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

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

doi:10.1136/svn-2021-001461

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

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

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

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.

Original language	English (US)
Pages (from-to)	451-456
Number of pages	6
Journal	Stroke and Vascular Neurology
Volume	7
Issue number	5
DOIs	https://doi.org/10.1136/svn-2021-001461
State	Published - Mar 30 2022

Keywords

clinical trial
stroke

ASJC Scopus subject areas

Clinical Neurology
Cardiology and Cardiovascular Medicine

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10.1136/svn-2021-001461

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Li, Z., Wang, C., Zhang, X., Zong, L., Zhou, H., Gu, H., Jiang, Y., Pan, Y., Meng, X., Zhou, Q., Zhao, H., Yang, X., Wang, M., Xiong, Y., Zhao, X., Wang, Y., Liu, L., Ma, X., Morgan, L., ... Wang, Y. (2022). Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China. Stroke and Vascular Neurology, 7(5), 451-456. https://doi.org/10.1136/svn-2021-001461

Li, Z, Wang, C, Zhang, X, Zong, L, Zhou, H, Gu, H, Jiang, Y, Pan, Y, Meng, X, Zhou, Q, Zhao, H, Yang, X, Wang, M, Xiong, Y, Zhao, X, Wang, Y, Liu, L, Ma, X, Morgan, L, Xian, Y, Schwamm, LH & Wang, Y 2022, 'Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke: IMPROVE stroke care in China', Stroke and Vascular Neurology, vol. 7, no. 5, pp. 451-456. https://doi.org/10.1136/svn-2021-001461

@article{d00995c0ba0e4df88d3da057a47c348f,

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

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.",

keywords = "clinical trial, stroke",

author = "Zixiao Li and Chunjuan Wang and Xinmiao Zhang and Lixia Zong and Hongyu Zhou and Hongqiu Gu and Yong Jiang and Yuesong Pan and Xia Meng and Qi Zhou and Haifen Zhao and Xin Yang and Meng Wang and Yunyun Xiong and Xingquan Zhao and Yilong Wang and Liping Liu and Xudong Ma and Louise Morgan and Ying Xian and Schwamm, {Lee H.} and Yongjun Wang",

note = "Funding Information: This trial was funded by Boeheringer Ingelheim (2017–2019) and Medrtonic Inc (2017–2018), the Ministry of Science and Technology of the People{\textquoteright}s Republic of China (2017YFC1310901), the National Natural Science Foundation of China (92046016), Beijing Talents Project (2018000021223ZK03), CAMS Innovation Fund for Medical Sciences (2019-I2M-5-029) and Beijing Municipal Committee of Science and Technology (Z201100005620010). Publisher Copyright: {\textcopyright} 2022 BMJ Publishing Group. All rights reserved.",

year = "2022",

month = mar,

day = "30",

doi = "10.1136/svn-2021-001461",

language = "English (US)",

volume = "7",

pages = "451--456",

journal = "Stroke and Vascular Neurology",

issn = "2059-8688",

publisher = "BMJ Publishing Group",

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TY - JOUR

T1 - Rationale and design of a stepped wedge cluster randomised trial to improve acute reperfusion treatment quality for stroke

T2 - IMPROVE stroke care in China

AU - Li, Zixiao

AU - Wang, Chunjuan

AU - Zhang, Xinmiao

AU - Zong, Lixia

AU - Zhou, Hongyu

AU - Gu, Hongqiu

AU - Jiang, Yong

AU - Pan, Yuesong

AU - Meng, Xia

AU - Zhou, Qi

AU - Zhao, Haifen

AU - Yang, Xin

AU - Wang, Meng

AU - Xiong, Yunyun

AU - Zhao, Xingquan

AU - Wang, Yilong

AU - Liu, Liping

AU - Ma, Xudong

AU - Morgan, Louise

AU - Xian, Ying

AU - Schwamm, Lee H.

AU - Wang, Yongjun

N1 - Funding Information: This trial was funded by Boeheringer Ingelheim (2017–2019) and Medrtonic Inc (2017–2018), the Ministry of Science and Technology of the People’s Republic of China (2017YFC1310901), the National Natural Science Foundation of China (92046016), Beijing Talents Project (2018000021223ZK03), CAMS Innovation Fund for Medical Sciences (2019-I2M-5-029) and Beijing Municipal Committee of Science and Technology (Z201100005620010). Publisher Copyright: © 2022 BMJ Publishing Group. All rights reserved.

PY - 2022/3/30

Y1 - 2022/3/30

N2 - 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.

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.

KW - clinical trial

KW - stroke

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JO - Stroke and Vascular Neurology

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ER -

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

Abstract

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