Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06378151
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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:
Participants will be:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Physician's eligibility:
Inclusion criteria
Exclusion criteria
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
Exclusion criteria
Emergency clinicians assigned to the intervention group will receive the following training and resources.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: Immediately after the intervention (TLT conversation)
With direct observation, the study team will record the completion of TLT components using an intervention fidelity checklist.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: At enrollment
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.
Time frame: After 24 hours, 48 hours, and 1 week
Review EHR for new documentation of reference to TLT, serious illness conversation, change in code status, or advance directive forms by inpatient clinicians.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: Immediately after the intervention (TLT conversation)
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.
Time frame: At enrollment
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.
Time frame: At enrollment, after 24 hours, after 48 hours, and after 1 week
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.
Time frame: At enrollment, after 48 hours, and after 1 week
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.
Time frame: After 24 hours, 48 hours, and 1 week
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.
Time frame: Immediately after patient's discharge or death
The number of days from ICU admission to the first family meeting was documented by the ICU clinical team.
Time frame: Immediately after patient's discharge or death
The ICU LOS is recorded in days, from admission to the ICU until discharge, based on hospital records.
Time frame: Immediately after patient's discharge or death
Hospital LOS is recorded in days, from admission to the hospital until discharge, as recorded in the patient's hospital record.
Time frame: Immediately after patient's discharge or death
The total number of family meetings conducted in the ICU, as documented in patient records.
Time frame: Immediately after patient's discharge or death
The number and type of specific ICU procedures performed, such as CPR or the use of pressors, will be recorded for each patient.
Time frame: Immediately after patient's discharge or death
ICU mortality is the percentage of patients who die while in the ICU, documented by the hospital's patient management system.
Time frame: Immediately after patient's discharge or death
Hospital disposition refers to the patient's status upon discharge, including return home, transfer to another facility, or death, as noted in discharge records.
Time frame: Immediately after patient's discharge or death
Hospice utilization is recorded as the incidence of patients transferred to hospice care from the hospital, verified by hospice admission records.
Brigham and Women's Hospital
Other
Time-limited Trials in the Emergency Department: A Randomized Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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