INSPIRE Trial for Abdominal Infections

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal (ABD) Infection
• Intervention / Treatment: Other: Arm 1: Routine Care; Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection

• Study Type: Interventional
• Enrollment (Actual): 198480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Riverside, California, United States, 92501
      • Riverside Community Hospital
    • San Jose, California, United States, 95124
      • Good Samaritan Hospital
    • San Jose, California, United States, 95116
      • Regional Medical Center of San Jose
    • Thousand Oaks, California, United States, 91362
      • Los Robles Hospital & Medical Center
    • West Hills, California, United States, 91307
      • West Hills Hospital & Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80012
      • The Medical Center of Aurora
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
    • Lone Tree, Colorado, United States, 80124
      • Sky Ridge Medical Center
    • Thornton, Colorado, United States, 80229
      • North Suburban Medical Center
  • Florida
    • Bradenton, Florida, United States, 34209
      • Blake Medical Center
    • Brandon, Florida, United States, 33511
      • Brandon Regional Hospital
    • Brooksville, Florida, United States, 34613
      • Oak Hill Hospital
    • Englewood, Florida, United States, 34223
      • Englewood Community Hospital
    • Fort Pierce, Florida, United States, 34950
      • Lawnwood Regional Medical Center
    • Fort Walton Beach, Florida, United States, 32547
      • Fort Walton Beach Medical Center
    • Hudson, Florida, United States, 34667
      • Regional Medical Center of Bayonet Point
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Lake City, Florida, United States, 32055
      • Lake City Medical Center
    • Largo, Florida, United States, 33770
      • Largo Medical Center
    • Margate, Florida, United States, 33063
      • Northwest Medical Center
    • Miami, Florida, United States, 33133
      • Mercy Hospital
    • Miami, Florida, United States, 33175
      • Kendall Regional Medical Center
    • Orange Park, Florida, United States, 32073
      • Orange Park Medical Center
    • Oviedo, Florida, United States, 32765
      • Oviedo Medical Center
    • Panama City, Florida, United States, 32405
      • Gulf Coast Regional Medical Center
    • Port Charlotte, Florida, United States, 33952
      • Fawcett Memorial Hospital
    • Port Saint Lucie, Florida, United States, 34952
      • St. Lucie Medical Center
    • Saint Petersburg, Florida, United States, 33709
      • Northside Hospital
    • Saint Petersburg, Florida, United States, 33710
      • St. Petersburg General Hospital
    • Saint Petersburg, Florida, United States, 33707
      • Palms of Pasadena
    • Sarasota, Florida, United States, 34233
      • Doctors Hospital of Sarasota
    • Sun City Center, Florida, United States, 33573
      • South Bay Hospital
    • Tallahassee, Florida, United States, 32308
      • Capital Regional Medical Center
    • Tampa, Florida, United States, 33609
      • HCA Florida South Tampa Hospital
    • Tampa, Florida, United States, 33615
      • HCA Florida West Tampa Hospital
    • Trinity, Florida, United States, 34655
      • Medical Center of Trinity
    • West Palm Beach, Florida, United States, 33407
      • JFK Medical Center - North Campus
  • Georgia
    • Dublin, Georgia, United States, 31040
      • Fairview Park Hospital
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Eastern Idaho Regional Medical Center
  • Kansas
    • Overland Park, Kansas, United States, 66209
      • Menorah Medical Center
    • Overland Park, Kansas, United States, 66215
      • Overland Park Regional Medical Center
    • Wichita, Kansas, United States, 67214
      • Wesley Medical Center
    • Wichita, Kansas, United States, 67220
      • Wesley Woodlawn Hospital & ER
  • Kentucky
    • Bowling Green, Kentucky, United States, 41204
      • TriStar Greenview Regional Hospital
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Lakeview Regional Medical Center
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • Missouri
    • Independence, Missouri, United States, 64057
      • Centerpoint Medical Center
    • Kansas City, Missouri, United States, 64132
      • Research Medical Center
    • Lee's Summit, Missouri, United States, 64063
      • Lee's Summit Medical Center
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Sunrise Hospital & Medical Center
    • Las Vegas, Nevada, United States, 89109
      • Southern Hills Hospital & Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Trident Medical Center
    • Myrtle Beach, South Carolina, United States, 29572
      • Grand Strand Medical Center
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Parkridge Medical Center
    • Chattanooga, Tennessee, United States, 37412
      • Parkridge East Hospital
    • Dickson, Tennessee, United States, 37055
      • TriStar Horizon Medical Center
    • Hendersonville, Tennessee, United States, 37075
      • TriStar Hendersonville Medical Center
    • Nashville, Tennessee, United States, 37203
      • TriStar Centennial Medical Center
    • Nashville, Tennessee, United States, 37211
      • TriStar Southern Hills Medical Center
    • Smyrna, Tennessee, United States, 37167
      • TriStar StoneCrest Medical Center
  • Texas
    • Arlington, Texas, United States, 76015
      • Medical City Arlington
    • Austin, Texas, United States, 78705
      • St. David's Medical Center
    • Austin, Texas, United States, 78758
      • St. David's North Austin Medical Center
    • Brownsville, Texas, United States, 78526
      • Valley Regional Medical Center
    • Conroe, Texas, United States, 77304
      • HCA Houston Healthcare Conroe
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Medical Center - Bay Area
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Medical Center - Heart Hospital
    • Corpus Christi, Texas, United States, 78412
      • Corpus Christi Medical Center - Doctors Regional
    • Dallas, Texas, United States, 75230
      • Medical City Dallas
    • Denton, Texas, United States, 76210
      • Medical City Denton
    • El Paso, Texas, United States, 79902
      • Las Palmas Medical Center
    • El Paso, Texas, United States, 79925
      • Del Sol Medical Center
    • Fort Worth, Texas, United States, 76104
      • Medical City Fort Worth
    • Fort Worth, Texas, United States, 76177
      • Medical City Alliance
    • Frisco, Texas, United States, 75034
      • Medical City Frisco
    • Houston, Texas, United States, 77082
      • HCA Houston Healthcare West
    • Irving, Texas, United States, 75039
      • Medical City Las Colinas
    • Kingwood, Texas, United States, 77339
      • HCA Houston Healthcare Kingwood
    • Lewisville, Texas, United States, 75057
      • Medical City Lewisville
    • Live Oak, Texas, United States, 78233
      • Methodist Hospital Northeast
    • McAllen, Texas, United States, 78503
      • Rio Grande Regional Hospital Main Campus
    • McKinney, Texas, United States, 75069
      • Medical City McKinney
    • North Richland Hills, Texas, United States, 76180
      • Medical City North Hills
    • Pasadena, Texas, United States, 77504
      • HCA Houston Healthcare Southeast
    • Pearland, Texas, United States, 77584
      • HCA Houston Healthcare Pearland
    • Plano, Texas, United States, 75075
      • Medical City Plano
    • Round Rock, Texas, United States, 78681
      • St. David's Round Rock Medical Center
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital
    • San Antonio, Texas, United States, 78201
      • Methodist Hospital Texsan
    • San Antonio, Texas, United States, 78212
      • Methodist Hospital Metropolitan
    • San Antonio, Texas, United States, 78229
      • Methodist Hospital | Specialty and Transplant
    • Texas City, Texas, United States, 77591
      • HCA Houston Healthcare Mainland
    • Weatherford, Texas, United States, 76086
      • Medical City Weatherford
    • Webster, Texas, United States, 77598
      • HCA Houston Healthcare Clear Lake
  • Utah
    • Ogden, Utah, United States, 84405
      • Ogden Regional Medical Center
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • LewisGale Hospital Montgomery
    • Pulaski, Virginia, United States, 24301
      • LewisGale Hospital Pulaski
    • Reston, Virginia, United States, 20190
      • Reston Hospital Center
    • Richmond, Virginia, United States, 23229
      • Henrico Doctors' Hospital
    • Richmond, Virginia, United States, 23225
      • CJW Medical Center (Chippenham & Johnston Willis Campuses)
    • Salem, Virginia, United States, 24153
      • LewisGale Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Facility Inclusion Criteria:

1. HCA Healthcare hospitals admitting adults for abdominal infection
2. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1: Routine Care; Continuation of routine antibiotic stewardship strategies.	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 abdominal infection in the first 3 days of hospitalization.	Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vancomycin Days of Antibacterial Therapy 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. Vancomycin days-of-therapy per empiric day is defined as the the number of days that vancomycin is received by a patient, averaged over the empiric period, and summed across all participants. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.	First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods
Antipseudomonal Antibiotic Days Of 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. Antipseudomonal days-of-therapy per empiric day is defined as the summed number of different antipseudomonal 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 antipseudomonal antibiotics administered at least once during each of the first 3 days would yield 6 days of antipseudomonal days-of-therapy.	First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Empiric and Total Antibiotic Costs	Empiric and total antibiotic costs for abdominal infection during hospitalization. Note: this outcome is intended for a secondary manuscript.	12 months
Incidence of Hospital-Onset MDRO-Positive Cultures	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.	12 months
Intensive Care Unit (ICU) Transfer [Safety Outcome 1]	Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.	Duration of hospitalization for each patient during 12-month baseline and 12-month intervention periods
Length-of-stay [Safety Outcome 2]	Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.	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	The number of different ES antibiotics received each day, on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript	12 months
Incidence of Hospital-Onset C. Difficile	Hospital-onset C. difficile positive tests (specimen obtained) on hospital days ≥4 and ≤14. Note: this outcome is intended for a secondary manuscript.	12 months

Collaborators and Investigators

• Sponsor: Harvard Pilgrim Health Care
• Collaborators: Brigham and Women's Hospital; University of California, Irvine; University of Massachusetts, Amherst; Rush University; Hospital Corporation of America
• Investigators: 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

Publications and helpful links

General Publications

• 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 Abdominal Infection: The INSPIRE 4 Cluster Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):733-743. doi: 10.1001/jamasurg.2025.1108.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): May 9, 2025
• Study Completion (Actual): May 9, 2025

Study Registration Dates

• First Submitted: June 14, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: CPOE; ABD; Empiric Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: PH000763B_ABD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No