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Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)

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ClinicalTrials.gov Identifier: NCT03684629
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Study design is a perspective, multi-center, historial control study of acute ischemic stroke patients. For achieving the target of diagnosis and treatment KPI (Key performance indicator) of AIS patients and improving the defects of the traditional working mode, our center developed the medical records data acquisition and KPI statistics system based on computer scan. This method guarantee the authenticity of the data, It computes the KPI of the corresponding medical institutions in the corresponding period and gives feedback on a regular basis. This study aims to explore whether this new working mode can continuously improve the overall KPI of all hospitals in Zhejiang province, and thus reflect the improvement of quality and standardization of medical service in AIS patients.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke and Transient Ischemic Attacks Behavioral: the response of KPI and corresponding suggestion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Scan Based Analysing System on Improving Stroke Management Quality Evaluation (CASE)
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 15, 2018
Estimated Study Completion Date : September 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the response of KPI and corresponding suggestion
The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month.
Behavioral: the response of KPI and corresponding suggestion
The KPI of the AIS patients who were admitted to a single hospital continuously at the time of hospitalization were studied. The hospital included in the study upload the medical records of all AIS patients by medical records scanning system since that month into the group. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the corresponding monthly KPI. The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month.

No Intervention: a control arm



Primary Outcome Measures :
  1. Rate of neurological deficit score [ Time Frame: six month ]
    the rate of the case number of cerebral infarction patients who have completed the National Institutes of Health Stroke Scale (NIHSS) at the time of admission in the total number of cerebral infarction patients hospitalized in the same period

  2. Rate of intravenous tPA within 4.5 hours of onset [ Time Frame: six month ]
    the rate of AIS patients who received intravenous recombinant tissue plasminogen activator (rt-pa) thrombolytic therapy within 4.5 hours in patients with cerebral infarction who were admitted to hospital within 4.5 hours

  3. Rate of administration of aspirin or other antiplatelet agents within 48 hours of admission [ Time Frame: six month ]
    The rate of patients who received aspirin or other antiplatelet agents within 48 hours of admission to the hospital in the total number of cerebral infarction patients hospitalized in the same period

  4. Rate of statin use during hospitalization [ Time Frame: six month ]
    The rate of patients hospitalized for cerebral infarction who were treated with statins in the total number of cerebral infarction patients hospitalized in the same period

  5. Rate of statin treatment at discharge [ Time Frame: six month ]
    The rate of patients with cerebral infarction who received statin at discharge in the total number of patients with non-cardiac infarction who were hospitalized in the same period

  6. Rate of antithrombotic therapy at discharge [ Time Frame: six month ]
    The rate of patients with cerebral infarction who received antithrombotic drugs (such as aspirin, other antiplatelet agents, heparin, warfarin or new oral anticoagulants) at discharge in the total number of hospitalized patients with cerebral infarction in the same period.

  7. Rate of anticoagulant treatment for patients with atrial fibrillation at discharge [ Time Frame: six month ]
    The rate of patients with cerebral infarction complicated with atrial fibrillation who received anticoagulants (e.g., heparin, low molecular heparin, warfarin, new oral anticoagulants) at discharge in the total number of patients with cerebral infarction complicated with atrial fibrillation treated in hospital in the same period


Secondary Outcome Measures :
  1. Rate of prevention of deep vein thrombosis [ Time Frame: six month ]
    The rate of patients who were unable to get out of bed for cerebral infarction within 48 hours of admission that were given prophylactic measures including heparin and/or DVT (Deep vein thrombosis) in patients who were unable to get out of bed for cerebral infarction treated in hospital in the same period

  2. Rate of blood vessel assessment within one week of hospitalization [ Time Frame: six month ]
    The rate of patients with cerebral infarction hospitalized for 1 week who had completed the evaluation of the blood vessels in the neck and cranial (such as the ultrasound of the blood vessels in the neck or cranial, CT or MR angiography, or DSA) in the total number of cerebral infarction patients hospitalized in the same period

  3. Rate of swallowing function evaluation [ Time Frame: six month ]
    The rate of patients who had a history of drinking water test in the total number of stroke patients who were hospitalized in the same period.

  4. Rate of lipid level assessment [ Time Frame: six month ]
    The rate of the number of patients who were assessed on lipid level during hospitalization in the total number of patients who were hospitalized during the same period.

  5. Rate of rehabilitation evaluation and implementation [ Time Frame: six month ]
    The rate of cerebral infarction patients who received rehabilitation evaluation and implementation during the hospital period (48 hours after the patient's condition was stable) in the total number of patients who were hospitalized during the same period.

  6. Rate of offerring quit smoking counseling or health benefits education [ Time Frame: six month ]
    The rate of patients who received smoking cessation counseling or health benefits education during hospitalization in total number of patients with cerebral infarction who were hospitalized during the same period

  7. Rate of antihypertensive therapy for cerebral infarction patients with hypertension at discharge [ Time Frame: six month ]
    The rate of patients with cerebral infarction complicated with hypertension who were given antihypertensive drugs at discharge in the total number of patients with cerebral infarction complicated with hypertension who were hospitalized in the same period

  8. 7)Rate of Patients with diabetes were given hypoglycemic drug treatment at discharge [ Time Frame: six month ]
    The rater of patients with cerebral infarction complicated with diabetes who were given hypoglycemic drugs at discharge in the total number of patients with cerebral infarction complicated with diabetes treated in hospital in the same period

  9. Average day in hospital [ Time Frame: six month ]
    The rate of the total number of days in hospital to the total number of patients with cerebral infarction in the same period

  10. averaged hospital costs [ Time Frame: six month ]
    Ratio of total hospital drug costs to total number of patients with cerebral infarction in the same period



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute ischemic stroke or transient ischemic attacks patients

Exclusion Criteria:

  • patients who losing his medical record of having the incomplete medical record

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684629


Contacts
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Contact: Lou Min, Ph.D 8613738085675 loumingxc@vip.sina.com

Locations
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China
The second affiliated hosipital of Zhejiang University Recruiting
Zhejiang, China
Contact: Min Lou, Ph.D    13958007213    loumingxc@vip.sina.com   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Director: Lou Min, Ph.D The second affiliated hosipital of Zhejiang University

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03684629     History of Changes
Other Study ID Numbers: CASE
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Ischemia