Trial Outcomes & Findings for Culturally Tailoring an Advance Care Planning Intervention for American Indians (NCT NCT05304117)
NCT ID: NCT05304117
Last Updated: 2025-07-03
Results Overview
The proportion of participants who self-report advance directive completion.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
155 participants
Primary outcome timeframe
Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)
Results posted on
2025-07-03
Participant Flow
Participant milestones
| Measure |
Advance Care Planning Experimental
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist
Waitlist Group- Baseline control measures will be collected at the same time as Cohort 1 completes their pretest. Six Months after Cohort 1, participants will be pretested again before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
|---|---|---|
|
Overall Study
STARTED
|
114
|
41
|
|
Overall Study
COMPLETED
|
105
|
41
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Culturally Tailoring an Advance Care Planning Intervention for American Indians
Baseline characteristics by cohort
| Measure |
Advance Care Planning Experimental
n=114 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist
n=41 Participants
Waitlist Group- Baseline control measures will be collected at the same time as Cohort 1 completes their pretest. Six Months after Cohort 1, participants will be pretested again before attending a Community Information Session on advance care planning and an one-on-one Sharing Session about Advance Care Planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Total
n=155 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
69 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Continuous
|
63.93 years
STANDARD_DEVIATION 16.7 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 13.8 • n=7 Participants
|
64.82 years
STANDARD_DEVIATION 15.37 • n=5 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
96 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 participants
n=5 Participants
|
41 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Advance Care Plans
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)The proportion of participants who self-report advance directive completion.
Outcome measures
| Measure |
Advance Care Planning Experimental (Cohort 1)
n=105 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist (Cohort 2)
n=41 Participants
Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention.
|
Advance Care Planning Experimental Cohort 2
Participants in this arm had a baseline survey and then were waitlisted for the intervention for approximately 3-6 months, and were given a post-test 5-8 months after the 1st baseline (8 weeks after intervention).
|
|---|---|---|---|
|
Count of Self-Report of Advance Directive
Baseline
|
10 Participants
|
5 Participants
|
—
|
|
Count of Self-Report of Advance Directive
Cohort 1-8 weeks after intervention; Cohort 2- 3-6 months after baseline but before intervention
|
67 Participants
|
6 Participants
|
—
|
|
Count of Self-Report of Advance Directive
Cohort 1- 6 months after intervention; Cohort 2- 8 weeks after intervention
|
67 Participants
|
29 Participants
|
—
|
PRIMARY outcome
Timeframe: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)The mean ACP Readiness scores range from 1-6, with higher scores indicating greater readiness.
Outcome measures
| Measure |
Advance Care Planning Experimental (Cohort 1)
n=91 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist (Cohort 2)
n=41 Participants
Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention.
|
Advance Care Planning Experimental Cohort 2
n=37 Participants
Participants in this arm had a baseline survey and then were waitlisted for the intervention for approximately 3-6 months, and were given a post-test 5-8 months after the 1st baseline (8 weeks after intervention).
|
|---|---|---|---|
|
Average Advance Care Planning -Engagement Readiness
Baseline
|
3.20 score on a scale
Standard Deviation 1.01
|
3.26 score on a scale
Standard Deviation 1.05
|
3.26 score on a scale
Standard Deviation 1.05
|
|
Average Advance Care Planning -Engagement Readiness
post-test
|
4.12 score on a scale
Standard Deviation 0.80
|
3.56 score on a scale
Standard Deviation 0.87
|
4.26 score on a scale
Standard Deviation 0.76
|
PRIMARY outcome
Timeframe: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)The mean ACP Self-Efficacy scores range from 1-6, with higher scores indicating greater self-efficacy. not at all, a little, somewhat, fairly, extremely Higher scores indicate better outcomes.
Outcome measures
| Measure |
Advance Care Planning Experimental (Cohort 1)
n=91 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist (Cohort 2)
n=41 Participants
Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention.
|
Advance Care Planning Experimental Cohort 2
n=37 Participants
Participants in this arm had a baseline survey and then were waitlisted for the intervention for approximately 3-6 months, and were given a post-test 5-8 months after the 1st baseline (8 weeks after intervention).
|
|---|---|---|---|
|
Average Advance Care Planning-Engagement Self-Efficacy
Baseline
|
4.33 score on a scale
Standard Deviation 0.93
|
4.28 score on a scale
Standard Deviation 0.99
|
4.28 score on a scale
Standard Deviation 0.99
|
|
Average Advance Care Planning-Engagement Self-Efficacy
8 weeks
|
5.29 score on a scale
Standard Deviation 0.85
|
4.84 score on a scale
Standard Deviation 0.87
|
5.56 score on a scale
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)The sum (0-8) ACP Barriers Score with higher scores indicating more barriers.
Outcome measures
| Measure |
Advance Care Planning Experimental (Cohort 1)
n=91 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist (Cohort 2)
n=41 Participants
Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention.
|
Advance Care Planning Experimental Cohort 2
n=37 Participants
Participants in this arm had a baseline survey and then were waitlisted for the intervention for approximately 3-6 months, and were given a post-test 5-8 months after the 1st baseline (8 weeks after intervention).
|
|---|---|---|---|
|
Average Number of Barriers to Advance Care Planning
Baseline
|
1.96 score on a scale
Standard Deviation 1.93
|
2.39 score on a scale
Standard Deviation 2.23
|
2.39 score on a scale
Standard Deviation 2.23
|
|
Average Number of Barriers to Advance Care Planning
Post-test
|
1.44 score on a scale
Standard Deviation 1.97
|
1.44 score on a scale
Standard Deviation 1.6
|
1.11 score on a scale
Standard Deviation 1.31
|
SECONDARY outcome
Timeframe: Cohort 1 Experimental: Baseline and Post-test (week 8); Cohort 2 Waitlist: Baseline 1 and Baseline 2 (3-6 months after baseline and immediately before intervention); Cohort 2 Experimental; Baseline 1 and post-test (5-8 months after 1st baseline)The sum (0-8) of ACP Facilitators Score , with higher scores indicating more facilitators.
Outcome measures
| Measure |
Advance Care Planning Experimental (Cohort 1)
n=91 Participants
Community Information Session on advance care planning and private one-on-one Sharing Session about advance care planning.
Advance Care Planning: Community Information Session and Private Sharing Session with trained social worker
|
Advance Care Planning Waitlist (Cohort 2)
n=41 Participants
Waitlist Group- Baseline control measures collected at consent, and again 3-6 months later before attending a Community Information Session on advance care planning and a one-on-one Sharing Session about Advance Care Planning. Data also collected 8 weeks post intervention.
|
Advance Care Planning Experimental Cohort 2
n=37 Participants
Participants in this arm had a baseline survey and then were waitlisted for the intervention for approximately 3-6 months, and were given a post-test 5-8 months after the 1st baseline (8 weeks after intervention).
|
|---|---|---|---|
|
Average Number of Facilitators for Advance Care Planning
Baseline
|
5.65 score on a scale
Standard Deviation 1.44
|
6.24 score on a scale
Standard Deviation 1.2
|
6.24 score on a scale
Standard Deviation 1.2
|
|
Average Number of Facilitators for Advance Care Planning
Post-test
|
6.52 score on a scale
Standard Deviation 1.43
|
5.95 score on a scale
Standard Deviation 1.55
|
5.19 score on a scale
Standard Deviation 1.27
|
Adverse Events
Advance Care Planning Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Advance Care Planning Waitlist
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 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