Trial Outcomes & Findings for Advance Care Planning in the Emergency Department (NCT NCT05209880)

NCT ID: NCT05209880

Last Updated: 2025-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

141 participants

Primary outcome timeframe

Change from baseline ACP engagement at one month

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.	Control Arm No intervention will be conducted (standard of care).
1-Month Follow-up STARTED	70	71
1-Month Follow-up COMPLETED	58	56
1-Month Follow-up NOT COMPLETED	12	15
3-Month Follow-up STARTED	70	71
3-Month Follow-up COMPLETED	44	51
3-Month Follow-up NOT COMPLETED	26	20
6-Month Follow-up STARTED	70	71
6-Month Follow-up COMPLETED	35	40
6-Month Follow-up NOT COMPLETED	35	31

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Control Arm No intervention will be conducted (standard of care).
1-Month Follow-up Spoke with Doctor	5	5
1-Month Follow-up Lost to Follow-up	7	9
1-Month Follow-up Discontinued	0	1
3-Month Follow-up Spoke with Doctor	17	7
3-Month Follow-up Lost to Follow-up	8	10
3-Month Follow-up Discontinued	1	3
6-Month Follow-up Spoke with Doctor	25	14
6-Month Follow-up Lost to Follow-up	9	14
6-Month Follow-up Discontinued	1	3

Baseline Characteristics

Advance Care Planning in the Emergency Department

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention Arm n=70 Participants 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. 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.	Control Arm n=71 Participants No intervention will be conducted (standard of care).	Total n=141 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants	71 participants n=7 Participants	141 participants n=5 Participants
Serious Illness Solid tumor cancer with metastases or recent hospitalization	39 Participants n=5 Participants	46 Participants n=7 Participants	85 Participants n=5 Participants
Serious Illness COPD on home oxygen or recent hospitalization	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Serious Illness CHF (NYHA Class III/IV) or recent hospitalization	16 Participants n=5 Participants	13 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous Mean (SD)	65.6 years STANDARD_DEVIATION 8.70 • n=5 Participants	67.8 years STANDARD_DEVIATION 9.62 • n=7 Participants	66.7 years STANDARD_DEVIATION 9.21 • n=5 Participants
Age, Customized Median [Min, Max]	66.0 years n=5 Participants	68.0 years n=7 Participants	66.0 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	38 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	33 Participants n=7 Participants	68 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants	70 Participants n=7 Participants	136 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	53 Participants n=7 Participants	103 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Serious Illness CKD on dialysis or recent hospitalization	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Serious Illness ED Clinician would not be surprised if patient died in the next 12 months	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline ACP engagement at one month

Population: Some participants did not complete the 1-month follow-up survey. Thus, the number analyzed is different at baseline compared to the 1-month mark.

Outcome measures

Outcome measures
Measure	Intervention Arm n=70 Participants 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. 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.	Control Arm n=71 Participants No intervention will be conducted (standard of care).
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month Baseline	2.84 score on a scale Standard Deviation 1.29	2.87 score on a scale Standard Deviation 1.40
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month 1-Month	3.37 score on a scale Standard Deviation 1.07	3.32 score on a scale Standard Deviation 1.28

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1, 3, and 6 months

The electronic medical records will be reviewed to find the patients' vital status.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1, 3, and 6 months

The electronic medical record will be reviewed to find clinician documentation of ACP conversations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline ACP engagement at three months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Change from baseline ACP engagement at six months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 1, 3, and 6 months

Participants are asked if they had completed ACP conversations with their loved ones and clinicians.

Outcome measures

Outcome data not reported

Adverse Events

Intervention Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Control Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kei Ouchi, MD, MPH

Brigham and Women's Hospital

Phone: 6175257771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place