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Advance Care Planning in the Emergency Department

Mass General Brigham logo

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)

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).

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Kei Ouchi, MD, MPH

Data sourced from clinicaltrials.gov

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