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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03325608
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : May 2, 2022
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : March 29, 2018
Actual Primary Completion Date : October 31, 2021
Actual Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Number of (ED) Emergency Department Visits [ Time Frame: Month 12 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325608


Locations
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United States, New York
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
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Principal Investigator: Joshua Chodosh, MD NYU Langone Health
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03325608    
Other Study ID Numbers: 16-01473
1R01AG054574-01 ( U.S. NIH Grant/Contract )
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes