A Randomized Recruitment Intervention

在临床试验的参与者中，几乎没有观察到种族/民族多样性， 发病率低（<5%）。有限的种族/民族多样性限制了我们评估和解决潜在问题的能力。 治疗反应的差异。我们建议进行一项招募干预的随机试验， 种族/民族多样性。对于更常见的疾病，如高血压，社区方法 成功地增加了临床试验的多样性，但当疾病不太流行时， 而且通过这些有针对性的社区方法更难接触到患有这种疾病的人。 我们的干预措施将集中在专科诊所，在这些诊所，低患病率疾病的治疗试验通常是 进行。干预的目标将是专家和临床试验协调员。的 干预是从在改善医疗保健的背景下改变提供者行为的方法中衍生出来的 质量（专家）和患者导航方法，用于帮助不同种族/民族的患者 医疗保健系统（协调员）。临床研究中心将是随机化单位。 假设：在临床研究中心随机入组的不同种族/人种的受试者比例 干预将大于随机分配至对照组的研究中心的比例。 我们将通过比较干预措施和 对照研究中心：a）临床试验专家和协调员自我效能较基线的变化， 鼓励社区医生或其工作人员向少数群体转诊的预期结果， 与潜在参与者互动; B）性能指标（表2）; c）临床试验技能的变化 研究者和协调员，通过转诊至试验中心的数量与 社区医生，试验参与者对临床试验中心研究者满意度的差异， 协调员，社区医生对他们转介到治疗试验的满意度的差异，以及 征聘日志中报告的活动数量和类型存在差异。

Little racial/ethnic diversity continues to be observed among participants in clinical trials for diseases of low prevalence (<5%). The limited racial/ethnic diversity limits our ability to assess and address potential differences in therapeutic response. We propose a randomized trial of a recruitment intervention to increase racial/ethnic diversity. For more common diseases such as hypertension, community approaches have successfully increased diversity in clinical trials, but are less successful when the disease is less prevalent and persons with the disease are more difficult to contact through these targeted community approaches. Our intervention will focus on specialty clinics where treatment trials for low prevalence diseases are usually conducted. The target ofthe intervention will be the specialists and clinical trial coordinators. The intervention is derived from approaches to changing provider behavior in the context of improving healthcare quality (specialists) and patient navigation methods used to assist racially/ethnically diverse patients in navigating the healthcare system (coordinators). Clinical site will be the unit of randomization. Hypothesis: The proportion of racially/ethnically diverse participants enrolled in clinical sites randomized to the intervention will be greater than the proportion in sites randomized to control. We will describe mediating factors affecting success ofthe intervention by comparing intervention and control sites on: a) change from baseline in clinical trial specialists' and coordinators' self-efficacy and outcome expectancy in encouraging minority referrals from community physicians or their staff and in interacting with potential participants; b) performance measures (Table 2); c) changes in skills of clinical trial investigators and coordinators as measured by differences in number of referrals to the trial sites from community physicians, differences in trial participants satisfaction with clinical trial site investigators and coordinators, differences in community physicians' satisfaction with their referrals to the treatment trial, and differences in numbers and types of activities reported on recruitment logs.