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 急性呼吸衰竭的当前重症监护室（ICU）护理无法满足患者的需求 在生命的尽头，他们的家人和专业的ICU团队。努力改善生命终止ICU护理 专注于家庭和临床医生之间的沟通。然而，患者的寿命结束不良结果， 家庭和ICU团队仍然很棘手，部分原因是系统级的流程和规范驱动 ICU护理交付。时限试验有望破坏质量较差的系统级驱动因素 护理和建立护理过程，以更好地支持患者，家庭和ICU团队。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一项协议，以尝试生活 - 维持预定义时期的治疗，然后重新评估其效用。这个患者护理模型是 姑息治疗专家提出的以解决原型不确定性，并导致竞争愿望 同样由许多患者持有 - 尽可能延长寿命并避免延长寿命 治疗如果恢复的机会很低。在文献中描述了时限试验，并由 姑息和重症监护专业社会，目前用于ICU实践。然而，时间有限的试验 在实践中保持正式状态不佳，几乎没有证据来指导ICU临床医生如何进行试验。 这项研究的核心目的是定义急性时限制试验的最佳护理输送过程 呼吸衰竭。该申请响应NHLBI在姑息治疗中特别关注的通知（NOT-HL-- 20-737），包括关注基于ICU的姑息治疗模型的急性呼吸衰竭以及如何 ICU结构和培养会影响姑息治疗。该项目是一种顺序混合方法， 目前使用时限制试验的五个ICU中的前瞻性观察研究。在AIM 1中，专注于 急性呼吸衰竭患者的50个时限试验的人种志将用于绘制电流 急性呼吸衰竭患者的时间限时试验治疗过程。在AIM 2中，一个潜在的 对5,810名急性呼吸衰竭患者的观察队列研究将用于阐明 时间限时的试验过程与患者，替代物和ICU的生活终结结果之间的关系 团队。 AIMS 2A和2B将测试时间限制的试验过程是否与更好的寿命相关联 结果和AIM 2C将通过过程影响生命终止结果的机制来表征其机制。 这项工作将将限时试验从承诺模型转变为明确定义和优化的护理 交付过程。此过程将立即采取行动，以指导当前使用或 考虑时间限制的试验。这项研究还将为设计和测试建立必要的基础 复杂的健康干预措施，这些干预措施支持时间限制的试验并保障意外危害。