Patient Reported Outcomes in Stroke Care
- Conditions
- Stroke
- Interventions
- Other: PROMs
- Registration Number
- NCT03795948
- Lead Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 975
-
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
- Substantially impaired communication capacity due to aphasia or dementia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description PROM Evaluation for stroke patients PROMs Patient will be enrolled and PROMs will be collected.
- Primary Outcome Measures
Name Time Method Global patient reported health-related quality of life 90 days PROMIS-10
- Secondary Outcome Measures
Name Time Method Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care after study completion (2 years) Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)
Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care after study completion (2 years) qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention
Psychometric evaluation of the patient-reported outcome measures after study completion (2 years) Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population
Patient reported mental health status 90 days PHQ-4 (depression, anxiety)
Recurrence of disease 90 days patient-reported measures
Use of healthcare services after stroke 90 days Patient-reported measures about the patient's level of care and use of specific rehabilitation measures as part of the ICHOM stroke standard set, specifically two questions ranging from 0 to 5 and 0 to 4 with 0 denoting self-containment and no use of rehabilitation services respec-tively and 5 and 4 denoting high level care-dependency and admission in longterm care facilities respectively.
Acute complications of treatment at discharge from inpatient care, on average 6 days after admission clinical assessment of symptomatic intracranial hemorrhage
Trial Locations
- Locations (1)
Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)
🇩🇪Hamburg, Germany