Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (POISED)
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|ClinicalTrials.gov Identifier: NCT03325608|
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : May 2, 2022
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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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1654 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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.
- Number of (ED) Emergency Department Visits [ Time Frame: Month 12 ]
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|Ages Eligible for Study:||75 Years and older (Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
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
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Joshua Chodosh, MD||NYU Langone Health|
|Responsible Party:||NYU Langone Health|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|