The Cancer in the Family Clinical Decision Support Tool (Text Version)

On September 28, 2010, Linda Squiers made this presentation at the 2010 Annual Conference. Select to access the PowerPoint® presentation (3.8 MB).  

---

Slide 1

The Cancer in the Family Clinical Decision Support Tool

Linda Squiers, PhD

Moderated by: Gurvaneet Randhawa, MD

September 2010

www.rti.org

Note: Every slide has the RTI International logo on the bottom right-hand side.

Slide 2

RTI Study Team

Robert Furberg, MBA
Lauren McCormack, PhD
Marjorie Margolies, BA
Roger Osborn, BS
Eric Peele, BA
Doug Rupert, MPH
Claudia Squire, MS
Janice Tzeng, MPH
Nedra Whitehead, PhD, MS, CGC
Sue West, PhD

Slide 3

The tool should...

• Be user-friendly and computerized.
• Easily updated and maintained.
• Capable of working on different IT platforms, systems, and architecture.
• Empirically and accurately assess patients' risk of BRCA mutations and provide results via cancer family history.
• Encourage patient-provider communication.
• Educate patients on HBOC, BRCA mutations, genetic counseling and BRCA testing.
• Encourage patients to share cancer family history.
• Educate providers risk for HBOC, including USPSTF recommendations about referring patients for BRCA counseling and testing.

Slide 4

Development Challenges

• Motivation: providers and patients:
  • Provider priorities: clinicians not trained in genetics, perceived risk, perceived benefit.
• Only a small minority of women will be at increased risk. How can the tool help women who are not at increased risk for BRCA mutations?
• Collecting family history:
  • Providers and patients unsure about what a complete family history includes.
  • Asking relatives about cancer history.
  • Length of time to gather and enter cancer family history.
• Integration with EMRs.

Slide 5

Development of Cancer in the Family Tool

An image of a flowchart labeled "Development of Cancer in the Family Tool" is shown.

Slide 6

Patients—Steps in Using the Tool

Flowchart: Tool Login (Home) → Step 1: Learn about HBOC and BRCA → Step 2: Decide Whether to Gather Family History & Learn Risk →
Step 3: Collect Family History
↓
Step 4: Calculate BRCA Risk → Step 5: Understand Risk → Step 6: Action Plan → Clinic Visit: Review Risk with Provider

Slide 7

Login Screen

This is a screen shot of the login page for the tool. Users login with a user name and password on the left side. A welcome message appears in the center. To the far right, is an icon that can be selected to launch a video that takes the user on a tour of the Web site.

Slide 8

Patient Interface—Introduction

This is a screen shot of the patient tool's introduction page that outlines the 6 steps of the tool: Step 1: Learn; Step 2: Decide; Step 3: Gather; Step 4: Calculate; step 5: Know; and Step 6: Plan.

Slide 9

Patient Interface—Step 2: Decide

This is a screen shot of the patient tool, Step 2: Decide, which displays a decision point where patients need to decide if they want to continue on to collect their family history.

Slide 10

Patient Interface—Step 3: Gather

This is a screen shot of the patient tool, Step 3: Gather, which discusses how to gather your family's history of cancer.

Slide 11

Patient Interface—Step 3: Gather

This is a screen shot of the patient tool, Step 3: Gather, with a display of the "Create Your Family Tree - Siblings" section.

Slide 12

Patient Interface—Step 3: Gather

This is a screen shot of the patient tool, Step 3: Gather, which displays the section where patients enter in their family members' history of breast and ovarian cancer.

Slide 13

Patient Interface—Step 3: Gather

This is a screen shot of the patient tool, Step 3: Gather, which shows the family tree that is produced by the tool. It uses male and female gender symbols, and includes the relationship for each family member (e.g., brother) and their age.

Slide 14

Patient Interface—Step 4: Calculate

This is a screen shot of Step 4: Calculate, of the tool. It displays the patient's risk results in a box at the bottom of the page.

Slide 15

Patient Interface—Action Plan

This is a screen shot of the patient's action plan produced by the tool. It displays the patients risk results and tips for talking to your doctor.

Slide 16

Providers—Steps in Using the Tool

Step 1: Explore Tool

• BRCA Basics
• Beyond Basics
• Sharing Risk Results

Step 2: See Study Patients
(Use Tool During Visit)

• Review Family History
• Review BRCA Risk
• Review Screening Recommendations ← Includes USPSTF cancer screening recommendations (e.g., Pap, cervical cancer)
• Provide Genetic Counseling Referral (if appropriate)

Step 3: Complete Checklist

• Each Patient Visit

Slide 17

Provider Interface—Patient List

This is a screen shot of the provider interface of the tool where providers find the study patient.

Slide 18

Provider Interface—BRCA Basics

This is a screen shot of the BRCA Basics content page in the provider interface.

Slide 19

Provider Interface—Beyond Basics

This is a screen shot of the Beyond Basics page in the provider tool.

Slide 20

Provider Interface—Sharing Results

This is a screen shot of the Sharing Results page in the provider tool.

Slide 21

Provider Interface—Additional Resources

This is a screen shot of the Additional Resources page in the provider interface. It provides links to other information pages on hereditary cancer and treatments.

Slide 22

Provider Interface—Patient Risk Results

This is screen shot of the provider printout which includes the patient's risk results in numeric form.

Slide 23

Provider Interface—Patient Risk Results

This is a screen shot of the family history data in table format included in the provider printout.

Slide 24

Usability Testing

Patients (n=8)

Education

• 4 high school graduates
• 3 some college

Slide 25

Usability Testing

Patients (n=8)

Education

• 4 high school graduates
• 3 some college
• 1 college graduate

Age

• 3 were 18-34
• 4 were 35-49
• 1 was 50-64

Race

• 3 African American
• 4 White
• 1 Asian

5 had a family history of breast/ovarian cancer

Providers (n=6)

• Providers sent link approximately 1 week before interview:
  • Asked to review and complete a worksheet.
  • Then interviewed by RTI interviewer.
• Provider Type
  • 2 preventive medicine residents
  • 3 family medicine MD
  • 1 OB-GYN
  • 5 females/1 male

Slide 26

Modifications to Patient Interface Based on Usability Testing

• Clarifying language about risk (mutations vs. cancer risk).
• Security features (concerns about PHI):
  • Added RTI's Privacy Policy at bottom of home page.
  • Password protected accounts.
  • Eliminate full names for cancer family history.
  • Store data on RTI's secure server.
• Provided clarifications on instructions on using the tool:
  • Instructional tips throughout the tool, especially in introduction.
  • Side bar navigation steps numbered.
  • Step 3: Gather—broken down into several sub-steps.
  • Pedigree renamed Family Tree and Health History and modified with new symbols:
    • B1, B2 and O
    • Dropped age at diagnosis
    • Size of legend increased

Slide 27

Issues Raised in Provider Usability Testing

• Images (e.g., male mammography technician and physicians)
• Content
  • Make more concise by using succinct, bulleted content collapsed beneath each subheading
  • Reorganize Beyond Basics and make less redundant with BRCA Basics
• Identifying patients
  • Patient username convention developed
  • Can sort alphabetically and by appointment date
• Output
  • Made physician version of risk results
    • Use numeric risk and categorical risk
    • Include pedigree and table
    • PDF
  • Develop Visit Summary PDF (for future)

Slide 28

Take-a-Tour Video for Patient Tool

• Goal: develop a brief, persuasive, and engaging multimedia asset that effectively communicates the purpose of the tool, the importance of BRCA screening, and the estimated burden associated with the tool.
• 7-8 minutes.
• Voice over narration.
• Native resolution in high definition, but delivered through Flash.

Slide 29

Pilot Testing Overview

Slide 30

Evaluation

• Implementation Evaluation:
  • Was the tool used as planned?
• Outcome Evaluation:
  • What are the potential effects of the tool on patients and providers?
• Pilot Evaluation Procedures, Instruments, and Processes:
  • How well did the evaluation protocol work?

Slide 31

Pilot Testing Overview

Timeline

• April-June 2010 (8 weeks)

Clinical Sites

• Baylor Health Care System (Dallas, TX)
• Fairfax Family Practice (Fairfax, VA)

Slide 32

Pilot Testing Participants

Patient Participants

• Women with scheduled annual exams
• Age 21-60, English fluency
• No personal cancer history
• Residential access to computer / Web

Provider Participants

• Primary care provider
• Scheduled to see patients during pilot
• Number of providers involved varies by site

Slide 33

Pilot Study Sites

Site	Providers (n=9)	Patients (n=48)
BHCS Garland	3	17
BHCS Southlake	3	19
Fairfax	3	12

Patient and provider samples not representative

Slide 34

BRCA Risk Results (n=48)

Increased Risk (n=2) 4.2%
Not at Increased Risk (n=44) 91.6%
Missing/Don't Remember (n=2) 4.2%

Slide 35

Perceived Accuracy and Satisfaction

Very accurate (n=18) 37.5%
Somewhat accurate (n=18) 37.5%

Satisfied with Decision to Learn Risk

Very satisfied (n=27) 56.3%
Somewhat satisfied (n=10) 20.8%

Slide 36

Family History Collection

• 75% entered some or all family cancer history.
• 71% said very easy or easy to enter history.
• 75% found worksheet useful or very useful.
• 73% printed results of risk assessment.
• 65% brought printout to doctor's visit.

Slide 37

Percent of Patients that Rated Tool as Very Effective or Effective

....in helping them understand...

• 80% BRCA mutations.
• 79% Advantages/disadvantages of learning risk.
• 70% Results of BRCA risk assessment.
• 79% Satisfied or very satisfied with tool.

Slide 38

Patient Knowledge about Risks of Breast and Ovarian Cancer (n = 48)

Item	Baseline	Posttest 1
A woman who does not have a BRCA1 or BRCA2 gene mutation can still get cancer.
True*	27 (43.8%)	43 (89.6%)
False	0 (00.0%)	0 (00.0%)
Don't know	21 (43.8%)	4 (08.3%)
Missing	0 (00.0%)	1 (02.1%)
A woman who has a BRCA1 or BRCA2 gene mutation.
Will definitely get breast or ovarian cancer	0 (00.0%)	1 (02.1%)
Is at lower risk for breast or ovarian cancer	0 (00.0%)	0 (00.0%)
Is at greater risk for breast or ovarian cancer*	26 (54.2%)	45 (93.8%)
Don't know	22 (45.8%)	0 (00.0%)
Missing	0 (00.0%)	1 (02.1%)
Your chances of having a BRCA1 or BRCA2 gene mutation is based on...
Whether your mother had breast cancer and/or ovarian cancer	2 (04.2%)	0 (00.0%)
Your entire family history of all diseases	7 (14.6%)	1 (02.1%)
Your entire family history of breast and ovarian cancer*	17 (35.4%)	44 (91.7%)
Don't know	22 (45.8%)	0 (00.0%)
Missing	0 (00.0%)	1 (02.1%)
A BRCA genetic test cannot tell you...
If you have a BRCA1 or BRCA2 mutation	2 (04.2%)	0 (00.0%)
If you will get breast and/or ovarian cancer*	25 (52.1%)	42 (87.5%)
If you have a greater chance of breast and ovarian cancer	0 (00.0%)	1 (02.1%)
Don't know	21 (43.8%)	4 (08.3%)
Missing	0 (00.0%)	0 (00.0%)

* Correct Answer

Slide 39

Provider Findings

Slide 40

Educational Module

Quality of Information
Extremely high 56%
High 33%

Made Me Feel More Confident
Strongly agree 56%
Agree 44%

Learned a Great Deal
Strongly agree 22%
Agree 56%

Slide 41

Clinical Visit Activities

Referrals Provided
Genetic counseling 4%
Mammography 60%
Pap test 44%

Visit Activities
Reviewed patient's family history 88%
Updated patient's family history 67%
Explained risk result 88%
Addressed questions about risk 83%

Slide 42

Provider Checklist Responses Following Visit with Patient (n = 9 providers for 48 patients)

When did you use the tool to review this patient's risk results	No. (%)
Before patient's appointment	16 (33.3%)
During patient's appointment	22 (45.8%)
Both before and during patient's appointment	4 (8.3%)
Did not use tool	4 (8.3%)
Missing	2 (4.2%)

Slide 43

Tool Perceptions

Ease of Use	Baseline*	Post-Study*
Tool is clear and understandable	3.0	4.3
Tool will be easy to use	2.3	4.2
Trialability
Can properly try out tool before using it in practice	3.0	4.5
Tool will take too long to learn	2.7	1.8

* Responses on a strongly agree (5)—strongly disagree (1) scale

Slide 44

Tool Perceptions

Ease of Use	Baseline*	Post-Study*
Tool will likely improve clinical care	4.4	4.0
Tool will be useful for patients	4.3	4.4
Workflow Effects
Tool will allow me to accomplish tasks more quickly	1.8	2.8
Tool will fit well with the way I like to work	3.3	3.8
Tool will be compatible with workflow	2.8	3.3

* Responses on a strongly agree (5)—strongly disagree (1) scale

Slide 45

Conclusions

• Patient and provider outcomes positive.
• Evaluation protocol worked well.
  • Recruit challenging.
    • Getting through to participants via phone was difficult.
  • Email may help.
• No major redesign needed.
  • Enhancements to printouts desired.
  • Produce appointment summary for providers.
  • Additional references and resources.

Slide 46

Future Studies

• Use a control or comparison group.
  • Important to assess proportion of patients in primary care population at increased risk.
  • High risk cutoff of 0.01 used. We recommend 0.02 for future studies.
• Randomly select clinic sites.
• Ensure more representative patient and provider population.
• Alternate ways of using the tool:
  • Providers could discuss results with patients by phone.
    • Use different types of providers to discuss results (e.g., nurse).
  • Patient tool could be stand alone tool.
  • Develop the current tool to transfer risk results to EMR.

Slide 47

For Discussion

Slide 48

Surgeon General's My Family Health Portrait

New version released 1/2009

• Web-based
• Family history can be downloaded to individual's computer and shared
• Standards based, customizable and open source allowing for use in EHRs or CDS
• Includes history for 15 common diseases and other to be added
• Now allows addition of family members beyond 1st and 2nd degree relatives

Limitations

• Age at diagnosis is collected by age category rather than actual age which affects risk calculation in BRCAPRO
• Does not ask if breast cancer was unilateral or bilateral
• Limited cognitive and usability testing prior to release

Slide 49

Other Available Interactive Tools

• Interactive Cancer Family Tree, University of Nebraska Medical Center: http://app1.unmc.edu/gencancer/
• MyGenerations, NorthShore University Health System's Center for Medical Genetics, Illinois: http://www.northshore.org/genetics/mygenerations/
• Family HealthLink, The Ohio State University Medical Center: https://familyhealthlink.osumc.edu/Notice.aspx
• Breast Cancer Genetics Referral Screening Tool (B-RST): http://www.brcagenscreen.org/

Slide 50

Future IT Development Projects

• Include more thorough formative research:
  • Interviews or focus groups with user groups.
  • Cognitive testing of draft content.
  • Multiple rounds of usability testing.

Slide 51

Results from ITS Feasibility Assessment: EMR Integration

Operating Systems and Internet Access

• Practices have restricted access to many outside Web sites (especially those with video).

Electronic Medical Records (EMRs)

• EMRs cannot be linked to outside tools or systems to protect patient privacy without arduous review and approval.
• Tool-EMR integration is strongly desired by physicians, who want to document patients' BRCA risk results within existing medical records.
• Patients cannot access their EMRs to view results or enter/update family history.
• Test results and tool output cannot be sent directly to EMRs. However, staff can manually scan or save visual files into the system.
• Physicians and practices are adverse to the time/cost of maintaining a tool themselves.