Evaluating UTI Diagnosis in Nursing Homes
Evaluating UTI Diagnosis in Nursing Homes
This prospective study is to determine if the use of Guidance UTI, a PCR-based test that
 detects and identifies common UTI pathogens and informs of antimicrobial susceptibility,
 affords more efficacious treatment of UTI, as compared to traditional non-molecular standard
 urine culture (SUC) and sensitivity testing methods for patients of nursing homes.
The objective of this study is to determine if prospective data, collected over 12 months
 from 200 nursing homes, will show that the use of Guidance UTI for detection and
 identification of pathogens in UTI, and antimicrobial susceptibility information, affords
 more efficacious treatment of UTI compared to traditional standard urine culture (SUC). The
 superiority hypothesis is that Guidance® UTI is more effective will be measured by the number
 of UTI-related adverse events requiring emergent hospital services, antibiotic ordering
 accuracy, UTI- treatment related C.diff events, and overall urine testing rate for UTI. The
 results of this study will provide evidence-based diagnosis and treatment approach extremely
 common clinical condition among this target group. This could help preserve the efficacy of
 valuable antimicrobials during a time of steadily increasing antimicrobial resistance and
 protect future patients from inappropriate, antimicrobial therapy for their UTI.
Nursing Home Inclusion/Exclusion Criteria:

 -  Facility is either a SNF, Long term care setting, assisted living.

 -  Must be certified by Medicare and Medicaid and can either be nonprofit or for-profit
 freestanding facility.

 -  Minimum bed size 50 (beds size= staffed beds and not occupied beds) with no more than
 35% of total beds in the home dedicated to short-stay (acute care) residents OR a
 minimum of 60 beds dedicated for long-term stay.

 -  Independent Living Facilities enrolled in NHSN LTCF and willing/able to complete UTI
 and CDI components and add study sponsor as NHSN user for the facility.

 -  Must be enrolled into NHSN LTCF UTI and CDI component and add study sponsor as NHSN.

 -  Successful completion of a 30-day training period followed by a 30-day testing period
 before randomization and 12 months of prospective data collection.

 -  Trained staff (data capture, result interpretation etc.,) present at all times.

 -  Must be willing/able to capture 100% of UTI events on each Monthly Reporting Plan for
 LTCF NHSN UTI and C. diff module.

 -  The facility may not participate in another UTI trial during the course of the study
 that will affect the method of care in which the assigned testing methods in this
 protocol are delivered.