Implementation of a Guideline-Based Preference Elicitation Tool to Enhance Shared Decision-Making in Supervised Exercise Therapy for Patients With Intermittent Claudication: A Multi-Methods Cluster Randomized Trial

IMPORTANCE: Shared decision-making is not yet common practice in physical therapy, emphasizing the need for effective decision aids. A preference elicitation tool (PE-tool) was designed to complement supervised exercise therapy (SET) in intermittent claudication treatment. OBJECTIVE: Primarily, to assess the impact of implementing the PE-tool on patients' functional walking distance (FWD), maximal walking distance (MWD) and health-related quality of life (HRQoL) after 3 and 6 months. Secondarily, to assess the tool's impact on shared decision-making and person-centeredness. DESIGN: Nationwide pragmatic cluster randomized trial. SETTING: Primary care physical therapy practices in the Netherlands. PARTICIPANTS: Primary care physical therapists and patients with intermittent claudication receiving SET. EXPOSURE(S): Therapists assigned to the intervention group had access to the PE-tool to complement SET, whereas therapists in the control group delivered SET. MAIN OUTCOME(S) AND MEASURE(S): Group differences in FWD, MWD, and HRQoL at 3- and 6-month follow-ups were assessed using routinely collected clinical data. Audio-recorded consultations between therapists and patients in the intervention (n = 72) and control group (n = 74) were assessed using the OPTION-5 instrument to assess shared decision-making. Participating patients completed a questionnaire afterwards to assess person-centeredness. RESULTS: Intention-to-treat analyses indicated no statistically significant differences between intervention (n = 1199 patients) and control (n = 915 patients) groups at both follow-ups for FWD and MWD. For HRQoL, a statistically significant difference favoring the control group was found at 3-month follow-up (MD = -0.3 points), but not at 6-month (MD = -0.3 points). Statistically significant effects favoring the intervention group were found for shared decision-making (MD = +39.0 points) and person-centeredness (MD = +2.0 points). CONCLUSIONS: Use of the PE-tool in intermittent claudication treatment did not improve patient-level outcomes compared to SET alone, but positively impacted levels of shared decision-making and person-centeredness. RELEVANCE: Although achieving health improvements through decision aids remains complex, the novel tool could support therapists in adopting a more collaborative and person-centered approach.