D-CARE: The Dementia Care Study: Design of a Pragmatic Trial of the Effectiveness and Cost Effectiveness of Health System-Based Versus Community-Based Dementia Care Versus Usual Dementia Care.
Alzheimer's disease
care coordination
dementia
pragmatic trials
Journal
Journal of the American Geriatrics Society
ISSN: 1532-5415
Titre abrégé: J Am Geriatr Soc
Pays: United States
ID NLM: 7503062
Informations de publication
Date de publication:
11 2020
11 2020
Historique:
received:
06
07
2020
revised:
26
08
2020
accepted:
27
08
2020
pubmed:
20
9
2020
medline:
1
4
2021
entrez:
19
9
2020
Statut:
ppublish
Résumé
Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown. Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad. Four clinical trial sites (CTSs) based in academic and clinical health systems. A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers. Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline. Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales. NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims. The results will be reported in the spring of 2024. D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.
Sections du résumé
BACKGROUND/OBJECTIVES
Although several approaches have been developed to provide comprehensive care for persons living with dementia (PWD) and their family or friend caregivers, the relative effectiveness and cost effectiveness of community-based dementia care (CBDC) versus health system-based dementia care (CBDC) and the effectiveness of both approaches compared with usual care (UC) are unknown.
DESIGN
Pragmatic randomized three-arm superiority trial. The unit of randomization is the PWD/caregiver dyad.
SETTING
Four clinical trial sites (CTSs) based in academic and clinical health systems.
PARTICIPANTS
A total of 2,150 English- or Spanish-speaking PWD who are not receiving hospice or residing in a nursing home and their caregivers.
INTERVENTIONS
Eighteen months of (1) HSDC provided by a nurse practitioner or physician's assistant dementia care specialist who works within the health system, or (2) CBDC provided by a social worker or nurse care consultant who works at a community-based organization, or (3) UC with as needed referral to the Alzheimer's Association Helpline.
MEASUREMENTS
Primary outcomes: PWD behavioral symptoms and caregiver distress as measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Severity and Modified Caregiver Strain Index scales.
SECONDARY OUTCOMES
NPI-Q Distress, caregiver unmet needs and confidence, and caregiver depressive symptoms. Tertiary outcomes: PWD long-term nursing home placement rates, caregiver-reported PWD functional status, cognition, goal attainment, "time spent at home," Dementia Burden Scale-Caregiver, a composite measure of clinical benefit, Quality of Life of persons with dementia, Positive Aspects of Caregiving, and cost effectiveness using intervention costs and Medicare claims.
RESULTS
The results will be reported in the spring of 2024.
CONCLUSION
D-CARE will address whether emphasis on clinical support and tighter integration with other medical services has greater benefit than emphasis on social support that is tied more closely to community resources. It will also assess the effectiveness of both interventions compared with UC and will evaluate the cost effectiveness of each intervention.
Identifiants
pubmed: 32949145
doi: 10.1111/jgs.16862
pmc: PMC8086629
mid: NIHMS1687049
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2492-2499Subventions
Organisme : NIA NIH HHS
ID : R01 AG061078
Pays : United States
Organisme : Patient-Centered Outcomes Research Institute
ID : PCS-2017C1-6534
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001863
Pays : United States
Organisme : NIA NIH HHS
ID : P30 AG049638
Pays : United States
Organisme : NIH HHS
Pays : United States
Organisme : NIA NIH HHS
ID : P30 AG024832
Pays : United States
Commentaires et corrections
Type : ErratumIn
Informations de copyright
© 2020 The American Geriatrics Society.
Références
JAMA Intern Med. 2019 Feb 1;179(2):161-166
pubmed: 30575846
Gerontologist. 1969 Autumn;9(3):179-86
pubmed: 5349366
J Appl Gerontol. 2017 May;36(5):570-591
pubmed: 26912728
J Am Geriatr Soc. 2019 Nov;67(11):2267-2273
pubmed: 31355423
Biostatistics. 2000 Dec;1(4):465-80
pubmed: 12933568
Gerontologist. 1970 Spring;10(1):20-30
pubmed: 5420677
Gerontologist. 2011 Apr;51(2):261-72
pubmed: 21242317
J Am Geriatr Soc. 2013 Dec;61(12):2214-2218
pubmed: 24329821
Age Ageing. 2005 Mar;34(2):130-5
pubmed: 15713856
J Am Geriatr Soc. 2015 Jul;63(7):1448-52
pubmed: 26046666
Int J Environ Res Public Health. 2008 Dec;5(5):394-8
pubmed: 19151434
Alzheimers Dement. 2013 Jan;9(1):19-29
pubmed: 23154049
J Neuropsychiatry Clin Neurosci. 2000 Spring;12(2):233-9
pubmed: 11001602
J Am Geriatr Soc. 2018 Sep;66(9):1785-1789
pubmed: 30094817
J Gerontol. 1982 May;37(3):323-9
pubmed: 7069156
JAMA. 2006 May 10;295(18):2148-57
pubmed: 16684985
J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S127-32
pubmed: 12646602
BMC Neurol. 2016 Apr 12;16:46
pubmed: 27067253
Stroke. 2013 Jan;44(1):227-9
pubmed: 23138443
N Engl J Med. 2013 Apr 4;368(14):1326-34
pubmed: 23550670
Qual Life Res. 2017 Mar;26(3):685-693
pubmed: 28000094
J Am Geriatr Soc. 2020 Nov;68(11):2478-2485
pubmed: 32975812
J Affect Disord. 2009 Apr;114(1-3):163-73
pubmed: 18752852
N Engl J Med. 2016 Oct 27;375(17):1610-1612
pubmed: 27783911
J Comp Eff Res. 2016 May;5(3):297-308
pubmed: 27144508
BMJ. 2015 May 08;350:h2147
pubmed: 25956159