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. 2024 Dec 23;19(12):e0313858.
doi: 10.1371/journal.pone.0313858. eCollection 2024.

Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department

Tadayuki Hashimoto  1   2 , Rachel K Putman  3 , Anthony F Massaro  3 , Youkie Shiozawa  1 , Katherine McGough  4 , Kerry K McCabe  5 , Judith A Linden  5 , Wei Wang  6 , Shan W Liu  7   8 , Maura Kennedy  7   8 , Thanh H Neville  9 , Jacqueline M Kruser  10 , Rebecca L Sudore  11 , Mara A Schonberg  7   12 , James A Tulsky  13   14 , Kei Ouchi  1   7   13   15
Affiliations

Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department

Tadayuki Hashimoto et al. PLoS One. .

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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Conflict of interest statement

Dr. Kei Ouchi has received funding personally from Jolly Good, Inc (a virtual reality company) for consulting. This does not alter our adherence to PLOS ONE policies on sharing data and materials. There are no patents, products in development or marketed products associated with this research to declare.

Figures

Fig 1
Fig 1. SPIRIT 2013 schedule.
SPIRIT schedule of enrollment, interventions, and assessments timepoints along the study period.
Fig 2
Fig 2. Time-Limited Trials in the Emergency Department (ED): A study schema.
ED clinicians are divided into an intervention group and a control group, each consisting of 20 members. The intervention group is equipped with resources to implement TLTs. This group will identify and apply TLTs to suitable patients among those they treat. Outcomes will be measured for both clinicians and patients within these groups, with assessments of patients conducted in both the ED and the ICU.
Fig 3
Fig 3. Conceptual model for Time-Limited Trials in the emergency department.
See this image and copyright information in PMC

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