Advance Care Planning in the Emergency Department

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

An Advance Care Planning Intervention in the Emergency Department: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209880
• Other study ID #: 2021P003093
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: Brigham and Women's Hospital
• Contact: Kei Ouchi, MD, MPH
• Phone: 6177325640
• Email: kei_ouchi[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease Requiring Chronic Dialysis
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Emergencies
• Heart Failure
• Kidney Diseases
• Lung Diseases, Obstructive
• Metastatic Cancer
• Pulmonary Disease, Chronic Obstructive
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• ED GOAL
The emergency department clinician-led, behavioral intervention (ED GOAL) is designed to engage seriously ill yet clinically stable older adults in the emergency department to address their values and preferences towards end-of-life care with their outpatient clinicians. The intervention consists of an interview to discuss participants' values and preferences for end-of-life care. The participants will receive coaching on how to initiate/re-introduce discussions about end-of-life wishes with their loved ones and outpatient clinicians. The participants' outpatient clinicians will also receive a summary of what participants disclosed via email or mailed letter.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in advance care planning (ACP) engagement with clinicians 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.	Change from baseline ACP engagement at one month
Secondary	Feeling heard and understood survey	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.	Baseline & 1, 3, and 6 months
Secondary	Quality of communication survey	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.	Baseline & at 1, 3, and 6 months
Secondary	Healthcare utilization	Electronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.	At 6 and 12 months before and 1, 6, 12 months after enrollment
Secondary	Mortality	The electronic medical records will be reviewed to find the patients' vital status.	At 1, 3, and 6 months
Secondary	Qualitative benefits and obstacles of advance care planning (ACP) conversations after ED GOAL	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.	At 1, 3, and/or 6 months
Secondary	Electronic medical record documentation of advance care planning (ACP) conversations	The electronic medical record will be reviewed to find clinician documentation of ACP conversations.	At 1, 3, and 6 months
Secondary	Change in advance care planning (ACP) engagement with clinicians 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 from baseline ACP engagement at three months
Secondary	Change in advance care planning (ACP) engagement with clinicians 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.	Change from baseline ACP engagement at six months
Secondary	Participant-reported completion of advance care planning (ACP) conversations	Participants are asked if they had completed ACP conversations with their loved ones and clinicians.	At 1, 3, and 6 months

External Links

•   National Institutes of Health study record