A Randomized Recruitment Intervention

描述（由申请人提供）：在低患病率（<5%）疾病的临床试验参与者中继续观察到很少的种族/民族多样性。有限的种族/民族多样性限制了我们评估和解决治疗反应中潜在差异的能力。我们提出了一个随机试验的招聘干预，以增加种族/民族的多样性。对于更常见的疾病，如高血压，社区方法已成功地增加了临床试验的多样性，但当疾病不太普遍，患者更难以通过这些有针对性的社区方法联系时，则不太成功。我们的干预措施将集中在通常进行低患病率疾病治疗试验的专科诊所。干预的目标将是专家和临床试验协调员。干预措施源自在提高医疗质量（专家）和患者导航方法的背景下改变提供者行为的方法，用于帮助种族/民族多样化的患者导航医疗系统（协调员）。临床研究中心将是随机化单位。假设：随机分配至临床研究中心的不同种族/人种参与者的比例 干预的比例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和对照地点来描述影响干预成功的中介因素：a）临床试验专家和协调员的自我效能与基线相比的变化，鼓励社区医生或其工作人员转诊少数群体以及与潜在参与者互动的预期结果; B）绩效指标（表2）; c）临床试验研究者和协调员的技能变化，通过社区医生向试验中心转诊的数量差异、试验参与者对临床试验中心研究者和协调员的满意度差异来衡量，社区医生对转介到治疗试验的满意度的差异，以及招募日志上报告的活动数量和类型的差异。 公共卫生相关性：我们正在研究方法，以增加种族和民族多样化的参与者的数量，研究治疗帕金森氏症或某些癌症等不太常见的疾病。研究人员发现，种族/民族群体对高血压和其他常见疾病的治疗反应存在差异。为了了解如何治疗来自不同种族和民族群体的低患病率疾病患者，我们需要他们参与新治疗方法的研究。

DESCRIPTION (provided by applicant): 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 therapeutc 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 les 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 of the 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 of the intervention by comparing intervention and control sites on: a) change from baseline in clinical trial specialists' and coordinators' self-efficacy an 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 satisfacion 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. PUBLIC HEALTH RELEVANCE: We are studying approaches to increase the number of racially and ethnically diverse participants in studies of treatments for less common diseases like Parkinson's or some cancers. Researchers found race/ethnic group differences in response to treatments for hypertension and other common diseases. To understand how to treat patients from racially and ethnically diverse groups with diseases of low prevalence we need their participation in studies of new treatments.