Design of a cluster-randomized minority recruitment trial: RECRUIT

Barbara C. Tilley, Arch G. Mainous, Daniel W. Smith, M. Diane McKee, Rossybelle P. Amorrortu, Jennifer Alvidrez, Vanessa Diaz, Marvella E. Ford, Maria E. Fernandez, Robert A. Hauser, Carlos Singer, Veronica Landa, Aron Trevino, Stacia M. DeSantis, Yefei Zhang, Elvan Daniels, Derrick Tabor, Sally W. Vernon

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. Methods: We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. Results: RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). Conclusion: RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

Original languageEnglish (US)
Pages (from-to)286-298
Number of pages13
JournalClinical Trials
Volume14
Issue number3
DOIs
StatePublished - Jun 1 2017

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Physicians
Quality Improvement
Research Personnel
Clinical Trials
Ethnic Groups
Cluster Analysis
Minority Groups
National Institutes of Health (U.S.)
Population Characteristics
Random Allocation
Biomedical Research
Referral and Consultation
Hypertension
Population

Keywords

  • cluster-randomized trial
  • continuous quality improvement
  • intervention mapping
  • Minority recruitment
  • trust

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology

Cite this

Tilley, B. C., Mainous, A. G., Smith, D. W., McKee, M. D., Amorrortu, R. P., Alvidrez, J., ... Vernon, S. W. (2017). Design of a cluster-randomized minority recruitment trial: RECRUIT. Clinical Trials, 14(3), 286-298. https://doi.org/10.1177/1740774517690146

Design of a cluster-randomized minority recruitment trial : RECRUIT. / Tilley, Barbara C.; Mainous, Arch G.; Smith, Daniel W.; McKee, M. Diane; Amorrortu, Rossybelle P.; Alvidrez, Jennifer; Diaz, Vanessa; Ford, Marvella E.; Fernandez, Maria E.; Hauser, Robert A.; Singer, Carlos; Landa, Veronica; Trevino, Aron; DeSantis, Stacia M.; Zhang, Yefei; Daniels, Elvan; Tabor, Derrick; Vernon, Sally W.

In: Clinical Trials, Vol. 14, No. 3, 01.06.2017, p. 286-298.

Research output: Contribution to journalArticle

Tilley, BC, Mainous, AG, Smith, DW, McKee, MD, Amorrortu, RP, Alvidrez, J, Diaz, V, Ford, ME, Fernandez, ME, Hauser, RA, Singer, C, Landa, V, Trevino, A, DeSantis, SM, Zhang, Y, Daniels, E, Tabor, D & Vernon, SW 2017, 'Design of a cluster-randomized minority recruitment trial: RECRUIT', Clinical Trials, vol. 14, no. 3, pp. 286-298. https://doi.org/10.1177/1740774517690146
Tilley BC, Mainous AG, Smith DW, McKee MD, Amorrortu RP, Alvidrez J et al. Design of a cluster-randomized minority recruitment trial: RECRUIT. Clinical Trials. 2017 Jun 1;14(3):286-298. https://doi.org/10.1177/1740774517690146
Tilley, Barbara C. ; Mainous, Arch G. ; Smith, Daniel W. ; McKee, M. Diane ; Amorrortu, Rossybelle P. ; Alvidrez, Jennifer ; Diaz, Vanessa ; Ford, Marvella E. ; Fernandez, Maria E. ; Hauser, Robert A. ; Singer, Carlos ; Landa, Veronica ; Trevino, Aron ; DeSantis, Stacia M. ; Zhang, Yefei ; Daniels, Elvan ; Tabor, Derrick ; Vernon, Sally W. / Design of a cluster-randomized minority recruitment trial : RECRUIT. In: Clinical Trials. 2017 ; Vol. 14, No. 3. pp. 286-298.
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T1 - Design of a cluster-randomized minority recruitment trial

T2 - RECRUIT

AU - Tilley, Barbara C.

AU - Mainous, Arch G.

AU - Smith, Daniel W.

AU - McKee, M. Diane

AU - Amorrortu, Rossybelle P.

AU - Alvidrez, Jennifer

AU - Diaz, Vanessa

AU - Ford, Marvella E.

AU - Fernandez, Maria E.

AU - Hauser, Robert A.

AU - Singer, Carlos

AU - Landa, Veronica

AU - Trevino, Aron

AU - DeSantis, Stacia M.

AU - Zhang, Yefei

AU - Daniels, Elvan

AU - Tabor, Derrick

AU - Vernon, Sally W.

PY - 2017/6/1

Y1 - 2017/6/1

N2 - Background: Racial/ethnic minority groups remain underrepresented in clinical trials. Many strategies to increase minority recruitment focus on minority communities and emphasize common diseases such as hypertension. Scant literature focuses on minority recruitment to trials of less common conditions, often conducted in specialty clinics and dependent on physician referrals. We identified trust/mistrust of specialist physician investigators and institutions conducting medical research and consequent participant reluctance to participate in clinical trials as key-shared barriers across racial/ethnic groups. We developed a trust-based continuous quality improvement intervention to build trust between specialist physician investigators and community minority-serving physicians and ultimately potential trial participants. To avoid the inherent biases of non-randomized studies, we evaluated the intervention in the national Randomized Recruitment Intervention Trial (RECRUIT). This report presents the design of RECRUIT. Specialty clinic follow-up continues through April 2017. Methods: We hypothesized that specialist physician investigators and coordinators trained in the trust-based continuous quality improvement intervention would enroll a greater proportion of minority participants in their specialty clinics than specialist physician investigators in control specialty clinics. Specialty clinic was the unit of randomization. Using continuous quality improvement, the specialist physician investigators and coordinators tailored recruitment approaches to their specialty clinic characteristics and populations. Primary analyses were adjusted for clustering by specialty clinic within parent trial and matching covariates. Results: RECRUIT was implemented in four multi-site clinical trials (parent trials) supported by three National Institutes of Health institutes and included 50 associated specialty clinics from these parent trials. Using current data, we have 88% power or greater to detect a 0.15 or greater difference from the currently observed control proportion adjusting for clustering. We detected no differences in baseline matching criteria between intervention and control specialty clinics (all p values > 0.17). Conclusion: RECRUIT was the first multi-site randomized control trial to examine the effectiveness of a trust-based continuous quality improvement intervention to increase minority recruitment into clinical trials. RECRUIT's innovations included its focus on building trust between specialist investigators and minority-serving physicians, the use of continuous quality improvement to tailor the intervention to each specialty clinic's specific racial/ethnic populations and barriers to minority recruitment, and the use of specialty clinics from more than one parent multi-site trial to increase generalizability. The effectiveness of the RECRUIT intervention will be determined after the completion of trial data collection and planned analyses.

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