INSPIRE Trial for Abdominal Infections

January 16, 2024 updated by: Richard Platt, Harvard Pilgrim Health Care

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Empiric Extended-Spectrum Days of Therapy (Empiric ES-DOT)
Time Frame: 12 month intervention
The number of different extended-spectrum antibiotics per empiric day, summed across the first 3 days of hospitalization.
12 month intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancomycin Days of Therapy per Empiric Day
Time Frame: 12 months
The number of days Vancomycin was received on the first 3 days of hospitalization.
12 months
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.
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive Care Unit (ICU) Transfer [Safety Outcome]
Time Frame: 12 months
Days to ICU transfer, from hospital days ≥ 3 and ≤ 14.
12 months
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.
12 months
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
12 months
Empiric and Total Antibiotic Costs
Time Frame: 12 months

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 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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Pilgrim Health Care

Collaborators

Brigham and Women's Hospital
University of California, Irvine
University of Massachusetts, Amherst
Rush University
HCA Healthcare, Inc

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2028

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)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PH000763B_ABD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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