Clinical trial NCT02945085: 3D Team Care for Cognitively Vulnerable Older Adults
Official title: 3D Team Care for Cognitively Vulnerable Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Depression
Delirium
Keywords: older adults
family caregivers
Medicare Advantage beneficiaries
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of Connecticut
First posted: 2016-10-26
Enrollment: 506
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with expertise in geriatrics and geriatric psychiatry. Specific aims are to determine Home Based Care Team effects on hospitalization or emergency department use, and other outcomes including depression, disability, and quality of life.

Detailed description: This study addresses how to achieve better outcomes for cognitively vulnerable community-dwelling older adults and their families. Cognitive vulnerability means living with dementia, depression, and/or a recent episode of delirium (the 3Ds). Cognitive vulnerability in older adults is often overlooked by primary care and hospital-based providers, and represents a marker for overall vulnerability or frailty often missed when disease-specific approaches are emphasized in the care for older adults. Such patients often cannot adequately self-manage their comorbidities. Many studies of older adults and their families have demonstrated the great burden of living with cognitive vulnerability. The investigators will test the effectiveness of a team care model focused on the 3Ds (Home Based Care Team) guided by nurse practitioners with geriatrics expertise. Other team member disciplines will include pharmacy, social work, occupational and physical therapy, nutrition, and community health worker. Long-term objectives are to determine whether this care model can become a widely available approach for improving healthcare systems for older adults with cognitive vulnerability and their families, while improving outcomes of importance to these patients and families. A project Steering Committee, including cognitively vulnerable patients and family caregivers, will provide extensive input into many aspects of the research process.

Eligibility criteria: Inclusion Criteria:

* Evidence of dementia, depression, and/or delirium, based on diagnostic codes found in medical claims data and based on screening at time of study screening.
* Living in the community, including assisted living facility, at time of randomization
* Plan to live in geographic area for 12 months
* Speak or understand English
* Willing to be randomly assigned to intervention or active comparator group

Exclusion Criteria:

* Diagnosed schizophrenia or bipolar disorder
* Bedbound and non-communicative
* Life expectancy \<12 months
* Already enrolled in active comparator program
* For individuals with dementia, family caregiver is unavailable or unwilling to enroll in study

Primary outcomes:
measure: Proportion hospitalized or used emergency department without hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ9)
timeFrame: 12 months
measure: Caregiver Assessment of Function and Upset (CAFU)
timeFrame: 12 months
measure: Family caregiver perceived well-being
timeFrame: 12 months
Other outcomes:
measure: World Health Organization (WHO) Disability Assessment Schedule, 12 item short form.
timeFrame: 12 months
measure: Quality of Life-Alzheimer's Disease Scale (QOL-AD)
timeFrame: 12 months
measure: Neuropsychiatric Inventory (NPI-C)
timeFrame: 12 months
measure: Center for Epidemiologic Studies-Depression Scale (CES-D)
timeFrame: 12 months
measure: Zarit Burden Scale, 12-item short form
timeFrame: 12 months
Locations:
city: Farmington
country: United States
facility: UConn Center on Aging
state: Connecticut
Study officials:
affiliation: UConn Health
name: Richard H Fortinsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levine AMP, Emonds EE, Smith MA, Rickles NM, Kuchel GA, Steffens DC, Ohlheiser A, Fortinsky RH. Pharmacist Identification of Medication Therapy Problems Involving Cognition Among Older Adults Followed by a Home-Based Care Team. Drugs Aging. 2021 Feb;38(2):157-168. doi: 10.1007/s40266-020-00821-7. Epub 2020 Dec 23.
citation: Fortinsky RH, Kuchel GA, Steffens DC, Grady J, Smith M, Robison JT. Clinical trial testing in-home multidisciplinary care management for older adults with cognitive vulnerability: Rationale and study design. Contemp Clin Trials. 2020 May;92:105992. doi: 10.1016/j.cct.2020.105992. Epub 2020 Mar 16.