A Randomized Recruitment Intervention Trial

Study Overview
=================
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.

Official Title
-----------------
A Randomized Recruitment Intervention Trial

Conditions
-----------------
Recruitment of Minorities

Intervention / Treatment
-----------------
* Behavioral: RECRUIT intervention
* Behavioral: Control


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECRUIT intervention<br>Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods. | Behavioral: RECRUIT intervention<br>* Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.<br>|
| Experimental: Control<br>Clinical sites can use which ever recruitment methods they prefer. | Behavioral: Control<br>* Non-intervention control.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of racially/ethnically diverse participants (minorities) enrolled | 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. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participant referrals | Differences between intervention and control sites in number of participant referrals. | up to 2 years | 
| Recruitment Activities | Numbers and types of activities reported on recruitment logs by all sites. | up to 2 years | 
| Investigator and Coordinator Outcome expectations | Change from baseline in physician investigator and coordinator outcome expectations (intervention sites only). | up to 2 years | 
| Qualitative Key Informant Interviews | Qualitative key informant phone interviews of the physician investigators and coordinators (intervention and control sites). | up to 2 years | 
| Participant Satisfaction | 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. | up to 2 years | 
| Investigator and Coordinator Self-Efficacy | Change from baseline in physician investigator and coordinator self-efficacy(intervention sites only). | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minority, Recruitment