Patient Reported Outcomes in Stroke Care

Stroke Clinical Trial

— EPOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03795948
• Other study ID #: 0977_114
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 975
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• PROMs
Introduction 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.

Locations

Country	Name	City	State
Germany	Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global patient reported health-related quality of life	PROMIS-10	90 days
Secondary	Patient reported mental health status	PHQ-4 (depression, anxiety)	90 days
Secondary	Recurrence of disease	patient-reported measures	90 days
Secondary	Acute complications of treatment	clinical assessment of symptomatic intracranial hemorrhage	at discharge from inpatient care, on average 6 days after admission
Secondary	Use of healthcare services after stroke	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.	90 days
Secondary	Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care	Quantitative indicators on feasibility of the intervention (i.e. recruitente and respective response rate)	after study completion (2 years)
Secondary	Psychometric evaluation of the patient-reported outcome measures	Psychometric evaluation of the patient-reported outcome measueres of the ICHOM stroke standard set in the study population	after study completion (2 years)
Secondary	Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care	qualitative interviews with the staff and patients on acceptability, feasibility, barriers, and facilitators of the intervention	after study completion (2 years)