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OpenTrials
Completed

NCT Number: NCT04912245

A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia

The purpose of this study is to pilot test a telehealth Advance Care Planning (ACP) intervention among those with either mild cognitive impairment (MCI) or unrecognized dementia. Our goal is to pilot-test and evaluate a pragmatic Telehealth ACP intervention among patients with either the diagnosis of mild cognitive impairment (MCI) or unrecognized dementia.

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Key information

Conditions

Advance Care Planning Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Telemedicine Unrecognized Dementia

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Geriatric Medicine-Plaza 1 Davie, Bermuda Run, North Carolina, United States

Loading trial locations.

About this study

Telehealth has the potential to overcome barriers related to timing and travel restraints and to provide patients and their caregivers with an opportunity to discuss their goals, values, and priorities for their healthcare within their home setting. Recent studies have demonstrated patients' willingness to use telehealth and have shown that it can play an integral role in dementia care management.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of recognized or probable Mild cognitive impairment (MCI) or mild dementia determined by either ICD10 diagnostic codes or electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule (eRADAR)
  • Have decisional capacity according to their primary care physician (PCP) to complete ACP
  • Completed visit with their PCP within the past 12 months
  • Affiliated with an Accountable Care Organization.
  • English-speaking

Exclusion criteria

  • Moderate to severe hearing loss that would preclude participating in a video or telephone intervention
  • No phone number available for patient.
  • Lives in a long-term care facility

Treatment and study plan

Telehealth Visit

Behavioral

Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.

Primary outcomes

  1. Number of Patient/Care Partner Agreeing to Participate

    Time frame: Baseline to Month 9

    Study will measure the amount of patient or patient-care partner dyads who agree to participate.

  2. Number of Participants With Telehealth Advance Care Planning (ACP) Completed

    Time frame: month 9

    Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.

Secondary outcomes

  1. Number of Participants With One or More Advance Care Planning (ACP) Discussions

    Time frame: month 9

    Study will measure the number of ACP discussions documented in the electronic health record.

  2. Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes

    Time frame: month 9

    Study will measure the usage of ACP billing codes (99497 and 99498).

  3. Quality of Advance Care Planning (ACP) Discussion Scores

    Time frame: month 9

    Discussion quality will be operationalized using a scoring system derived from the ACP Wise documentation program. Score range of 0 (indicating no advance care planning questions answered) to 9 (indicating nine advance care planning questions answered). High-quality ACP discussions will be defined as addressing ≥4 out of 9 core components in the ACP discussion, with 1 point assigned if the following factors were addressed as part of the ACP discussion: Disease understanding, health-related goals, what matters most in their life, important milestones, health-related worries, named surrogate decision-maker, unacceptable states at the end-of-life (e.g. being in a coma, etc.), goals if their health was to worsen, and documentation of code status.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (Tele Voice)

Acronym: ACP

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2021
Registry last updated
Mar 7, 2023

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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