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

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Electronic Order Entry System + CDSS
Electronic Order Entry System Only
Usual Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring venous thromboembolism, thromboprophylaxis, anticoagulants, hospitalized medical patients, electronic order sets, decision support, knowledge translation, patient safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital
  • St. Joseph's Healthcare Hamilton
  • Juravinski Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Hamilton General Hospital

Juravinski Hospital

St. Joseph's Hospital

Arm Description

Outcomes

Primary Outcome Measures

Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis
'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
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
Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.

Full Information

First Posted
July 19, 2011
Last Updated
October 14, 2015
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01401725
Brief Title
Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients
Acronym
E-SENTRY
Official Title
Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
venous thromboembolism, thromboprophylaxis, anticoagulants, hospitalized medical patients, electronic order sets, decision support, knowledge translation, patient safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hamilton General Hospital
Arm Type
Experimental
Arm Title
Juravinski Hospital
Arm Type
Active Comparator
Arm Title
St. Joseph's Hospital
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Electronic Order Entry System + CDSS
Intervention Description
Physicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Order Entry System Only
Intervention Description
Physicians at this hospital will use an Electronic Order Entry System
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)
Primary Outcome Measure Information:
Title
Proportion of hospitalized medical patients who are appropriately managed for VTE prophylaxis
Description
'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.
Time Frame
Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Hospital-acquired venous thromboembolism
Description
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.
Time Frame
Participants will be followed for 30 days, from the date of hospital admission
Title
Major bleeding
Description
Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.
Time Frame
Participants will be followed for 30 days, from the date of hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Menaka Pai, MD, FRCPC
Organizational Affiliation
McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James D Douketis, MD, FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
18574271
Citation
Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW. Prevention of venous thromboembolism: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008 Jun;133(6 Suppl):381S-453S. doi: 10.1378/chest.08-0656.
Results Reference
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PubMed Identifier
17310052
Citation
Dentali F, Douketis JD, Gianni M, Lim W, Crowther MA. Meta-analysis: anticoagulant prophylaxis to prevent symptomatic venous thromboembolism in hospitalized medical patients. Ann Intern Med. 2007 Feb 20;146(4):278-88. doi: 10.7326/0003-4819-146-4-200702200-00007.
Results Reference
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PubMed Identifier
15758007
Citation
Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.
Results Reference
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PubMed Identifier
10838650
Citation
Durieux P, Nizard R, Ravaud P, Mounier N, Lepage E. A clinical decision support system for prevention of venous thromboembolism: effect on physician behavior. JAMA. 2000 Jun 7;283(21):2816-21. doi: 10.1001/jama.283.21.2816.
Results Reference
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PubMed Identifier
15755945
Citation
Garg AX, Adhikari NK, McDonald H, Rosas-Arellano MP, Devereaux PJ, Beyene J, Sam J, Haynes RB. Effects of computerized clinical decision support systems on practitioner performance and patient outcomes: a systematic review. JAMA. 2005 Mar 9;293(10):1223-38. doi: 10.1001/jama.293.10.1223.
Results Reference
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Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients

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