A logic model for precision medicine implementation research December 4, 2017 Maren T. Scheuner, MD, MPH, FACMG Chief, Medical Genetics, VA Greater Los Angeles Healthcare System Director, VISN 22 Clinical Genetics Program Professor of Medicine, David Geffen School of Medicine at UCLA
Disclosures • No conflicts to disclose • Full-time employee of the Department of Veterans Affairs (VA) • Views expressed are my own and do not represent the opinions of the VA • Academic affiliation, David Geffen School of Medicine at UCLA • Funding from VA HSR&D
Acknowledgements Funding: VA HSRD Field-based Meeting Administrative support: Program committee: VA OR&D Leadership: • Jamiyla Bolton • Catherine Chanfreau, PhD • David Atkins, MD • Barbara Lerner, PhD • Gregory Brent, MD • Amy Kilbourne PhD • Ismelda Canelo • Sara Knight, PhD • Ron Przygodzki PhD • Mark Canning • Jane Peredo, MS, CGC • Miho Tanaka, PhD • Britney Chow • Dawn Provenzale, MD • Daniel Foster • Marcia Russell, MD • Maren Scheuner, MD, MPH • Elise Hulsebos • Uyi Igodan • Corrine Voils, PhD • Kristina Oishi • Demetrius Williams • Elizabeth M. Yano, PhD, MSPH
Goal of the Conference To foster the creation of partnerships between key stakeholder groups to advance a research agenda focused on the outcomes of precision medicine to impact policy, research, and delivery of precision medicine.
Precision medicine definition: An innovative approach to health care that incorporates genetic information and other biomarkers into personalized clinical decisions that can improve clinical, reproductive, behavioral, and psychosocial outcomes for individuals and their family members.
Conference Participants • 80+ participants, about half VA and half non-VA • Dr. David Shulkin (VA Under Secretary for Health) spoke about the VA’s Precision Oncology Program • 46 speakers and 4 moderators described experience with precision medicine, programmatic goals, research needs, priority areas, opportunities and challenges • Stakeholder groups: Clinicians Patients/family members/advocacy organizations Policy/Decision makers Administrators/Managers Ethicists/Lawyers Researchers Information technology experts
Methods • Developed and administered a web-based survey that asked participants to rate the value of and whether a third-party should pay for 44 PM outcomes (Poster B94). • Pre-conference survey results informed the conference discussion • Audio-recorded and transcribed conference proceedings. • Identified research topics mentioned during the conference. • Thematic coding of quotes was performed by two investigators independently, with a third helping to resolve discrepancies. • Themes were assigned to a research topic and sub-themes were characterized as challenges, opportunities, or strategies.
Classification of Quotes 637 total quotes 316 quotes mapped to 10 research topics 44 themes identified 243 sub-themes Research topic Themes Challenges Opportunities Strategies Information technology 7 7 11 21 Dissemination & Implementation 6 18 6 22 Outcomes research 5 8 10 9 Learning system 5 6 11 6 Organization/Provider behavior 4 8 4 19 Ethics/Equity 4 11 3 9 Veteran engagement 4 1 5 8 Partnered research 3 3 10 8 Economics research 3 5 4 1 Clinical research 3 4 5 0 TOTAL 44 71 69 103
Classification of Quotes Organization/Provider Research, Workforce, Challenge, Genomics expertise is insufficient 637 total quotes “… we want the relevant experts. You probably know you 316 quotes mapped to 10 research topics can go all over this country and you have people ‘doing 44 themes identified 243 sub-themes what the experts do’ even though they're not expert. And they may also be doing some harm. At the very least, Research topic Themes Challenges Opportunities Strategies they're doing a lousy job and very often not serving the Information technology 7 7 11 21 patient and they're wasting, again, all of our money ….” Dissemination & Implementation 6 18 6 22 Payer/Policy Maker Outcomes research 5 8 10 9 Learning system 5 6 11 6 Organization/Provider behavior 4 8 4 19 Ethics/Equity 4 11 3 9 Veteran engagement 4 1 5 8 Partnered research 3 3 10 8 Economics research 3 5 4 1 Clinical research 3 4 5 0 TOTAL 44 71 69 103
Classification of Quotes 637 total quotes Economics Research, Health care utilization, 316 quotes mapped to 10 research topics Opportunity, Ending the diagnostic odyssey 44 themes identified 243 sub-themes “… diagnostic uncertainty has been shown to be a driver of utilization of medical services; if you don’t know Research topic Themes Challenges Opportunities Strategies what your diagnosis is, then you utilize more services, Information technology 7 7 11 21 and where we haven’t done research, at least in genetic Dissemination & Implementation 6 18 6 22 diagnosis, even when there’s no treatment, does the Outcomes research 5 8 10 9 establishment of a diagnosis reduce utilization, which in Learning system 5 6 11 6 fact would be an economic benefit that could be Organization/Provider behavior 4 8 4 19 recognized by healthcare systems and payers, etc.” Ethics/Equity 4 11 3 9 clinical geneticist Veteran engagement 4 1 5 8 Partnered research 3 3 10 8 Economics research 3 5 4 1 Clinical research 3 4 5 0 TOTAL 44 71 69 103
Classification of Quotes Dissemination & implementation, Access/Variation in PM Care, Strategy, Centralized technical assistance 637 total quotes “So the program has a clinical component … and it tries to do 316 quotes mapped to 10 research topics things that individual docs can’t easily do alone, but if there’s a 44 themes identified 243 sub-themes central core doing it, they’re empowered. They’re not worried or scared that they’re not delivering the best care. They are Research topic Themes Challenges Opportunities Strategies delivering the best care because we have a concerted program Information technology 7 7 11 21 that helps them do it, they’re not on their own.” Oncologist Dissemination & Implementation 6 18 6 22 Outcomes research 5 8 10 9 Learning system 5 6 11 6 Organization/Provider behavior 4 8 4 19 Ethics/Equity 4 11 3 9 Veteran engagement 4 1 5 8 Partnered research 3 3 10 8 Economics research 3 5 4 1 Clinical research 3 4 5 0 TOTAL 44 71 69 103
Synthesis of Findings • Mapped opportunities and challenges to the Consolidated Framework for Implementation Research (CFIR) constructs to help inform implementation planning. • Mapped strategies to the Expert Recommendations for Implementing Change (ERIC) compilation to help prioritize implementation strategies. • Created a logic model to provide a roadmap for a precision medicine program.
• The CFIR provides a pragmatic structure for approaching complex, interacting, multi- level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. • It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings. • The CFIR comprises five major domains that interact in rich and complex ways to influence implementation effectiveness.
CFIR Domains and Constructs Characteristics of Inner Outer Individuals Implementation the intervention setting setting involved process • Patient needs • Knowledge and • Planning • Intervention • Structural • Engaging and resources beliefs about the source characteristics • Cosmopolitanism • Executing • Evidence strength • Networks and intervention • Peer pressure • Self-efficacy • Reflecting and and quality communications • External policies • Individual stage • Relative • Culture evaluating • Implementation and incentives of change advantage • Individual • Adaptability climate • Trialability • Readiness for identification • Complexity with the implementation • Design quality & organization • Other personal packaging • Cost attributes Damschroder LI, Aron DC, Keith RE, et al. Implent Sci 2009;4:50. doi: 10.1186/1748-5908-4-50.
PM Opportunities and Challenges Mapped to CFIR Domains and Constructs Characteristics of Inner Outer Individuals Implementation the intervention setting setting involved process • Patient needs • Knowledge and • Planning • Intervention • Structural • Engaging and resources beliefs about the source characteristics • Cosmopolitanism • Executing • Evidence strength • Networks and intervention • Peer pressure • Self-efficacy • Reflecting and & quality communications • External policies • Individual stage • Relative • Culture evaluating • Implementation and incentives of change advantage • Individual • Adaptability climate • Trialability • Readiness for identification • Complexity with the implementation • Design quality & organization • Other personal packaging • Cost attributes
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