ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06079203
Collaborator
National Institute on Aging (NIA) (NIH)
19,200
1
8
55
349.3
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
19200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
ED-LEAD: Emergency Departments Leading the Transformation of Alzheimer's and Dementia Care
Anticipated Study Start Date
:
Jan 2, 2024
Anticipated Primary Completion Date
:
Aug 1, 2028
Anticipated Study Completion Date
:
Aug 1, 2028
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Number of Emergency Department (ED) revisits [Up to 30 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
66 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Joshua Chodosh, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT06079203
Other Study ID Numbers:
- 23-00516
- U19AG078105-01A1
First Posted:
Oct 12, 2023
Last Update Posted:
Oct 12, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by NYU Langone Health
Additional relevant MeSH terms: