Trial Outcomes & Findings for A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment (NCT NCT06509373)
NCT ID: NCT06509373
Last Updated: 2026-08-31
Results Overview
Percentage of participants who open the advance care planning tool (ACPVoice) mychart message
COMPLETED
NA
300 participants
Up to month 6
2026-08-31
Participant Flow
Participant milestones
| Measure |
ACPVoice Intervention
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
138
|
150
|
|
Overall Study
NOT COMPLETED
|
12
|
0
|
Reasons for withdrawal
| Measure |
ACPVoice Intervention
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Overall Study
progression of dementia
|
2
|
0
|
|
Overall Study
transitioned to hospice
|
4
|
0
|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
reschedule PCP visit outside study window
|
2
|
0
|
Baseline Characteristics
A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment
Baseline characteristics by cohort
| Measure |
ACPVoice Intervention
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
80.53 years
STANDARD_DEVIATION 8.36 • n=14 Participants
|
81.65 years
STANDARD_DEVIATION 7.78 • n=36 Participants
|
81.09 years
STANDARD_DEVIATION 8.07 • n=324 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=14 Participants
|
97 Participants
n=36 Participants
|
185 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=14 Participants
|
53 Participants
n=36 Participants
|
115 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
149 Participants
n=14 Participants
|
148 Participants
n=36 Participants
|
297 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=14 Participants
|
39 Participants
n=36 Participants
|
52 Participants
n=324 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=14 Participants
|
109 Participants
n=36 Participants
|
244 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
PRIMARY outcome
Timeframe: Up to month 6Population: Standard of care participants had access to the usual Epic ACP tool but did not receive ACPVoice messaging or outreach.
Percentage of participants who open the advance care planning tool (ACPVoice) mychart message
Outcome measures
| Measure |
ACPVoice Intervention
n=138 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Engagement Rate
|
68.8 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Up to month 6In the ACPVoice arm, completion was defined as completion of the ACPVoice questionnaire following outreach through the patient portal and follow-up reminders. In the Standard of Care arm, completion was defined as completion of the standard Epic ACP questionnaire (ACP For My Care Team Questionnaire) available through the patient portal without additional prompting or outreach.
Outcome measures
| Measure |
ACPVoice Intervention
n=138 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Percentage of Intervention Completion
|
79 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 months pre intervention, up to month 6 post interventionPopulation: 12 participants in the ACPVoice arm did not complete the intervention
Number of participants with documentation of advance care planning within the electronic health record by primary care provider. Preintervention data collected from a chart review after participant enrolled in study.
Outcome measures
| Measure |
ACPVoice Intervention
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Advance Care Planning Documentation Rates by Primary Care Providers
12 months pre intervention
|
1 Participants
|
0 Participants
|
|
Advance Care Planning Documentation Rates by Primary Care Providers
6 months post intervention
|
70 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months pre intervention, up to month 6 post interventionPopulation: 12 participants in the ACPVoice arm did not complete the intervention
Number of participants with advance care planning billing code usage (CPT codes 99497, 99498; HCPCS codes 1123, 1124). Data collected from a chart review after participant enrolled in study.
Outcome measures
| Measure |
ACPVoice Intervention
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Rate of Advance Care Planning Billing Code Usage
12 months pre intervention
|
2 Participants
|
0 Participants
|
|
Rate of Advance Care Planning Billing Code Usage
6 months post intervention
|
42 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months pre intervention, month 6 post interventionPopulation: 12 participants in the ACPVoice arm did not complete the intervention
Number of participants with a documented designated surrogate decision maker in the electronic health record. Data collected from a chart review after participant enrolled in study.
Outcome measures
| Measure |
ACPVoice Intervention
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health , have a primary care physician at one of the participating sites, and have an active patient portal account.
Advance Care Planning Tool - ACPVoice: Eligible patients will be sent a secure MyChart message with a motivational message asking them to complete the advance care planning tool (ACPVoice) with their care partner/surrogate decision-maker or loved one before their upcoming primary care visit. The ACPVoice tool will be attached electronically to the mychart message. A reminder message will be sent to an non-responders with a different motivational message.
|
Standard of Care
n=150 Participants
Community-dwelling persons living with cognitive impairment aged 65 and older with known or probable mild cognitive impairment or dementia or elevated eRADAR score (with decision-making capacity), who are affiliated with the Atrium-Wake Forest Baptist Health, have a primary care physician within the Atrium-Wake Forest Baptist Health Network, and have an active patient portal account.
Standard of Care for Advance Care Planning: Patients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care.
|
|---|---|---|
|
Rate of Documented Designated Surrogate Decision Maker
12 months pre intervention
|
0 Participants
|
0 Participants
|
|
Rate of Documented Designated Surrogate Decision Maker
6 months post intervention
|
68 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodData will be collected via qualitative interviews with participants and providers.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodHigh-quality advance care planning documentation will be defined as addressing ≥4 of the 8 core components with 1 point assigned for each of the following questions related to: health-related goals, what matters most/most important in their life, health-related worries/concerns, named surrogate decision-maker, how much information they would like to know, unacceptable states at the end-of-life, goals if their health was to worsen, and questions about advance care planning forms. Score of 0-8 with 0 indicating no advance care planning questions answered to 8 indicating eight core advance care planning questions answered.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodData will be collected via a RedCap survey asking 5 questions: i. How confident are you your primary care clinician/team knows what is important to you?, ii. How confident are you that what is important to you will determine the medical care you receive in the future? , iii. To what extent did completing this care planning tool increase or decrease your sense of control over medical decisions?, iv. Before completing the care planning tool, did your primary care clinician/team ask what is important to you? , and v. After completing the care planning tool, did your primary care clinician/team ask what is important to you? .
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodData will be assessed via a RedCap survey with 4 questions: I felt heard and understood by this provider and team, I felt this provider and team put my best interests first when making recommendations about my care, I felt this provider and team saw me as a person, not just someone with a medical problem, I felt this provider and team understood what is important to me in my life.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodData will be measured using the Brief Digital Health Care Literacy Scale.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodDefined as the number of patients who complete the advance care planning tool (ACPVoice) over the telephone.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodDefined as the number of patients who were mailed and completed the advance care planning tool (ACPVoice) via mail.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months during the implementation period and up to 6 months post the implementation periodData will be collected via Redcap survey asking "How strongly do you agree or disagree that your current medical/treatment plan meets your preferences".
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months post implementation period17 multiple choice items regarding provider opinion on the interventions acceptability, appropriateness, feasibility and overall satisfaction. Total score range is 17-84 with a higher score indicating a more favorable opinion of the intervention.
Outcome measures
Outcome data not reported
Adverse Events
ACPVoice Intervention
Standard of Care
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