Training family physicians in shared decision making for the use of antibiotics for acute respiratory infections: a pilot clustered randomized controlled trial France Legare �� �� MD, PhD,*1 Michel Labrecque MD, PhD,* Annie LeBlanc PhD,* Merlin Njoya MSc,* Claudine Laurier PhD,�� Luc Cote �� �� PhD,�� Gaston Godin PhD,�� Robert L. Thivierge MD,��� Annette O��Connor RN, PhD** and Sylvie St-Jacques PhD* *Research Centre of the Centre Hospitalier Universitaire de Quebec, �� Quebec, �� QC, Canada, ��Faculty of Pharmacy, Universite �� de Montreal, �� Montreal, �� QC, Canada, ��Department of Family and Emergency Medicine, Universite �� Laval, Quebec, �� QC, Canada, ��Faculty of Nursing, Universite �� Laval, Quebec, �� QC, Canada, ���Faculty of Medicine, Universite �� de Montreal, �� Montreal, �� QC, Canada and **Faculty of Health Sciences, School of Nursing, University of Ottawa, Ottawa, ON, Canada Correspondence France Legare �� �� MD, PhD, CCFP, FCFP Department of Family and Emergency Medicine Universite �� Laval Quebec, �� QC Canada G1L 3L5 E-mail: france.legare@mfa.ulaval.ca 1 Tier2 Canada chair in implementing shared decision making in primary care. Accepted for publication 23 May 2010 Keywords: acute respiratory infec- tions, continuing medical education, continuing professional development, implementation, randomized control trial, shared decision making Re-use of this article is permitted in accordance with the Terms and Conditions set out at http://wiley onlinelibrary.com/onlineopen #OnlineOpen_Terms. Abstract Background Experts estimate that the prevalence of antibiotics use exceeds the prevalence of bacterial acute respiratory infections (ARIs). Objective To develop, adapt and validate DECISION+ and esti- mate its impact on the decision of family physicians (FPs) and their patients on whether to use antibiotics for ARIs. Design Two-arm parallel clustered pilot randomized controlled trial. Setting and participants Four family medicine groups were ran- domized to immediate DECISION+ participation (the experimen- tal group) or delayed DECISION+ participation (the control group). Thirty-three FPs and 459 patients participated. Intervention DECISION+ isamultiple-component,continuingpro- fessional development program in shared decision making that addresses the use of antibiotics for ARIs. Main outcome measures Throughout the pilot trial, DECISION+ was adapted in response to participant feedback. After the consul- tation, patients and FPs independently self-reported the decision (immediate use, delayed use, or no use of antibiotics) and its quality. Agreement between their decisional conflict was assessed. Two weeks later, patients assessed their decisional regret and health status. Results Compared to the control group, the experimental group reduced its immediate use of antibiotics (49 vs. 33% absolute difference = 16% P = 0.08). Decisional conflict agreement was stronger in the experimental group (absolute difference of Pearson��s r = 0.26 P = 0.06). Decisional regret and perceptions of the quality of the decision and of health status in the two groups were similar. doi: 10.1111/j.1369-7625.2010.00616.x 96 �� 2010 Blackwell Publishing Ltd Health Expectations, 14 (Suppl. 1), pp.96���110

Discussion and conclusions DECISION+ was developed success- fully and appears to reduce the use of antibiotics for ARIs without affecting patients�� outcomes. A larger trial is needed to confirm this observation. Introduction The use of antibiotics for acute respiratory infections (ARIs) has contributed to the antibio- tics resistance that presently plagues Canadians.1 ARIs are the most frequently reported motive for primary care consultations in North Amer- ica.2 While ARIs have many forms, a large proportion is viral: only 38% of acute rhino- sinusitis cases in adults, 5���15% of acute phar- yngitis cases in adults, and 6���18% of ARI cases in children are bacterial.3,4 Nonetheless, experts estimate that antibiotics are used for between 63 and 67% cases of ARI5���7. This suggests that antibiotics are overused.8,9 Attempts to optimize the use of antibiotics for ARIs in ambulatory settings have proven less effective than anticipated.10 Various aspects of the provider���patient interaction have been studied. The physician��s perception of the patient��s (or the parent��s) expectations or resis- tance to a diagnosis of viral infection is one of the strongest predictors of a physician��s decision to prescribe antibiotics.11���15 In patients, a good understanding of the nature of their illness (i.e., that the ARI is viral) is associated with their satisfaction with the consultation.16 This sug- gests that the beliefs, concerns and expectations of both physicians and patients should be taken into consideration when developing interven- tions to reduce the inappropriate use of anti- biotics for the treatment of ARIs. Typically, however, interventions have been provider- oriented: little attention has been paid to patient- based interventions and even less to interventions combining physicians, patients and public education. A promising solution can be found in shared decision making (SDM), a process in which a healthcare decision is made by both the clinician and the patient together.17,18 SDM aims to help patients play an active role in decisions con- cerning their health, the ultimate goal of patient- centered care.19 SDM rests on the best evidence of the risks and benefits of all the available options.17 Thus, the clinician��s ability to com- municate with the patient in such a way as to enable him ���her to weigh the risks and benefits of various treatment choices is essential.20 Indeed, SDM takes place in a context in which the patient��s values and preferences are sought out and his ���her opinions valued without excluding the values, preferences and opinions of the cli- nician.21 It is a partnership in which the responsibilities and rights of each party are articulated, the benefits to each are clear, and the uncertainty associated with the best choice is made explicit (clinical equipoise).22 SDM holds that ��mutual acceptance [of a treatment option]��� remains a necessary prerequisite�� to agreement between the patient and the provider on a plan of action.23 Moreover, SDM has been shown to lower the overuse of screening or treatment options not clearly associated with health benefits for all.24 Conceptual framework In our published protocol,25 we argue that teaching family physicians (FPs) about the probabilistic aspect of a diagnosis (in this case, a diagnosis of bacterial versus viral ARI) pre- senting them with the best evidence of the ben- efits and the risks associated with the clinical options (e.g., prescribing or not prescribing antibiotics) and giving them strategies to communicate with patients and involve them in decision-making, leads to SDM during the clinical encounter (Fig. 1). This SDM would optimize FPs�� and patients�� decisions regarding screening or therapeutic options such as antibio- tics. Optimal decisions by FPs would translate SDM and avoiding excessive antibiotic use, F Legare �� �� et al. �� 2010 Blackwell Publishing Ltd Health Expectations, 14 (Suppl. 1), pp.96���110 97

into optimal prescriptions and optimal decisions by patients would lead to their optimal use of treatment (e.g., taking antibiotics for their ARI if appropriate). In addition, patients would not regret their decision. Ultimately, population health would improve and quality of life would ameliorate. Consequently, one of our main outcomes of interest was the level of agreement between the patient��s decisional conflict score and the decisional conflict score of his ��� her FP. Although, in this pilot trial, decisional conflict was not one of our main outcomes of interest, its assessment in patients may be valuable. A Cochrane systematic review of 55 studies indi- cates that patient decision aids known to increase patients�� involvement in decision-mak- ing are associated with reduced decisional con- flict in patients.26 This suggests that increasing patients�� involvement in the decision-making process may help lower their decisional conflict. This finding is congruent with a meta-analysis of 10 studies indicating that decisional conflict is strongly associated with patients�� decisional delay and decisional regret.27 In turn, decisional regret correlates with overall quality of life ratings.28 Notwithstanding its potential for optimizing decisions in clinical practice, SDM is not yet widely adopted and tests of its effectiveness are needed.29 For this reason, we conducted a pilot trial in the clinical context of ARI, whose aims were (1) to assess the feasibility of recruiting family medicine groups (FMGs), FPs and their patients (2) to develop, adapt and validate DECISION+ training workshops and related material (for a description of DECISION+, see ��Intervention��) (3) to evaluate physicians�� par- ticipation and satisfaction regarding DECI- SION+ and (4) to estimate the impact of DECISION+ on (i) physicians�� and patients�� decision whether to use antibiotics, (ii) physi- cians�� and patients�� decisional conflict scores and the level of agreement between those scores, (iii) the prescription profile of antibiotics for ARIs, (iv) FPs�� intention to practice SDM, (v) FPs�� intention to follow clinical practice guidelines for the treatment of ARIs, (vi) FPs�� scores on a script concordance test, and (vii) patients�� decisional regret.25 This paper covers aims 2 and 4. Aims 1 and 3 are discussed elsewhere.30 Materials and methods Trial design and population Between November 2007 and March 2008, we conducted a pilot, two-arm parallel clustered randomized clinical trial (RCT) whose main objective was to assess the feasibility of a larger clustered RCT. Details of the trial protocol are reported elsewhere.25 Briefly, FMGs from the Quebec City, Canada, greater urban area were invited to participate. An FMG is a group of FPs who work closely with nurses to offer family medicine services to registered individuals. Participating FMGs were randomized either to an experimental group that was immediately W2 W3 Optimal prescription Health Improvement Optimal use of treatment 7 6 Shared decision- making 5 W1 8 W2 W3 Best estimate of diagnostic probabilities Knowledge of the best evidence about risks and benefits Effective communication of risks and benefits 3 2 1 Active participation of patient in the decision- making process 4 Figure 1 DECISION+ conceptual framework. SDM and avoiding excessive antibiotic use, F Legare �� �� et al. �� 2010 Blackwell Publishing Ltd Health Expectations, 14 (Suppl. 1), pp.96���110 98