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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03325608
Other study ID # 16-01473
Secondary ID 1R01AG054574-01
Status Completed
Phase N/A
First received
Last updated
Start date March 29, 2018
Est. completion date October 31, 2021

Study information

Verified date March 2023
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dementia is a common problem for older patients presenting to emergency departments and for the family caregivers who often lack support, understanding, and skills to manage the problems related to the need for emergency department visits. The purpose of Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED-CPCIP, here on referred to as POISED) randomized controlled trial is to use previously established quality improvement methods of root cause analysis to uncover reasons for emergency department use and to focus on caregiver activation within a program of dementia care management. The goals of this study are to reduce recurrent emergency department visits and improve caregiver symptoms of depression, anxiety and need for social support.


Recruitment information / eligibility

Status Completed
Enrollment 889
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 75 Years and older
Eligibility Inclusion Criteria: - Must be in the emergency department for care at the point of recruitment - Must be English- or Spanish-speaking - Must have a family member or friend who provides caregiving assistance - Must have a plan to be discharged to home (ESI = 4 or 5) - Must have score <3 on the MiniCog or if using caregiver assessment by IQCODE must be >3.4 - Must have capacity to consent or have a proxy. Exclusion Criteria: - Care recipient (CR) is a resident of a nursing home or other supportive facility - CR scores > 3 on the MiniCog or the caregiver assessment by IQCODE was < 3.4 - Caregiver (CG) declines participation - CR is not being discharged to home

Study Design


Related Conditions & MeSH terms


Intervention

Other:
POISED Care
Program of dementia care management.

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (3)

Lead Sponsor Collaborator
NYU Langone Health National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment Percentage of participants who visit the ED within 6 months of being enrolled. Up to Month 6
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