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

Recruitment of racial and ethnic minorities to clinical trials conducted within specialty clinics: an intervention mapping approach.
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DOI:
10.1186/s13063-018-2507-9
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发表时间:
2018-02-17
期刊:
影响因子:
2.5
通讯作者:
Tilley BC
Tilley BC
中科院分区:
医学4区
文献类型:
--
作者:
Amorrortu RP;Arevalo M;Vernon SW;Mainous AG 3rd;Diaz V;McKee MD;Ford ME;Tilley BC

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尽管努力增加临床试验的多样性,但种族/少数民族群体的代表性普遍不足,限制了研究人员在不同人群中测试新干预措施的有效性和安全性的能力。我们描述了一个系统框架的使用,干预映射(IM),开发一个干预来修改协调员和专家调查员的招募行为,目标是增加在专科诊所进行的试验的多样性。据我们所知,IM尚未在此设置中使用。使用IM框架来确保干预成分以健康行为理论和证据为指导。IM的步骤包括(1)进行需求评估,(2)确定决定因素和目标,(3)选择有理论依据的方法和实际应用,(4)开发和创建项目组件,(5)制定采用和实施计划,以及(6)创建评估计划。干预措施包括五个教育模块,一个面对面的模块和四个基于网络的模块,以及对协调员的技术援助电话。模块讨论了干预的基本原理,制定临床特定计划以获得少数族裔服务医生的转诊,以医生为中心和以患者为中心的沟通,以及患者导航。这项评估是一项随机试验,最近在50家专科诊所完成,目前正在分析中。使用IM,我们开发了一种招募干预措施,重点是与少数族裔服务医生建立关系,以鼓励少数族裔患者转诊。IM增强了我们对可能影响少数族裔招聘的因素的理解,并帮助我们整合与受众相关的多个学科的策略。
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.
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