ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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
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)
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)
|
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)
|
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)
|
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
|
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
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
|
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 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
|
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 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
|
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
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 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
Time Frame: Up to 30 days
|
Up to 30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of ED revisits
Time Frame: Up to 14 days
|
Up to 14 days
|
|
Number of ED revisits
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Number of hospitalizations
Time Frame: Up to 14 days
|
Up to 14 days
|
|
Number of hospitalizations
Time Frame: Up to 30 days
|
Up to 30 days
|
|
Number of hospitalizations
Time Frame: Up to 6 months
|
Up to 6 months
|
|
Number of healthy days at home
Time Frame: Up to 6 months
|
Up to 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joshua Chodosh, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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