A Randomized Clinical Trial of Scenario Planning for Older Adults with Serious Injury

严重损伤老年人情景规划的随机临床试验

• 批准号: 10502063
• 负责人: Margaret Schwarze
• 金额: $ 74.22万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10502063
• 关键词: Address; Admission activity; Affect; American College of Surgeons; Award; Businesses; Caring; Cause of Death; Cessation of life; Clinical Trials; Cognitive; Collaborations; Communication; Communication Tools; Conflict (Psychology); Data Collection; Decision Making; Distress; Effectiveness; Elderly; Emergency Situation; Evaluation; Event; Family; Family member; Feasibility Studies; Force of Gravity; Frequencies; Future; Goals; Government; Healthcare; Healthcare Systems; Hospitals; Injury; Intensive Care; Intensive Care Units; Intervention; Lead; Length of Stay; Life; Measurement; Measures; Mediating; Military Personnel; Morals; Operative Surgical Procedures; Outcome; Outcome Study; Patient Care; Patients; Persons; Pilot Projects; Positioning Attribute; Procedures; Process; Professional Organizations; Prognosis; Provider; Quality of life; Randomized; Randomized Clinical Trials; Recording of previous events; Reporting; Research; Risk; Site; Surgeon; Testing; Training; Translating; Trauma; Trauma Research; Traumatic injury; Treatment outcome; Uncertainty; United States; burnout; care delivery; care outcomes; communication aid; design; effectiveness study; effectiveness testing; end of life; end of life care; end-of-life communication; experience; family support; implementation intervention; improved; injured; innovation; interpersonal conflict; intervention effect; member; mortality; mortality statistics; multidisciplinary; novel; older patient; pilot test; primary outcome; programs; public health priorities; secondary outcome; severe injury; support tools; surrogate decision maker; tool; trauma care; trauma centers; treatment group; trend

ABSTRACT For older adults, poor communication about serious injury and life-limiting illness has consequences for patients and families, clinicians, and healthcare systems. Afflicting 500,000 older adults annually, treatment for traumatic injury frequently involves burdensome interventions (like prolonged life support), major changes in functional or cognitive status, and high mortality. Surgeons use mortality statistics to communicate about the gravity of illness, but current communication standards often lead to goal discordant care, moral distress for clinicians, and prolongation of the dying process. Given high treatment burdens and frequency of poor prognosis, seriously injured older adults would benefit from communication interventions that clarify patients' goals, alleviate conflict in the ICU, and reduce unwanted invasive procedures for dying patients. A Randomized Clinical Trial of Scenario Planning for Older Adults with Serious Injury is a 5-year R01 Clinical Trial that responds specifically to NOSI-AG-20-041 for evaluation of decision support tools and communication aids for seriously ill older patients and their surrogate decision-makers to achieve goal- concordant care. We have developed a novel communication tool called Best Case/Worst Case-ICU that uses scenario planning—narrative description of plausible futures—and a graphic aid to illustrate information about the patient's care trajectory and overall prognosis for daily use in the trauma ICU. We pilot tested this intervention and found that surgeons can use this tool to support families and it may improve quality of communication and reduce clinician moral distress. We are now ready to test the intervention in a large-scale effectiveness study. We propose a pragmatic multisite randomized clinical trial following 4,500 older adults with traumatic injury. We aim to test the effectiveness of the Best Case/Worst Case-ICU intervention on quality of communication (Aim 1), clinician moral distress (Aim 2), and length of stay in the ICU (Aim 3). This award will allow us to test an intervention that is easily scalable and can be disseminated rapidly for use with older adults with serious illness. 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 we demonstrate effectiveness, it has the potential to transform how surgeons and other ICU clinicians talk with patients and families about treatment and prognosis and dramatically improve care older adults receive in the trauma ICU. Our multidisciplinary team has a long history of collaboration and is well positioned to achieve our objectives. The feasibility of this study is enhanced by support from the Coalition for National Trauma Research, which comprises the major trauma professional organizations in the United States and uses the American College of Surgeons' Trauma Quality Improvement Program as a data collection platform.

摘要 对于老年人来说，关于严重伤害和限制生命的疾病的沟通不畅会导致以下后果： 患者和家庭、临床医生和医疗保健系统。每年有500，000名老年人受到治疗 创伤性损伤通常涉及繁重的干预（如延长生命支持）， 功能或认知状态以及高死亡率。外科医生使用死亡率统计数据来传达 疾病的严重性，但目前的沟通标准往往导致目标不和谐的照顾，道德困扰， 临床医生和死亡过程的延长。鉴于治疗负担重， 预后，严重受伤的老年人将受益于沟通干预，澄清患者的 目标，缓解ICU中的冲突，并减少对垂死患者不必要的侵入性手术。 一项针对严重创伤老年人情景规划的随机临床试验，为期5年， R 01专门响应NOSI-AG-20-041的临床试验，用于评价决策支持工具和 为重病老年患者及其代理决策者提供沟通辅助工具，以实现目标- 和谐的关怀我们已经开发了一种新的通信工具，称为最佳情况/最差情况-ICU， 情景规划--对可能的未来的叙述性描述--以及一个图形辅助工具来说明有关 患者的护理轨迹和整体预后，供创伤ICU日常使用。我们试验了这个 干预，并发现外科医生可以使用这种工具来支持家庭，它可以提高质量， 沟通和减少临床医生的道德困扰。我们现在已经准备好大规模测试干预措施 有效性研究。我们提出了一个务实的多地点随机临床试验后，4,500名老年人与 外伤我们的目的是测试最佳情况/最差情况-ICU干预对治疗质量的有效性。 沟通（目标1）、临床医生道德困扰（目标2）和ICU住院时间（目标3）。 该奖项将使我们能够测试一种易于扩展并可迅速传播的干预措施 用于患有严重疾病的老年人。这项研究是创新的，因为它测试了情景规划- 决策策略，已成功地应用于企业和政府，但并不广泛 用于医疗保健。这项研究意义重大，因为如果我们证明有效性，它有可能 改变外科医生和其他ICU临床医生与患者和家属谈论治疗和预后的方式 并显著改善老年人在创伤重症监护室接受的护理。我们的多学科团队有一个长期的 合作的历史，并有能力实现我们的目标。增强了本研究的可行性 在国家创伤研究联盟的支持下，该联盟由主要的创伤专业人员组成， 组织在美国，并使用美国外科医生学会创伤质量改进 程序作为数据收集平台。