INSPIRE Trial for Skin and Soft Tissue Infections

Study Overview
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Brief Summary
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The INSPIRE Skin and Soft Tissue 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 skin and soft tissue 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 Skin and Soft Tissue (SST) Infections

Conditions
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Skin and Soft Tissue (SST) Infection

Intervention / Treatment
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* Other: Arm 1: Routine Care
* Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection


Participation Criteria
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Eligibility Criteria
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Facility Inclusion Criteria: HCA Healthcare hospitals admitting adults for skin and soft tissue 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 skin and soft tissue 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: Cluster randomized controlled trial
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 skin/soft tissue infection in the first 3 days of hospitalization. | Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue 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 a skin/soft tissue 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 Antibacterial Days of Therapy (Empiric ES-DOT) | The number of different extended-spectrum antibacterials on each of the first 3 days of hospitalization. | 12 month intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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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SST, CPOE, Empiric Therapy