Teaching Conflicts of Interest and Shared Decision-Making to Improve Risk Communication: a Randomized Controlled Trial

Background Risk communication is a core aspect of a physician’s work and a fundamental prerequisite for successful shared decision-making. However, many physicians are not able to adequately communicate risks to patients due to a lack of understanding of statistics as well as inadequate management of conflicts of interest (COI). Objective To evaluate the effects of an integrated curriculum encompassing COI and shared decision-making on the participants’ risk communication competence, that is, their competence to advise patients on the benefits and harms of diagnostic or therapeutic interventions. Design A rater-blind randomized controlled trial with a 30 (± 1)-week follow-up conducted from October 2016 to June 2017 at two German academic medical centers. Participants Sixty-three medical students in their fourth or fifth year. Interventions Participants received either a newly developed 15-h curriculum or a course manual adapted from teaching as usual. Main Measures Primary outcome: change in risk communication performance in a video-observed structured clinical examination (VOSCE). Key Results Participants were 25.7 years old on average (SD 3.6); 73% (46/63) were female. Increase in risk communication performance was significantly higher in the intervention group with post-intervention Cohen’s d of 2.35 (95% confidence interval (CI) 1.62 to 3.01, p < 0.01) and of 1.83 (CI 1.13 to 2.47, p < 0.01) 30 (± 1) weeks later. Secondary outcomes with the exception of frequency of interactions with the pharmaceutical industry also showed relevant improvements in the intervention as compared with the control group ( d between 0.91 and 2.04 ( p < 0.001)). Conclusions Our results show that an integrated curriculum encompassing COI and risk communication leads to a large and sustainable increase in risk communication performance. We interpret the large effect sizes to be a result of the integration of topics that are usually taught separately, leading to a more effective organization of knowledge. Trial Registration: The trial is registered in the International Clinical Trials Registry with the trial number DRKS00010890.