Abstract
BackgroundDespite 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.MethodsThe 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.ResultsThe 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.ConclusionsUsing 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.
Highlights
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
Step 1: needs assessment In September 2011, we received funding for Recruitment Intervention Trial (RECRUIT) and formed a planning group consisting of 14 stakeholders including specialist investigators and family practice physicians from diverse racial and ethnic backgrounds, and an interdisciplinary team including a psychologist, epidemiologist, biostatistician, and behavioral scientists
Such trials are often conducted at specialty clinics where minority patients often have limited access to services [22,23,24]
Summary
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. Recent studies in various diseases (e.g., cancer, neurologic diseases, and cardiovascular disease) indicate that study populations underrepresent the race and ethnicity of Previous research identified minority patient barriers to participation in clinical trials such as mistrust in medical researchers, fear of randomization/experimentation, and other logistical issues (language, transportation and financial barriers) [8,9,10,11,12]. A recent review of minority recruitment interventions addressing multiple levels of recruitment barriers found that strategies such as opening trials within community sites to overcome transportation problems, and the use of nurse navigators and research staff to overcome specific patient barriers helped increase minority recruitment [14]. The authors identified the importance of having investigators develop trusting relationships with community clinicians in clinical trial recruitment efforts.
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