N/A N=141 Randomized Supportive Care

Advance Care Planning in the Emergency Department

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

Bottom Line

View on ClinicalTrials.gov: NCT05209880 ↗

Enrolled (actual)

141

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month — 2.84; 2.87; 3.37; 3.32 score on a scale — p=0.5835

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ED GOAL (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Brigham and Women's Hospital
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month	2.84; 2.87; 3.37; 3.32	0.5835
SECONDARY Feeling Heard and Understood Survey	7; 6; 4; 6; 12; 12	—
SECONDARY Quality of Communication Survey	8.80; 8.53; 8.65; 8.61; 8.03; 8.07	—
SECONDARY Healthcare Utilization	0; 0; 0; 0; 2; 2	—
SECONDARY Mortality	1; 1; 4; 4	—
SECONDARY Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL	16; 7; 17; 3; 15; 17	—
SECONDARY Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations	0; 0; 10; 5; 17; 7	—
SECONDARY Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months	2.84; 2.87; 3.56; 3.55	—
SECONDARY Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months	2.84; 2.87; 3.73; 3.70	—
SECONDARY Participant-reported Completion of Advance Care Planning (ACP) Conversations	12; 5; 33; 28; 7; 5	—

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.

Eligibility Criteria

Inclusion Criteria

≥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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05209880). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.