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

Stroke Clinical Trial

— SSSS  

Official title:

Shanghai Stroke Service System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02735226
• Other study ID #: Shanghai Stroke Service System
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2016
• Last updated: July 18, 2017
• Start date: January 2014
• Est. completion date: December 2018

Study information

• Verified date: July 2017
• Source: Shanghai Stroke Service System
• Contact: Yi Dong, M.D
• Phone: 86-21-52887145
• Email: drdongyi[@]yeah.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
China	Dongfang Hospital affiliated to Shanghai University of TCM	Shanghai	Shanghai
China	Huashan Hospital,Fudan University	Shanghai	Shanghai
China	Renji hospital,Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	Shanghai Jiao Tong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University	Shanghai	Shanghai
China	The Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai
China	The Sixth People's Hospital affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Zhongshan Hospital affiliated to Fudan University	Shanghai	Shanghai

Sponsors (12)

Lead Sponsor	Collaborator
Shanghai Stroke Service System	Changhai Hospital, Changzheng Hospital, Dongfang Hospital Affiliated to Beijing University of Chinese Medicine, Huashan Hospital, RenJi Hospital, Ruijin Hospital, Shanghai Zhongshan Hospital, ShuGuang Hospital, the Ninth People's Hospital, the Sixth People's Hospital, theTenth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	To assess the rate of antiplatelet agent used for stroke prevention.	This would include the rate of patients being prescribed dual antiplatelet therapy, and the duration/compliance of taking antiplatelet medicine.	5 years
Secondary	To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation.	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