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Trial record 1 of 4 for:    15755945 [PUBMED-IDS]
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Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients (E-SENTRY)

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ClinicalTrials.gov Identifier: NCT01401725
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : October 16, 2015
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Menaka Pai, McMaster University

Tracking Information
First Submitted Date  ICMJE July 19, 2011
First Posted Date  ICMJE July 25, 2011
Last Update Posted Date October 16, 2015
Study Start Date  ICMJE April 2011
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01401725 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients
Official Title  ICMJE Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients
Brief Summary Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • 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.
  • Behavioral: Electronic Order Entry System Only
    Physicians at this hospital will use an Electronic Order Entry System
  • Other: Usual Care
    Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)
Study Arms
  • Experimental: Hamilton General Hospital
    Intervention: Behavioral: Electronic Order Entry System + CDSS
  • Active Comparator: Juravinski Hospital
    Intervention: Behavioral: Electronic Order Entry System Only
  • St. Joseph's Hospital
    Intervention: Other: Usual Care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2015)
600
Original Estimated Enrollment  ICMJE
 (submitted: July 22, 2011)
2820
Actual Study Completion Date June 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients at least 18 years of age
  • Hospitalization on a general internal medicine ward

Exclusion Criteria:

  • Receiving therapeutic anticoagulation at time of hospitalization
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01401725
Other Study ID Numbers  ICMJE HHS150411
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Menaka Pai, McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE Hamilton Health Sciences Corporation
Investigators  ICMJE
Principal Investigator: Menaka Pai, MD, FRCPC McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital
Principal Investigator: James D Douketis, MD, FRCPC McMaster University
PRS Account McMaster University
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP