Computerized Antibiotic Stewardship Study
- Conditions
- Communicable Diseases
- Interventions
- Other: Computerized decision support and audit & feedbackOther: Audit & FeedbackOther: Standard antibiotic stewardship
- Registration Number
- NCT03120975
- Lead Sponsor
- Benedikt Huttner
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16176
CLUSTER (WARD) LEVEL
- Acute-care wards with at least 150 admissions/year
- Use of a computerized physician order entry system (CPOE)
PHYSICIAN LEVEL * All physicians involved in antibiotic prescribing decisions in the participating wards
PATIENT LEVEL
* All patients hospitalized in the participating wards
CLUSTER (WARD) LEVEL
- Emergency room
- Outpatient clinics
- Overflow wards
- Absence of a matchable wards with regard to specialty and baseline antibiotic use
- Hematopoietic stem cell
PHYSICIAN LEVEL * None
PATIENT LEVEL
* None
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Computerized decision support Audit & Feedback - Computerized decision support Standard antibiotic stewardship - Computerized decision support Computerized decision support and audit & feedback - Standard antibiotic stewardship Standard antibiotic stewardship -
- Primary Outcome Measures
Name Time Method Days of therapy (DOT)/admission 12 months Overall days of therapy of antibiotics per admission on the ward level
- Secondary Outcome Measures
Name Time Method Antimicrobial days (AD) per 100 PD and per admission 12 months Length of therapy per 100 PD and per admission
Days per treatment period overall 12 months Overall days per treatment period. A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Defined daily doses (DDD)/100 patient days (PD) and per admission 12 months Overall defined daily doses per 100 patient days and admission on the ward level
30 day-mortality 12 months All cause 30 day-mortality
Days of therapy(DOT)/100 patient days 12 months Overall days of therapy per 100 patient days (PD) on the ward level
In-hospital mortality 12 months All-cause in-hospital mortality
appropriate diagnostic exams 12 months proportion of patients with appropriate diagnostic exams
Incidence of Clostridium difficile infections (CDI) 12 months Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission
Costs of administered antimicrobials 12 months Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics
Days per treatment period for community acquired pneumonia 12 months A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
ICU transfer 12 months % of admissions transferred to ICU after initial non-ICU admission
number of infectious diseases consultations 12 months proportion of patients with infectious diseases consultation
Days per treatment period for upper urinary tract infection 12 months A treatment period is defined as antibiotic treatment not interrupted by more than one calendar day or discharge.
Hospital readmission within 30 days of discharge 12 months Unplanned hospital readmission within 30 days of discharge
Guideline compliance 12 months Proportion of patients treated in compliance with facility-based guideline
IV-oral switch 12 months Proportion of patients converted from intravenous to oral therapy between days 4 and 7
Hospital length of stay (LOS) 12 months Hospital length of stay
De-escalation 12 months Proportion of patients with "de-escalation" and "escalation" of antibiotic therapy by calendar day 4 of treatment
Incidence of multidrug-resistant organisms (MDRO) 12 months 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
User satisfaction 12 months User satisfaction with the system
costs of the intervention 12 months total costs of the intervention
Trial Locations
- Locations (3)
Ente Ospedaliera Cantonale - Ospedale Civico
🇨ðŸ‡Lugano, TI, Switzerland
Ente Ospedaliera Cantonale - Ospedale San Giovanni
🇨ðŸ‡Bellinzona, TI, Switzerland
Geneva University Hospitals
🇨ðŸ‡Geneva, GE, Switzerland