METHODS: We will conduct a stepped-wedge cluster randomized trial in outpatient urology practices affiliated with a large academic medical center in the USA. We will randomize five urologic surgeons to four intervention sequences and enroll their patients with a first-time diagnosis of slow-growing prostate cancer independently at each period. Primary outcomes include frequency of cost conversations, initiator of cost conversations, and whether or not a referral is made to address costs. These outcomes will be collected by patient report (post-visit survey) and by observation (audio-recorded clinic visits) with consent. Other outcomes include the following: patient-reported decisional conflict post-visit and at 3-month follow-up, decision regret at 3-month follow-up, shared decision-making post-visit, communication post-visit, and financial toxicity post-visit and at 3-month follow-up; clinician-reported attitudes about shared decision-making before and after the study, and feasibility of sustained intervention use. We will use hierarchical regression analysis to assess patient-level outcomes, including urologic surgeon as a random effect to account for clustering of patient participants.
CONCLUSIONS: This study evaluates a two-part intervention to improve cost discussions between urologic surgeons and patients when deciding how to manage slow-growing prostate cancer. Establishing the effectiveness of the strategy under study will allow for its replication in other clinical decision contexts.
BACKGROUND: ClinicalTrials.gov NCT04397016 . Registered on 21 May 2020.