Improving How People Living With Dementia Are Selected for Care Coordination

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05651308
Collaborator
National Institute on Aging (NIA) (NIH), Brown University (Other)
688
1
2
18.8
36.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Care coordination delivered based on perceived need
  • Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
688 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
Actual Study Start Date :
Dec 5, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Active Comparator: Control

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

Outcome Measures

Primary Outcome Measures

  1. Number of emergency department visits or hospital admissions [Over 12 months (beginning 1 month after the start of care coordination)]

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

Secondary Outcome Measures

  1. Acceptability, as measured by the proportion of participants who are engaged with care [Up to 1 year]

    Participants are considered engaged with care if they agree to receive care coordination

  2. Appropriateness, as measured by the proportion of problems with communication that are identified by participants and that are in scope for the work of care coordinators [Up to 1 year]

    The proportion of problems identified that are in scope for the work of care coordinators

  3. Fidelity, as measured by the proportion of eligible individuals who receive care coordination services [Up to 1 year]

    The proportion of eligible individuals who receive care coordination services

  4. Efficiency, as measured by the total number of care-coordinator hours used [Up to 1 year]

    The total number of care-coordinator hours used in each study group

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York Presbyterian Hospital - Weill Cornell Medicine New York New York United States 10065

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • National Institute on Aging (NIA)
  • Brown University

Investigators

  • Principal Investigator: Lisa M Kern, MD, MPH, Weill Medical College of Cornell University
  • Study Director: Vincent Mor, PhD, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT05651308
Other Study ID Numbers:
  • 22-10025292
  • 3U54AG063546-03
  • Subaward 00002102
First Posted:
Dec 15, 2022
Last Update Posted:
Dec 15, 2022
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weill Medical College of Cornell University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 15, 2022