Clinical trial NCT02735226: Stroke Prevention and Treatment System in Shanghai: a Network of Public Healthcare of Stroke
Official title: Shanghai Stroke Service System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: stroke
Shanghai Healthcare
Healthcare Quality, Access, and Evaluation
Lead sponsor: Shanghai Stroke Service System
Sponsor class: OTHER
Collaborators: name: Huashan Hospital
name: Shanghai Zhongshan Hospital
name: Ruijin Hospital
name: theTenth People's Hospital
name: the Sixth People's Hospital
name: RenJi Hospital
name: ShuGuang Hospital
name: Dongfang Hospital Beijing University of Chinese Medicine
name: Changzheng Hospital
name: Changhai Hospital
name: the Ninth People's Hospital
First posted: 2016-04-12
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with acute stroke are admitted to these 11 hospital in Shanghai for secondary prevention.

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.

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.

Eligibility 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

Primary outcomes:
measure: The acute stroke service and treatment provided in Shanghai area
timeFrame: 5 years
measure: The secondary prevention of stroke provided after discharge in Shanghai area
timeFrame: 5 years
Secondary outcomes:
measure: To assess the rate of antiplatelet agent used for stroke prevention.
timeFrame: 5 years
measure: To assess the rate of using anticoagulant medication for stroke prevention in patients with atrial fibrillation.
timeFrame: 5 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shuguang Hospital affiliated to Shanghai Traditional Chinese Medicine University
state: Shanghai
city: Shanghai
country: China
facility: The Shanghai Tenth People's Hospital, Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Dongfang Hospital affiliated to Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Renji hospital，Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine Ruijin Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: The Sixth People's Hospital affiliated to Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Shanghai Stroke Service System
name: Qiang Dong, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu J, Xie Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Xian Y, Shen H, Li H, Wang DZ, Campbell BC, Parsons MW, Dong Y, Dong Q. Effect of the Shanghai Stroke Service System (4S) on the quality of stroke care and outcomes: A prospective quality improvement project. Int J Stroke. 2023 Jun;18(5):599-606. doi: 10.1177/17474930221125993. Epub 2022 Oct 15.
citation: Dong Y, Han Y, Shen H, Wang Y, Ma F, Li H, Wang Y, Dong Q. Who may benefit from lower dosages of intravenous tissue plasminogen activator? Results from a cluster data analysis. Stroke Vasc Neurol. 2020 Dec;5(4):348-352. doi: 10.1136/svn-2020-000388. Epub 2020 Jul 1.
citation: Dong Y, Fang K, Wang X, Chen S, Liu X, Zhao Y, Guan Y, Cai D, Li G, Liu J, Liu J, Zhuang J, Wang P, Chen X, Shen H, Wang DZ, Xian Y, Feng W, Campbell BC, Parsons M, Dong Q. The network of Shanghai Stroke Service System (4S): A public health-care web-based database using automatic extraction of electronic medical records. Int J Stroke. 2018 Jul;13(5):539-544. doi: 10.1177/1747493018765492. Epub 2018 Mar 21.