A Randomized Recruitment Intervention

描述(由申请人提供)：在低患病率(5%)的疾病临床试验参与者中，继续观察到几乎没有种族/民族多样性。有限的种族/民族多样性限制了我们评估和处理治疗反应中潜在差异的能力。我们建议进行一项招募干预的随机试验，以增加种族/民族多样性。对于高血压等更常见的疾病，社区方法在临床试验中成功地增加了多样性，但当疾病在LES流行并且通过这些有针对性的社区方法更难接触到患者时，社区方法就不那么成功了。我们的干预将集中在专科诊所，那里通常进行低患病率疾病的治疗试验。干预的对象将是专家和临床试验协调员。这种干预源于在提高医疗质量的背景下改变提供者行为的方法(专家)，以及用于帮助种族/民族多样化的患者导航医疗系统的患者导航方法(协调员)。临床现场将以随机化为单位。假设：在临床地点登记的不同种族/民族的参与者的比例随机到 干预的比例将大于随机对照地点的比例。我们将通过比较干预地点和对照地点来描述影响干预成功的调解因素：a)临床试验专家和协调员自我效能的变化，以及在鼓励社区医生或其工作人员转诊少数人并与潜在参与者互动方面的预期结果；b)绩效衡量(表2)；c)临床试验调查人员和协调员技能的变化，衡量标准是社区医生转诊到试验地点的次数不同，试验参与者对临床试验地点调查人员和协调员满意的程度不同，社区医生对治疗试验转诊的满意度差异，以及招募日志中报告的活动数量和类型的差异。 与公共卫生相关：我们正在研究增加不同种族和民族的参与者参与帕金森氏症或某些癌症等不太常见疾病的治疗研究的方法。研究人员发现，对高血压和其他常见疾病的治疗反应存在种族/民族差异。为了了解如何治疗来自种族和民族多样化群体的低发病率疾病患者，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.