Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial

Wansi Zhong; Longting Lin; Xiaoxian Gong; Zhicai Chen; Yi Chen; Shenqiang Yan; Ying Zhou; Xuting Zhang; Haitao Hu; Lusha Tong; Chaochan Cheng; Qun Gu; Yong Chen; Xiaojin Yu; Yuhui Huang; Changzheng Yuan; Min Lou; MISSION investigators

doi:10.1371/journal.pmed.1004034

Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial

PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.

Authors

Wansi Zhong¹, Longting Lin², Xiaoxian Gong¹, Zhicai Chen¹, Yi Chen¹, Shenqiang Yan¹, Ying Zhou¹, Xuting Zhang¹, Haitao Hu¹, Lusha Tong¹, Chaochan Cheng³, Qun Gu⁴, Yong Chen⁵, Xiaojin Yu⁶, Yuhui Huang⁷, Changzheng Yuan⁷, Min Lou¹; MISSION investigators

Affiliations

¹ Department of Neurology, the Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou, China.
² Imaging Laboratory Manger, Sydney Brain Center, University of New South Wales, Australia.
³ Department of Neurology, Yongkang First People's Hospital, Yongkang, China.
⁴ Department of Neurology, Huzhou First People's Hospital, Huzhou, China.
⁵ Department of Neurology, Li Huili Hospital of Ningbo Medical Center, Ningbo, China.
⁶ Key Laboratory of Environmental Medicine Engineering, Ministry of Education, School of Public Health, Southeast University, Nanjing, China.
⁷ Department of Big Data in Health Science, School of Public Health, Zhejiang University, Hangzhou, China.

Abstract

Background: Rapid intravenous thrombolysis (IVT) for acute ischemic stroke (AIS) is crucial for improving outcomes. However, few randomized trials of interventions aimed at reducing in-hospital delay have been carried out in China. We aimed to evaluate the effect of a multicomponent intervention on thrombolytic door-to-needle time (DNT) of AIS patients via video teleconference based on the Behavior Change Wheel (BCW) method.

Methods and findings: This cluster-randomized trial, conducted between January 1, 2019 and December 31, 2019, randomly allocated 22 hospitals equally to PEITEM (Persuasion Environment reconstruction Incentivization Training Education Modeling) intervention or routine care plus stroke registry and subsequently enrolled 1,634 AIS patients receiving IVT within 4.5 hours upon stroke onset from participant hospitals. The PEITEM group received a 1-year PEITEM 6-component intervention based on the behavioral theory monthly via video teleconference. The primary outcome was the proportion of patients with a DNT of 60 minutes or less. A total of 987 patients participated in the PEITEM group (mean age, 69 years; female, 411 [41.6%]) and 647 patients in the control group (mean age, 70 years; female, 238 [36.8%]). Of all participants, the proportion of DNT ≤60 minutes in the PEITEM group was higher than in the control group (82.0% versus 73.3%; adjusted odds ratio, 1.77; 95% confidence interval (CI), 1.17 to 2.70; ICC, 0.04; P = 0.007). Among secondary outcomes, the average DNT was 43 minutes in the PEITEM group and 50 minutes in the control group (adjusted mean difference: -8.83; 95% CI, -14.03 to -3.64; ICC, 0.12; P = 0.001). Favorable functional outcome (score of 0 to 1 on the modified Rankin scale (mRS)) was achieved in 55.6% patients of the PEITEM group and 50.4% of the control group (adjusted odds ratio, 1.38; 95% CI, 1.00 to 1.90; ICC, 0.01; P = 0.049). Main study limitations include non-blinding of clinicians, and that specific interventions component responsible for the observed changes could not be determined.

Conclusions: The teleconference-delivered PEITEM intervention resulted in a moderate but clinically relevant shorter DNT and better functional outcome in AIS patients receiving IVT.

Trial registration: Clinicaltrials.gov NCT03317639.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Administration, Intravenous
Aged
Female
Fibrinolytic Agents / therapeutic use
Humans
Ischemic Stroke*
Stroke* / drug therapy
Thrombolytic Therapy / methods

Substances

Fibrinolytic Agents

Associated data

ClinicalTrials.gov/NCT03317639

Grants and funding

This study was funded by the National Natural Science Foundation of China (Funding number: 81971101, received by ML, http://www.nsfc.gov.cn/ ), the National Key Research and Development Program of China (Funding number: 2016YFC1301503, received by ML, https://service.most.gov.cn), and the Science Technology Department of Zhejiang Province (Funding number: 2018C04011, received by ML, http://kjt.zj.gov.cn). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.