Dementia
Conditions
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.
Interventions
OTHERPOISED Care
Program of dementia care management.
Sponsors
National Institute on Aging (NIA)
National Institutes of Health (NIH)
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment | Up to Month 6 | Percentage of participants who visit the ED within 6 months of being enrolled. |
Countries
United States
Participant flow
Pre-assignment details
The protocol enrollment of 889 represents the total number of patient/care-provider dyads; 247 dyads did not start the trial.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 320 |
| POISED Care Intervention - Care Givers of Patients Caregivers of patients assigned to receive the POISED Care Intervention. | 320 |
| 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. | 322 |
| Usual Care - Care Givers of Patients Caregivers of patients assigned to receive usual care. | 322 |
| Total | 1,284 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death of Caregiver | 0 | 0 | 2 | 2 |
| Overall Study | Death of Care Recipient | 34 | 34 | 28 | 28 |
| Overall Study | Ineligible | 7 | 7 | 5 | 5 |
| Overall Study | Lost to Follow-up | 23 | 23 | 30 | 30 |
| Overall Study | Withdrawal by Subject | 49 | 49 | 35 | 35 |
Baseline characteristics
| Characteristic | POISED Care Intervention - Patients | POISED Care Intervention - Care Givers of Patients | Usual Care - Patients | Usual Care - Care Givers of Patients | Total |
|---|---|---|---|---|---|
| Age, Continuous | 85.3 years STANDARD_DEVIATION 6.3 | 60.9 years STANDARD_DEVIATION 11.8 | 85.1 years STANDARD_DEVIATION 6.1 | 59.6 years STANDARD_DEVIATION 13.3 | 72.725 years STANDARD_DEVIATION 9.375 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 58 Participants | 33 Participants | 69 Participants | 188 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 188 Participants | 261 Participants | 184 Participants | 251 Participants | 884 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 104 Participants | 1 Participants | 105 Participants | 2 Participants | 212 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 8 Participants | 7 Participants | 8 Participants | 29 Participants |
| Race/Ethnicity, Customized Black or African American | 56 Participants | 58 Participants | 57 Participants | 58 Participants | 229 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 43 Participants | 0 Participants | 56 Participants | 99 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 57 Participants | 4 Participants | 64 Participants | 4 Participants | 129 Participants |
| Race/Ethnicity, Customized White | 199 Participants | 207 Participants | 192 Participants | 193 Participants | 791 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 8 Participants | 7 Participants | 8 Participants | 29 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 58 Participants | 57 Participants | 58 Participants | 229 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 57 Participants | 47 Participants | 64 Participants | 60 Participants | 228 Participants |
| Race (NIH/OMB) White | 199 Participants | 207 Participants | 192 Participants | 193 Participants | 791 Participants |
| Region of Enrollment United States | 320 participants | 320 participants | 322 participants | 322 participants | 1284 participants |
| Sex/Gender, Customized Female | 221 Participants | 230 Participants | 201 Participants | 240 Participants | 892 Participants |
| Sex/Gender, Customized Male | 99 Participants | 89 Participants | 121 Participants | 80 Participants | 389 Participants |
| Sex/Gender, Customized Prefer Not to Answer | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Sex/Gender, Customized Unknown or not reported | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 34 / 320 | 0 / 320 | 28 / 322 | 2 / 322 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Up to Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| POISED Care Intervention - Patients | Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment | 41.60 percentage of participants |
| Usual Care - Patients | Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment | 39.40 percentage of participants |