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Completed

NCT Number: NCT03317639

Improving In-hospital Stroke Service Utilisation in China

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).

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Key information

Conditions

Thrombolytic Therapy Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Door to Treatment Time Nervous System Diseases Quality Improvement Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • AIS patients receiving IVT within 4.5 hours

Exclusion criteria

  • Patients who are not willing to attend this trial

Treatment and study plan

Behaviour Change Wheel model guided intervention

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.

Primary outcomes

  1. Difference in the percentage of patients who Door-to-Needle Time≤60min

    Time frame: 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 outcomes

  1. Door-to-needle time

    Time frame: Up to 24 hours

    The time between hospital arrival and the initiation of IVT

  2. Onset-to-needle time

    Time frame: Up to 24 hours

    The time between the symptom onset and the initiation of IVT

  3. modified Rankin Scale score at discharge

    Time frame: Up to 3 month

    modified Rankin Scale score at discharge, on which scores range from 0 (no neurologic deficit) to 6 (death)

  4. Symptomatic intracranial hemorrhage

    Time frame: 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

  5. Favorable neurological outcomes

    Time frame: 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)

  6. Death

    Time frame: Up to 3 month

    Death at discharge

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Aug 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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