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.

抽象的 现在，近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很短 患者经常住院、疼痛、疲劳、认知功能障碍和抑郁，但很少有这种情况。 及时接受姑息治疗以缓解症状、记录护理目标并为生命终结做好准备。 治疗负担和预后不良，患有终末期肾病的老年人将受益于 上游干预措施既可以改善透析决策，又可以促进及时收到 姑息治疗旨在明确目标、解决症状并减少不必要的侵入性操作。 该提案服务于增加对生命有限的老年患者使用姑息治疗的长期目标 疾病并减少临终时不必要的侵入性治疗。 “最好的情况/最坏的情况：针对患有以下疾病的患者进行情景规划的多中心随机临床试验 终末期肾病”是一项为期五年的 R01，专门针对 PA-18-502 进行开发和 对重病老年患者和/或其代理决策者的创新决策辅助进行评估。 研究团队开发了一种名为“最佳情况/最坏情况”的新型沟通工具，该工具采用 情景规划和图形辅助来说明选项、承认不确定性并描述结果 我们已经在患者的基本健康状况和预后的背景下对这种干预措施进行了试点测试。 患有肾脏疾病的患者，并证明肾脏病学家可以使用该工具来改善决策 关于透析，这可能会增加姑息治疗的利用率，我们现在准备测试干预措施。 我们提出了一项多中心整群随机试验，其中 320 名患者进行了一项研究。 使用最佳案例/最差案例工具接受肾病专家的沟通，或者 我们的目的是测试最好情况/最坏情况干预在收到信息后的效果。 临终时的姑息治疗和治疗强度（目标 1）、生活质量（目标 2）以及 为患有终末期肾病的老年患者提供沟通（目标 3）。 该奖项将使我们能够测试一种易于扩展且可以快速传播使用的干预措施 这项研究是针对患有限制生命的肾脏疾病的老年患者的，因为它测试了场景。 规划——一种已成功应用于企业和政府的决策策略——但 该研究并未广泛应用于医疗保健领域，因为如果干预措施有效，它就具有重要意义。 有可能改变专家谈论选择的方式并显着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。 鉴于我们强大的试点数据和姑息治疗研究的承诺，在该奖项的范围内 合作小组及其肾病专家成员进行了这项研究。