Increasing and Diversifying Clinical Trials: The Yale Model

Tesheia Johnson, MBA, MHSTesheia Johnson, MBA, MHSLast month, the deputy director and chief operating officer of the Yale Center for Clinical Investigation (YCCI) Tesheia Johnson, MBA, MHS, shared Yale’s comprehensive and integrated model to increase and diversify clinical trial participation with an invited group of Duke Cancer Institute and Duke School of Medicine staff.

Johnson highlighted the impact of Yale’s marketing, communication and branding strategy, its community stakeholder engagement and its use of EPIC EHR (electronic health record system) and MyChart on increasing study accrual.

The Yale Center for Clinical Investigation was launched in 2005 and was one of 12 institutions, including Duke, that was funded in 2006 by the Clinical and Translational Science Award (CTSA) — the NIH’s largest single investment in biomedical research. Duke and Yale remain as current awardees of the CTSA and continue to build on their collaborative partnership, while developing and sustaining their infrastructure to accelerate clinical research and innovation — with the ultimate goal of improving population health.

Rebecca Moen, MBA, said that Johnson — who's also chief operating officer for Yale’s CTSA — was her mentor back in 2008 when Moen first started managing Duke’s CTSA.

“She’s so energetic and so passionate about what she does,” said Moen, who serves as the Chief Administration Officer of the Duke Clinical & Translational Science Institute (CTSI) and provides programmatic, administrative and operational leadership for the Duke CTSI and the Center for Community and Population Health.  

“We’re working together with Duke on multiple fronts — CTSA related, A.M.E. Zion Church-related, and OnCore related,” said Johnson. “So, it’s nice that we have so many things in common that we’re working together to try to solve. The more that we’re working together, the more we’re using our influence to push the limits of what we can do together to innovate, so I’m happy to share.”

Yale’s extensive outreach to healthcare providers and patients in the community, has resulted in “a huge percentage” of minorities now expressing interest in research, said Johnson. Her team has engaged 25 Cultural Ambassadors who help recruit participants for trials, review study materials and protocol design, and attend a variety of meetings. These Cultural Ambassadors are faith leaders from African Methodist Episcopal Churches of Zion, and Junta – a Latino serving community based organization.  

Duke also engages cultural ambassadors — 18 in total — who advise on protocols. Nadine Barrett, PhD, director of the Community Engagement Core within the Duke CTSA and inaugural director of Duke Cancer Institute’s Office of Health Equity and Disparities (OHED), said that some of these ambassadors have even had input into Duke Cancer Institute grants and programs that connect patients in the community with screening and treatment services and eliminate barriers to quality healthcare and research.

With encouragement from and training provided by the Yale team, Barrett’s CTSA community engagement team is now moving into year two of its partnership with the African Methodist Episcopal (AME) Churches of Zion in North Carolina. The A.M.E. Zion/Duke collaborative partnership works to advance the health of local communities by reducing health disparities, cultivating trust, increasing knowledge in health research, and bridging the gap between medical development and community needs.   

Johnson noted that eight percent of Yale’s clinical volume is now driven by research, due in large part to the medical school’s dean having made increased patient participation in clinical trials and the means to achieving this a priority.

She detailed how, in Yale’s new “Help Us Discover” campaign, located within MyChart, patients can opt-in to participation in clinical trials by building profiles directly and explaining how they would like to be contacted about clinical research. They can also call and speak with someone to officially opt out.

“Almost 2000 people found that tab and said ‘I want to participate in research’ and all were referred to a study team; with 1305 referred and screened onto studies, and 1000 having signed consent and participated in studies,” said Johnson, adding that 350 of those 1000 were minorities.

Barrett noted that one of the primary reasons people do not participate in clinical trials is because they are not asked. Nationally, only about two to five percent of minorities participate in clinical trials.   

“It’s important to think about some of the opportunities that we can take toward increasing clinical trial participation in general and then ensuring that as we increase, we also diversify,” said Barrett. “At Yale, I think the stakeholder engagement aspect of their work is huge, as it ensures buy-in from the community. At the end of the day if the community does not feel like it resonates with them, then it significantly reduces the impact of our work. At Duke we’ve been doing great work and it’s always wonderful when we can meet with our sister organizations, and learn what’s worked, and what are the lessons learned as we continue to move forward with our work here.”


Circle photo (top): Collaborators Nadine Barrett, PhD (director of the Community Engagement Core within the Duke Clinical and Translational Science Award (CTSA) and inaugural director of Duke Cancer Institute’s Office of Health Equity and Disparities (OHED)); Tesheia Johnson, MBA, MHS, (deputy director and chief operating officer of the Yale Center for Clinical Investigation (YCCI) and chief operating officer for Yale’s CTSA)' and Pamela Maxson, PhD (director, Center for Community & Population Health Improvement at the Duke Clinical & Translational Science Institute)