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

July 18, 2017 updated by: Qiang Dong, Shanghai Stroke Service System

Shanghai Stroke Service System

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • Zhongshan Hospital affiliated to Fudan University
        • Contact:
        • Principal Investigator:
          • Xin Wang, M.D., Ph.D.
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huashan Hospital，Fudan University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kun Fang, M.D.
        • Sub-Investigator:
          • Yi Dong, M.D.
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University
        • Contact:
        • Principal Investigator:
          • Xiaofei Yu, M.D.，Ph.D.
      • Shanghai, Shanghai, China, 200072
        • Recruiting
        • The Shanghai Tenth People's Hospital, Tongji University
        • Contact:
        • Principal Investigator:
          • Xueyuan Liu, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Dongfang Hospital affiliated to Shanghai University of TCM
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Renji Hospital,Shanghai Jiaotong University School of Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yangtai Guan, Ph.D., M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Changhai Hospital
        • Contact:
        • Principal Investigator:
          • Benqiang Deng, M.D.
      • Shanghai, Shanghai, China
        • Active, not recruiting
        • Shanghai Changzheng Hospital
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Jiao Tong University School of Medicine Ruijin Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yi Fu, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
        • Principal Investigator:
          • Jianren Liu, M.D.
      • Shanghai, Shanghai, China
        • Recruiting
        • The Sixth People's Hospital affiliated to Shanghai Jiaotong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuwu Zhao, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with acute stroke are admitted to these 11 hospital in Shanghai for secondary prevention.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years
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,
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Stroke Service System

Collaborators

Changhai Hospital
Shanghai Zhongshan Hospital
RenJi Hospital
Huashan Hospital
Ruijin Hospital
ShuGuang Hospital
theTenth People's Hospital
the Sixth People's Hospital
Dongfang Hospital Beijing University of Chinese Medicine
Changzheng Hospital
the Ninth People's Hospital

Investigators

  • Principal Investigator: Qiang Dong, M.D., Ph.D, Shanghai Stroke Service System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 31, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimate)

April 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shanghai Stroke Service System

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The data is planning to make individual participant data available, especially to anticipating collaborator.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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