Community engagement strategies improve recruitment and enrollment in a pragmatic clinical trial.

Introduction: Rural communities make up 19% of the US population, yet are underrepresented in clinical trials. Community engagement methods can facilitate collaboration and trust with local healthcare personnel to enhance enrollment. The purpose of this manuscript is to describe community engagement methods and their impact on enrollment in a pragmatic clinical trial.

Methods: We describe a variety of methods used in the Fibromyalgia TENS in Physical Therapy Study (FM-TIPS) to enhance enrollment in rural communities and low-enrolling clinics. Community engagement methods were implemented partway through the trial for selected groups: Targeted Rural (TR) (n = 10), Targeted Low Enrolling (TLE) (n = 6), and compared to Untargeted Groups (UT) (n = 13). The impact of these methods on inquiries, screening, and enrollment were evaluated by comparing actual enrollment to projected enrollment.

Results: We trained and employed community engagement coordinators to implement strategies in TR and TLE physical therapy clinics. These included, posting flyers, community events, physician outreach, social media ads, and direct mailing. These methods increased study inquiries, screening and enrollment in the study. Specifically, when compared to projected values there were increases in enrollment for both the TR and the TLE groups, but not the UT group. Of those that passed screening 99% of rural and 32% of urban residents enrolled in the study.

Conclusion: A multi-pronged and individualized community engagement approach can increase enrollment of rural residents in clinical trials. Building strong relationships and partnering with community clinics and local communities is essential to success.