search
Back to results

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

Primary Purpose

Alzheimer's Disease Related Dementia, Alzheimer Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emergency Care Redesign (ECR)
Nurse-led Telephonic Care (NLTC)
Community Paramedic-led Transitions Intervention (CPTI)
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alzheimer's Disease Related Dementia focused on measuring Dementia

Eligibility Criteria

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

Inclusion Criteria: patients age 66 and older have two or more ICD-10 visit diagnoses (one of which must be ambulatory) for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD) care partners age 18 and older Exclusion Criteria: patients who are under 66 years old

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

No intervention

Single intervention: Emergency Care Redesign (ECR)

Single intervention: Nurse-led Telephonic Care (NLTC)

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

Two intervention: ECR and NLTC

Two interventions: ECR and CPTI

Two interventions: NLTC and CPTI

All interventions: ECR, NLTC, and CPTI

Arm Description

No intervention, serving as a usual care control group

Outcomes

Primary Outcome Measures

Number of Emergency Department (ED) revisits

Secondary Outcome Measures

Number of ED revisits
Number of ED revisits
Number of hospitalizations
Number of hospitalizations
Number of hospitalizations
Number of healthy days at home

Full Information

First Posted
October 6, 2023
Last Updated
October 6, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)
search

1. Study Identification

Unique Protocol Identification Number
NCT06079203
Brief Title
ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
Official Title
ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2, 2024 (Anticipated)
Primary Completion Date
August 2028 (Anticipated)
Study Completion Date
August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA)

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease Related Dementia, Alzheimer Disease
Keywords
Dementia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention, serving as a usual care control group
Arm Title
Single intervention: Emergency Care Redesign (ECR)
Arm Type
Experimental
Arm Title
Single intervention: Nurse-led Telephonic Care (NLTC)
Arm Type
Experimental
Arm Title
Single intervention: Community Paramedic-led Transitions Intervention (CPTI)
Arm Type
Experimental
Arm Title
Two intervention: ECR and NLTC
Arm Type
Experimental
Arm Title
Two interventions: ECR and CPTI
Arm Type
Experimental
Arm Title
Two interventions: NLTC and CPTI
Arm Type
Experimental
Arm Title
All interventions: ECR, NLTC, and CPTI
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Emergency Care Redesign (ECR)
Intervention Description
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
Intervention Name(s)
Nurse-led Telephonic Care (NLTC)
Intervention Description
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
Intervention Name(s)
Community Paramedic-led Transitions Intervention (CPTI)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Emergency Department (ED) revisits
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Number of ED revisits
Time Frame
Up to 14 days
Title
Number of ED revisits
Time Frame
Up to 6 months
Title
Number of hospitalizations
Time Frame
Up to 14 days
Title
Number of hospitalizations
Time Frame
Up to 30 days
Title
Number of hospitalizations
Time Frame
Up to 6 months
Title
Number of healthy days at home
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients age 66 and older have two or more ICD-10 visit diagnoses (one of which must be ambulatory) for Alzheimer's Disease or Alzheimer's Disease Related Dementias (AD/ADRD) care partners age 18 and older Exclusion Criteria: patients who are under 66 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

We'll reach out to this number within 24 hrs