Door to needle time for thrombolysis: A secondary analysis of the TIPS cluster randomized controlled trial

Abstract Background The Thrombolysis ImPlementation in Stroke (TIPS) study evaluated a hospital-based intervention aimed at improving the rates of intravenous thrombolysis in Australia. The current study assessed the effects of this intervention on the door-to-needle time for intravenous thrombolysis and also determined the intervention effects on door-to-needle time within metropolitan and non-metropolitan hospital locations. Methods TIPS was a clustered randomized controlled trial that involved 20 hospitals in Australia, with 10 hospitals receiving a multi-component practice-change intervention. De-identified patient data collected in the trial included the arrival, assessment, and treatment times for acute ischemic stroke patients. A posthoc exploration using mixed-effects regression modelling was used to assess intervention effects on door-to-needle time, and the effects within hospital location (metropolitan versus non-metropolitan). Results The intervention vs. control difference in the door-to-needle times was non-significant overall or within a hospital location. To provide additional context for the findings, we also evaluated the results within each intervention hospitals. During the active-intervention period, the intervention hospitals showed a significant decrease in the door-to-needle time of 9.25 minutes (95%CI: -16.93, -1.57), but during the post-intervention period, the result was not significant. During the active intervention period, control hospitals showed a significant decrease in the door-to-needle time of 5.26 minutes (95% CI: -8.37; -2.14) and during the post-intervention period, the decrease was 12.13 minutes (95%CI: -17.44, -6.81). Conclusion Across these primary stroke care centres in Australia, a secular trend towards shorter door-to-needle times across both intervention and control hospitals was evident. The intervention resulted in only a modest but significant reduction within experimental groups during the active intervention period, which was not sustained during the post-intervention period.