Clinical trial · Interventional
Advance Care Planning in the Emergency Department
An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
NCT05209880CI-TRIAL-00105397completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Kidney Disease Requiring Chronic Dialysis | — | UNRESOLVED | — |
| Chronic Obstructive Pulmonary Disease | — | UNRESOLVED | — |
| Congestive Heart Failure | — | UNRESOLVED | — |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ED GOAL | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Arm
- description
- 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.
- interventionNames
- Behavioral: ED GOAL
- type
- NO_INTERVENTION
- label
- Control Arm
- description
- No intervention will be conducted (standard of care).
Primary outcomes (1)
- measure
- Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
- timeFrame
- Change from baseline ACP engagement at one month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDShiozawa 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
- DERIVEDOuchi 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
- DERIVEDPrachanukool 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