Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16176 participants
INTERVENTIONAL
2018-09-03
2020-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Computerized decision support
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
Audit & Feedback
\* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
Standard antibiotic stewardship
* Infectious diseases consultation "on demand"
* Review of positive blood cultures
* Availability of a antibiotic use guidelines (on paper and as PDF)
Standard antibiotic stewardship
Standard antibiotic stewardship
* Infectious diseases consultation "on demand"
* Review of positive blood cultures
* Availability of a antibiotic use guidelines (on paper and as PDF)
Interventions
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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
Audit & Feedback
\* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
Standard antibiotic stewardship
* Infectious diseases consultation "on demand"
* Review of positive blood cultures
* Availability of a antibiotic use guidelines (on paper and as PDF)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
University of Geneva, Switzerland
OTHER
Ente Ospedaliero Cantonale, Ticino, Switzerland
OTHER
Benedikt Huttner
OTHER
Responsible Party
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Benedikt Huttner
Principal Investigator
Principal Investigators
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Benedikt D Huttner, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Geneva University Hospitals and University of Geneva
Locations
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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
Countries
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References
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Catho G, De Kraker M, Waldispuhl Suter B, Valotti R, Harbarth S, Kaiser L, Elzi L, Meyer R, Bernasconi E, Huttner BD. Study protocol for a multicentre, cluster randomised, superiority trial evaluating the impact of computerised decision support, audit and feedback on antibiotic use: the COMPuterized Antibiotic Stewardship Study (COMPASS). BMJ Open. 2018 Jun 27;8(6):e022666. doi: 10.1136/bmjopen-2018-022666.
Catho G, Centemero NS, Catho H, Ranzani A, Balmelli C, Landelle C, Zanichelli V, Huttner BD; on the behalf of the Q-COMPASS study group. Factors determining the adherence to antimicrobial guidelines and the adoption of computerised decision support systems by physicians: A qualitative study in three European hospitals. Int J Med Inform. 2020 Sep;141:104233. doi: 10.1016/j.ijmedinf.2020.104233. Epub 2020 Jul 13.
Catho G, Sauser J, Coray V, Da Silva S, Elzi L, Harbarth S, Kaiser L, Marti C, Meyer R, Pagnamenta F, Portela J, Prendki V, Ranzani A, Centemero NS, Stirnemann J, Valotti R, Vernaz N, Suter BW, Bernasconi E, Huttner BD; COMPASS study group. Impact of interactive computerised decision support for hospital antibiotic use (COMPASS): an open-label, cluster-randomised trial in three Swiss hospitals. Lancet Infect Dis. 2022 Oct;22(10):1493-1502. doi: 10.1016/S1473-3099(22)00308-5. Epub 2022 Jul 20.
Related Links
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Other Identifiers
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407240_167079
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017-00454
Identifier Type: -
Identifier Source: org_study_id