- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02455102
Electronic Warning System for Atrial Fibrillation
December 21, 2015 updated by: University Hospital Inselspital, Berne
Electronic Warning System to Improve Stroke Prevention in Atrial Fibrillation - A Quality Improvement Initiative at the University Hospital Bern
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
1707
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
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-
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Bern, Switzerland, 3012
- Swiss Cardiovascular Center, Inselspital, University of Bern
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All in-patients with atrial fibrillation
Exclusion Criteria:
- Ongoing anticoagulant therapy
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Electronic alert
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive an electronic warning alert.
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A newly-installed warning system for stroke prevention in atrial fibrillation.
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No Intervention: No electronic alert
Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive no electronic warning alert.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of initiation of adequate measures to prevent stroke (oral anticoagulant prescription) by physician in charge
Time Frame: End of hospital stay (expected average duration of 1 week)
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Reviewed from discharge letter
|
End of hospital stay (expected average duration of 1 week)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of the CHA2DS2VASc score calculation tool by the physician in charge
Time Frame: During hospital stay (expected average duration of 1 week)
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During hospital stay (expected average duration of 1 week)
|
Rate of correct evaluation of the CHA2DS2VASC Score through the calculation tool by physician in charge
Time Frame: End of hospital stay (expected average duration of 1 week)
|
End of hospital stay (expected average duration of 1 week)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nils Kucher, Prof. M.D., Department of Angiology, Swiss Cardiovascular Center, University of Berne
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.
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
September 1, 2014
Primary Completion (Actual)
October 1, 2015
Study Completion (Actual)
October 1, 2015
Study Registration Dates
First Submitted
May 6, 2015
First Submitted That Met QC Criteria
May 22, 2015
First Posted (Estimate)
May 27, 2015
Study Record Updates
Last Update Posted (Estimate)
December 22, 2015
Last Update Submitted That Met QC Criteria
December 21, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 022/14
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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