Background: In North America, although it varies according to the specific type of acute respiratory infections (ARI), use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT) is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD) program in shared decision making, on the optimal use of antibiotics in the context of ARI.
Methods/design: This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG) in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group), or a delayed DECISION+ group (control group). Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1) and after (Phase 2) exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3). The primary outcome measures to assess the feasibility of a larger RCT include: 1) proportion of contacted FMG that agree to participate; 2) proportion of recruited physicians who participate in the DECISION+ program; 3) level of satisfaction of physicians regarding DECISION+; and 4) proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures.
Discussion: This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making.
Trial registration: ClinicalTrials.gov Identifier: NCT00354315.