title: Study on the utility of a statewide counselling programme for improving mortality outcomes of patients withStaphylococcus aureusbacteraemia in Thuringia (SUPPORT): a study protocol of a cluster-randomised crossover trial.
abstract: Staphylococcus aureusbacteraemia (SAB) is a frequent infection with high mortality rates. It requires specific diagnostic and therapeutic management such as prolonged intravenous administration of antibiotics and aggressive search for and control of infectious sources. Underestimation of disease severity frequently results in delayed or inappropriate management of patients with SAB leading to increased mortality rates. According to observational studies, patient counselling by infectious disease consultants (IDC) improves survival and reduces the length of hospital stay as well as complication rates. In many countries, IDC are available only in some tertiary hospitals. In this trial, we aim to demonstrate that the outcome of patients with SAB in small and medium size hospitals that do not employ IDC can be improved by unsolicited ID phone counselling. The SUPPORT trial will be the first cluster-randomised controlled multicentre trial addressing this question.
  
  
  
  SUPPORT is a single-blinded, multicentre interventional, cluster-randomised, controlled crossover trial with a minimum of 15 centres that will include 250 patients with SAB who will receive unsolicited IDC counselling and 250 who will receive standard of care. Reporting of SAB will be conducted by an electronic real-time blood culture registry established for the German Federal state of Thuringia (ALERTSNet) or directly by participating centres in order to minimise time delay before counselling. Mortality, disease course and complications will be monitored for 90 days with 30-day all-cause mortality rates as the primary outcome. Generalised linear mixed modelling will be used to detect the difference between the intervention sequences. We expect improved outcome of patients with SAB after IDC.
  
  
  
  We obtained ethics approval from the Ethics committee of the Jena University Hospital and from the Ethics committee of the State Chamber of Physicians of Thuringia. Results will be published in a peer-reviewed journal and additionally disseminated through public media.
  
  
  
  DRKS00010135.
authors.affiliation: Center for Infectious Disease and Infection Control, Jena University Hospital, Jena, Germany.|Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.|Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Weis
authors.affiliation: Center for Infectious Disease and Infection Control, Jena University Hospital, Jena, Germany.|Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Hagel
authors.affiliation: Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: R P H
authors.initials: RP
authors.lastname: Schmitz
authors.affiliation: Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.|Center for Clinical Studies, Jena University Hospital, Jena, Germany.
authors.forename: A
authors.initials: A
authors.lastname: Scherag
authors.affiliation: Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.|Department of Anesthesiology and Intensive Care, Jena University Hospital, Jena, Germany.|Center for Clinical Studies, Jena University Hospital, Jena, Germany.
authors.forename: F M
authors.initials: FM
authors.lastname: Brunkhorst
authors.affiliation: Center for Infectious Disease and Infection Control, Jena University Hospital, Jena, Germany.|Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: C
authors.initials: C
authors.lastname: Forstner
authors.affiliation: Institute for Medical Microbiology, Jena University Hospital, Jena, Germany.
authors.forename: B
authors.initials: B
authors.lastname: Löffler
authors.affiliation: Center for Infectious Disease and Infection Control, Jena University Hospital, Jena, Germany.|Center for Sepsis Control and Care, Jena University Hospital, Jena, Germany.
authors.forename: M W
authors.initials: MW
authors.lastname: Pletz
mesh_terms: D061605:Administration, Intravenous; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D002985:Clinical Protocols; D016000:Cluster Analysis; D003376:Counseling / Q000379:methods; D018592:Cross-Over Studies; D005858:Germany / Q000453:epidemiology; D006801:Humans; D010353:Patient Education as Topic; D015397:Program Evaluation; D011785:Quality Assurance, Health Care; D012017:Referral and Consultation; D013203:Staphylococcal Infections / Q000188:drug therapy / Q000453:epidemiology / Q000517:prevention & control; D013211:Staphylococcus aureus / Q000187:drug effects*; D013689:Telephone
chemical_list: D000900:Anti-Bacterial Agents
keywords: Staphylococcus aureus bacteremia; infectious disease counseling; randomized controlled trial