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

Abstract

IntroductionStaphylococci 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 Centers (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 analysisThe 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 disseminationThe 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 numberDRKS00014320.

System for Context-Specific Visualization of Clinical Practice Guidelines (GuLiNav): Concept and Software Implementation

“…The idea for a contextualized guideline visualization emerged during the early stages of the development of a guideline-based CDSS for the treatment of specific bloodstream infections [ 9 ]. The context-specific visualization concept was evaluated as part of a formative usability test, and clinicians generally approved of it.…”

“…Managing the complexity of medical algorithms and guidelines is a core challenge for the successful establishment of guideline-based CDSSs. In addition, existing CDSS-related research projects (such as the study by Hagel et al [ 9 ] to use a CDSS for the treatment of bloodstream infections) stressed the need—and critical effort—to obtain regulatory approval as a certified medical device (especially under the Medical Device Regulation). Establishing organizational as well as technical structures to qualify for the respective regulatory approval is inevitably necessary to use the concept in clinical practice.…”

“…Examples of these guidelines can be seen in Figure 3 and Figure 4 . The examples are adaptations of the guideline used within the Hospital-Wide Electronic Medical Record Evaluated Computerized Decision Support System to Improve Outcomes of Patients With Staphylococcal Bloodstream Infection (HELP) study for the treatment of staphylococcal bloodstream infections [ 9 ], which initially motivated this research. Note that the example is simplified to be a fitting example for the rather technical focus of this article.…”

“…Greenes et al [ 5 ] propose that this focus of the interaction of the CDSS with individual decisions and actions should be complemented by a perspective that also considers the entire workflow. We also noticed the need for more attention to the overarching process when participating in the development of a guideline-based CDSS to assist in the treatment of bloodstream infections [ 9 ]. In this medical use case, the clinical workflow is executed over a relatively long period of time (up to 10 days).…”

Management of Staphylococcus aureus Bloodstream Infections

“…Several studies have shown that an adherence to treatment guidelines and particularly infectious disease bedside-consultation can lead to a reduction of mortality by up to 50% ( 10 – 12 ). Given the limited availability of infectious diseases physicians, who are usually based in larger hospitals and the standardized management outlined above, novel approaches are currently under investigation, such as computerized decision support systems and phone consultations, to improve outcome by providing respective expertise also in smaller hospitals ( 80 , 81 ). However, it has yet to be proven whether these approaches are as effective as bedside-consultations by infectious diseases physicians.…”