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Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study
Quantitative Health Sciences Publications and Presentations
  • Ellen M. Funkhouser, University of Alabama
  • Deborah A. Levine, Ohio State University
  • Joe K. Gerald, University of Arizona
  • Thomas K. Houston, University of Massachusetts Medical School
  • Nancy K. Johnson, Birmingham VA Medical Center
  • Jeroan J. Allison, University of Massachusetts Medical School
  • Catarina I. Kiefe, University of Massachusetts Medical School
UMMS Affiliation
Department of Quantitative Health Sciences
Publication Date
Document Type
Veterans Health; Veterans; Randomized Controlled Trials as Topic

BACKGROUND: The Veterans Health Administration (VHA) oversees the largest integrated healthcare system in the United States. The feasibility of a large-scale, nationwide, group-randomized implementation trial of VHA outpatient practices has not been reported. We describe the recruitment and enrollment of such a trial testing a clinician-directed, Internet-delivered intervention for improving the care of postmyocardial infarction patients with multiple comorbidities.

METHODS: With a recruitment goal of 200 eligible community-based outpatient clinics, parent VHA facilities (medical centers) were recruited because they oversee their affiliated clinics and the research conducted there. Eligible facilities had at least four VHA-owned and -operated primary care clinics, an affiliated Institutional Review Board (IRB), and no ongoing, potentially overlapping, quality-improvement study. Between December 2003 and December 2005, in two consecutive phases, we used initial and then intensified recruitment strategies.

RESULTS: Overall, 48 of 66 (73%) eligible facilities were recruited. Of the 219 clinics and 957 clinicians associated with the 48 facilities, 168 (78%) clinics and 401 (42%) clinicians participated. The median time from initial facility contact to clinic enrollment was 222 days, which decreased by over one-third from the first to the second recruitment phase (medians: 323 and 195 days, respectively; p < .001), when more structured recruitment with physician recruiters was implemented and a dedicated IRB manager was added to the coordinating center staff.

CONCLUSIONS: Large group-randomized trials benefit from having dedicated physician investigators and IRB personnel involved in recruitment. A large-scale, nationally representative, group-randomized trial of community-based clinics is feasible within the VHA or a similar national healthcare system.

  • UMCCTS funding
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© 2011 Funkhouser et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

DOI of Published Version
Implement Sci. 2011 Sep 9;6:105. doi:10.1186/1748-5908-6-105. The electronic version of this article is the complete one and can be found online at:
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Citation Information
Ellen M. Funkhouser, Deborah A. Levine, Joe K. Gerald, Thomas K. Houston, et al.. "Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study" Vol. 6 (2011) ISSN: 1748-5908 (Linking)
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