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A Randomized Recruitment Intervention Trial (RECRUIT)

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ClinicalTrials.gov Identifier: NCT01911208
Recruitment Status : Completed
First Posted : July 30, 2013
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
Barbara Tilley, The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment Phase
Recruitment of Minorities Behavioral: RECRUIT intervention Behavioral: Control Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Randomized Recruitment Intervention Trial
Study Start Date : November 2011
Actual Primary Completion Date : October 6, 2017
Actual Study Completion Date : October 6, 2017

Arm Intervention/treatment
Experimental: RECRUIT intervention
Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.
Behavioral: RECRUIT intervention
Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.

Experimental: Control
Clinical sites can use which ever recruitment methods they prefer.
Behavioral: Control
Non-intervention control.




Primary Outcome Measures :
  1. Percentage of racially/ethnically diverse participants (minorities) enrolled [ Time Frame: 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 Outcome Measures :
  1. Number of participant referrals [ Time Frame: up to 2 years ]
    Differences between intervention and control sites in number of participant referrals.

  2. Recruitment Activities [ Time Frame: up to 2 years ]
    Numbers and types of activities reported on recruitment logs by all sites.

  3. Investigator and Coordinator Outcome expectations [ Time Frame: up to 2 years ]
    Change from baseline in physician investigator and coordinator outcome expectations (intervention sites only).

  4. Qualitative Key Informant Interviews [ Time Frame: up to 2 years ]
    Qualitative key informant phone interviews of the physician investigators and coordinators (intervention and control sites).

  5. Participant Satisfaction [ Time Frame: 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.

  6. Investigator and Coordinator Self-Efficacy [ Time Frame: up to 2 years ]
    Change from baseline in physician investigator and coordinator self-efficacy(intervention sites only).



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911208


Locations
United States, Texas
University of Texas Health Science Center School of Public Health
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
Principal Investigator: Barbara C. Tilley, PhD The University of Texas Health Science Center, Houston

Responsible Party: Barbara Tilley, SPH Faculty - Biostatistics, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01911208     History of Changes
Other Study ID Numbers: NIMHD006941
U24MD006941 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2013    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Barbara Tilley, The University of Texas Health Science Center, Houston:
Minority
Recruitment