Morbidity Rate for UTI Through Use of PCR-Based Diagnosis and Management

Completed

• Conditions: Urinary Tract Infections
• Interventions: Diagnostic Test: Guidance UTI

• Registration Number: NCT04108910
• Lead Sponsor: Pathnostics

Brief Summary

This retrospective study is to determine if the use of PCR for detection and identification of pathogens in UTI along with antimicrobial susceptibility information, affords more efficacious treatment of UTI, as compared to traditional urine culture for patients served by House Call Physicians.

Detailed Description

The objective of this study is to determine if retrospective data will show that use of PCR for detection and identification of pathogens in UTI, and antimicrobial susceptibility information, affords more efficacious treatment of UTI, thereby reducing UTI-related morbidity and costs in a patient population that is served by House Call Physicians. House call physicians attend elderly and other adults patients who are suffering from illness or chronic conditions in the safety, privacy, and comfort of their home or assisted living location. In making house calls, physicians ease the burden and difficulty of these chronic patients from traveling to the doctor's office.

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2019-07
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Completion: 2020-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-01
• Last Update Posted: 2024-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66381

Inclusion Criteria

• All patients that the House Call Physician suspects the patient has a UTI and are tagged with the following codes within the medical record

Exclusion Criteria

• Records where the NPI does not match a known provider or the office listed is not a Specific Population
• Hospice patients
• Records for which DX codes of "X" and "NoDx" where there isn't a diagnostic description.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Guidance PCR/Pooled Sensitivity	Guidance UTI	Patients treated based upon multiplex UTI PCR/pooled sensitivity results

Primary Outcome Measures

Name	Time	Method
ER Visits and or Hospital Admission Rate within 30 days of initial visit related to UTI	18 Months	Examine retrospective data of a House Call Patient population to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity, as measured by the composite variable number of emergency room/urgent care clinic visits plus the number of admissions to hospital within 30 days of an initial presentation for UTI.

Secondary Outcome Measures

Name	Time	Method
Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity.	18 Months	Examine retrospective data to determine if use of PCR, compared with conventional urine culture, leads to a reduction in UTI-related morbidity: * As measured by the number of emergency room visits within 30 days of an initial presentation for UTI.; * As measured by the number of urgent care clinic visits within 30 days of an initial presentation for UTI.; * As measured by the number of cases escalated from an urgent care clinic to an emergency room within 30 days of an initial presentation for UTI.; * As measured by the number of admissions to hospital within 30 days of initial presentation for UTI.; * As measured by the total hospital length of stay resulting from hospital admission within 30 days of initial presentation for UTI.