Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China

IF 2.6 1区医学

Journal of Investigative Medicine Pub Date : 2022-03-30 DOI:10.1136/svn-2021-001461

Zixiao Li, Chunjuan Wang, Xinmiao Zhang, Lixia Zong, Hongyu Zhou, H. Gu, Yong Jiang, Yuesong Pan, X. Meng, Qi Zhou, Haifen Zhao, Xin Yang, Meng Wang, Yunyun Xiong, Xingquan Zhao, Yilong Wang, Liping Liu, Xudong Ma, Louise Morgan, Ying Xian, L. Schwamm, Yongjun Wang

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引用次数: 1

Abstract

Background Reperfusion therapy is the most effective treatment for acute ischaemic stroke (AIS) but remains underutilised 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. Aims This study aims to investigate the efficacy of a comprehensive quality improvement intervention on adherence to guideline-recommended reperfusion therapy for patients with AIS in China. Design The Improve Acute Reperfusion Treatment Quality for Stroke in China (IMPROVE Stroke Care in China) trial is designed as a stepped wedge cluster randomised 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 patients with AIS. The participating hospitals (clusters) were randomised 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 7644, and was determined by the number of cases to be enrolled in five 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 mixed-effects logistic regression with a random effect for the cluster (hospital), and a fixed effect for the strategy and period. Conclusions If the efficacy is well established, this targeted comprehensive intervention STEP will inform national strategies to increase adherence to guideline-recommended performance on reperfusion therapy. Trial registration number clinicaltrials.gov Identifier: NCT003578107

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改善卒中急性再灌注治疗质量的楔形聚类随机试验的基本原理和设计:改善中国卒中护理

背景再灌注治疗是治疗急性缺血性脑卒中（AIS）最有效的方法，但在中国尚未得到充分利用。迫切需要制定量身定制的策略，在指南建议的符合条件的患者时间窗口内增加静脉溶栓（IVT）和血管内血栓切除术（EVT）的依从性。本研究旨在探讨综合质量改善干预对中国AIS患者遵守指南推荐的再灌注治疗的疗效。设计改善中国卒中急性再灌注治疗质量（改善中国卒中护理）试验是在51家医院内设计的一项阶梯式楔形群随机试验。我们开发了综合干预“STEP”（策略、工具包、探索、范式），以促进中风中心工作流程的重建，并缩短AIS患者住院再灌注治疗的延迟。参与的医院（集群）被随机分为三组（队列），用于不同的干预实施预定义步骤。主要结果是符合条件的患者在时间窗口内IVT或EVT的粘附率。样本量估计为7644，由五个研究期间的病例数决定，以检测相对增加30%（从19%到25%），90%的幂和0.03的组内相关系数。所有疗效分析将基于意向治疗原则进行。主要结果将使用混合效应逻辑回归进行分析，集群（医院）具有随机效应，策略和时期具有固定效应。结论如果疗效得到很好的证实，这种有针对性的综合干预STEP将为国家战略提供信息，以提高对指南推荐的再灌注治疗效果的遵守率。试验注册号clinicaltrials.gov标识符：NCT003578107

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来源期刊

Journal of Investigative Medicine MEDICINE, GENERAL & INTERNALMEDICINE, RESE-MEDICINE, RESEARCH & EXPERIMENTAL

自引率

0.00%

发文量

111

期刊介绍： Journal of Investigative Medicine (JIM) is the official publication of the American Federation for Medical Research. The journal is peer-reviewed and publishes high-quality original articles and reviews in the areas of basic, clinical, and translational medical research. JIM publishes on all topics and specialty areas that are critical to the conduct of the entire spectrum of biomedical research: from the translation of clinical observations at the bedside, to basic and animal research to clinical research and the implementation of innovative medical care.