Clinical trial NCT04912245: A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia
Official title: A Telehealth Advance Care Planning Intervention in Those With Mild Cognitive Impairment or Unrecognized Dementia (Tele Voice)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advance Care Planning
Telemedicine
Mild Cognitive Impairment
Unrecognized Dementia
Dementia
Keywords: Dementia
telehealth
Advance Care Planning
Mild Cognitive Impairment
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-06-03
Enrollment: 152
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Number of Patient/Care Partner Agreeing to Participate
timeFrame: Baseline to Month 9
measure: Number of Participants With Telehealth Advance Care Planning (ACP) Completed
timeFrame: month 9
Secondary outcomes:
measure: Number of Participants With One or More Advance Care Planning (ACP) Discussions
timeFrame: month 9
measure: Number of Participants Who Used One or More Advance Care Planning (ACP) Billing Codes
timeFrame: month 9
measure: Quality of Advance Care Planning (ACP) Discussion Scores
timeFrame: month 9
Other outcomes:
Locations:
city: Bermuda Run
country: United States
facility: Geriatric Medicine-Plaza 1 Davie
state: North Carolina
city: Conover
country: United States
facility: Wake Forest Health Network Family Medicine Conover
state: North Carolina
city: High Point
country: United States
facility: WFHN Family Medicine-Premier
state: North Carolina
city: Jamestown
country: United States
facility: Wake Forest Health Network Internal Medicine
state: North Carolina
city: Kernersville
country: United States
facility: WFBIK Geriatric Medicine-Kernersville
state: North Carolina
city: Thomasville
country: United States
facility: WFHN Family Medicine-Thomasville
state: North Carolina
city: Winston-Salem
country: United States
facility: Geriatric Medicine- Sticht Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Jennifer Gabbard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Volhard T, Jessen F, Kleineidam L, Wolfsgruber S, Lanzerath D, Wagner M, Maier W. Advance directives for future dementia can be modified by a brief video presentation on dementia care: An experimental study. PLoS One. 2018 May 24;13(5):e0197229. doi: 10.1371/journal.pone.0197229. eCollection 2018.
citation: Harrison Dening K, Sampson EL, De Vries K. Advance care planning in dementia: recommendations for healthcare professionals. Palliat Care. 2019 Feb 27;12:1178224219826579. doi: 10.1177/1178224219826579. eCollection 2019.
citation: Mitchell SL, Kiely DK, Lipsitz LA. The risk factors and impact on survival of feeding tube placement in nursing home residents with severe cognitive impairment. Arch Intern Med. 1997 Feb 10;157(3):327-32.
citation: Teno JM, Mitchell SL, Kuo SK, Gozalo PL, Rhodes RL, Lima JC, Mor V. Decision-making and outcomes of feeding tube insertion: a five-state study. J Am Geriatr Soc. 2011 May;59(5):881-6. doi: 10.1111/j.1532-5415.2011.03385.x. Epub 2011 May 3.
citation: Mitchell SL, Teno JM, Intrator O, Feng Z, Mor V. Decisions to forgo hospitalization in advanced dementia: a nationwide study. J Am Geriatr Soc. 2007 Mar;55(3):432-8. doi: 10.1111/j.1532-5415.2007.01086.x.
citation: Teno JM, Gruneir A, Schwartz Z, Nanda A, Wetle T. Association between advance directives and quality of end-of-life care: a national study. J Am Geriatr Soc. 2007 Feb;55(2):189-94. doi: 10.1111/j.1532-5415.2007.01045.x.
citation: Givens JL, Prigerson HG, Jones RN, Mitchell SL. Mental health and exposure to patient distress among families of nursing home residents with advanced dementia. J Pain Symptom Manage. 2011 Aug;42(2):183-91. doi: 10.1016/j.jpainsymman.2010.10.259. Epub 2011 Mar 12.
citation: Kiely DK, Givens JL, Shaffer ML, Teno JM, Mitchell SL. Hospice use and outcomes in nursing home residents with advanced dementia. J Am Geriatr Soc. 2010 Dec;58(12):2284-91. doi: 10.1111/j.1532-5415.2010.03185.x.
citation: De Vleminck A, Morrison RS, Meier DE, Aldridge MD. Hospice Care for Patients With Dementia in the United States: A Longitudinal Cohort Study. J Am Med Dir Assoc. 2018 Jul;19(7):633-638. doi: 10.1016/j.jamda.2017.10.003. Epub 2017 Nov 16.
citation: Piers R, Albers G, Gilissen J, De Lepeleire J, Steyaert J, Van Mechelen W, Steeman E, Dillen L, Vanden Berghe P, Van den Block L. Advance care planning in dementia: recommendations for healthcare professionals. BMC Palliat Care. 2018 Jun 21;17(1):88. doi: 10.1186/s12904-018-0332-2.
citation: Bally KW, Krones T, Jox RJ. Advance Care Planning for People with Dementia: The Role of General Practitioners. Gerontology. 2020;66(1):40-46. doi: 10.1159/000500809. Epub 2019 Jun 18.
citation: Farrell TW, Ferrante LE, Brown T, Francis L, Widera E, Rhodes R, Rosen T, Hwang U, Witt LJ, Thothala N, Liu SW, Vitale CA, Braun UK, Stephens C, Saliba D. AGS Position Statement: Resource Allocation Strategies and Age-Related Considerations in the COVID-19 Era and Beyond. J Am Geriatr Soc. 2020 Jun;68(6):1136-1142. doi: 10.1111/jgs.16537.
citation: Block BL, Smith AK, Sudore RL. During COVID-19, Outpatient Advance Care Planning Is Imperative: We Need All Hands on Deck. J Am Geriatr Soc. 2020 Jul;68(7):1395-1397. doi: 10.1111/jgs.16532. Epub 2020 May 14. No abstract available.
citation: Shigekawa E, Fix M, Corbett G, Roby DH, Coffman J. The Current State Of Telehealth Evidence: A Rapid Review. Health Aff (Millwood). 2018 Dec;37(12):1975-1982. doi: 10.1377/hlthaff.2018.05132.
citation: Tousi B. Dementia Care in the Time of COVID-19 Pandemic. J Alzheimers Dis. 2020;76(2):475-479. doi: 10.3233/JAD-200461.
citation: Bossen AL, Kim H, Williams KN, Steinhoff AE, Strieker M. Emerging roles for telemedicine and smart technologies in dementia care. Smart Homecare Technol Telehealth. 2015;3:49-57. doi: 10.2147/SHTT.S59500. Epub 2015 Mar 22.
citation: Guisado-Fernandez E, Blake C, Mackey L, Silva PA, Power D, O'Shea D, Caulfield B. A Smart Health Platform for Measuring Health and Well-Being Improvement in People With Dementia and Their Informal Caregivers: Usability Study. JMIR Aging. 2020 Jul 23;3(2):e15600. doi: 10.2196/15600.
citation: Williams K, Blyler D, Vidoni ED, Shaw C, Wurth J, Seabold D, Perkhounkova Y, Van Sciver A. A randomized trial using telehealth technology to link caregivers with dementia care experts for in-home caregiving support: FamTechCare protocol. Res Nurs Health. 2018 Jun;41(3):219-227. doi: 10.1002/nur.21869. Epub 2018 Mar 5.
citation: Lee E. Do Technology-Based Support Groups Reduce Care Burden Among Dementia Caregivers? A Review. J Evid Inf Soc Work. 2015;12(5):474-87. doi: 10.1080/15433714.2014.930362. Epub 2015 Mar 20.
citation: Malmgren Fange A, Schmidt SM, Nilsson MH, Carlsson G, Liwander A, Dahlgren Bergstrom C, Olivetti P, Johansson P, Chiatti C; TECH@HOME Research Group. The TECH@HOME study, a technological intervention to reduce caregiver burden for informal caregivers of people with dementia: study protocol for a randomized controlled trial. Trials. 2017 Feb 9;18(1):63. doi: 10.1186/s13063-017-1796-8.
citation: Hatcher-Martin JM, Adams JL, Anderson ER, Bove R, Burrus TM, Chehrenama M, Dolan O'Brien M, Eliashiv DS, Erten-Lyons D, Giesser BS, Moo LR, Narayanaswami P, Rossi MA, Soni M, Tariq N, Tsao JW, Vargas BB, Vota SA, Wessels SR, Planalp H, Govindarajan R. Telemedicine in neurology: Telemedicine Work Group of the American Academy of Neurology update. Neurology. 2020 Jan 7;94(1):30-38. doi: 10.1212/WNL.0000000000008708. Epub 2019 Dec 4.
citation: Gabbard J, Pajewski NM, Callahan KE, Dharod A, Foley KL, Ferris K, Moses A, Willard J, Williamson JD. Effectiveness of a Nurse-Led Multidisciplinary Intervention vs Usual Care on Advance Care Planning for Vulnerable Older Adults in an Accountable Care Organization: A Randomized Clinical Trial. JAMA Intern Med. 2021 Mar 1;181(3):361-369. doi: 10.1001/jamainternmed.2020.5950.
citation: Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
citation: Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.
citation: Wilkinson T, Ly A, Schnier C, Rannikmae K, Bush K, Brayne C, Quinn TJ, Sudlow CLM; UK Biobank Neurodegenerative Outcomes Group and Dementias Platform UK. Identifying dementia cases with routinely collected health data: A systematic review. Alzheimers Dement. 2018 Aug;14(8):1038-1051. doi: 10.1016/j.jalz.2018.02.016. Epub 2018 Apr 3.
citation: Nakagawa S, Johnson PCD, Schielzeth H. The coefficient of determination R2 and intra-class correlation coefficient from generalized linear mixed-effects models revisited and expanded. J R Soc Interface. 2017 Sep;14(134):20170213. doi: 10.1098/rsif.2017.0213. Epub 2017 Sep 13.
citation: Allore HG, Goldfeld KS, Gutman R, Li F, Monin JK, Taljaard M, Travison TG. Statistical Considerations for Embedded Pragmatic Clinical Trials in People Living with Dementia. J Am Geriatr Soc. 2020 Jul;68 Suppl 2(Suppl 2):S68-S73. doi: 10.1111/jgs.16616.
citation: Dong H, Robison LL, Leisenring WM, Martin LJ, Armstrong GT, Yasui Y. Estimating the burden of recurrent events in the presence of competing risks: the method of mean cumulative count. Am J Epidemiol. 2015 Apr 1;181(7):532-40. doi: 10.1093/aje/kwu289. Epub 2015 Feb 17.
citation: Rondeau V, Marzroui Y, Gonzalez JR. frailtypack: An R Package for the Analysis of Correlated Survival Data with Frailty Models Using Penalized Likelihood Estimation or Parametrical Estimation. 2012. 2012;47(4):28.
citation: Oliveira IR, Molenberghs G, Demetrio CG, Dias CT, Giolo SR, Andrade MC. Quantifying intraclass correlations for count and time-to-event data. Biom J. 2016 Jul;58(4):852-67. doi: 10.1002/bimj.201500093. Epub 2016 Feb 22.