INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Urinary Tract Infections (UTI)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harvard Pilgrim Health Care
- Enrollment
- 55,412
- Locations
- 59
- Primary Endpoint
- Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Facility Inclusion Criteria:
- •HCA hospitals admitting adults for UTI
- •Facility use of MEDITECH as their electronic health record system
Exclusion Criteria
- •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.
Arms & Interventions
Routine Care
Continued routine antibiotic stewardship strategies.
Intervention: Routine Care (Other)
INSPIRE CPOE Smart Prompt
Use of a computerized physician order entry (CPOE) smart prompt alert to guide empiric choice of antibiotics for UTI in non-ICU patients in the first 3 days of hospitalization.
Intervention: INSPIRE CPOE Smart Prompt (Other)
Outcomes
Primary Outcomes
Extended-Spectrum Days Of Antibacterial Therapy (ES-DOT) Per Empiric Day
Time Frame: 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 Outcomes
- Vancomycin Days of Antibacterial Therapy Per Empiric Day(First 3 days of hospitalization for each patient during 15-month intervention period)
- Antipseudomonal Antibiotic Days Of Therapy (ES-DOT) Per Empiric Day(First 3 days of hospitalization for each patient during 15-month intervention period)
Investigators
Richard Platt
Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care