Last month, Duke Clinical and Translational Science Institute (CTSI) hosted Tesheia Johnson, MBA, MHS, Deputy Director of the Yale Center for Clinical Investigation, Associate Director for Clinical Research at the Yale School of Medicine, and Chief Operating Officer of Yale’s CTSA. Ms. Johnson presented an overview of the “Yale Model,” the Yale Center for Clinical Investigation (YCCI) at Yale School of Medicine’s comprehensive, integrated model to increase and diversify clinical trial participation. This model was developed at the YCCI, home to Yale’s Clinical and Translational Science Award (CTSA), with diverse input from multiple stakeholders and implemented by Johnson and members of her team in response to Yale’s commitment to ensuring that all clinical research conducted at the Yale is of the highest quality, particularly as it pertains to the engagement and protection of study participants.
Early in the development of this model, Johnson and her team deliberately involved community stakeholders through focus groups for guidance and feedback, particularly around diversity in patient enrollment and perceptions about participating in research at Yale. Through the many roles Johnson has in clinical research administration at Yale, she is familiar with the difficulties associated with clinical trial recruitment. Her talk focused on what the YCCI has done to centralize Yale’s research enterprise infrastructure, including creating a volunteer database, partnering with cultural ambassadors from AME Zion churches and Junta for Progressive Action,(a Latino, community based non-profit organization in New Haven, Connecticut), designing engaging advertising campaigns, developing clinical studies with relevance to the community, and developing processes and procedures that streamline and optimize study recruitment procedures.
One such procedure is Yale’s use of electronic health records and MyChart to scan patient information and flag records that fit the criteria for recruiting studies. Patients can choose to learn more about these studies or opt out. Using EHR, the Yale research community can communicate with patients more efficiently and more easily refer them to clinical trials. Likewise, study participants receive compensation more quickly and can create their own research profiles to highlight studies of interest to them.
Another component of this model is the cultural ambassadors program. This program trains influential faith and community-based leaders in research design and methods so they can serve as research liaisons and consultants. Leaders also learn how to effectively communicate how research can help their community achieve better health through partnership in clinical research and give critical feedback on research protocols to make them more relevant. These leaders are also taught to recognize and work to break down barriers that might exist between the academic institution and local community, building trust among community members and a willingness to learn more about how to influence Yale’s research enterprise to answer clinical questions of interest to the community.
When the National Institutes of Health (NIH) CTSA program began, Duke and Yale were among the original 12 awardees of the grant. Since then, they’ve worked together on several collaborative efforts. With encouragement from and training provided by the Yale team, the Duke CTSI Community Engagement team is now moving into year two of its partnership with the African Methodist Episcopal (AME) Zion churches in North Carolina. The AME Zion/Duke partnership is working to advance the health of our local communities by reducing health disparities, cultivating trust, increasing knowledge in health research, and bridging the gap between medical development and community needs. The AME Zion and Duke teams have taken what they’ve learned from the “Yale Model” to foster health equity and improve health in the African American community in North Carolina.
In Yale’s case, input from the community was important in the development of marketing materials. While Yale engaged the services of a professional marketing agency to hone its branding and create effective messaging in its advertisements, having those messages and images vetted by community members helped improve the impact and effectiveness of Yale’s outreach to the community.
Yale’s coordinated and comprehensive program has increased positive visibility for the research program at the university. Johnson noted that Yale reports 8 percent of new patients currently come to Yale initially for research, with that figure expected to grow over time. By continuing to engage with stakeholders and the community, Johnson expects this model will evolve and improve, and is excited to share the lessons learned and best practices with collaborators at Duke.