Cost talk: protocol for a stepped-wedge cluster randomized trial of an intervention helping patients and urologic surgeons discuss costs of care for slow-growing prostate cancer during shared decision-making

Abstract

Background Costs of care are important to patients making cancer treatment decisions, but clinicians often do not feel prepared to discuss treatment costs. We aim to (1) assess the impact of a conversation-based decision aid (Option Grid) containing cost information about slow-growing prostate cancer management options, combined with urologic surgeon training, on the frequency and quality of patient-urologic surgeon cost conversations, and (2) examine the impact of the decision aid and surgeon training on decision quality. 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. Discussion 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. Trial registration ClinicalTrials.govNCT04397016. Registered on 21 May 2020

Costs of Neonatal Medical Complexity: Impact on New Parent Stress and Decision-Making

“…45 A randomized trial is ongoing to assess impact of "Cost Talk," a conversation decision aid for treatment decisions about cancer. 46 Others have explored the use of shared decisionmaking tools to trigger discussions about cost. 47 The interdisciplinary team can contribute to conversations about cost, including social workers and case managers 48 but, our study shows, cannot be limited to discussions of enrolling for supplemental security income.…”

“…Natt et al have reported on the success of standardized patient scenarios to teach medical students to discuss cost as a part of medical decision-making (45). A randomized trial is ongoing to assess impact of "Cost Talk," a conversation decision aid for treatment decisions about cancer (46). Others have explored the use of shared decision-making tools to trigger discussions about cost (47).…”

The impact of adding cost information to a conversation aid to support shared decision making about low‐risk prostate cancer treatment: Results of a stepped‐wedge cluster randomised trial

“…Detailed methods are described in a published protocol 35 . Reporting follows the 2018 CONSORT extension for stepped wedge randomised controlled trials 36 …”

Financial burden of men with localized prostate cancer: a process paper

“…Step 1: identifying the problem This research question arose from an existing project, evaluating a prostate cancer treatment decision aid that includes relative cost information led by a member of the research team (Politi et al, 2021). Formative interviews identified a gap in cost information for those making decisions about prostate cancer treatment options and their clinicians.…”

“…Survival is similar for non-metastatic, localized prostate cancer across treatment options (i.e., radiation, surgery, active surveillance), but patients must weigh quality of life tradeoffs (e.g., distress, urinary incontinence, erectile dysfunction) during this preference-sensitive decision (Bill-Axelson et al, 2014;Lamers et al, 2017;Sanda et al, 2018). Providing cost estimates of the cost burden associated with different prostate cancer treatment pathways alongside clinical tradeoffs can support this decision; cost can be a substantial qualityof-life tradeoff that is often not discussed or not precisely known to patients during decision-making (Politi et al, 2021). There is a growing call regarding the importance of including direct and indirect cost information in shared-decision making conversations for prostate cancer as nonmetastatic treatment outcomes are generally similar and costs can help inform patients as they weigh their options (Ubel et al, 2013;Politi et al, 2023).…”