Improving In-hospital Stroke Service Utilisation in China

Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times

A cluster randomised controlled trial will be conducted, using hospital as randomisation unit. Hospitals in Zhejiang Province, China, will be randomised into two arms (1:1): an intervention arm and a control arm. Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model, whereas hospitals in the control arm will receive no intervention and maintain existing care. The randomisation will be conducted after one-year baseline data collection. The following baseline data will be used for randomisation match: hospital classification, beds in stroke centre, thrombolysis patient number, and percentage of patients receiving thrombolysis within 60 minutes of stroke onset. Hospitals with no stroke centre or with <20 cases received thrombolysis per year will be excluded from the study. The primary outcome will be difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage (post-intervention).

Study Overview

• Status: Completed
• Conditions: Acute Stroke; Thrombolytic Therapy; Door to Treatment Time; Quality Improvement
• Intervention / Treatment: Behavioral: Behaviour Change Wheel model guided intervention

• Study Type: Interventional
• Enrollment (Actual): 1634
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • The Second Affiliated Hospital of Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AIS patients receiving IVT within 4.5 hours

Exclusion Criteria:

• Patients who are not willing to attend this trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: an intervention arm; Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model	Behavioral: Behaviour Change Wheel model guided intervention; Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.
No Intervention: a control arm; hospitals in the control arm will receive no intervention and maintain existing care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the percentage of patients who Door-to-Needle Time≤60min	Difference between intervention arm and control arm in the percentage of patients receiving thrombolysis within 60 minutes of stroke onset on the follow-up stage	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Door-to-needle time	The time between hospital arrival and the initiation of IVT	Up to 24 hours
Onset-to-needle time	The time between the symptom onset and the initiation of IVT	Up to 24 hours
modified Rankin Scale score at discharge	modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death)	Up to 3 month
Symptomatic intracranial hemorrhage	Intracranial hemorrhage at 24 hours associated with an increase of ≥4 points of NIHSS score from baseline, according to European Cooperative Acute Stroke Study (ECASS) II trial	At 24 hours
Favorable neurological outcomes	Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death)	At 90 days
Death	Death at discharge	Up to 3 month

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Ningbo Medical Center Lihuili Hospital; The Central Hospital of Lishui City; First Affiliated Hospital of Wenzhou Medical University; Shaoxing Second Hospital; Haining People' s Hospital; Haiyan People' s Hospital; Huzhou No.1 People' s Hospital; Jiashan No.1 People' s Hospital; Tongxiang No.1 People' s Hospital; Yiwu Central Hospital; Yongkang No.1 People' s Hospital; Yuyao People' s Hospital; Deqing People' s Hospital; Dongyang People' s Hospital; Jinhua People' s Hospital; Lishui People' s Hospital; Lin' an People' s Hospital; Longquan People' s Hospital; Qingtian People' s Hospital; Shaoxing Central Hospital; Wenzhou Central Hospital; Xiangshan No.1 People' s Hospital

Publications and helpful links

General Publications

• Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. 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.
• Wang J, Gong X, Zhong W, Zhou Y, Lou M. Novel Prehospital Triage Scale for Detecting Large Vessel Occlusion and Its Cause. J Am Heart Assoc. 2021 Sep 7;10(17):e021201. doi: 10.1161/JAHA.121.021201. Epub 2021 Aug 21.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): August 19, 2021
• Last Update Submitted That Met QC Criteria: August 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: MISSION CHINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No