Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients with End-Stage Kidney Disease

摘要 现在所有开始透析的患者中，近一半的人年龄在65岁以上。开始透析后的中位生存期很短 患者经常住院、疼痛、疲劳、认知功能障碍和抑郁。然而，几乎没有人 及时接受姑息治疗，以缓解症状，记录护理目标，并为临终做好准备。vt.给出 治疗的负担和不良的预后，终末期肾病的老年人将受益于 上游干预既改善了有关透析的决策，又促进了及时收到 姑息治疗，以明确目标，解决症状，减少不必要的侵入性程序。这 该提案服务于增加对限制生命的老年患者使用姑息治疗的长期目标 在生命末期减少不必要的侵入性治疗。 “最佳病例/最坏病例：一项多点随机临床试验--针对慢性阻塞性肺病患者的情景规划 终末期肾脏疾病“是一种为期五年的R01，专门针对PA-18-502的发育和 为重病老年患者和/或他们的代理决策者评估创新的决策辅助工具。我们的 研究团队开发了一种新的沟通工具，名为“Best Case/Worst Case”，该工具使用 情景规划和图形化辅助工具，用于说明选项、承认不确定性和描述结果 在患者潜在的健康和预后的背景下。我们已经对这一干预措施进行了试点测试 肾脏疾病患者，并证明肾脏科医生可以使用这一工具来改进决策 关于透析，这可能会增加姑息治疗的利用率。我们现在已经准备好在一个 大规模疗效研究。我们提出了一项多点整群随机试验，其中320名患者进行了 透析启动决定使用Best Case/Worst Case工具接收肾病医生的通信，或 像往常一样交流。我们的目标是测试最佳情况/最坏情况干预对收到 临终时的姑息护理和治疗强度(目标1)、生活质量(目标2)和 老年终末期肾病患者的沟通(目标3)。 这一奖项将使我们能够测试一种易于扩展并可以快速传播使用的干预措施 患有限制生命的肾脏疾病的老年患者。这项研究具有创新性，因为它测试了情景 规划-一种决策策略，已成功应用于商业和政府-但 在医疗保健中没有广泛使用。这项研究意义重大，因为如果干预有效，它就会有 有可能改变专家谈论选择的方式，并极大地改善姑息治疗的接受情况。 我们的多学科团队有着悠久的合作历史。我们处于有利地位，能够实现我们的目标 在这个奖项的范围内，考虑到我们强有力的试点数据和姑息治疗研究的承诺 合作小组及其肾病学家--成员进行这项研究。

ABSTRACT Nearly half of all patients starting dialysis are now over age 65. Median survival after initiating dialysis is short and patients experience frequent hospital stays, pain, fatigue, cognitive dysfunction and depression. Yet few receive palliative care in time to alleviate symptoms, document care goals and prepare for end of life. Given the burdens of treatment and poor prognosis, older adults with end-stage kidney disease would benefit from upstream interventions that both improve decision making about dialysis and promote timely receipt of palliative care in order to clarify goals, address symptoms and reduce unwanted invasive procedures. This proposal serves the long-term goal of increasing the use of palliative care for older patients with life-limiting illnesses and reducing unwanted invasive treatments at the end of life. “Best Case/Worst Case: A Multisite Randomized Clinical Trial of Scenario Planning for Patients with End-Stage Kidney Disease” is a five-year R01 that responds specifically to PA-18-502 for development and evaluation of innovative decision aids for seriously ill older patients and/or their proxy decision makers. Our research team has developed a novel communication tool called “Best Case/Worst Case” that employs scenario planning and a graphic aid to illustrate options, acknowledge uncertainty and describe outcomes within the context of the patient's underlying health and prognosis. We have pilot-tested this intervention for patients with kidney disease and demonstrated that nephrologists can use this tool to improve decision making about dialysis and this may increase utilization of palliative care. We are now ready to test the intervention in a large-scale efficacy study. We propose a multisite cluster randomized trial in which 320 patients making a dialysis initiation decision receive nephrologist communication using the Best Case/Worst Case tool, or communication as usual. We aim to test the effect of the Best Case/Worst Case intervention on receipt of palliative care and intensity of treatment at the end of life (Aim 1), quality of life (Aim 2), and the quality of communication (Aim 3) for older patients with end-stage kidney disease. This award will allow us to test an intervention that is easily scalable and can be disseminated rapidly for use with older patients with life-limiting kidney disease. The research is innovative because it tests scenario planning —a decision-making strategy that has been successfully applied in business and government—but is not widely used in healthcare. The research is significant because if the intervention is effective, it has the potential to transform how specialists talk about options and dramatically improve receipt of palliative care. Our multidisciplinary team has a long history of collaboration. We are well positioned to achieve our objectives within the scope of this award given our strong pilot data and commitment from the Palliative Care Research Cooperative Group and its nephrologist-members to conduct this study.