RT Journal Article
SR Electronic
T1 Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 451
OP 456
DO 10.1136/svn-2021-001461
VO 7
IS 5
A1 Li, Zixiao
A1 Wang, Chunjuan
A1 Zhang, Xinmiao
A1 Zong, Lixia
A1 Zhou, Hongyu
A1 Gu, Hongqiu
A1 Jiang, Yong
A1 Pan, Yuesong
A1 Meng, Xia
A1 Zhou, Qi
A1 Zhao, Haifen
A1 Yang, Xin
A1 Wang, Meng
A1 Xiong, Yunyun
A1 Zhao, Xingquan
A1 Wang, Yilong
A1 Liu, Liping
A1 Ma, Xudong
A1 Morgan, Louise
A1 Xian, Ying
A1 Schwamm, Lee H
A1 Wang, Yongjun
YR 2022
UL http://svn.bmj.com/content/7/5/451.abstract
AB 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 Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request. http://paper.ncrcnd.ttctrc.com/default/projects.