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

Not Applicable

Completed

• Conditions: Advance Care Planning; Dementia; Mild Cognitive Impairment; Unrecognized Dementia; Telemedicine
• Interventions: Behavioral: Telehealth visit

• Registration Number: NCT04912245
• Lead Sponsor: Wake Forest University Health Sciences

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.

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 Timeline

• Study First Submitted: 2021-05-28
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-03
• Study Start: 2021-07-13
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Status Verified: 2022-07
• Results First Submitted: 2022-11-16
• Results First Submitted QC: 2023-03-03
• Last Update Submitted: 2023-03-03
• Results First Posted: 2023-03-07
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telehealth visit	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.

Primary Outcome Measures

Name	Time	Method
Number of Patient/Care Partner Agreeing to Participate	Baseline to Month 9	Study will measure the amount of patient or patient-care partner dyads who agree to participate.
Number of Participants With Telehealth Advance Care Planning (ACP) Completed	month 9	Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With One or More Advance Care Planning (ACP) Discussions	month 9	Study will measure the number of ACP discussions documented in the electronic health record.
Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes	month 9	Study will measure the usage of ACP billing codes (99497 and 99498).
Quality of Advance Care Planning (ACP) Discussion Scores	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.

Trial Locations

Locations (7)

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

Wake Forest Health Network Family Medicine Conover; 🇺🇸 Conover, North Carolina, United States

WFHN Family Medicine-Premier; 🇺🇸 High Point, North Carolina, United States

Wake Forest Health Network Internal Medicine; 🇺🇸 Jamestown, North Carolina, United States

WFHN Family Medicine-Thomasville; 🇺🇸 Thomasville, North Carolina, United States

WFBIK Geriatric Medicine-Kernersville; 🇺🇸 Kernersville, North Carolina, United States

Geriatric Medicine- Sticht Center; 🇺🇸 Winston-Salem, North Carolina, United States