The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment.
Stroke is the second most common cause of death in Germany and the most common cause for life-long disability in adulthood. After stroke, patients often experience incisive changes in their health, daily routine and quality of life. The developed model of care (StroCare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. It aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. This is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. The presented study is a multi-centred controlled interventional study with a pre-post design. Stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating BARMER health insurance agency (for the Intervention and control group and additionally for a historic control). The main hypotheses are : (1) The StroCare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported physical quality of life) and (2) the StroCare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
409
the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
University Medical Center Hamburg-Eppendorf
Hamburg, Germany
Patient-reported physical QoL: PROMIS-10
Patient-reported physical Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Physcial Health with scores ranging from 0-20 and higher scores indicating better health state.
Time frame: 1 year after index ischemic event
Patient-reported mental QoL
Patient-reported mental Quality of Life measured with Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10); one of two provided global scores: Global Mental Health with scores ranging from 0-20 and higher scores indicating better health state.
Time frame: 1 year after index ischemic event
Patient-reported mental health status
Patient reported mental health Status measured with the Patient health questionnaire (PHQ-4); the questionnaire provides two sub-scores measuring anxiety and depression with scores ranging from 0-6 each with higher scores indiciating more symptoms of anxiety or depression, respectively
Time frame: 1 year after index ischemic event
Functional Status modified Rankin Scale questionnaire (smRSq)
Functional Status measured with the modified Rankin Scale (mRS); the nRS ranges from 0 (no disability) to 6 (death)
Time frame: 1 year after index ischemic event
Overall survival
Overall survival measured with the ICHOM Standard set
Time frame: 1 year after index ischemic event
Stroke recurrence
Stroke recurrence measured with the ICHOM Standard set
Time frame: 1 year after index ischemic event
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Utilisation of health care Services
Utilisation of health care Services extracted from the medical record and the electronic Portal (only Intervention Group), i.e., number of admissions to hospital, number of outpatient contacts, weekly hours of physiotherapy, speech therapy, occupational therapy
Time frame: 1 year after index ischemic event
Patient' s waiting time between Treatment phases (Transition) to the ambulant neurological Rehabilitation Treatment)
Waiting time extracted from the medical record and the electronic Portal (only Intervention Group)
Time frame: 1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): blood pressure
Current values Blood Pressure will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
Time frame: 1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): LDL-cholesterol
Current values of LDL-cholesterol will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
Time frame: 1 year after index ischemic event
Success in reahin target values of relevant risk factors (individually defined target values based on available guidelines): HbA1c
Current values of HbA1c will be extracted from the medical record and the electronic portal and compared to the individually defined target values based on current guidelines and individuall assessement of the overall patient's situation
Time frame: 1 year after index ischemic event
Costs
Routine data
Time frame: 1 year after index ischemic event