Abstract
BACKGROUND: Practice-based research networks (PBRNs) have been implemented to support clinical research in German general practice since 2020. General practitioners (GPs) are often critical concerning the feasibility of clinical trials. Among others, high workload, lack of resources in GP teams and little acceptance of the trial requirements by the patients are assumed barriers. Therefore, the aim of this study was to evaluate the perspectives of the GP teams and their patients on the set up of BayFoNet during the implementation of the two pilot cluster-randomized trials to improve this collaboration on a sustainable basis. METHODS: GPs and medical assistants (MAs) were interviewed using semi-structured interviews based on the Consolidated Framework for Implementation Research. Implementation research and verbatim transcripts were analyzed using qualitative content analysis. Patient attitudes were evaluated quantitatively with questionnaires based on the theoretical domains framework using descriptive statistics. RESULTS: A total of 15 GPs and 15 MAs were interviewed, and 109 complete patient questionnaires were returned. Main facilitators for GPs' active participation in clinical research were networking as well as active participation of GP teams at different levels of the research process. Increased awareness concerning PBRNs might promote a lively network. From the GPs' perspective, lack of motivation among MAs and patients was a perceived barrier to support clinical research in general practice. MAs emphasized their own increase in knowledge and competence as well as the importance of clinical research for improved patient care. In contrast to the GPs, most MAs were not aware of BayFoNet as a network structure. The surveyed patients rated their own capabilities and opportunities to actively participate in the pilot studies as very good. Prior to the implementations of the interventions, some patients experienced some difficulty in defining clear goals for their own participation. DISCUSSION: Increased awareness concerning PBRNs might promote a lively network. Target-group specific dissemination strategies as well as opportunities for GP teams and their patients to participate in clinical research should be elaborated. This might increase the feasibility of clinical trials and the motivation of all participants to conduct clinical trials in general practice. TRIAL REGISTRATION: Pilot cluster-randomized trial 1 (MicUTI) was prospectively registered on December 19, 2022 at www. CLINICALTRIALS: gov (NCT05667207); Pilot cluster-randomized trial 2 (IMONEDA) was prospectively registered on April 22, 2022 at www.bfarm.de (DRKS00028805).