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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease; Alzheimer's Disease Related Dementia
• Intervention / Treatment: Behavioral: Emergency Care Redesign (ECR); Behavioral: Nurse-led Telephonic Care (NLTC); Behavioral: Community Paramedic-led Transitions Intervention (CPTI)

• Study Type: Interventional
• Enrollment (Actual): 19200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

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

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; No intervention, serving as a usual care control group
Experimental: Single intervention: Emergency Care Redesign (ECR)	Behavioral: 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
Experimental: Single intervention: Nurse-led Telephonic Care (NLTC)	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
Experimental: Single intervention: Community Paramedic-led Transitions Intervention (CPTI)	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
Experimental: Two intervention: ECR and NLTC	Behavioral: 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; 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
Experimental: Two interventions: ECR and CPTI	Behavioral: 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; 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
Experimental: Two interventions: NLTC and CPTI	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; 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
Experimental: All interventions: ECR, NLTC, and CPTI	Behavioral: 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; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Emergency Department (ED) revisits	Up to 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of ED revisits	Up to 14 days
Number of ED revisits	Up to 6 months
Number of hospitalizations	Up to 14 days
Number of hospitalizations	Up to 30 days
Number of hospitalizations	Up to 6 months
Number of healthy days at home	Up to 6 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Joshua Chodosh, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: October 6, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dementia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 23-00516; U19AG078105-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Since the outcomes data for this study is largely CMS data, the study team will not be able to share it. In fact, once the study ends, the study team won't be able to access the data. CMS data cannot be made available by the study team.

Drug and device information, study documents

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