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

Christine Paul, Christopher Levi, Cate D'Este, Mark Parsons, C Bladin, Richard Lindley, John Attia, Frans Henskens, E Lalor, Mark Longworth, Sandra Middleton, Annika Ryan, Erin Kerr, Robert Sanson-Fisher, Craig Anderson, Ian Bruce, Heather Buchan, Camelia Burdusel, Ernest Butler, Greg CadiganZoe Campbell, Tim Coles, Alastair Corbett, Susan Day, Sonia Denisenko, Jennifer Dennett, Helen Dewey, G Donnan, Michelle Doughty, Malcolm Evans, Frances Gearon, Richard Geraghty, Richard Gerraty, Sumitha Gounden, Alice Grady, Rohan Grimley, Jeremy Grimshaw, Graeme Hankey, Kelvin Hill, Kim Hoffman, Susan Huckson, James Hughes, Amanda Jayakody, Bronwyn Jenkins, Martin Jude, Malcolm Kanard, Matthew Kinchington, Martin Krause, Sarah Kuhle, Paul Laird, Andrew Lee, Stanley Levy, Karen Longworth, Beverley MacDonald, Mackey Elizabeth, Krishna Mandaleson, Katherine Mohr, Stephen Moore, Kristy Morris, Elizabeth O'Brien, Bruce Paddock, Kim Parrey, Rachel Peake, M Pollack, Christopher Price, Shiho Rose, Jayantha Rupasinghe, Fiona Ryan, Andrew Searles, Rochelle Smits, Margaret Stevenson, Sanjeev Taneja, Zoe Terpening, Natalie Teasdale, John Watson, Alison Wilson, Yolande Weiner, Tissa Wijeratne, Nigel Wolfe

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    13 Citations (Scopus)

    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.Objectives: 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 and design: 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.Discussion: 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.Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12613000939796.

    Original languageEnglish
    Article number38
    Number of pages13
    JournalImplementation Science
    Volume9
    Issue number38
    DOIs
    Publication statusPublished - 2014

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    Paul, C., Levi, C., D'Este, C., Parsons, M., Bladin, C., Lindley, R., Attia, J., Henskens, F., Lalor, E., Longworth, M., Middleton, S., Ryan, A., Kerr, E., Sanson-Fisher, R., Anderson, C., Bruce, I., Buchan, H., Burdusel, C., Butler, E., ... Wolfe, N. (2014). 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. Implementation Science, 9(38), [38]. https://doi.org/10.1186/1748-5908-9-38