Advance Care Planning in the Emergency Department

NCT05209880 | Completed Results

• 1 other identifier: 2021P003093
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Advance Care Planning; Palliative Care; Goals of Care; ED GOAL

Outcome Measures

Primary Outcomes (1)

• Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month

  ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.

  Change from baseline ACP engagement at one month

Secondary Outcomes (9)

• Feeling Heard and Understood Survey

  Surveys were done at baseline and once at 1, 3, or 6 months. If participants reported discussing end-of-life wishes with their doctor during a follow-up, the survey was given then or at 6 months, whichever came first. Follow-up results were summed.

• Quality of Communication Survey

  Baseline & 1, 3, or 6 months (same as Outcome 2). Additionally, the baseline questionnaire was asked with respect to the study clinician, whereas the follow-up was asked with respect to the primary doctor. Thus, only the follow-up value is reported.

• Healthcare Utilization

  At 6 and 12 months before and 1, 6, 12 months after enrollment

• Mortality

  At 1, 3, and 6 months

• Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL

  At 1, 3, and/or 6 months

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: ED GOAL

Control Arm

NO INTERVENTION

No intervention will be conducted (standard of care).

Interventions

ED GOAL 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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)
• English-speaking
• Capacity to consent
• Patient with mild cognitive impairment or mild dementia with capacity to consent (requires a caregiver/study partner to enroll)
• 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.

You may not qualify if:

• Acute physical or emotional distress
• Determined by treating or study clinician not to be appropriate
• Clearly documented goals for medical care\*\* (Unless the treating or study clinician recommends that the intervention is clinically indicated)
• Delirium (assessed using 3D-CAM)
• Already enrolled in this study
• Unable/unwilling to schedule the follow-ups on the calendar
• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• 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 Oct;32(10):1076-1083. doi: 10.1111/acem.70109. Epub 2025 Jul 29.

  PMID: 40729413 DERIVED

• 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.

  PMID: 40531532 DERIVED

• 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.

  PMID: 36210436 DERIVED

Related Links

• National Institutes of Health study record

MeSH Terms

Conditions

Heart Failure; Neoplasm Metastasis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Results Point of Contact

• Title: Kei Ouchi, MD, MPH
• Organization: Brigham and Women's Hospital

kouchi@bwh.harvard.edu

6175257771

Study Officials

• Kei Ouchi, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 27, 2022
• Study Start: March 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: March 13, 2026
• Results First Posted: May 6, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)