Abstract
BackgroundStroke 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.ObjectivesTo 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 designA 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.DiscussionTIPS 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 registrationAustralian New Zealand Clinical Trials Registry: ACTRN12613000939796
Highlights
Stroke is a leading cause of death and disability internationally
Hospitals in the intervention group will receive a multicomponent multidisciplinary collaborative intervention based on behavioural principles as described by the Behaviour Change Wheel framework for the design and implementation of evidence-based practice [47]
The accuracy of ICD coding for all types of stroke is good [48,49,50,51], with a New South Wales (NSW) tertiary hospital reporting 96% accuracy in stroke discharge diagnosis identified by a random selection of stroke medical records [50,51]
Summary
Stroke is a leading cause of death and disability internationally. Effective treatments for stroke can provide major reductions in health burden Stroke is a major cause of death and disability internationally, with over 5 million deaths from stroke worldwide [1]. Stroke accounted for approximately 1 in every 19 deaths in the United States in 2009 [2], with US projections indicating that an additional 4 million people will have had a stroke by 2030 [3], a 22% increase in prevalence from 2013 [4]. The mean cost per person for stroke care in the United States in 2009 was estimated at $6,018 [5]. The majority of strokes (89%) are admitted to hospital [10], and approximately 50% of sufferers are left either deceased or dependent [11]
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