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.

在疾病临床试验的参与者中仍然观察到很少的种族/民族多样性 患病率低（<5%）。有限的种族/民族多样性限制了我们评估和解决潜力的能力 治疗反应的差异。我们建议进行一项招募干预的随机试验，以增加 种族/民族多样性。对于高血压等更常见的疾病，社区方法已经 在临床试验中成功地增加了多样性，但当疾病不太流行时，效果就不那么成功了 通过这些有针对性的社区方法，更难接触到患有该疾病的人。 我们的干预措施将集中于专科诊所，这些诊所通常对低流行性疾病进行治疗试验 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背景下改变提供者行为的方法 用于帮助不同种族/民族患者的质量（专家）和患者导航方法 导航医疗保健系统（协调员）。临床中心将是随机化的单位。 假设：临床中心随机招募的种族/族裔多样化参与者的比例 干预措施将大于随机对照地点的比例。 我们将通过比较干预和干预来描述影响干预成功的中介因素。 控制点：a) 临床试验专家和协调员自我效能较基线的变化，以及 鼓励少数群体从社区医生或其工作人员处转诊以及在 与潜在参与者互动； b) 绩效衡量（表2）； c) 临床试验技能的变化 调查员和协调员的数量，通过转介至试验地点的人数差异来衡量 社区医生、试验参与者对临床试验地点研究者的满意度差异以及 协调员、社区医生对转介治疗试验的满意度差异，以及 招聘日志中报告的活动数量和类型存在差异。