Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study (TPX-ENHANCE)

May 8, 2023 updated by: Marc Blondon
The primary objective is to evaluate and compare the short-term and medicum-term effectiveness of 2 types of interventions in 2 different hospitals to improve the adequacy of hospital thromboprophylaxis among acute medical inpatients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

600

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

  • Switzerland
      • Geneva, Switzerland
        • Recruiting
        • Geneva University Hospitals
        • Contact:
      • Lugano, Switzerland
        • Recruiting
        • Ospedale Regionale di Lugano
        • Contact:

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

Description

Inclusion Criteria:

  • acute medical inpatients hospitalized at the Geneva University Hospitals or the Lugano Regional Hospitals

Exclusion Criteria:

  • patients already on therapeutic anticoagulation
  • patients with an estimated life expectancy of <3 months
  • pregnancy
  • patients hospitalized for COVID-19

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription
Other: Comprehensive electronic tool in the electronic medical chart
Use of a comprehensive electronic tool in the electronic medical chart to help the stratification of risk of VTE and the subsequent prescription of an adequate thromboprophylaxis
Other: Educative sessions
Educative sessions on thromboprophylaxis
Experimental: Implementation of educative sessions and pocket cards for thromboprophylaxis
Other: Educative sessions
Educative sessions on thromboprophylaxis
Other: Pocket card
Pocket card (guide for thromboprophylaxis)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with an adequate thromboprophylaxis
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of venous thromboembolism
Time Frame: 90 days
90 days
Incidence of major bleeding
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marc Blondon

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)

September 1, 2020

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

April 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-01976

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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