NCT Number: NCT03697070
The INSPIRE-ASP PNA 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 PNA is infected with a resistant pathogen.
Note: that enrolled "subjects" represents 59 individual HCA hospitals that have been randomized.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Riverside Community Hospital, Riverside, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Facility Inclusion Criteria:
Facility 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 PNA. Prisoners were excluded from prompts and analysis.
Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having PNA due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization.
Continuation of other antibiotic stewardship activities in accordance with national standards.
Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
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.
Time frame: 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.
Time frame: 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.
Time frame: Duration of hospitalization for each patient during 15-month intervention period
Days from start of standard-spectrum antibacterial until switch to extended-spectrum antibacterial during hospital stay, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.
Time frame: Duration of hospitalization for each patient during 15-month intervention period
Days from hospital admission until transfer to ICU, if that occurs. If it doesn't occur, the number of days is censored (capped) at the patient's hospital discharge or at the end of data collection. Almost all patients will be discharged before the end of trial data collection.
Time frame: Duration of hospitalization for each patient during 15-month intervention period
Days from hospital admission until discharge. If the patient remains in the hospital at the end of the trial data collection, the number of days is censored (capped) at that time. Almost all patients will be discharged before the end of trial data collection.
Time frame: 15 month intervention
The summed number of different ES antibacterials received each day, measured repeatedly on or after 4 calendar days of admission and divided by the number of days from hospital day 4 through discharge.
Note: this outcome is intended for a secondary manuscript.
Time frame: 15 month intervention
Empiric and total antibacterial costs during hospitalization.
Note: this outcome is intended for a secondary manuscript.
Time frame: 15 month intervention
Hospital-onset C. difficile positive tests (specimen obtained) after 3 calendar days of admission during hospitalization.
Note: this outcome is intended for a secondary manuscript.
Time frame: 15 month intervention
Newly-detected hospital-onset MDRO-positive cultures (on or after 3 calendar days of admission). Includes total MDRO and specific MDRO subsets.
Note: this outcome is intended for a secondary manuscript.
Time frame: 15 month intervention
The summed number of different fluoroquinolone antibacterials received each day, measured repeatedly over (1) the first three days (empiric) of an admission and divided by the number of days of the admission and (2) all days of an admission divided by the total number of admission days.
Note: this outcome is intended for a secondary manuscript.
Harvard Pilgrim Health Care
Other
INtelligent Stewardship Prompts to Improve Real-time Empiric Antibiotic Selection for Patients With Pneumonia
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