Evaluating UTI Diagnosis in Nursing Homes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-07

Study Completion Date

2024-11-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes