Key Points:
- Research coordinators embedded in community-based practices can help ensure that underrepresented and underserved patients have equitable point-of-care access to decentralized clinical trials.
- This study evaluated a need-based protocol-specific workshop to train medical assistants at Health360x practices in research coordination, and compared them to enrollees in a formal didactic Clinical Research Coordinator Certificate program.
- Medical assistants enrolled in the Health360x needs-based, protocol-specific training program were more likely to complete the training and remain engaged in research activities.
- This flexible training approach can be used to build sustainable, equitable research infrastructure in community-based practices over time.
There is lack of diversity and representation in clinical trial participation. There is a critical need to build out a dynamic and nimble research enterprise that is patient-centered, leverages frontline practitioners as investigators for decentralized trials, and prioritizes diversity and inclusion in both research staff and participants. However, research workforce staffing is a barrier to scaling and sustaining point-of-care decentralized clinical trials (DCT).
On April 7, 2024, the principal results of the “Health 360x Registry: Scalable Workforce for Equitable Access To Point Of Care Decentralized Clinical Trials” were presented at ACC Scientific Sessions 2024. The purpose of this study was to evaluate a needs-based, protocol-specific approach to training medical assistants (MAs) as clinical research coordinators (CRCs).
The Health 360x Registry and Network, which includes mostly research naïve community practices serving predominantly Black, Latinx, and rural residents, all of whom are traditionally under-represented in clinical trials, was leveraged for this study. Overall, 37 MAs completed the Health360x needs-based protocol-specific training workshop to become CRCs for an ongoing real-world cardiovascular study recruiting 5,000 Black participants. In addition to the workshop, they received ongoing online support and team based mentorship form Clinical Research Associates (CRAs). They were compared to 23 enrollees in the Clinical Research Coordinatory Certificate (CRCC) program at Morehouse School of Medicine, a 12 week didactic online course.
Enrollees in the Health360x training group were significantly younger with less experience in research and were less likely to have completed college compared to the CRCC enrollees, however race, ethnicity, and gender were similar in both groups. Health360x enrollees were more likely to complete the entire training than those in the CRCC group. Despite less experience and lower formal educational attainment at baseline, post-training evaluation found that Health360x trainees demonstrated a high level of competency in key research skills.
Elizabeth Ofili, MD, MPH, FACC of Morehouse School of Medicine concluded: “Health 360x Registry needs-based and protocol-specific training of research naïve medical assistants were more likely to complete training and remain in research. Ongoing mentorship by CRA are key success and sustainability factors.”