Advance Care Planning in the Emergency Department
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:
🦠 Congestive Heart Failure 🦠 Metastatic Cancer 🦠 Chronic Kidney Disease Requiring Chronic Dialysis 🦠 Chronic Obstructive Pulmonary Disease
🗓️ Study Start (Actual) 1 March 2022
🗓️ Primary Completion (Estimated) 31 December 2023
✅ Study Completion (Estimated) 30 June 2024
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 10 January 2022
  • First Submitted that Met QC Criteria 22 January 2022
  • First Posted 27 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 June 2023
  • Last Update Posted 22 June 2023
  • Last Verified June 2023