Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke
Authors: Wang Chun-Juan , Gu Hong-Qiu , Zong Li-Xia , Zhang Xin-Miao , Zhou Qi , Jiang Yong , Li Hao , Meng Xia , Yang Xin , Wang Meng , Huo Xiao-Chuan , Wangqin Run-Qi , Bei Yu-Zhang , Qi Xiu-Hui , Liu Xiao-Yun , Hu Shi-Qiang , Wang Zhi-Min , Zhao Xing-Quan , Wang Yi-Long , Liu Li-Ping , Ma Xu-Dong , Morgan Louise , Xian Ying , Schwamm Lee H. , Wang Yong-Jun , Li Zi-Xiao ,   IMPROVE Stroke Care in China investigators, Yang Qingcheng , Chen Guangsheng , Ma Qianli , Li Xiaobo , Chen Jun , Zhao Xiuli , Wang Hongping , Niu Xiaoyuan , Xu Jianhua , Zhao Lile , Wang Zicheng , Huang Danqin , Jin Xiaoping , Chen Shengli , Li Jianhua , Yu Juming , Liu Ping , Li Guozhong , Hao Yanlei , Yang Guancheng , Huang Xiaoxin , Zhou Chengfang , Yang Junsu , Gu Jun , Sun Peng , Guo Zaiyu , Ma Guoping , Chen Guohua , Tang Mingshan , Wang Ning , Chen Lixia , Li Juntao , Li Aiwu , Li Song , Cao Minghua , Guo Jianqiang , Ren Youquan , Li Tong , Zhang Lihong , Xie Zhaoming , Dong Junlin , Kong Xiangfeng , Liang Hui , Zhang Yan 
Published: June 2023

Importance

Reperfusion therapy is the most effective treatment for acute ischemic stroke but remains underused in China.

Objective

To evaluate the effect of a problem-oriented, culturally adapted, targeted quality improvement intervention on reperfusion therapy for patients with acute ischemic stroke in China.

Design, Setting, and Participants

In this stepped-wedge cluster randomized clinical trial, patients from 16 secondary and 33 tertiary hospitals in China with acute ischemic stroke within 6 hours of symptom onset were consecutively recruited between July 1, 2018, and June 30, 2020.

Interventions

Hospitals were randomly assigned to 1 of 3 sequences to receive the targeted quality improvement intervention (n = 5689), in which workflow reconstruction was promoted to reduce in-hospital reperfusion treatment delays, or usual care (n = 6443), in which conventional stroke care was left to the discretion of the stroke team.

Main Outcomes and Measures

The primary outcome was the reperfusion therapy rate, a composite outcome of intravenous recombinant tissue plasminogen activator (IV rtPA) or endovascular thrombectomy (EVT) for eligible patients who arrived within 3.5 or 4.5 hours of symptom onset. Secondary outcomes were the IV rtPA administration rate among eligible patients who arrived within 3.5 hours of symptom onset, the EVT rate among eligible participants who arrived within 4.5 hours of symptom onset, the proportion of patients with door-to-needle time within 60 minutes, the proportion of patients with door-to-puncture time within 90 minutes, in-hospital mortality, and 3-month disability as measured by a modified Rankin Scale score greater than 2.

Results

All 12 132 eligible patients (mean [SD] age, 66 [12.1] years; 7759 male [64.0%]) completed the trial. The reperfusion rate was 53.5% (3046 of 5689) for the eligible patients in the intervention period and 43.9% (2830 of 6443) in the control period. No significant improvement in primary outcomes was found for the intervention after adjusting for cluster, period, and imbalanced baseline covariates (adjusted risk difference [ARD], 5.5%; 95% CI, −8.0% to 19.0%; adjusted odds ratio [AOR], 1.26; 95% CI, 0.72-2.21) or for the secondary outcomes. However, significant improvements were found in secondary hospitals for reperfusion therapy (1081 of 1870 patients [57.8%] vs 945 of 2022 patients [42.9%]; ARD, 19.0%; 95% CI, 6.4%-31.6%; AOR, 2.24; 95% CI, 1.29-3.88), IV rtPA administration (1062 of 1826 patients [58.2%] vs 916 of 2170 patients [42.2%]; ARD, 20.3%; 95% CI, 7.4%-33.1%; AOR, 2.37; 95% CI, 1.34-4.19), and EVT (51 of 231 patients [22.1%] vs 37 of 259 patients [14.3%]; ARD, 13.6%; 95% CI, 1.0%-26.3%; AOR, 3.03; 95% CI, 1.11-8.25) in subgroup analyses.

Conclusions and Relevance

In this stepped-wedge cluster randomized clinical trial of patients with acute ischemic stroke in China, the use of a targeted quality improvement intervention compared with usual care did not improve the reperfusion therapy rate. However, the intervention may be effective in secondary hospitals.

Trial Registration

ClinicalTrials.gov Identifier: NCT03578107