Optimizing Time-Limited Trials of Mechanical Ventilation in Acute Respiratory Failure: A Mixed Methods Observational Study

摘要 目前重症监护病房(ICU)提供的急性呼吸衰竭护理服务不能满足患者的需求 生命即将结束时，他们的家人和他们的跨专业ICU团队。努力改善临终ICU护理 都专注于家庭和临床医生之间的沟通。然而，患者的临终结局很差， 家庭和ICU团队仍然难以处理，部分原因是推动 重症监护室的护理服务。有时间限制的试验有望扰乱低质量生命周期结束的系统级驱动程序 护理和建立护理提供流程，以更好地支持患者、家属和ICU团队。一段时间- 有限的“试验”是患者、他们的代理决策者和临床医生之间的协议，以尝试生命-- 维持治疗一段预定的时间，然后重新评估其效用。这种病人护理模式是 由姑息治疗专家提出，以解决预后的不确定性，并驾驭相互竞争的欲望 多个病人同时握住--尽可能延长生命，避免延长生命维持时间 如果痊愈的机会很低，就进行治疗。有时间限制的试验已经在文献中得到了描述，并得到了 姑息治疗和危重护理专业协会，目前在ICU实践中使用。然而，有时间限制的试验 在实践中仍然缺乏正规化，几乎没有证据指导ICU临床医生如何进行试验。 本研究的中心目标是确定急性呼吸窘迫综合征限时试验的最佳护理提供流程。 呼吸衰竭。此应用程序响应NHLBI对姑息治疗(非HL-HL)的特殊兴趣通知 20-737)，包括重点介绍基于ICU的急性呼吸衰竭姑息治疗的模式以及如何 ICU结构和文化影响姑息护理的提供。本项目是一种顺序混合的方法， 目前使用限时试验的五个ICU的前瞻性观察性研究。在目标1中，聚焦 对急性呼吸衰竭患者进行的50项限时试验的民族志将被用来绘制当前 急性呼吸衰竭患者限时试行护理的实施过程。在《目标2》中，一位未来的， 对5810名急性呼吸衰竭患者进行的观察性队列研究将用于阐明 有时间限制的试验过程与患者、代理人和ICU的临终结局之间的关系 团队。目标2a和2b将测试有时间限制的试验过程是否与更好的生命结束相关 结果和目标2c将描述进程影响临终结果的机制。 这项工作将把有时间限制的试验从有希望的模式转变为明确定义和优化的护理 交付过程。这一程序将立即可操作，以指导目前使用或 考虑到有时间限制的试验。这项研究也将为设计和测试奠定必要的基础 支持有时间限制的试验和防止意外伤害的复杂卫生干预措施。

ABSTRACT Current intensive care unit (ICU) care delivery for acute respiratory failure fails to meet the needs of patients near the end of life, their families, and their interprofessional ICU teams. Efforts to improve end-of-life ICU care have focused on communication between families and clinicians. Yet, poor end-of-life outcomes for patients, families, and ICU teams remain intractable, in part because of the system-level processes and norms that drive ICU care delivery. Time-limited trials have promise to disrupt system-level drivers of poor quality end-of-life care and establish processes of care delivery that better support patients, families, and ICU teams. A time- limited “trial” is an agreement among patients, their surrogate decision makers, and clinicians to attempt life- sustaining treatment for a predefined period and then re-evaluate its utility. This patient care model was proposed by palliative care experts to address prognostic uncertainty, and navigate competing desires simultaneously held by many patients—to extend life when possible and to avoid prolonged life-sustaining treatment if the chance of recovery is low. Time-limited trials have been described in the literature, endorsed by palliative and critical care professional societies, and are currently used in ICU practice. Yet, time-limited trials remain poorly formalized in practice with little evidence to guide ICU clinicians in how to conduct trials. The central objective of this study is to define the optimal care delivery processes of a time-limited trial in acute respiratory failure. This application responds to NHLBI’s Notice of Special Interest in Palliative Care (NOT-HL- 20-737), including the focus on models of ICU-based palliative care for acute respiratory failure and on how ICU structure and culture influence palliative care delivery. This project is a sequential mixed methods, prospective observational study in five ICUs where time-limited trials are currently used. In Aim 1, focused ethnography of 50 time-limited trials in patients with acute respiratory failure will be used to map current processes of time-limited trial care delivery for patients with acute respiratory failure. In Aim 2, a prospective, observational cohort study in 5,810 patients with acute respiratory failure will be used to elucidate the relationships between time-limited trial processes and end-of-life outcomes for patients, surrogates, and ICU teams. Aims 2a and 2b will test whether time-limited trial processes are associated with better end-of-life outcomes and Aim 2c will characterize mechanisms by which processes influence end-of-life outcomes. This work will transform time-limited trials from a promising model into a clearly defined and optimized care delivery process. This process will be immediately actionable to guide frontline ICU teams currently using or considering time-limited trials. This study will also establish the necessary foundation for the design and testing of complex health interventions that support time-limited trials and safeguard against unintended harms.