NCT03317639

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

August 19, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

October 15, 2017

Last Update Submit

August 15, 2021

Conditions

Thrombolytic TherapyAcute StrokeDoor to Treatment TimeQuality Improvement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Door-to-needle time

    Up to 24 hours

  • Onset-to-needle time

    Up to 24 hours

  • modified Rankin Scale score at discharge

    Up to 3 month

  • Symptomatic intracranial hemorrhage

    At 24 hours

  • Favorable neurological outcomes

    At 90 days

  • +1 more secondary outcomes

Study Arms (2)

an intervention arm

EXPERIMENTAL

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

a control arm

NO INTERVENTION

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

Interventions

Behaviour Change Wheel model guided interventionBEHAVIORAL

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.

an intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • AIS patients receiving IVT within 4.5 hours

You may not qualify if:

  • Patients who are not willing to attend this trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

Related Publications (3)

  • 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.

    PMID: 37565934DERIVED

  • 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.

    PMID: 35788767DERIVED

  • 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.

    PMID: 34423654DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2017

First Posted

October 23, 2017

Study Start

January 1, 2018

Primary Completion

December 31, 2019

Study Completion

June 30, 2020

Last Updated

August 19, 2021

Record last verified: 2021-01

Locations

CN(1)