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

 描述(申请人提供)：每年，数以百万计的美国人被送进重症监护病房(ICU)，这可能会引发一系列关于治疗和临终关怀的决定。对于患有慢性危重病的患者来说尤其如此。慢性危重病(CCI)是认知障碍、长期使用维持生命的cre的高危人群，需要替代决策者(Sdm)来决定生命的结束。CCI的SDMS经常描述与患者病情及其决策角色的不确定性相关的高心理应激状态。许多SDM发现很难理解、处理和应用来自临床医生的信息来为他们所爱的人做出明智的决定。目前，SDMS没有有效的工具来帮助他们做出关于在生命末期护理认知受损的CCI患者的明智决定。因此，我们建议修改和测试一种基于虚拟化身的决策支持技术的有效性，该技术被称为交互式虚拟临终和姑息治疗决策支持(Encept)。这个项目分为两个阶段。在第一阶段，我们将通过迭代的、以用户为中心的过程来修改我们的涉足原型。第二阶段是一项三臂临床试验，对270名认知受损的CCI患者进行SDMS，比较参与支持(IS)和仅信息支持(IS)和常规护理(UC)。本项目的具体目标是：[1]确定图形用户界面的基本要素和修改ICU中发生的一组常见临终决策的涉及原型所需的教育内容；[2)评估在基线后第1、3和7天暴露于参与、IS或UC的受试者在决策准备和决策质量方面是否存在差异，同时考虑协变量(先前的SDM经验、患者偏好的SDM知识和SDM的宗教信仰)；和[3]在考虑基线后90天的协变量的情况下，根据研究条件确定SDMS和他们的CCI患者的决策后结果是否存在差异。在ICU中寻找提高临终关怀决策质量的策略的重要性已经得到了很好的认识。这将是第一项测试干预措施的研究，这些干预措施是针对CCI患者SDMS的独特需求而量身定做的，使用基于互动化身的格式提供。这是一种易于交付、被广泛接受的格式，非常适合这群脆弱且难以接触到的决策者。如果证明有效，这些以技术为基础的临终决策干预还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SDMS及其认知受损的亲人的结局。

 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.