Abstract
IntroductionThe impact of stroke-related impairment on activities of daily living may vary between patients, and can only be estimated by applying patient-reported outcome measures. The International Consortium for Health Outcome Measurement has developed a standard set of instruments that combine clinical and longitudinal patient-reported outcome measures for stroke. The present study was designed (1) to implement and evaluate the feasibility of the use of it as a consistent outcome measure in clinical routine at the stroke center of a German university hospital, (2) to characterize impairment in everyday life caused by stroke, and (3) to identify predictive factors associated with patient-relevant outcomes.MethodsWe plan to enroll 1040 consecutive patients with the diagnosis of acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage in a prospective observational study. Demographics, cardiovascular risk factors, and living situation are assessed at inpatient surveillance. At 90 days and 12 months after inclusion, follow-up assessments take place including the Patient-reported Outcomes Measurement Information System 10-Question Short Form (PROMIS-10), the Patient- Health Questionnaire-4, and the simplified modified Ranking Scale questionnaire. The acceptance and feasibility (1) will be assessed by a process evaluation through qualitative semi-structured interviews with clinical staff and patients and quantitative analyses of the data quality evaluating practicability, acceptance, adoption, and fidelity to protocol. The primary outcome of objective 2 and 3 is health-related quality of life measured with the PROMIS-10. Additional outcomes are depressive and anxiety symptoms and patient participation in their social roles. Patient-reported outcomes will be assessed in their longitudinal course using (generalized) mixed regressions. Exploratory descriptive and inference statistical analyses will be used to find patterns of patient characteristics and predictive factors of the outcome domains.PerspectiveThe results will describe and further establish the evaluation of stroke patients of a stroke center by standardized PROMs in everyday life.Trial registrationThe trial is registered at ClinicalTrials.gov (NCT03795948). Approval of the local ethics committee (Ethik-Kommission der Ärztekammer Hamburg) has been obtained.
Highlights
MethodsWe plan to enroll 1040 consecutive patients with the diagnosis of acute ischemic stroke, transient ischemic attack, or intracerebral hemorrhage in a prospective observational study
The impact of stroke-related impairment on activities of daily living may vary between patients, and can only be estimated by applying patient-reported outcome measures
Direct deficits resulting from stroke, e.g. paresis or aphasia, are spotted, and well characterized by clinical rating scales, which are used in clinical practice
Summary
Aim of the trial The objectives of the current study are to implement the ICHOM-Standard Set for Stroke (ICHOM-SSS) in routine stroke care, and appraise this implementation, i.e. A process evaluation will be conducted, measuring the degree of feasibility in this study, acceptance of patients, clinical and administrative staff, practicability, realization, and adoption of the implementation process and execution of this assessment, reach, and fidelity to protocol (Table 1). These outcomes are chosen by means of the current standards of feasibility studies [6, 11, 18]. Should the analysis show that such an implementation is feasible and accepted amongst affected persons, measures will be taken that the implemented enquiry remains in use within the routine health care at the stroke unit of the University Medical Centre Hamburg-Eppendorf after the end of the trial.
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