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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
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

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)
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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

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Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients

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