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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

300 participants

Primary outcome timeframe

Up to month 6

Results posted on

2026-08-31

Participant Flow

Participant milestones

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

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

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 6

Population: 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

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 6

In 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

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 intervention

Population: 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

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 intervention

Population: 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

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 intervention

Population: 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

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 period

Data 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 period

High-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 period

Data 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 period

Data 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 period

Data 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 period

Defined 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 period

Defined 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 period

Data 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 period

17 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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Standard of Care

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

Erica Lawrence

Atrium Health Wake Forest Baptist

Phone: 336.713.8531

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place