Trial Outcomes & Findings for ENgaging in Advance Care Planning Talks Group Visit Intervention (NCT NCT03141242)
NCT ID: NCT03141242
Last Updated: 2021-07-16
Results Overview
An MDPOA form is in electronic medical chart or an orally appointed decision maker
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
0, 6 months
Results posted on
2021-07-16
Participant Flow
Participant milestones
| Measure |
ENACT Group Visit
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
Received Allocated Intervenion
|
44
|
55
|
|
Overall Study
6 Month Interview
|
51
|
49
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENgaging in Advance Care Planning Talks Group Visit Intervention
Baseline characteristics by cohort
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Education Level
Some college
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Continuous
|
77.4 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
77.2 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
77.3 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
106 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 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
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
55 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Relationship Status
Married/partnered
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Relationship Status
Widowed
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Relationship Status
Divorced or separated
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Relationship Status
Single
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Education Level
High school graduate
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education Level
College graduate
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Education Level
Postgraduate or professional education
|
32 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Insurance Type
Medicare
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Insurance Type
Medicare Supplement
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Insurance Type
Medicaid
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Insurance Type
Tricare
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Insurance Type
Other
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Caregiver in the last 12 months
Yes
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Caregiver in the last 12 months
No
|
43 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Self-rated quality of life
Excellent
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Self-rated quality of life
Fair
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Self-rated quality of life
Good
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Self-rated quality of life
Poor
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
ACP documentation in EHR at baseline
Yes
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
ACP documentation in EHR at baseline
No
|
31 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Self-report of memory concerns
|
24 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 6 monthsAn MDPOA form is in electronic medical chart or an orally appointed decision maker
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Presence of Medical Decision-maker Documentation in the EHR
0 Months
|
41 participants
|
38 participants
|
|
Presence of Medical Decision-maker Documentation in the EHR
6 Months
|
51 participants
|
40 participants
|
PRIMARY outcome
Timeframe: 0 and 6 monthsPresence of any advance directive document in the EHR (e.g., MDPOA, living will, Colorado MOST form)
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Presence of Advance Directive in the EHR
Advance directive in EHR at 0 months
|
24 Participants
|
22 Participants
|
|
Presence of Advance Directive in the EHR
Advance directive in EHR at 6 months
|
39 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 0, 3, 6, 12 monthsAny advance directive is present in the medical chart
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Change in Advance Directive in Medical Record
3 Months
|
38 participants
|
24 participants
|
|
Change in Advance Directive in Medical Record
0 Months
|
24 participants
|
22 participants
|
|
Change in Advance Directive in Medical Record
6 Months
|
39 participants
|
25 participants
|
|
Change in Advance Directive in Medical Record
12 Months
|
42 participants
|
28 participants
|
SECONDARY outcome
Timeframe: 0, 6 monthsThe Advance Care Planning (ACP) Engagement Scale will be used to assess readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing). Items are rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate a higher level of engagement with the advance care planning behavior and a better outcome.
Outcome measures
| Measure |
ENACT Group Visit
n=51 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=49 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Change in Readiness to Engage in ACP (ACP Engagement Score)
|
4.56 units on a scale
Standard Deviation .4
|
4.13 units on a scale
Standard Deviation .4
|
SECONDARY outcome
Timeframe: 0, 6 monthsPatient response to the question "How ready are you to sign official papers naming a medical decision maker to make medical decisions for you?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.
Outcome measures
| Measure |
ENACT Group Visit
n=51 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=49 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Change in Readiness to Chose a Surrogate Decision Maker
0 months
|
4.49 units on a scale
Standard Deviation 0.9
|
4.25 units on a scale
Standard Deviation 1.2
|
|
Change in Readiness to Chose a Surrogate Decision Maker
6 months
|
4.8 units on a scale
Standard Deviation 0.7
|
4.39 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 0, 6 monthsPatient response to the question "How ready are you to talk with your decision maker about what kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome."
Outcome measures
| Measure |
ENACT Group Visit
n=51 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=49 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker
0 months
|
4.65 units on a scale
Standard Deviation 0.8
|
4.25 units on a scale
Standard Deviation 1.1
|
|
Change in Readiness to Discuss Values and Care Preferences With Surrogate Decision Maker
6 months
|
4.74 units on a scale
Standard Deviation 0.8
|
4.28 units on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 0 and 6 monthsPatient response to the question "How ready are you to talk to your doctor about the kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Readiness to Talk to Patient's Physician About Future Medical Care
0 months
|
3.47 units on a scale
Standard Deviation 1.1
|
3.47 units on a scale
Standard Deviation 1.3
|
|
Readiness to Talk to Patient's Physician About Future Medical Care
6 months
|
3.99 units on a scale
Standard Deviation 1.2
|
3.59 units on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 0 and 6 monthsPatient response to the question "How ready are you to sign official papers putting your wishes in writing about the kind of medical care you would want if you were very sick or near the end of life?". Responses were rated on a Likert scale, with possible scores ranging from 1-5. Higher scores indicate more readiness and a better outcome.
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Readiness to Sign Official Papers About Medical Care
0 months
|
4.24 units on a scale
Standard Deviation 1.0
|
4.04 units on a scale
Standard Deviation 1.1
|
|
Readiness to Sign Official Papers About Medical Care
6 months
|
4.69 units on a scale
Standard Deviation 0.9
|
4.26 units on a scale
Standard Deviation 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 monthsPercent of individuals who participate of eligible patients, by clinic-based screening
Outcome measures
| Measure |
ENACT Group Visit
n=835 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Percent of Recruitment (Reach)
|
110 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Enrollment thru 6 month follow upPercent of individuals who complete the intervention and the 6 month follow up
Outcome measures
| Measure |
ENACT Group Visit
n=55 Participants
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 Participants
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Percent of Retention
|
51 Participants
|
49 Participants
|
Adverse Events
ENACT Group Visit
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Mailed Resources
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ENACT Group Visit
n=55 participants at risk
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
ENACT group visit: Participation in two 2 hour group visits about advance care planning.
|
Mailed Resources
n=55 participants at risk
Participants will receive printed advance care planning resources by mail.
Mailed Resources: Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
|
|---|---|---|
|
Psychiatric disorders
Psychological Distress
|
1.8%
1/55 • Number of events 1 • 6 months
(Same as Clinical trials.gov) Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
0.00%
0/55 • 6 months
(Same as Clinical trials.gov) Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place