NCT03120975

Computerized Antibiotic Stewardship Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16,176 (actual)
• Sponsor: Benedikt Huttner · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Communicable Diseases

Interventions

Type	Name	Description
OTHER	Computerized decision support and audit & feedback	* 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
OTHER	Audit & Feedback	\* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
OTHER	Standard antibiotic stewardship	* Infectious diseases consultation "on demand" * Review of positive blood cultures * Availability of a antibiotic use guidelines (on paper and as PDF)

Timeline

• Start date: 2018-09-03
• Primary completion: 2020-02-29
• Completion: 2020-03-31
• First posted: 2017-04-19
• Last updated: 2020-11-19

Locations

3 sites across 1 country: Switzerland