Trial Outcomes & Findings for Advance Care Planning in the Emergency Department (NCT NCT05209880)
NCT ID: NCT05209880
Last Updated: 2026-03-13
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
NA
Target enrollment
141 participants
Primary outcome timeframe
Change from baseline ACP engagement at one month
Results posted on
2026-03-13
Participant Flow
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
| 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
| 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
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
35 Participants
n=41 Participants
|
38 Participants
n=39 Participants
|
73 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=41 Participants
|
33 Participants
n=39 Participants
|
68 Participants
n=80 Participants
|
|
Age, Continuous
Mean (SD)
|
65.6 years
STANDARD_DEVIATION 8.70 • n=41 Participants
|
67.8 years
STANDARD_DEVIATION 9.62 • n=39 Participants
|
66.7 years
STANDARD_DEVIATION 9.21 • n=80 Participants
|
|
Age, Customized
Median [Min, Max]
|
66.0 years
n=41 Participants
|
68.0 years
n=39 Participants
|
66.0 years
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=41 Participants
|
1 Participants
n=39 Participants
|
5 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
66 Participants
n=41 Participants
|
70 Participants
n=39 Participants
|
136 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
6 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=41 Participants
|
15 Participants
n=39 Participants
|
30 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=41 Participants
|
53 Participants
n=39 Participants
|
103 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
0 Participants
n=39 Participants
|
2 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=41 Participants
|
71 participants
n=39 Participants
|
141 participants
n=80 Participants
|
|
Serious Illness
Solid tumor cancer with metastases or recent hospitalization
|
39 Participants
n=41 Participants
|
46 Participants
n=39 Participants
|
85 Participants
n=80 Participants
|
|
Serious Illness
COPD on home oxygen or recent hospitalization
|
3 Participants
n=41 Participants
|
5 Participants
n=39 Participants
|
8 Participants
n=80 Participants
|
|
Serious Illness
CHF (NYHA Class III/IV) or recent hospitalization
|
16 Participants
n=41 Participants
|
13 Participants
n=39 Participants
|
29 Participants
n=80 Participants
|
|
Serious Illness
CKD on dialysis or recent hospitalization
|
10 Participants
n=41 Participants
|
4 Participants
n=39 Participants
|
14 Participants
n=80 Participants
|
|
Serious Illness
ED Clinician would not be surprised if patient died in the next 12 months
|
2 Participants
n=41 Participants
|
3 Participants
n=39 Participants
|
5 Participants
n=80 Participants
|
PRIMARY outcome
Timeframe: Change from baseline ACP engagement at one monthPopulation: 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.
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.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
Baseline
|
2.87 score on a scale
Standard Deviation 1.40
|
2.84 score on a scale
Standard Deviation 1.29
|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at One Month
1-Month
|
3.32 score on a scale
Standard Deviation 1.28
|
3.37 score on a scale
Standard Deviation 1.07
|
SECONDARY outcome
Timeframe: 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.Population: The number analyzed at follow-up differs from the overall number as not all participants completed the follow-up 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.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Feeling Heard and Understood Survey
Baseline · Not at all
|
6 Participants
|
7 Participants
|
|
Feeling Heard and Understood Survey
Baseline · Slightly
|
6 Participants
|
4 Participants
|
|
Feeling Heard and Understood Survey
Baseline · Moderately
|
12 Participants
|
12 Participants
|
|
Feeling Heard and Understood Survey
Baseline · Quite a bit
|
15 Participants
|
17 Participants
|
|
Feeling Heard and Understood Survey
Baseline · Completely
|
32 Participants
|
30 Participants
|
|
Feeling Heard and Understood Survey
Follow-up · Not at all
|
4 Participants
|
5 Participants
|
|
Feeling Heard and Understood Survey
Follow-up · Slightly
|
3 Participants
|
1 Participants
|
|
Feeling Heard and Understood Survey
Follow-up · Moderately
|
7 Participants
|
9 Participants
|
|
Feeling Heard and Understood Survey
Follow-up · Quite a bit
|
11 Participants
|
19 Participants
|
|
Feeling Heard and Understood Survey
Follow-up · Completely
|
27 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 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.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
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Quality of Communication Survey
How good is doctor at talking about your FEELINGS concerning the possibility you might get sicker?
|
8.53 score on a scale
Standard Deviation 1.80
|
8.80 score on a scale
Standard Deviation 1.81
|
|
Quality of Communication Survey
How good is doctor at talking about the DETAILS concerning the possibility you might get sicker?
|
8.61 score on a scale
Standard Deviation 1.87
|
8.65 score on a scale
Standard Deviation 1.54
|
|
Quality of Communication Survey
How good is your doctor at talking to you about HOW LONG you might have to live?
|
8.07 score on a scale
Standard Deviation 2.48
|
8.03 score on a scale
Standard Deviation 2.11
|
|
Quality of Communication Survey
How good is your doctor at talking with you about WHAT DYING MIGHT BE LIKE?
|
7.75 score on a scale
Standard Deviation 3.11
|
6.69 score on a scale
Standard Deviation 3.07
|
|
Quality of Communication Survey
How good is doctor at involving you in DECISIONS ABOUT TREATMENTS you want if you get too sick?
|
9.19 score on a scale
Standard Deviation 1.41
|
9.08 score on a scale
Standard Deviation 1.62
|
|
Quality of Communication Survey
How good is your doctor at asking about the things in life that are IMPORTANT TO YOU?
|
7.79 score on a scale
Standard Deviation 2.63
|
8.52 score on a scale
Standard Deviation 1.73
|
|
Quality of Communication Survey
How good is your doctor at asking about your SPIRITUAL OR RELIGIOUS beliefs?
|
7.40 score on a scale
Standard Deviation 2.97
|
8.67 score on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: At 6 and 12 months before and 1, 6, 12 months after enrollmentElectronic medical records will be reviewed to find the number of urgent care visits, ED visits, hospitalizations, hospice visits, and outpatient visits.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Healthcare Utilization
Hospitalizations 1 Month After
|
0 visits
Interval 0.0 to 2.0
|
0 visits
Interval 0.0 to 2.0
|
|
Healthcare Utilization
Hospitalizations 6 Months After
|
0 visits
Interval 0.0 to 4.0
|
0 visits
Interval 0.0 to 4.0
|
|
Healthcare Utilization
Hospitalizations 12 Months After
|
1 visits
Interval 0.0 to 7.0
|
1 visits
Interval 0.0 to 7.0
|
|
Healthcare Utilization
Outpatient Visits 6 Months After
|
12 visits
Interval 0.0 to 80.0
|
12 visits
Interval 0.0 to 58.0
|
|
Healthcare Utilization
Outpatient Visits 12 Months After
|
21 visits
Interval 0.0 to 122.0
|
19 visits
Interval 0.0 to 98.0
|
|
Healthcare Utilization
Urgent Care Visits 6 Months Prior
|
0 visits
Interval 0.0 to 3.0
|
0 visits
Interval 0.0 to 3.0
|
|
Healthcare Utilization
Urgent Care Visits 12 Months Prior
|
0 visits
Interval 0.0 to 4.0
|
0 visits
Interval 0.0 to 4.0
|
|
Healthcare Utilization
ED Visits 6 Months Prior
|
2 visits
Interval 1.0 to 7.0
|
2 visits
Interval 1.0 to 7.0
|
|
Healthcare Utilization
ED Visits 12 Months Prior
|
2 visits
Interval 1.0 to 9.0
|
2.5 visits
Interval 1.0 to 10.0
|
|
Healthcare Utilization
Hospitalizations 6 Months Prior
|
1 visits
Interval 0.0 to 5.0
|
1 visits
Interval 0.0 to 5.0
|
|
Healthcare Utilization
Hospitalizations 12 Months Prior
|
2 visits
Interval 0.0 to 11.0
|
2 visits
Interval 0.0 to 11.0
|
|
Healthcare Utilization
ED Visits 1 Month After
|
0 visits
Interval 0.0 to 3.0
|
0 visits
Interval 0.0 to 3.0
|
|
Healthcare Utilization
ED Visits 6 Months After
|
0 visits
Interval 0.0 to 7.0
|
0 visits
Interval 0.0 to 7.0
|
|
Healthcare Utilization
ED Visits 12 Months After
|
0 visits
Interval 0.0 to 10.0
|
1 visits
Interval 0.0 to 16.0
|
|
Healthcare Utilization
Outpatient Visits 1 Month After
|
2 visits
Interval 0.0 to 15.0
|
2 visits
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: At 1, 3, and 6 monthsThe electronic medical records will be reviewed to find the patients' vital status.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Mortality
1-Month
|
1 Participants
|
1 Participants
|
|
Mortality
6-Month
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and/or 6 monthsPopulation: Only participants from the intervention arm were included in the qualitative study because the purpose of the qualitative analysis was to explore participants' experiences and perceptions specific to the ED GOAL intervention. Participants in the control arm did not receive the intervention and therefore were not eligible for this portion of the study.
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
| Measure |
Control Arm
No intervention will be conducted (standard of care).
|
Intervention Arm
n=52 Participants
See intervention description above.
|
|---|---|---|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Raised awareness/clarity about wishes
|
—
|
16 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Learned about ACP
|
—
|
7 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Encouraged to take action
|
—
|
17 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Making wishes known
|
—
|
3 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No effect on attitudes toward ACP
|
—
|
15 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Spoke with clinician
|
—
|
17 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Spoke with family/loved ones
|
—
|
21 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No action taken towards ACP
|
—
|
16 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Medical Orders for Life-Sustaining Treatment (MOLST) completed
|
—
|
7 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Living will completed
|
—
|
9 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
HCP/Power of attorney completed
|
—
|
5 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Helped conversation with clinician
|
—
|
11 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Motivated to initiate conversation with clinician
|
—
|
6 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Clarified specific wishes through conversation with clinician
|
—
|
8 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No effect on conversation with clinician
|
—
|
7 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Would recommend others to have ACP conversation with clinician
|
—
|
24 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No opportunity to have a conversation with clinician
|
—
|
13 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
HCP aware, no need to tell clinician
|
—
|
2 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Not a priority to have a conversation with clinician
|
—
|
6 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Not sick enough to have a conversation with clinician
|
—
|
5 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Don't understand what ACP is to have a conversation with clinician
|
—
|
3 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Uncomfortable to have a conversation with clinician
|
—
|
1 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Lessened the burden on loved ones
|
—
|
2 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Prepared loved ones
|
—
|
4 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Helped conversation with love dones
|
—
|
12 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Clarified specific wishes through conversation with loved ones
|
—
|
14 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Motivated to initiate conversation with loved ones
|
—
|
16 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No effect on conversation with loved ones
|
—
|
9 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Would recommend others to have ACP conversation with loved ones
|
—
|
36 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Would not/maybe recommend others to have ACP conversation with loved ones
|
—
|
4 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No opportunity to have a conversation with loved ones
|
—
|
1 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Don't understand what ACP is to have a conversation with loved ones
|
—
|
2 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Not a priority to have a conversation with loved ones
|
—
|
2 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No one to talk with
|
—
|
2 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Family not ready to have a conversation
|
—
|
3 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Already had a conversation with loved ones
|
—
|
3 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Positive effect on attitudes towards crisis
|
—
|
33 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No effect on attitudes towards crisis
|
—
|
18 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Positive effect on end-of-life decision making
|
—
|
27 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
Negative effect on end-of-life decision making
|
—
|
1 Participants
|
|
Qualitative Benefits and Obstacles of Advance Care Planning (ACP) Conversations After ED GOAL
No effect on end-of-life decision making
|
—
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20 Participants
|
SECONDARY outcome
Timeframe: At 1, 3, and 6 monthsThe electronic medical record will be reviewed to find clinician documentation of ACP conversations.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
1-Month
|
5 Participants
|
10 Participants
|
|
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
Baseline
|
0 Participants
|
0 Participants
|
|
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
3-Month
|
7 Participants
|
17 Participants
|
|
Electronic Medical Record Documentation of Advance Care Planning (ACP) Conversations
6-Month
|
9 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Change from baseline ACP engagement at three monthsPopulation: Some participants did not complete the 3-month follow-up survey. Thus, the number analyzed is different at baseline compared to the 3-month mark.
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.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months
Baseline
|
2.87 score on a scale
Standard Deviation 1.40
|
2.84 score on a scale
Standard Deviation 1.29
|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at Three Months
3-Month
|
3.55 score on a scale
Standard Deviation 1.25
|
3.56 score on a scale
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Change from baseline ACP engagement at six monthsPopulation: Some participants did not complete the 6-month follow-up survey. Thus, the number analyzed is different at baseline compared to the 6-month mark.
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.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months
Baseline
|
2.87 score on a scale
Standard Deviation 1.40
|
2.84 score on a scale
Standard Deviation 1.29
|
|
Change in Advance Care Planning (ACP) Engagement With Clinicians at Six Months
6-Month
|
3.70 score on a scale
Standard Deviation 1.23
|
3.73 score on a scale
Standard Deviation 1.13
|
SECONDARY outcome
Timeframe: At 1, 3, and 6 monthsPopulation: Some participants did not complete the follow-up surveys.
Participants are asked if they had completed ACP conversations with their loved ones and clinicians.
Outcome measures
| Measure |
Control Arm
n=71 Participants
No intervention will be conducted (standard of care).
|
Intervention Arm
n=70 Participants
See intervention description above.
|
|---|---|---|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
6-Month · Have you talked to loved ones about medical care you would want if you were too sick to speak? (Yes)
|
27 Participants
|
30 Participants
|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
1-Month · Have you talked to doctor about medical care you would want if you were too sick to speak? (Yes)
|
5 Participants
|
12 Participants
|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
1-Month · Have you talked to loved ones about medical care you would want if you were too sick to speak? (Yes)
|
28 Participants
|
33 Participants
|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
3-Month · Have you talked to doctor about medical care you would want if you were too sick to speak? (Yes)
|
5 Participants
|
7 Participants
|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
3-Month · Have you talked to loved ones about medical care you would want if you were too sick to speak? (Yes)
|
37 Participants
|
33 Participants
|
|
Participant-reported Completion of Advance Care Planning (ACP) Conversations
6-Month · Have you talked to doctor about medical care you would want if you were too sick to speak? (Yes)
|
2 Participants
|
9 Participants
|
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place