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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Hamilton Health Sciences Corporation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT01401725
First received: July 19, 2011
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Venous Thromboembolism
Behavioral: Electronic Order Entry System + CDSS
Behavioral: Electronic Order Entry System Only
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    '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.


Secondary Outcome Measures:
  • Hospital-acquired venous thromboembolism [ Time Frame: Participants will be followed for 30 days, from the date of hospital admission ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.


Estimated Enrollment: 2820
Study Start Date: April 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401725

Locations
Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Menaka Pai, MD, FRCPC McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital
Principal Investigator: James D Douketis, MD, FRCPC McMaster University
  More Information

Publications:
Responsible Party: Dr. Menaka Pai, Hamilton Health Sciences Corporation - Hamilton General Hospital
ClinicalTrials.gov Identifier: NCT01401725     History of Changes
Other Study ID Numbers: HHS150411
Study First Received: July 19, 2011
Last Updated: July 22, 2011
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee

Keywords provided by McMaster University:
venous thromboembolism
thromboprophylaxis
anticoagulants
hospitalized medical patients
electronic order sets
decision support
knowledge translation
patient safety

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on July 31, 2014