title: The evaluation of a tailored intervention to improve the management of suspected viral encephalitis: protocol for a cluster randomised controlled trial.
abstract: BACKGROUND
  Viral encephalitis is a devastating condition for which delayed treatment is associated with increased morbidity and mortality. Clinical audits indicate substantial scope for improved detection and treatment. Improvement strategies should ideally be tailored according to identified needs and barriers to change. The aim of the study is to evaluate the effectiveness and cost-effectiveness of a tailored intervention to improve the secondary care management of suspected encephalitis.
  
  
  METHODS
  The study is a two-arm cluster randomised controlled trial with allocation by postgraduate deanery. Participants were identified from 24 hospitals nested within 12 postgraduate deaneries in the United Kingdom (UK). We developed a multifaceted intervention package including core and flexible components with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. The primary outcome will be a composite of the proportion of patients with suspected encephalitis receiving timely and appropriate diagnostic lumbar puncture within 12 h of hospital admission and aciclovir treatment within 6 h. We will gather outcome data pre-intervention and up to 12 months post-intervention from patient records. Statistical analysis at the cluster level will be blind to allocation. An economic evaluation will estimate intervention cost-effectiveness from the health service perspective.
  
  
  BACKGROUND
  Controlled Trials: ISRCTN06886935.
authors.affiliation: Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. r.backman@liverpool.ac.uk.
authors.forename: Ruth
authors.initials: R
authors.lastname: Backman
authors.affiliation: Leeds Institute of Health Sciences, University of Leeds, Charles Thackrah Building, 101 Clarendon Road, Leeds, LS2 9LJ, United Kingdom. r.foy@leeds.ac.uk.
authors.forename: Robbie
authors.initials: R
authors.lastname: Foy
authors.affiliation: Department Epidemiology and Population Health, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. diggle@liverpool.ac.uk.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Diggle
authors.affiliation: Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. rachel.kneen@liverpool.ac.uk.|Department of Neurology, Alder Hey Children's NHS Foundation Trust, Eaton Road, Liverpool, L12 2AP, United Kingdom. rachel.kneen@liverpool.ac.uk.
authors.forename: Rachel
authors.initials: R
authors.lastname: Kneen
authors.affiliation: Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. sdefres@liverpool.ac.uk.|Royal Liverpool and Broadgreen University Hospitals Trust, Liverpool, L7 8XP, United Kingdom. sdefres@liverpool.ac.uk.
authors.forename: Sylviane
authors.initials: S
authors.lastname: Defres
authors.affiliation: Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. Benedict.Michael@liverpool.ac.uk.|The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerly, Liverpool, L9 7LJ, United Kingdom. Benedict.Michael@liverpool.ac.uk.
authors.forename: Benedict Daniel
authors.initials: BD
authors.lastname: Michael
authors.affiliation: Health Economics Group, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter, EX2 4SG, United Kingdom. A.Medina-Lara@exeter.ac.uk.
authors.forename: Antonieta
authors.initials: A
authors.lastname: Medina-Lara
authors.affiliation: Department of Clinical Infection, Microbiology and Immunology, Institute of Infection and Global Health, University of Liverpool, Ronald Ross Building, 8 West Derby Street, Liverpool, L69 7BE, United Kingdom. t.solomon@liverpool.ac.uk.|The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerly, Liverpool, L9 7LJ, United Kingdom. t.solomon@liverpool.ac.uk.
authors.forename: Tom
authors.initials: T
authors.lastname: Solomon
mesh_terms: D000212:Acyclovir / Q000627:therapeutic use; D000328:Adult; D002648:Child; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D018792:Encephalitis, Viral / Q000175:diagnosis / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D058996:Quality Improvement; D013129:Spinal Puncture; D013997:Time Factors
chemical_list: D000212:Acyclovir