Act/PDSA.” Using these key
words, 438 articles were retrieved. Inclusion criteria included reported processes involving
nursing; projects/research involving methods such as FMEA, RCA, Six Sigma, Lean, or PDSA;
qualitative and quantitative analyses; and reporting patient outcomes. Projects and research were
excluded if they did not involve nursing on the improvement team, did not provide sufficient
information to describe the process used and outcomes realized, nursing was not directly
involved in the patient/study outcomes, or the setting was in a developing country. Findings from
the projects and research included in the final analysis were grouped into common themes related
to applied quality improvement.
Author Affiliation
Ronda G. Hughes, Ph.D., M.H.S., R.N., senior health scientist administrator, Agency for
Healthcare Research and Quality. E-mail: [email protected].
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and system causes of errors in nursing: a taxonomy. 87. Smith DS, Haig K. Reduction of adverse drug events
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safety. AORN J 2003;78:16-21. and errors: piloting lean principles at Intermountain
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75. Croteau RJ, Schyve PM. Proactively error-proofing
health care processes. In: Spath PL, ed. Error 89. Docimo AB, Pronovost PJ, Davis RO, et al. Using
reduction in health care: a systems approach to the online and offline change model to improve
improving patient safety. Chicago, IL: AHA Press, efficiency for fast-track patients in an emergency
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76. Williams E, Talley R. The use of failure mode effect 90. Gowdy M, Godfrey S. Using tools to assess and
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subcommittee. Hosp Pharm 1994;29:331-6, 339. 2003;29(7):363-8.
77. Reiling GJ, Knutzen BL, Stoecklein M. FMEA–the 91. Germaine J. Six Sigma plan delivers stellar results.
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92. Semple D, Dalessio L. Improving telemetry alarm
78. Adachi W, Lodolce AE. Use of failure mode and response to noncritical alarms using a failure mode
effects analysis in improving safety of IV drug and effects analysis. J Healthc Qual 2004;26(5):Web
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93. Erdek MA, Pronovost PJ. Improving assessment and
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National Center for Patient Safety’s Prospective Risk
Analysis System. J Qual Improv 2002;28(5):248-67.
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94. Burgmeier J. Failure mode and effect analysis: an 108. van Tilburg CM, Liestikow IP, Rademaker CMA, et
application in reducing risk in blood transfusion. J al. Health care failure mode and effect analysis: a
Qual Improv 2002;28(6):331-9. useful proactive risk analysis in a pediatric oncology
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95. Mutter M. One hospital’s journey toward reducing
medication errors. Jt Comm J Qual Patient Saf 109. Eisenberg P, Painer JD. Intravascular therapy process
2003;29(6):279-88. improvement in a multihospital system: don’t get
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96. Rex JH, Turnbull JE, Allen SJ, et al. Systematic root 2002;182-6.
cause analysis of adverse drug events in a tertiary
referral hospital. J Qual Improv 2000;26(10):563-75. 110. Singh R, Servoss T, Kalsman M, et al. Estimating
impacts on safety caused by the introduction of
97. Bolch D, Johnston JB, Giles LC, et al. Hospital to electronic medical records in primary care. Inform
home: an integrated approach to discharge planning Prim Care 2004;12:235-41.
in a rural South Australian town. Aust J Rural Health
2005;13:91-6. 111. Papastrat K, Wallace S. Teaching baccalaureate
nursing students to prevent medication errors using a
98. Horbar JD, Plsek PE, Leahy K. NIC/Q 2000: problem-based learning approach. J Nurs Educ
establishing habits for improvement in neonatal 2003;42(10:459-64.
intensive care units. Pediatrics 2003;111:d397-410.
112. Berwick DM. Continuous improvement as an ideal in
99. Singh R, Singh A, Servoss JT, et al. Prioritizing health care. N Engl J Med 1989;320(1):53-6.,
threats to patient safety in rural primary care. Inform
Prim Care. 2007;15(4):221-9. 113. Pexton C, Young D. Reducing surgical site infections
through Six Sigma and change management. Patient
100. Dunbar AE, Sharek PJ, Mickas NA, et al. Safety Qual Healthc [e-Newsletter]. 2004. Available
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better practices to improve pain management of Accessed November 14, 2007.
neonates. Pediatrics 2006;118(Supplement 2):S87-94.
114. Salvador A, Davies B, Fung KFK, et al. Program
101. Weir VL. Best-practice protocols: preventing adverse evaluation of hospital-based antenatal home care for
drug events. Nurs Manage 2005;36(9):24-30. high-risk women. Hosp Q 2003;6(3):67-73.
102. Plews-Ogan ML, Nadkarni MM, Forren S, et al. 115. Apkon M, Leonard J, Probst L, et al. Design of a
Patient safety in the ambulatory setting. A clinician- safer approach to intravenous drug infusions: failure
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25. 2004;13:265-71.
103. Baird RW. Quality improvement efforts in the 116. Kim GR, Chen AR, Arceci RJ, et al. Computerized
intensive care unit: development of a new heparin order entry and failure modes and effects analysis.
protocol. BUMC Proceedings 2001;14:294-6. Arch Pediatr Adolesc Med 2006;160:495-8.
104. Luther KM, Maguire L, Mazabob J, et al. Engaging 117. Horner JK, Hanson LC, Wood D, et al. Using quality
nurses in patient safety. Crit Care Nurs Clin N Am improvement to address pain management practices
2002;14(4):341-6. in nursing homes. J Pain Symptom Manage.
2005;30(3):271-7.
105. Middleton S, Chapman B, Griffiths R, et al.
Reviewing recommendations of root cause analyses. 118. van Tiel FH, Elenbaas TW, Voskuilen BM, et al.
Aust Health Rev 2007;31(2):288-95. Plan-do-study-act cycles as an instrument for
improvement of compliance with infection control
106. Farbstein K, Clough J. Improving medication safety measures in care of patients after cardiothoracic
across a multihospital system. J Qual surgery. J Hosp Infect 2006;62:64-70.
Improv2001;27(3):123-37.
119. Dodds S, Chamberlain C, Williamson GR, et al.
107. Esmail R, Cummings C, Dersch D, et al. Using Modernising chronic obstructive pulmonary disease
healthcare failure mode and effect analysis tool to admissions to improve patient care: local outcomes
review the process of ordering and administrating from implementing the Ideal Design of Emergency
potassium chloride and potassium phosphate. Healthc Access project. Accid Emerg Nurs. 2006
Q 2005;8:73-80. Jul;14(3):141-7.
22
Quality Methods, Benchmarking
120. Warburton RN, Parke B, Church W, et al. 124. Day S, Dalto J, Fox J, et al. Failure mode and effects
Identification of seniors at risk: process evaluation of analysis as a performance improvement tool in
a screening and referral program for patients aged > trauma. J Trauma Nurs 2006;13(3):111-7.
75 in a community hospital emergency department.
Int J Health Care Qual Assur 2004;17(6):339-48. 125. Johnson T, Currie G, Keill P, et al. New York-
Presbyterian hospital: translating innovation into
121. Nowinski CV, Mullner RM. Patient safety: solutions practice. Jt Comm J Qual Patient Saf
in managed care organizations? Q Manage Health 2005;31(10):554-60.
Care 2006;15(3):130-6.
126. Aldarrab A. Application of lean Six Sigma for
122. Wojciechowski E, Cichowski K. A case review: patients presenting with ST-elevation myocardial
designing a new patient education system. The infarction: the Hamilton Health Sciences experience.
Internet J Adv Nurs Practice 2007;8(2). Healthc Q 2006;9(1):56-60.
23
Evidence Table. Quality Methods
safety features.
Apkon 2004115 Medication safety Quality Infusion drug 11-bed pediatric None Standardization of the infusion delivery
improvement errors intensive care unit process, with the combined effect of
(Level 4) (ICU) in a prolonging infusion hang times from 24 to
children’s hospital 72 hours, shifting preparation to the
pharmacy, and purchasing
premanufactured solutions resulted in 1,500
fewer infusions prepared by nurses per
year; process changes preferred by nurses
and patients.
Quality or Safety Study Outcome Study Setting &
Source Issue Related to Design Type Measure(s) Study Study Key Finding(s)
Clinical Practice Population Intervention
Burgmeier Blood transfusion Quality Errors associated 1 hospital in Ohio Following the Following the new process changes for
94
2002 improvement with blood FMEA, blood transfusions, no outcome errors were
products implemented the reported within the first 3 months.
administered to following New process continued to be assessed,
patients changes: a finding more failures to be addressed, and
(Level 4) standardized data are aggregated and reported monthly.
form listing Flowcharting before beginning the FMEA
choices for blood process itself was important.
products and FMEA process was time consuming,
documenting tedious, and difficult.
medical
necessity, form is
faxed to the
blood bank; used
a blood-barrier
system; required
staff training; and
changes in
25
policies and
procedures.
Day 2006124 Dialysis treatment Quality Risks for error in 1 hospital in Utah None Risk factors included inconsistent
improvement the process of nephrology consult/dialysis communication
administering process; dialysis technicians performing
dialysis beyond their scope of work; scheduling
(Level 4) treatments for chronic dialysis patients
without a formal consult/order; nurses
inconsistently involved in dialysis process;
revised
documentation
flow sheets, and
provided a
resource manual.
Quality or Safety Study Outcome Study Setting &
Source Issue Related to Design Type Measure(s) Study Study Key Finding(s)
Clinical Practice Population Intervention
Erdek 200493 Pain management Prospective Pain 2 surgical ICUs in Implemented 4 Pain assessment improved from 42% to
study management and 1 hospital in PDSA cycles, 71%, and pain management improved from
assessment Maryland including 59% to 97%.
(Level 4) educating staff Documentation of pain assessment
on pain improved among nurses.
management,
modifying pain
scales at
patients’
bedsides,
residents
documenting
pain scores for
past 24 hours,
and creating
expectation that
pain > 3 is a
defect.
31
Farbstein Medication safety Quality Types of 6 improvement Implementation The results presented from the 6
106
2001 improvement medication projects in of best practices, improvement projects included faster
administration hospitals in using PDSA to therapeutic anticoagulation for patients
errors Massachusetts assess impact receiving heparin; fewer look-alike/sound-
(Level 4) alike errors; fewer PCA administration
adverse events; safer administration of
coumadin; improved patient information on
their medication; and improved processing
of the morning dispensing of medications in
documentation of
medication
administration.
Redesigned oral
hygiene
processes, used
head positioning,
and used
collection and
culture
techniques for
better diagnosis.
Six Sigma
Germaine Surgical site Quality OR turnover 1 hospital in Implemented OR Turnover decreased from 34 minutes to an
91
2007 infections improvement (Level 4) Michigan turnaround average of 18 minutes, allowing volume to
OR patient protocol increase by 5%.
throughput Surgical site infections decreased from
2.14% to 1.07%.
Quality or Safety Study Outcome Study Setting &
Source Issue Related to Design Type Measure(s) Study Study Key Finding(s)
Clinical Practice Population Intervention
Guinane Groin injury in Quality Groin injury rates A team of Implemented Groin injuries decreased from 4% to less
81
2004 cardiac improvement (Level 4) physicians, groin than 1% (e.g., 41,666 defects to 8,849.5
catheterization nurses, and management defects) – sigma value improved from 3.23
patients administrators process to to 3.87.
involved in the decrease injury Length of stay that exceeded the specified
care of cardiac rates, reduce the upper limit decreased from 16% of the time
catheterization cost of care, and to only 3% of the time.
patients in 1 improve Operating costs that exceeded the specified
hospital customer upper limit decreased from 18% to 3% of
satisfaction the time.
Johnson Chest pain Quality Time for 1 hospital in New Implemented an Increases in diagnosis of cardiac disease,
125
2005 management improvement diagnosis and York algorithm, cardiac catheterization, and stenting/bypass
evidence-based preprinted surgery, especially in women, Latinos, and
treatment of orders, and use patients > 60 years old.
patients with of cardiac nurse
chest pain practitioners from
presentation in
ED through
37
discharge
Pexton Surgical site Quality Rate of colon and 1 medical center A preoperative Surgical site infection rates decreased by
2004113 infections improvement vascular surgical in West Virginia order set with a 91% (2.86 sigma), with an estimated
site infections checklist potential annual savings of more than $1
(Level 4) including million.
recommended
antibiotics and
weight-based
dosages,
Thompson Medication Quality Missing Pharmacy and Implemented: Rapid, substantial, and continuing
84
2003 administration improvement medications nursing units at 1 specific improvements in medication administration
Complexity of the hospital in processes were achieved.
medication Pennsylvania Nursing staff reported higher levels of
administration satisfaction, associated with workflow
process improvements.
(Level 4)
1
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
indicators identified potential quality-of-care problems and served as the starting point for further
investigation.
In 1998, under contract with AHRQ, researchers at the University of California, San
Francisco (UCSF) and the Stanford University Evidence-Based Practice Center (EPC) reviewed
and revised the original set of measures.5 This revision served to expand the HCUP Quality
Indicators by (1) identifying quality indicators reported in the literature and in use by health care
organizations, (2) evaluating both the HCUP Quality Indicators and other indicators using
literature reviews and empirical methods, and (3) incorporating risk adjustment. The revised set,
now known as the AHRQ QIs, originally included two modules: the PQIs released in April 2002,
and the IQIs released in June 2002. Other modules were eventually added based on requests from
the user community; specifically, the PSIs were released in May 2003, and the most recent set of
measures, the PDIs, were added to the existing QI modules in February 2006. An additional
module, the Neonatal Quality Indicators (NQIs), is currently under development and will be
released in the near future.
2
AHRQ Quality Indicators
The research team also undertook a literature review that was structured in two phases. The
first phase identified potential measures within the literature that were applicable to comparisons
among providers or among geographic areas. In addition, potential indicators were identified
using the various established databases of measures such as those from the Joint Commission for
the Accreditation of Healthcare Organizations, Healthy People 2010, and so on. In the second
phase of the literature review, the team performed an initial screen of the candidate indicators for
3
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
relevance and accuracy. If an indicator met the criteria as described in Table 2, it received a
comprehensive literature review and empirical evaluation.
The next phase of development was to identify potential risk-adjustment models for each of
the selected candidate measures. Users of the QIs preferred a risk-adjustment system that was (1)
open with published logic; 2) cost effective with data collection costs minimized and with any
additional data collection being well justified; (3) designed using a multiple-use coding system,
such as those used for reimbursement; and (4) officially recognized by government, hospital
groups, or other organizations. In general, the All Patient Refined-Diagnosis Related Groups
(APR-DRGs) tended to fit more of the user preferences than other alternatives considered. In
addition, the APR-DRGs were reported to perform as well as or better than other risk-adjustment
systems for several conditions.7–9 The APR-DRGs are used in various AHRQ QIs; however, this
method is not used with the PDIs, which use a novel and specialized risk-adjustment system that
includes the data element Present on Admission (POA), the AHRQ Clinical Classification
System, and stratification.
4
AHRQ Quality Indicators
on the NIS were provided for reference as well. Finally the panelists were given a list of potential
questions regarding indicator definitions that the team planned to explore. Each panelist
completed a 10-item questionnaire that asked them to determine the candidate indicator’s ability
to screen out conditions present on admission, to identify conditions with high potential for
preventability, to identify medical errors, or to evaluate access to high-quality outpatient care.
Panelist were also asked to consider potential sources of bias, reporting or charting problems,
potential ways of gaming the indicator, and possible adverse effects of implementing the
measure. Finally, panelists were invited to suggest changes to the candidate indicator.
After the questionnaires were returned, the team convened a series of conference calls with
the panelists to discuss their opinions regarding the candidate measures. Using a modified
version of the RAND/UCLA method developed in the 1980s. The RAND/UCLA
Appropriateness Method10 is used to synthesize the best available scientific evidence and expert
opinion on health care issues. This method is a way to reach formal agreement on how the
current science is interpreted by care givers in the real world. For the development of the QIs, the
primary goal of the interaction was to allow for and encourage varied opinions about the
appropriateness of an indicator. For our purposes, consensus was not the goal of the discussion,
and agreement and disagreement on every indicator under consideration was noted. Following
each conference call, modifications were made to each indicator as suggested by the panelists.
The revised indicators were then redistributed to the panelists, along with questionnaires, and
instructions to reevaluate and again rate each indicator based on their current opinion after the
conference call discussions. Once the final round of questionnaires was received, the team
calculated median scores to determine the degree of agreement among panelists. In addition, the
team calculated scores indicating the level of acceptability of the indicator and the dispersion of
ratings across the panel. The following criteria covered in the questionnaire were used to
summarize the panel’s options on each indicator:
• Overall usefulness of the indicator, both for internal quality improvement purposes and
comparisons between hospitals
• Likelihood that the indicator measures a complication and not a comorbidity
(specifically, present on admission)
• Preventability of complication
• Extent to which a complication is due to medical error
• Likelihood that a complication that occurs is charted
• Extent that the indicator is subject to bias (systematic differences, such as case mix, that
could affect the indicator in a way not related to quality of care)
For area-level indicators, panelists provided feedback on the following areas:
• Overall usefulness of the indicator, both internally within an area and for comparisons
between areas
• Extent to which an event reflects poor access to quality outpatient care
• Consistency in terminology for charting the principal diagnosis
• Extent that the indicator is subject to bias
The next step in the development process involved peer review of the candidate measures.
Nominations were sought for clinicians, policy advisors, professors, researchers, and managers
in quality improvement to participate on this panel. The group was instructed to provide
comments on the indicators with constructive suggestions for content and presentation
enhancements.
5
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
Once the panel reviews and evaluations were complete, the candidate indicators could go
through further empirical testing to refine their definitions. After that, the indicator may undergo
further clinical and peer review, which can occur over several rounds until the definition of the
indicator is finalized. As with any measure of performance, the process of refinement is ongoing
and becomes part of the measure maintenance activities of the measure developer. Figure 1
provides a graphic account of the basic development process.
As a measure developer, AHRQ maintains these measures and on an annual basis, provides
revisions to the measures, including ICD-9-CM and DRG code updates, an update to the
reference population used in calculating the QIs, and refinement of the specifications based on
additional evidence in the literature and user input. Literature reviews are completed on one QI
module every year, which allows time for new research to be completed and subsequently
published in peer reviewed journals.
6
AHRQ Quality Indicators
codes. Inclusion and exclusion criteria are based upon DRGs: sex, age, procedure dates, and
admission type. The numerator is equal to the number of cases flagged with the complication or
situation of interest, for example, postoperative sepsis, avoidable hospitalization for asthma, and
death. The denominator is equal to the number of patients considered to be at risk for that
complication or situation, for example, elective surgical patients, county population from census
data, and so on. The QI rate is equal to the numerator divided by the denominator. As with any
type of performance measure, regardless of its data source, there are advantages to using certain
measures as well as limitations associated with using them. What is presented below is a review
of the data source used by the QIs as well as a review of the indicators by module. The strengths
and limitations of the QIs are also discussed.
*
These are external causes of injury and poisoning that capture how the injury or poisoning happened, the intent,
and the place where the event occurred.
†
These are supplementary classification codes that document factors influencing health status and contact with
heath services, including such areas as health hazards related to communicable diseases, the need for isolation due to
other potential health hazards and prophylactic measures, and persons with conditions influencing their health status,
etc.
7
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
• Used to bill and pay for hospital services and contain information from the discharge claim.
• Standardized format, which is available electronically from all hospitals that bill for services.
• Used for health care quality research, evaluation, public reporting, and quality improvement.
• Typical data elements include patient gender, age, diagnoses, procedures, length of stay,
admission source, discharge status, total charges, primary payer, and hospital identifier.
• Depending on the data source, other data elements that may be available include patient race,
county or ZIP Code of residence, secondary payer, detailed charges, and identifier of primary
physician or surgeon.
• Data format and quality may differ across hospitals or data organizations, such as the number
of diagnosis and procedure codes available and the sequencing of the codes, the audits or
edits applied to the data before and after submission, and the data values accepted.
The AHRQ QIs are valuable because they are based on widely available data that can be used
to assess quality. Theses QI indicators also have uniform definitions and standardized algorithms
that can be used with virtually any administrative data set, which allows for comparisons across
States, regions, communities, and hospitals.
As with any data source used to assess performance, there are a number of drawbacks to
using administrative data to examine the quality of care delivered by health care providers.
Despite the large number of ICD-9-CM codes available and the implied detail they contain, these
codes do not have operational clinical definitions assigned, which make assignment by coders
somewhat variable. While coders are generally formally trained in coding methods and
instructed to use the terminology in the medical record, clinicians seldom use a consistent
lexicon in their charting. Thus, the meaning of codes without a clinical context, or without the
considerations of disease progression, and the interaction of comorbidities can provide an
inaccurate clinical picture—limiting the usefulness of the data. Yet despite this limitation, data
availability, coding systems, and coding practices are improving, which enhance our ability to
identify quality problems as well as success stories, which can be further identified and studied.
8
AHRQ Quality Indicators
9
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
delineate how much of the observed relationships are due to true access to care issues,
difficulties in potentially underserved populations, or other patient characteristics unrelated to
quality of care that vary systematically by socioeconomic status. Second, the evidence related to
potentially avoidable hospital admissions is limited for each indicator because many of the
indicators have been developed as parts of sets. Finally, despite the relationships demonstrated at
the patient level between higher quality ambulatory care and lower rates of hospital admission,
few studies have directly addressed the question of whether effective treatments in outpatient
settings would reduce the overall incidence of hospitalizations.
10
AHRQ Quality Indicators
The mortality indicators for inpatient conditions cover conditions for which mortality has
been shown to vary substantially across institutions and for which evidence suggests that high
mortality may be associated with deficiencies in the quality of care. The mortality indicators for
inpatient medical conditions are:
• Acute myocardial infarction (AMI) mortality rate
• AMI mortality rate, without transfer cases
• Congestive heart failure mortality rate
• Acute stroke mortality rate
• Gastrointestinal hemorrhage mortality rate
• Hip fracture mortality rate
• Pneumonia mortality rate
Also included in the IQIs are utilization indicators that examine procedures whose use varies
significantly across hospitals and for which questions have been raised about overuse, underuse,
or misuse. High or low rates for these indicators are likely to represent inappropriate or
inefficient delivery of care. The procedure utilization indicators are:
• Cesarean section delivery rate
• Primary cesarean delivery rate
• Vaginal birth after cesarean (VBAC) rate, all
• VBAC rate, uncomplicated
• Laparoscopic cholecystectomy rate
• Incidental appendectomy in the elderly rate
• Bilateral cardiac catheterization rate
There are currently 28 IQIs that are measured at the provider or hospital level, as well as 4
area-level indicators that are suited for use at the population or regional level. These 4 indicators,
which are utilization measures, include:
• CABG area rate
• Hysterectomy area rate
• Laminectomy or spinal fusion area rate
• PTCA area rate
The IQIs can be used by a variety of stakeholders in the health care arena to improve quality
of care at the level of individual hospitals, the community, the State, or the Nation. The IQIs
represent advancement in assessing quality of care using hospital administrative data. While
these data are relatively inexpensive and convenient to use and represent a rich data source that
can provide valuable information, like other data sources that have various limitations, the data
should be used carefully when assessing and interpreting the quality of health care within an
institution.
11
Patient Safety and Quality: An Evidence-Based Handbook for Nurses
12
AHRQ Quality Indicators
medical record systems, to improving staff awareness of patient safety risks. Clinical process
interventions also present strong evidence for reducing the risk of adverse events related to a
patient’s exposure to hospital care. These PSIs can be used to better prioritize and evaluate local
and national initiatives. Some potential actions, after an in-depth analysis of the system and
process of care, include the following:
• Review and synthesize the evidence base and best practices from scientific literature.
• Work with the multiple disciplines and departments involved in care of surgical patients
to redesign care based on best practices with an emphasis on coordination and
collaboration.
• Evaluate information technology solutions.
• Implement performance measurements for improvement and accountability.
The ability to assess all patients at risk for a particular patient safety problem, along with the
relative low cost of collecting the data, are particular strengths of the datasets that use
administrative data. However, many important areas of interest, such as adverse drug events,
cannot currently be monitored well using administrative data and using this data source to
identify patient safety events tends to favor specific types of indicators. For example, the PSIs
cited in this chapter contain a large proportion of surgical indicators, rather than medical or
psychiatric measures, because medical or psychiatric complications are often difficult to
distinguish from comorbidities that are present on admission. In addition, medical populations
tend to be more heterogeneous than surgical populations, especially elective surgical
populations, making it difficult to account for case mix.
While PSIs may be more applicable to patient safety when limited to elective surgical
admissions, the careful use of administrative data holds promise to identify problems for further
analysis and study. The limitations of this measure set include those inherent with the use of
administrative data, clinical accuracy of the discharged-based diagnosis coding, and indicator
discriminatory power. Specifically,
• Administrative data are unlikely to capture all cases of a complication, regardless of the
preventability, without false positives and false negatives (sensitivity and specificity).
• When the codes are accurate in defining an event, the clinical vagueness inherent in the
description of the code itself (e.g., hypotension) may lead to a highly heterogeneous pool
of clinical states represented by that code.
• Incomplete reporting is an issue in the accuracy of any data source used for identifying
patient safety problems, as medical providers might fear adverse consequences as a result
of full disclosure in potentially public r