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Time-limited Trials in the Emergency Department

Time-limited Trials in the Emergency Department

Recruiting
18 years and older
All
Phase N/A

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Overview

A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use in seriously ill older adults being admitted to the intensive care unit from the emergency department.

Description

A randomized controlled trial of a structured conversation between clinicians and patients/surrogates to facilitate shared decision-making for intensive care use (i.e., Time-Limited Trial, TLT) in seriously ill older adults being admitted to the intensive care unit from the emergency department (ED).

The goal is to evaluate the feasibility and acceptability of TLT initiated in the ED for seriously ill older adults who are starting intensive care.

The main questions it aims to answer are:

  • Is TLT feasible to be conducted by trained ED clinicians?
  • Do patients or their surrogates find TLT acceptable in understanding and respecting their end-of-life care preferences?

Participants will be:

  • Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists to conduct TLT conversations.
  • Seriously ill older adults receiving intensive care in the ED.

Researchers will compare clinicians using TLT with those providing usual care to see if TLT leads to improved patient-centered decision-making and better alignment with patients' end-of-life care preferences.

Eligibility

Physician's eligibility:

Inclusion Criteria:

  • Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.

Exclusion Criteria:

  • Emergency clinicians unwilling to consent and be randomized to intervention TLT training.

Patient's eligibility:

The subjects will be seriously ill older adults, or their surrogates being cared for by the participating emergency clinicians (both the intervention or control arms). If the emergency clinicians determine that the patient is not able to provide consent due to cognitive impairment, dementia, delirium, or critical illness, the surrogates will participate in the TLT conversations.

Inclusion Criteria:

  1. ≥50 years or older with ≥one serious life-limiting illness* being admitted to the intensive care unit in the ED; or
  2. ≥75 years or older being admitted to intensive care unit in the ED; or
  3. ED clinicians will not be surprised if the patient died in the current hospital admission or in the near future; and
  4. English speaking *Serious illness criteria with high one-year mortality are selected based on best practice recommendations such as 1) stage III/IV or metastatic cancer;
  5. end-stage renal disease on dialysis; 3) chronic heart/lung disease requiring home oxygen supplementation or experiencing shortness of breath with walking; 4) moderate to severe dementia (surrogate required for enrollment); or 5) ≥2 hospitalizations or ED visits in the past six months.

Exclusion Criteria:

  1. Unable or unwilling to provide informed consent; or
  2. Non-English speaking; or
  3. Clinically inappropriate, determined by emergency clinicians, and no surrogate is available

Study details
    Emergencies

NCT06378151

Brigham and Women's Hospital

15 September 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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