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Stroke Prevention and Treatment System in Shanghai: a Network of Public Healthcare of Stroke (SSSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02735226
Recruitment Status : Unknown
Verified July 2017 by Qiang Dong, Shanghai Stroke Service System.
Recruitment status was:  Recruiting
First Posted : April 12, 2016
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Huashan Hospital
Shanghai Zhongshan Hospital
Ruijin Hospital
theTenth People's Hospital
the Sixth People's Hospital
RenJi Hospital
ShuGuang Hospital
Dongfang Hospital Beijing University of Chinese Medicine
Changzheng Hospital
Changhai Hospital
the Ninth People's Hospital
Information provided by (Responsible Party):
Qiang Dong, Shanghai Stroke Service System

Brief Summary:
The Shanghai Stroke Service System(4S) has been established as the network of stroke care in greater Shanghai metropolitan area. The system includes 11 territorial-care hospitals and their comprehensive stroke unites that provide 24h/7day acute stroke care to a population of 40 million in Shanghai. The System comprised of two consecutive phases, the acute phase that emphasized on providing thrombolysis, and the in-hospital phase that concentrated on the effort of recovery and secondary stroke prevention. The novel electronic data aquisition system provides the contiguous data of clinical care of stroke patients from the acute phase of management to inpatient rehabilitation. This system has been implemented and maintained as an ongoing quality of stroke care project that monitored the process of routine stroke care in Shanghai. It is funded by the Shanghai Municipal Commission of Health and Family Planning. Our analysis of the project was approved by the Ethics Committee, which agreed that no written informed consents were needed since the study only was consisted of a population-based retrospective data analysis.

Condition or disease Intervention/treatment
Stroke Other: stroke network and policy intervention

Detailed Description:

The goal of Shanghai stroke service system is to promote and facilitate high quality standardized stroke care in Shanghai area. The 11 hospitals involved are committed to provide the best stroke care to their patients. This quality goal consists of two parts: the acute phase of stroke care and the subsequent care during the hospitalization. To accomplish this goal, each hospital has organized a multidisciplinary stroke team that will address day-to-day stroke care. Each hospital provides prioritized neuroimaging service to patients with acute stroke 24hr per day, 7days per week. A stroke neurologist is on site 24hr per day, 7 days per week in each hospital. This team will follow the guidelines to carry out standardized secondary stroke prevention once the patient has been admitted.

The stroke clinical pathway is available on line in computers of each hospital. This pathway can be accessed from hospital computers, or from outside.

Stroke team members in each hospital obtained and entered all data on each stroke patient: demographics, stroke onset time, onset to thrombolytic time, presenting NIHSS, timing of diagnostic procedures, treatment strategies, performance of quality measures, comorbidities, in-hospital mortality, etc. These data are contained in a three-page form, which are embedded in the electronic health record of each patient.

If ICD-10 stroke codes were entered as the primary discharge diagnoses, the electronic health record systems would not allow the discharge of the patient until all required documentation has been completed. The EHR would not allow for any empty fields before it could be closed. Data quality was assured by automatic feasibility checks. The novel electronic data acquisition system provides the continuous clinical care data on all stroke patients from their acute management phase to inpatient rehabilitation or discharge.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Shanghai Stroke Service System
Study Start Date : January 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Group/Cohort Intervention/treatment
Acute Stroke patient
Patients who are presented to hospital within 7days from onset. The key measurement of clinical quality controlled in patients with acute stroke managment and inhouse stroke care were record automatically
Other: stroke network and policy intervention
Shanghai stroke service and network contributes to update the ability of stroke care of comprehensive and primary stroke center,to improve radiation ability of comprehensive stroke centers and try to form a close relationship between comprehensive stroke centers and its primary stroke centers.




Primary Outcome Measures :
  1. The acute stroke service and treatment provided in Shanghai area [ Time Frame: 5 years ]

    The phase of acute stroke therapy. Under this category, the acute stroke care specific quality measurement items are:

    Stroke onset to hospital ER Time

    Door to CT Time

    Door to seen by a doctor Time

    Door to IV TPA Time

    Door to groin puncture time for IA therapy

    Door to admission to a hospital bed Time


  2. The secondary prevention of stroke provided after discharge in Shanghai area [ Time Frame: 5 years ]

    2. Secondary stroke prevention prescribed.

    Antithrombotics prescribed

    Swallowing evaluation performed before oral feeding starts

    DVT prophylaxis prescribed

    Anticoagulation for atrial fibrillation prescribed

    Brain imaging including vascular imaging performed

    Stroke education provided

    Educating patient to stop smoking

    Statins prescribed

    Rate of catheter related UTI

    Rate of aspiration pneumonia

    Hospital length of stay

    Discharge destination

    The time frame for this project is 5 years. All elements of acute stroke care will be collected during the hospital stay.



Secondary Outcome Measures :
  1. To assess the rate of antiplatelet agent used for stroke prevention. [ Time Frame: 5 years ]
    This would include the rate of patients being prescribed dual antiplatelet therapy, and the duration/compliance of taking antiplatelet medicine.

  2. To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation. [ Time Frame: 5 years ]
    To assess the rate of bridging therapy used during hospitalization. Bridging therapy is to give intravenous or subcutaneous anticoagulation while waiting for warfarin to be therapeutic. In addition, the rate of prescribing new oral anticoagulants for stroke prevention in atrial fibrillation will be assessed,



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with acute stroke are admitted to these 11 hospital in Shanghai for secondary prevention.
Criteria

Inclusion Criteria:

  • 18 years old or older
  • primary diagnosis as acute stroke or TIA within 7 days from onset
  • admitted in stroke unit.

Exclusion Criteria:

  • child or teenager younger than 18 years old
  • woman with pregnant
  • outpatient
  • any other reason that patient cannot be admitted for secondary prevention

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): NCT02735226


Contacts
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Contact: Yi Dong, M.D 86-21-52887145 drdongyi@yeah.net
Contact: Kun Fang, M.D 86-21-52887146 drfrankhs@hotmail.com

Locations
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China, Shanghai
Zhongshan Hospital affiliated to Fudan University Recruiting
Shanghai, Shanghai, China, 200030
Contact: Xin Wang, M.D.,Ph.D.    13501909896    wang.xin@zs-hospital.sh.cn   
Principal Investigator: Xin Wang, M.D., Ph.D.         
Huashan Hospital,Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Qiang Dong, M.D., Ph.D.    86-13701875129    qiang_dong163@163.com   
Contact: Yi Dong, M.D.    86-13916665674    drdongyi@yeah.net   
Sub-Investigator: Kun Fang, M.D.         
Sub-Investigator: Yi Dong, M.D.         
Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Xiaofei Yu, M.D.,Ph.D.    13331978806    doctorxiaoyu@sina.com   
Principal Investigator: Xiaofei Yu, M.D.,Ph.D.         
The Shanghai Tenth People's Hospital, Tongji University Recruiting
Shanghai, Shanghai, China, 200072
Contact: Xueyuan Liu    13564578127    lxyshtj@163.com   
Principal Investigator: Xueyuan Liu, M.D.         
Dongfang Hospital affiliated to Shanghai University of TCM Recruiting
Shanghai, Shanghai, China
Contact: Gang Li, M.D.    13621691786    ligang0531@yeah.net   
Contact: Changsong Li    13122751682    kite1107@126.com   
Principal Investigator: Gang Li, M.D.         
Renji hospital,Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Yangtai Guan, Ph.D., M.D.    13386271865    yangtaiguan@hotmail.com   
Contact: Ying Chen    13501763660    13501763660@163.com   
Principal Investigator: Yangtai Guan, Ph.D., M.D.         
Shanghai Changhai Hospital Recruiting
Shanghai, Shanghai, China
Contact: Benqiang Deng, M.D.    13701936570    13701936570@163.com   
Principal Investigator: Benqiang Deng, M.D.         
Shanghai Changzheng Hospital Active, not recruiting
Shanghai, Shanghai, China
Shanghai Jiao Tong University School of Medicine Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: Yi Fu    86-021-64370045    fuyiki@sina.com   
Contact: Shufen Chen    1379532986    csf_cindy@hotmail.com   
Principal Investigator: Yi Fu, M.D.         
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China
Contact: Jianren Liu, M.D.    liujr021@vip.163.com    liujr021@vip.163.com   
Principal Investigator: Jianren Liu, M.D.         
The Sixth People's Hospital affiliated to Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China
Contact: Yuwu Zhao, M.D.    15901713716    zhaoyuwu2005@126.com   
Contact: Hongmei Wang    18930177606    dd-tt12345@163.com   
Principal Investigator: Yuwu Zhao, M.D.         
Sponsors and Collaborators
Shanghai Stroke Service System
Huashan Hospital
Shanghai Zhongshan Hospital
Ruijin Hospital
theTenth People's Hospital
the Sixth People's Hospital
RenJi Hospital
ShuGuang Hospital
Dongfang Hospital Beijing University of Chinese Medicine
Changzheng Hospital
Changhai Hospital
the Ninth People's Hospital
Investigators
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Principal Investigator: Qiang Dong, M.D., Ph.D Shanghai Stroke Service System
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Qiang Dong, Director of Shanghai Stroke Service system, Shanghai Stroke Service System
ClinicalTrials.gov Identifier: NCT02735226    
Other Study ID Numbers: Shanghai Stroke Service System
First Posted: April 12, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data is planning to make individual participant data available, especially to anticipating collaborator.
Keywords provided by Qiang Dong, Shanghai Stroke Service System:
stroke
Shanghai Healthcare
Healthcare Quality, Access, and Evaluation
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases