Time-limited Trials in the Emergency Department

Purpose

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.

Condition

  • Emergencies

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Clinician-level randomization
Primary Purpose
Health Services Research
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Intervention group 		Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.
  • Other: TLT training
    Emergency clinicians assigned to the intervention group will receive the following training and resources. 1. The TLT Conversation Guide: The structured conversation guide entails discussing patients' values and goals, prognosis, and shared decision-making to use a trial of intensive care. Originally used in ICU settings, we systematically refined the guide to be used in the ED incorporating inputs from patient advisors' and emergency clinicians' inputs. 2. Clinician Training: The clinician training will include a one-hour didactic on research methodologies and serious illness communication skills, followed by a four-hour communication training with trained actors. 3. EHR Documentation: An EHR template for documenting the TLT conversation findings has been developed. 4. Intensivist Communication: A standard template to communicate the TLT conversation findings to the intensivists has been developed.
No Intervention
Control group 		Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists.

Recruiting Locations

Brigham and Women's Hospital
Boston, Massachusetts 02115
Contact:
Kei Ouchi, MD, MPH
kouchi@bwh.harvard.edu

More Details

Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Kei Ouchi, MD, MPH
617-732-5640
kouchi@bwh.harvard.edu

Detailed 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.