3D Team Care for Cognitively Vulnerable Older Adults

NCT ID: NCT02945085

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

506 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-06

Study Completion Date

2024-07-31

Brief Summary

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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

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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.

Conditions

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Dementia Depression Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home Based Care Team

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

Group Type EXPERIMENTAL

Home Based Care Team

Intervention Type 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.

Telephone Based Care Team

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

Group Type ACTIVE_COMPARATOR

Telephone Based Care Team

Intervention Type 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.

Interventions

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Home Based Care Team

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.

Intervention Type OTHER

Telephone Based Care Team

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role collaborator

UConn Health

OTHER

Sponsor Role lead

Responsible Party

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Fortinsky, Richard

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard H Fortinsky, PhD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

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UConn Center on Aging

Farmington, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33354755 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32194252 (View on PubMed)

Other Identifiers

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17-021-1

Identifier Type: -

Identifier Source: org_study_id

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