title: Thrombolysis ImPlementation in Stroke (TIPS): evaluating the effectiveness of a strategy to increase the adoption of best evidence practice--protocol for a cluster randomised controlled trial in acute stroke care.
abstract: BACKGROUND
  Stroke is a leading cause of death and disability internationally. One of the three effective interventions in the acute phase of stroke care is thrombolytic therapy with tissue plasminogen activator (tPA), if given within 4.5 hours of onset to appropriate cases of ischaemic stroke.
  
  
  OBJECTIVE
  To test the effectiveness of a multi-component multidisciplinary collaborative approach compared to usual care as a strategy for increasing thrombolysis rates for all stroke patients at intervention hospitals, while maintaining accepted benchmarks for low rates of intracranial haemorrhage and high rates of functional outcomes for both groups at three months.
  
  
  METHODS
  A cluster randomised controlled trial of 20 hospitals across 3 Australian states with 2 groups: multi- component multidisciplinary collaborative intervention as the experimental group and usual care as the control group. The intervention is based on behavioural theory and analysis of the steps, roles and barriers relating to rapid assessment for thrombolysis eligibility; it involves a comprehensive range of strategies addressing individual-level and system-level change at each site. The primary outcome is the difference in tPA rates between the two groups post-intervention. The secondary outcome is the proportion of tPA treated patients in both groups with good functional outcomes (modified Rankin Score (mRS <2) and the proportion with intracranial haemorrhage (mRS ≥2), compared to international benchmarks.
  
  
  CONCLUSIONS
  TIPS will trial a comprehensive, multi-component and multidisciplinary collaborative approach to improving thrombolysis rates at multiple sites. The trial has the potential to identify methods for optimal care which can be implemented for stroke patients during the acute phase. Study findings will include barriers and solutions to effective thrombolysis implementation and trial outcomes will be published whether significant or not.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry: ACTRN12613000939796.
authors.affiliation: The University of Newcastle, (UoN) University Drive, Callaghan, NSW 2308, Australia. chris.paul@newcastle.edu.au.
authors.forename: Christine L
authors.initials: CL
authors.lastname: Paul
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Levi
authors.forename: Catherine A
authors.initials: CA
authors.lastname: D'Este
authors.forename: Mark W
authors.initials: MW
authors.lastname: Parsons
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Bladin
authors.forename: Richard I
authors.initials: RI
authors.lastname: Lindley
authors.forename: John R
authors.initials: JR
authors.lastname: Attia
authors.forename: Frans
authors.initials: F
authors.lastname: Henskens
authors.forename: Erin
authors.initials: E
authors.lastname: Lalor
authors.forename: Mark
authors.initials: M
authors.lastname: Longworth
authors.forename: Sandy
authors.initials: S
authors.lastname: Middleton
authors.forename: Annika
authors.initials: A
authors.lastname: Ryan
authors.forename: Erin
authors.initials: E
authors.lastname: Kerr
authors.forename: Robert W
authors.initials: RW
authors.lastname: Sanson-Fisher
mesh_terms: D001241:Aspirin / Q000008:administration & dosage; D001315:Australia; D003299:Cooperative Behavior; D004059:Diffusion of Innovation; D004632:Emergency Medical Services / Q000379:methods; D019317:Evidence-Based Medicine; D005343:Fibrinolytic Agents / Q000008:administration & dosage; D019983:Guideline Adherence; D006801:Humans; D010348:Patient Care Team / Q000458:organization & administration; D017410:Practice Guidelines as Topic; D011787:Quality of Health Care / Q000458:organization & administration*; D012107:Research Design; D020521:Stroke / Q000188:drug therapy*; D015912:Thrombolytic Therapy / Q000379:methods*; D010959:Tissue Plasminogen Activator / Q000008:administration & dosage; D014218:Triage / Q000379:methods
chemical_list: D005343:Fibrinolytic Agents; D010959:Tissue Plasminogen Activator; D001241:Aspirin