Back to resultsA Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (ACP)
Primary Purpose
Advance Care Planning, Telemedicine, Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth visit
Sponsored by
About this trial
This is an interventional supportive care trial for Advance Care Planning focused on measuring Dementia, telehealth, Advance Care Planning, Mild Cognitive Impairment
Eligibility Criteria
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
Sites / Locations
- Geriatric Medicine-Plaza 1 Davie
- Wake Forest Health Network Family Medicine Conover
- WFHN Family Medicine-Premier
- Wake Forest Health Network Internal Medicine
- WFBIK Geriatric Medicine-Kernersville
- WFHN Family Medicine-Thomasville
- Geriatric Medicine- Sticht Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Telehealth visit
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Patient/Care Partner Agreeing to Participate
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
Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.
Secondary Outcome Measures
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.
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).
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.
Full Information
NCT ID
NCT04912245
First Posted
May 28, 2021
Last Updated
March 3, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04912245
Brief Title
A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia
Acronym
ACP
Official Title
A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (Tele Voice)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 13, 2021 (Actual)
Primary Completion Date
May 9, 2022 (Actual)
Study Completion Date
May 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advance Care Planning, Telemedicine, Mild Cognitive Impairment, Unrecognized Dementia, Dementia
Keywords
Dementia, telehealth, Advance Care Planning, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telehealth visit
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth visit
Intervention Description
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 Measure Information:
Title
Number of Patient/Care Partner Agreeing to Participate
Description
Study will measure the amount of patient or patient-care partner dyads who agree to participate.
Time Frame
Baseline to Month 9
Title
Number of Participants With Telehealth Advance Care Planning (ACP) Completed
Description
Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.
Time Frame
month 9
Secondary Outcome Measure Information:
Title
Number of Participants With One or More Advance Care Planning (ACP) Discussions
Description
Study will measure the number of ACP discussions documented in the electronic health record.
Time Frame
month 9
Title
Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes
Description
Study will measure the usage of ACP billing codes (99497 and 99498).
Time Frame
month 9
Title
Quality of Advance Care Planning (ACP) Discussion Scores
Description
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.
Time Frame
month 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Gabbard, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geriatric Medicine-Plaza 1 Davie
City
Bermuda Run
State/Province
North Carolina
ZIP/Postal Code
27006
Country
United States
Facility Name
Wake Forest Health Network Family Medicine Conover
City
Conover
State/Province
North Carolina
ZIP/Postal Code
28613
Country
United States
Facility Name
WFHN Family Medicine-Premier
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27265
Country
United States
Facility Name
Wake Forest Health Network Internal Medicine
City
Jamestown
State/Province
North Carolina
ZIP/Postal Code
27282
Country
United States
Facility Name
WFBIK Geriatric Medicine-Kernersville
City
Kernersville
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
WFHN Family Medicine-Thomasville
City
Thomasville
State/Province
North Carolina
ZIP/Postal Code
27360
Country
United States
Facility Name
Geriatric Medicine- Sticht Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.sykes.com/reports/2020-telehealth-survey/
Description
Telehealth Survey
URL
https://doi.org/10.26419/res.00269.001
Description
2019 Tech Trends and the 50+
URL
https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
Description
Centers for Medicare & Medicaid (2020) Medicare Telemedicine Health Care Provider Fact Sheet
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A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia
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