Acute Stroke, Door to Treatment Time, Quality Improvement, Thrombolytic Therapy
Conditions
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).
Interventions
BEHAVIORALBehaviour 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.
Sponsors
Shaoxing Second Hospital
Haining People' s Hospital
Haiyan People' s Hospital
Huzhou No.1 People' s Hospital
Jiashan No.1 People' s Hospital
Ningbo Medical Center Lihuili Hospital
Tongxiang No.1 People' s Hospital
First Affiliated Hospital of Wenzhou Medical University
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
The Central Hospital of Lishui City
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* AIS patients receiving IVT within 4.5 hours
Exclusion criteria
* Patients who are not willing to attend this trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the percentage of patients who Door-to-Needle Time≤60min | Up to 24 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | Up to 3 month | Death at discharge |
| Door-to-needle time | Up to 24 hours | The time between hospital arrival and the initiation of IVT |
| Favorable neurological outcomes | At 90 days | Score of 0 to 1 on the modified Rankin Scale, on which scores range from 0 (no neurologic deficit) to 6 (death) |
| modified Rankin Scale score at discharge | Up to 3 month | modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death) |
| Symptomatic intracranial hemorrhage | At 24 hours | 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 |
| Onset-to-needle time | Up to 24 hours | The time between the symptom onset and the initiation of IVT |
Countries
China
Outcome results
None listed