Abstract
BACKGROUND: Decision aids (DAs) may increase engagement in decision-making by addressing barriers that disproportionately impact socioeconomically disadvantaged patients. The impact of a breast cancer surgery DA on increasing patient engagement in decision-making was tested in clinics serving a high proportion of socioeconomically disadvantaged patients. METHODS: A stepped-wedge trial was conducted with 10 National Cancer Institute Community Oncology Research Program clinics (Alliance for Clinical Trials in Oncology, June 2019 to December 2021). The clinics were randomized to time of transition from usual care (UC) to delivery of a web-based DA. Patients with stages 0-3 breast cancer eligible for surgery provided consent before a surgical consultation. Engagement was measured by Patient's Self-Efficacy in Patient-Physician Interactions (PEPPI-5, follow-up survey) and count of Active Patient Behaviors (audio-recorded consultation). Intervention effects were tested with linear mixed-effects models, accounting for surgeon and clinic-level clustering, time, and enrollment after COVID. Heterogeneity of treatment effect by socioeconomic disadvantage (using the Area Deprivation Index) was assessed with an interaction term. RESULTS: The study enrolled 576 patients, and 44 % (136/309) of the patients reviewed the DA. No significant difference in engagement was observed between DA and UC for PEPPI-5 (- 0.8; 95 % CI, - 2.1-0.6; p = 0.260) or Active Patient Behaviors (2.5; 95 % CI, - 4.1-9.2; p = 0.456). No heterogeneity of treatment effect was observed. Socioeconomic disadvantage was associated with fewer Active Patient Behaviors (- 5.9; 95 % CI, - 0.6-- 1.2; p = 0.013). CONCLUSION: This trial conducted in clinics that serve diverse populations, observed no significant relationship between a web-based DA and patient engagement. Future analyses will explore DA implementation, characteristics of patients who reviewed the DA, and persistent barriers to engagement.