The INSPIRE-ASP UTI Trial
- Conditions
- Urinary Tract Infection (UTI)
- Registration Number
- NCT03697096
- Lead Sponsor
- Harvard Pilgrim Health Care
- Brief Summary
The INSPIRE-ASP UTI trial is a cluster-randomized controlled trial of HCA hospitals comparing routine empiric antibiotic stewardship practices with real-time precision medicine computerized physician order entry smart prompts providing the probability that a non-critically ill adult admitted with UTI is infected with a resistant pathogen.
Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55412
- HCA hospitals admitting adults for UTI
- Facility use of MEDITECH as their electronic health record system
Facility
Note: unit of randomization is the hospital, however the CPOE alert intervention will calculate risk estimates for adults age >=18 admitted to non-ICU wards and who are ordered to receive extended-spectrum antibiotics for UTI. Prisoners were excluded from prompts and analysis.
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 days of hospitalization for each patient during 15-month intervention period The number of different extended-spectrum antibacterials received by the patient each empiric day-of-therapy (outcome measure unit), averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
- Secondary Outcome Measures
Name Time Method Vancomycin Days of Antibacterial Therapy Per Empiric Day First 3 days of hospitalization for each patient during 15-month intervention period The number of days that Vancomycin is received by the patient averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. 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 days of hospitalization for each patient during 15-month intervention period The number of different antipseudomonals received by the patient each empiric day of therapy, averaged over the empiric days (the first 3 days of hospitalization), summed across all participants. Note that Days-of-Therapy unit is a standardized national measure for antibacterial use in hospitals. For clarity the calculation is as follows: we define a DOT for a particular ES antibiotic as a day in which any number of doses of that antibiotic is given. Different ES antibiotics are summed across the empiric days for each patient admission, then divided by the empiric days for that patient-admission to determine each admission's DOT per at-risk day. If an admission is less than 3 days, only the number of days the patient is admitted will contribute to the numerator and denominator.
Trial Locations
- Locations (59)
Riverside Community Hospital
🇺🇸Riverside, California, United States
Regional Medical Center of San Jose
🇺🇸San Jose, California, United States
Los Robles Regional Medical Center
🇺🇸Thousand Oaks, California, United States
The Medical Center of Aurora
🇺🇸Aurora, Colorado, United States
Swedish Medical Center
🇺🇸Denver, Colorado, United States
Sky Ridge Medical Center
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
Brandon Hospital
🇺🇸Brandon, Florida, United States
Fort Walton Medical Center
🇺🇸Fort Walton Beach, Florida, United States
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
Scroll for more (49 remaining)Riverside Community Hospital🇺🇸Riverside, California, United States