Improving In-hospital Stroke Service Utilisation in China

Study Overview
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Brief Summary
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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).

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

Conditions
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Thrombolytic Therapy, Acute Stroke, Door to Treatment Time, Quality Improvement

Intervention / Treatment
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* Behavioral: Behaviour Change Wheel model guided intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AIS patients receiving IVT within 4.5 hours Exclusion Criteria: Patients who are not willing to attend this trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: an intervention arm<br>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<br>* 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.<br>|
| No Intervention: a control arm<br>hospitals in the control arm will receive no intervention and maintain existing care | |

What is the study measuring?
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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 |