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

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.

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.

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 R² = .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.

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.

Not applicable.