Trial Outcomes & Findings for Trial to Reduce Antimicrobial Use In Nursing Home Residents With Alzheimer's Disease and Other Dementias (NCT 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

Recruitment status

COMPLETED

Study phase

Target enrollment

430 participants

Primary outcome timeframe

12 months

Results posted on

2021-08-10

Participant Flow

Participant milestones

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

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

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=5 Participants	85.3 years STANDARD_DEVIATION 8.6 • n=7 Participants	86.3 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	163 Participants n=5 Participants	190 Participants n=7 Participants	353 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	22 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	166 Participants n=5 Participants	200 Participants n=7 Participants	366 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

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 months

The 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

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 months

The 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

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 months

The 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

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 82 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 102 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Mitchell MD, MPH

Hebrew SeniorLife

Phone: 6172813669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place