Clinical trial NCT00574262: Quality Assessment in Acute Stroke Care
Official title: Quality of Acute Stroke Care Evaluated With a Clinical Pathway on a 16 Bed Stroke Unit - a Prospective Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
clinical pathway
quality of care
secondary prevention
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with an acute ischemic stroke admitted to the stroke unit of the university hospital in Muenster, Germany

Brief summary: The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.


Eligibility criteria: Inclusion Criteria:

* admission to the stroke unit of the university hospital in Muenster, Germany
* acute ischemic stroke or transient ischemic attack

Exclusion Criteria:

* intracerebral haemorrhage
* neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack
* intraarterial thrombolysis
* necessity of artificial ventilation

Primary outcomes:
measure: frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %)
timeFrame: duration of stay on stroke unit
Secondary outcomes:
measure: frequency of stroke been classified according to the TOAST criteria (preset target 55 - 65 %)
timeFrame: duration of stay on stroke unit
measure: frequency of initiated or improved antithrombotic secondary prevention (preset target 90 - 95 %)
timeFrame: duration of stay on stroke unit
measure: frequency of initiated or improved statin therapy (preset target 40 - 50 %)
timeFrame: duration of stay on stroke unit
measure: frequency of totally completed clinical diagnostics regarding the etiology of the stroke (preset target 60 -70 %)
timeFrame: duration of stay on stroke unit
measure: frequency of initiated or improved antihypertension therapy and reduction of systolic and diastolic blood pressure by more than 10 mmHg (preset target 60 - 70 %)
timeFrame: duration of stay on stroke unit
measure: frequency of a reduction on the NIH-SS by at least two points (preset target 50 - 60 %)
timeFrame: duration of stay on stroke unit
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Neurology, University Hospital of Muenster
Study officials:
affiliation: Department of Neurology, University Hospital of Muenster, Germany
name: Wolf Rüdiger Schäbitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heuschmann PU, Biegler MK, Busse O, Elsner S, Grau A, Hasenbein U, Hermanek P, Janzen RW, Kolominsky-Rabas PL, Kraywinkel K, Lowitzsch K, Misselwitz B, Nabavi DG, Otten K, Pientka L, von Reutern GM, Ringelstein EB, Sander D, Wagner M, Berger K. Development and implementation of evidence-based indicators for measuring quality of acute stroke care: the Quality Indicator Board of the German Stroke Registers Study Group (ADSR). Stroke. 2006 Oct;37(10):2573-8. doi: 10.1161/01.STR.0000241086.92084.c0. Epub 2006 Sep 7.
citation: Kwan J. Care pathways for acute stroke care and stroke rehabilitation: from theory to evidence. J Clin Neurosci. 2007 Mar;14(3):189-200. doi: 10.1016/j.jocn.2006.01.026.
citation: Taylor WJ, Wong A, Siegert RJ, McNaughton HK. Effectiveness of a clinical pathway for acute stroke care in a district general hospital: an audit. BMC Health Serv Res. 2006 Feb 23;6:16. doi: 10.1186/1472-6963-6-16.