Advanced Care PlanningPortal-VoiceNCT06509373
A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment
A study testing Advance Care Planning Tool - ACPVoice in people with Advanced Care Planning, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and documentation in persons living with cognitive impairment in outpatient primary care. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Advanced Care Planning
- What is being tested?
- Advance Care Planning Tool - ACPVoice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 27 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years old and older
- Diagnosis of recognized or probable mild cognitive impairment or mild dementia or elevated eRADAR score
- Completed visit with their primary care provider (PCP) within the past 12 months and have upcoming PCP visit in next 6 months
- Have an active patient portal account
Who cannot join
- Lives in a long-term care facility
- Severe vision impairment/blindness (as they need to be able to read portal messages)
- Enrolled in hospice
- Lacks decisional capacity as deemed by PCP
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and documentation in persons living with cognitive impairment in outpatient primary care.
Read the detailed description
The goal of this study is to explore whether sending a portal-based ACP tool (called ACPVoice) paired with a motivational message within the patient portal before a routine primary care physician visit can improve ACP discussions and documentation within the electronic health record among persons living with cognitive impairment in outpatient primary care.
- Conditions
- Advanced Care Planning
- Being tested
- Advance Care Planning Tool - ACPVoice, Standard of Care for Advance Care Planning
- Keywords
- Advance Care Planning, Mild Cognitive Impairment, Dementia, Patient Portal
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Care Planning Tool - ACPVoiceBehavioural
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 for Advance Care PlanningBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACPVoice Intervention | Experimental | 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. Receives: Behavioral: Advance Care Planning Tool - ACPVoice |
| Standard of Care | Active comparator | 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. Receives: Behavioral: Standard of Care for Advance Care Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement Rate
Percentage of participants who open the advance care planning tool (ACPVoice) mychart message
Measured: Up to month 6
Percentage of Intervention Completion
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.
Measured: Up to month 6
Secondary outcomes (3)
Advance Care Planning Documentation Rates by Primary Care Providers
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.
Measured: 12 months pre intervention, up to month 6 post intervention
Rate of Advance Care Planning Billing Code Usage
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.
Measured: 12 months pre intervention, up to month 6 post intervention
Rate of Documented Designated Surrogate Decision Maker
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.
Measured: 12 months pre intervention, month 6 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start19 Aug 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Care PlanningStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Gabbard, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509373
- Sponsor's protocol ID
- IRB00112143
- Other IDs
- 5K23AG070234-03
- Acronym
- Portal-Voice
- Status last verified
- Dec 2025
- First submitted
- 12 Jul 2024
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06509373
- Acronym / sponsor ID
- Portal-Voice / IRB00112143
- Conditions
- Advanced Care Planning
- Keywords
- Advance Care Planning, Mild Cognitive Impairment, Dementia, Patient Portal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 19 Jul 2024 (actual)
- Results
- Posted 31 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to examine the feasibility of using a patient portal based advance care planning (ACP) tool to improve ACP discussions and documentation in persons living with cognitive impairment in outpatient primary care.
Detailed description
The goal of this study is to explore whether sending a portal-based ACP tool (called ACPVoice) paired with a motivational message within the patient portal before a routine primary care physician visit can improve ACP discussions and documentation within the electronic health record among persons living with cognitive impairment in outpatient primary care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACPVoice Intervention | Experimental | Behavioral: Advance Care Planning Tool - ACPVoiceCommunity-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. |
| Standard of Care | Active comparator | Behavioral: Standard of Care for Advance Care PlanningCommunity-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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age 65 years old and older
- Diagnosis of recognized or probable mild cognitive impairment or mild dementia or elevated eRADAR score
- Completed visit with their primary care provider (PCP) within the past 12 months and have upcoming PCP visit in next 6 months
- Have an active patient portal account
Key exclusion criteria (4 listed)
- Lives in a long-term care facility
- Severe vision impairment/blindness (as they need to be able to read portal messages)
- Enrolled in hospice
- Lacks decisional capacity as deemed by PCP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advance Care Planning Tool - ACPVoiceEligible 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. | Behavioural | ACPVoice Intervention |
| Standard of Care for Advance Care PlanningPatients will have access to the standardized advance care planning questionnaires readily available already within their mychart account which is part of standard of care. | Behavioural | Standard of Care |
Primary outcome
Engagement Rate
Time frame: Up to month 6
Percentage of participants who open the advance care planning tool (ACPVoice) mychart message
Percentage of Intervention Completion
Time frame: 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.
3 secondary outcomes
Advance Care Planning Documentation Rates by Primary Care Providers
Time frame: 12 months pre intervention, up to month 6 post intervention
Rate of Advance Care Planning Billing Code Usage
Time frame: 12 months pre intervention, up to month 6 post intervention
Rate of Documented Designated Surrogate Decision Maker
Time frame: 12 months pre intervention, month 6 post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Gabbard, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Advance Care Planning Tool - ACPVoice in people with Advanced Care Planning, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement Rate (time frame: Up to month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.