Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients (E-SENTRY)
|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.
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|