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

BMC Cardiovasc Disord. 2020 Oct 6;20(1):432. doi: 10.1186/s12872-020-01705-9.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Australia
  • Disability Evaluation
  • Female
  • Fibrinolytic Agents / administration & dosage*
  • Fibrinolytic Agents / adverse effects
  • Functional Status
  • Humans
  • Infusions, Intravenous
  • Intracranial Hemorrhages / chemically induced
  • Ischemic Stroke / diagnosis
  • Ischemic Stroke / drug therapy*
  • Male
  • Middle Aged
  • Outcome and Process Assessment, Health Care / trends*
  • Recovery of Function
  • Risk Assessment
  • Risk Factors
  • Thrombolytic Therapy / adverse effects
  • Thrombolytic Therapy / trends*
  • Time Factors
  • Treatment Outcome

Substances

  • Fibrinolytic Agents

Associated data

  • ANZCTR/ACTRN12613000939796