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.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
11 Feb 2022
Historique:
entrez: 12 2 2022
pubmed: 13 2 2022
medline: 21 4 2022
Statut: epublish

Résumé

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. 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. Proportion of all stroke patients receiving EVT, accounting for clustering. 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. 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. ACTRN12619000750189; UTNU1111-1230-4161.

Identifiants

pubmed: 35149571
pii: bmjopen-2021-055461
doi: 10.1136/bmjopen-2021-055461
pmc: PMC8845197
doi:

Types de publication

Clinical Trial Controlled Clinical Trial Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e055461

Informations de copyright

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

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.

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Auteurs

Annika Ryan (A)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Christine L Paul (CL)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Martine Cox (M)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Olivia Whalen (O)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Andrew Bivard (A)

Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.
Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.

John Attia (J)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Christopher Bladin (C)

Eastern Health Clinical School, Monash University, Box Hill, Victoria, Australia.

Stephen M Davis (SM)

Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.
Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.

Bruce C V Campbell (BCV)

Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.

Mark Parsons (M)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia.
Department 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.

Rohan S Grimley (RS)

Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.
School of Medicine, Griffith University, Southport, Queensland, Australia.

Craig Anderson (C)

The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Geoffrey A Donnan (GA)

Department of Medicine and Neurology, Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Parkville, Victoria, Australia.
Melbourne Brain Centre, Royal Melbourne Hospital, University of Melbourne, Melbourne, Victoria, Australia.

Christopher Oldmeadow (C)

Data Sciences, Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.

Sarah Kuhle (S)

Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.

Frederick R Walker (FR)

Centre 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.

Rebecca J Hood (RJ)

Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
Centre 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.

Steven Maltby (S)

Centre 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.

Angela Keynes (A)

Centre 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.

Candice Delcourt (C)

The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.
Department of Clinical Medicine, Faculty of Medicine, Health and Human Sciences, Macquarie University, Macquarie Park, New South Wales, Australia.

Luke Hatchwell (L)

The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Alejandra Malavera (A)

The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia.

Qing Yang (Q)

Apollo Medical Imaging Technology Pty Ltd, Melbourne, Victoria, Australia.

Andrew Wong (A)

Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Queensland, Australia.

Claire Muller (C)

Queensland State-wide Stroke Clinical Network, Healthcare Improvement Unit, Queensland Health, Herston, Queensland, Australia.
Royal Brisbane and Women's Hospital, University of Queensland, Brisbane, Queensland, Australia.

Arman Sabet (A)

School of Medicine, Griffith University, Southport, Queensland, Australia.
Department of Neurology, Gold Coast University Hospital, Southport, Queensland, Australia.

Carlos Garcia-Esperon (C)

Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia.
Area Administration, Hunter New England Local Health District, New Lambton, New South Wales, Australia.

Helen Brown (H)

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia.

Neil Spratt (N)

Division of Medicine, Department of Neurology, John Hunter Hospital, New Lambton Heights, New South Wales, Australia.
School of Biomedical Sciences and Pharmacy, Translational Stroke Laboratory, The University of Newcastle, Callaghan, New South Wales, Australia.

Timothy Kleinig (T)

Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia.

Ken Butcher (K)

Department 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.
Clinical Neuroscience, Prince of Wales Hospital, Randwick, New South Wales, Australia.

Christopher R Levi (CR)

School of Medicine and Public Health, College of Health, Medicine and Wellbeing, The University of Newcastle, Callaghan, New South Wales, Australia christopher.levi@health.nsw.gov.au.
Area Administration, Hunter New England Local Health District, New Lambton, New South Wales, Australia.

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