Improving How People Living With Dementia Are Selected for Care Coordination

NCT ID: NCT05651308

Last Updated: 2025-03-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-05

Study Completion Date

2024-04-30

Brief Summary

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Many people living with dementia (PLWD) and their care partners may benefit from the assistance of a care coordinator, a member of the medical team who facilitates communication among all the people involved. However, care coordinators' time is limited, and there is uncertainty about which patients should be selected to receive their help. This pragmatic clinical trial embedded in an accountable care organization will determine the comparative effectiveness of two approaches for assigning care coordinators to PLWD.

Detailed Description

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This project will use a pragmatic clinical trial embedded in an accountable care organization (ACO) to determine the comparative effectiveness of two different approaches for selecting PLWD to receive support from care coordinators: (1) an approach that assigns PLWD to care coordinators based on care partners' self-reported difficulty with care coordination, or (2) usual care, which generally assigns PLWD to care coordinators after hospital discharge, regardless of perceived need. The investigators will include community-dwelling Medicare beneficiaries ≥65 years old with dementia who have been attributed to the NewYork Quality Care ACO and who have fragmented care. The investigators will randomize the participants into two groups. This study is highly pragmatic, and the intervention is sustainable and scalable. Moreover, the proposed approach has the potential to improve care delivery and outcomes for PLWD.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

The intervention group will assign care coordinators to PLWD based on perceived need for assistance with care coordination. Perceived need will be measured through a proxy's responses to a previously validated telephone survey on perceptions of care coordination.

Group Type EXPERIMENTAL

Care coordination delivered based on perceived need

Intervention Type BEHAVIORAL

If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.

Control

Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.

Group Type ACTIVE_COMPARATOR

Care coordination delivered based on usual care (e.g. discharge from hospital)

Intervention Type BEHAVIORAL

If a patient is discharged from a hospital, the patient will be selected for care management services.

Interventions

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Care coordination delivered based on perceived need

If proxies for patients in intervention group report on the survey that they experience difficulty coordinating care among the patients' providers, the patient will be selected for care management services. Those services will attempt to address the problems with care coordination that the proxy reported.

Intervention Type BEHAVIORAL

Care coordination delivered based on usual care (e.g. discharge from hospital)

If a patient is discharged from a hospital, the patient will be selected for care management services.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Medicare beneficiaries ≥65 years old who:
* Are attributed to the NewYork Quality Care accountable care organization by Medicare,
* Have dementia (as measured in claims using the Bynum standard 1-year definition),
* Reside in the community, and
* Had fragmented ambulatory care in the previous 12 months (defined as a reversed Bice-Boxerman Index greater than or equal to the median score for this population, using Medicare claims)

Exclusion Criteria

* Those who reside in long-term care or nursing home facilities (based on addresses in Medicare claims), or
* Enrolled in home hospice
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa M Kern, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Vincent Mor, PhD

Role: STUDY_DIRECTOR

Brown University

Locations

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New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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3U54AG063546-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Subaward 00002102

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22-10025292

Identifier Type: -

Identifier Source: org_study_id

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