Clinical trial NCT00744029: Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)
Official title: Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: prehospital delays
intervention
population-based
stroke
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2008-08-29
Enrollment: 1388
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). The investigators additionally included a bookmark and sticker with the EMS telephone number. A total of 75,720 inhabitants received the intervention. Between 2004 and 2005, 741 patients with cerebrovascular events were admitted from the control areas (n=24) and 647 from the intervention areas (n=24).

Detailed description: Background and Purpose:

In patients with acute stroke, systemic thrombolysis needs to be administered within three hours of symptom onset. The aim of the present study was to reduce prehospital delays in a population-based intervention.

Methods:

We performed a cluster-randomized trial with 48 zip code areas as cluster units in the catchment area of three inner-city hospitals in Berlin. The primary endpoint was time between symptom onset and hospital admission. The intervention consisted of an educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS). We additionally included a bookmark and sticker with the EMS telephone number. We fitted a lognormal survival regression model (time-to-admission) with frailty terms shared by inhabitants of the same zip code area.

Eligibility criteria: Inclusion Criteria:

* All patients with stroke or transient ischaemic attacks from the postal code areas of the study being admitted to one of the participating hospitals

Exclusion Criteria:

* Patients with stroke or transient ischaemic attacks from outside the postal code areas of the study

Primary outcomes:
measure: Time between symptom onset and hospital admission
timeFrame: Admission to hospital
Secondary outcomes:
measure: Proportion of patients with thrombolysis
timeFrame: hospital stay
measure: Mortality
timeFrame: hospital stay
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute of Social Medicine, Epidemiology and Health Economics
Study officials:
affiliation: Institute for Social Medicine, Epidemiology and Health Economics
name: Stefan N Willich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller-Nordhorn J, Nolte CH, Rossnagel K, Jungehulsing GJ, Reich A, Roll S, Villringer A, Willich SN. Knowledge about risk factors for stroke: a population-based survey with 28,090 participants. Stroke. 2006 Apr;37(4):946-50. doi: 10.1161/01.STR.0000209332.96513.82. Epub 2006 Mar 2.
citation: Rossnagel K, Jungehulsing GJ, Nolte CH, Muller-Nordhorn J, Roll S, Wegscheider K, Villringer A, Willich SN. Out-of-hospital delays in patients with acute stroke. Ann Emerg Med. 2004 Nov;44(5):476-83. doi: 10.1016/j.annemergmed.2004.06.019.
citation: Jungehulsing GJ, Rossnagel K, Nolte CH, Muller-Nordhorn J, Roll S, Klein M, Wegscheider K, Einhaupl KM, Willich SN, Villringer A. Emergency department delays in acute stroke - analysis of time between ED arrival and imaging. Eur J Neurol. 2006 Mar;13(3):225-32. doi: 10.1111/j.1468-1331.2006.01170.x.
citation: Jungehulsing GJ, Muller-Nordhorn J, Nolte CH, Roll S, Rossnagel K, Reich A, Wagner A, Einhaupl KM, Willich SN, Villringer A. Prevalence of stroke and stroke symptoms: a population-based survey of 28,090 participants. Neuroepidemiology. 2008;30(1):51-7. doi: 10.1159/000115750. Epub 2008 Feb 7.
citation: Muller-Nordhorn J, Wegscheider K, Nolte CH, Jungehulsing GJ, Rossnagel K, Reich A, Roll S, Villringer A, Willich SN. Population-based intervention to reduce prehospital delays in patients with cerebrovascular events. Arch Intern Med. 2009 Sep 14;169(16):1484-90. doi: 10.1001/archinternmed.2009.232.