Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED)
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
POISED Care
Sponsored by

About this trial
This is an interventional treatment trial for Dementia
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
POISED Care
Usual Care
Arm Description
Dyads randomized to the POISED Care intervention will work with the POISED care management team - consisting of specially-trained nurses functioning as care managers (CMs) and para-professionals in the role of care manager assistants (CMAs) - to create an individualized care plan through the lens of cognitive impairment with an emphasis on coordinating care with the patient's primary care provider (PCP) and achieving relevance with the goals and capacity of the family care-giver and care-recipient.
Participants will receive referrals to services at the time of enrollment.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03325608
First Posted
October 25, 2017
Last Updated
March 29, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03325608
Brief Title
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Acronym
POISED
Official Title
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 29, 2018 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Aging (NIA), National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
889 (Actual)
8. Arms, Groups, and Interventions
Arm Title
POISED Care
Arm Type
Experimental
Arm Description
Dyads randomized to the POISED Care intervention will work with the POISED care management team - consisting of specially-trained nurses functioning as care managers (CMs) and para-professionals in the role of care manager assistants (CMAs) - to create an individualized care plan through the lens of cognitive impairment with an emphasis on coordinating care with the patient's primary care provider (PCP) and achieving relevance with the goals and capacity of the family care-giver and care-recipient.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will receive referrals to services at the time of enrollment.
Intervention Type
Other
Intervention Name(s)
POISED Care
Intervention Description
Program of dementia care management.
Primary Outcome Measure Information:
Title
Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment
Description
Percentage of participants who visit the ED within 6 months of being enrolled.
Time Frame
Up to Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
36264626
Citation
Chodosh J, Connor K, Fowler N, Gao S, Perkins A, Grudzen C, Messina F, Mangold M, Smilowitz J, Boustani M, Borson S. Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients: Protocol for a Multisite Randomized Controlled Trial. JMIR Res Protoc. 2022 Oct 20;11(10):e36607. doi: 10.2196/36607.
Results Reference
derived
Learn more about this trial
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
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