Advance Care Planning in the Emergency Department

Not Applicable

Completed

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

Interventions: Behavioral: ED GOAL

Registration Number: NCT05209880

Lead Sponsor: Brigham and Women's Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 141

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
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

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	ED GOAL	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.

Primary Outcome Measures

Name	Time	Method
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month	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 Outcome Measures

Name	Time	Method
Quality of Communication Survey	Baseline & at 1, 3, and 6 months	A validated instrument to measure the quality of communication about end-of-life care. This instrument is a 10-point Likert scale ranging from "the very worse I could imagine (0)" to "the very best I could imagine (10)". A higher score indicates a better outcome. Engelberg RA, Downey L, Curtis JR. Psychometric characteristics of a quality of communication questionnaire assessing communication about end-of-life care. J Palliat Med. 2006 Oct;9(5):1086-98.
Healthcare Utilization	At 6 and 12 months before and 1, 6, 12 months after enrollment	Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.
Mortality	At 1, 3, and 6 months	The electronic medical records will be reviewed to find the patients' vital status.
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL	At 1, 3, and/or 6 months	Semi-structured interviews to assess the benefits of ED GOAL and obstacles participants faced in completing more ACP conversations with their outpatient clinicians and loved ones after ED GOAL.
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations	At 1, 3, and 6 months	The electronic medical record will be reviewed to find clinician documentation of ACP conversations.
Feeling Heard and Understood Survey	Baseline & 1, 3, and 6 months	A validated instrument for seriously ill patients to report how well they feel heard and understood about their wishes for end-of-life care. This instrument is a 5-point Likert scale: "not at all (1)," "slightly (2)," "moderately (3)," "quite a bit (4)," and "completely (5)." A higher score indicates a better outcome. Gramling R, Stanek S, Ladwig S, Gajary-Coots E, Cimino J, Anderson W, Norton SA; AAHPM Research Committee Writing Group, Aslakson RA, Ast K, Elk R, Garner KK, Gramling R, Grudzen C, Kamal AH, Lamba S, LeBlanc TW, Rhodes RL, Roeland E, Schulman-Green D, Unroe KT. Feeling Heard and Understood: A Patient-Reported Quality Measure for the Inpatient Palliative Care Setting. J Pain Symptom Manage. 2016 Feb;51(2):150-4. doi: 10.1016/j.jpainsymman.2015.10.018. Epub 2015 Nov 17. PMID: 26596879.
Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months	Change from baseline ACP engagement at three months	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.
Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months	Change from baseline ACP engagement at six months	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.
Participant-reported Completion of Advance Care Planning (ACP) Conversations	At 1, 3, and 6 months	Participants are asked if they had completed ACP conversations with their loved ones and clinicians.