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.

抽象的 对于老年人，关于严重伤害和生命疾病的沟通不良会导致 患者，家庭，临床医生和医疗保健系统。每年遭受500,000名老年人的痛苦，治疗 创伤性损伤经常涉及破旧的干预措施（例如延长寿命支持），重大变化 功能性或认知状况以及高死亡率。外科医生使用死亡率统计数据来交流 疾病的重力，但是当前的沟通标准通常会导致目标不一致的护理，道德困扰 临床医生，以及垂死过程的延长。鉴于高处理伯恩根和差的频率 预后，重伤的老年人将受益于澄清患者的交流干预措施 目标，减轻ICU的冲突，并减少垂死患者的不必要的入侵程序。 针对严重伤害老年人的场景计划的随机临床试验是5年 R01临床试验专门针对NOSI-AG-20-041进行回答，以评估决策支持工具和 为重病老年患者及其代理决策者实现目标的沟通帮助 - 一致的护理。我们开发了一种新颖的通信工具，称为最佳案例/最差的案例ICU 方案规划 - 合理期货的叙述描述和图形辅助，以说明有关信息的信息 患者的护理轨迹和总体预后，用于日常创伤ICU。我们试行了此测试 干预并发现外科医生可以使用此工具来支持家庭，并且可以提高 沟通并减少临床道德困扰。我们现在准备在大规模测试干预措施 有效性研究。我们提出了一项务实的多站点随机临床试验，此前有4,500名老年人 创伤性伤害。我们旨在测试最佳情况/最坏情况下的ICU干预质量质量的有效性 沟通（AIM 1），临床道德困扰（AIM 2）和ICU的住宿时间（AIM 3）。 该奖项将使我们能够测试易于扩展的干预措施，并且可以迅速传播 与患有严重疾病的老年人一起使用。该研究具有创新性，因为它测试了方案规划 - 成功应用于商业和政府的决策策略，但并不广泛 用于医疗保健。这项研究很重要，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临床医生如何与患者和家人谈论治疗和预后 并且大大改善了老年人在ICU中接受的护理。我们的多学科团队有很长的 协作的历史，可以实现我们的目标。这项研究的可行性得到了增强 在国家创伤研究联盟的支持下，该研究包括主要的创伤专业人员 美国的组织，并使用美国外科医生学院的创伤质量改善 作为数据收集平台的程序。