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: 10708157
• 负责人: Margaret Schwarze
• 金额: $ 86.16万
• 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/10708157
• 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; Educational process of instructing; Effectiveness; Elderly; Emergency Situation; Evaluation; Event; Family; Family member; Feasibility Studies; Feeling hopeless; Force of Gravity; Frequencies; Future; Goals; Government; Healthcare; Healthcare Systems; Hospitals; Injury; Intensive Care; Intensive Care Units; Intervention; 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; 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; randomized, clinical trials; 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.

抽象的 对于老年人来说，关于严重伤害和危及生命的疾病的沟通不畅会产生后果 每年有 500,000 名老年人受苦，治疗 创伤性损伤经常涉及繁重的干预措施（如延长生命支持）、身体状况的重大变化 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相关信息。 疾病的严重性，但当前的沟通标准常常导致护理目标不一致、道德困扰 由于治疗负担高和贫困频率高，死亡过程延长。 预后，严重受伤的老年人将受益于澄清患者病情的沟通干预措施 目标，缓解 ICU 中的冲突，并减少对垂死患者进行不必要的侵入性操作。 针对严重受伤老年人的情景规划的随机临床试验为期 5 年 R01 临床试验专门响应 NOSI-AG-20-041，用于评估决策支持工具和 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 我们开发了一种新颖的沟通工具，称为“最佳情况/最坏情况-ICU”，它使用 情景规划——对可能的未来的叙述性描述——以及用于说明有关信息的图形辅助 我们在创伤 ICU 中对患者的护理轨迹和日常使用的总体预后进行了试点测试。 干预，发现外科医生可以使用这个工具来支持家庭，并且可以提高治疗质量 沟通并减少临床医生的道德困扰，我们现在准备大规模测试干预措施。 我们提出一项针对 4,500 名患有此病的老年人进行的实用性多中心随机临床试验。 我们的目的是测试最佳情况/最坏情况 ICU 干预对创伤性损伤质量的有效性。 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且可以快速传播的干预措施 这项研究具有创新性，因为它测试了情景规划——a 已成功应用于企业和政府的决策策略，但尚未广泛应用 这项研究意义重大，因为如果我们证明其有效性，它就有潜力。 改变外科医生和其他 ICU 患者与患者和家属谈论治疗和预后的方式 并显着改善老年人在创伤 ICU 中接受的护理 我们的多学科团队拥有长期的经验。 合作的历史，并且能够很好地实现我们的目标，增强了这项研究的可行性。 得到国家创伤研究联盟的支持，该联盟由主要创伤专业人士组成 美国的组织并使用美国外科医生学会的创伤质量改进 程序作为数据收集平台。