NCT03325608

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
889

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 31, 2023

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

3.7 years

First QC Date

October 25, 2017

Results QC Date

December 13, 2022

Last Update Submit

October 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

POISED Care

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

Participants will receive referrals to services at the time of enrollment.

Interventions

Program of dementia care management.

POISED Care

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Joshua Chodosh, MD, MSHS, FACP
Organization
NYU Langone Health

Study Officials

  • Joshua Chodosh, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2017

First Posted

October 30, 2017

Study Start

March 7, 2018

Primary Completion

November 2, 2021

Study Completion

November 2, 2021

Last Updated

October 16, 2024

Results First Posted

March 31, 2023

Record last verified: 2024-10

Locations