Feasibility of a randomised trial of a continuing medical education program in shared decision-making on the use of antibiotics for acute respiratory infections in primary care: the DECISION+ pilot trial

Abstract

BackgroundThe misuse and limited effectiveness of antibiotics for acute respiratory infections (ARIs) are well documented, and current approaches targeting physicians or patients to improve appropriate use have had limited effect. Shared decision-making could be a promising strategy to improve appropriate antibiotic use for ARIs, but very little is known about its implementation processes and outcomes in clinical settings. In this matter, pilot studies have played a key role in health science research over the past years in providing information for the planning, justification, and/or refinement of larger studies. The objective of our study was to assess the feasibility and acceptability of the study design, procedures, and intervention of the DECISION+ program, a continuing medical education program in shared decision-making among family physicians and their patients on the optimal use of antibiotics for treating ARIs in primary care.MethodsA pilot clustered randomised trial was conducted. Family medicine groups (FMGs) were randomly assigned, to either the DECISION+ program, which included three 3-hour workshops over a four- to six-month period, or a control group that had a delayed exposure to the program.ResultsAmong 21 FMGs contacted, 5 (24%) agreed to participate in the pilot study. A total of 39 family physicians (18 in the two experimental and 21 in the three control FMGs) and their 544 patients consulting for an ARI were recruited. The proportion of recruited family physicians who participated in all three workshops was 46% (50% for the experimental group and 43% for the control group), and the overall mean level of satisfaction regarding the workshops was 94%.ConclusionsThis trial, while aiming to demonstrate the feasibility and acceptability of conducting a larger study, has identified important opportunities for improving the design of a definitive trial. This pilot trial is informative for researchers and clinicians interested in designing and/or conducting studies with FMGs regarding training of physicians in shared decision-making.Trial RegistrationClinicaltrials.Gov NCT00354315

Training family physicians in shared decision-making to reduce the overuse of antibiotics in acute respiratory infections: a cluster randomized trial

“…[8][9][10][11][12] The current study was a multi centre, parallel cluster randomized trial conducted in a network of the 12 family practice teaching units (unit of randomization) affiliated with the Department of Family Medicine and Emergency Medicine at Université Laval in 6 regions of Quebec. The trial had 2 arms and was conducted in 3 phases (Figure 1): baseline data collection (family physician and patient recruitment, July through October 2010); intervention (DECISION+2, November 2010); and postintervention data collection (patient recruitment, November 2010 through April 2011).…”

“…8 However, because only 46% of enrolled providers in the pilot trial participated in all three 3-hour workshops, we improved the training program before conducting a definitive trial. 9 Following an in-depth evaluation with participants in the pilot trial, 10,11 we modified the training program and renamed it DECISION+2. In the current study, we evaluated its effect on the proportion of patients who decided to use antibiotics for acute respiratory infections after physician consultation.…”

How big should the pilot study for my cluster randomised trial be?

“…The decision about number of participants in each cluster will, in turn, determine the total number of participants. Okwen et al, 8 Jairath et al, 16 and Leblanc et al 18 are examples of this. In our simulations, we only applied this situation to studies involving naturally large clusters, because when clusters are naturally small entire clusters would usually be invited to participate leaving no flexibility in number of participants per cluster.…”

“…', 19 while in the DECISION þ pilot trial a number of thresholds for feasibility were reported, including: 'the proportion of contacted FMGs participating in the pilot study would be 50% or greater' and 'the mean level of satisfaction from family physicians regarding the workshops would be 65% or greater'. 18 Furthermore, Reeves et al ask the question in relation to producing feedback summaries (their intervention): 'Could ward-level postal surveys be conducted successfully?'. 15 Presumably, if the response rate was very low the investigators would have considered their trial not feasible.…”

Decision-making in oncology

“…Decision-making in oncology is more than ever associated with high levels of uncertainty [1,2] and therefore with potential patient and physician decisional conflict [3][4][5]. Decisional conflict [6] is 'a state of uncertainty about which course of action to take when choice among competing actions involves risk, loss, regret or challenge to personal life values (p. 209)' [5].…”