Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 975
- Locations
- 1
- Primary Endpoint
- Global patient reported health-related quality of life
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Substantially impaired communication capacity due to aphasia or dementia
Outcomes
Primary Outcomes
Global patient reported health-related quality of life
Time Frame: 90 days
PROMIS-10
Secondary Outcomes
- 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)