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Completed

NCT Number: NCT06509373

A Portal-based Advance Care Planning Intervention Among Community-Dwelling Persons Living With Cognitive Impairment

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.

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Key information

Conditions

Advanced Care Planning Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Advance Care Planning Tool - ACPVoice

Behavioral

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 Planning

Behavioral

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.

Primary outcomes

  1. Reach/Engagement

    Time frame: 6 months post intervention

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

  2. Intervention Completion

    Time frame: 6 months post intervention

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

Secondary outcomes

  1. Advance Care Planning Documentation Rates by Primary Care Providers

    Time frame: 12 months pre intervention

    Documentation of advance care planning within the electronic health record by primary care provider.

  2. Advance Care Planning Documentation Rates by Primary Care Providers

    Time frame: 6 months post intervention

    Documentation of advance care planning within the electronic health record by primary care provider.

  3. Advance Care Planning Billing Code Usage

    Time frame: 12 months pre intervention

    Advance care planning billing codes usages will be recorded.

  4. Advance Care Planning Billing Code Usage

    Time frame: 6 months post intervention

    Advance care planning billing codes usages will be recorded.

  5. Documented Designated Surrogate Decision Maker

    Time frame: 12 months pre intervention

    Measured by number of designated surrogate decision makers documented in the electronic health record.

  6. Documented Designated Surrogate Decision Maker

    Time frame: 6 months post intervention

    Measured by number of designated surrogate decision makers documented in the electronic health record.

Other outcomes

  1. Barrier to Adoption

    Time frame: 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.

  2. Quality of Advance Care Planning Documentation

    Time frame: 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.

  3. Participant Confidence related to PCP knowing what is important to them

    Time frame: 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? .

  4. Feeling Heard and Understood

    Time frame: 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.

  5. Digital Health Literacy

    Time frame: 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.

  6. Telephone Advance Care Planning Completion Rates

    Time frame: 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.

  7. Paper Advance Care Planning Documentation Rates

    Time frame: 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.

  8. Preference-concordant care

    Time frame: 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".

  9. Provider Survey Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: Portal-Voice

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 19, 2024
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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