Hospital-wide ELectronic medical record evaluated computerised decision support system to improve outcomes of Patients with staphylococcal bloodstream infection (HELP): study protocol for a multicentre stepped-wedge cluster randomised trial

Media type: E-Article
Title: Hospital-wide ELectronic medical record evaluated computerised decision support system to improve outcomes of Patients with staphylococcal bloodstream infection (HELP): study protocol for a multicentre stepped-wedge cluster randomised trial
Contributor: Hagel, Stefan; Gantner, Julia; Spreckelsen, Cord; Fischer, Claudia; Ammon, Danny; Saleh, Kutaiba; Phan-Vogtmann, Lo An; Heidel, Andrew; Müller, Susanne; Helhorn, Alexander; Kruse, Henner; Thomas, Eric; Rißner, Florian; Haferkamp, Silke; Vorwerk, Jens; Deffge, Saskia; Juzek-Küpper, Marc Fabian; Lippmann, Norman; Lübbert, Christoph; Trawinski, Henning; Wendt, Sebastian; Wendt, Thomas; Dürschmid, Andreas; Konik, Margarethe; [...]
imprint: BMJ, 2020
Published in: BMJ Open
Language: English
DOI: 10.1136/bmjopen-2019-033391
ISSN: 2044-6055
Keywords: General Medicine
Origination:
Footnote:
Description: <jats:sec><jats:title>Introduction</jats:title><jats:p><jats:italic>Staphylococci</jats:italic> are the most commonly identified pathogens in bloodstream infections. Identification of <jats:italic>Staphylococcus aureus</jats:italic> 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 <jats:italic>Staphylococcus</jats:italic> bacteraemia. The CDSS is evaluated using data of the <jats:italic>Data Integration Cent</jats:italic><jats:italic>ers</jats:italic> (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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p>DRKS00014320.</jats:p></jats:sec>
Access State: Open Access

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