Article Text
Abstract
Introduction Staphylococci are the most commonly identified pathogens in bloodstream infections. Identification of Staphylococcus aureus in blood culture (SAB) requires a prompt and adequate clinical management. The detection of coagulase-negative staphylococci (CoNS), however, corresponds to contamination in about 75% of the cases. Nevertheless, antibiotic therapy is often initiated, which contributes to the risk of drug-related side effects. We developed a computerised clinical decision support system (HELP-CDSS) that assists physicians with an appropriate management of patients with Staphylococcus bacteraemia. The CDSS is evaluated using data of the Data Integration Cent ers (DIC) established at each clinic. DICs transform heterogeneous primary clinical data into an interoperable format, and the HELP-CDSS displays information according to current best evidence in bacteraemia treatment. The overall aim of the HELP-CDSS is a safe but more efficient allocation of infectious diseases specialists and an improved adherence to established guidelines in the treatment of SAB.
Methods and analysis The study is conducted at five German university hospitals and is designed as a stepped-wedge cluster randomised trial. Over the duration of 18 months, 135 wards will change from a control period to the intervention period in a randomised stepwise sequence. The coprimary outcomes are hospital mortality for all patients to establish safety, the 90-day disease reoccurrence-free survival for patients with SAB and the cumulative vancomycin use for patients with CoNS bacteraemia. We will use a closed, hierarchical testing procedure and generalised linear mixed modelling to test for non-inferiority of the CDSS regarding hospital mortality and 90-day disease reoccurrence-free survival and for superiority of the HELP-CDSS regarding cumulative vancomycin use.
Ethics and dissemination The study is approved by the ethics committee of Jena University Hospital and will start at each centre after local approval. Results will be published in a peer-reviewed journal and presented at scientific conferences.
Trial registration number DRKS00014320.
- staphylococcus bacteremia
- antibiotic stewardship
- clinical decision support system
- healthcare interoperability standards
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Footnotes
Twitter @RainerRohrig, @ScheragAndre
SH, JG, MWP and AS contributed equally.
Contributors StH, JG, MWP and AS contributed equally and worked on the study concept, design and manuscript. SuM supports the study as the project manager. AS, JG and CF were responsible for statistical planning and analysis. StH, MWP, SD, MFJ-K, NL, CL, HT, SW, MK, P-MR, OW and StM developed the clinical and microbiological foundations for the computerised clinical decision support system (CDSS). DA, KS, CF, LAP-V, AnH, AlH, HK, ET and FR worked on the technical specification of the CDSS and the clinical data extraction and transformation at Jena University Hospital. SiH, JV, AD, TW and DT worked on the clinical data extraction and transformation at their respective centers. RR, JS-C, JF, SJ and CS worked on technical and legal issues concerning the implementation of the CDSS.
Funding This work was supported by the German Federal Ministry of Education and Research, grant numbers for the five study centres are Jena University Hospital: 01ZZ1803C, Halle University Hospital: 01ZZ1803N, Leipzig University Hospital: 01ZZ1803D, Aachen University Hospital: 01ZZ1803B and Essen University Hospital: 01ZZ1803P.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.