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临床试验/NCT02735226
NCT02735226Unknown不适用

Shanghai Stroke Service System

Shanghai Stroke Service System11 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100,000
试验地点
11
主要终点
The acute stroke service and treatment provided in Shanghai area

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The acute stroke service and treatment provided in Shanghai area

时间窗: 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

The secondary prevention of stroke provided after discharge in Shanghai area

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Shanghai Stroke Service System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiang Dong

Director of Shanghai Stroke Service system

Shanghai Stroke Service System

研究点 (11)

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