NCT02455102

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,707

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 22, 2015

Status Verified

December 1, 2015

Enrollment Period

1.1 years

First QC Date

May 6, 2015

Last Update Submit

December 21, 2015

Conditions

Keywords

PreventionAnticoagulationElectronic warning system

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Use of the CHA2DS2VASc score calculation tool by the physician in charge

    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

    End of hospital stay (expected average duration of 1 week)

Study Arms (2)

Electronic alert

ACTIVE COMPARATOR

Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive an electronic warning alert.

Other: Electronic warning alert

No electronic alert

NO INTERVENTION

Physicians, whose patients with atrial fibrillation do not receive stroke preventive measures, will receive no electronic warning alert.

Interventions

A newly-installed warning system for stroke prevention in atrial fibrillation.

Electronic alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All in-patients with atrial fibrillation

You may not qualify if:

  • Ongoing anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Cardiovascular Center, Inselspital, University of Bern

Bern, Canton of Bern, 3012, Switzerland

Location

Related Publications (1)

  • Silbernagel G, Spirk D, Hager A, Baumgartner I, Kucher N. Electronic Alert System for Improving Stroke Prevention Among Hospitalized Oral-Anticoagulation-Naive Patients With Atrial Fibrillation: A Randomized Trial. J Am Heart Assoc. 2016 Jul 22;5(7):e003776. doi: 10.1161/JAHA.116.003776.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nils Kucher, Prof. M.D.

    Department of Angiology, Swiss Cardiovascular Center, University of Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 27, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 22, 2015

Record last verified: 2015-12

Locations