Status
Conditions
About
The B-SPATIAL-Registry will provide a tool of quality assessment for stroke specific Treatments such as endovascular treatment. It will also enable the participating hospitals to compare the quality of care of their facility. At the same time, B-SPATIAL will provide an opportunity of scientific evaluation of new therapeutic procedures or specific treatments in stroke (i.e. reversal of oral anticoagulation in intracerebral hemorrhage or intravenous thrombolysis), not sufficiently investigated so far. Finally, the B-SPATIAL Registry will allow for an identification of key quality indicators that assure valid quality assessment aiming at a reduced documentation load for future quality management.
Full description
Background
Quality assessment of acute stroke care is organized in regional stroke registries in Germany - for the federal state of Berlin in the Berlin Stroke Registry (BSR). The current documentation of the Berlin Stroke Registry is focused on the documentation of process quality in participating hospitals.
So far, outcome quality is only assessed by surrogate parameters such as complications and mortality during in-hospital stay. However, according to consensus recommendations, disability-free survival versus death and dependency is the most important outcome measure after acute stroke. Because of the high variability of the clinical course after stroke, this outcome is generally assessed after three months by using the modified Rankin Scale (mRS).
Motivation
In early 2015, several published trials showed that mechanical thrombectomy improves the prognosis of ischemic stroke patients with acute large artery occlusion of proximal brain supplying arteries. Currently, this invasive catheter based treatment is not available in many hospitals with acute Stroke Unit. It is likely that the quality of technical procedures depends on the expertise and experience of treating interventionalists. Current studies suggest a close relationship between effectiveness of the approach and time to treatment, similar to intravenous thrombolysis. This time dependency makes prehospital triage more challenging because selection of the appropriate facility is likely to influence patient outcome.
Intracerebral hemorrhage (ICH) is less frequent than ischemic stroke but is associated with worse prognosis. Recent studies suggest that blood pressure lowering may improve prognosis if started during the hyperacute phase of ICH. With limited scientific evidence, many patients undergo neurosurgical intervention. It remains unclear whether delivery of hemorrhagic stroke patients to hospitals with neurosurgery leads to better outcome.
Hence, pre-hospital care with delivery to more or less specialized clinical facilities may have a crucial impact for both subtypes of stroke. The introduction of specialized stroke ambulances (Stroke Emergency Mobiles, STEMOs) opens new avenues for pre-hospital stroke diagnosis, treatment and patient triage. The effects of STEMO care are planned to be assessed by the parallel B-PROUD-Study (NCT02869386).
Purpose
The B-SPATIAL-Registry will provide a tool of quality assessment for new specific treatments. It will also enable the participating hospitals to compare the quality of care of their own facility.
Because this registry represents an quality monitoring initiative, the telephone follow-up is collected with an opt-out solution, allowing to decline participation after the patients are informed on the follow-up telephone call at discharge and through a letter send one month prior to the actual call. As written informed consent is not required, this method will facilitate a high follow-up rate particularly in patients with severe neurological deficits or treated in non-academic hospitals.
In B-SPATIAL we want to identify key quality indicators that assure valid quality assessment despite reduced documentation load in future quality management.
Specific Aims of the registry:
Pre-specified analyses:
Ischemic stroke
Hemorrhagic stroke
Data sources
The documentation will include pre-hospital, in-hospital and post-discharge processes such as:
Patients
In order to ensure valid analysis of treatment rates in participating hospitals, patients will be included according to the following inclusion criteria:
Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
Patients with main discharge diagnosis of intracranial hemorrhage and hospital admission within 6 hours of stroke onset.
Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
Data documentation
Databank characteristics
Responsibilities
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion criteria:
Patients with hospital main discharge diagnoses according to ICD 10: Ischemic stroke (I63) or TIA (G45.0-G45.3 and G45.5-G45.9, respectively) and
Patients with main discharge diagnosis of intracranial hemorrhage and symptom onset within 6 hours of hospital admission
Patients with other main discharge diagnoses and documented intravenous thrombolysis (OPS 8-020.8) in order to monitor the treatment rate of stroke mimics
Exclusion Critera:
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal