The factors affecting implementing shared decision-making in clinical trials: a cross-sectional survey of clinical research coordinators’ perceptions in Japan

BACKGROUND: The shared decision-making model has been proposed as the ideal treatment decision-making process in medical encounters. However, the decision to participate in clinical trials rarely involves shared decision-making. In this study, we investigated the perceptions of Japanese clinical research coordinators who routinely support the informed consent process. METHODS: This study aimed to (1) identify clinical research coordinators’ perceptions of the current status of shared decision-making implementation and its influencing factors, and (2) obtain suggestions to enhance the shared decision-making process in clinical trials. A cross-sectional survey was conducted using a web questionnaire based on the Theory of Planned behaviour. Invitations were sent to 1087 Japanese medical institutions, and responses from the participants were captured via the web. The shared decision-making process in clinical trials was defined according to the Shared Decision-Making Questionnaire for Doctors. The effect of the attitudes toward shared decision-making, clinical research coordinators’ subjective norms towards its implementation, perceived barriers to autonomous decision-making, and the number of difficult steps in the shared decision-making process on the shared decision-making current status as the shared decision-making intention was assessed by multiple regression analysis. RESULTS: In total, 373 clinical research coordinators responded to the questionnaire. Many believed that they were already implementing shared decision-making. Attitudes toward shared decision-making (t = 3.400, p < .001), clinical research coordinators’ subjective norms towards its implementation (t = 2.239, p = .026), perceived barriers to autonomous decision-making (t = 3.957, p < .001), and the number of difficult steps in the shared decision-making process (t = 3.317, p = .001) were found to significantly influence current status (Adjusted R(2) = .123). However, results on perceived barriers to autonomous decision-making and the number of difficult steps in the shared decision-making process indicate a lack of knowledge of shared decision-making and decision-support skills among clinical research coordinators. CONCLUSIONS: Clinical research coordinators might positively perceive shared decision-making based on normative beliefs without sufficient knowledge of it. Therefore, providing appropriate training on shared decision-making to clinical research coordinators and increasing awareness among stakeholders could enable its improvement. TRIAL REGISTRATION: Not applicable.