NCT05651308

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
385

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 15, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
11 months until next milestone

Results Posted

Study results publicly available

March 13, 2025

Completed
Last Updated

March 13, 2025

Status Verified

February 1, 2025

Enrollment Period

1.4 years

First QC Date

December 5, 2022

Results QC Date

January 21, 2025

Last Update Submit

February 21, 2025

Conditions

Keywords

care coordinationaccountable care organization

Outcome Measures

Primary Outcomes (1)

  • Number of Emergency Department Visits or Hospital Admissions

    Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims

    Over 12 months (beginning 1 month after the start of care coordination)

Secondary Outcomes (4)

  • Acceptability

    Up to 1 year

  • Appropriateness

    Up to 1 year

  • Fidelity

    Up to 1 year

  • Efficiency

    Up to 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Care coordination delivered based on perceived need

Control

ACTIVE COMPARATOR

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

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

Interventions

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

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

Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Presbyterian Hospital - Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Lisa M. Kern, MD, MPH
Organization
Weill Cornell Medicine

Study Officials

  • Lisa M Kern, MD, MPH

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Vincent Mor, PhD

    Brown University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 15, 2022

Study Start

December 5, 2022

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 13, 2025

Results First Posted

March 13, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations