Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach

• Published in: Current controlled trials in cardiovascular medicine Vol. 19; no. 1; pp. 115 - 10
• Main Authors: Amorrortu, Rossybelle P., Arevalo, Mariana, Vernon, Sally W., Mainous, Arch G., Diaz, Vanessa, McKee, M. Diane, Ford, Marvella E., Tilley, Barbara C.
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 17.02.2018; BioMed Central; BMC
• Subjects: Analysis; Attitude of Health Personnel; Behavior; Cancer; Cardiovascular disease; Clinical trials; Clinical Trials as Topic - methods; Clinics; Community; Continental Population Groups; Cultural Diversity; Diabetes; Enrollments; Ethnic Groups; Family physicians; Health promotion; Healthcare Disparities - ethnology; Humans; Inservice Training; Interpersonal Relations; Intervention; Literature reviews; Medical referrals; Minorities; Minority & ethnic groups; Minority Groups; Multiculturalism & pluralism; Participation; Patient Selection; Patient-centered care; Patients; Physicians; Planning; Program development; Recruiting; Referral and Consultation; Relationship building; Research Personnel - education; Research Personnel - psychology; Research Subjects; Social cognitive theory; Specialist; Stakeholder Participation; Training; Trust; United States; United States > US; Training; Social cognitive theory; Program development; Trust; Relationship building; Specialist
• DOI: 10.1186/s13063-018-2507-9
• ISSN: 1745-6215

Despite efforts to increase diversity in clinical trials, racial/ethnic minority groups generally remain underrepresented, limiting researchers' ability to test the efficacy and safety of new interventions across diverse populations. We describe the use of a systematic framework, intervention mapping (IM), to develop an intervention to modify recruitment behaviors of coordinators and specialist investigators with the goal of increasing diversity in trials conducted within specialty clinics. To our knowledge IM has not been used in this setting. The IM framework was used to ensure that the intervention components were guided by health behavior theories and the evidence. The IM steps consisted of (1) conducting a needs assessment, (2) identification of determinants and objectives, (3) selection of theory-informed methods and practical applications, (4) development and creation of program components, (5) development of an adoption and implementation plan, and (6) creation of an evaluation plan. The intervention included five educational modules, one in-person and four web-based, plus technical assistance calls to coordinators. Modules addressed the intervention rationale, development of clinic-specific plans to obtain minority-serving physician referrals, physician-centered and patient-centered communication, and patient navigation. The evaluation, a randomized trial, was recently completed in 50 specialty clinics and is under analysis. Using IM we developed a recruitment intervention that focused on building relationships with minority-serving physicians to encourage minority patient referrals. IM enhanced our understanding of factors that may influence minority recruitment and helped us integrate strategies from multiple disciplines that were relevant for our audience.