Study Results
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View full resultsBasic Information
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COMPLETED
NA
141 participants
INTERVENTIONAL
2022-03-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
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.
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.
Control Arm
No intervention will be conducted (standard of care).
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Kei Ouchi
Assistant Professor of Emergency Medicine
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
Countries
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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National Institutes of Health study record
Other Identifiers
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2021P003093
Identifier Type: -
Identifier Source: org_study_id
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