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Improving In-hospital Stroke Service Utilisation in China

Primary Purpose

Thrombolytic Therapy, Acute Stroke, Door to Treatment Time

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Behaviour Change Wheel model guided intervention
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombolytic Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AIS patients receiving IVT within 4.5 hours

Exclusion Criteria:

  • Patients who are not willing to attend this trial

Sites / Locations

  • The second affiliated hospital of Zhejiang University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

an intervention arm

a control arm

Arm Description

Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Door-to-needle time
The time between hospital arrival and the initiation of IVT
Onset-to-needle time
The time between the symptom onset and the initiation of IVT
modified Rankin Scale score at discharge
modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death)
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
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)
Death
Death at discharge

Full Information

First Posted
October 15, 2017
Last Updated
August 15, 2021
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03317639
Brief Title
Improving In-hospital Stroke Service Utilisation in China
Official Title
Improving In-hospital Stroke Service Utilisation (MISSION) in China: A Cluster Randomised Trial of Interventions to Shorten Door to Needle Times
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombolytic Therapy, Acute Stroke, Door to Treatment Time, Quality Improvement

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1634 (Actual)

8. Arms, Groups, and Interventions

Arm Title
an intervention arm
Arm Type
Experimental
Arm Description
Hospitals in the intervention arm will receive a multi-components intervention based on the Behaviour Change Wheel model
Arm Title
a control arm
Arm Type
No Intervention
Arm Description
hospitals in the control arm will receive no intervention and maintain existing care
Intervention Type
Behavioral
Intervention Name(s)
Behaviour Change Wheel model guided intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in the percentage of patients who Door-to-Needle Time≤60min
Description
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
Secondary Outcome Measure Information:
Title
Door-to-needle time
Description
The time between hospital arrival and the initiation of IVT
Time Frame
Up to 24 hours
Title
Onset-to-needle time
Description
The time between the symptom onset and the initiation of IVT
Time Frame
Up to 24 hours
Title
modified Rankin Scale score at discharge
Description
modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death)
Time Frame
Up to 3 month
Title
Symptomatic intracranial hemorrhage
Description
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
Title
Favorable neurological outcomes
Description
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
Title
Death
Description
Death at discharge
Time Frame
Up to 3 month

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AIS patients receiving IVT within 4.5 hours Exclusion Criteria: Patients who are not willing to attend this trial
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
35788767
Citation
Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul.
Results Reference
derived
PubMed Identifier
34423654
Citation
Wang J, Gong X, Zhong W, Zhou Y, Lou M. Novel Prehospital Triage Scale for Detecting Large Vessel Occlusion and Its Cause. J Am Heart Assoc. 2021 Sep 7;10(17):e021201. doi: 10.1161/JAHA.121.021201. Epub 2021 Aug 21.
Results Reference
derived

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Improving In-hospital Stroke Service Utilisation in China

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