Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05651308
Other study ID # 22-10025292
Secondary ID 3U54AG063546-03S
Status Completed
Phase N/A
First received
Last updated
Start date December 5, 2022
Est. completion date March 31, 2024

Study information

Verified date May 2024
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 385
Est. completion date March 31, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States New York Presbyterian Hospital - Weill Cornell Medicine New York New York

Sponsors (3)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Brown University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 Up to 1 year
Secondary 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 Up to 1 year
Secondary Fidelity, as measured by the proportion of eligible individuals who receive care coordination services The proportion of eligible individuals who receive care coordination services Up to 1 year
Secondary Efficiency, as measured by the total number of care-coordinator hours used The total number of care-coordinator hours used in each study group Up to 1 year
See also
  Status Clinical Trial Phase
Completed NCT05686486 - Gentle Gymnastics and Relationship Between Family Caregivers and Residents With Dementia in Nursing Homes N/A
Terminated NCT05451693 - Outreach-ER: A Dementia Care Intervention Program
Recruiting NCT05820919 - Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase N/A
Enrolling by invitation NCT06040294 - Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills N/A
Completed NCT05114187 - An Internet-Based Education Program for Care Partners of People Living With Dementia N/A
Recruiting NCT06322121 - Vascular Aspects in Dementia: Part 2
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT04426838 - Cognitive Behavioral Therapy for Insomnia for the Dementia Caregiving Dyad N/A
Recruiting NCT03462485 - Pilot Study of the Effects of Playing Golf on People With Dementia N/A
Active, not recruiting NCT03677284 - Managing Time With Dementia: Effects of Time Assistive Products in People With Dementia N/A
Completed NCT03849937 - Changing Talk Online (CHATO) Study N/A
Recruiting NCT06284213 - Biomarkers for Vascular Contributions to Cognitive Impairment and Dementia Consortium
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Completed NCT04571697 - A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Recruiting NCT06033066 - Financial Incentives and Recruitment to the APT Webstudy N/A
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT05684783 - Dementia Champions in Homecare
Completed NCT03147222 - Function Focused Care: Fracture Care at Home N/A