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Improving How People Living With Dementia Are Selected for Care Coordination

Primary Purpose

Dementia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care coordination delivered based on perceived need
Care coordination delivered based on usual care (e.g. discharge from hospital)
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dementia focused on measuring care coordination, accountable care organization

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian Hospital - Weill Cornell Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Acceptability, as measured by the proportion of participants who are engaged with care
Participants are considered engaged with care if they agree to receive care coordination
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
The proportion of problems identified that are in scope for the work of care coordinators
Fidelity, as measured by the proportion of eligible individuals who receive care coordination services
The proportion of eligible individuals who receive care coordination services
Efficiency, as measured by the total number of care-coordinator hours used
The total number of care-coordinator hours used in each study group

Full Information

First Posted
December 5, 2022
Last Updated
December 12, 2022
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05651308
Brief Title
Improving How People Living With Dementia Are Selected for Care Coordination
Official Title
Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute on Aging (NIA), Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
care coordination, accountable care organization

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
688 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Usual care assigns patients to care coordinators in response to a discharge from a hospital or a direct referral from a physician.
Intervention Type
Behavioral
Intervention Name(s)
Care coordination delivered based on perceived need
Intervention Description
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
Intervention Name(s)
Care coordination delivered based on usual care (e.g. discharge from hospital)
Intervention Description
If a patient is discharged from a hospital, the patient will be selected for care management services.
Primary Outcome Measure Information:
Title
Number of emergency department visits or hospital admissions
Description
Occurrence of an emergency department visit or hospital admission, as measured in Medicare claims
Time Frame
Over 12 months (beginning 1 month after the start of care coordination)
Secondary Outcome Measure Information:
Title
Acceptability, as measured by the proportion of participants who are engaged with care
Description
Participants are considered engaged with care if they agree to receive care coordination
Time Frame
Up to 1 year
Title
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
Description
The proportion of problems identified that are in scope for the work of care coordinators
Time Frame
Up to 1 year
Title
Fidelity, as measured by the proportion of eligible individuals who receive care coordination services
Description
The proportion of eligible individuals who receive care coordination services
Time Frame
Up to 1 year
Title
Efficiency, as measured by the total number of care-coordinator hours used
Description
The total number of care-coordinator hours used in each study group
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Kern, MD, MPH
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vincent Mor, PhD
Organizational Affiliation
Brown University
Official's Role
Study Director
Facility Information:
Facility Name
New York Presbyterian Hospital - Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving How People Living With Dementia Are Selected for Care Coordination

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