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

NCT04912245 | Completed Results

• 2 other identifiers: IRB00074429U54AG063546
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Advance Care Planning; Telemedicine; Mild Cognitive Impairment; Unrecognized Dementia; Dementia

Keywords

Dementia; telehealth; Advance Care Planning; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

• Number of Patient/Care Partner Agreeing to Participate

  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

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

  month 9

Secondary Outcomes (3)

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

  month 9

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

  month 9

• Quality of Advance Care Planning (ACP) Discussion Scores

  month 9

Study Arms (1)

Telehealth visit

OTHER

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

Interventions

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.

Telehealth visit

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (7)

Geriatric Medicine-Plaza 1 Davie

Bermuda Run, North Carolina, 27006, United States

Location

Wake Forest Health Network Family Medicine Conover

Conover, North Carolina, 28613, United States

Location

WFHN Family Medicine-Premier

High Point, North Carolina, 27265, United States

Location

Wake Forest Health Network Internal Medicine

Jamestown, North Carolina, 27282, United States

Location

WFBIK Geriatric Medicine-Kernersville

Kernersville, North Carolina, 27262, United States

Location

WFHN Family Medicine-Thomasville

Thomasville, North Carolina, 27360, United States

Location

Geriatric Medicine- Sticht Center

Winston-Salem, North Carolina, 27157, United States

Location

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Related Links

• Telehealth Survey
• 2019 Tech Trends and the 50+
• Centers for Medicare \& Medicaid (2020) Medicare Telemedicine Health Care Provider Fact Sheet

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Tele Voice
• Organization: Wake Forest University Health Sciences

jgabbard@wakehealth.edu

336.716.8028

Study Officials

• Jennifer Gabbard, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pragmatic pilot study where 300 patients with either mild cognitive impairment (MCI) or unrecognized dementia and their care partner (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of their primary care team in hopes of enrolling 94 patients. Patients are still eligible to participate in the study even if a care partner/loved one does not attend the ACP visit with them or if the patient does not have a care partner.

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 3, 2021
• Study Start: July 13, 2021
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: March 7, 2023
• Results First Posted: March 7, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)