Reduction of Prehospital Delays in Stroke and Transient Ischaemic Attack (TIA)

Stroke Clinical Trial

— BASS  

Official title:

Population-Based Intervention to Reduce Prehospital Delays in Patients With Stroke and Transient Ischaemic Attack

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744029
• Other study ID #: Project Z1b
• Status: Completed
• Phase: N/A
• First received: August 28, 2008
• Last updated: August 29, 2008
• Start date: February 2004
• Est. completion date: June 2007

Study information

• Verified date: August 2008
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1388
• Est. completion date: June 2007
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Ischemic Attack, Transient
• Stroke

Intervention

Behavioral:
• educational material
Educational letter indicating stroke symptoms and emphasizing the importance of calling the emergency medical services (EMS) as well as a bookmark and sticker with the EMS telephone number.

Locations

Country	Name	City	State
Germany	Institute of Social Medicine, Epidemiology and Health Economics	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Jungehülsing GJ, Müller-Nordhorn J, Nolte CH, Roll S, Rossnagel K, Reich A, Wagner A, Einhäupl 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. do — View 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):2 — View Citation

Müller-Nordhorn J, Nolte CH, Rossnagel K, Jungehülsing 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. Epub 2006 Mar 2. — View Citation

Rossnagel K, Jungehülsing GJ, Nolte CH, Müller-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time between symptom onset and hospital admission		Admission to hospital	No
Secondary	Proportion of patients with thrombolysis		hospital stay	No
Secondary	Mortality		hospital stay	No