Abstract
BackgroundMultiple 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.MethodsA 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.ResultsThere 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).ConclusionThe 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 registrationClinical Trial Registration-URL: http://www.anzctr.org.au/ Unique Identifier: ACTRN12613000939796.
Highlights
Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines
Despite the non-significant change in overall thrombolysis rates seen in the trial, it was considered possible that the Thrombolysis ImPlementation in Stroke (TIPS) intervention may have had a positive effect on individual patient clinical outcomes, for example, influencing improved selection of cases for thrombolysis treatment and streamlining of workflows [9]
All hospitals that participated in the TIPS study had either a Stroke Care Unit or staffing equivalent to a stroke physician and a nurse, and an emergency department
Summary
Multiple studies have attempted to increase the rate of intravenous thrombolysis for ischemic stroke using interventions to promote adherence to guidelines. 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. The Thrombolysis Implementation in Stroke (TIPS) study, was a cluster-randomized trial which aimed to improve thrombolysis rates through a multi-level, multicomponent, in-hospital intervention which was implemented in 10 of 20 study hospitals across Australia [6]. Despite the non-significant change in overall thrombolysis rates seen in the trial, it was considered possible that the TIPS intervention may have had a positive effect on individual patient clinical outcomes, for example, influencing improved selection of cases for thrombolysis treatment and streamlining of workflows [9]. A posthoc analysis of the TIPS database provides a unique opportunity to explore whether differences in individual patient clinical outcomes occurred within and between study groups
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