This prospective, multicenter, comparative cohort observational study is to determine whether
      the use of Guidance® UTI Clinical Pathway, a standardized infrastructure for specimen
      collection and result delivery, compared with current traditional pathways for urine testing
      reduces the proportion of UTI patients with poor outcomes.

Evaluating UTI Diagnosis in Nursing Homes

Urinary Tract Infections

The objective of this study is to determine if prospective data, collected over 12 months
      from over 200 nursing homes, will show that the use of Guidance® UTI Clinical Pathway is more
      effective than the Traditional Clinical Pathways for urine testing in UTI diagnosis in
      Nursing Homes. Guidance® UTI Clinical Pathway provides standardized infrastructure for
      specimen collection, and result dissemination via assigned report point person to verify
      receipt of actionable data. The pathway also includes several in-services on molecular
      testing for UTI, Pooled Antibiotic Susceptibility Testing, and polymicrobial infections to
      help providers better understand test methodology. Standardizing a Clinical Care Pathway for
      testing and reporting of clinical results approach may lead to a reduction in empiric broad
      spectrum antibiotic use and in turn better health-related outcomes for patients. Such
      efficiency in clinical decision making at the time of initial presentation may lead to
      improved patient care by avoiding ineffective therapy due to mismanagement or incomplete lab
      diagnosis. The study will be observing the implementation of the Guidance® UTI Clinical
      Pathway and comparing it to traditional clinical care pathways from facility-level data
      entered into the National Healthcare Safety Network for its LTCF (Long Term Care Facilities)
      Component.

Examine the proportion of patients with UTI-related adverse events requiring emergency hospital services over the course the study with a composite measure of the number of UTI related ED visits and/or subsequent hospitalizations and/or sepsis events.

Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use as measured by the rate of empiric antibiotic starts and the rate of antimicrobial changes for UTI indication.

Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway is more effective than standard urine testing approaches in the clinical evaluation of UTI diagnosis and management as measured by UTI incidence and corresponding urine testing rate
(UTI and Catheter associated (CA)-UTI bacterial identification incidence rates (diagnostic aim)
Population UTI Rate = (UTI Episodes/Resident Days) x 1,000
CA-UTI Rate = (CA-UTI Episode/Catheter days) x 1,000

Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects as measured by:
C. diff event rate = (Total C. diff events/ total resident days) x 1,000

Facilities will be provided a standardized infrastructure and process for collecting and reporting of urine test results including unique lab requisitions that contain the option to order Guidance® UTI, Standard Urine Culture (SUC), and Urine Analysis (UA) along with a protocol for results notification to a central point person within the Nursing Home (NH) facility

Facilities will employ their current standard clinical care practices for suspected UTI, including SUC, UA, and Guidance® UTI testing as per current reporting practices. Providers at these facilities will have the option to order any diagnostic test they deem appropriate.

Evaluating UTI Diagnosis in Nursing Homes

About this trial

Study ID

Status

Type

Placebo

Accepting

Trial Timing

What is this trial about?

What are the Participation Requirements?

Locations

Location

Status