Computerized Antibiotic Stewardship Study

Study Overview
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Brief Summary
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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
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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).

Official Title
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Improvement of Antibiotic Use in Hospitals Through Pragmatic, Multifaceted, Computerized Interventions: a Multicentre, Cluster-randomized Trial - COMPASS Study (COMPuterized Antibiotic Stewardship Study)

Conditions
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Communicable Diseases

Intervention / Treatment
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* Other: Computerized decision support and audit & feedback
* Other: Audit & Feedback
* Other: Standard antibiotic stewardship


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group, cluster-randomized superiority trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized decision support<br> | Other: Computerized decision support and audit & feedback<br>* 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<br>Other: Audit & Feedback<br>* * regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)<br>Other: Standard antibiotic stewardship<br>* Infectious diseases consultation on demand Review of positive blood cultures Availability of a antibiotic use guidelines (on paper and as PDF)<br>|
| Active Comparator: Standard antibiotic stewardship<br> | Other: Standard antibiotic stewardship<br>* Infectious diseases consultation on demand Review of positive blood cultures Availability of a antibiotic use guidelines (on paper and as PDF)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of therapy (DOT)/admission | Overall days of therapy of antibiotics per admission on the ward level | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of therapy(DOT)/100 patient days | Overall days of therapy per 100 patient days (PD) on the ward level | 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 | 12 months | 
| Antimicrobial days (AD) per 100 PD and per admission | Length of therapy per 100 PD and per admission | 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. | 12 months | 
| 30 day-mortality | All cause 30 day-mortality | 12 months | 
| In-hospital mortality | All-cause in-hospital mortality | 12 months | 
| Hospital readmission within 30 days of discharge | Unplanned hospital readmission within 30 days of discharge | 12 months | 
| Hospital length of stay (LOS) | Hospital length of stay | 12 months | 
| ICU transfer | % of admissions transferred to ICU after initial non-ICU admission | 12 months | 
| Guideline compliance | Proportion of patients treated in compliance with facility-based guideline | 12 months | 
| De-escalation | Proportion of patients with de-escalation and escalation of antibiotic therapy by calendar day 4 of treatment | 12 months | 
| IV-oral switch | Proportion of patients converted from intravenous to oral therapy between days 4 and 7 | 12 months | 
| appropriate diagnostic exams | proportion of patients with appropriate diagnostic exams | 12 months | 
| Incidence of Clostridium difficile infections (CDI) | Incidence of healthcare-facility onset Clostridium difficile infection denominated by 10 000 PD and admission | 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 | 12 months | 
| User satisfaction | User satisfaction with the system | 12 months | 
| Costs of administered antimicrobials | Costs of administered antimicrobials (overall and by class) per admission and per admission receiving antibiotics | 12 months | 
| costs of the intervention | total costs of the intervention | 12 months | 
| number of infectious diseases consultations | proportion of patients with infectious diseases consultation | 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. | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-Infective Agents, Decision Support Systems, Clinical, Quality Improvement