StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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StroCare - Optimised Cross-sectoral, Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

Conditions
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Stroke

Intervention / Treatment
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* Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the BARMER health insurance agency with the following diagnosis (ICD-10): Ischemic attack (I63) Transient ischemic attack and related syndromes (G45) Intracerebral haermorrhage (I64) Written informed consent Sufficient mastery of German language Exclusion Criteria: Substantially impaired communication capacity due to aphasia or dementia Patients with artificial Respiration Insufficient adherence Premorbid score of mRS≥4 Patients with artificial Respiration (Z99.1) Dementia (F00.x., F01.x. or G30.x) or aphasia (R47) Death during inpatient Treatment or the Admission to a nursing home following the acute treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: For a 12-months period patients undergoing aftercare treatment as usual are enrolled as an active control group. Subsequently, the intervention is implemented (StroCare treatment) and enrolment of the intervention group takes place for another 12 months. 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), routine data provided by the collaborating BARMER health insurance agency (for the intervention and control group and additionally for a historic control).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StroCare treatment group<br>Optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation | Other: optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation<br>* the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions<br>|
| No Intervention: control group<br>routine aftercare stroke treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 year after index ischemic event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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) | 1 year after index ischemic event | 
| Overall survival | Overall survival measured with the ICHOM Standard set | 1 year after index ischemic event | 
| Stroke recurrence | Stroke recurrence measured with the ICHOM Standard set | 1 year after index ischemic event | 
| 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 | 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) | 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 | 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 | 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 | 1 year after index ischemic event | 
| Costs | Routine data | 1 year after index ischemic event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Patient-reported outcomes (PROs), Cross-sectoral care, Stroke aftercare, Aftercare coordination, Post-rehabilitation support, Evidence based treatment, Patient-centred care, Quality of life, Morbidity, Mortality, Functional status, Feasibility, Acceptance, Process evaluation, Health economics