Article Text

Protocol
TACTICS - Trial of Advanced CT Imaging and Combined Education Support for Drip and Ship: evaluating the effectiveness of an ‘implementation intervention’ in providing better patient access to reperfusion therapies: protocol for a non-randomised controlled stepped wedge cluster trial in acute stroke
  1. Annika Ryan1,2,
  2. Christine L Paul1,2,
  3. Martine Cox1,2,
  4. Olivia Whalen1,2,
  5. Andrew Bivard3,4,
  6. John Attia1,2,
  7. Christopher Bladin5,
  8. Stephen M Davis3,4,
  9. Bruce C V Campbell3,
  10. Mark Parsons1,6,
  11. Rohan S Grimley7,8,
  12. Craig Anderson9,10,
  13. Geoffrey A Donnan3,4,
  14. Christopher Oldmeadow11,
  15. Sarah Kuhle7,
  16. Frederick R Walker12,
  17. Rebecca J Hood2,12,
  18. Steven Maltby12,
  19. Angela Keynes12,
  20. Candice Delcourt9,13,
  21. Luke Hatchwell9,
  22. Alejandra Malavera9,
  23. Qing Yang14,
  24. Andrew Wong15,
  25. Claire Muller7,15,
  26. Arman Sabet8,16,
  27. Carlos Garcia-Esperon2,17,
  28. Helen Brown18,
  29. Neil Spratt19,20,
  30. Timothy Kleinig21,
  31. Ken Butcher6,22,
  32. Christopher R Levi1,17
  1. 1School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia
  2. 2Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
  3. 3Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia
  4. 4Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia
  5. 5Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia
  6. 6Department of Neurology, Liverpool Hospital, Ingham Institute for Applied Medical Research, University of New South Wales South Western Sydney Clinical School, Liverpool, New South Wales, Australia
  7. 7Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia
  8. 8School of Medicine, Griffith University, Southport, Queensland, Australia
  9. 9The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
  10. 10Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
  11. 11Data Sciences, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia
  12. 12Centre for Advanced Training Systems, School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia
  13. 13Department of Clinical Medicine, Faculty of Medicine, Health and Human Sciences, Macquarie University, Macquarie Park, New South Wales, Australia
  14. 14Apollo Medical Imaging Technology Pty Ltd, Melbourne, Victoria, Australia
  15. 15Royal Brisbane and Women’s Hospital, University of Queensland, Brisbane, Queensland, Australia
  16. 16Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia
  17. 17Area Administration, Hunter New England Local Health District, New Lambton, New South Wales, Australia
  18. 18Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
  19. 19Division of Medicine, Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia
  20. 20School of Biomedical Sciences and Pharmacy, Translational Stroke Laboratory, The University of Newcastle, Callaghan, New South Wales, Australia
  21. 21Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia
  22. 22Clinical Neuroscience, Prince of Wales Hospital, Randwick, New South Wales, Australia
  1. Correspondence to Professor Christopher R Levi; christopher.levi{at}health.nsw.gov.au

Abstract

Introduction Stroke reperfusion therapies, comprising intravenous thrombolysis (IVT) and/or endovascular thrombectomy (EVT), are best practice treatments for eligible acute ischemic stroke patients. In Australia, EVT is provided at few, mainly metropolitan, comprehensive stroke centres (CSC). There are significant challenges for Australia’s rural and remote populations in accessing EVT, but improved access can be facilitated by a ‘drip and ship’ approach. TACTICS (Trial of Advanced CT Imaging and Combined Education Support for Drip and Ship) aims to test whether a multicomponent, multidisciplinary implementation intervention can increase the proportion of stroke patients receiving EVT.

Methods and analysis This is a non-randomised controlled, stepped wedge trial involving six clusters across three Australian states. Each cluster comprises one CSC hub and a minimum of three primary stroke centre (PSC) spokes. Hospitals will work in a hub and spoke model of care with access to a multislice CT scanner and CT perfusion image processing software (MIStar, Apollo Medical Imaging). The intervention, underpinned by behavioural theory and technical assistance, will be allocated sequentially, and clusters will move from the preintervention (control) period to the postintervention period.

Primary outcome Proportion of all stroke patients receiving EVT, accounting for clustering.

Secondary outcomes Proportion of patients receiving IVT at PSCs, proportion of treated patients (IVT and/or EVT) with good (modified Rankin Scale (mRS) score 0–2) or poor (mRS score 5–6) functional outcomes and European Quality of Life Scale scores 3 months postintervention, proportion of EVT-treated patients with symptomatic haemorrhage, and proportion of reperfusion therapy-treated patients with good versus poor outcome who presented with large vessel occlusion at spokes.

Ethics and dissemination Ethical approval has been obtained from the Hunter New England Human Research Ethics Committee (18/09/19/4.13, HREC/18/HNE/241, 2019/ETH01238). Trial results will be disseminated widely through published manuscripts, conference presentations and at national and international platforms regardless of whether the trial was positive or neutral.

Trial registration number ACTRN12619000750189; UTNU1111-1230-4161.

  • education & training (see medical education & training)
  • quality in health care
  • stroke medicine
  • change management
  • interventional radiology
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Footnotes

  • Contributors AR, CLP, MC, OW, AB, JA, CB, SMD, BCVC, MP, RSG, CA, GAD, CO, SK, FRW, RJH, SM, AK, LH, AM, CD and CRL contributed considerably to study design and critically revised the article. AW, CM, AS, CG-E, HB, NS, TK, KB and QY contributed to the conception of study elements and critically revised the article. In addition to this, AR drafted the manuscript and provided conceptual input into study design and process measures for the implementation intervention. MC contributed to drafting the manuscript, managed ethics applications and assisted with site recruitment. OW contributed to drafting the manuscript and the take home kit. CLP provided conceptual input into the development of data collection, study design, process measures and intervention strategy. CRL and AB codesigned the study, managed site recruitment and provided conceptual input into data collection and imaging education. SK assisted with site recruitment, contracts and agreements. FRW, RJH, SM and AK oversaw the development and internal testing of the VR training application and ongoing technical support. JA and CO provided conceptual advice on data collection, study design, statistical analysis and power calculations. AM assisted with meeting documentation and data elements. LH and CD assisted with site recruitment and data elements. AR, CLP, OW, MC and CRL were part of the writing group for the manuscript. All authors read and approved the final manuscript.

  • Funding This is a National Health and Medical Research Council-funded partnership grant (APP1132621) with external funding from Boehringer Ingelheim, Queensland Health and Apollo Medical Imaging Technology. Infrastructure funding is provided by the University of Newcastle, Hunter Medical Research Institute, George Institute for Global Health, Melbourne University and Queensland Health. The trial is managed by the George Institute for Global Health, in partnership with the University of Newcastle and Hunter New England Local Health District. Boehringer Ingelheim will provide cash contribution towards venue, travel and accommodation costs associated with cluster workshops, with involvement subject to strict guidelines including exclusion from study design, data collection, management, roll-out, analysis, evaluation and publication. Queensland Health provides support for a programme manager in Queensland. Apollo Medical Imaging Technology provides funding for optimisation of the AutoMIStar CT perfusion system.

  • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

  • Competing interests Boehringer Ingelheim is the manufacturer of the tissue plasminogen activator (tPA) drug and thus has an interest in the study. They, however, have no right to publish any results arising from this trial.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.