NCT01401725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 16, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

July 19, 2011

Last Update Submit

October 14, 2015

Conditions

Venous Thromboembolism

Keywords

venous thromboembolismthromboprophylaxisanticoagulantshospitalized medical patientselectronic order setsdecision supportknowledge translationpatient safety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Hospital-acquired venous thromboembolism

    Participants will be followed for 30 days, from the date of hospital admission

  • Major bleeding

    Participants will be followed for 30 days, from the date of hospital admission

Study Arms (3)

Hamilton General Hospital

EXPERIMENTAL
Behavioral: Electronic Order Entry System + CDSS

Juravinski Hospital

ACTIVE COMPARATOR
Behavioral: Electronic Order Entry System Only

St. Joseph's Hospital

OTHER
Other: Usual Care

Interventions

Electronic Order Entry System + CDSSBEHAVIORAL

Physicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions.

Hamilton General Hospital
Electronic Order Entry System OnlyBEHAVIORAL

Physicians at this hospital will use an Electronic Order Entry System

Juravinski Hospital
Usual CareOTHER

Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)

St. Joseph's Hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Receiving therapeutic anticoagulation at time of hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (5)

  • 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.

    PMID: 18574271BACKGROUND

  • 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.

    PMID: 17310052BACKGROUND

  • 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.

    PMID: 15758007BACKGROUND

  • 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.

    PMID: 10838650BACKGROUND

  • 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.

    PMID: 15755945BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Menaka Pai, MD, FRCPC

    McMaster University, Hamilton Health Sciences, Corporation - Hamilton General Hospital

    PRINCIPAL INVESTIGATOR

  • James D Douketis, MD, FRCPC

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 19, 2011

First Posted

July 25, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 16, 2015

Record last verified: 2015-10

Locations

CA(3)