TY - JOUR
T1 - Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics
T2 - An intervention mapping approach
AU - Amorrortu, Rossybelle P.
AU - Arevalo, Mariana
AU - Vernon, Sally W.
AU - Mainous, Arch G.
AU - Diaz, Vanessa
AU - McKee, M. Diane
AU - Ford, Marvella E.
AU - Tilley, Barbara C.
N1 - Publisher Copyright:
© 2018 The Author(s).
PY - 2018/2/17
Y1 - 2018/2/17
N2 - Background: 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. Methods: 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. Results: 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. Conclusions: 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.
AB - Background: 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. Methods: 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. Results: 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. Conclusions: 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.
KW - Program development
KW - Relationship building
KW - Social cognitive theory
KW - Specialist
KW - Training
KW - Trust
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U2 - 10.1186/s13063-018-2507-9
DO - 10.1186/s13063-018-2507-9
M3 - Article
C2 - 29454389
AN - SCOPUS:85042164718
SN - 1745-6215
VL - 19
JO - Trials
JF - Trials
IS - 1
M1 - 115
ER -