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.
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
- Conditions the study is for
- Advance Care Planning, Telemedicine, Mild Cognitive Impairment
- What is being tested?
- Telehealth visit
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Advance Care Planning, Telemedicine, Mild Cognitive Impairment, Unrecognized Dementia, Dementia
- 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 group | Role | What they receive |
|---|---|---|
| Telehealth visit | Other | 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. Receives: Behavioral: Telehealth visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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
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
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.
- First posted3 Jun 2021
- Study start13 Jul 2021
- Primary completion9 May 2022
- Study completion9 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Jennifer Gabbard, MD, Principal investigator, Wake Forest University Health Sciences
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 32390616Harrison 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 30908605Mantovani 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 32568197Sugimoto 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 32568192Borda 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 31854201Bond 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 29206564Bischoff 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 23350921Mehta 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 30855636Brinkman-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 24651708Houben 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 24598477Sinuff 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 25623923Hammes 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 20649688Sellars 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 30404576Sudore 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (Tele Voice)
- ClinicalTrials.gov ID
- NCT04912245
- Acronym / sponsor ID
- ACP / IRB00074429
- Conditions
- Advance Care Planning, Telemedicine, Mild Cognitive Impairment, Unrecognized Dementia, Dementia
- Keywords
- Dementia, telehealth, Advance Care Planning, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 9 May 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telehealth visit | Other | Behavioral: Telehealth visitPatients 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth visitPatients 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. | Behavioural | Telehealth visit |
Primary outcome
Number of Patient/Care Partner Agreeing to Participate
Time frame: 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
Time frame: month 9
Study will measure the amount of patients or patient-care partner dyads who complete the ACP telehealth intervention.
3 secondary outcomes
Number of Participants With One or More Advance Care Planning (ACP) Discussions
Time frame: month 9
Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes
Time frame: month 9
Quality of Advance Care Planning (ACP) Discussion Scores
Time frame: month 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32390616Ayton 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.
- Background: PubMed 30908605Harrison 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.
- Background: PubMed 32568197Mantovani 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.
- Background: PubMed 32568192Sugimoto 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.
- BackgroundBorda 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
- Background: PubMed 31854201Gabbard 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.
- Background: PubMed 29206564Bond 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.
- Background: PubMed 23350921Bischoff 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.
- Background: PubMed 30855636Mehta 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.
- Background: PubMed 24651708Brinkman-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.
- Background: PubMed 24598477Houben 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.
- Background: PubMed 25623923Sinuff 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.
- Telehealth SurveyLink provided by the sponsor.
- 2019 Tech Trends and the 50+Link provided by the sponsor.
- Centers for Medicare \& Medicaid (2020) Medicare Telemedicine Health Care Provider Fact SheetLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Gabbard, MD principal investigator
Wake Forest University Health Sciences
7 sites in 1 country: see every site and its status.
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.