The INSPIRE-ASP Trial (INtelligent Stewardship Prompts to Improve Real-Time Empiric Antibiotic Selection for Patients) for Abdominal (ABD) Infections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Harvard Pilgrim Health Care
- Enrollment
- 198,480
- Locations
- 101
- Primary Endpoint
- Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Study Overview
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.
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 Healthcare hospitals admitting adults for abdominal infection
- •Facility use of MEDITECH as their electronic health record system
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.
Arms & Interventions
Arm 1: Routine Care
Continuation of routine antibiotic stewardship strategies.
Intervention: Arm 1: Routine Care (Other)
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: Arm 2: INSPIRE Stewardship Bundle for Abdominal Infection (Other)
Outcomes
Primary Outcomes
Extended-Spectrum Days of Antibacterial Therapy (ES-DOT) Per Empiric Day
Time Frame: 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 Outcomes
- 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)
- 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)
Investigators
Richard Platt
MD, MSc, Professor and Chair, Department of Population Medicine
Harvard Pilgrim Health Care