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

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia	Other: POISED Care Other: Usual Care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

1654 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 29, 2018

Actual Primary Completion Date :

Oct 31, 2021

Actual Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention 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) will conduct a biopsychosocial/environmental needs assessment by phone within 48 hours of emergency room discharge if not possible during the ED stay.	Other: POISED Care Using information collected, a propose plan of care and tailored interventions to the patients. Patients will understand natural history, and the prognosis of dementia; care protocols will be implemented.
Placebo Comparator: Usual Care will receive referrals to services at the time of enrollment.	Other: Usual Care Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit.

Arm

Intervention/Treatment

Experimental: Intervention

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) will conduct a biopsychosocial/environmental needs assessment by phone within 48 hours of emergency room discharge if not possible during the ED stay.

Other: POISED Care

Using information collected, a propose plan of care and tailored interventions to the patients. Patients will understand natural history, and the prognosis of dementia; care protocols will be implemented.

Placebo Comparator: Usual Care

will receive referrals to services at the time of enrollment.

Other: Usual Care

Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit.

Outcome Measures

Primary Outcome Measures

Number of (ED) Emergency Department Visits [Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

75 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health
National Institute on Aging (NIA)
National Institutes of Health (NIH)

Investigators

Principal Investigator: Joshua Chodosh, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT03325608

Other Study ID Numbers:

16-01473
1R01AG054574-01

First Posted:

Oct 30, 2017

Last Update Posted:

May 2, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Emergencies

Study Results

No Results Posted as of May 2, 2022