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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02455102
Other study ID # 022/14
Secondary ID
Status Completed
Phase N/A
First received May 6, 2015
Last updated December 21, 2015
Start date September 2014
Est. completion date October 2015

Study information

Verified date December 2015
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

The aim of this randomized controlled study is to evaluate whether a newly designed electronic warning system will increase the initiation rate of adequate stroke preventive measures in patients with atrial fibrillation.


Description:

A large proportion of patients with atrial fibrillation do not receive stroke prevention therapy in line with the guidelines, in spite of the presence of an increased risk of stroke. It will be investigated whether an electronic alert to physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will increase the rate of adequate stroke preventive measures as compared to a control group of patients without an electronic alert. The electronic alerts will be sent if patients with atrial fibrillation but without adequate stroke preventive measures receive in-patient treatment at the University Hospital Bern. The electronic alert system includes a feature that helps the physicians in charge to evaluate the CHA2DS2VASC Score. At the end of the hospital stay medical discharge letters will be reviewed for initiation of adequate stroke preventive measures.


Recruitment information / eligibility

Status Completed
Enrollment 1707
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All in-patients with atrial fibrillation

Exclusion Criteria:

- Ongoing anticoagulant therapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Electronic warning alert
A newly-installed warning system for stroke prevention in atrial fibrillation.

Locations

Country Name City State
Switzerland Swiss Cardiovascular Center, Inselspital, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge Reviewed from discharge letter End of hospital stay (expected average duration of 1 week) No
Secondary Use of the CHA2DS2VASc score calculation tool by the physician in charge During hospital stay (expected average duration of 1 week) No
Secondary Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge End of hospital stay (expected average duration of 1 week) No
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