INSPIRE Trial for Skin and Soft Tissue Infections
The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Skin and Soft Tissue (SST) Infections
1 other identifier
interventional
118,562
1 country
102
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 9, 2024
CompletedResults Posted
Study results publicly available
August 26, 2025
CompletedAugust 26, 2025
August 1, 2025
1.4 years
June 14, 2022
May 9, 2025
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Days-of-Therapy is a standardized national measure for antibacterial use in hospitals that counts each different antibiotic administered on each calendar day as one day of therapy, regardless of doses given. Extended-spectrum days-of-therapy per empiric day is defined as the summed number of different extended-spectrum antibiotics received per patient each calendar day, beginning at admission. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator. For example, 2 different extended-spectrum antibiotics administered at least once during each of the first 3 days would yield 6 days of extended-spectrum days-of-therapy.
First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Secondary Outcomes (1)
Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day
First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Other Outcomes (6)
Intensive Care Unit (ICU) Transfer [Safety Outcome 1]
Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods
Length-of-stay [Safety Outcome 2]
Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods
Extended-Spectrum Days of Therapy With Inpatient Extended-Spectrum (ES) Antibiotic Treatment After Empiric Period
12 months
- +3 more other outcomes
Study Arms (2)
Arm 1: Routine Care
ACTIVE COMPARATORContinuation of routine antibiotic stewardship strategies.
Arm 2: INSPIRE Stewardship Bundle
ACTIVE COMPARATORUse 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.
Interventions
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
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.
Eligibility Criteria
You may qualify if:
- HCA Healthcare hospitals admitting adults for skin and soft tissue infection
- Facility use of MEDITECH as their electronic health record system
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard Pilgrim Health Carelead
- Hospital Corporation of Americacollaborator
- University of California, Irvinecollaborator
- University of Massachusetts, Amherstcollaborator
- Brigham and Women's Hospitalcollaborator
- Rush Universitycollaborator
Study Sites (102)
Riverside Community hospital
Riverside, California, 92501, United States
Regional Medical Center of San Jose
San Jose, California, 95116, United States
Good Samaritan Hospital
San Jose, California, 95124, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, 91360, United States
West Hills Hospital & Medical Center
West Hills, California, 91307, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Blake Medical Center
Bradenton, Florida, 34209, United States
Brandon Regional Hospital
Brandon, Florida, 33511, United States
Oak Hill Hospital
Brooksville, Florida, 34613, United States
Englewood Community Hospital
Englewood, Florida, 34223, United States
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, 32547, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, 34950, United States
Regional Medical Center Bayonet Point
Hudson, Florida, 34667, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216, United States
Lake City Medical Center
Lake City, Florida, 32055, United States
Largo Medical Center
Largo, Florida, 33770, United States
Northwest Medical Center
Margate, Florida, 33060, United States
Mercy Hospital
Miami, Florida, 33133, United States
Kendall Regional Medical Center
Miami, Florida, 33175, United States
Orange Park Medical Center
Orange Park, Florida, 32073, United States
Oviedo Medical Center
Oviedo, Florida, 32765, United States
Gulf Coast Regional Medical Center
Panama City, Florida, 32405, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, 33952, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, 34952, United States
Doctors Hospital of Sarasota
Sarasota, Florida, 34233, United States
Palms of Pasadena
St. Petersburg, Florida, 33707, United States
Northside Hospital
St. Petersburg, Florida, 33709, United States
St. Petersburg General Hospital
St. Petersburg, Florida, 33710, United States
South Bay Hospital
Sun City Center, Florida, 33573, United States
Capital Regional Medical Center
Tallahassee, Florida, 32308, United States
HCA Florida South Tampa Hospital
Tampa, Florida, 33609, United States
HCA Florida West Tampa Hospital
Tampa, Florida, 33615, United States
Medical Center of Trinity
Trinity, Florida, 34655, United States
JFK Medical Center - North Campus
West Palm Beach, Florida, 33407, United States
Fairview Park Hospital
Dublin, Georgia, 31040, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, 83404, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Overland Park Regional Medical Center
Overland Park, Kansas, 66215, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
Wesley Woodlawn Hospital & ER
Wichita, Kansas, 67220, United States
TriStar Greenview Regional Hospital
Bowling Green, Kentucky, 42104, United States
Lakeview Regional Medical Center
Covington, Louisiana, 70433, United States
Tulane Medical Center
New Orleans, Louisiana, 70112, United States
Centerpoint Medical Center
Independence, Missouri, 64057, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, 64063, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Southern Hills Hospital & Medical Center
Las Vegas, Nevada, 89148, United States
Trident Medical Center
Charleston, South Carolina, 29406, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, 29572, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
Parkridge East Hospital
Chattanooga, Tennessee, 37412, United States
TriStar Horizon Medical Center
Dickson, Tennessee, 37055, United States
TriStar Hendersonville Medical Center
Hendersonville, Tennessee, 37075, United States
TriStar Centennial Medical Center
Nashville, Tennessee, 37203, United States
TriStar Southern Hills Medical Center
Nashville, Tennessee, 37211, United States
TriStar StoneCrest Medical Center
Smyrna, Tennessee, 37167, United States
Medical City Arlington
Arlington, Texas, 76015, United States
St. David's Medical Center
Austin, Texas, 78705, United States
St. David's North Austin Medical Center
Austin, Texas, 78758, United States
Valley Regional Medical Center
Brownsville, Texas, 78526, United States
HCA Houston Healthcare Conroe
Conroe, Texas, 77304, United States
Corpus Christi Medical Center - Doctors Regional
Corpus Christi, Texas, 78411, United States
Corpus Christi Medical Center - Bay Area
Corpus Christi, Texas, 78412, United States
Corpus Christi Medical Center - Heart Hospital
Corpus Christi, Texas, 78412, United States
Medical City Dallas
Dallas, Texas, 75230, United States
Medical City Denton
Denton, Texas, 76210, United States
Las Palmas Medical Center
El Paso, Texas, 79902, United States
Del Sol Medical Center
El Paso, Texas, 79925, United States
Medical City Fortworth
Fort Worth, Texas, 76104, United States
Medical City Alliance
Fort Worth, Texas, 76177, United States
Medical City Frisco
Frisco, Texas, 75034, United States
HCA Houston Healthcare West
Houston, Texas, 77082, United States
Medical City Las Colinas
Irving, Texas, 75039, United States
HCA Houston Healthcare Kingwood
Kingwood, Texas, 77339, United States
Medical City Lewisville
Lewisville, Texas, 75057, United States
Methodist Hospital | Metropolitan
Live Oak, Texas, 78212, United States
Methodist Hospital | Northeast
Live Oak, Texas, 78233, United States
Rio Grande Regional Hospital Main Campus
McAllen, Texas, 78503, United States
Medical City McKinney
McKinney, Texas, 75069, United States
Medical City North Hills
North Richland Hills, Texas, 76180, United States
HCA Houston Healthcare Southeast
Pasadena, Texas, 77504, United States
HCA Houston Healthcare Pearland
Pearland, Texas, 77584, United States
Medical City Plano
Plano, Texas, 75075, United States
St. David's Round Rock Medical Center
Round Rock, Texas, 78681, United States
Methodist Hospital | Texsan
San Antonio, Texas, 78201, United States
Methodist Hospital | Specialty and Trasnplant
San Antonio, Texas, 78229, United States
Methodist Hospital
San Antonio, Texas, 78229, United States
HCA Houston Healthcare Mainland
Texas City, Texas, 77591, United States
Medical City Weatherford
Weatherford, Texas, 76086, United States
HCA Houston Healthcare Clear Lake
Webster, Texas, 77598, United States
Ogden Regional Medical Center
Ogden, Utah, 84405, United States
LewisGale Hospital Montgomery
Blacksburg, Virginia, 24060, United States
John Randolph Medical Center
Hopewell, Virginia, 23860, United States
LewisGale Hospital Pulaski
Pulaski, Virginia, 24301, United States
Reston Hospital Center
Reston, Virginia, 20190, United States
Henrico Doctor's Hospital
Richmond, Virginia, 23220, United States
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, 23225, United States
LewisGale Medical Center
Salem, Virginia, 24153, United States
Related Publications (1)
Gohil SK, Septimus E, Kleinman K, Varma N, Sands KE, Avery TR, Mauricio A, Sljivo S, Rahm R, Roemer K, Cooper WS, McLean LE, Nickolay NG, Poland RE, Weinstein RA, Fakhry SM, Guy J, Moody J, Coady MH, Smith KN, Meador B, Froman A, Eibensteiner K, Hayden MK, Kubiak DW, Burks C, Burgess LH, Calderwood MS, Perlin JB, Platt R, Huang SS. Improving Empiric Antibiotic Selection for Patients Hospitalized With Skin and Soft Tissue Infection: The INSPIRE 3 Skin and Soft Tissue Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):680-691. doi: 10.1001/jamainternmed.2025.0887.
PMID: 40208610RESULT
MeSH Terms
Conditions
Results Point of Contact
- Title
- Dr. Shruti Gohil, MD, MPH
- Organization
- Division of Infectious Diseases, University of California Irvine School of Medicine
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc, Professor and Chair, Department of Population Medicine
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 21, 2022
Study Start
January 1, 2023
Primary Completion
May 9, 2024
Study Completion
May 9, 2024
Last Updated
August 26, 2025
Results First Posted
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share