INSPIRE Trial for Abdominal Infections
- Conditions
- Abdominal (ABD) Infection
- Registration Number
- NCT05423743
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198480
- HCA Healthcare hospitals admitting adults for abdominal infection
- Facility use of MEDITECH as their electronic health record system
Facility
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods 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.
- Secondary Outcome Measures
Name Time Method Vancomycin Days of Antibacterial Therapy Per Empiric Day First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods 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.Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day First 3 calendar days of hospitalization for each patient during the 12-month baseline and 12-month intervention periods 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.
Trial Locations
- Locations (101)
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
Scroll for more (91 remaining)Riverside Community Hospital🇺🇸Riverside, California, United States