A Randomized Recruitment Intervention

随机招募干预

• 批准号: 8278258
• 负责人: BARBARA C. TILLEY
• 金额: $ 116.23万
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-20 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8278258
• 关键词: Achievement; Address; Affect; Alzheimer' s Disease; Amyotrophic Lateral Sclerosis; Beauty; Behavior; Caring; Caucasians; Caucasoid Race; Clinic; Clinical Trials; Communities; Community Physician; Development; Diabetes Mellitus; Disease; Enrollment; Ethnic group; European; Expectancy; Healthcare Systems; Huntington Disease; Hypertension; Intervention; Low Prevalence; Malignant Neoplasms; Measures; Mediating; Methods; Minority; Outcome; Parkinson Disease; Participant; Patients; Performance; Persons; Provider; Race; Randomized; Reporting; Research; Research Personnel; Self Efficacy; Site; Specialist; Testing; base; clinical research site; health care quality; hypertension treatment; improved; medical specialties; racial and ethnic; randomized trial; response; satisfaction; skills; success; treatment trial

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.

描述（由申请人提供）：在临床试验中，几乎没有种族/种族多样性在低患病率（<5％）的临床试验中观察到。有限的种族/种族多样性限制了我们评估和解决治疗反应潜在差异的能力。我们建议对招聘干预的随机试验，以增加种族/种族多样性。对于更常见的疾病，例如高血压，社区方法在临床试验中成功增加了多样性，但是当疾病流行时，疾病的疾病患者的成功率较小，并且通过这些有针对性的社区方法更难接触患有疾病的人。我们的干预将集中在专业诊所上，通常进行低患病率疾病的治疗试验。干预的目标是专家和临床试验协调员。该干预措施源于在改善医疗保健质量（专家）和用于协助种族/种族多样性患者进行医疗保健系统（协调员）的患者导航方法的情况下改变提供者行为的方法。临床部位将是随机分组的单位。假设：在随机分配给临床部位的种族/种族不同参与者的比例 干预措施将大于随机控制的站点的比例。我们将通过比较干预和控制地点来描述影响干预措施成功的中介因素： b）绩效指标（表2）； c）临床试验研究者和协调员技能的变化，通过转介数量的差异，来自社区医生的试验地点的差异，试验参与者对临床试验现场研究人员的满意度差异，社区医师对治疗试验的转诊的满意度的差异以及对招聘数目的数量和活动的差异。 公共卫生相关性：我们正在研究增加种族和种族多元化参与者数量的方法，以研究帕金森氏症或某些癌症等常见疾病的治疗研究。研究人员发现，种族/族裔群体对高血压和其他常见疾病的治疗方法有所不同。要了解如何从患有种族和种族多样性的群体中治疗患者，患有低患病率的疾病，我们需要他们参与新疗法研究。