INSPIRE Trial for Abdominal Infections

• ClinicalTrials.gov Identifier: NCT05423743
• Recruitment Status: Active, not recruiting
• First Posted: June 21, 2022
• Last Update Posted: January 18, 2024
• Sponsor: Harvard Pilgrim Health Care
• 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

Tracking Information

• First Submitted Date: June 14, 2022
• First Posted Date: June 21, 2022
• Last Update Posted Date: January 18, 2024
• Actual Study Start Date: August 2, 2022
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2022)

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 14, 2022)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 14, 2022)

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

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

• Condition: Abdominal (ABD) Infection

Intervention

• Other: Arm 1: Routine Care
  Routine Antibiotic Stewardship Arm - Continuation of antibiotic stewardship activities in accordance with national standards.
• 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.

Study Arms

• Active Comparator: Arm 1: Routine Care
  Continuation of routine antibiotic stewardship strategies.
  Intervention: Other: Arm 1: Routine Care
• 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.
  Intervention: Other: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 14, 2022): 102
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2028
• Estimated Primary Completion Date: December 2027 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05423743
• Other Study ID Numbers: PH000763B_ABD
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Richard Platt, Harvard Pilgrim Health Care
• Original Responsible Party: Same as current
• Current Study Sponsor: Harvard Pilgrim Health Care
• Original Study Sponsor: Same as current

Collaborators

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

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

• PRS Account: Harvard Pilgrim Health Care
• Verification Date: January 2024