Promoting acute thrombolysis for ischaemic stroke (PRACTISE) - Protocol for a cluster randomised controlled trial to assess the effect of implementation strategies on the rate and effects of thrombolysis for acute ischaemic stroke (ISRCTN 20405426)

作者：Dirks Maaike^*; Niessen Louis W; Huijsman Robbert; van Wijngaarden Jeroen; Minkman Mirella M N; Franke Cees L; van Oostenbrugge Robert J; Koudstaal Peter J; Dippel Diederik W J

来源：International Journal of Stroke, 2007, 2(2): 151-159.

DOI：10.1111/j.1747-4949.2007.00119.x

Rationale Thrombolysis with intravenous rtPA is an effective treatment for patients with ischaemic stroke if given within 3 h from onset. Generally, more than 20% of stroke patients arrive in time to be treated with thrombolysis. Nevertheless, in most hospitals, only 1-8% of all stroke patients are actually treated. Interorganisational, intraorganisational, medical and psychological barriers are hampering broad implementation of thrombolysis for acute ischaemic stroke.
Aims To evaluate the effect of a high-intensity implementation strategy for intravenous thrombolysis in acute ischaemic stroke, compared with regular implementation; to identify success factors and obstacles for implementation and to assess its cost-effectiveness, taking into account the costs of implementation.
Design The PRACTISE study is a national cluster-randomised-controlled trial. Twelve hospitals have been assigned to the regular or high-intensity intervention by random allocation after pair-wise matching. The high-intensity implementation consists of training sessions in conformity with the Breakthrough model, and a tool kit. All patients who are admitted with acute stroke and onset of symptoms not longer than 24 h are registered.
Study outcomes The primary outcome measure is treatment with thrombolysis. Secondary outcomes are admission within 4 h after onset of symptoms, death or disability at 3 months, the rate of haemorrhagic complications in patients treated with thrombolysis, and costs of implementation and stroke care in the acute setting. Tertiary outcomes are derived from detailed criteria for the organisational characteristics, such as door-to-needle time and protocol violations. These can be used to monitor the implementation process and study the effectiveness of specific interventions.
Discussion This study will provide important information on the effectiveness and cost-effectiveness of actively implementing an established treatment for acute ischaemic stroke. The multifaceted aspect of the intervention will make it difficult to attribute a difference in the primary outcome measure to a specific aspect of the intervention. However, careful monitoring of intermediate parameters as well as monitoring of accomplished SMART tasks can be expected to provide useful insights into the nature and role of factors associated with implementation of thrombolysis for acute ischaemic stroke, and of effective acute interventions in general.

• 出版日期2007-5
• 单位河北医科大学