Back to resultsEffectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study (TPX-ENHANCE)
Primary Purpose
Venous Thromboembolism
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Comprehensive electronic tool in the electronic medical chart
Educative sessions
Pocket card
Sponsored by
About this trial
This is an interventional prevention trial for Venous Thromboembolism
Eligibility Criteria
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
Sites / Locations
- Geneva University HospitalsRecruiting
- Ospedale Regionale di LuganoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription
Implementation of educative sessions and pocket cards for thromboprophylaxis
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with an adequate thromboprophylaxis
Secondary Outcome Measures
Incidence of venous thromboembolism
Incidence of major bleeding
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05306821
Brief Title
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
Acronym
TPX-ENHANCE
Official Title
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marc Blondon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implementation of an electronic tool for risk stratification and thromboprophylaxis prescription
Arm Type
Experimental
Arm Title
Implementation of educative sessions and pocket cards for thromboprophylaxis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Comprehensive electronic tool in the electronic medical chart
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Educative sessions
Intervention Description
Educative sessions on thromboprophylaxis
Intervention Type
Other
Intervention Name(s)
Pocket card
Intervention Description
Pocket card (guide for thromboprophylaxis)
Primary Outcome Measure Information:
Title
Proportion of patients with an adequate thromboprophylaxis
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Incidence of venous thromboembolism
Time Frame
90 days
Title
Incidence of major bleeding
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Geneva University Hospitals
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Blondon
Phone
+41.22.372.92.92
Email
marc.blondon@hcuge.ch
Facility Name
Ospedale Regionale di Lugano
City
Lugano
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pietro Gianella, MD
Phone
0041.91.811.61.11
Email
pietro.gianella@eoc.ch
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Effectiveness of Interventions for Hospital Medical Thromboprophylaxis: a Bicentric Swiss Quality-improvement Study
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