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Implementation Science
Published in: Implementation Science 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Christine L Paul, Christopher R Levi, Catherine A D’Este, Mark W Parsons, Christopher F Bladin, Richard I Lindley, John R Attia, Frans Henskens, Erin Lalor, Mark Longworth, Sandy Middleton, Annika Ryan, Erin Kerr, Robert W Sanson-Fisher, the Thrombolysis ImPlementation in Stroke (TIPS) Study Group

Published in: Implementation Science | Issue 1/2014

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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: ACTRN12613000939​796
Appendix
Available only for authorised users
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Metadata
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
Authors
Christine L Paul
Christopher R Levi
Catherine A D’Este
Mark W Parsons
Christopher F Bladin
Richard I Lindley
John R Attia
Frans Henskens
Erin Lalor
Mark Longworth
Sandy Middleton
Annika Ryan
Erin Kerr
Robert W Sanson-Fisher
the Thrombolysis ImPlementation in Stroke (TIPS) Study Group
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2014
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/1748-5908-9-38

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