Recruitment of Minorities
Conditions
Keywords
Minority, Recruitment
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALRECRUIT intervention
Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.
BEHAVIORALControl
Non-intervention control.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: 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.
Exclusion criteria
* site does not agree to be randomized; * investigator or coordinator is under 18 years of age.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of racially/ethnically diverse participants (minorities) enrolled | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participant referrals | up to 2 years | Differences between intervention and control sites in number of participant referrals. |
| Recruitment Activities | up to 2 years | Numbers and types of activities reported on recruitment logs by all sites. |
| Investigator and Coordinator Outcome expectations | up to 2 years | Change from baseline in physician investigator and coordinator outcome expectations (intervention sites only). |
| Participant Satisfaction | up to 2 years | Potential/enrolled participant satisfaction with intervention and control trial site investigators and coordinators. Subjects will be given a satisfaction survey at screening and at every follow up visit. |
| Investigator and Coordinator Self-Efficacy | up to 2 years | Change from baseline in physician investigator and coordinator self-efficacy(intervention sites only). |
| Qualitative Key Informant Interviews | up to 2 years | Qualitative key informant phone interviews of the physician investigators and coordinators (intervention and control sites). |
Countries
United States
Outcome results
None listed