A Randomized Recruitment Intervention

随机招募干预

• 批准号: 8688806
• 负责人: BARBARA C. TILLEY
• 金额: $ 70.74万
• 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/8688806
• 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; Instruction; 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; Therapeutic; base; clinical research site; health care quality; hypertension treatment; improved; medical specialties; racial and ethnic; randomized trial; response; satisfaction; skills; success; treatment trial

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.

在参与者中，几乎没有种族/种族多样性在临床试验的参与者中持续观察到 低患病率（<5％）。有限的种族/种族多样性限制了我们评估和解决潜力的能力 治疗反应的差异。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，社区方法有 在临床试验中成功增加了多样性，但是当疾病较少的情况下，成功率较低 通过这些有针对性的社区方法，患有疾病的人更难接触。 我们的干预措施将集中于专业诊所，在这些诊所中，通常 实施。干预的目标将是专家和临床试验协调员。这 干预源于在改善医疗保健的情况下改变提供商行为的方法 质量（专家）和患者导航方法用于协助种族/种族多样的患者 导航医疗系统（协调员）。临床部位将是随机分组的单位。 假设：在随机分配到的临床部位的种族/种族多元化参与者的比例 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 控制站点：a）从临床试验专家和协调员的自我效能和协调员中的基线变化 鼓励社区医生或其员工的少数群体推荐的预期结果以及 与潜在参与者互动； b）绩效指标（表2）； c）临床试验技能的变化 研究人员和协调员通过从转诊数量到试验地点的差异来衡量 社区医生，试验参与者对临床试验现场调查人员的满意和 协调员，社区医师对他们转介治疗试验的满意程度的差异，以及 招聘日志报告的活动数量和类型的差异。