Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial.

TitleUsing increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial.
Publication TypeJournal Article
Year of Publication2021
AuthorsTilley, BC, Mainous, AG, Amorrortu, RP, M McKee, D, Smith, DW, Li, R, DeSantis, SM, Vernon, SW, Koch, G, Ford, ME, Diaz, V, Alvidrez, J
Corporate Authorsadditional RECRUIT Trial Center and Parent Trials' investigators
JournalContemp Clin Trials
Date Published2021 10
KeywordsHumans, Minority Groups, Patient Selection, Pilot Projects, Prospective Studies, Trust

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites). RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8). In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts. TRIAL REGISTRATION ClinicalTrials.govNCT01911208.

Alternate JournalContemp Clin Trials
PubMed ID34333138
PubMed Central IDPMC8665835
Grant ListP30 AG021677 / AG / NIA NIH HHS / United States
P30 DK123704 / DK / NIDDK NIH HHS / United States
U01 NS043127 / NS / NINDS NIH HHS / United States
U24 MD006941 / MD / NIMHD NIH HHS / United States