Abstract
BackgroundTo 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/designThe 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.DiscussionDECISION+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 RegistrationClinicalTrials.gov: NCT01116076
Highlights
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)
We argue that SDM has the potential to improve the clinical decision-making process regarding antibiotic use for ARIs by empowering patients to make informed decisions about when to take further action [13,14]
Study population Family Practice Teaching Units and their Family Physicians Following the approval by Family Medicine residency program committee at Université Laval, the 12 FPTU directors will be contacted by means of a letter sent by the research team briefly explaining that a new SDM training course addressing the use of antibiotics in the context of ARIs will be formally evaluated by means of a RCT, and that the participation of their FPTU to the trial would be appreciated
Summary
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. In a study based onthe National Research System of the College of Family Physicians of Canada, of 408 clinical encounters for respiratory tract infections (52.6% for acute bronchitis, 23.3% for an undiagnosed condition and 15.5% for viral illness), in 56.9% of visits, the patient received antibiotics immediately [4] This figure contrasts with the study’s observation that in 70% of the encounters, family physicians (FPs) expressed uncertainty about the need for antibiotics [4]. Given that only 38% of adults with acute rhinosinusitis, 6 to 18% of children with an ARI, and 5 to 15% of adults with pharyngitis have a bacterial infection [6,7], this suggests that antibiotics are overused, a phenomenon that in the words of Patrick and Hutchison (2009) may build a population’s resistance to antibiotics and reduce the success of future therapy [1]
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