Improving Stroke Care in Greece in Terms of Management, Costs and Health Outcomes- Stroke Units Necessity for Patients (SUN4P)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 913
- 试验地点
- 10
- 主要终点
- Modified Rankin Scale (mRS) score
研究概览
简要总结
The main objectives of the proposed project are:
- To provide essential data on acute stroke management (quality indicators) incorporating hard clinical outcomes that will contribute to an ongoing process of quality improvement
- To develop an interactive multichannel platform, for collecting, cleansing and curating high quality in-hospital and follow up data, applying multidimensional quality assessment analysis, providing statistical and analytic reports, monitoring behavioral changes and supporting overall project's management.
- To evaluate patients' and physicians' experiences and their impact on stroke management.
- To assess severe negative impact of stroke on the life of survivors including quality of life and disability
- To measure health related and non- health (loss of productivity, informal care) related national expenditure for stroke care using a bottom up approach
- To evaluate the value of care focusing on health outcomes compared with total costs of achieving them
详细描述
A prospective cohort multicenter study of patients with first ever acute stroke, hemorrhagic and ischemic, (ICD-10 codes: I61, I63 and I64) admitted within 48 hours of symptoms onset to seven NHS and University hospitals will be conducted. About 1,000 patients (2% of all new cases/annually) will be recruited from six urban and semi-urban areas with 5.5 mil people (50% of Greek population), reporting 25,000 discharged stroke cases annually (53% of all stroke discharges), according to data derived from Hellenic Statistical Authority. All patients will be followed for three months. Moreover, a sub-group of the 300 firstly recruited patients will be followed for a year to obtain data on post hospital health and social needs, health services utilization (medication, rehabilitation, outpatient visits) and productivity loss . Patient enrolment and follow up is estimated to last 18 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Diagnosis of hemorrhagic or ischemic stroke (ICD-10: I61, I63 and I64)
- •Patients with First ever acute stroke
排除标准
- 未提供
结局指标
主要结局
Modified Rankin Scale (mRS) score
时间窗: Three months
mRS measures the degree of disability or dependence in the daily activities of patients after a stroke or other causes of neurological disability (0: no symptoms at all - 6: Dead)
National Institutes of Health Stroke Scale (NIHSS) score
时间窗: Three months
NIHSS is a method for assessing the severity of a stroke experienced by a patient (0: No Stroke Symptoms, 42: Severe Stroke)
Mortality
时间窗: Three months
Patient based stroke (inpatient and outpatient) mortality
Cost
时间窗: Three months
Average cost per patient
次要结局
未报告次要终点
研究者
OLGA SISKOU
Senior Researcher
National and Kapodistrian University of Athens