Abstract

BackgroundIn 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/designThis 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.DiscussionThis 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 RegistrationClinicalTrials.gov Identifier: NCT00354315

Highlights

  • In North America, 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 subsequent randomized controlled trial (RCT) will be considered feasible if: 1) the proportion of contacted FMG that participate to the pilot study is 50% or greater, 2) the proportion of recruited physicians who participate in all three workshops is 70% or greater, 3) the mean level of satisfaction regarding the workshops is 65% or greater, and 4) the proportion of missing data in each completed questionnaire is less than 10%

  • This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT regarding training of family physicians in shared decision making

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Summary

Introduction

In North America, 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. ARI are the most frequently reported reasons for consulting a primary care provider in North America and include acute otitis media, acute rhinosinusitis, acute pharyngitis, and acute bronchitis. Together, these infections, excluding pharyngitis but including chronic sinusitis and eustachian tube disorders account for 5.7% of the primary diagnosis groups for adults and reach a total of 16.3% for children under the age of twelve in community based practices [2]. In North America, it varies according to the specific type of ARI [5,6,7,8,9,10,11,12,13], the use of antibiotic is estimated to be 63% to 67%, well above the expected prevalence of bacterial infections [5,7,8,9,10,11,14,15,16,17]

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