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

Abstract

Abstract 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.