INSPIRE Trial for Abdominal Infections

Study Overview
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Brief Summary
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The INSPIRE Abdominal Infection Trial is a cluster-randomized controlled trial of HCA Healthcare hospitals comparing routine empiric antibiotic stewardship practices with real-time, precision medicine computerized physician order entry (CPOE) smart prompts providing the probability that a non-critically ill adult admitted with abdominal infection is infected with a resistant pathogen. Note: enrolled subjects represent 102 individual HCA Healthcare hospitals that have been randomized into 92 clusters. Hospitals were grouped into the same randomization cluster if they shared campuses or antibiotic stewardship staff.

Official Title
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The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections

Conditions
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Abdominal (ABD) Infection

Intervention / Treatment
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* Other: Arm 1: Routine Care
* Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection


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

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: Arm 1: Routine Care<br>Continuation of routine antibiotic stewardship strategies. | Other: Arm 1: Routine Care<br>* Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.<br>|
| Active Comparator: Arm 2: INSPIRE Stewardship Bundle<br>Use of computerized physician order entry (CPOE) smart prompts, clinician feedback, and activities to support CPOE adoption (including education and alignment of CPOE workflows) to guide empiric choice of antibiotics for abdominal infection in the first 3 days of hospitalization. | Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection<br>* Quality improvement intervention that includes (1) computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimates for having an abdominal infection due to a multidrug-resistant organism (MDRO) and recommends standard spectrum antibiotics for low risk patients in the first 3 days of hospitalization; (2) clinician feedback reports, and (3) activities to support CPOE adoption (including education and alignment of CPOE workflows). Other antibiotic stewardship activities to continue in accordance with national standards.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT) | The number of different extended-spectrum antibiotics per empiric day, summed across the first 3 days of hospitalization. | 12 month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancomycin Days of Therapy per Empiric Day | The number of days Vancomycin was received on the first 3 days of hospitalization. | 12 months | 
| Antipseudomonal Antibiotic Days of Therapy per Empiric Day | The number of different antipseudomonal antibiotics, per empiric day, summed across the first 3 days of hospitalization. | 12 months | 

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