TY - JOUR
T1 - Recruitment activities for a nationwide, population-based, group-randomized trial
T2 - The VA MI-Plus study
AU - Funkhouser, Ellen
AU - Levine, Deborah A.
AU - Gerald, Joe K.
AU - Houston, Thomas K.
AU - Johnson, Nancy K.
AU - Allison, Jeroan J.
AU - Kiefe, Catarina I.
N1 - Funding Information:
This project was funded in part by grant SDR 03-090-1 from the VA Health Services Research and Development (HSR&D) and by grant number R01 HL70786 from the National Heart, Lung, and Blood Institute.
Funding Information:
The study was funded through the VHA Health Services Research and Development (HSR&D) office [IHD 04-387] and by a parallel National Institutes of Health study [R01 HL70786-02][10,11]. We conducted formative work with a panel of expert physicians using nominal group techniques to choose from among 36 potential quality indicators for complex ambulatory post-MI patients that would be both most feasible and most valid [8]. We also conducted focus groups and case-vignette surveys of clinicians, including VHA clinicians, to develop the intervention. The Birmingham VA Medical Center, Birmingham, AL, served as the study’s coordinating center. After approval from its IRB and R&D committees, the Birmingham facility and its six affiliated outpatient clinics were the first study enrollees in November 2003.
PY - 2011/9/9
Y1 - 2011/9/9
N2 - 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.
AB - 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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U2 - 10.1186/1748-5908-6-105
DO - 10.1186/1748-5908-6-105
M3 - Article
C2 - 21906278
AN - SCOPUS:80052587575
SN - 1748-5908
VL - 6
JO - Implementation Science
JF - Implementation Science
IS - 1
M1 - 105
ER -