A Randomized Recruitment Intervention Trial

NCT01911208 | Completed

• 2 other identifiers: NIMHD006941U24MD006941
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Recruitment of Minorities

Keywords

Minority; Recruitment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of participant referrals

  up to 2 years

• Recruitment Activities

  up to 2 years

• Investigator and Coordinator Outcome expectations

  up to 2 years

• Qualitative Key Informant Interviews

  up to 2 years

• Participant Satisfaction

  up to 2 years

Study Arms (2)

RECRUIT intervention

EXPERIMENTAL

Clinical sites will work with the RECRUIT team to enhance and individualize their recruitment methods.

Behavioral: RECRUIT intervention

Control

EXPERIMENTAL

Clinical sites can use which ever recruitment methods they prefer.

Behavioral: Control

Interventions

RECRUIT intervention BEHAVIORAL

Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.

RECRUIT intervention

Control BEHAVIORAL

Non-intervention control.

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• site does not agree to be randomized;
• investigator or coordinator is under 18 years of age.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Texas Health Science Center School of Public Health

Houston, Texas, 77030, United States

Location

Related Publications (2)

• 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.

  PMID: 34333138 DERIVED

• 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.

  PMID: 32838555 DERIVED

Study Officials

• Barbara C. Tilley, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SPH Faculty - Biostatistics

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: July 30, 2013
• Study Start: November 1, 2011
• Primary Completion: October 6, 2017
• Study Completion: October 6, 2017
• Last Updated: June 29, 2018

Record last verified: 2018-06

Locations

US (1)