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

March 3, 2023 updated by: Wake Forest University Health Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Bermuda Run, North Carolina, United States, 27006
        • Geriatric Medicine-Plaza 1 Davie
      • Conover, North Carolina, United States, 28613
        • Wake Forest Health Network Family Medicine Conover
      • High Point, North Carolina, United States, 27265
        • WFHN Family Medicine-Premier
      • Jamestown, North Carolina, United States, 27282
        • Wake Forest Health Network Internal Medicine
      • Kernersville, North Carolina, United States, 27262
        • WFBIK Geriatric Medicine-Kernersville
      • Thomasville, North Carolina, United States, 27360
        • WFHN Family Medicine-Thomasville
      • Winston-Salem, North Carolina, United States, 27157
        • Geriatric Medicine- Sticht Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Telehealth visit
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.
Behavioral: Telehealth visit
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Month 9
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.
month 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
month 9
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).
month 9
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.
month 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2021

Primary Completion (Actual)

May 9, 2022

Study Completion (Actual)

May 9, 2022

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Estimate)

March 7, 2023

Last Update Submitted That Met QC Criteria

March 3, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00074429
  • U54AG063546 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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