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

August 29, 2008 updated by: Charite University, Berlin, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10098
        • Institute of Social Medicine, Epidemiology and Health Economics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
No intervention was performed
Active Comparator: Intervention group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time between symptom onset and hospital admission
Time Frame: Admission to hospital
Admission to hospital

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with thrombolysis
Time Frame: hospital stay
hospital stay
Mortality
Time Frame: hospital stay
hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Stefan N Willich, MD, Institute for Social Medicine, Epidemiology and Health Economics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

August 28, 2008

First Submitted That Met QC Criteria

August 28, 2008

First Posted (Estimate)

August 29, 2008

Study Record Updates

Last Update Posted (Estimate)

September 1, 2008

Last Update Submitted That Met QC Criteria

August 29, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Project Z1b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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