Limits...
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.

Show MeSH

Related in: MedlinePlus

Study design & timeframe.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 1: Study design & timeframe.

Mentions: The cluster randomised controlled trial will involve 20 hospitals in the Eastern Australian states of New South Wales (NSW), Victoria (VIC) and Queensland (QLD). Hospitals are the unit of randomisation and the unit of analysis. SCUs manage the majority of stroke patients across the Eastern states of Australia. 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 control hospitals will receive no intervention and are free to make practice changes of their own accord. Thus the study is an implementation effectiveness trial rather than an efficacy trial. The follow-up period will be two years post-baseline (i.e., Year 1 to 2 = baseline, Year 3 = intervention, Year 4 = follow-up), with an additional three months for measurement of functional outcomes for those thrombolysed in the final month of follow-up. Figure 1 describes the study design.


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)

Study design & timeframe.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 1: Study design & timeframe.
Mentions: The cluster randomised controlled trial will involve 20 hospitals in the Eastern Australian states of New South Wales (NSW), Victoria (VIC) and Queensland (QLD). Hospitals are the unit of randomisation and the unit of analysis. SCUs manage the majority of stroke patients across the Eastern states of Australia. 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 control hospitals will receive no intervention and are free to make practice changes of their own accord. Thus the study is an implementation effectiveness trial rather than an efficacy trial. The follow-up period will be two years post-baseline (i.e., Year 1 to 2 = baseline, Year 3 = intervention, Year 4 = follow-up), with an additional three months for measurement of functional outcomes for those thrombolysed in the final month of follow-up. Figure 1 describes the study design.

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