INSPIRE Trial for Skin and Soft Tissue Infections
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ClinicalTrials.gov Identifier: NCT05423756 |
Recruitment Status :
Active, not recruiting
First Posted : June 21, 2022
Last Update Posted : January 18, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
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Skin and Soft Tissue (SST) Infection | Other: Arm 1: Routine Care Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 102 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Cluster randomized controlled trial |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections |
Actual Study Start Date : | August 2, 2022 |
Estimated Primary Completion Date : | December 2027 |
Estimated Study Completion Date : | December 2028 |
Arm | Intervention/treatment |
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Active Comparator: Arm 1: Routine Care
Continuation of routine antibiotic stewardship strategies.
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Other: Arm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards. |
Active Comparator: Arm 2: INSPIRE Stewardship Bundle
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.
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Other: Arm 2: INSPIRE Stewardship Bundle for Skin and Soft Tissue Infection
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. |
- Empiric Extended-Spectrum Antibacterial Days of Therapy (Empiric ES-DOT) [ Time Frame: 12 month intervention ]The number of different extended-spectrum antibacterials on each of the first 3 days of hospitalization.
- Antipseudomonal Antibiotic Days of Therapy per Empiric Day [ Time Frame: 12 months ]The number of different antipseudomonal antibiotics, per empiric day, summed across the first 3 days of hospitalization.
- Intensive Care Unit (ICU) Transfer [Safety Outcome] [ Time Frame: 12 months ]Days to ICU transfer, from hospital days ≥ 3 and ≤ 14.
- Length-of-stay [Safety Outcome] [ Time Frame: 12 months ]Days from hospital admission until discharge or hospital day 14, where admission day is hospital day 1.
- Extended-Spectrum Days of Therapy with Inpatient Extended-Spectrum (ES) Antibiotic Treatment after Empiric Period [ Time Frame: 12 months ]
The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14.
Note: this outcome is intended for a secondary manuscript
- Empiric and Total Antibiotic Costs [ Time Frame: 12 months ]
Empiric and total antibiotic costs for skin and soft tissue infection during hospitalization.
Note: this outcome is intended for a secondary manuscript.
- Incidence of Hospital-Onset C. difficile [ Time Frame: 12 months ]
Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14.
Note: this outcome is intended for a secondary manuscript.
- Incidence of Hospital-Onset MDRO-Positive Cultures [ Time Frame: 12 months ]
Newly-detected hospital-onset MDRO-positive cultures on hospital days ≥4 and ≤14. Includes total MDRO and specific MDRO subsets.
Note: this outcome is intended for a secondary manuscript.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
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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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05423756
Study Director: | Shruti Gohil, MD, MPH | UC Irvine Division of Infectious Diseases | |
Principal Investigator: | Susan Huang, MD, MPH | UC Irvine Division of Infectious Diseases | |
Principal Investigator: | Richard Platt, MD, MS | Harvard Pilgrim Health Care Institute/Harvard Medical School |
Responsible Party: | Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care |
ClinicalTrials.gov Identifier: | NCT05423756 |
Other Study ID Numbers: |
PH000763B_SST |
First Posted: | June 21, 2022 Key Record Dates |
Last Update Posted: | January 18, 2024 |
Last Verified: | January 2024 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
SST CPOE Empiric Therapy |
Infections Communicable Diseases Disease Attributes Pathologic Processes |