ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care

NCT ID: NCT06079203

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

19200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2028-08-31

Brief Summary

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The purpose of this study is to improve the care of persons living with dementia (PLWD) and their informal care partners by addressing emergency and post-emergency care through different combinations of three PLWD-care partner dyad focused interventions. The primary aims are to use coaching to help connect PLWD and their care partners with community support and services to improve transitional care, quality of care, care satisfaction and reduce future ED visits and hospitalizations.

Detailed Description

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Conditions

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Alzheimer's Disease Related Dementia Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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No intervention

No intervention, serving as a usual care control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Single intervention: Emergency Care Redesign (ECR)

Group Type EXPERIMENTAL

Emergency Care Redesign (ECR)

Intervention Type BEHAVIORAL

Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift

CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond

Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services

Single intervention: Nurse-led Telephonic Care (NLTC)

Group Type EXPERIMENTAL

Nurse-led Telephonic Care (NLTC)

Intervention Type BEHAVIORAL

Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call \~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers

Single intervention: Community Paramedic-led Transitions Intervention (CPTI)

Group Type EXPERIMENTAL

Community Paramedic-led Transitions Intervention (CPTI)

Intervention Type BEHAVIORAL

Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within \~5 days of index ED visit. One home visit and three telephone encounters over 30 days

Two intervention: ECR and NLTC

Group Type EXPERIMENTAL

Emergency Care Redesign (ECR)

Intervention Type BEHAVIORAL

Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift

CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond

Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services

Nurse-led Telephonic Care (NLTC)

Intervention Type BEHAVIORAL

Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call \~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers

Two interventions: ECR and CPTI

Group Type EXPERIMENTAL

Emergency Care Redesign (ECR)

Intervention Type BEHAVIORAL

Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift

CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond

Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services

Community Paramedic-led Transitions Intervention (CPTI)

Intervention Type BEHAVIORAL

Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within \~5 days of index ED visit. One home visit and three telephone encounters over 30 days

Two interventions: NLTC and CPTI

Group Type EXPERIMENTAL

Nurse-led Telephonic Care (NLTC)

Intervention Type BEHAVIORAL

Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call \~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers

Community Paramedic-led Transitions Intervention (CPTI)

Intervention Type BEHAVIORAL

Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within \~5 days of index ED visit. One home visit and three telephone encounters over 30 days

All interventions: ECR, NLTC, and CPTI

Group Type EXPERIMENTAL

Emergency Care Redesign (ECR)

Intervention Type BEHAVIORAL

Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift

CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond

Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services

Nurse-led Telephonic Care (NLTC)

Intervention Type BEHAVIORAL

Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call \~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers

Community Paramedic-led Transitions Intervention (CPTI)

Intervention Type BEHAVIORAL

Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within \~5 days of index ED visit. One home visit and three telephone encounters over 30 days

Interventions

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Emergency Care Redesign (ECR)

Care Process Redesign: Care process redesign with a shared structured worksheet for data gathering, standardized assessment and referral. Education of all providers (Physician, Nurse, and Social Work Champion) on new processes at huddles and via on-line training, smart phone-compatible animated videos, faculty meetings, e-mail and from ED champions on shift

CDS System: Alerts and new workflow to refer the dyad to social work or care manager. Continued use throughout study period and beyond

Follow up: Within 72 hours of ED visit if discharged home Social Work Champion will have a single phone call. Triadic telephone encounter to ensure understanding of discharge plan, medication management and connection to community services

Intervention Type BEHAVIORAL

Nurse-led Telephonic Care (NLTC)

Telephonic support for dyad for safe ED to home care transition, and to enhance knowledge and management of AD/ADRD and co-morbid conditions. First call to dyad within 72 hours of index ED visit from Registered nurses. Each call \~30 minutes depending on needs and willingness of dyad. Calls also occur at 14 days, and at least monthly thereafter for 6 months. Dyad or nurse can initiate additional as-needed calls and coordinate care and care needs with other providers

Intervention Type BEHAVIORAL

Community Paramedic-led Transitions Intervention (CPTI)

Community paramedics to provide coaching with dyad to improve medication management, outpatient follow up, understanding of red flags necessitating medical care. Home visit within \~5 days of index ED visit. One home visit and three telephone encounters over 30 days

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* patients age 66 and older
* have at least one ICD-10 visit diagnoses for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD) from an inpatient or outpatient encounter within the last 3 years of the ED visit and are discharged (observation patients included)

Exclusion Criteria

* patients who are under 66 years old
Minimum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Chodosh, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Julia Levine, MPA

Role: CONTACT

646-501-2632

Diana Hernandez, BS

Role: CONTACT

646-501-8252

Other Identifiers

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U19AG078105-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-00516

Identifier Type: -

Identifier Source: org_study_id

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