A Clinical Trial of Decision Support for End of Life Care Among Surrogate Decision Makers of the Chronically Critically Ill

慢性危重病替代决策者临终关怀决策支持的临床试验

• 批准号: 9281558
• 负责人: Ronald Lee Hickman
• 金额: $ 51.37万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-02 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9281558
• 关键词: Accounting; Admission activity; American; Anxiety; Behavioral; Caring; Chronic; Clinical Trials; Cognitive; Communication; Conflict (Psychology); Critical Illness; Data; Decision Making; Effectiveness; Elements; Evaluation; Exposure to; Face; Family member; Health; Health Personnel; Healthcare; Hospitalization; Impaired cognition; Impairment; Intensive Care Units; Intervention; Knowledge; Life; Mechanical ventilation; Medical Care Team; Mental Depression; Modeling; Outcome; Palliative Care; Patient Preferences; Patient-Focused Outcomes; Patients; Persons; Phase; Population; Process; Psychological Stress; Public Health; Readiness; Regrets; Religious Belief; Research Priority; Resources; Role; Self Efficacy; Stress; Syndrome; Tablet Computer; Technology; Testing; Uncertainty; anxiety symptoms; arm; base; cohort; common symptom; comparative; depressive symptoms; efficacy testing; end of life; end of life care; end-of-life decision making; evidence base; experience; graphical user interface; high risk; improved; improved outcome; insight; loved ones; negative affect; new technology; primary outcome; prototype; psychologic; public health relevance; skills; support tools; surrogate decision maker; therapy design; therapy development; tool; treatment as usual; usability; virtual

 DESCRIPTION (provided by applicant): Each year, millions of Americans are admitted to an intensive care unit (ICU), which can initiate a cascade of decisions about treatment and end of life care. This is particularly the case for patients with chronic critical illness. The chronicall critically ill (CCI) are at high risk for cognitive impairment, prolonged use of life- sustaining cre, and the need for a surrogate decision maker (SDM) to make decisions about end of life. SDMs of the CCI often describe high states of psychological stress associated with the uncertainty of the patient's condition and their decision making role. Many SDMs find it difficult to comprehend, process, and apply information from clinicians to make informed decisions for their loved ones. Presently, SDMs have no effective tools to help them make informed decisions about the care of a cognitively impaired CCI patient at end of life. Thus, we propose to revise and test the efficacy of an avatar-based decision support technology referred to as Interactive Virtual Decision Support for End of Life and Palliative Care (INVOLVE). This project has two phases. In Phase 1, we will revise our INVOLVE prototype through an iterative, user-centered process. Phase 2 is a three-arm, clinical trial of 270 SDMs of cognitively impaired CCI patients, comparing INVOLVE versus information-only support (IS) and usual care (UC). The specific aims for this project are: [1] identify the essential elements of the graphical user interface and educational content needed to revise the INVOLVE prototype for a set of common end of life decisions that occur in the ICU; [2] evaluate if there are differences in the decision making readiness and decision making quality between subjects exposed to INVOLVE, IS, or UC on Days 1, 3, and 7 days post-baseline while accounting for covariates (prior SDM experience, SDM knowledge of the patient's preferences, and SDM's religious beliefs); and [3] determine if there are differences in the post-decision outcomes of SDMs and their CCI patient by study condition while accounting for covariates at 90 days post-baseline. The importance of finding strategies to improve the quality of decision making for end of life care in the ICU has been well recognized. This will be the first study to test interventions tailored to the unique needs of the SDMs of CCI patients delivered using an interactive avatar based format. This is a format that is easily delivered, well accepted, and well suited for this vulnerable and difficult to reach cohort f decision makers. If proven efficacious, these technology-based interventions for end of life decision making may also offer sustainable solutions that can be easily adapted to varied populations to improve the outcomes of SDMs and their cognitively impaired loved ones.

 描述（由申请人提供）：每年，数百万美国人被送进重症监护室（ICU），这可能会引发一系列关于治疗和临终关怀的决定。对于慢性危重病患者尤其如此。慢性危重病患者（CCI）有认知障碍的高风险，长期使用维持生命的cre，以及需要代理决策者（SDM）来做出关于生命结束的决定。CCI的SDM通常描述与患者状况及其决策角色的不确定性相关的高心理压力状态。许多SDM发现很难理解，处理和应用临床医生的信息，为他们所爱的人做出明智的决定。目前，SDM还没有有效的工具来帮助他们在生命结束时对认知受损的CCI患者的护理做出明智的决定。因此，我们建议修改和测试的效果，基于化身的决策支持技术被称为交互式虚拟决策支持的生命结束和姑息治疗（INVOLVE）。该项目分为两个阶段。在第一阶段，我们将通过一个迭代的、以用户为中心的过程来修改我们的INVOLVE原型。第2阶段是一项三组临床试验，涉及270例认知受损CCI患者的SDM，比较了INVOLVE与仅信息支持（IS）和常规护理（UC）。该项目的具体目标是：[1]确定图形用户界面的基本要素和教育内容，这些要素和教育内容需要修改INVOLVE原型，以用于ICU中发生的一组常见的生命末期决策;[2]评价在第1、3、4、5、6、7、8、10、11、12、14、15、16、18、19基线后90天和7天，同时考虑协变量（既往SDM经验、SDM对患者偏好的了解以及SDM的宗教信仰）;[3]确定SDM及其CCI患者的决策后结果是否存在差异，同时考虑基线后90天的协变量。寻找策略以提高ICU临终关怀决策质量的重要性已得到广泛认可。这将是第一项测试针对CCI患者SDM独特需求的干预措施的研究，这些干预措施使用基于交互式头像的格式提供。这是一种易于交付、易于接受的格式，非常适合这一脆弱和难以接触的决策者群体。如果被证明是有效的，这些基于技术的干预措施也可以提供可持续的解决方案，可以很容易地适应不同的人群，以改善SDM及其认知受损亲人的结果。