Evaluating UTI Diagnosis in Nursing Homes

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.

Study Overview

• Status: Suspended
• Conditions: Urinary Tract Infections

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.

• Study Type: Observational
• Enrollment (Estimated): 40000

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92614
      • Pathnostics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Cohort of residents residing in the NH facility during 12 consecutive months.-

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Guidance Clinical Pathway; 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
Traditional Clinical Pathway; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Pathnostics
• Investigators: Principal Investigator: Dave Baunoch, PhD, Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 22, 2021
• First Submitted That Met QC Criteria: March 22, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Skilled Nursing Facility; PCR; Clostridium difficile; Nursing Home; Long Term Care Facility; National Healthcare Safety Network
• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Tract Infections
• Other Study ID Numbers: 2021-PUTINH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No