Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients (E-SENTRY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01401725|
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Venous Thromboembolism||Behavioral: Electronic Order Entry System + CDSS Behavioral: Electronic Order Entry System Only Other: Usual Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
|Experimental: Hamilton General Hospital||
Behavioral: Electronic Order Entry System + CDSS
Physicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions.
|Active Comparator: Juravinski Hospital||
Behavioral: Electronic Order Entry System Only
Physicians at this hospital will use an Electronic Order Entry System
|St. Joseph's Hospital||
Other: Usual Care
Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)
- Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis [ Time Frame: Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days ]'Appropriate management' is defined as: (i) appropriate non-receipt of any form of prophylaxis when the patient has no VTE risk factors; (ii) appropriate receipt of pharmacologic prophylaxis when VTE risk factors are present and the patient has no contraindications for pharmacologic prophylaxis; or (iii) appropriate receipt of mechanical prophylaxis, when VTE risk factors are present and the patient has contraindications for pharmacologic prophylaxis.
- Hospital-acquired venous thromboembolism [ Time Frame: Participants will be followed for 30 days, from the date of hospital admission ]
VTE is defined as the presence of DVT or PE objectively confirmed by at least one of compression ultrasonography, venography, ventilation-perfusion lung scanning, CT pulmonary angiography, or a conventional pulmonary arteriogram.
'Hospital-acquired' VTE is that which is not clinically evident or suspected at the time of admission, but is diagnosed during or up to 30 days after hospital admission.
- Major bleeding [ Time Frame: Participants will be followed for 30 days, from the date of hospital admission ]Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01401725
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Hamilton, Ontario, Canada, L8V 1C3|
|Principal Investigator:||Menaka Pai, MD, FRCPC||McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital|
|Principal Investigator:||James D Douketis, MD, FRCPC||McMaster University|