3116 — Recruitment into a Nationwide Group Randomized Trial of CBOCs: The VA MI-Plus Study
Funkhouser EM (REAP-Birmingham), Levine DA
(REAP-Birmingham), Gerald JK
(REAP-Birmingham), Houston TK
(REAP-Birmingham), Johnson-Roe NK
(REAP-Birmingham), Kiefe CI
Group-randomized trials (GRTs) are a recent but increasingly important tool for implementation research. The ablity to recruit multiple sites is key for the success of a GRT. We describe here the recruitment activities and enrollment rates at the facility (VAMC), CBOC, and provider level for the VA myocardial infarction (MI)-Plus study, a nationwide GRT of VA primary care providers practicing in Community-Based Outpatient Clinics (CBOCs). The CBOCs were the unit of randomization. The intervention consisted of interactive Internet case-based learning modules.
We identified facilities, using the VAST database of 12/2004, that had research capability, a physician willing to be a local PI, and at least 4 non-contract associated CBOCs. A MI-Plus study investigator called the ACOS primary care, head of research, and chief of cardiology at each facility. CBOC eligibility consisted of use of CPRS and provider access to the Internet. During the second year of recruitment, the MI-Plus study hired a research assistant whose primary responsibility was to deal with IRB protocols. Providers were contacted via 1) initial email, 2) postal letter and study flier, 3) weekly email reminders, and 4) monthly reports to the local P.I. Once a provider enrolled, the CBOC from which he/she enrolled was randomized to either the intervention or control arm.
Overall, 108 facilities were identified using the VAST database, and an additional 10 during recruitment: 72 were eligible, of which 48 (66.7%) participated. These 48 facilities were located nationwide. The initial facility was recruited 11/2003. Additional facilities were recruited in two waves: 17 in Wave 1 (03/2003-08/2004) and 30 in Wave 2 (01-06/2005); 2 were recruited after Wave 2. There were 219 CBOCs associated with the 48 facilities, of which 168 (76.7%) enrolled. Of 957 providers associated with the enrolled CBOCs, 401 (41.9%) logged on to the website.
With careful planning, appropriate protocols and staffing, it is possible to recruit a nationwide sample of CBOC providers in a reasonable time frame.
The feasibility of a large-scale, nationally representative group-randomized trial of VA CBOC providers makes VA a methodologically attractive environment for implementation research in primary care.