Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke (ANGEL-ACT): Phase Two
NCT ID: NCT04151589
Last Updated: 2019-11-13
Study Results
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Basic Information
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UNKNOWN
NA
664 participants
INTERVENTIONAL
2019-08-22
2021-06-30
Brief Summary
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During the first phase of the ANGEL-ACT (NCT03370939, a prospective multi-center registry study), problems and difficulties in the emergency work flow of acute ischemic stroke care in China have been identified, such as inadequate pre-hospital notification, delay of in-hospital diagnosis and treatment, difficulty in treatment consent, lack of professional training of endovascular treatment,etc., especially in the delay of in-hospital diagnosis and treatment.
ANGEL-ACT II is a cluster randomized, parallel controlled study. The aim of this study was to evaluate the effectiveness of multi-modal medical quality improvement measures on the delay of hospital-level emergency work flow of acute ischemic stroke management as well as its impact on patient prognosis. The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Interventional Site
The process below will be allocated in Interventional Sites:
1. At each interventional sites, implementing full assessment of current emergency work flow of acute ischemic stroke patients who eligible for endovascular treatment. All interventional sites would undergo assessment in order to form a baseline.
2. Drafting intervention approaches based on the assessment results of all interventional sites. These approaches are executable, reproducible, and measurable.
3. Emergency work flow management APP would be installed on smartphones of designated personnel at each interventional sites.
4. Both intervention approaches and APP would be incorporated with original work flow at each interventional site.
5. Training sessions would be held in interventional sites or online every 3 month once the patient enrolment begin.
6. Outcome data would be analysed and dispatched every 3 month for each interventional sites.
ANGEL Intervention Package and Toolbox
The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis, patient-centred management frame based lean six-sigma, and other specialised approach.
Control Site
The control site would not undergo any emergency work flow modification for acute ischemic stroke patients who eligible for endovascular treatment.
No interventions assigned to this group
Interventions
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ANGEL Intervention Package and Toolbox
The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis, patient-centred management frame based lean six-sigma, and other specialised approach.
Eligibility Criteria
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Inclusion Criteria
* Secondary or tertiary hospitals
* Available of emergency department and neurology ward for stroke patients
* Must have 24 hours × 7 days emergency department for stroke
* Capable of rt-PA thrombolysis and endovascular treatment
* Age ≥ 18 years old
* Admitted from emergency or outpatient department;
* Acue ischemic stroke with large artery occlusion
* Within 24 hours after the onset, and eligible for endovascular treatment.
* The patient or legal representative give written informed consent
Exclusion Criteria
* Unwillingness to participate ANGEL-ACT II and follow the protocol
* Currently participating other stroke treatment improving program/project or similar clinical studies
* Unsuitable for this study investigators' discretion
* Progressive stroke or in-hospital stroke
18 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Zhongrong Miao
Director of Department of interventional neurology
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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Facility Contacts
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Other Identifiers
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2016YFC1301501-2
Identifier Type: -
Identifier Source: org_study_id
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