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Advance Care PlanningACPNCT04912245

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

A study testing Telehealth visit in people with Advance Care Planning and Telemedicine, run by Wake Forest University Health Sciences at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Telehealth visit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
7 sitesUnited States
Study dates
13 Jul 2021to 9 May 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Geriatric Medicine-Plaza 1 Davie

    Bermuda Run, North Carolina, 27006

  • Wake Forest Health Network Family Medicine Conover

    Conover, North Carolina, 28613

  • WFHN Family Medicine-Premier

    High Point, North Carolina, 27265

  • Wake Forest Health Network Internal Medicine

    Jamestown, North Carolina, 27282

  • WFBIK Geriatric Medicine-Kernersville

    Kernersville, North Carolina, 27262

  • WFHN Family Medicine-Thomasville

    Thomasville, North Carolina, 27360

  • Geriatric Medicine- Sticht Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Telehealth visit
Keywords
Dementia, telehealth, Advance Care Planning, Mild Cognitive Impairment
Medical subject headings
Cognitive Dysfunction, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telehealth visitBehavioural

    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.

Study groups in NCT04912245
Study groupRoleWhat they receive
Telehealth visitOtherPatients 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.
Receives: Behavioral: Telehealth visit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patient/Care Partner Agreeing to Participate

    Study will measure the amount of patient or patient-care partner dyads who agree to participate.

    Measured: Baseline to Month 9

  2. 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.

    Measured: month 9

Secondary outcomes (3)
  1. 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.

    Measured: month 9

  2. 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).

    Measured: month 9

  3. 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.

    Measured: month 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2021
  2. Study start13 Jul 2021
  3. Primary completion9 May 2022
  4. Study completion9 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04912245
Sponsor's protocol ID
IRB00074429
Other IDs
U54AG063546
Acronym
ACP
Status last verified
Jul 2022
First submitted
28 May 2021
Last updated
7 Mar 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ayton D, Gardam M, Ward S, Brodaty H, Pritchard E, Earnest A, Krysinska K, Banaszak-Holl J, McNeil J, Ahern S. How Can Quality of Dementia Care Be Measured? The Development of Clinical Quality Indicators for an Australian Pilot Dementia Registry. J Alzheimers Dis. 2020;75(3):923-936. doi: 10.3233/JAD-191044.

    PubMed 32390616
  • Harrison KL, Hunt LJ, Ritchie CS, Yaffe K. Dying With Dementia: Underrecognized and Stigmatized. J Am Geriatr Soc. 2019 Aug;67(8):1548-1551. doi: 10.1111/jgs.15895. Epub 2019 Mar 25. No abstract available.

    PubMed 30908605
  • Mantovani E, Zucchella C, Schena F, Romanelli MG, Venturelli M, Tamburin S. Towards a Redefinition of Cognitive Frailty. J Alzheimers Dis. 2020;76(3):831-843. doi: 10.3233/JAD-200137.

    PubMed 32568197
  • Sugimoto T, Ono R, Kimura A, Saji N, Niida S, Sakai T, Rakugi H, Toba K, Sakurai T. Impact of Cognitive Frailty on Activities of Daily Living, Cognitive Function, and Conversion to Dementia Among Memory Clinic Patients with Mild Cognitive Impairment. J Alzheimers Dis. 2020;76(3):895-903. doi: 10.3233/JAD-191135.

    PubMed 32568192
  • Borda M, G, Soennesyn H, Steves C, J, Osland Vik-Mo A, Pérez-Zepeda M, U, Aarsland D: Frailty in Older Adults with Mild Dementia: Dementia with Lewy Bodies and Alzheimer's Disease. Dement Geriatr Cogn Disord Extra 2019;9:176-183. doi: 10.1159/000496537

  • Gabbard J, Johnson D, Russell G, Spencer S, Williamson JD, McLouth LE, Ferris KG, Sink K, Brenes G, Yang M. Prognostic Awareness, Disease and Palliative Understanding Among Caregivers of Patients With Dementia. Am J Hosp Palliat Care. 2020 Sep;37(9):683-691. doi: 10.1177/1049909119895497. Epub 2019 Dec 19.

    PubMed 31854201
  • Bond WF, Kim M, Franciskovich CM, Weinberg JE, Svendsen JD, Fehr LS, Funk A, Sawicki R, Asche CV. Advance Care Planning in an Accountable Care Organization Is Associated with Increased Advanced Directive Documentation and Decreased Costs. J Palliat Med. 2018 Apr;21(4):489-502. doi: 10.1089/jpm.2017.0566. Epub 2017 Dec 5.

    PubMed 29206564
  • Bischoff KE, Sudore R, Miao Y, Boscardin WJ, Smith AK. Advance care planning and the quality of end-of-life care in older adults. J Am Geriatr Soc. 2013 Feb;61(2):209-14. doi: 10.1111/jgs.12105. Epub 2013 Jan 25.

    PubMed 23350921
  • Mehta A, Kelley AS. Advance Care Planning Codes-Getting Paid for Quality Care. JAMA Intern Med. 2019 Jun 1;179(6):830-831. doi: 10.1001/jamainternmed.2018.8105. No abstract available.

    PubMed 30855636
  • Brinkman-Stoppelenburg A, Rietjens JA, van der Heide A. The effects of advance care planning on end-of-life care: a systematic review. Palliat Med. 2014 Sep;28(8):1000-25. doi: 10.1177/0269216314526272. Epub 2014 Mar 20.

    PubMed 24651708
  • Houben CHM, Spruit MA, Groenen MTJ, Wouters EFM, Janssen DJA. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc. 2014 Jul;15(7):477-489. doi: 10.1016/j.jamda.2014.01.008. Epub 2014 Mar 2.

    PubMed 24598477
  • Sinuff T, Dodek P, You JJ, Barwich D, Tayler C, Downar J, Hartwick M, Frank C, Stelfox HT, Heyland DK. Improving End-of-Life Communication and Decision Making: The Development of a Conceptual Framework and Quality Indicators. J Pain Symptom Manage. 2015 Jun;49(6):1070-80. doi: 10.1016/j.jpainsymman.2014.12.007. Epub 2015 Jan 24.

    PubMed 25623923
  • Hammes BJ, Rooney BL, Gundrum JD. A comparative, retrospective, observational study of the prevalence, availability, and specificity of advance care plans in a county that implemented an advance care planning microsystem. J Am Geriatr Soc. 2010 Jul;58(7):1249-55. doi: 10.1111/j.1532-5415.2010.02956.x.

    PubMed 20649688
  • Sellars M, Chung O, Nolte L, Tong A, Pond D, Fetherstonhaugh D, McInerney F, Sinclair C, Detering KM. Perspectives of people with dementia and carers on advance care planning and end-of-life care: A systematic review and thematic synthesis of qualitative studies. Palliat Med. 2019 Mar;33(3):274-290. doi: 10.1177/0269216318809571. Epub 2018 Nov 8.

    PubMed 30404576
  • Sudore RL, Heyland DK, Lum HD, Rietjens JAC, Korfage IJ, Ritchie CS, Hanson LC, Meier DE, Pantilat SZ, Lorenz K, Howard M, Green MJ, Simon JE, Feuz MA, You JJ. Outcomes That Define Successful Advance Care Planning: A Delphi Panel Consensus. J Pain Symptom Manage. 2018 Feb;55(2):245-255.e8. doi: 10.1016/j.jpainsymman.2017.08.025. Epub 2017 Sep 1.

    PubMed 28865870

Questions about this trial

What is this clinical trial studying?

A study testing Telehealth visit in people with Advance Care Planning and Telemedicine, run by Wake Forest University Health Sciences at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patient/Care Partner Agreeing to Participate (time frame: Baseline to Month 9). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04912245, which also lists 45 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.

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