Key result
Implementing intensified recruitment strategies, including physician recruiters and a dedicated IRB manager, significantly decreased the median time from initial facility contact to clinic enrollment from 323 to 195 days.
Absolute Event Rate: 195% vs 323%
p-value: p=<0.001
A large-scale, nationally representative, group-randomized trial of community-based clinics is feasible within a national healthcare system like the VHA, especially when utilizing dedicated physician investigators and IRB personnel for recruitment.
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.
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Funkhouser et al. (2011) studied Post-myocardial infarction (clinician recruitment) (n=66). Intensified recruitment strategies (physician recruiters and dedicated IRB manager) vs. Initial recruitment strategies was evaluated on Median time from initial facility contact to clinic enrollment (days) (p=<0.001). Implementing intensified recruitment strategies, including physician recruiters and a dedicated IRB manager, significantly decreased the median time from initial facility contact to clinic enrollment from 323 to 195 days.
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