Electronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients

April 18, 2017 updated by: University Hospital Inselspital, Berne

Electronic Alert System Combined With a Risk Score Calculation Tool for Improving Appropriate Thromboprophylaxis in Hospitalized Medical Patients: a Randomized Controlled Trial

The investigators aim to investigate whether a computer-based alert system in the electronic patient chart and order entry system using the Geneva Risk Score as clinical decision support tool to estimate the risk of venous thromboembolism improves the rate of appropriate thromboprophylaxis among hospitalized medical patients.

Study Overview

Detailed Description

The use of thromboprophylaxis among acutely ill hospitalized medical patients remains inconsistent. The present study aims to improve the use of appropriate thromboprophylaxis by implementing a computer-based alert system combined with a Geneva Risk Score calculation tool in the electronic patient chart and order entry system. Consecutive acutely ill medical patients without indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment admitted to the medical wards of the University Hospital Bern, Switzerland, will be randomized in a 1:1 fashion to the alert group in which an alert and the Geneva Risk Score calculation tool will be issued in the electronic patient chart or to the control group in which no alert will be issued. The primary endpoint is the rate of appropriate thromboprophylaxis during hospital stay.

Study Type

Interventional

Enrollment (Actual)

1756

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

      • Bern, Switzerland, 3010
        • Swiss Cardiovascular Center, Inselspital, University of Bern

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:

  • Acutely ill medical patients admitted to medical wards

Exclusion Criteria:

  • Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment

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
Experimental: Alert Group
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
No Intervention: Control Group
No electronic alert and no Geneva Risk Score calculation tool issued in the electronic patient chart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of appropriate thromboprophylaxis
Time Frame: During hospital stay (expected average duration of 1 week)
During hospital stay (expected average duration of 1 week)

Secondary Outcome Measures

Outcome Measure
Time Frame
Use of the Geneva Risk Score calculation tool by the physician in charge
Time Frame: During hospital stay (expected average duration of 1 week)
During hospital stay (expected average duration of 1 week)
Rate of correct calculation of the Geneva Risk Score through the calculation tool by the physician in charge
Time Frame: During hospital stay (expected average duration of 1 week)
During 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., Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland

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 (Actual)

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 18, 2017

First Submitted That Met QC Criteria

April 18, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 18, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 159/14

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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