Advance Care Planning in the Emergency Department

Mass General Brigham

Status: Completed

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

Treatments: Behavioral: ED GOAL

Study type: Interventional

Funder types: Other

Identifiers

NCT05209880

2021P003093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Intervention Arm

Experimental group

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.

Treatment:

Behavioral: ED GOAL

Control Arm

No Intervention group

Description:

No intervention will be conducted (standard of care).