Back to resultsElectronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients
Primary Purpose
Venous Thromboembolism
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism
Eligibility Criteria
Inclusion Criteria:
- Acutely ill medical patients admitted to medical wards
Exclusion Criteria:
- Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
Sites / Locations
- Swiss Cardiovascular Center, Inselspital, University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Alert Group
Control Group
Arm Description
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
No electronic alert and no Geneva Risk Score calculation tool issued in the electronic patient chart
Outcomes
Primary Outcome Measures
Rate of appropriate thromboprophylaxis
Secondary Outcome Measures
Use of the Geneva Risk Score calculation tool by the physician in charge
Rate of correct calculation of the Geneva Risk Score through the calculation tool by the physician in charge
Full Information
NCT ID
NCT03124017
First Posted
April 18, 2017
Last Updated
April 18, 2017
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT03124017
Brief Title
Electronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients
Official Title
Electronic Alert System Combined With a Risk Score Calculation Tool for Improving Appropriate Thromboprophylaxis in Hospitalized Medical Patients: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1756 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alert Group
Arm Type
Experimental
Arm Description
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No electronic alert and no Geneva Risk Score calculation tool issued in the electronic patient chart
Intervention Type
Other
Intervention Name(s)
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
Primary Outcome Measure Information:
Title
Rate of appropriate thromboprophylaxis
Time Frame
During hospital stay (expected average duration of 1 week)
Secondary Outcome Measure Information:
Title
Use of the Geneva Risk Score calculation tool by the physician in charge
Time Frame
During hospital stay (expected average duration of 1 week)
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acutely ill medical patients admitted to medical wards
Exclusion Criteria:
Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nils Kucher, Prof. M.D.
Organizational Affiliation
Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Cardiovascular Center, Inselspital, University of Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
28836340
Citation
Spirk D, Stuck AK, Hager A, Engelberger RP, Aujesky D, Kucher N. Electronic alert system for improving appropriate thromboprophylaxis in hospitalized medical patients: a randomized controlled trial. J Thromb Haemost. 2017 Nov;15(11):2138-2146. doi: 10.1111/jth.13812. Epub 2017 Sep 20.
Results Reference
derived
Learn more about this trial
Electronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients
We'll reach out to this number within 24 hrs