3D Team Care for Cognitively Vulnerable Older Adults

NCT02945085 | Completed DMC

• 1 other identifier: 17-021-1
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Depression; Delirium

Keywords

older adults; family caregivers; Medicare Advantage beneficiaries

Outcome Measures

Primary Outcomes (1)

• Proportion hospitalized or used emergency department without hospitalization

  Evidence of hospitalization or visit to emergency department without hospital admission will be based on data from the Medicare Advantage insurer's medical claims data warehouse.

  12 months

Secondary Outcomes (3)

• Patient Health Questionnaire (PHQ9)

  12 months

• Caregiver Assessment of Function and Upset (CAFU)

  12 months

• Family caregiver perceived well-being

  12 months

Other Outcomes (5)

• World Health Organization (WHO) Disability Assessment Schedule, 12 item short form.

  12 months

• Quality of Life-Alzheimer's Disease Scale (QOL-AD)

  12 months

• Neuropsychiatric Inventory (NPI-C)

  12 months

Study Arms (2)

Home Based Care Team

EXPERIMENTAL

Primarily in-home treatment provided by team led by nurse practitioner with geriatrics and geriatric psychiatry expertise.

Other: Home Based Care Team

Telephone Based Care Team

ACTIVE COMPARATOR

Primarily telephone-based treatment provided by existing care management program offered by collaborating Medicare Advantage insurer.

Other: Telephone Based Care Team

Interventions

Home Based Care Team OTHER

Clinical team will conduct comprehensive clinical assessments focused on cognitive impairment and depression, conduct comprehensive medication review and reconciliation, offer Problem Solving Therapy, and offer brief occupational therapy, physical therapy, nutrition, and social support services.

Home Based Care Team

Telephone Based Care Team OTHER

Telephone contact will be made by nurses. Depending on level of need, follow up telephone and, in some cases, in home visits will be made by nurse or social worker from care management program.

Telephone Based Care Team

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UConn Health: lead
• Patient-Centered Outcomes Research Institute: collaborator
• University of Connecticut: collaborator

Study Sites (1)

UConn Center on Aging

Farmington, Connecticut, 06030-5215, United States

Location

Related Publications (2)

• 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.

  PMID: 33354755 DERIVED

• 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.

  PMID: 32194252 DERIVED

MeSH Terms

Conditions

Dementia; Depression; Delirium

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard H Fortinsky, PhD

  UConn Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 23, 2016
• First Posted: October 26, 2016
• Study Start: March 6, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)