A Randomized Recruitment Intervention Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percentage of racially/ethnically diverse participants (minorities) enrolled
研究概览
简要总结
The purpose of this study is to test a recruitment intervention to increase racial and ethnic diversity in clinical trials. The trial will be conducted in specialty care clinics. In RECRUIT minorities are those underrepresented in clinical trials and include:
- African Americans/ Blacks
- Asians
- Native Hawaiians/Other Pacific Islanders
- Hispanic/Latinos
- Native Americans/Alaskan Natives
详细描述
Low minority participation in clinical trials limits our ability to assess and address potential differences in therapeutic responses. To address the problem of low minority recruitment we are initiating a randomized trial of a recruitment intervention (RECRUIT) funded by the National Institute on Minority Health and Health disparities (NIMHD) to increase racial/ethnic diversity in clinical trials.
Our specific approach is directed toward multi-site trials conducted at specialty clinics within academic centers with recruiting venues that include community practices or practices of colleagues in other areas of the academic center. The intervention will focus on approximately 60 specialty clinics. Clinical sites will be randomized to the intervention or control group. The target of the intervention will be the site investigators and clinical trial coordinators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A parent trial must :
- •have a coordinating Center willing to allow their Clinical Sites to participate;
- •be studying be studying a condition that requires community or health system physician referral
- •be studying an intervention where the recruitment approach cannot be made directly to minority community members
- •need to increase recruitment of racially/ethnically diverse participants* to the trial as demonstrated by current trial progress or historical data from other trials in the same disease;
- •be a Phase II or Phase III trial
- •be conducted in at least six multiple sites;
- •expect each Clinical Site to recruit at least 10 participants;
- •be funded by a sponsor (NIH or pharmaceutical company or other) that has a strong commitment to recruiting racially/ethnically diverse subjects;
- •be willing to have investigators and coordinators attend a special training meeting (at RECRUIT expense);
- •require randomization to intervention or control (could be best medical care or active control or placebo or other type of control);
- •provide transportation costs for trial participants who need assistance in getting to trial sites or use some RECRUIT reimbursement for this purpose.
- •The clinical site must
- •be a funded Clinical Site in the parent trial;
- •be located in an area where at least 20% of the population within 30 miles in the age group under study in the parent trial are from diverse populations.
排除标准
- •site does not agree to be randomized;
- •investigator or coordinator is under 18 years of age.
研究组 & 干预措施
RECRUIT intervention
Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.
干预措施: RECRUIT intervention (Behavioral)
Control
Clinical sites can use which ever recruitment methods they prefer.
干预措施: Control (Behavioral)
结局指标
主要结局
Percentage of racially/ethnically diverse participants (minorities) enrolled
时间窗: Up to 2 years
Minorities as defined in this trial include those underrepresented in clinical trials and considered underrepresented by NIH criteria with the addition of those of Asian descent.
次要结局
- Participant Satisfaction(up to 2 years)
- Number of participant referrals(up to 2 years)
- Investigator and Coordinator Self-Efficacy(up to 2 years)
- Investigator and Coordinator Outcome expectations(up to 2 years)
- Recruitment Activities(up to 2 years)
- Qualitative Key Informant Interviews(up to 2 years)
研究者
Barbara Tilley
SPH Faculty - Biostatistics
The University of Texas Health Science Center, Houston