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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06079203
• Other study ID #: 23-00516
• Secondary ID: U19AG078105-01A1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 2028

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Senem Suzek, MA
• Phone: 646-501-0601
• Email: Senem.Suzek[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19200
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 66 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Emergencies

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Emergency Department (ED) revisits		Up to 30 days
Secondary	Number of ED revisits		Up to 14 days
Secondary	Number of ED revisits		Up to 6 months
Secondary	Number of hospitalizations		Up to 14 days
Secondary	Number of hospitalizations		Up to 30 days
Secondary	Number of hospitalizations		Up to 6 months
Secondary	Number of healthy days at home		Up to 6 months