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

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Other: POISED Care

Detailed Description

POISED, a 4-year study, will test whether a novel care management intervention for family CGs of ED users with cognitive impairment and likely Alzheimer's disease and related dementias will reduce ED use at 3 and 6 months over the intervention period. ED use and other measures will also be examined during a brief follow-up at 12 months (6 months after completed intervention).

• Study Type: Interventional
• Enrollment (Actual): 889
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: POISED Care; 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.	Other: POISED Care; Program of dementia care management.
No Intervention: Usual Care; Participants will receive referrals to services at the time of enrollment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institutes of Health (NIH); National Institute on Aging (NIA)
• Investigators: Principal Investigator: Joshua Chodosh, MD, NYU Langone Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): November 2, 2021
• Study Completion (Actual): November 2, 2021

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 11, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Emergencies; Dementia
• Other Study ID Numbers: 16-01473; 1R01AG054574-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No