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Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS)

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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

Tracking Information
First Submitted Date  ICMJE April 3, 2013
First Posted Date  ICMJE June 5, 2013
Results First Submitted Date  ICMJE August 11, 2014
Results First Posted Date  ICMJE September 23, 2014
Last Update Posted Date September 23, 2014
Study Start Date  ICMJE July 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Change in the rates of appropriate VTE prophylaxis [ Time Frame: Baseline, at 1year, at 2 years ]
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.
Change History Complete list of historical versions of study NCT01869075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2013)
Change in use of pre-printed orders with VTE prophylaxis [ Time Frame: 1 year and 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Toronto Thromboprophylaxis Patient Safety Initiative
Official Title  ICMJE Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: Knowledge Translation (KT) toolkit
  • No Intervention: HFS - Usual Care
    Usual Care
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 30, 2013)
1895
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • age at least 18 years
  • at risk for VTE

Exclusion Criteria:

  • on therapeutic anticoagulation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01869075
Other Study ID Numbers  ICMJE 019-2006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Artemis Diamantouros, Sunnybrook Health Sciences Centre
Study Sponsor  ICMJE Sunnybrook Health Sciences Centre
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: William H Geerts, MD Sunnybrook Health Sciences Centre
PRS Account Sunnybrook Health Sciences Centre
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP