Time-limited Trials in the Emergency Department

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Emergencies
• Intervention / Treatment: Other: TLT training

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.; 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.; 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.; EHR Documentation: An EHR template for documenting the TLT conversation findings has been developed.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention fidelity	With direct observation, the study team will record the completion of TLT components using an intervention fidelity checklist.	Immediately after the intervention (TLT conversation)
EHR documentation by inpatient clinicians	Review EHR for new documentation of reference to TLT, serious illness conversation, change in code status, or advance directive forms by inpatient clinicians.	After 24 hours, 48 hours, and 1 week
The number of days to the first family meeting in ICU	The number of days from ICU admission to the first family meeting was documented by the ICU clinical team.	Immediately after patient's discharge or death
ICU length of stay (LOS)	The ICU LOS is recorded in days, from admission to the ICU until discharge, based on hospital records.	Immediately after patient's discharge or death
Hospital LOS	Hospital LOS is recorded in days, from admission to the hospital until discharge, as recorded in the patient's hospital record.	Immediately after patient's discharge or death
The number of family meetings	The total number of family meetings conducted in the ICU, as documented in patient records.	Immediately after patient's discharge or death
ICU procedures (e.g., CPR, pressors, etc.)	The number and type of specific ICU procedures performed, such as CPR or the use of pressors, will be recorded for each patient.	Immediately after patient's discharge or death
ICU mortality	ICU mortality is the percentage of patients who die while in the ICU, documented by the hospital's patient management system.	Immediately after patient's discharge or death
Patterns of hospital disposition	Hospital disposition refers to the patient's status upon discharge, including return home, transfer to another facility, or death, as noted in discharge records.	Immediately after patient's discharge or death
Rate of hospice utilization	Hospice utilization is recorded as the incidence of patients transferred to hospice care from the hospital, verified by hospice admission records.	Immediately after patient's discharge or death
Clinician-reported feasibility	The study team will ask the interventionist emergency clinician to complete two 5-point Likert scale questions. The scale includes the following response options: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome.	Immediately after the intervention (TLT conversation)
Clinician-reported satisfaction	The study team will ask the interventionist emergency clinician to complete 5-point Likert scale questions (i.e., "How satisfied are you with the conversation? "Not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)"). A higher score indicates a better outcome.	Immediately after the intervention (TLT conversation)
Clinician-reported likelihood of recovery	A 5-point Likert scale to identify clinicians' reported likelihood of their patient's recovery to their baseline function regarding the patient's quality of life, physical function, and cognitive function. The scale includes the following response options: "very unlikely (1)," "unlikely (2)," "neutral / neither likely nor unlikely (3)," "likely (4)," and "very likely (5)." Higher scores indicate a greater clinician-reported likelihood of recovery.	At enrollment
Heard and understood	A National Quality Forum endorsed, validated measure for palliative care modified to fit the context of serious illness conversations. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome.	Immediately after the intervention (TLT conversation)
Patient-reported end-of-life quality of communication	A validated, quality of end-of-life communication survey. This instrument is a 10-point Likert scale ranging from "the very worst I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome.	Immediately after the intervention (TLT conversation)
Patient-reported likelihood of recovery	A 5-point Likert scale to identify patients'/surrogates' understanding of the likelihood of the patient's recovery to their baseline function regarding their quality of life, physical function, and cognitive function. The scale includes the following response options: "very unlikely (1)," "unlikely (2)," "neutral / neither likely nor unlikely (3)," "likely (4)," and "very likely (5)." Higher scores indicate a greater patient-reported likelihood of recovery.	At enrollment
Needs at the end-of-life screening tool	Two questions from a validated, survey (Needs at the End-of-life Screening Tool) on the clarity of the information provided by the clinician, and on the patient's goals of care. This instrument is a 10-point Likert scale ranging from "not at all (0)" to "completely (10)". A higher score indicates a better outcome.	At enrollment, after 24 hours, after 48 hours, and after 1 week
Patient-reported anxiety scale	A subscale of the validated Hospital Anxiety and Depression Scale (HADS), the HADS-Anxiety (HADS-A) subscale will be used to assess patients' or surrogates' anxiety levels. Scores range from 0 to 21, with higher scores indicating greater anxiety.	At enrollment, after 48 hours, and after 1 week
Decisional regret scale	A five-item validated survey of decisional regret. This instrument is a 5-point Likert scale: "strongly agree (1)," "agree (2)," "neither agree nor disagree (3)," "disagree (4)," and "strongly disagree (5)." The results will be converted into a score from 0 to 100. A higher score indicates greater regret.	After 24 hours, 48 hours, and 1 week

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Kei Ouchi, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: February 8, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Time-Limited Trials; emergency department; palliative care
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Emergencies
• Other Study ID Numbers: 2023P002243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No