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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.

Paul CL, Levi CR, D'Este CA, Parsons MW, Bladin CF, Lindley RI, Attia JR, Henskens F, Lalor E, Longworth M, Middleton S, Ryan A, Kerr E, Sanson-Fisher RW, Thrombolysis ImPlementation in Stroke (TIPS) Study Gro - Implement Sci (2014)

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: The University of Newcastle, (UoN) University Drive, Callaghan, NSW 2308, Australia. chris.paul@newcastle.edu.au.

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.

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Related in: MedlinePlus

Timing of delivery of intervention activities.
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Related In: Results  -  Collection

License 1 - License 2
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Figure 2: Timing of delivery of intervention activities.

Mentions: The TIPS intervention components described below are grounded in behavioural theory and accord with the Behaviour Change Wheel (BCW) method [47]. The BCW emphasises the importance of ensuring that proponents have the capability, opportunity and motivation to perform the desired behaviour through interventions such as education, persuasion, incentivisation, coercion, training, restriction, environmental restructuring, modelling and enablement. A situational analysis based on the ‘patient journey’ is a foundational intervention component in that it delineates the steps and associated staff roles involved in successful delivery of thrombolysis. The TIPS intervention components are delivered via a number of intervention activities, the timing and content of which is presented in Figure 2.


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.

Paul CL, Levi CR, D'Este CA, Parsons MW, Bladin CF, Lindley RI, Attia JR, Henskens F, Lalor E, Longworth M, Middleton S, Ryan A, Kerr E, Sanson-Fisher RW, Thrombolysis ImPlementation in Stroke (TIPS) Study Gro - Implement Sci (2014)

Timing of delivery of intervention activities.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4016636&req=5

Figure 2: Timing of delivery of intervention activities.
Mentions: The TIPS intervention components described below are grounded in behavioural theory and accord with the Behaviour Change Wheel (BCW) method [47]. The BCW emphasises the importance of ensuring that proponents have the capability, opportunity and motivation to perform the desired behaviour through interventions such as education, persuasion, incentivisation, coercion, training, restriction, environmental restructuring, modelling and enablement. A situational analysis based on the ‘patient journey’ is a foundational intervention component in that it delineates the steps and associated staff roles involved in successful delivery of thrombolysis. The TIPS intervention components are delivered via a number of intervention activities, the timing and content of which is presented in Figure 2.

Bottom Line: 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.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: The University of Newcastle, (UoN) University Drive, Callaghan, NSW 2308, Australia. chris.paul@newcastle.edu.au.

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.

Show MeSH
Related in: MedlinePlus