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

BMJ Open, vol. 10, pp. e033391

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.

Authors 32

1. Stefan Hagel

   Jena University Hospital

   Affiliation as printed

   Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Thüringen, Germany

2. Julia Gantner

   Jena University Hospital

   Affiliation as printed

   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany

3. Cord Spreckelsen

   Jena University Hospital

   Affiliation as printed

   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany

4. Claudia Fischer

   Jena University Hospital

   Affiliation as printed

   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany

5. Danny Ammon

   Jena University Hospital

   Affiliation as printed

   IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany

6. Kutaiba Saleh

   Jena University Hospital

   Affiliation as printed

   IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany

7. Lo An Phan-Vogtmann

   Jena University Hospital

   Affiliation as printed

   Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany

8. Andrew J Heidel

   Jena University Hospital

   Affiliation as printed

   IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany

9. Alexander Helhorn

   Jena University Hospital

   Affiliation as printed

   IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany

10. Henner Kruse

    Jena University Hospital

    Affiliation as printed

    IT Department, Data Integration Center, Jena University Hospital, Jena, Thüringen, Germany

11. Florian Rißner

    Jena University Hospital

    Affiliation as printed

    Center for Clinical Studies, Jena University Hospital, Jena, Thüringen, Germany

12. Silke Haferkamp Aachen IT Department Data Integration Center

    Universitätsklinikum Aachen

    Affiliation as printed

    IT Department, Data Integration Center, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

13. Jens Vorwerk Aachen IT Department Data Integration Center

    Universitätsklinikum Aachen

    Affiliation as printed

    IT Department, Data Integration Center, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

14. Saskia Deffge Aachen Department of Intensive and Intermediate Care

    Universitätsklinikum Aachen

    Affiliation as printed

    Department of Intensive and Intermediate Care, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

15. Marc Fabian Juzek-Küpper Aachen Medical Faculty Division of Infection Control and Infectious Diseases

    Universitätsklinikum Aachen

    Affiliation as printed

    Medical Faculty, Division of Infection Control and Infectious Diseases, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

16. Norman Lippmann

    University Hospital Leipzig · Leipzig University

    Affiliation as printed

    Institute of Medical Microbiology and Epidemiology on Infectious Diseases, University Hospital Leipzig, Leipzig, Sachsen, Germany

17. Christoph Lübbert

    University Hospital Leipzig · Leipzig University

    Affiliation as printed

    Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany

18. Henning Trawinski

    University Hospital Leipzig · Leipzig University

    Affiliation as printed

    Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany

19. Sebastian Wendt

    University Hospital Leipzig · Leipzig University

    Affiliation as printed

    Department of Gastroenterology and Rheumatology, Division of Infectious Diseases and Tropical Medicine, University Hospital Leipzig, Leipzig, Sachsen, Germany

20. Thomas Georg Wendt

    University Hospital Leipzig

    Affiliation as printed

    IT Department, Data Integration Center, University Hospital Leipzig, Leipzig, Sachsen, Germany

21. Andreas Dürschmid

    University Hospital Leipzig

    Affiliation as printed

    IT Department, Data Integration Center, University Hospital Leipzig, Leipzig, Sachsen, Germany

22. Margarethe Konik

    University of Duisburg-Essen

    Affiliation as printed

    Department of Nephrology, Clinic for Infectiology, University of Duisburg-Essen, Essen, Nordrhein-Westfalen, Germany

23. Stefan Moritz

    University Hospital in Halle

    Affiliation as printed

    Section of Clinical Infectious Diseases, University Hospital Halle, Halle, Sachsen-Anhalt, Germany

24. Daniel Tiller

    University Hospital in Halle

    Affiliation as printed

    IT Department, Data Integration Center, University Hospital Halle, Halle, Sachsen-Anhalt, Germany

25. Rainer Röhrig Aachen Institute of Medical Informatics

    Universitätsklinikum Aachen

    Affiliation as printed

    Institute of Medical Informatics, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

26. Jonas Schulte-Coerne

    Technical University of Munich

    Affiliation as printed

    Department of Informatics, Technical University of Munich, Munchen, Bayern, Germany

27. Jonas Fortmann Aachen Institute of Medical Informatics

    Universitätsklinikum Aachen

    Affiliation as printed

    Institute of Medical Informatics, University Hospital Aachen, Aachen, Nordrhein-Westfalen, Germany

28. Stephan Jonas

    Technical University of Munich

    Affiliation as printed

    Department of Informatics, Technical University of Munich, Munchen, Bayern, Germany

29. Oliver Witzke

    Essen University Hospital · Stiftung Universitätsmedizin Essen

    Affiliation as printed

    Institute for Infectious Diseases, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany

30. Peter‐Michael Rath

    Essen University Hospital

    Affiliation as printed

    Institute for Medical Microbiology, University Hospital Essen, Essen, Nordrhein-Westfalen, Germany

31. Mathias Wilhelm Pletz

    Jena University Hospital

    Affiliation as printed

    Institute for Infectious Diseases and Infection Control, Jena University Hospital, Jena, Thüringen, Germany

32. André Scherag corresponding

    Jena University Hospital

    Affiliation as printed

    Institute of Medical Statistics, Computer and Data Sciences, Jena University Hospital, Jena, Thüringen, Germany