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

Dementia Clinical Trial

— ACP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04912245
• Other study ID #: IRB00074429
• Secondary ID: U54AG063546
• Status: Completed
• Phase: N/A
• Start date: July 13, 2021
• Est. completion date: May 9, 2022

Study information

• Verified date: July 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advance Care Planning
• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Mild Cognitive Impairment
• Telemedicine

Intervention

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.

Locations

Country	Name	City	State
United States	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	WFBIK Geriatric Medicine-Kernersville	Kernersville	North Carolina
United States	WFHN Family Medicine-Thomasville	Thomasville	North Carolina
United States	Geriatric Medicine- Sticht Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (45)

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* Note: There are 45 references in all — Click here to view all references

Outcome

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

External Links

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