NCT01869075

Brief Summary

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE, is one of the common and preventable complications of hospital stay. VTE prophylaxis through the use of evidence-based anticoagulant medication options or mechanical prophylaxis have been shown to reduce this risk and improve patient safety. Despite an abundance of evidence, use of VTE prophylaxis remains low. This study assesses the effectiveness of quality improvement strategies (use of pre-printed orders, audit and feedback, involvement of the pharmacist as project need and as a reminder to the physician, and education of staff) on use of appropriate VTE prophylaxis. The study aims to measure if the use of these strategies improves the use of VTE prophylaxis and therefore, improves patient safety and patient care by reducing the risk of developing DVT or PE.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,895

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

July 1, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 23, 2014

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

2.7 years

First QC Date

April 3, 2013

Results QC Date

August 11, 2014

Last Update Submit

September 16, 2014

Conditions

Keywords

Quality ImprovementPatient SafetyKnowledge Translation

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Prescribed Appropriate VTE Prophylaxis

    Rates of appropriate VTE prophylaxis were determined as the number of patients who received VTE prophylaxis as a proportion of the number of patient at risk. Rates reported are for the active phases (phase 1 and phase 2) and compare intervention to control. Appropriate VTE prophylaxis was defined as: in "Hip Fracture Surgery" - evidence-based VTE prophylaxis ordered within 24 of admission, restarted within 24 hours after surgery and continued for at least 10 days post-discharge in "Major General Surgery" - evidence-based VTE prophylaxis ordered within 24 hours post-surgery and continued for the duration of hospital stay in "Acute Medical Illness" - evidence-based VTE prophylaxis ordered within 24 hours of admission and continued for the duration of hospital stay. Evidence-based VTE prophylaxis was determined to be according to the American College of Chest Physicians (ACCP) guidelines. The 9th version was the most current version at the time of the study.

    End of study (end of phase 2) - measured over duration of hospital stay.

Study Arms (6)

AMI - Knowledge Translation toolkit

EXPERIMENTAL

AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

Other: Knowledge Translation (KT) toolkit

AMI - Usual Care

NO INTERVENTION

Usual care

MGS - Knowledge Translation Toolkit

EXPERIMENTAL

Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff

Other: Knowledge Translation (KT) toolkit

MGS - Usual Care

NO INTERVENTION

Usual Care

HFS - Knowledge Translation Toolkit

EXPERIMENTAL

Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

Other: Knowledge Translation (KT) toolkit

HFS - Usual Care

NO INTERVENTION

Usual Care

Interventions

KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff

Also known as: AMI - Knowledge Translation (KT) toolkit, MGS - Knowledge Translation (KT) toolkit, HFS - Knowledge Translation (KT) toolkit
AMI - Knowledge Translation toolkitHFS - Knowledge Translation ToolkitMGS - Knowledge Translation Toolkit

Eligibility Criteria

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

You may qualify if:

  • age at least 18 years
  • at risk for VTE

You may not qualify if:

  • on therapeutic anticoagulation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

  • Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. doi: 10.1378/chest.126.3_suppl.338S.

    PMID: 15383478BACKGROUND

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Artemis Diamantouros
Organization
Sunnybrook HSC

Study Officials

  • William H Geerts, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
KT Pharmacist

Study Record Dates

First Submitted

April 3, 2013

First Posted

June 5, 2013

Study Start

July 1, 2006

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

September 23, 2014

Results First Posted

September 23, 2014

Record last verified: 2014-09

Locations