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

最好情况/最坏情况：针对终末期肾病患者情景规划的多中心随机临床试验

• 批准号: 10357958
• 负责人: Margaret Schwarze
• 金额: $ 63.7万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10357958
• 关键词: Address; Admission activity; Affect; American; Award; Awareness; Businesses; Caregivers; Caring; Cessation of life; Chronic Disease; Cluster randomized trial; Collaborations; Communication; Communication Tools; Control Groups; Data; Decision Aid; Decision Making; Development; Dialysis patients; Dialysis procedure; Elderly; Emergency department visit; End stage renal failure; Enrollment; Evaluation; Exposure to; Family member; Fatigue; Future; Glomerular Filtration Rate; Goals; Government; Health; Healthcare; Hospitalization; Hour; Impaired cognition; Improve Access; Intensive Care Units; Intervention; Kidney; Kidney Diseases; Kidney Failure; Length of Stay; Life; Measurement; Measures; Mediating; Mental Depression; Nature; Operative Surgical Procedures; Outcome; Pain; Palliative Care; Patient Care; Patients; Persons; Pilot Projects; Positioning Attribute; Procedures; Prognosis; Provider; Proxy; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Reporting; Research; Site; Societies; Specialist; Surgeon; Symptoms; Testing; Time; Training; Training Programs; Uncertainty; Waiting Lists; care delivery; chronic pain; cohort; design; efficacy study; end of life; end of life care; end-of-life communication; experience; group intervention; human old age (65+); improved; innovation; member; multidisciplinary; novel; older patient; palliating symptoms; pilot test; public health priorities; reduce symptoms; secondary outcome; shared decision making; tool; treatment as usual; treatment choice; trend

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.

摘要 现在，几乎一半开始透析的患者年龄超过65岁。开始透析后的中位生存期较短 并且患者经历频繁的住院、疼痛、疲劳、认知功能障碍和抑郁。但很少 及时接受姑息治疗以缓解症状，记录护理目标并为生命结束做好准备。给定 治疗负担和预后不良，老年终末期肾病患者将受益于 上游干预，既改善透析决策，又促进及时接受 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 该提案服务于长期目标，即增加对老年患者的姑息治疗， 疾病和减少生命结束时不必要的侵入性治疗。 “最佳情况/最差情况：一项多中心随机临床试验， “终末期肾病”是一个五年R 01，对PA-18-502的发展有特异性反应， 对老年重病患者和/或其代理决策者的创新决策辅助工具进行评价。我们 一个研究小组开发了一种名为“最佳情况/最差情况”的新型沟通工具， 情景规划和图形辅助工具，用于说明各种备选方案、确认不确定性和描述结果 在病人的基本健康和预后的背景下。我们已经对这种干预措施进行了试点测试， 肾脏病患者，并证明肾脏病学家可以使用此工具来改善决策 这可能会增加姑息治疗的利用率。我们现在准备好在一个 大规模功效研究。我们提出了一项多中心随机分组试验，其中320例患者， 使用最佳情况/最差情况工具接收肾病专家的透析开始决策沟通，或 通讯如常。我们的目标是测试最佳情况/最差情况干预对收到 临终关怀和治疗强度（目标1），生活质量（目标2）， 交流（目的3）为老年终末期肾病患者。 这个奖项将使我们能够测试一种干预措施，这种干预措施很容易扩展，可以迅速传播使用 老年肾脏疾病患者的治疗。该研究具有创新性，因为它测试了 规划-一种已成功应用于企业和政府的决策策略-但 在医疗保健中没有广泛使用。这项研究意义重大，因为如果干预措施有效， 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。我们有能力实现我们的目标 在这个奖项的范围内，鉴于我们强大的试点数据和承诺，从姑息治疗研究 合作组及其肾病学家成员进行这项研究。