Improving the uptake of thrombolysis in patients with acute ischaemic stroke has proved difficult despite being the guideline-recommended treatment for achieving better outcomes.
The Thrombolysis Implementation in Stroke (TIPS) study, published early this year, found a multicomponent intervention over 16 months resulted in only a small and transient increase in intravenous thrombolysis rates in the 10 hospitals where it was implemented compared to 10 control hospitals.
Now a post hoc analysis has shown the intervention also failed to have a positive effect on individual patient clinical outcomes.
The study, published in BMC Cardiovascular Disorders, compared clinical outcomes of disability and post-thrombolysis hemorrhage in 1,184 patients.
It found there was no significant difference in excellent or poor outcomes, as measured by modified Rankin Scale at 90 days, in patients treated at the intervention versus control hospitals.
A non-significant decrease in the rate of haemorrhages following intravenous thrombolysis was seen during both the active and post-intervention periods in the intervention group.
“Therefore, our hypothesis that exposure to the TIPS intervention may have resulted in enhanced care and more favourable outcomes for thrombolysis patients treated in the intervention hospitals is not supported by the data.”
The researchers said it was possible the study was not powered to detect a statistically significant change.
“A second factor is the trend throughout the trial for increasingly favourable outcome rates in the control group.”
They said a number of programs and initiatives that were active during the study period, including guideline revisions and stroke audit reports, could have driven changes across all hospitals.
“It is also conceivable that there was some degree of contamination and some crossover of interventional material between control and intervention sites, despite all care being taken to avoid this occurrence, due to the relatively small and tight-knit community of stroke care providers in Australia.”
“Currently, therefore, to our knowledge, there is no clinical trial evidence to suggest that health systems interventions targeting implementation of best evidence practise in stroke thrombolysis can improve thrombolysis patients’ clinical outcomes.”
Co-investigator on the TIPS studies Professor Christine Paul, from the University of Newcastle’s School of Medicine and Public Health, told the limbic it was very difficult to achieve practice change in a pressured hospital system.
“There is very little time that clinicians and other health staff have to reflect on practice and to implement change. And our intervention didn’t come with dollars that they could use to have someone do anything on the ground.”
“We were there as support but we weren’t giving them extra nurse time or the money to backfill someone …so they had to make changes within their existing resources and still performing their normal clinical roles. That is a challenge for any kind of implementation study.”
She noted that the TACTICS study underway in three states was also testing the impact of an education support package in improving access for stroke patients to endovascular therapies.