Tilley Barbara C, Mainous Arch G, Smith Daniel W, McKee M Diane, Amorrortu Rossybelle P, Alvidrez Jennifer, Diaz Vanessa, Ford Marvella E, Fernandez Maria E, Hauser Robert A, Singer Carlos, Landa Veronica, Trevino Aron, DeSantis Stacia M, Zhang Yefei, Daniels Elvan, Tabor Derrick, Vernon Sally W
1 Department of Biostatistics, School of Public Health, University of Texas Health Science Center at Houston (UTHEALTH), Houston, TX, USA.
2 Department of Health Services Research, Management & Policy, College of Public Health & Health Professions, University of Florida, Gainesville, FL, USA.
Clin Trials. 2017 Jun;14(3):286-298. doi: 10.1177/1740774517690146. Epub 2017 Mar 19.
Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017.
We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates.
RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17).
RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.
种族/族裔少数群体在临床试验中的代表性仍然不足。许多增加少数群体参与度的策略都聚焦于少数群体社区，并强调诸如高血压等常见疾病。很少有文献关注将少数群体招募到不那么常见疾病的试验中，这类试验通常在专科诊所进行，且依赖医生转诊。我们发现，专科医生研究人员和开展医学研究的机构之间的信任/不信任，以及随之而来的参与者不愿参与临床试验，是不同种族/族裔群体共有的关键障碍。我们开发了一种基于信任的持续质量改进干预措施，以建立专科医生研究人员与社区为少数群体服务的医生之间的信任，并最终与潜在的试验参与者建立信任。为避免非随机研究固有的偏差，我们在全国随机招募干预试验（RECRUIT）中对该干预措施进行了评估。本报告介绍了RECRUIT的设计。专科诊所的随访持续到2017年4月。
我们假设，接受基于信任的持续质量改进干预培训的专科医生研究人员和协调员，在其专科诊所招募的少数群体参与者比例将高于对照专科诊所的专科医生研究人员。专科诊所是随机分组的单位。通过持续质量改进，专科医生研究人员和协调员根据其专科诊所的特点和人群调整招募方法。在母试验中，主要分析针对专科诊所的聚类情况进行了调整，并匹配了协变量。
RECRUIT在由美国国立卫生研究院的三个研究所支持的四项多中心临床试验（母试验）中实施，包括这些母试验中的50家相关专科诊所。根据现有数据，在调整聚类后，如果与当前观察到的对照比例存在0.15或更大的差异，我们有88%或更高的把握度能够检测到这种差异。我们发现干预组和对照组专科诊所在基线匹配标准上没有差异（所有p值>0.17）。
RECRUIT是首个多中心随机对照试验，旨在检验基于信任的持续质量改进干预措施在增加少数群体参与临床试验方面的有效性。RECRUIT的创新之处包括：专注于建立专科研究人员与为少数群体服务的医生之间的信任；利用持续质量改进根据每个专科诊所特定的种族/族裔人群和少数群体招募障碍来调整干预措施；利用来自多个母多中心试验的专科诊所来提高普遍性。RECRUIT干预措施的有效性将在完成试验数据收集和计划分析后确定。
