Advance Care Planning in the Emergency Department

NCT ID: NCT05209880

Last Updated: 2025-05-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-07-01

Brief Summary

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This is a two-armed, parallel-design, pre-/post-intervention assessment study. The investigators will conduct a randomized controlled trial for ED GOAL on a cohort of 120 older adults with serious illness to collect patient-centered outcomes and determine preliminary efficacy on increasing advance care planning engagement (self-reported and/or in the electronic medical record) one month after leaving the emergency department. The investigators will also conduct qualitative interviews with participants of ED GOAL.

Detailed Description

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ED GOAL, a 6-minute motivational interview conducted in the emergency department (ED), which engages participants to address advance care planning (ACP) conversations with their outpatient clinicians and avoids a time-consuming, sensitive conversation in the time-pressured ED environment. This study is designed to determine the preliminary efficacy of ED GOAL on increasing ACP engagement (by self-report and in the electronic medical record) one month after leaving the ED.

Conditions

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Congestive Heart Failure Metastatic Cancer Chronic Kidney Disease Requiring Chronic Dialysis Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention Arm

The intervention will take place in the emergency department or days after an emergency department visit at home/hospital virtually using zoom or phone by our trained clinicians. At the time of follow-up assessments, participants may also receive additional counseling by our trained clinicians as needed.

Group Type EXPERIMENTAL

ED GOAL

Intervention Type BEHAVIORAL

The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

Control Arm

No intervention will be conducted (standard of care).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ED GOAL

The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. ≥50 years of age AND ≥1 Serious illness\* OR ED clinician would not be surprised if patient died in the next 12 months (a validated prognostic sign)
2. English-speaking
3. Capacity to consent

1. Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
2. Caregiver of patient with moderate/severe dementia with capacity to consent

(\*) NYHA Stage III/IV congestive heart failure, chronic obstructive lung disease on home oxygen, chronic kidney disease on dialysis, or metastatic solid tumor cancer. In addition, patients with NYHA Stage I/II congestive heart failure, chronic obstructive lung disease not on home oxygen, chronic kidney disease not on dialysis will be included if recent hospitalization in the last 12 months exists.

Exclusion Criteria

1. Acute physical or emotional distress
2. Determined by treating or study clinician not to be appropriate
3. Clearly documented goals for medical care\*\* (Unless the treating or study clinician recommends that the intervention is clinically indicated)
4. Delirium (assessed using 3D-CAM)
5. Already enrolled in this study
6. Unable/unwilling to schedule the follow-ups on the calendar
7. Receive both the outpatient care for serious illness and primary care outside of the Mass General Brigham health system

(\*\*)e.g., MOLST, medical order for life-sustaining treatment, documented serious illness conversations in clinician notes within the last 3 months, etc.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kei Ouchi

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kei Ouchi, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Shiozawa Y, Morton S, Shirai N, Oelschlager H, Kiernat L, Chary AN, Revette AC, Haimovich A, Desai S, Chang KW, Liu SW, Kennedy M, Schonberg MA, Ouchi K. Exploring Patients' Perceptions of an Advance Care Planning Intervention in the Emergency Department: A Qualitative Study. Acad Emerg Med. 2025 Jul 29. doi: 10.1111/acem.70109. Online ahead of print.

Reference Type DERIVED
PMID: 40729413 (View on PubMed)

Ouchi K, Block SD, Rentz DM, Berry DL, Oelschlager H, Shiozawa Y, Rossmassler S, Berger AL, Hasdianda MA, Wang W, Boyer E, Sudore RL, Tulsky JA, Schonberg MA. Serious Illness Conversations in the Emergency Department for Older Adults With Advanced Illnesses: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2516582. doi: 10.1001/jamanetworkopen.2025.16582.

Reference Type DERIVED
PMID: 40531532 (View on PubMed)

Prachanukool T, Block SD, Berry D, Lee RS, Rossmassler S, Hasdianda MA, Wang W, Sudore R, Schonberg MA, Tulsky JA, Ouchi K. Emergency department-based, nurse-initiated, serious illness conversation intervention for older adults: a protocol for a randomized controlled trial. Trials. 2022 Oct 9;23(1):866. doi: 10.1186/s13063-022-06797-6.

Reference Type DERIVED
PMID: 36210436 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2021P003093

Identifier Type: -

Identifier Source: org_study_id

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