1. The Community Engagement Studio: Strengthening Research Capacity through Community Engagement Consuelo H. Wilkins, MD, MSCI Executive Director, Meharry Vanderbilt Alliance Associate Professor of Medicine Vanderbilt University School of Medicine and Meharry Medical College AAMC Meeting February 12, 2015

2. What is stakeholder engagement?  Patient- (1) a person who has lived with and/or experienced an illness or injury, (2) a caregiver or family member of such a person, or (3) a member of a relevant advocacy organization.  Stakeholder- all other members of healthcare community, such as clinicians, hospitals and health systems, purchasers, payers, industry, training institutions, and policy makers.  Engagement- A bidirectional relationship between the stakeholder and researcher that results in informed decision- making about the selection, conduct, and use of research. PCORI; Concannon et al, 2012; J Gen Intern Med 27(8):985–91

3. Benefits of Engaging Patients in Research  Patients and consumers bring experiential knowledge, which is only gained by having the daily experience of living with a certain disease or condition or living in a certain community.  It is more practical and complements the researchers’ scientific knowledge.  Engaging stakeholders can  Prioritize topics important to patients  Identify outcomes & comparators relevant to patients  Improve patient enrollment and decreases attrition  Enhance dissemination (more meaningful and understandable)  Increase chances of uptake of research results Leshner et al 2013; Michener et al 2012; Frank et al 2014; Krumholz 2012

4. Challenges to Engaging Stakeholders  A new concept for many researchers  Skills typically developed in rigorous research training do not translate to identifying, recruiting and convening stakeholders  Without training and experience, strategies are often ineffective, burdensome and leave stakeholders feeling disenfranchised  Becoming proficient requires training and hands-on experience, which may take years  Research infrastructure may be limited Mallery 2012; Staley 2009; Garces 2012

5. The Community Engagement Studio Community Engagement Studios (CE Studios) are dynamic, consultative sessions that are specifically intended to elicit patient, community or other stakeholder input on a research project. The process is more deliberative than a focus group and the participants are compensated as stakeholder "experts," not research participants.

6.  Structured process of eliciting project- specific input  May be used in any phase of translational research  Stakeholders selected based on researchers’ needs  An experienced core team identifies stakeholders and prepares them for engagement; reduces burden to researcher Community Engagement Studios Joosten, et al. (in press). Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input from Stakeholders to Inform Research. Academic Medicine.

7. Request for CES CES team reviews requests Consultation with CES team Determines stakeholders’ characteristics Recruit “experts” Coaching on engaging non-researchers Pre-meeting training Summary of oral and and written stakeholder feedback ResearcherStakeholder Facilitated Meeting Researcher presentation Stakeholder feedback Co-learning experience Community Engagement Studio Team Identifies researchers’ needs Researcher Outcomes -changes in knowledge, attitudes, study design -more patient-centered interventions, comparators, and outcomes -usefulness of evidence for decision-making Stakeholder Outcomes -perceptions of value, relevance and acceptability -changes in knowledge and attitudes about research -relevance of outcomes to patients Community Engagement Studio

8. Funded by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, grant (U54TR000123). The CTSA program is led by the NIH's National Center for Advancing Translational Sciences (NCATS). Levels of Community Involvement

9. Before: No participants enrolled after 3 months of active recruitment Clinical trial recruitment before and after a Community Engagement Studio After: Targeted enrollment reached ahead of schedule; 100% retention in randomized, blinded, placebo controlled trial with 10 study visits

10. CE Studios address a number of barriers to stakeholder engagement  Time commitment for both researchers and stakeholders minimized  CE Studio team guides the selection of stakeholders based on characteristics required to provide researcher with specific input  Stakeholder recruitment done by CE Studio team, not investigators  Researchers receive coaching in stakeholder engagement  Preparation for stakeholders provided pre-meeting  A trained/neutral facilitator moderates the sessions  Compensation provided to stakeholders

11. Community Engagement Studio Summary  Proven method for meaningfully engaging community members  Establishing infrastructure is necessary for sustainability of community- engaged efforts  Appropriate compensation standards for experts must be developed and implemented  Community engagement is appropriate and necessary in all stages of research  CES model easy to replicate and adaptable in varied contexts  Not a community advisory board, but opportunity to actively engage community and receive input

12. Consuelo H. Wilkins, MD, MSCI consuelo.h.wilkins@meharry-vanderbilt.org www.meharry-vanderbilt.org

13. Examples of Prior Community Engagement Studios