Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2023 Jun 1;6(6):e2316465.
doi: 10.1001/jamanetworkopen.2023.16465.

Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke: A Stepped-Wedge Cluster Randomized Clinical Trial

Chun-Juan Wang  1   2   3 , Hong-Qiu Gu  1   3 , Li-Xia Zong  2 , Xin-Miao Zhang  2 , Qi Zhou  1   3 , Yong Jiang  1 , Hao Li  1 , Xia Meng  1 , Xin Yang  1   3 , Meng Wang  1   3 , Xiao-Chuan Huo  4 , Run-Qi Wangqin  5 , Yu-Zhang Bei  6 , Xiu-Hui Qi  7 , Xiao-Yun Liu  8 , Shi-Qiang Hu  9 , Zhi-Min Wang  10 , Xing-Quan Zhao  2   11 , Yi-Long Wang  2 , Li-Ping Liu  12 , Xu-Dong Ma  13 , Louise Morgan  14 , Ying Xian  15 , Lee H Schwamm  16 , Yong-Jun Wang  1   2   3   11   17 , Zi-Xiao Li  1   2   3   17   18 ; IMPROVE Stroke Care in China investigators
Collaborators, Affiliations
Randomized Controlled Trial

Effectiveness of a Quality Improvement Intervention on Reperfusion Treatment for Patients With Acute Ischemic Stroke: A Stepped-Wedge Cluster Randomized Clinical Trial

Chun-Juan Wang et al. JAMA Netw Open. .

Abstract

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.

PubMed Disclaimer

Conflict of interest statement

Conflict of Interest Disclosures: Dr Schwamm reported receiving personal fees from Genentech, Life Image, Penumbra, and Diffusion Pharmaceuticals; receiving grants from Medtronic; and serving as a member of the steering committee for the ongoing TIMELESS (Tenecteplase in Stroke Patients Between 4.5 and 24 Hours) trial (NCT03785678) and as a continuing medical education lecturer for MediaSphere, Medscape/WebMD, and Medtronic outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Flow of Hospitals and Participants Through the Improve Acute Reperfusion Treatment Quality for Stroke in China (IMPROVE Stroke Care in China)
EVT indicates endovascular thrombectomy; ITT, Intention to treat; and IVT, intravenous thrombolysis.
Figure 2.
Figure 2.. Unadjusted Temporal Trends in Reperfusion Therapy
A, Reperfusion therapy among eligible patients who arrived within 3.5 or 4.5 hours of symptom onset. B, Intravenous thrombolysis among eligible patients who arrived within 3.5 hours of symptom onset. C, Endovascular thrombectomy among eligible patients who arrived within 4.5 hours of symptom onset. Whiskers indicate 95% CIs.
Figure 3.
Figure 3.. Subgroup Analysis for the Effect of Intervention on Reperfusion Therapy
AOR indicates adjusted odds ratio; ARD, adjusted risk difference; EVT, endovascular thrombectomy; IV rtPA, intravenous recombinant tissue plasminogen activator; and OR, odds ratio. aResults were yielded from generalized estimating equation logistic regression models and adjusting for a medical history of stroke or transient ischemic attack, medication history of antiplatelet agent and statin, and hospital location.
See this image and copyright information in PMC

References

    1. Vos T, Lim SS, Abbafati C, et al. ; GBD 2019 Diseases and Injuries Collaborators . Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020;396(10258):1204-1222. doi:10.1016/S0140-6736(20)30925-9 - DOI - PMC - PubMed
    1. Feigin VL, Nguyen G, Cercy K, et al. ; GBD 2016 Lifetime Risk of Stroke Collaborators . Global, regional, and country-specific lifetime risks of stroke, 1990 and 2016. N Engl J Med. 2018;379(25):2429-2437. doi:10.1056/NEJMoa1804492 - DOI - PMC - PubMed
    1. Ma Q, Li R, Wang L, et al. . Temporal trend and attributable risk factors of stroke burden in China, 1990-2019: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2021;6(12):e897-e906. doi:10.1016/S2468-2667(21)00228-0 - DOI - PMC - PubMed
    1. Emberson J, Lees KR, Lyden P, et al. ; Stroke Thrombolysis Trialists’ Collaborative Group . Effect of treatment delay, age, and stroke severity on the effects of intravenous thrombolysis with alteplase for acute ischaemic stroke: a meta-analysis of individual patient data from randomised trials. Lancet. 2014;384(9958):1929-1935. doi:10.1016/S0140-6736(14)60584-5 - DOI - PMC - PubMed
    1. Wardlaw JM, Murray V, Berge E, et al. . Recombinant tissue plasminogen activator for acute ischaemic stroke: an updated systematic review and meta-analysis. Lancet. 2012;379(9834):2364-2372. doi:10.1016/S0140-6736(12)60738-7 - DOI - PMC - PubMed

Publication types

Substances

Associated data