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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG054574-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Usual Care | No Intervention | Participants will receive referrals to services at the time of enrollment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POISED Care | Other | Program of dementia care management. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Chodosh, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36264626 | Derived | 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. |
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The protocol enrollment of "889" represents the total number of patient/care-provider dyads; 247 dyads did not start the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | POISED Care Intervention - Patients | Participants assigned to the POISED Care 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. 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. |
| FG001 | POISED Care Intervention - Caregivers of Patients | Caregivers of patients assigned to receive the POISED Care intervention. |
| FG002 | Usual Care - Patients | Patients will receive referrals to services at the time of enrollment. Usual Care: Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit. |
| FG003 | Usual Care - Caregivers of Patients | Caregivers of patients assigned to receive usual care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | POISED Care Intervention - Patients | Participants assigned to the POISED Care 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to Month 6 |
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6 months
Serious and Other Adverse Events were not formally monitored/assessed among participants (patients and caregivers).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | POISED Care Intervention - Patients | Participants assigned to the POISED Care 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. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joshua Chodosh, MD, MSHS, FACP | NYU Langone Health | 212-263-6768 | Joshua.Chodosh@nyumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2021 | Dec 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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| Death of Caregiver |
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| Death of Care Recipient |
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| Withdrawal by Subject |
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| Ineligible |
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| BG001 | POISED Care Intervention - Care Givers of Patients | Caregivers of patients assigned to receive the POISED Care Intervention. |
| BG002 | Usual Care - Patients | Patients will receive referrals to services at the time of enrollment. Usual Care: Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit. |
| BG003 | Usual Care - Care Givers of Patients | Caregivers of patients assigned to receive usual care. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Usual Care - Patients | Patients will receive referrals to services at the time of enrollment. Usual Care: Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit. |
|
|
| 34 |
| 320 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | POISED Care Intervention - Care Givers of Patients | Caregivers of patients assigned to POISED Care intervention. | 0 | 320 | 0 | 0 | 0 | 0 |
| EG002 | Usual Care - Patients | Patients will receive referrals to services at the time of enrollment. Usual Care: Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit. | 28 | 322 | 0 | 0 | 0 | 0 |
| EG003 | Usual Care - Care Givers of Patients | Caregivers of patients assigned to usual care. | 2 | 322 | 0 | 0 | 0 | 0 |
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| D001523 | Mental Disorders |