Structured conversations for decision-making in emergency care

Time-limited Trials in the Emergency Department: A Randomized Trial

This study tests if having structured conversations about care options helps seriously ill older adults in the emergency department make better decisions about their treatment compared to usual care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Brigham and Women's Hospital (other)
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT06378151 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the feasibility and acceptability of structured conversations, known as Time-Limited Trials (TLT), between clinicians and patients or their surrogates in the emergency department. The focus is on seriously ill older adults who are being admitted to the intensive care unit. The study compares the outcomes of patients whose clinicians use TLT to those receiving usual care, aiming to improve patient-centered decision-making and alignment with end-of-life care preferences. The trial involves trained emergency department clinicians conducting these conversations with patients or their surrogates.

Who should consider this trial

Good fit: Ideal candidates are seriously ill older adults aged 50 and above with life-limiting illnesses or those aged 75 and older being admitted to intensive care.

Not a fit: Patients who are not seriously ill or those who do not have surrogates available for decision-making may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance shared decision-making and ensure that end-of-life care preferences are better respected for seriously ill older adults.

How similar studies have performed: Other studies have shown promise in using structured conversations for decision-making in critical care settings, suggesting that this approach may be effective.

Eligibility 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 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; 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 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

Where this trial is running

Boston, Massachusetts

• Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)

Study contacts

• Principal investigator: Kei Ouchi, MD, MPH — Brigham and Women's Hospital
• Study coordinator: Kei Ouchi, MD, MPH

Conditions: Emergencies, Time-Limited Trials, emergency department, palliative care