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Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869075
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : September 23, 2014
Last Update Posted : September 23, 2014
Sponsor:
Collaborators:
North York General Hospital
Toronto East General Hospital
Trillium Health Centre
Lakeridge Health Corporation
York Central Hospital, Ontario
Scarborough General Hospital
Markham Stoufville Hospital
Information provided by (Responsible Party):
Artemis Diamantouros, Sunnybrook Health Sciences Centre

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.


Condition or disease Intervention/treatment Phase
Venous Thromboembolism Other: Knowledge Translation (KT) toolkit Not Applicable

Detailed Description:

The study includes 8 Toronto area hospitals consisting of 7 community hospital and one academic health sciences centre.

Three patient groups at each site are included in the study: patients admitted for: Acute Medical Illness (AMI), Major General Surgery (MGS) and Hip Fracture Surgery (HFS). Patients had to be at least 18 years old and be considered at risk for VTE according to the American College of Chest Physicians (CHEST) guidelines.

The study design is a cluster randomized trial where each patient group at each site is a cluster.

A baseline chart audit of approximately 50 patients in each group at each site was conducted to determine an intraclass coefficient and proportion of adherence.

The main outcome measure was the rate of prescribing appropriate prophylaxis in patients at risk. This was calculated as the number of at risk patients receiving appropriate prophylaxis / the number of at risk patients for whom prophylaxis is indicated.

Based on the baseline results, it was estimated that a sample size of 432 would be needed for the intervention phases. A sample of 720 patients (15 in each cluster at each site) was included.

The study is broken down into three phases: baseline, phase 1 and phase 2. At baseline, all groups received usual care. At phase 1, one cluster at each site was randomized to intervention while the other two served as control. In phase 2, 2 groups received intervention while one continued to serve as control. Each of the phases, phase 1 and 2 had 360 unique patients. Patients in baseline were not included in phase 1 or 2 and patients in phase 1 were not included in phase 2.

The main outcome measure was prescribing of appropriate VTE prophylaxis. A chart audit was used to collect data at baseline, end of phase 1 and end of phase 2.

Each phase is approximately 1 year in length. Analysis involves descriptive statistics using counts and proportions to capture rates of appropriate VTE prophylaxis and rates of non-adherence. A logistic regression model will be used to compare rates of appropriate VTE prophylaxis over time within groups adjusted for clustering.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1895 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
Study Start Date : July 2006
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Patient Safety

Arm Intervention/treatment
Experimental: AMI - Knowledge Translation toolkit
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
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
Other Names:
  • AMI - Knowledge Translation (KT) toolkit
  • MGS - Knowledge Translation (KT) toolkit
  • HFS - Knowledge Translation (KT) toolkit

No Intervention: AMI - Usual Care
Usual care
Experimental: MGS - Knowledge Translation Toolkit
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Other: Knowledge Translation (KT) toolkit
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
Other Names:
  • AMI - Knowledge Translation (KT) toolkit
  • MGS - Knowledge Translation (KT) toolkit
  • HFS - Knowledge Translation (KT) toolkit

No Intervention: MGS - Usual Care
Usual Care
Experimental: HFS - Knowledge Translation Toolkit
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Other: Knowledge Translation (KT) toolkit
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
Other Names:
  • AMI - Knowledge Translation (KT) toolkit
  • MGS - Knowledge Translation (KT) toolkit
  • HFS - Knowledge Translation (KT) toolkit

No Intervention: HFS - Usual Care
Usual Care



Primary Outcome Measures :
  1. Percentage of Patients Prescribed Appropriate VTE Prophylaxis [ Time Frame: End of study (end of phase 2) - measured over duration of hospital stay. ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age at least 18 years
  • at risk for VTE

Exclusion Criteria:

  • on therapeutic anticoagulation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869075


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
North York General Hospital
Toronto East General Hospital
Trillium Health Centre
Lakeridge Health Corporation
York Central Hospital, Ontario
Scarborough General Hospital
Markham Stoufville Hospital
Investigators
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Principal Investigator: William H Geerts, MD Sunnybrook Health Sciences Centre

Publications:
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Responsible Party: Artemis Diamantouros, KT Pharmacist, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01869075     History of Changes
Other Study ID Numbers: 019-2006
First Posted: June 5, 2013    Key Record Dates
Results First Posted: September 23, 2014
Last Update Posted: September 23, 2014
Last Verified: September 2014

Keywords provided by Artemis Diamantouros, Sunnybrook Health Sciences Centre:
Quality Improvement
Patient Safety
Knowledge Translation

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