Trial Outcomes & Findings for ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment (NCT NCT03711396)
NCT ID: NCT03711396
Last Updated: 2021-11-22
Results Overview
The 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.
COMPLETED
NA
26 participants
0, 3 months
2021-11-22
Participant Flow
Participant milestones
| Measure |
Advance Care Planning Group Visits - aMCI
Participants with amnestic mild cognitive impairment (aMCI) will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.
|
Advance Care Planning Group Visits - Care Partners
Participants who are the care partners of persons with amnestic mild cognitive impairment (aMCI) will attend group visits (with the person with aMCI) to discuss advance care planning with their study partners. Group visits will last up to two hours and be held up to twice.
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|---|---|---|
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Overall Study
STARTED
|
13
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13
|
|
Overall Study
COMPLETED
|
13
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENgaging in Advance Care Planning Talks Group Visit Intervention for Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Intervention
n=13 Participants
Participants attended two group visits one month apart to discuss advance care planning and to receive information about advance care planning.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
78.7 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
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Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
|
Education
High School Graduate
|
3 Participants
n=5 Participants
|
|
Education
Some College
|
1 Participants
n=5 Participants
|
|
Education
College Graduate
|
2 Participants
n=5 Participants
|
|
Education
Any Post-graduate
|
7 Participants
n=5 Participants
|
|
Relationship status
Married/with partner
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10 Participants
n=5 Participants
|
|
Relationship status
Widowed
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1 Participants
n=5 Participants
|
|
Relationship status
Divorced/separated
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2 Participants
n=5 Participants
|
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Caregiver in the last 12 months
Yes
|
2 Participants
n=5 Participants
|
|
Caregiver in the last 12 months
No
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11 Participants
n=5 Participants
|
|
Self-Rated Health
Excellent
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8 Participants
n=5 Participants
|
|
Self-Rated Health
Good
|
3 Participants
n=5 Participants
|
|
Self-Rated Health
Fair
|
2 Participants
n=5 Participants
|
|
Self-Rated Health
Poor
|
0 Participants
n=5 Participants
|
|
Self-Rated Health
Very Poor
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0 Participants
n=5 Participants
|
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Relationship of Study Partner to Participant
Spouse
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9 Participants
n=5 Participants
|
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Relationship of Study Partner to Participant
Partner
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1 Participants
n=5 Participants
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Relationship of Study Partner to Participant
Child
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 0, 3 monthsPopulation: Participants with aMCI
The 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 |
Advance Care Planning Group Visits - Persons With aMCI
n=13 Participants
Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
|
Advance Care Planning Group Visits - Care Partners
Care partners of persons with amnestic Mild Cognitive Impairment who participated in the advance care planning group visits.
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|---|---|---|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to sign official papers naming a medical decision maker at 0 months
|
1.92 units on a scale
Standard Deviation 1.12
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to talk to decision maker at 0 months
|
1.54 units on a scale
Standard Deviation 0.88
|
—
|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to talk to doctor at 0 months
|
2.77 units on a scale
Standard Deviation 1.36
|
—
|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to sign papers putting wishes into writing at 0 months
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2.00 units on a scale
Standard Deviation 1.15
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—
|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to sign official papers naming a medical decision maker at 3 months
|
1.77 units on a scale
Standard Deviation 0.93
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to talk to decision maker at 3 months
|
2.38 units on a scale
Standard Deviation 0.96
|
—
|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to talk to doctor at 3 months
|
2.00 units on a scale
Standard Deviation 0.91
|
—
|
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Change in Readiness to Engage in ACP (ACP Engagement Scale)
Readiness to sign papers putting wishes into writing at 3 months
|
2.08 units on a scale
Standard Deviation 1.16
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—
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SECONDARY outcome
Timeframe: 0, 3 monthsPopulation: Care partners of persons with aMCI
Care partner report of the Advance Care Planning (ACP) Engagement Scale will be used to assess care partner perspectives on the person with amnestic mild cognitive impairment's 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 |
Advance Care Planning Group Visits - Persons With aMCI
n=13 Participants
Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
|
Advance Care Planning Group Visits - Care Partners
Care partners of persons with amnestic Mild Cognitive Impairment who participated in the advance care planning group visits.
|
|---|---|---|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to sign official papers naming a medical decision maker at 0 months
|
1.92 units on a scale
Standard Deviation 1.19
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to talk to decision maker at 0 months
|
2.31 units on a scale
Standard Deviation 1.25
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to talk to doctor at 0 months
|
2.62 units on a scale
Standard Deviation 0.96
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to sign papers putting wishes into writing at 0 months
|
1.62 units on a scale
Standard Deviation 0.77
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to sign official papers naming a medical decision maker at 3 months
|
1.69 units on a scale
Standard Deviation 1.11
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to talk to decision maker at 3 months
|
2.54 units on a scale
Standard Deviation 0.88
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to talk to doctor at 3 months
|
1.77 units on a scale
Standard Deviation .93
|
—
|
|
Change in Readiness to Engage in ACP (ACP Engagement Score) - Care Partner Reported
Readiness to sign papers putting wishes into writing at 3 months
|
1.92 units on a scale
Standard Deviation 0.95
|
—
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OTHER_PRE_SPECIFIED outcome
Timeframe: Following Session Participation, 15 minutes after completedPopulation: Combined persons with aMCI and care partners groups
Investigator-developed 7-item evaluation to assess participant rating of intervention comfort in the group setting, usefulness, preference compared to one-on-one visits, and helpfulness of talking with others. Each item is rated from "strong disagree" to "strongly agree" on a 5-point Likert scale. Scores can range from 1-5 with a score of 5 being a better outcome. This scale has not been specifically named. It has been published in the included reference.
Outcome measures
| Measure |
Advance Care Planning Group Visits - Persons With aMCI
n=13 Participants
Participants with amnestic Mild Cognitive Impairment will attend group visits to discuss advance care planning with their study partners. Group visits will last up to two hours and be help up to twice.
|
Advance Care Planning Group Visits - Care Partners
n=13 Participants
Care partners of persons with amnestic Mild Cognitive Impairment who participated in the advance care planning group visits.
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|---|---|---|
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Advance Care Planning Intervention Evaluation
Group setting is better for ACP discussion than normal doctor visit
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4.23 score on a scale
Standard Deviation 1.09
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4.69 score on a scale
Standard Deviation 0.48
|
|
Advance Care Planning Intervention Evaluation
The group discussion gave me useful information
|
4.62 score on a scale
Standard Deviation 0.51
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5.00 score on a scale
Standard Deviation 0.00
|
|
Advance Care Planning Intervention Evaluation
I felt comfortable talking about ACP in the group setting
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4.54 score on a scale
Standard Deviation 0.66
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4.92 score on a scale
Standard Deviation 0.28
|
|
Advance Care Planning Intervention Evaluation
Talking with other people about ACP was helpful
|
4.23 score on a scale
Standard Deviation 1.36
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5.00 score on a scale
Standard Deviation 0.00
|
|
Advance Care Planning Intervention Evaluation
I feel the group visit addressed my specific questions
|
4.31 score on a scale
Standard Deviation 0.75
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4.46 score on a scale
Standard Deviation 0.66
|
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Advance Care Planning Intervention Evaluation
I feel able to discuss ACP with my regular healthcare provider
|
4.62 score on a scale
Standard Deviation 0.51
|
4.38 score on a scale
Standard Deviation 0.65
|
|
Advance Care Planning Intervention Evaluation
I would recommend these group visit sessions to a friend
|
4.38 score on a scale
Standard Deviation 1.45
|
4.92 score on a scale
Standard Deviation 0.28
|
Adverse Events
Advance Care Planning Group Visits
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Hillary D. Lum
University of Colorado School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place