title: Triage, treatment and transfer of patients with stroke in emergency department trial (the T3Trial): a cluster randomised trial protocol.
abstract: Internationally recognised evidence-based guidelines recommend appropriate triage of patients with stroke in emergency departments (EDs), administration of tissue plasminogen activator (tPA), and proactive management of fever, hyperglycaemia and swallowing before prompt transfer to a stroke unit to maximise outcomes. We aim to evaluate the effectiveness in EDs of a theory-informed, nurse-initiated, intervention to improve multidisciplinary triage, treatment and transfer (T3) of patients with acute stroke to improve 90-day death and dependency. Organisational and contextual factors associated with intervention uptake also will be evaluated.
  
  
  
  This prospective, multicentre, parallel group, cluster randomised trial with blinded outcome assessment will be conducted in EDs of hospitals with stroke units in three Australian states and one territory. EDs will be randomised 1:1 within strata defined by state and tPA volume to receive either the T3intervention or no additional support (control EDs). Our T3intervention comprises an evidence-based care bundle targeting: (1) triage: routine assignment of patients with suspected stroke to Australian Triage Scale category 1 or 2; (2) treatment: screening for tPA eligibility and administration of tPA where applicable; instigation of protocols for management of fever, hyperglycaemia and swallowing; and (3) transfer: prompt admission to the stroke unit. We will use implementation science behaviour change methods informed by the Theoretical Domains Framework [1, 2] consisting of (i) workshops to determine barriers and local solutions; (ii) mixed interactive and didactic education; (iii) local clinical opinion leaders; and (iv) reminders in the form of email, telephone and site visits. Our primary outcome measure is 90 days post-admission death or dependency (modified Rankin Scale >2). Secondary outcomes are health status (SF-36), functional dependency (Barthel Index), quality of life (EQ-5D); and quality of care outcomes, namely, monitoring and management practices for thrombolysis, fever, hyperglycaemia, swallowing and prompt transfer. Outcomes will be assessed at the patient level. A separate process evaluation will examine contextual factors to successful intervention uptake. At the time of publication, EDs have been randomised and the intervention is being implemented.
  
  
  
  This theoretically informed intervention is aimed at addressing important gaps in care to maximise 90-day health outcomes for patients with stroke.
  
  
  
  Australian and New Zealand Clinical Trials Registry ACTRN12614000939695 . Registered 2 September 2014.
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Executive Suite, Level 5 DeLacy Building, St Vincent's Hospital, Victoria Road, Darlinghurst, 2010, New South Wales, Australia. Sandy.middleton@acu.edu.au.
authors.forename: Sandy
authors.initials: S
authors.lastname: Middleton
authors.affiliation: John Hunter Hospital, Newcastle, Australia.|Centre for Translational Neuroscience and Mental Health, University of Newcastle/Hunter Medical Research Institute, Newcastle, Australia.
authors.forename: Chris
authors.initials: C
authors.lastname: Levi
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Executive Suite, Level 5 DeLacy Building, St Vincent's Hospital, Victoria Road, Darlinghurst, 2010, New South Wales, Australia.
authors.forename: Simeon
authors.initials: S
authors.lastname: Dale
authors.affiliation: Centre for Diabetes and Endocrinology Research, Westmead Hospital and University of Sydney, Westmead, Sydney, New South Wales, Australia.
authors.forename: N Wah
authors.initials: NW
authors.lastname: Cheung
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Executive Suite, Level 5 DeLacy Building, St Vincent's Hospital, Victoria Road, Darlinghurst, 2010, New South Wales, Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: McInnes
authors.affiliation: Faculty of Health, Eastern Health - Deakin University Nursing and Midwifery Research Centre School of Nursing and Midwifery, Burwood, Victoria, 3125, Australia.
authors.forename: Julie
authors.initials: J
authors.lastname: Considine
authors.affiliation: National Centre for Epidemiology and Population Health (NCEPH), Australian National University, Canberra, Australian Capital Territory, Australia.
authors.forename: Catherine
authors.initials: C
authors.lastname: D'Este
authors.affiliation: Stroke and Ageing Research, School of Clinical Sciences at Monash Health, Monash University, Clayton, Melbourne, Victoria, Australia.|Florey Institute of Neuroscience and Mental Health, University of Melbourne, Parkville, Victoria, Australia.
authors.forename: Dominique A
authors.initials: DA
authors.lastname: Cadilhac
authors.affiliation: Clinical Epidemiology Program, Ottawa Health Research Institute, 1053 Carling Avenue, Administration Building, Room 2-017, Ottawa, Ontario, K1Y 4E9, Canada.|Department of Medicine, University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.
authors.forename: Jeremy
authors.initials: J
authors.lastname: Grimshaw
authors.affiliation: Department of Medicine, Monash University, Melbourne, Australia.|Neurosciences Clinical Institute, Epworth Hospital, Richmond, Victoria, 3121, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Gerraty
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Executive Suite, Level 5 DeLacy Building, St Vincent's Hospital, Victoria Road, Darlinghurst, 2010, New South Wales, Australia.
authors.forename: Louise
authors.initials: L
authors.lastname: Craig
authors.affiliation: Nursing Research Institute, St Vincent's Health Australia (Sydney) and Australian Catholic University, Executive Suite, Level 5 DeLacy Building, St Vincent's Hospital, Victoria Road, Darlinghurst, 2010, New South Wales, Australia.
authors.forename: Verena
authors.initials: V
authors.lastname: Schadewaldt
authors.affiliation: School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, 2300, Australia.
authors.forename: Patrick
authors.initials: P
authors.lastname: McElduff
authors.affiliation: Alfred Hospital, Melbourne, Victoria, 3004, Australia.|Department of Surgery, Central Clinical School, Monash University, Melbourne, Australia.|Faculty of Science, Engineering and Technology, Swinburne University of Technology, Melbourne, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Fitzgerald
authors.affiliation: Speech Pathology Department, Prince of Wales Hospital, High St, Randwick, New South Wales, 2031, Australia.
authors.forename: Clare
authors.initials: C
authors.lastname: Quinn
authors.affiliation: Statewide Stroke Clinical Network, Brisbane, 4000, Australia.
authors.forename: Greg
authors.initials: G
authors.lastname: Cadigan
authors.affiliation: Department of Health Victoria, Victorian Stroke Clinical Network, Melbourne, Victoria, 3000, Australia.
authors.forename: Sonia
authors.initials: S
authors.lastname: Denisenko
authors.affiliation: Stroke Services NSW, NSW Agency for Clinical Innovation, Chatswood, New South Wales, Australia.
authors.forename: Mark
authors.initials: M
authors.lastname: Longworth
authors.affiliation: School of Epidemiology, Public Health and Preventive Medicine (SEPHPM), University of Ottawa, 451 Smyth Road, Ottawa, Ontario, K1H 8M5, Canada.|Nulungu Research Institute, University of Notre Dame Australia, Broome, Western Australia, Australia.
authors.forename: Jeanette
authors.initials: J
authors.lastname: Ward
mesh_terms: D000328:Adult; D000368:Aged; D016000:Cluster Analysis; D003625:Data Collection; D003680:Deglutition Disorders / Q000628:therapy; D004311:Double-Blind Method; D004636:Emergency Service, Hospital; D005260:Female; D005334:Fever / Q000628:therapy; D006801:Humans; D006943:Hyperglycemia / Q000628:therapy; D016247:Information Storage and Retrieval; D008297:Male; D008875:Middle Aged; D009517:New South Wales; D010360:Patient Transfer / Q000379:methods; D011446:Prospective Studies; D011787:Quality of Health Care; D011793:Queensland; D018401:Sample Size; D020521:Stroke / Q000451:nursing*; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use; D057170:Translational Research, Biomedical; D016896:Treatment Outcome; D014218:Triage / Q000379:methods*; D014739:Victoria; D055815:Young Adult
chemical_list: D010959:Tissue Plasminogen Activator
keywords: Care bundle; Cluster randomised trial; Dysphagia; Fever; Hyperglycaemia; Implementation science; Nurse-led; Stroke; Theoretical domains framework; Thrombolysis