Improving In-hospital Stroke Service Utilisation in China

Not Applicable

Completed

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

• Registration Number: NCT03317639
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-08-15
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1634

Inclusion Criteria

• AIS patients receiving IVT within 4.5 hours

Exclusion Criteria

• Patients who are not willing to attend this trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
an intervention arm	Behaviour Change Wheel model guided intervention	Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Onset-to-needle time	Up to 24 hours	The time between the symptom onset and the initiation of IVT
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)
Door-to-needle time	Up to 24 hours	The time between hospital arrival and the initiation of IVT
Death	Up to 3 month	Death at discharge
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
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)

Trial Locations

Locations (1)

The second affiliated hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China