Politi Mary C, Forcino Rachel C, Parrish Katelyn, Durand Marie-Anne, O'Malley A James, Elwyn Glyn
Division of Public Health Sciences, Department of Surgery, Washington University School of Medicine, 660 S. Euclid Ave., Campus Box 8100, St. Louis, MO, 63110, USA.
The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine at Dartmouth, Dartmouth College, Lebanon, NH, USA.
Trials. 2021 Jun 29;22(1):422. doi: 10.1186/s13063-021-05369-4.
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.
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.
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.
ClinicalTrials.gov NCT04397016 . Registered on 21 May 2020.
治疗费用对于癌症患者做出治疗决策很重要，但临床医生往往觉得没有准备好讨论治疗费用。我们旨在：（1）评估包含生长缓慢的前列腺癌管理方案成本信息的基于对话的决策辅助工具（选项网格），结合泌尿外科医生培训，对患者与泌尿外科医生成本对话的频率和质量的影响；（2）研究决策辅助工具和医生培训对决策质量的影响。
我们将在美国一家大型学术医疗中心附属的门诊泌尿外科开展一项阶梯楔形整群随机试验。我们将把五名泌尿外科医生随机分配到四个干预序列中，并在每个阶段独立招募他们首次诊断为生长缓慢的前列腺癌的患者。主要结局包括成本对话的频率、成本对话的发起者以及是否因费用问题进行转诊。这些结局将通过患者报告（访后调查）和经同意的观察（门诊就诊录音）来收集。其他结局包括：患者报告的访后及3个月随访时的决策冲突、3个月随访时的决策后悔、访后的共同决策、访后的沟通以及访后及3个月随访时的经济毒性；临床医生报告的研究前后对共同决策的态度以及持续使用干预措施的可行性。我们将使用分层回归分析来评估患者层面的结局，将泌尿外科医生作为随机效应纳入以考虑患者参与者的聚类情况。
本研究评估了一项两部分的干预措施，以改善泌尿外科医生和患者在决定如何管理生长缓慢的前列腺癌时的成本讨论。确定所研究策略的有效性将使其能够在其他临床决策环境中得以复制。
ClinicalTrials.gov NCT04397016。于2020年5月21日注册。
