Clinical trial NCT03317639: Improving In-hospital Stroke Service Utilisation in China
Official title: Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombolytic Therapy
Acute Stroke
Door to Treatment Time
Quality Improvement
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Shaoxing Second Hospital
name: Haining People' s Hospital
name: Haiyan People' s Hospital
name: Huzhou No.1 People' s Hospital
name: Jiashan No.1 People' s Hospital
name: Ningbo Medical Center Lihuili Hospital
name: Tongxiang No.1 People' s Hospital
name: First Affiliated Hospital of Wenzhou Medical University
name: Yiwu Central Hospital
name: Yongkang No.1 People' s Hospital
name: Yuyao People's Hospital
name: Deqing People' s Hospital
name: Dongyang People's Hospital
name: Jinhua People' s Hospital
name: Lishui People' s Hospital
name: Lin' an People' s Hospital
name: Longquan People' s Hospital
name: Qingtian People' s Hospital
name: Shaoxing Central Hospital
name: Wenzhou Central Hospital
name: Xiangshan No.1 People' s Hospital
name: The Central Hospital of Lishui City
First posted: 2017-10-23
Enrollment: 1634
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* AIS patients receiving IVT within 4.5 hours

Exclusion Criteria:

* Patients who are not willing to attend this trial

Primary outcomes:
measure: Difference in the percentage of patients who Door-to-Needle Time≤60min
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Door-to-needle time
timeFrame: Up to 24 hours
measure: Onset-to-needle time
timeFrame: Up to 24 hours
measure: modified Rankin Scale score at discharge
timeFrame: Up to 3 month
measure: Symptomatic intracranial hemorrhage
timeFrame: At 24 hours
measure: Favorable neurological outcomes
timeFrame: At 90 days
measure: Death
timeFrame: Up to 3 month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
citation: 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.
citation: 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.