Clinical trial NCT05209880: Advance Care Planning in the Emergency Department
Official title: An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
timeFrame: Change from baseline ACP engagement at one month
Secondary outcomes:
measure: Feeling Heard and Understood Survey
timeFrame: Baseline & 1, 3, and 6 months
measure: Quality of Communication Survey
timeFrame: Baseline & at 1, 3, and 6 months
measure: Healthcare Utilization
timeFrame: At 6 and 12 months before and 1, 6, 12 months after enrollment
measure: Mortality
timeFrame: At 1, 3, and 6 months
measure: Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
timeFrame: At 1, 3, and/or 6 months
measure: Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
timeFrame: At 1, 3, and 6 months
measure: Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months
timeFrame: Change from baseline ACP engagement at three months
measure: Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months
timeFrame: Change from baseline ACP engagement at six months
measure: Participant-reported Completion of Advance Care Planning (ACP) Conversations
timeFrame: At 1, 3, and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Kei Ouchi, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.