Health
Literacy in
Clinical
Research
Practice and Impact
PROCEEDINGS OF A WORKSHOP
Alexis Wojtowicz and Melissa G. French, Rapporteurs
Roundtable on Health Literacy
Board on Population Health and Public Health Practice
Health and Medicine Division
THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by contracts between the National Academy of Sciences and AbbVie Inc.; California Dental Association; East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Media; Health Literacy Partners; Health Resources and Services Administration (HHSH25034011T); Merck Sharp & Dohme Corp.; National Library of Medicine; Northwell Health; Office of Disease Prevention and Health Promotion (HHSP23337043); Pfizer Inc.; and UnitedHealth Group. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-49969-9
International Standard Book Number-10: 0-309-49969-0
Digital Object Identifier: https://doi.org/10.17226/25616
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Copyright 2020 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Health literacy in clinical research: Practice and impact: Proceedings of a workshop. Washington, DC: The National Academies Press. https://doi.org/10.17226/25616.
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PLANNING COMMITTEE ON HEALTH LITERACY IN CLINICAL TRIALS: PRACTICE AND IMPACT1
ANNLOUISE R. ASSAF, Patient Health Activation Expert and Global Medical Impact Assessment Senior Director, Pfizer Worldwide Medical and Safety; Professor (Adjunct), Brown University School of Public Health
BARBARA E. BIERER, Professor of Medicine and Faculty Director, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
TERRY C. DAVIS, Professor of Medicine and Pediatrics, Louisiana State University Health Sciences Center–Shreveport
LAUREN McCORMACK, Vice President, Public Health Research Division, RTI International
LAURIE MYERS, Global Health Literacy Director, Merck Sharp & Dohme Corp.
CATINA O’LEARY, President and Chief Executive Officer, Health Literacy Media
PHYLLIS J. PETTIT NASSI, Associate Director, Research and Science, Special Populations, American Indian Program, University of Utah Huntsman Cancer Institute
PATTY SPEARS, Research Patient Advocate, University of North Carolina Lineberger Comprehensive Cancer Center
CONSUELO H. WILKINS, Vice President for Health Equity, Vanderbilt University Medical Center
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s planning committees are solely responsible for organizing the workshop, identifying topics, and choosing speakers. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
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ROUNDTABLE ON HEALTH LITERACY1
LAWRENCE G. SMITH (Chair), Dean, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell; Executive Vice President and Physician-in-Chief, Northwell Health
ANNLOUISE R. ASSAF, Patient Health Activation Expert and Global Medical Impact Assessment Senior Director, Pfizer Worldwide Medical and Safety; Professor (Adjunct), Brown University School of Public Health
SUZANNE BAKKEN, Alumni Professor of Nursing and Professor of Biomedical Informatics, Columbia University
GEMIRALD DAUS, Public Health Analyst, Office of Health Equity, Health Resources and Services Administration
TERRY C. DAVIS, Professor of Medicine and Pediatrics, Louisiana State University Health Sciences Center–Shreveport
JENNIFER DILLAHA, Medical Director for Immunizations, Medical Advisor, Health Literacy and Communication, Arkansas Department of Health
JAMES DUHIG, Head, Risk Communication and Behavioral Systems, Office of Patient Safety, AbbVie Inc.
ALICIA FERNÁNDEZ, Professor of Medicine, Director, UCSF Latinx Center of Excellence, University of California, San Francisco, Zuckerberg San Francisco General Hospital
LISA FITZPATRICK, Senior Medical Director, DC Department of Health Care Finance, and Professorial Lecturer, The George Washington Milken Institute of Public Health
LORI K. HALL, Director of Health Literacy, Global Medical Strategy and Operations, Eli Lilly and Company
LINDA HARRIS, Director, Division of Health Communication and eHealth Team, Office of Disease Prevention and Health Promotion, U.S. Department of Health and Human Services
NICOLE HOLLAND, Assistant Professor and Director of Health Communication, Education, and Promotion, Tufts University School of Dental Medicine
ELLEN MARKMAN, Lewis M. Terman Professor of Psychology, Stanford University
JOHANNA MARTINEZ, Graduate Medical Education Director of Diversity and Health Equity, Northwell Health
___________________
1 The National Academies of Sciences, Engineering, and Medicine’s forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published Proceedings of a Workshop rests with the workshop rapporteurs and the institution.
MICHAEL McKEE, Associate Professor of Family Medicine, Director of MDisability, University of Michigan Medical School
LAURIE MYERS, Global Health Literacy Director, Merck Sharp & Dohme Corp.
CATINA O’LEARY, President and Chief Executive Officer, Health Literacy Media
MICHAEL PAASCHE-ORLOW, Professor of Medicine, Boston University School of Medicine
TERRI ANN PARNELL, Principal and Founder, Health Literacy Partners
LINDSEY A. ROBINSON, Diplomate, ABPD, California Dental Association
STEVEN RUSH, Director, Health Literacy Innovations, UnitedHealth Group
OLAYINKA SHIYANBOLA, Assistant Professor, Division of Social and Administrative Sciences, University of Wisconsin–Madison School of Pharmacy
VANESSA SIMONDS, Assistant Professor, Community Health, Montana State University
CHRISTOPHER R. TRUDEAU, Associate Professor of Medical Humanities, University of Arkansas for Medical Sciences; Associate Professor of Law, Bowen School of Law, University of Arkansas at Little Rock
EARNESTINE WILLIS, Kellner Professor in Pediatrics, Medical College of Wisconsin
AMANDA J. WILSON, Head, Engagement and Training, National Library of Medicine
MICHAEL S. WOLF, Professor, Medicine and Learning Sciences, Associate Division Chief, Research Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University
WINSTON F. WONG, Medical Director, Disparities Improvement and Quality Initiatives, Kaiser Permanente
Health and Medicine Division Staff
MELISSA G. FRENCH, Senior Program Officer (until January 2020)
ALEXIS WOJTOWICZ, Research Associate
ANNA W. MARTIN, Administrative Assistant
ROSE MARIE MARTINEZ, Senior Board Director, Board on Population Health and Public Health Practice
Reviewers
This Proceedings of a Workshop was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published proceedings as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We thank the following individuals for their review of this proceedings:
CONNIE CITRO, Division of Behavioral and Social Sciences and Education, The National Academies of Sciences, Engineering, and Medicine
SYLVIA BAEDORF KASSIS, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the content of the proceedings nor did they see the final draft before its release. The review of this proceedings was overseen by DEBORAH E. POWELL, University of Minnesota Medical School. She was responsible for making certain that an independent examination of this proceedings was carried out in accordance with standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the rapporteurs and the National Academies.
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Acknowledgments
The sponsors of the Roundtable on Health Literacy made it possible to plan and conduct the workshop Health Literacy in Clinical Trials: Practice and Impact, which this proceedings summarizes. Federal sponsors from the U.S. Department of Health and Human Services are the Health Resources and Services Administration; National Library of Medicine; and Office of Disease Prevention and Health Promotion. Nonfederal sponsorship was provided by AbbVie Inc.; California Dental Association; East Bay Community Foundation (Kaiser Permanente); Eli Lilly and Company; Health Literacy Media; Health Literacy Partners; Merck Sharp & Dohme Corp.; Northwell Health; Pfizer Inc.; and UnitedHealth Group.
The workshop presentations were interesting and stimulated much discussion, and the Roundtable on Health Literacy would like to thank each of the speakers and moderators for their time and effort. Speakers and moderators were Emma Andrews, Connie Arnold, Annlouise R. Assaf, Barbara E. Bierer, Ebony Boulware, Deborah Collyar, Terry C. Davis, Lauren McCormack, Monika Mitra, Catina O’Leary, Phyllis J. Pettit Nassi, Saira Z. Sheikh, Lawrence G. Smith, Patty Spears, Jovonni R. Spinner, Alicia Staley, Christopher R. Trudeau, Consuelo H. Wilkins, and Rebecca J. Williams.
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Contents
Organization of the Proceedings
2 HEALTH LITERACY AS AN ETHICAL IMPERATIVE IN CLINICAL TRIALS
Health Literacy Helps Patients Make Decisions: A Patient Perspective
3 EMBEDDING HEALTH LITERACY IN CLINICAL TRIALS TO IMPROVE RECRUITMENT AND RETENTION
Enrolling Minorities with Variable Literacy in Clinical Trials
Lessons Learned from Behavioral Trials of African Americans
Health-Literate Materials for Recruitment and Retention
Technological Tools to Improve Patient Experiences
4 EXPERIENCES IMPLEMENTING HEALTH LITERACY BEST PRACTICES IN CLINICAL TRIALS
Lessons Learned from Two Health Literacy Interventions to Improve Colorectal Cancer Screenings
Making Clinical Trials and Informed Consent More Patient-Centered
Critical Conversations in Clinical Trials
5 DESIGNING CLINICAL TRIALS WITH HEALTH LITERACY BEST PRACTICES
6 REFLECTIONS, RESEARCH DIRECTIONS, AND POTENTIAL OPPORTUNITIES FOR IMPLEMENTATION
B Biographical Sketches of Workshop Moderators, Speakers, and Panelists
Boxes, Figure, and Tables
BOXES
2-1 Possible Patient Questions Regarding Clinical Trials
3-1 Key Points Raised by Individual Panelists
4-1 Current Challenges Related to Informed Consent
4-2 Strategies for Creating a Health-Literate Clinical Trials Environment
6-1 Highlights from Rapporteur Presentations
6-2 Key Observations from Roundtable Members
A-1 Workshop Objectives and Questions
FIGURE
Acronyms and Abbreviations
AE | adverse event |
AI/AN | American Indian/Alaska Native |
CARE | Committee on Advocacy, Research Communication, Ethics, and Disparities |
CEO | chief executive officer |
CRC | colorectal cancer |
CTSA | Clinical Translational Science Awards (NIH) |
CTTI | Clinical Trials Transformation Initiative |
CV | curriculum vitae |
eIC | electronic informed consent |
EMA | European Medicines Agency |
EU | European Union |
FDA | U.S. Food and Drug Administration |
FIT | fecal immunochemical test |
FOBT | fecal occult blood test |
FQHC | federally qualified health center |
GDPR | General Data Protection Regulation (European Union) |
HIPAA | Health Insurance Portability and Accountability Act |
HLM | Health Literacy Media |
IRB | Institutional Review Board |
LSU | Louisiana State University |
MIMICT | Materials to Increase Minority Involvement in Clinical Trials |
MRCT Center | Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard |
NIH | National Institutes of Health |
NLM | National Library of Medicine |
OMHHE | Office of Minority Health and Health Equity |
PAIR | Patient Advocates in Research |
PALS | Patient Advocates for Lupus Studies |
PCP | primary care physician or primary care provider |
PRO | patient-reported outcome |
PSA | public service announcement |
PURPLE | Programs to Address Unmet Needs and Promote Representation of All Participants in Lupus Clinical Trials Using Mobile Technology for Engagement |
PWD | people with disabilities |
RA | research assistant |
REMS | risk evaluation and mitigation strategies |
RIC | Recruitment Innovation Center |
SACHRP | Secretary’s Advisory Committee on Human Research Protections |
UNC | University of North Carolina |
WHI | Women’s Health Initiative |