Trial Outcomes & Findings for Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients (NCT NCT03325608)
NCT ID: NCT03325608
Last Updated: 2024-10-16
Results Overview
Percentage of participants who visit the ED within 6 months of being enrolled.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
889 participants
Primary outcome timeframe
Up to Month 6
Results posted on
2024-10-16
Participant Flow
The protocol enrollment of "889" represents the total number of patient/care-provider dyads; 247 dyads did not start the trial.
Participant milestones
| Measure |
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.
|
POISED Care Intervention - Caregivers of Patients
Caregivers of patients assigned to receive the POISED Care intervention.
|
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.
|
Usual Care - Caregivers of Patients
Caregivers of patients assigned to receive usual care.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
320
|
320
|
322
|
322
|
|
Overall Study
COMPLETED
|
207
|
207
|
222
|
222
|
|
Overall Study
NOT COMPLETED
|
113
|
113
|
100
|
100
|
Reasons for withdrawal
| Measure |
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.
|
POISED Care Intervention - Caregivers of Patients
Caregivers of patients assigned to receive the POISED Care intervention.
|
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.
|
Usual Care - Caregivers of Patients
Caregivers of patients assigned to receive usual care.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
23
|
23
|
30
|
30
|
|
Overall Study
Death of Caregiver
|
0
|
0
|
2
|
2
|
|
Overall Study
Death of Care Recipient
|
34
|
34
|
28
|
28
|
|
Overall Study
Withdrawal by Subject
|
49
|
49
|
35
|
35
|
|
Overall Study
Ineligible
|
7
|
7
|
5
|
5
|
Baseline Characteristics
Program of Intensive Support in Emergency Departments for Care Partners of Cognitively Impaired Patients
Baseline characteristics by cohort
| Measure |
POISED Care Intervention - Patients
n=320 Participants
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.
|
POISED Care Intervention - Care Givers of Patients
n=320 Participants
Caregivers of patients assigned to receive the POISED Care Intervention.
|
Usual Care - Patients
n=322 Participants
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.
|
Usual Care - Care Givers of Patients
n=322 Participants
Caregivers of patients assigned to receive usual care.
|
Total
n=1284 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
85.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 11.8 • n=7 Participants
|
85.1 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
72.725 years
STANDARD_DEVIATION 9.375 • n=21 Participants
|
|
Sex/Gender, Customized
Female
|
221 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
201 Participants
n=5 Participants
|
240 Participants
n=4 Participants
|
892 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Male
|
99 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
389 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex/Gender, Customized
Prefer Not to Answer
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
188 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
188 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
251 Participants
n=4 Participants
|
884 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
104 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
212 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
229 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
199 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
791 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
57 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
228 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
56 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
229 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
199 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
791 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
99 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
57 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
129 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
320 participants
n=5 Participants
|
320 participants
n=7 Participants
|
322 participants
n=5 Participants
|
322 participants
n=4 Participants
|
1284 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Month 6Percentage of participants who visit the ED within 6 months of being enrolled.
Outcome measures
| Measure |
POISED Care Intervention - Patients
n=315 Participants
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.
|
Usual Care - Patients
n=317 Participants
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.
|
|---|---|---|
|
Percentage of Participants With an Emergency Department (ED) Visit Within 6 Months After Enrollment
|
41.60 percentage of participants
Interval 36.1 to 47.3
|
39.40 percentage of participants
Interval 34.0 to 45.1
|
Adverse Events
POISED Care Intervention - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 34 deaths
POISED Care Intervention - Care Givers of Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care - Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 28 deaths
Usual Care - Care Givers of Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place