Venous ThromboembolismNCT03124017
Electronic Alert System for Improving Thromboprophylaxis in Hospitalized Medical Patients
A study testing Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart in people with Venous Thromboembolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,756 participants
- Where
- 1 siteSwitzerland
- Study dates
- Mar 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acutely ill medical patients admitted to medical wards
Who cannot join
- Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Cardiovascular Center, Inselspital, University of Bern
Bern, 3010
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chartOther
| Study group | Role | What they receive |
|---|---|---|
| Alert Group | Experimental | Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appropriate thromboprophylaxis
Measured: 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
Measured: 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
Measured: During hospital stay (expected average duration of 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study startMar 2015
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,756 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nils Kucher, Prof. M.D., Principal investigator, Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124017
- Sponsor's protocol ID
- 159/14
- Status last verified
- Apr 2017
- First submitted
- 18 Apr 2017
- Last updated
- 21 Apr 2017
- Results posted
- No
Publications
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.
PubMed 28836340
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Alert System Combined With a Risk Score Calculation Tool for Improving Appropriate Thromboprophylaxis in Hospitalized Medical Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03124017
- Acronym / sponsor ID
- 159/14
- Conditions
- Venous Thromboembolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,756 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alert Group | Experimental | Other: Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chartElectronic 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Acutely ill medical patients admitted to medical wards
Key exclusion criteria (1 listed)
- Indication for therapeutic anticoagulation or ongoing therapeutic anticoagulant treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart | Other | Alert Group |
Primary outcome
Rate of appropriate thromboprophylaxis
Time frame: During hospital stay (expected average duration of 1 week)
2 secondary outcomes
Use of the Geneva Risk Score calculation tool by the physician in charge
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 28836340Spirk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nils Kucher, Prof. M.D. principal investigator
Swiss Cardiovascular Center, Division of Vascular Medicine, University of Bern, University Hospital Bern, Bern, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart in people with Venous Thromboembolism, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of appropriate thromboprophylaxis (time frame: During hospital stay (expected average duration of 1 week)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.