Amorrortu Rossybelle P, Arevalo Mariana, Vernon Sally W, Mainous Arch G, Diaz Vanessa, McKee M Diane, Ford Marvella E, Tilley Barbara C
Department of Biostatistics & Data Sciences, The University of Texas Health Science Center at Houston (UT Health) School of Public Health, 1200 Hermann Pressler, Houston, TX, 77030, USA.
Department of Health Promotion and Behavioral Sciences, The University of Texas Health Science Center at Houston (UT Health) School of Public Health, 1200 Hermann Pressler, Houston, TX, 77030, USA.
Trials. 2018 Feb 17;19(1):115. doi: 10.1186/s13063-018-2507-9.
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.
尽管人们努力增加临床试验的多样性，但种族/族裔少数群体在试验中的代表性普遍仍然不足，这限制了研究人员在不同人群中测试新干预措施有效性和安全性的能力。我们描述了如何使用一种系统框架——干预映射（IM）来开发一种干预措施，以改变协调员和专科研究人员的招募行为，目标是增加专科诊所内进行的试验的多样性。据我们所知，IM尚未在这种情况下使用过。
IM框架用于确保干预措施的各个组成部分以健康行为理论和证据为指导。IM步骤包括：（1）进行需求评估；（2）确定决定因素和目标；（3）选择基于理论的方法和实际应用；（4）开发和创建项目组成部分；（5）制定采用和实施计划；（6）创建评估计划。
该干预措施包括五个教育模块，一个面对面模块和四个网络模块，外加与协调员的技术援助电话。这些模块涉及干预的基本原理、制定针对特定诊所的计划以获取为少数群体服务的医生推荐、以医生为中心和以患者为中心的沟通以及患者引导。该评估作为一项随机试验，最近在50个专科诊所完成，正在进行分析。
通过使用IM，我们开发了一种招募干预措施，重点是与为少数群体服务的医生建立关系，以鼓励他们推荐少数群体患者。IM增强了我们对可能影响少数群体招募的因素的理解，并帮助我们整合了来自多个学科的、与我们的受众相关的策略。
