Time-limited Trials in the Emergency Department

Mass General Brigham

Status: Enrolling

Conditions: Emergencies

Treatments: Other: TLT training

Study type: Interventional

Funder types: Other

Identifiers

NCT06378151

2023P002243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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; 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; 2) 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 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Other: TLT training

Control group

No Intervention group

Description:

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