Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 975
- 试验地点
- 2
- 主要终点
- Global patient reported health-related quality of life
研究概览
简要总结
The presented study is an explorative prospective study. First, it focusses on the longitudinal analysis of outcome quality in stroke treatment (12 months). Particularly, it addresses patient reported quality of life after inpatient stroke treatment and influencing factors. Second, it focusses on the feasibility and acceptance of a standard set of measures capturing outcome quality of medical care in stroke patients.
详细描述
With a shift in focus to patient-centered health care and a constant effort to improve the quality of treatment, the role of the patient's perception of his/her medical care becomes essential. Patient reported outcome measures (PROMs) are among the most adequate instruments for assessing the patient's perspective on symptom load, functional status, and quality of life. After stroke, patients not only suffer from objectively scaled and measurable symptoms and impairments but also experience dramatic changes in everyday routine and quality of life.
In this project, a standardized outcome measurement, including PROMs, for stroke patients is used.
This stoke standard set was developed by the International Consortium for Health Outcomes Measurement (ICHOM; www.ICHOM.org); an international, interdisciplinary and inter-professional expert group with the contribution of patient representatives, aiming to create a comprehensive tool for measuring the most important outcomes and risk factors applicable to a broad variety of diseases.
Main objective of this study is the analysis of quality of life 90 and 360 days after stroke and its association with stroke specific risk factors and complications, also measured within the scope of the ICHOM tool.
Furthermore, the process and success of the implementation of the ICHOM stroke standard set within the stroke unit of the University Medical Centre Hamburg- Eppendorf (UKE) will be studied and evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients in inpatient care in the stroke unit of the UKE with the following diagnoses (ICD-10):
- •Ischemic attack (I63),
- •Transient ischemic attack (G45)
- •Intracerebral hemorrhage (I64)
- •Written informed consent
排除标准
- •Substantially impaired communication capacity due to aphasia or dementia
结局指标
主要结局
Global patient reported health-related quality of life
时间窗: 90 days
PROMIS-10
次要结局
- Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care(after study completion (2 years))
- Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care(after study completion (2 years))
- Psychometric evaluation of the patient-reported outcome measures(after study completion (2 years))
- Patient reported mental health status(90 days)
- Recurrence of disease(90 days)
- Use of healthcare services after stroke(90 days)
- Acute complications of treatment(at discharge from inpatient care, on average 6 days after admission)