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

优化急性呼吸衰竭机械通气的限时试验：混合方法观察研究

• 批准号: 10633823
• 负责人: Jacqueline Marie Kruser
• 金额: $ 72.72万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2028-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10633823
• 关键词: Acute respiratory failure; Address; Adherence; Agreement; Caring; Cessation of life; Clinical Trials; Cohort Studies; Communication; Complex; Conflict (Psychology); Critical Care; Data; Development; Distress; Engineering; Ensure; Environment; Ethnography; Family; Foundations; Future; Goals; Health; Healthcare; Hospitals; Individual; Intensive Care Units; Intervention; Interview; Knowledge; Length of Stay; Life; Life Experience; Literature; Maps; Measures; Mechanical ventilation; Medical; Methods; Modeling; Morals; National Heart, Lung, and Blood Institute; Nested Case-Control Study; Observational Study; Outcome; Palliative Care; Patient Care; Patient-Focused Outcomes; Patients; Pattern; Process; Process Measure; Professional Organizations; Quality of Care; Randomized, Controlled Trials; Recovery; Research; Respiratory Failure; Role; Structure; System; Testing; Time; Uncertainty; Variant; Visual; Work; care delivery; clinical practice; cohort; cost; design; end of life; end of life care; experience; improved; interest; member; observational cohort study; patient population; prevent; process improvement; prognostic; prospective; psychological distress; surrogate decision maker; timeline; tool; visual map

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.

抽象的 目前重症监护病房（ICU）针对急性呼吸衰竭的护理服务无法满足患者的需求 临终者、他们的家人以及他们的跨专业 ICU 团队 努力改善临终 ICU 护理。 然而，患者的临终结局却很糟糕， 家庭和 ICU 团队仍然难以处理，部分原因是驱动系统级流程和规范 ICU 护理服务的限时试验有望打破低质量临终的系统级驱动因素。 护理并建立护理提供流程，更好地支持患者、家属和 ICU 团队。 有限的“试验”是患者、他们的代理决策者和追随者之间的一项协议，以尝试生命- 维持治疗一段预定时间，然后重新评估其效用。 由姑息治疗专家提出，旨在解决预后不确定性并应对相互竞争的愿望 由许多患者同时持有——尽可能延长生命并避免延长生命维持时间 文献中描述了如果恢复机会较低的治疗方法，并得到了认可。 姑息治疗和重症监护专业协会，目前在 ICU 实践中使用，但有时间限制的试验。 在实践中仍然不够正式，几乎没有证据来指导 ICU 老年人如何进行试验。 本研究的中心目标是确定急性发作时限时试验的最佳护理提供流程。 本申请响应 NHLBI 的姑息治疗特别关注通知 (NOT-HL-)。 20-737），包括重点关注基于 ICU 的急性呼吸衰竭姑息治疗模式以及如何 ICU 结构和文化影响姑息治疗服务，该项目采用顺序混合方法。 目前在五个 ICU 中进行前瞻性观察研究，重点关注目标 1。 对急性呼吸衰竭患者进行的 50 项限时试验的人种学研究将用于绘制当前的情况 目标 2 是一项前瞻性的、针对急性呼吸衰竭患者的限时试验护理流程。 对 5,810 名急性呼吸衰竭患者进行的观察性队列研究将用于阐明 限时试验过程与患者、代理人和 ICU 临终结果之间的关系 目标 2a 和 2b 将测试限时试验过程是否与更好的寿命终止相关。 结果和目标 2c 将描述过程影响临终结果的机制。 这项工作将把限时试验从有前途的模型转变为明确定义和优化的护理 该流程将立即可用于指导当前使用或的一线 ICU 团队。 考虑到限时试验，这项研究还将为设计和测试奠定必要的基础。 复杂的健康干预措施，支持限时试验并防止意外伤害。