Improving In-hospital Stroke Service Utilisation in China

NCT ID: NCT03317639

Last Updated: 2021-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1634 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Thrombolytic Therapy Acute Stroke Door to Treatment Time Quality Improvement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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an intervention arm

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

Group Type EXPERIMENTAL

Behaviour Change Wheel model guided intervention

Intervention Type BEHAVIORAL

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.

a control arm

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* AIS patients receiving IVT within 4.5 hours

Exclusion Criteria

* Patients who are not willing to attend this trial
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shaoxing Second Hospital

OTHER

Sponsor Role collaborator

Haining People' s Hospital

UNKNOWN

Sponsor Role collaborator

Haiyan People' s Hospital

UNKNOWN

Sponsor Role collaborator

Huzhou No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

Jiashan No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

Ningbo Medical Center Lihuili Hospital

OTHER_GOV

Sponsor Role collaborator

Tongxiang No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role collaborator

Yiwu Central Hospital

OTHER

Sponsor Role collaborator

Yongkang No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

Yuyao People's Hospital

OTHER

Sponsor Role collaborator

Deqing People' s Hospital

UNKNOWN

Sponsor Role collaborator

Dongyang People's Hospital

OTHER

Sponsor Role collaborator

Jinhua People' s Hospital

UNKNOWN

Sponsor Role collaborator

Lishui People' s Hospital

UNKNOWN

Sponsor Role collaborator

Lin' an People' s Hospital

UNKNOWN

Sponsor Role collaborator

Longquan People' s Hospital

UNKNOWN

Sponsor Role collaborator

Qingtian People' s Hospital

UNKNOWN

Sponsor Role collaborator

Shaoxing Central Hospital

OTHER

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

Xiangshan No.1 People' s Hospital

UNKNOWN

Sponsor Role collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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Lynch EA, Bulto LN, Cheng H, Craig L, Luker JA, Bagot KL, Thayabaranathan T, Janssen H, McInnes E, Middleton S, Cadilhac DA. Interventions for the uptake of evidence-based recommendations in acute stroke settings. Cochrane Database Syst Rev. 2023 Aug 11;8(8):CD012520. doi: 10.1002/14651858.CD012520.pub2.

Reference Type DERIVED
PMID: 37565934 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35788767 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34423654 (View on PubMed)

Other Identifiers

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MISSION CHINA

Identifier Type: -

Identifier Source: org_study_id

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