Clinical trial NCT01911208: A Randomized Recruitment Intervention Trial
Official title: A Randomized Recruitment Intervention Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Recruitment of Minorities
Keywords: Minority
Recruitment
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2013-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Percentage of racially/ethnically diverse participants (minorities) enrolled
timeFrame: Up to 2 years
Secondary outcomes:
measure: Number of participant referrals
timeFrame: up to 2 years
measure: Recruitment Activities
timeFrame: up to 2 years
measure: Investigator and Coordinator Outcome expectations
timeFrame: up to 2 years
measure: Qualitative Key Informant Interviews
timeFrame: up to 2 years
measure: Participant Satisfaction
timeFrame: up to 2 years
measure: Investigator and Coordinator Self-Efficacy
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center School of Public Health
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Barbara C. Tilley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.