NCT06509373

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 19, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

February 27, 2026

Status Verified

December 1, 2025

Enrollment Period

10 months

First QC Date

July 12, 2024

Last Update Submit

February 25, 2026

Conditions

Keywords

Advance Care PlanningMild Cognitive ImpairmentDementiaPatient Portal

Outcome Measures

Primary Outcomes (2)

  • Reach/Engagement

    Percentage of participants who open the advance care planning tool (ACPVoice) mychart message

    6 months post intervention

  • Intervention Completion

    Percentage of participants who were sent the ACPVoice mychart message that complete the ACPVoice tool.

    6 months post intervention

Secondary Outcomes (6)

  • Advance Care Planning Documentation Rates by Primary Care Providers

    12 months pre intervention

  • Advance Care Planning Documentation Rates by Primary Care Providers

    6 months post intervention

  • Advance Care Planning Billing Code Usage

    12 months pre intervention

  • Advance Care Planning Billing Code Usage

    6 months post intervention

  • Documented Designated Surrogate Decision Maker

    12 months pre intervention

  • +1 more secondary outcomes

Other Outcomes (9)

  • Barrier to Adoption

    6 months during the implementation period and up to 6 months post the implementation period

  • Quality of Advance Care Planning Documentation

    6 months during the implementation period and up to 6 months post the implementation period

  • Participant Confidence related to PCP knowing what is important to them

    6 months during the implementation period and up to 6 months post the implementation period

  • +6 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Standard of Care for Advance Care Planning

Interventions

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.

ACPVoice Intervention

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.

Standard of Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementia

Interventions

Standard of CareAdvance Care Planning

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationPatient Care PlanningComprehensive Health CarePatient Care Management

Study Officials

  • Jennifer Gabbard, MD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2024

First Posted

July 19, 2024

Study Start

August 19, 2024

Primary Completion

June 27, 2025

Study Completion

December 10, 2025

Last Updated

February 27, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations