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CompletedNCT03795948

Patient Reported Outcomes in Stroke Care

Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
975 (actual)
Sponsor
Universitätsklinikum Hamburg-Eppendorf · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPROMsIntroduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke. Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life. Telephone assessments will be administered to support patients if necessary and validate their responses.

Timeline

Start date
2017-07-01
Primary completion
2019-06-30
Completion
2019-12-31
First posted
2019-01-08
Last updated
2020-04-10

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT03795948. Inclusion in this directory is not an endorsement.