JE DeWitt, Drake University College of Pharmacy; BA Sorofman, University of Iowa College of Pharmacy; BJ BootsMiller, Program in Health Sciences Research, Iowa City VAMC; T Tripp-Reimer, University of Iowa College of Nursing; BN Doebbeling, Program in Health Sciences Research, Iowa City VAMC and University of Iowa College of Medicine, Department of Internal Medicine

Objectives: This focus group study is part of a larger research project investigating the factors influencing the effectiveness of clinical practice guideline (CPG) implementation. In the first phase of the project, focus groups were conducted in VAMCs nationwide to study the process of CPG implementation. Although a predefined process was established to obtain participation of each selected site and coordinate the focus groups, this process had to be re-examined, modified, and locally adapted. The objective of this component was to identify the variation in approval and access to a national sample of VA facilities in order to conduct quality improvement focus groups.

Methods: The process of arranging and conducting 50 focus groups in 18 facilities was documented. The External Peer Review Program (EPRP) provides proxy data on the rates of successful implementation of CPGs at each VAMC. Facilities were selected to reflect a range of adherence, geographic location, bed-size, teaching affiliation, patient population gender, and racial/ethnic distributions. An initial contact was made with the Chief of Staff (COS) at each facility by mail. After formal approval from the COS, a site coordinator was identified. Information about the project was provided to the research office (if applicable) and approval for the visit was sought. Union representatives were also informed. The site coordinator assisted in identifying appropriate individuals for focus group participation, and selection of a date. At most facilities, 3 focus groups representing different stakeholder views of CPG implementation were conducted: administrators/managers, primary care providers (physicians, ARNPs, and PAs), and clinicians (e.g., nurses, pharmacists, and dieticians).

Results: Considerable variation existed in the process of securing approval, scheduling and coordinating the focus groups. The approval process ranged from verbal approval and designation of a key contact person via telephone by the Chief of Staff, to full review by the facility's IRB. Documentation requirements varied greatly. The "typical" process was to receive approval through the Medical Center Director or COS, have committee or system elements (such as quality improvement) review the process, receive IRB approval for the study of human subjects, and designate a single local coordinator. Variation was related to differences in administrative and organizational structure, administrative support for the project, presence of a research office, size of the institution, and affiliation with an academic medical center.

Conclusions: Wide variation in the process to implement a multi-center health services project existed. The approval process was influenced by how the facility viewed the project (research vs. quality improvement), the mission and organization of the hospital, concern about the implications of the project and/or results, recognition of QUERI support for the project, and availability of local staff to facilitate the process.

Impact: This study suggests the development of a systematic policy for obtaining approval to conduct multi-center health services research within the VA system.