An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial
Overview
- Phase
- N/A
- Intervention
- ED GOAL
- Conditions
- Congestive Heart Failure
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Kei Ouchi
Assistant Professor of Emergency Medicine
Brigham and Women's Hospital
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.
Arms & Interventions
Intervention Arm
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.
Intervention: ED GOAL
Control Arm
No intervention will be conducted (standard of care).
Outcomes
Primary Outcomes
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
Time Frame: Change from baseline ACP engagement at one month
ACP engagement is a one-item question from the validated ACP engagement survey that measures participants' self-reported readiness to discuss their values and preferences with their doctors. The instrument is a 5-point Likert scale ranging from "I have never thought about it (1)" to "I have already done it (5)." A higher score indicates a better outcome. Sudore RL, Heyland DK, Barnes DE, Howard M, Fassbender K, Robinson CA, Boscardin J, You JJ. Measuring Advance Care Planning: Optimizing the Advance Care Planning Engagement Survey. J Pain Symptom Manage. 2017 Apr;53(4):669-681.e8. doi: 10.1016/j.jpainsymman.2016.10.367. Epub 2016 Dec 29. PMID: 28042072; PMCID: PMC5730058.
Secondary Outcomes
- Healthcare Utilization(At 6 and 12 months before and 1, 6, 12 months after enrollment)
- Mortality(At 1, 3, and 6 months)
- Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL(At 1, 3, and/or 6 months)
- Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations(At 1, 3, and 6 months)
- Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months(Change from baseline ACP engagement at three months)
- Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months(Change from baseline ACP engagement at six months)
- Participant-reported Completion of Advance Care Planning (ACP) Conversations(At 1, 3, and 6 months)
- Feeling Heard and Understood Survey(Surveys were done at baseline and once at 1, 3, or 6 months. If participants reported discussing end-of-life wishes with their doctor during a follow-up, the survey was given then or at 6 months, whichever came first. Follow-up results were summed.)
- Quality of Communication Survey(Baseline & 1, 3, or 6 months (same as Outcome 2). Additionally, the baseline questionnaire was asked with respect to the study clinician, whereas the follow-up was asked with respect to the primary doctor. Thus, only the follow-up value is reported.)