Recruitment activities for a nationwide, population-based, group-randomized trial: the VA MI-Plus study
1 VA Research Enhancement Award Program (REAP), Birmingham VA Medical Center, Birmingham, AL, USA
2 Department of Medicine, University of Alabama at Birmingham School of Medicine, Birmingham, AL (DAL adjunct), USA
3 Ann Arbor VA Healthcare System and Departments of Medicine and Neurology, University of Michigan, Ann Arbor, MI, USA
4 Veterans Affairs Health Services Research and Development Center of Excellence, Ann Arbor, MI, USA
5 Community, Environment and Policy, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Arizona, USA
6 Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, Massachusetts, USA
Implementation Science 2011, 6:105 doi:10.1186/1748-5908-6-105Published: 9 September 2011
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.
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.
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.
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.