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Randomized Controlled Trial
. 2020 Oct 6;20(1):432.
doi: 10.1186/s12872-020-01705-9.

Thrombolysis implementation intervention and clinical outcome: a secondary analysis of a cluster randomized trial

Md Golam Hasnain  1 , Christine L Paul  2 , John R Attia  2   3   4 , Annika Ryan  2 , Erin Kerr  4 , Christopher Oldmeadow  3 , Catherine A D'Este  2   5 , Andrew Bivard  6 , Isobel J Hubbard  2 , Abul Hasnat Milton  7 , Christopher R Levi  2   8
Affiliations
Randomized Controlled Trial

Thrombolysis implementation intervention and clinical outcome: a secondary analysis of a cluster randomized trial

Md Golam Hasnain et al. BMC Cardiovasc Disord. .

Abstract

Background: Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. Still, many of them did not measure individual-level impact. This study aimed to make a posthoc comparison of the clinical outcomes of patients in the "Thrombolysis ImPlementation in Stroke (TIPS)" study, which aimed to improve rates of intravenous thrombolysis in Australia.

Methods: A posthoc analysis was conducted using individual-level patient data. Excellent (Three-month post treatment modified Rankin Score 0-2) and poor clinical outcome (Three-month post treatment modified Rankin Score 5-6) and post treatment parenchymal haematoma were the three main outcomes, and a mixed logistic regression model was used to assess the difference between the intervention and control groups.

Results: There was a non-significant higher odds of having an excellent clinical outcome of 57% (odds ratio: 1.57; 95% CI: 0.73-3.39) and 33% (odds ratio: 1.33; 95% CI: 0.73-2.44) during the active-and post-intervention period respectively, for the intervention compared to the control group. A non-significant lower odds of having a poor clinical outcome was also found in the intervention, relative to control group of 4% (odds ratio: 0.96; 95% CI: 0.56-2.07) and higher odds of having poor outcome of 44% (odds ratio: 1.44 95% CI: 0.61-3.41) during both active and post-intervention period respectively. Similarly, a non-significant lower odds of parenchymal haematoma was also found for the intervention group during the both active- (odds ratio: 0.53; 95% CI: 0.21-1.32) and post-intervention period (odds ratio: 0.96; 95% CI: 0.36-2.52).

Conclusion: The TIPS multi-component implementation approach was not effective in reducing the odds of post-treatment severe disability at 90 days, or post-thrombolysis hemorrhage.

Trial registration: Clinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796 .

Keywords: Clinical outcome; Implementation intervention; Intravenous thrombolysis; Ischemic stroke.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Legend: Framework of interventional activity
Fig. 2
Fig. 2
Legend: Distribution of patients within two study arms over three study periods
See this image and copyright information in PMC

References

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