Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
118562 participants
INTERVENTIONAL
2023-01-01
2024-05-09
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Arm 1: Routine Care
Continuation of routine antibiotic stewardship strategies.
Arm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
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.
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.
Interventions
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Arm 1: Routine Care
Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
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.
Eligibility Criteria
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Inclusion Criteria
2. Facility use of MEDITECH as their electronic health record system
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.
18 Years
ALL
No
Sponsors
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Hospital Corporation of America
INDUSTRY
University of California, Irvine
OTHER
University of Massachusetts, Amherst
OTHER
Brigham and Women's Hospital
OTHER
Rush University
OTHER
Harvard Pilgrim Health Care
OTHER
Responsible Party
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Richard Platt
MD, MSc, Professor and Chair, Department of Population Medicine
Principal Investigators
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Shruti Gohil, MD, MPH
Role: STUDY_DIRECTOR
UC Irvine Division of Infectious Diseases
Susan Huang, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
UC Irvine Division of Infectious Diseases
Richard Platt, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Harvard Pilgrim Health Care Institute/Harvard Medical School
Locations
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Wesley Medical Center
Wichita, Kansas, United States
Riverside Community hospital
Riverside, California, United States
Regional Medical Center of San Jose
San Jose, California, United States
Good Samaritan Hospital
San Jose, California, United States
Los Robles Hospital & Medical Center
Thousand Oaks, California, United States
West Hills Hospital & Medical Center
West Hills, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
Blake Medical Center
Bradenton, Florida, United States
Brandon Regional Hospital
Brandon, Florida, United States
Oak Hill Hospital
Brooksville, Florida, United States
Englewood Community Hospital
Englewood, Florida, United States
Fort Walton Beach Medical Center
Fort Walton Beach, Florida, United States
Lawnwood Regional Medical Center
Ft. Pierce, Florida, United States
Regional Medical Center Bayonet Point
Hudson, Florida, United States
Memorial Hospital Jacksonville
Jacksonville, Florida, United States
Lake City Medical Center
Lake City, Florida, United States
Largo Medical Center
Largo, Florida, United States
Northwest Medical Center
Margate, Florida, United States
Mercy Hospital
Miami, Florida, United States
Kendall Regional Medical Center
Miami, Florida, United States
Orange Park Medical Center
Orange Park, Florida, United States
Oviedo Medical Center
Oviedo, Florida, United States
Gulf Coast Regional Medical Center
Panama City, Florida, United States
Fawcett Memorial Hospital
Port Charlotte, Florida, United States
St. Lucie Medical Center
Port Saint Lucie, Florida, United States
Doctors Hospital of Sarasota
Sarasota, Florida, United States
Palms of Pasadena
St. Petersburg, Florida, United States
Northside Hospital
St. Petersburg, Florida, United States
St. Petersburg General Hospital
St. Petersburg, Florida, United States
South Bay Hospital
Sun City Center, Florida, United States
Capital Regional Medical Center
Tallahassee, Florida, United States
HCA Florida South Tampa Hospital
Tampa, Florida, United States
HCA Florida West Tampa Hospital
Tampa, Florida, United States
Medical Center of Trinity
Trinity, Florida, United States
JFK Medical Center - North Campus
West Palm Beach, Florida, United States
Fairview Park Hospital
Dublin, Georgia, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States
Menorah Medical Center
Overland Park, Kansas, United States
Overland Park Regional Medical Center
Overland Park, Kansas, United States
Wesley Woodlawn Hospital & ER
Wichita, Kansas, United States
TriStar Greenview Regional Hospital
Bowling Green, Kentucky, United States
Lakeview Regional Medical Center
Covington, Louisiana, United States
Tulane Medical Center
New Orleans, Louisiana, United States
Centerpoint Medical Center
Independence, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
Lee's Summit Medical Center
Lee's Summit, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Southern Hills Hospital & Medical Center
Las Vegas, Nevada, United States
Trident Medical Center
Charleston, South Carolina, United States
Grand Strand Medical Center
Myrtle Beach, South Carolina, United States
Parkridge Medical Center
Chattanooga, Tennessee, United States
Parkridge East Hospital
Chattanooga, Tennessee, United States
TriStar Horizon Medical Center
Dickson, Tennessee, United States
TriStar Hendersonville Medical Center
Hendersonville, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
TriStar Southern Hills Medical Center
Nashville, Tennessee, United States
TriStar StoneCrest Medical Center
Smyrna, Tennessee, United States
Medical City Arlington
Arlington, Texas, United States
St. David's Medical Center
Austin, Texas, United States
St. David's North Austin Medical Center
Austin, Texas, United States
Valley Regional Medical Center
Brownsville, Texas, United States
HCA Houston Healthcare Conroe
Conroe, Texas, United States
Corpus Christi Medical Center - Doctors Regional
Corpus Christi, Texas, United States
Corpus Christi Medical Center - Bay Area
Corpus Christi, Texas, United States
Corpus Christi Medical Center - Heart Hospital
Corpus Christi, Texas, United States
Medical City Dallas
Dallas, Texas, United States
Medical City Denton
Denton, Texas, United States
Las Palmas Medical Center
El Paso, Texas, United States
Del Sol Medical Center
El Paso, Texas, United States
Medical City Fortworth
Fort Worth, Texas, United States
Medical City Alliance
Fort Worth, Texas, United States
Medical City Frisco
Frisco, Texas, United States
HCA Houston Healthcare West
Houston, Texas, United States
Medical City Las Colinas
Irving, Texas, United States
HCA Houston Healthcare Kingwood
Kingwood, Texas, United States
Medical City Lewisville
Lewisville, Texas, United States
Methodist Hospital | Metropolitan
Live Oak, Texas, United States
Methodist Hospital | Northeast
Live Oak, Texas, United States
Rio Grande Regional Hospital Main Campus
McAllen, Texas, United States
Medical City McKinney
McKinney, Texas, United States
Medical City North Hills
North Richland Hills, Texas, United States
HCA Houston Healthcare Southeast
Pasadena, Texas, United States
HCA Houston Healthcare Pearland
Pearland, Texas, United States
Medical City Plano
Plano, Texas, United States
St. David's Round Rock Medical Center
Round Rock, Texas, United States
Methodist Hospital | Texsan
San Antonio, Texas, United States
Methodist Hospital | Specialty and Trasnplant
San Antonio, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
HCA Houston Healthcare Mainland
Texas City, Texas, United States
Medical City Weatherford
Weatherford, Texas, United States
HCA Houston Healthcare Clear Lake
Webster, Texas, United States
Ogden Regional Medical Center
Ogden, Utah, United States
LewisGale Hospital Montgomery
Blacksburg, Virginia, United States
John Randolph Medical Center
Hopewell, Virginia, United States
LewisGale Hospital Pulaski
Pulaski, Virginia, United States
Reston Hospital Center
Reston, Virginia, United States
Henrico Doctor's Hospital
Richmond, Virginia, United States
CJW Medical Center (Chippenham & Johnston Willis Campuses)
Richmond, Virginia, United States
LewisGale Medical Center
Salem, Virginia, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PH000763B_SST
Identifier Type: -
Identifier Source: org_study_id
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