Clinical trial NCT03795948: Patient Reported Outcomes in Stroke Care
Official title: Outcome Evaluation by Patient Reported Outcome Measures (PROMs) in Stroke Clinical Practice - EPOS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stoke
Patient-reported outcomes (PROs)
Quality of life
Morbidity
Mortality
Functional status
Patient-centered care
ICHOM
Treatment quality
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2019-01-08
Enrollment: 975
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Global patient reported health-related quality of life
timeFrame: 90 days
Secondary outcomes:
measure: Patient reported mental health status
timeFrame: 90 days
measure: Recurrence of disease
timeFrame: 90 days
measure: Acute complications of treatment
timeFrame: at discharge from inpatient care, on average 6 days after admission
measure: Use of healthcare services after stroke
timeFrame: 90 days
measure: Quantitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
timeFrame: after study completion (2 years)
measure: Psychometric evaluation of the patient-reported outcome measures
timeFrame: after study completion (2 years)
measure: Qualitative process evaluation of the implementation of the ICHOM stroke standard set in routine care
timeFrame: after study completion (2 years)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE)
Study officials:
affiliation: Department of Neurology, University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany
name: Thomalla Götz, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lebherz L, Fraune E, Thomalla G, Frese M, Appelbohm H, Rimmele DL, Harter M, Kriston L. Implementability of collecting patient-reported outcome data in stroke unit care - a qualitative study. BMC Health Serv Res. 2022 Mar 16;22(1):346. doi: 10.1186/s12913-022-07722-y.
citation: Rimmele DL, Schrage T, Lebherz L, Kriston L, Gerloff C, Harter M, Thomalla G. Profiles of patients' self-reported health after acute stroke. Neurol Res Pract. 2021 Aug 23;3(1):43. doi: 10.1186/s42466-021-00146-9.
citation: Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Outcome evaluation by patient reported outcome measures in stroke clinical practice (EPOS) protocol for a prospective observation and implementation study. Neurol Res Pract. 2019 Nov 1;1:28. doi: 10.1186/s42466-019-0034-0. eCollection 2019.
citation: Rimmele DL, Lebherz L, Frese M, Appelbohm H, Bartz HJ, Kriston L, Gerloff C, Harter M, Thomalla G. Health-related quality of life 90 days after stroke assessed by the International Consortium for Health Outcome Measurement standard set. Eur J Neurol. 2020 Dec;27(12):2508-2516. doi: 10.1111/ene.14479. Epub 2020 Sep 7.