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

They are only trying to setup guidelines, NOT PROTOCOLS. Wrong goal.

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

1. Zixiao Li1,2,3,4,
2. Chunjuan Wang1,2,
3. http://orcid.org/0000-0003-4571-6363Xinmiao Zhang1,2,
4. Lixia Zong1,2,
5. Hongyu Zhou1,2,
6. http://orcid.org/0000-0003-1608-1856Hongqiu Gu1,2,
7. Yong Jiang1,2,
8. http://orcid.org/0000-0003-3082-6789Yuesong Pan1,2,
9. Xia Meng1,2,
10. Qi Zhou2,
11. Haifen Zhao2,
12. Xin Yang1,2,
13. http://orcid.org/0000-0001-9678-4855Meng Wang1,2,
14. Yunyun Xiong1,2,
15. http://orcid.org/0000-0001-8345-5147Xingquan Zhao1,2,4,
16. http://orcid.org/0000-0002-3267-0039Yilong Wang1,2,
17. Liping Liu1,2,
18. Xudong Ma5,
19. Louise Morgan6,
20. Ying Xian7,
21. Lee H Schwamm8,
22. Yongjun Wang1,2,3,4

1. Correspondence to Dr Yongjun Wang; yongjunwang@ncrcnd.org.cn

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

Data availability statement

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.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

http://dx.doi.org/10.1136/svn-2021-001461