Improving How People Living With Dementia Are Selected for Care Coordination

Improving How People Living With Dementia Are Selected for Care Coordination: A Pragmatic Clinical Trial Embedded in an Accountable Care Organization

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: Care coordination delivered based on perceived need; Behavioral: Care coordination delivered based on usual care (e.g. discharge from hospital)

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 Type: Interventional
• Enrollment (Actual): 385
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital - Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 61 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	The number of people who accepted care management in each group	Up to 1 year
Appropriateness	The number of people with problems in scope for care coordinators, out of all people who received care management	Up to 1 year
Fidelity	The number of people who actually received care coordination services, out of all of those who agreed to receive it	Up to 1 year
Efficiency	The number of care coordinator encounters in each group. This measure allows more than one encounter per person.	Up to 1 year

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Brown University; National Institute on Aging (NIA)
• Investigators: Study Director: Vincent Mor, PhD, Brown University; Principal Investigator: Lisa M Kern, MD, MPH, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: December 5, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: care coordination; accountable care organization
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 22-10025292; 3U54AG063546-03 (U.S. NIH Grant/Contract); Subaward 00002102 (Other Grant/Funding Number: Brown University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No