title: Rationale, design and methodology of a trial evaluating three strategies designed to improve sedation quality in intensive care units (DESIST study).
abstract: OBJECTIVE
  To describe the rationale, design and methodology for a trial of three novel interventions developed to improve sedation-analgesia quality in adult intensive care units (ICUs).
  
  
  METHODS
  8 clusters, each a Scottish ICU. All mechanically ventilated sedated patients were potentially eligible for inclusion in data analysis.
  
  
  METHODS
  Cluster randomised design in 8 ICUs, with ICUs randomised after 45 weeks baseline data collection to implement one of four intervention combinations: a web-based educational programme (2 ICUs); education plus regular sedation quality feedback using process control charts (2 ICUs); education plus a novel sedation monitoring technology (2 ICUs); or all three interventions. ICUs measured sedation-analgesia quality, relevant drug use and clinical outcomes, during a 45-week preintervention and 45-week postintervention period separated by an 8-week implementation period. The intended sample size was >100 patients per site per study period.
  
  
  METHODS
  The primary outcome was the proportion of 12 h care periods with optimum sedation-analgesia, defined as the absence of agitation, unnecessary deep sedation, poor relaxation and poor ventilator synchronisation. Secondary outcomes were proportions of care periods with each of these four components of optimum sedation and rates of sedation-related adverse events. Sedative and analgesic drug use, and ICU and hospital outcomes were also measured.
  
  
  METHODS
  Multilevel generalised linear regression mixed models will explore the effects of each intervention taking clustering into account, and adjusting for age, gender and APACHE II score. Sedation-analgesia quality outcomes will be explored at ICU level and individual patient level. A process evaluation using mixed methods including quantitative description of intervention implementation, focus groups and direct observation will provide explanatory information regarding any effects observed.
  
  
  CONCLUSIONS
  The DESIST study uses a novel design to provide system-level evaluation of three contrasting complex interventions on sedation-analgesia quality. Recruitment is complete and analysis ongoing.
  
  
  BACKGROUND
  NCT01634451.
authors.affiliation: Anaesthetics, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK.
authors.forename: Timothy S
authors.initials: TS
authors.lastname: Walsh
authors.affiliation: Anaesthetics, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK.
authors.forename: Kalliopi
authors.initials: K
authors.lastname: Kydonaki
authors.affiliation: Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
authors.forename: Jean
authors.initials: J
authors.lastname: Antonelli
authors.affiliation: Edinburgh Clinical Trials Unit, University of Edinburgh, Edinburgh, UK.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Stephen
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Lee
authors.affiliation: Anaesthetics, Critical Care and Pain Medicine, University of Edinburgh, Edinburgh, UK.
authors.forename: Kirsty
authors.initials: K
authors.lastname: Everingham
authors.affiliation: Edinburgh Health Services Research Unit, Edinburgh, UK.
authors.forename: Janet
authors.initials: J
authors.lastname: Hanley
authors.affiliation: GE Healthcare Finland Oy, Helsinki, Finland.
authors.forename: Kimmo
authors.initials: K
authors.lastname: Uutelo
authors.affiliation: GE Healthcare Finland Oy, Helsinki, Finland.
authors.forename: Petra
authors.initials: P
authors.lastname: Peltola
authors.affiliation: Centre for Population Health Sciences, University of Edinburgh, Edinburgh, UK Edinburgh Health Services Research Unit, Edinburgh, UK.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Weir
mesh_terms: D000698:Analgesia / Q000379:methods*; D016000:Cluster Analysis; D003422:Critical Care / Q000592:standards*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D007362:Intensive Care Units / Q000592:standards; D008297:Male; D008991:Monitoring, Physiologic / Q000592:standards*; D017064:Process Assessment, Health Care / Q000379:methods; D058996:Quality Improvement; D012121:Respiration, Artificial / Q000379:methods*; D012606:Scotland / Q000453:epidemiology
chemical_list: D006993:Hypnotics and Sedatives
keywords: PAIN MANAGEMENT; clinical trial; quality improvement; sedation