Improving In-hospital Stroke Service Utilisation in China

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317639
• Other study ID #: MISSION CHINA
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1634
• Est. completion date: June 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• AIS patients receiving IVT within 4.5 hours

Exclusion Criteria:

• Patients who are not willing to attend this trial

Related Conditions & MeSH terms

• Acute Stroke
• Door to Treatment Time
• Quality Improvement
• Stroke
• Thrombolytic Therapy

Intervention

Behavioral:
• Behaviour 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.

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (23)

Lead Sponsor

Collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

Deqing People' s Hospital, Dongyang People' s Hospital, First Affiliated Hospital of Wenzhou Medical University, Haining People' s Hospital, Haiyan People' s Hospital, Huzhou No.1 People' s Hospital, Jiashan No.1 People' s Hospital, Jinhua People' s Hospital, Lin' an People' s Hospital, Lishui People' s Hospital, Longquan People' s Hospital, Ningbo Medical Center Lihuili Hospital, Qingtian People' s Hospital, Shaoxing Central Hospital, Shaoxing Second Hospital, The Central Hospital of Lishui City, Tongxiang No.1 People' s Hospital, Wenzhou Central Hospital, Xiangshan No.1 People' s Hospital, Yiwu Central Hospital, Yongkang No.1 People' s Hospital, Yuyao People' s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Door-to-needle time	The time between hospital arrival and the initiation of IVT	Up to 24 hours
Secondary	Onset-to-needle time	The time between the symptom onset and the initiation of IVT	Up to 24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Death	Death at discharge	Up to 3 month