Clinical trial NCT04815369: Evaluating UTI Diagnosis in Nursing Homes
Official title: Evaluating UTI Diagnosis in Nursing Homes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Urinary Tract Infections
Keywords: Nursing Home
Clostridium difficile
PCR
Long Term Care Facility
Skilled Nursing Facility
National Healthcare Safety Network
Lead sponsor: Pathnostics
Sponsor class: INDUSTRY
First posted: 2021-03-25
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cohort of residents residing in the NH facility during 12 consecutive months.-

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion

* Certified skilled nursing facilities (SNF) and nursing homes (NH)
* Nonprofit or for-profit freestanding facility certified by Medicare and Medicaid
* Currently utilizing an EMR system
* Minimum bed size of 100

Exclusion

* Assisted Living Facilities and Residential Care Facilities
* Participation in another UTI trial during the study period

Primary outcomes:
measure: Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce the proportion of patients with UTI-related adverse events.
timeFrame: 12 Months
Secondary outcomes:
measure: Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.
timeFrame: 30 Days
measure: 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 .
timeFrame: 12 Months
measure: Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.
timeFrame: 30 Days
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Pathnostics
state: California
Study officials:
affiliation: Clinical Trials
name: Dave Baunoch, PhD
role: PRINCIPAL_INVESTIGATOR
References: