BMJ open · 2025
Optimising time-limited trials in acute respiratory failure: a multicentre focused ethnography protocol.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Kruser Jacqueline M, Wiegmann Douglas A, Nadig Nandita R, Secunda Katharine E, Hanlon Bret M, Moy Joy X, Ahmad Arsalan, Campbell Emily G, Donnelly Helen K, Martinez Francisco J, Polley Madison, Orhan Cemre, Korth Erin, Stalter Lily N, Rowe Timothy J, Wu Andrew L, Viglianti Elizabeth M, Eisinger Ella C, Nguyen Oliver, Halpern Scott D, Clapp Justin T
Аннотация
INTRODUCTION: The 'time-limited trial' for patients with critical illness is a collaborative plan made by clinicians, patients and families to use life-sustaining therapies for a defined duration. After this period, the patient's response to therapy informs decisions about continuing recovery-focused care or transitioning to comfort-focused care. The promise of time-limited trials to help navigate the uncertain limits and benefits of life-sustaining therapies has been extensively discussed in the palliative and critical care literature, leading to their dissemination into clinical practice. However, we have little evidence to guide clinicians in how to conduct time-limited trials, leading to substantial variation in how and why they are currently used. The overall purpose of this study is to characterise the features of an optimal time-limited trial through a rich understanding of how they are currently shaping critical care delivery.
METHODS AND ANALYSIS: We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials' conceptual formulation and their heterogeneous, real-world use.
ETHICS AND DISSEMINATION: This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.
TRIAL REGISTRATION NUMBER: NCT06042621.
METHODS AND ANALYSIS: We are conducting an observational, multicentre, focused ethnography of time-limited trials in patients with acute respiratory failure receiving invasive mechanical ventilation in six intensive care units (ICUs) within five hospitals across the US. Study participants include patients, their surrogate decision makers and ICU clinicians. We are pursuing two complementary analyses of this rich data set using the open-ended, inductive approach of constructivist grounded theory and, in parallel, the structured, deductive methods of systems engineering. This cross-disciplinary, tailored approach intentionally preserves the tension between time-limited trials' conceptual formulation and their heterogeneous, real-world use.
ETHICS AND DISSEMINATION: This study has been reviewed and approved by the University of Wisconsin Institutional Review Board (IRB) as the single IRB (ID: 2022-1681; initial approval date 23 January 2023). Our findings will be disseminated through peer-reviewed publication, conference presentations, and summaries for the public.
TRIAL REGISTRATION NUMBER: NCT06042621.