Resolving Barriers to Intravenous Thrombolysis: Results of the PRACTISE Trial

Summary

In The Netherlands, the rates of thrombolysis for ischemic stroke in are not optimal, despite guidelines recommending its use. This article discusses results from the Promoting Acute Thrombolysis for Ischaemic Stroke [PRACTISE; ISRCTN 20405426] trial, which evaluated the effectiveness of an intensive multifaceted implementation strategy aimed at increasing the number of patients who are treated with thrombolysis.

  • Interventional RadiologyIschemia
  • Thrombotic Disorders

In The Netherlands, the rates of thrombolysis for ischemic stroke in are not optimal, despite guidelines recommending its use. Diederik W. J. Dippel, MD, PhD, Erasmus Medical Center, Rotterdam, The Netherlands, presented results from the Promoting Acute Thrombolysis for Ischaemic Stroke (PRACTISE: ISRCTN 20405426) trial, which evaluated the effectiveness of an intensive multifaceted implementation strategy aimed at increasing the number of patients who are treated with thrombolysis.

PRACTISE was a cluster-randomized, controlled trial in 12 hospitals in The Netherlands, divided into 2 pairs of 6 (intervention and control), based on academic versus nonacademic setting, size, and previous thrombolysis rate [Dirks et al. Stroke 2011. In press]. All patients with a stroke who were admitted within 24 hours of onset of symptoms were registered, and a minimal set of data was collected. Patients who were diagnosed with an ischemic stroke and admitted within 4 hours of symptom onset were registered in more detail. Data acquisition continued for 2 years.

Patients admitted to the 6 hospitals in the intervention group received a high-intensity intervention, based on a recurrent process of measuring, intervention, and feedback. Feedback consisted of training sessions that conformed to an adapted breakthrough model using local teams, SMART goals that were aimed at specific barriers, and 5 training sessions. A tool kit was available on the internet. The primary outcome was treatment with thrombolysis. Multilevel multivariate logistic regression was used with adjustments for cluster effect, academic or nonacademic classification, size of hospital, previous thrombolysis rate, patient's age and gender, and baseline clinical characteristics. At baseline, the mean thrombolysis rate was 5% at the control institutions and 6% at the institutions that received intervention. Of the 5515 patients who were registered (mean age 72 years, ∼50% women), 1657 were admitted within 4 hours from onset and 696 were treated with rtPA.

There was a high rate of thrombolysis overall: 12% in the control group and 13% in the intervention group (OR, 1.3; 95% CI, 0.9 to 1.7; p=ns). However, ischemic stroke patients who were admitted within 4 hours were more likely to receive thrombolysis in an intervention center (44%) compared with a control center (39%; OR, 1.6; 95% CI, 1.2 to 2.3). This difference was significant. Although there were more intracranial hemorrhages in the intervention group (n=22; 5.7%) compared with the control group (n=14; 4.6%), the difference was not statistically significant (RR, 1.09; 95% CI, 0.83 to 1.43), and these rates were comparable with those found in other studies and registries. The increased rate of thrombolysis was not explained by the number of admissions, mean onset-to-door time, or mean door-to-needle time, but in the intervention group, unconventional contraindications and contraindications related to “minimal symptoms” and “rapid improvement” were less frequent than in the control group.

Several cultural characteristics of the hospital organization were shown to be related to thrombolysis rate, including an association between thrombolysis and the availability of informal and formal feedback (OR, 1.18; 95% CI, 1.09 to 1.28); a learning culture (OR, 1.12; 95% CI, 1.02 to 1.23); uncompromising, individual clinical leadership (OR, 1.12; 95% CI, 1.03 to 1.23); explicit goals (OR, 1.08; 95% CI, 1.01 to 1.17); and sum score (OR, 1.12; 95% CI, 1.02 to 1.23) [Van Wijngaarden JD et al. Stroke 2009].

“Rates of IV thrombolysis should be about 20% of all admitted ischemic stroke patients in general hospitals,” Prof. Dippel said. “An intensive multifaceted implementation strategy increases the number of patients treated with thrombolysis, probably due to better application of contraindications for thrombolysis. Implementation of IV thrombolysis for ischemic stroke works and is cost-effective.”

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