A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia
NCT ID: NCT04912245
Last Updated: 2023-03-07
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
152 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-13
Study Completion Date
2022-05-09
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Advance Care Planning
Telemedicine
Mild Cognitive Impairment
Unrecognized Dementia
Dementia
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
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.
Primary Study Purpose
SUPPORTIVE_CARE
Blinding Strategy
NONE
Study Groups
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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.
Group Type
OTHER
Telehealth visit
Intervention Type
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.
Interventions
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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.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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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
* 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
* No phone number available for patient.
* Lives in a long-term care facility
Minimum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
Sponsor Role
collaborator
Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jennifer Gabbard, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Geriatric Medicine-Plaza 1 Davie
Bermuda Run, North Carolina, United States
Site Status
Wake Forest Health Network Family Medicine Conover
Conover, North Carolina, United States
Site Status
WFHN Family Medicine-Premier
High Point, North Carolina, United States
Site Status
Wake Forest Health Network Internal Medicine
Jamestown, North Carolina, United States
Site Status
WFBIK Geriatric Medicine-Kernersville
Kernersville, North Carolina, United States
Site Status
WFHN Family Medicine-Thomasville
Thomasville, North Carolina, United States
Site Status
Geriatric Medicine- Sticht Center
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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https://www.sykes.com/reports/2020-telehealth-survey/
Telehealth Survey
https://doi.org/10.26419/res.00269.001
2019 Tech Trends and the 50+
https://www.cms.gov/newsroom/fact-sheets/medicare-telemedicine-health-care-provider-fact-sheet
Centers for Medicare \& Medicaid (2020) Medicare Telemedicine Health Care Provider Fact Sheet
Other Identifiers
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IRB00074429
Identifier Type: -
Identifier Source: org_study_id
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