An interventional study of Behaviour Change Wheel model guided intervention in Thrombolytic Therapy, Acute Stroke and Door to Treatment Time, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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).
Exclusion Criteria:
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
hospitals in the control arm will receive no intervention and maintain existing care
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.
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
Time frame: Up to 24 hours
Door-to-needle time
The time between hospital arrival and the initiation of IVT
Time frame: Up to 24 hours
Onset-to-needle time
The time between the symptom onset and the initiation of IVT
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: At 90 days
Death
Death at discharge
Time frame: Up to 3 month
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University