A Randomized Recruitment Intervention Trial (RECRUIT)

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

Study Overview

• Status: Completed
• Conditions: Recruitment of Minorities
• Intervention / Treatment: Behavioral: RECRUIT intervention; Behavioral: Control

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
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Barbara C. Tilley, PhD, The University of Texas Health Science Center, Houston

Publications and helpful links

General Publications

• Tilley BC, Mainous AG 3rd, Amorrortu RP, McKee MD, Smith DW, Li R, DeSantis SM, Vernon SW, Koch G, Ford ME, Diaz V, Alvidrez J; additional RECRUIT Trial Center and Parent Trials' investigators. Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial. Contemp Clin Trials. 2021 Oct;109:106519. doi: 10.1016/j.cct.2021.106519. Epub 2021 Jul 30.
• DeSantis SM, Li R, Zhang Y, Wang X, Vernon SW, Tilley BC, Koch G. Intent-to-treat analysis of cluster randomized trials when clusters report unidentifiable outcome proportions. Clin Trials. 2020 Dec;17(6):627-636. doi: 10.1177/1740774520936668. Epub 2020 Aug 24.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 6, 2017
• Study Completion (Actual): October 6, 2017

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: July 29, 2013
• First Posted (Estimate): July 30, 2013

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Recruitment; Minority
• Other Study ID Numbers: NIMHD006941; U24MD006941 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided