Improving In-hospital Stroke Service Utilisation in China

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Completed

CT.gov ID

NCT03317639

Collaborator

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

1,634

Enrollment

Location

Arms

29.9

Actual Duration (Months)

54.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Thrombolytic Therapy Acute Stroke Door to Treatment Time Quality Improvement	Behavioral: Behaviour Change Wheel model guided intervention	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1634 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jun 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: an intervention arm 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 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.
No Intervention: a control arm hospitals in the control arm will receive no intervention and maintain existing care

Arm

Intervention/Treatment

Experimental: an intervention arm

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

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.

No Intervention: a control arm

hospitals in the control arm will receive no intervention and maintain existing care

Outcome Measures

Primary Outcome Measures

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

Door-to-needle time [Up to 24 hours]
The time between hospital arrival and the initiation of IVT
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)
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)
Death [Up to 3 month]
Death at discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AIS patients receiving IVT within 4.5 hours

Exclusion Criteria:

Patients who are not willing to attend this trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Zhejiang University	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT03317639

Other Study ID Numbers:

MISSION CHINA

First Posted:

Oct 23, 2017

Last Update Posted:

Aug 19, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Aug 19, 2021