国家神经系统疾病临床医学研究中心数据管理与共享系统

发表杂志：Stroke and Vascular Neurology

发表类型: Protocol

影响因子(IF): 9.893

PMID: 35354662 Pubmed原文链接 全文下载

Background: Reperfusion therapy is the most effective treatment for acute ischemic stroke (AIS) but remains under-utilized in China. There is an urgent need to develop tailored strategies to increase adherence to intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT) within the guideline-recommended time window for eligible patients

Design: The Improve Acute Reperfusion Treatment Quality for Stroke in China (IMPROVE Stroke Care in China) trial is designed as a stepped wedge cluster randomized trial within 51 hospitals. We developed the comprehensive intervention “STEP” (Strategies, Toolkit, Exploration, Paradigm) to promote the reconstruction of workflow in stroke centres and shorten in-hospital delay of reperfusion treatment for AIS patients. The participating hospitals (clusters) were randomized to three groups (cohorts) for different predefined steps to intervention implementation. The primary outcome was the adherent rate of IVT or EVT for eligible patients within the time window. The sample size was estimated to be 7,644, and was determined by the number of cases to be enrolled in 5 study periods to detect a relative increase of 30% (from 19% to 25%) with 90% power and intraclass correlation coefficient of 0.03. All efficacy analyses will be conducted based on the intention-to-treat principle. The primary outcome will be analysed using a mixedeffects logistic regression with a random effect for the cluster (hospital), and a fixed effect for the strategy and period.