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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists. |
|
| Control group | No Intervention | Attending physicians, resident physicians, or mid-level providers working in the ED who are willing to be randomized to become the study interventionists. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLT training | Other | Emergency clinicians assigned to the intervention group will receive the following training and resources.
|
| 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) |
| 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) |
| Clinician-reported feasibility |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Kei Ouchi, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26596879 | Background | 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. | |
| 17040146 |
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| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Clinician-level randomization
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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 |
| 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 |
| 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 |
| 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 |
| Background |
| 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. |
| 12926578 | Background | 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. |
| 39715103 | Derived | 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. |