Hashimoto Tadayuki, Putman Rachel K, Massaro Anthony F, Shiozawa Youkie, McGough Katherine, McCabe Kerry K, Linden Judith A, Wang Wei, Liu Shan W, Kennedy Maura, Neville Thanh H, Kruser Jacqueline M, Sudore Rebecca L, Schonberg Mara A, Tulsky James A, Ouchi Kei
Department of Emergency Medicine, Brigham and Women's Hospital, Boston, Massachusetts, United States of America.
Department of General Medicine, Osaka Medical and Pharmaceutical University, Takatsuki, Osaka, Japan.
PLoS One. 2024 Dec 23;19(12):e0313858. doi: 10.1371/journal.pone.0313858. eCollection 2024.
Time-limited trial (TLT) is a structured approach between clinicians and seriously ill patients or their surrogates to discuss patients' values and preferences, prognosis, and shared decision-making to use specific therapies for a prespecified period of time in the face of prognostic uncertainty. Some evidence exists that this approach may lead to more patient-centered care in the intensive care unit; however, it has never been evaluated in the emergency department (ED). The study protocol aims to assess the feasibility and acceptability of TLTs initiated in the ED.
We will conduct a parallel group, clinician-level, pilot randomized clinical trial among 40 ED clinicians. We will measure feasibility (e.g., the time it takes to conduct the TLTs by ED clinicians) and clinician and patient-reported acceptability of the TLT, and also track patients' clinical outcomes via medical record review.
This study protocol will investigate the potential of TLT initiated in the ED to lead to patient-centered intensive care utilization. By doing so, the study intends to improve palliative care integration for seriously ill older adults in the ED and intensive care unit.
ClinicalTrials.gov ID: NCT06378151 https://clinicaltrials.gov/study/NCT06378151; Pre-results; a randomized controlled trial: Time-limited Trials in the Emergency Department.
限时试验（TLT）是临床医生与重症患者或其代理人之间采用的一种结构化方法，用于讨论患者的价值观和偏好、预后，并在预后不确定的情况下就特定时间段内使用特定治疗方法进行共同决策。有证据表明，这种方法可能会在重症监护病房带来更以患者为中心的护理；然而，它从未在急诊科（ED）进行过评估。本研究方案旨在评估在急诊科启动限时试验的可行性和可接受性。
我们将在40名急诊科临床医生中进行一项平行组、临床医生层面的试点随机临床试验。我们将测量可行性（例如，急诊科临床医生进行限时试验所需的时间）以及临床医生和患者报告的限时试验可接受性，并通过病历审查跟踪患者的临床结果。
本研究方案将调查在急诊科启动的限时试验能否带来以患者为中心的重症监护利用。通过这样做，该研究旨在改善急诊科和重症监护病房中重症老年患者的姑息治疗整合。
ClinicalTrials.gov识别码：NCT06378151 https://clinicaltrials.gov/study/NCT06378151；预结果；一项随机对照试验：急诊科限时试验。
