Time-limited Trials in the Emergency Department

NCT ID: NCT06378151

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-12
• Study Completion Date: 2025-09-30

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.

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.

Conditions

Emergencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

TLT training

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

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

• 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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kei Ouchi

Associate Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kei Ouchi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kei Ouchi, MD, MPH

Role: CONTACT

kouchi@bwh.harvard.edu

617-732-5640

Facility Contacts

Kei Ouchi, MD, MPH

Role: primary

kouchi@bwh.harvard.edu

References

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.

Reference Type: BACKGROUND

PMID: 26596879 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17040146 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12926578 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39715103 (View on PubMed)

Other Identifiers

2023P002243

Identifier Type: -

Identifier Source: org_study_id