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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach

1 country

11 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

Study Start

First participant enrolled

January 1, 2014

Completed

2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed

12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2016

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed

Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

4.9 years

First QC Date

March 31, 2016

Last Update Submit

July 18, 2017

Conditions

Stroke

Keywords

strokeShanghai HealthcareHealthcare Quality, Access, and Evaluation

Outcome Measures

Primary Outcomes (2)

The acute stroke service and treatment provided in Shanghai area
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
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 Outcomes (2)

To assess the rate of antiplatelet agent used for stroke prevention.
5 years
To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation.
5 years

Study Arms (1)

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

Interventions

stroke network and policy interventionOTHER

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.

Acute Stroke patient

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Shanghai Stroke Service Systemlead
Huashan Hospitalcollaborator
Shanghai Zhongshan Hospitalcollaborator
Ruijin Hospitalcollaborator
theTenth People's Hospitalcollaborator
the Sixth People's Hospitalcollaborator
RenJi Hospitalcollaborator
ShuGuang Hospitalcollaborator
Dongfang Hospital Beijing University of Chinese Medicinecollaborator
Changzheng Hospitalcollaborator
Changhai Hospitalcollaborator
the Ninth People's Hospitalcollaborator

Study Sites (11)

Zhongshan Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Huashan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

The Shanghai Tenth People's Hospital, Tongji University

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Dongfang Hospital affiliated to Shanghai University of TCM