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

Annie Leblanc, France Légaré, Michel Labrecque, Gaston Godin, Robert Thivierge, Claudine Laurier, Luc Côté, Annette M O'Connor, Michel Rousseau, Annie Leblanc, France Légaré, Michel Labrecque, Gaston Godin, Robert Thivierge, Claudine Laurier, Luc Côté, Annette M O'Connor, Michel Rousseau

Abstract

Background: The 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.

Methods: A 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.

Results: Among 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%.

Conclusions: This 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 registration: Clinicaltrials.Gov NCT00354315.

Figures

Figure 1
Figure 1
Study design. FMG = family practice group; FP = family physician.
Figure 2
Figure 2
Patient recruitment and data collection periods I, II, & III. FMG = family practice group; FP = family physician; PT = patients.
Figure 3
Figure 3
Recruitment and retention of FMGs and family physicians. aThis FMG was not randomised in order to avoid breaking the allocation of concealment. FMG = family medicine group; D+ = DECISION+ pilot trial; FP = family physician; PT = patients; PI = principal investigator.

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