The INSPIRE-ASP UTI Trial

Study Overview
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Brief Summary
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The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen. Note: that enrolled subjects represents 59 individual HCA hospitals that have been randomized.

Official Title
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INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI): The INSPIRE-ASP UTI Trial

Conditions
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Urinary Tract Infection (UTI)

Intervention / Treatment
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* Other: Routine Care
* Other: INSPIRE CPOE Smart Prompt


Participation Criteria
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Eligibility Criteria
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Facility Inclusion Criteria: HCA hospitals admitting adults for UTI Facility use of MEDITECH as their electronic health record system Facility Exclusion Criteria: - Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine Care<br>Continued routine antibiotic stewardship strategies. | Other: Routine Care<br>* Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.<br>|
| Active Comparator: INSPIRE CPOE Smart Prompt<br>Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for UTI in non-ICU patients in the first 3 days of hospitalization. | Other: INSPIRE CPOE Smart Prompt<br>* Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having a UTI due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) per Empiric Day | The summed number of different extended-spectrum antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission. | 15 month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancomycin Days of Antibacterial Therapy per Empiric Day | The summed number of days of Vancomycin received each empiric day per at-risk-day (first 3 days of admission). Note: this outcome is intended for the primary manuscript. | 15 month intervention | 
| Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) per Empiric Day | The summed number of different antipseudomonal antibacterials received each empiric day, measured repeatedly over the first three days of an admission and divided by the number of empiric days of the admission. An empiric day is a day within the first three days of an admission. Note: this outcome is intended for the primary manuscript. | 15 month intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI, CPOE, Empiric Therapy