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Open Access Study protocol

Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial

France Légaré12*, Michel Labrecque12, Gaston Godin3, Annie LeBlanc4, Claudine Laurier5, Jeremy Grimshaw6, Josette Castel2, Isabelle Tremblay2, Pierre Frémont2, Michel Cauchon2, Kathleen Lemieux2 and Caroline Rhéaume2

Author Affiliations

1 Research Center of Centre Hospitalier Universitaire de Québec, Hospital St-François D'Assise, Knowledge Transfer and Health Technology Assessment Research Group, 10 Espinay, Québec, QC, G1L 3L5, Canada

2 Department of Family Medicine and Emergency Medicine, Faculty of Medicine, Université Laval, PavillonVandry, Cité Universitaire, Québec, QC, G1K 7P4, Canada

3 Faculty of Nursing, Université Laval, PavillonVandry, Cité Universitaire, Québec, QC, G1K 7P4, Canada

4 Knowledge and Encounter Unit, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA

5 Faculty of Pharmacy, Université de Montréal, Pavillon Jean-Coutu, Montréal, QC, H3T 1J4, Canada

6 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Civic Campus, Ottawa, ON, K1Y 4E9, Canada

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BMC Family Practice 2011, 12:3  doi:10.1186/1471-2296-12-3

Published: 26 January 2011

Abstract

Background

To explore ways to reduce the overuse of antibiotics for acute respiratory infections (ARIs), we conducted a pilot clustered randomized controlled trial (RCT) to evaluate DECISION+, a training program in shared decision making (SDM) for family physicians (FPs). This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician. Consequently, the objective of this study is to evaluate, in patients consulting for ARIs, if exposure of physicians to a modified version of DECISION+, DECISION+2, would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician.

Methods/design

The study is a multi-center, two-arm, parallel clustered RCT. The 12 family practice teaching units (FPTUs) in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be randomized to a DECISION+2 intervention group (experimental group) or to a no-intervention control group. These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study. There will be two data collection periods: pre-intervention (baseline) including 175 patients with ARIs in each study arm, and post-intervention including 175 patients with ARIs in each study arm (total n = 700). The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician. Secondary outcome measures include: 1) physicians and patients' decisional conflict; 2) the agreement between the parties' decisional conflict scores; and 3) perception of patients and physicians that SDM occurred. Also in patients, at 2 weeks follow-up, adherence to the decision, consultation for the same reason, decisional regret, and quality of life will be assessed. Finally, in both patients and physicians, intention to engage in SDM in future clinical encounters will be assessed. Intention-to-treat analyses will be applied and account for the nested design of the trial will be taken into consideration.

Discussion

DECISION+2 has the potential to reduce antibiotics use for ARIs by priming physicians and patients to share decisional process and empowering patients to make informed, value-based decisions.

Trial Registration

ClinicalTrials.gov: NCT01116076