Study Protocol for a Randomized Controlled Trial: Integrating the 'Time-limited Trial' in the Emergency Department

Overview

Journal PLoS One

Specialties General Medicine
Science

Date 2024 Dec 23

PMID 39715103

Authors

Tadayuki Hashimoto

Rachel K Putman

Anthony F Massaro

Youkie Shiozawa

Katherine McGough

Kerry K McCabe

Judith A Linden

Wei Wang

Shan W Liu

Maura Kennedy

Thanh H Neville

Jacqueline M Kruser

Rebecca L Sudore

Mara A Schonberg

James A Tulsky

Kei Ouchi

Affiliations

Soon will be listed here.

Abstract

Introduction: 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.

Methods And Analysis: 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.

Discussion: 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.

Trial Identifier And Registry Name: ClinicalTrials.gov ID: NCT06378151 https://clinicaltrials.gov/study/NCT06378151; Pre-results; a randomized controlled trial: Time-limited Trials in the Emergency Department.

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