Prescribing antibiotics frequently poses problems in practice, since patients don't always receive the right dosage of the right antibiotic for the right period of time. This promotes the emergence and spread of antibiotic resistance. The investigators of this trial aim to develop a system designed to help doctors to use antibiotics more appropriately. Under COMPASS (COMPuterized Antibiotic Stewardship Study), doctors in three Swiss hospitals will receive tips on the use of antibiotics that are integrated directly into electronic health record and will also be given regular feedback on their use of antibiotics. Parallel to this, data on the antimicrobial prescription practices of a control group which is not using the system will be collected.
Inappropriate use of antimicrobials favours the spread and emergence of antimicrobial resistance and other adverse patient outcomes. Antimicrobial stewardship (AMS) programs aim to promote the appropriate use of antimicrobials. Most AMS interventions are based on manual, personalized peer review of antibiotic prescriptions by specialists and are therefore time and resource intensive. Informatics based, computerized approaches to AMS are a promising way to "automatize" AMS, but there have been only few randomized controlled trials analysing their effectiveness in the hospital setting. The primary research question of this study is whether a multi-modal, computerized antibiotic stewardship intervention (I) reduces overall antibiotic exposure (O) in adult patients hospitalized in acute-care wards of secondary and tertiary care centers (P) compared to no such intervention ("standard-of- care") (C) over a one year time period (T) (the letters refer to the corresponding constituents of the PICOT framework). The primary objective of the study is to use the methodological rigor of a parallel group, cluster-randomized, controlled superiority trial in three Swiss hospitals to answer the primary research question. Secondary objectives are to assess the impact of the intervention on quality of antibiotic use, patient, microbiologic and economic outcomes. The primary outcome will be the difference in overall systemic antibiotic use measured in days of therapy (DOT) per admission based on administration data recorded in the electronic health record (EHR) over the whole intervention period. Secondary outcomes will include qualitative and quantitative antimicrobial use indicators (including non-HIV antivirals and antifungals), economic outcomes and key clinical and microbiologic indicators and patient safety indicators such as changes in readmission rates, need for intensive care and mortality. The study hypothesis is that the multimodal intervention is superior to standard-of-care regarding the primary outcome, i.e. that the intervention leads to a statistically significant reduction in overall antibiotic use expressed as days of therapy per admission compared to no such intervention ("standard-of-care" antibiotic stewardship).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
16,176
* suggestion of guideline concordant antimicrobial treatment based on indication entry in the computerized physician order entry system * mandatory reevaluation of antimicrobial therapy therapy on calendar day 4 of treatment * suggestion of standard antimicrobial treatment duration according to indication
\* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
* Infectious diseases consultation "on demand" * Review of positive blood cultures * Availability of a antibiotic use guidelines (on paper and as PDF)
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland
Ente Ospedaliera Cantonale - Ospedale San Giovanni
Bellinzona, Canton Ticino, Switzerland
Ente Ospedaliera Cantonale - Ospedale Civico
Lugano, Canton Ticino, Switzerland
Days of therapy (DOT)/admission
Overall days of therapy of antibiotics per admission on the ward level
Time frame: 12 months
Days of therapy(DOT)/100 patient days
Overall days of therapy per 100 patient days (PD) on the ward level
Time frame: 12 months
Defined daily doses (DDD)/100 patient days (PD) and per admission
Overall defined daily doses per 100 patient days and admission on the ward level
Time frame: 12 months
Antimicrobial days (AD) per 100 PD and per admission
Length of therapy per 100 PD and per admission
Time frame: 12 months
Days per treatment period overall
Overall days per treatment period. A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time frame: 12 months
30 day-mortality
All cause 30 day-mortality
Time frame: 12 months
In-hospital mortality
All-cause in-hospital mortality
Time frame: 12 months
Hospital readmission within 30 days of discharge
Unplanned hospital readmission within 30 days of discharge
Time frame: 12 months
Hospital length of stay (LOS)
Hospital length of stay
Time frame: 12 months
ICU transfer
% of admissions transferred to ICU after initial non-ICU admission
Time frame: 12 months
Guideline compliance
Proportion of patients treated in compliance with facility-based guideline
Time frame: 12 months
De-escalation
Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
Time frame: 12 months
IV-oral switch
Proportion of patients converted from intravenous to oral therapy between days 4 and 7
Time frame: 12 months
appropriate diagnostic exams
proportion of patients with appropriate diagnostic exams
Time frame: 12 months
Incidence of Clostridium difficile infections (CDI)
Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
Time frame: 12 months
Incidence of multidrug-resistant organisms (MDRO)
Incidence of clinical cultures with multidrug resistant organisms (methicillin-resistant Staphylococcus aureus (MRSA), Extended spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E), carbapenemase-producing Enterobacteriaceae (CPE), vancomycin-resistant enterococci (VRE), multidrug resistant P. aeruginosa) denominated per 1000 PD and admissions
Time frame: 12 months
User satisfaction
User satisfaction with the system
Time frame: 12 months
Costs of administered antimicrobials
Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
Time frame: 12 months
costs of the intervention
total costs of the intervention
Time frame: 12 months
number of infectious diseases consultations
proportion of patients with infectious diseases consultation
Time frame: 12 months
Days per treatment period for community acquired pneumonia
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time frame: 12 months
Days per treatment period for upper urinary tract infection
A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Time frame: 12 months
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