Abstract
BACKGROUND: The consequences of health disparities in underrepresented populations persist with increased disease burden and reduced access to care. Even with inclusion mandates, underserved populations are poorly represented across trials. This article describes recruitment and retention efforts of an underrepresented population in a large NIH-funded trial. METHODS: The BackInAction (BIA) study is a pragmatic, multi-site, three-arm, parallel-groups randomized controlled trial testing the effectiveness of acupuncture needling for reducing back pain-related disability among 800 older adults (≥65 years) with chronic low back pain. The Institute for Family Health (IFH), an FQHC in New York City, one of four BIA sites, provides primary care to largely underrepresented patients. The IFH recruitment goal was 123 participants. PCPs were oriented to trial referral, clinical research coordinators worked as navigators, and electronic health records (EHR) mechanisms were adapted to allow seamless communication between trial acupuncturists and the research team. RESULTS: IFH met its goal of 123 trial participants with sociodemographic (22.8% ≥ 75 yrs of age, 72.4% female, 59.4% reported having at least some college education, 62.6% reported an annual household income of less than $25 000) and ethnic/racial diversity (39.0% Hispanic, 35.6% Black, 22.0% White non-Hispanic, 26.8% Spanish-speaking). IFH study withdrawal rate was 12.2% with 18.7% missingness in follow-up data rates at the trial's 6-month primary endpoint. CONCLUSION: The IFH site team successfully recruited and retained diverse participants through trusted connections with the study population, building on experience with acupuncture research, engaging PCPs, study team members, primary care clinical sites and EHR communication options.