Evaluating UTI Diagnosis in Nursing Homes

Urinary Tract Infections Clinical Trial

Official title:

Evaluating UTI Diagnosis in Nursing Homes

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04815369
• Other study ID #: 2021-PUTINH
• Status: Suspended
• Start date: June 7, 2021
• Est. completion date: May 2024

Study information

• Verified date: August 2023
• Source: Pathnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40000
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urinary Tract Infections

Locations

Country	Name	City	State
United States	Pathnostics	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Pathnostics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	12 Months
Secondary	Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce overall inappropriate antibiotic use.	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.	30 Days
Secondary	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 .	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	12 Months
Secondary	Examine prospective data to determine if the use of Guidance® UTI Clinical Pathway, compared to traditional clinical pathways, will reduce UTI antibiotic collateral effects.	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	30 Days