Time-limited Trials in the Emergency Department

NCT06378151 | Active Not Recruiting

• 1 other identifier: 2023P002243
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergencies

Keywords

Time-Limited Trials; emergency department; palliative care

Outcome Measures

Primary Outcomes (2)

• Time to complete TLT conversations

  With direct observation, the study team will record how long (e.g., minutes) it takes to complete the TLT conversations by the interventionist ED clinicians.

  Immediately after the intervention (TLT conversation)

• Patient-reported acceptability of TLT conversations

  A 5-point Likert scale (i.e., "How acceptable was it for your doctor to talk to you about your expectations for ICU care?" and "How likely would you recommend this conversation for other patients like you?" "Not at all (1)" to "Completely (5)"). A higher score indicates a better outcome.

  Immediately after the intervention (TLT conversation)

Secondary Outcomes (19)

• Intervention fidelity

  Immediately after the intervention (TLT conversation)

• Clinician-reported feasibility

  Immediately after the intervention (TLT conversation)

• Clinician-reported satisfaction

  Immediately after the intervention (TLT conversation)

• Clinician-reported likelihood of recovery

  At enrollment

• EHR documentation by inpatient clinicians

  After 24 hours, 48 hours, and 1 week

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

TLT training OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• ≥50 years or older with ≥one serious life-limiting illness\* being admitted to the intensive care unit in the ED; or
• ≥75 years or older being admitted to intensive care unit in the ED; or
• ED clinicians will not be surprised if the patient died in the current hospital admission or in the near future; and
• 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.
• Unable or unwilling to provide informed consent; or
• Non-English speaking; or
• Clinically inappropriate, determined by emergency clinicians, and no surrogate is available

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group; Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17.

  PMID: 26596879 BACKGROUND

• Engelberg R, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98. doi: 10.1089/jpm.2006.9.1086.

  PMID: 17040146 BACKGROUND

• Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005.

  PMID: 12926578 BACKGROUND

• Hashimoto T, Putman RK, Massaro AF, Shiozawa Y, McGough K, McCabe KK, Linden JA, Wang W, Liu SW, Kennedy M, Neville TH, Kruser JM, Sudore RL, Schonberg MA, Tulsky JA, Ouchi K. Study protocol for a randomized controlled trial: Integrating the 'Time-limited Trial' in the emergency department. PLoS One. 2024 Dec 23;19(12):e0313858. doi: 10.1371/journal.pone.0313858. eCollection 2024.

  PMID: 39715103 DERIVED

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kei Ouchi, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Model Details: Clinician-level randomization

Study Record Dates

• First Submitted: February 8, 2024
• First Posted: April 22, 2024
• Study Start: April 12, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)