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

Venous Thromboembolism Clinical Trial

— E-SENTRY  

Official title:

Electronic Strategies to Enhance Venous Thromboprophylaxis in Hospitalized Medical Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401725
• Other study ID #: HHS150411
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: October 14, 2015
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2015
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health ResearchCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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.
• 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)

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View 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. — View 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. Review. — View Citation

Geerts WH, Bergqvist D, Pineo GF, Heit JA, Samama CM, Lassen MR, Colwell CW; American College of Chest Physicians. 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Participants will be followed for the duration of their hospital stay on a medical ward, an expected average of 5 days	Yes
Secondary	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.	Participants will be followed for 30 days, from the date of hospital admission	Yes
Secondary	Major bleeding	Major bleeding is defined using the International Society of Haemostasis and Thrombosis criteria.	Participants will be followed for 30 days, from the date of hospital admission	Yes