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INSPIRE Trial for Abdominal Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05423743
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : September 1, 2022
Sponsor:
Collaborators:
HCA Healthcare, Inc
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Rush University
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abdominal (ABD) Infection Other: Arm 1: Routine Care Other: Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This cluster-randomized trial will assess a novel quality improvement antibiotic stewardship strategy for empiric antibiotic selection.
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 Abdominal (ABD) Infections
Actual Study Start Date : August 2, 2022
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

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 CPOE Smart Prompt
Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for abdominal infection in non-critically ill patients in the first 3 days of hospitalization.
Other: Arm 2: INSPIRE CPOE Smart Prompt for Abdominal Infection
Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having an abdominal infection due to a multidrug-resistant organism (MDRO) and recommends appropriate antibiotic choice for non-critically ill patients in the first 3 days of hospitalization. Continuation of other antibiotic stewardship activities in accordance with national standards.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Intensive Care Unit (ICU) Transfer [Safety Outcome] [ Time Frame: 12 months ]
    Days to ICU transfer, from hospital days ≥ 3 and ≤ 14.

  2. 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.

  3. 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


  4. 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.


  5. 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.


  6. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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): NCT05423743


Contacts
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Contact: Micaela Coady, MS 617-867-4880 micaela_coady@harvardpilgrim.org
Contact: Shruti Gohil, MD, MPH skgohil@hs.uci.edu

Locations
Show Show 101 study locations
Sponsors and Collaborators
Harvard Pilgrim Health Care
HCA Healthcare, Inc
University of California, Irvine
University of Massachusetts, Amherst
Brigham and Women's Hospital
Rush University
Investigators
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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
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Responsible Party: Richard Platt, MD, MSc, Professor and Chair, Department of Population Medicine, Harvard Pilgrim Health Care
ClinicalTrials.gov Identifier: NCT05423743    
Other Study ID Numbers: PH000763B_ABD
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Platt, Harvard Pilgrim Health Care:
ABD
CPOE
Empiric Therapy
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes