Trial Outcomes & Findings for Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (NCT NCT03244917)
NCT ID: NCT03244917
Last Updated: 2021-08-10
Results Overview
The investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
COMPLETED
NA
430 participants
12 months
2021-08-10
Participant Flow
Participant milestones
| Measure |
TRAIN-AD
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Overall Study
STARTED
|
201
|
229
|
|
Overall Study
COMPLETED
|
199
|
227
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
TRAIN-AD
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias
Baseline characteristics by cohort
| Measure |
TRAIN-AD
n=199 Participants
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
n=227 Participants
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
Total
n=426 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87.7 years
STANDARD_DEVIATION 8.0 • n=99 Participants
|
85.3 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
86.3 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
163 Participants
n=99 Participants
|
190 Participants
n=107 Participants
|
353 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=99 Participants
|
200 Participants
n=107 Participants
|
366 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsThe investigators will compare the total number of antimicrobial courses for suspected UTIs and LRIs/person-year (primary outcome) over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Outcome measures
| Measure |
TRAIN-AD
n=199 Participants
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
n=227 Participants
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Total Antimicrobial Use for LRI and UTIs
|
0.55 antimicrobial courses per person-year
Interval 0.25 to 0.84
|
0.82 antimicrobial courses per person-year
Interval 0.49 to 1.14
|
SECONDARY outcome
Timeframe: 12 monthsThe investigators will compare the number of antimicrobial courses prescribed for suspected UTIs and LRIs when minimal criteria for treatment initiation are absent based on consensus guidelines/person-year (secondary outcome) in the intervention vs. control arm over 12 months.
Outcome measures
| Measure |
TRAIN-AD
n=199 Participants
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
n=227 Participants
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Antimicrobial Use When Minimal Criteria Are Absent for LRI and UTIs
|
0.37 antimicrobial courses per person-year
Interval 0.15 to 0.6
|
0.43 antimicrobial courses per person-year
Interval 0.23 to 0.62
|
SECONDARY outcome
Timeframe: 12 monthsThe investigators will compare the number of burdensome procedures used to evaluate suspected LRIs and UTIs (hospital transfer, bladder catheterization, chest x-ray, blood draws)/person-year between the intervention versus control arm
Outcome measures
| Measure |
TRAIN-AD
n=199 Participants
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
n=227 Participants
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Burdensome Interventions
|
1.07 interventions per person-year
Interval 0.54 to 1.6
|
1.69 interventions per person-year
Interval 0.87 to 2.51
|
SECONDARY outcome
Timeframe: 12 monthsThe investigators will compare the total number of antimicrobial courses prescribed for any reason /person-year over 12 months in the intervention vs. control (usual care) arms. Data will be obtained from review of the residents' charts and medication administration records q2months up to 12 months
Outcome measures
| Measure |
TRAIN-AD
n=199 Participants
Residents with advanced dementia living in nursing homes randomized to receive the TRAIN-AD program to guide the management of suspected urinary and respiratory tract infections
|
Control
n=227 Participants
Residents with advanced dementia living in facilities randomized to control arm that employed usual care to manage suspected urinary and respiratory tract infections
|
|---|---|---|
|
Total Antimicrobial Use
|
0.82 antimicrobial courses per person-year
Interval 0.52 to 1.13
|
1.19 antimicrobial courses per person-year
Interval 0.83 to 1.56
|
Adverse Events
TRAIN-AD
Control
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