title: Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study.
abstract: 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.
authors: VA Research Enhancement Award Program (REAP), Birmingham VA Medical Center, Birmingham, AL, USA. emfunk@uab.edu
authors: Ellen
authors: E
authors: Funkhouser
authors: Deborah A
authors: DA
authors: Levine
authors: Joe K
authors: JK
authors: Gerald
authors: Thomas K
authors: TK
authors: Houston
authors: Nancy K
authors: NK
authors: Johnson
authors: Jeroan J
authors: JJ
authors: Allison
authors: Catarina I
authors: CI
authors: Kiefe
mesh_terms: D000553:Ambulatory Care / Q000379:methods / Q000458:organization & administration* / Q000592:standards; D006801:Humans; D020407:Internet; D009203:Myocardial Infarction / Q000628:therapy*; D010044:Outpatient Clinics, Hospital / Q000458:organization & administration / Q000592:standards; D018579:Patient Selection; D013997:Time Factors; D014481:United States; D014493:United States Department of Veterans Affairs / Q000458:organization & administration*