NCT03124017

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,756

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
Last Updated

April 21, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

April 18, 2017

Last Update Submit

April 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of appropriate thromboprophylaxis

    During hospital stay (expected average duration of 1 week)

Secondary Outcomes (2)

  • Use of the Geneva Risk Score calculation tool by the physician in charge

    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

    During hospital stay (expected average duration of 1 week)

Study Arms (2)

Alert Group

EXPERIMENTAL

Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart

Other: Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart

Control Group

NO INTERVENTION

No electronic alert and no Geneva Risk Score calculation tool issued in the electronic patient chart

Interventions

Eligibility Criteria

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

You may qualify if:

  • Acutely ill medical patients admitted to medical wards

You may not qualify if:

  • Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Cardiovascular Center, Inselspital, University of Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Nils Kucher, Prof. M.D.

    Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland

    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

April 18, 2017

First Posted

April 21, 2017

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

June 1, 2016

Last Updated

April 21, 2017

Record last verified: 2017-04

Locations