Time-limited Trials in the Emergency Department

Emergencies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06378151
• Other study ID #: 2023P002243
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 30, 2025

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: Kei Ouchi, MD, MPH
• Phone: 617-732-5640
• Email: kouchi[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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; 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 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

Related Conditions & MeSH terms

• Emergencies

Intervention

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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)").	Immediately after the intervention (TLT conversation)
Secondary	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)
Secondary	Clinician-reported feasibility	The study team will ask the interventionist emergency clinician to complete two 5-point Likert scale questions.	Immediately after the intervention (TLT conversation)
Secondary	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)" to "Completely (5)").	Immediately after the intervention (TLT conversation)
Secondary	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
Secondary	Heard and understood	A National Quality Forum endorsed, validated measure for palliative care modified to fit the context of serious illness conversations.	Immediately after the intervention (TLT conversation)
Secondary	Patient-reported end-of-life quality of communication	A validated, quality of end-of-life communication survey.	Immediately after the intervention (TLT conversation)
Secondary	Decisional regret scale	A validated survey of decisional regret.	After 24 hours, 48 hours, and 1 week
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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