Clinical trial NCT06378151: Time-limited Trials in the Emergency Department
Official title: Time-limited Trials in the Emergency Department: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emergencies
Keywords: Time-Limited Trials; emergency department; palliative care
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinician-level randomization
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to complete TLT conversations
timeFrame: Immediately after the intervention (TLT conversation)
measure: Patient-reported acceptability of TLT conversations
timeFrame: Immediately after the intervention (TLT conversation)
Secondary outcomes:
measure: Intervention fidelity
timeFrame: Immediately after the intervention (TLT conversation)
measure: Clinician-reported feasibility
timeFrame: Immediately after the intervention (TLT conversation)
measure: Clinician-reported satisfaction
timeFrame: Immediately after the intervention (TLT conversation)
measure: Clinician-reported likelihood of recovery
timeFrame: At enrollment
measure: EHR documentation by inpatient clinicians
timeFrame: After 24 hours, 48 hours, and 1 week
measure: Heard and understood
timeFrame: Immediately after the intervention (TLT conversation)
measure: Patient-reported end-of-life quality of communication
timeFrame: Immediately after the intervention (TLT conversation)
measure: Patient-reported likelihood of recovery
timeFrame: At enrollment
measure: Needs at the end-of-life screening tool
timeFrame: At enrollment, after 24 hours, after 48 hours, and after 1 week
measure: Patient-reported anxiety scale
timeFrame: At enrollment, after 48 hours, and after 1 week
measure: Decisional regret scale
timeFrame: After 24 hours, 48 hours, and 1 week
measure: The number of days to the first family meeting in ICU
timeFrame: Immediately after patient's discharge or death
measure: ICU length of stay (LOS)
timeFrame: Immediately after patient's discharge or death
measure: Hospital LOS
timeFrame: Immediately after patient's discharge or death
measure: The number of family meetings
timeFrame: Immediately after patient's discharge or death
measure: ICU procedures (e.g., CPR, pressors, etc.)
timeFrame: Immediately after patient's discharge or death
measure: ICU mortality
timeFrame: Immediately after patient's discharge or death
measure: Patterns of hospital disposition
timeFrame: Immediately after patient's discharge or death
measure: Rate of hospice utilization
timeFrame: Immediately after patient's discharge or death
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kei Ouchi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.