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临床试验/NCT04397016
NCT04397016已完成不适用

Cost Talk: a Randomized Stepped Wedge Trial of Interventions Helping Patients Discuss Cancer Care Costs With Clinicians During Shared Decision Making

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2020年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
117
试验地点
2
主要终点
Frequency of cost conversations

研究概览

简要总结

The purpose of this study is to investigate whether an encounter decision aid (used during a consultation) containing cost information about options, combined with clinician training about cost discussions and available financial resources, influence surgeon-patient cost conversations, referrals to address costs, patients' financial stress, and high-quality decision-making for patients with slow-growing prostate cancer.

详细描述

The study will use a stepped wedge design to evaluate the encounter decision aid. Each participating urologic surgeon will begin in the usual care arm of the study. Subsequently, the surgeons will be randomized to the intervention arm at staggered time points to undergo training and begin using the decision aid intervention with patients who are diagnosed with slow-growing prostate cancer. This study will consist of two aims. The first aim is to examine the use of an encounter decision aid with cost information on the presence and impact of out-of-pocket cost conversations. The investigators will train participating clinicians on how to use the decision aid intervention and available financial resources. With patient and clinician consent, the investigators will audio record clinical encounters and measure cost conversations using a previously-developed checklist to code transcripts derived from the audio recordings. Patients can still participate if they do not consent to audio recording as these topics will be assessed in the self-report survey after their clinic or virtual visit. The second aim will examine the impact of an encounter decision aid with cost information on high-quality decision-making. The investigators will collect a post-visit questionnaire from participating patients, including patient-reported measures of decisional conflict, decision regret, and the shared decision-making process. Participants will be sent a follow-up questionnaire 3 months after their initial study enrollment to assess decision regret and financial toxicity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • At least 18 years of age
  • Visiting a participating urologist/urologic surgeon to discuss treatment options
  • Slow growing prostate cancer defined as Gleason score of 6 or 7 (3+4) and/or PSA (prostate-specific antigen) level less than 10ng/ml or at surgeon's discretion
  • Must be patients of one of the participating providers

排除标准

  • Patients who cannot give informed consent due to cognitive or emotional barriers

结局指标

主要结局

Frequency of cost conversations

时间窗: Immediately after the clinic or virtual visit

Initiator (surgeon, patient, or caregiver) of cost conversations

时间窗: Immediately after the clinic or virtual visit

Whether or not a referral is made to address costs

时间窗: Immediately after the clinic or virtual visit

次要结局

  • Number of patients who had a decisional conflict(Immediately after the clinic or virtual visit)
  • Number of patients who engaged in high-quality shared decision-making - CollaboRATE(Immediately after the clinic or virtual visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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