Clinical trial NCT03124017: 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
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thromboembolism
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 1756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Acutely ill medical patients admitted to medical wards

Exclusion Criteria:

* Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment

Primary outcomes:
measure: Rate of appropriate thromboprophylaxis
timeFrame: During hospital stay (expected average duration of 1 week)
Secondary outcomes:
measure: Use of the Geneva Risk Score calculation tool by the physician in charge
timeFrame: During hospital stay (expected average duration of 1 week)
measure: Rate of correct calculation of the Geneva Risk Score through the calculation tool by the physician in charge
timeFrame: During hospital stay (expected average duration of 1 week)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Swiss Cardiovascular Center, Inselspital, University of Bern
Study officials:
affiliation: Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland
name: Nils Kucher, Prof. M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.