Toronto Thromboprophylaxis Patient Safety Initiative

Venous Thromboembolism Clinical Trial

— TOPPS  

Official title:

Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869075
• Other study ID #: 019-2006
• Status: Completed
• Phase: N/A
• First received: April 3, 2013
• Last updated: September 16, 2014
• Start date: July 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2014
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1895
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age at least 18 years

• at risk for VTE

Exclusion Criteria:

• on therapeutic anticoagulation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Lakeridge Health Corporation, Markham Stoufville Hospital, North York General Hospital, Scarborough General Hospital, Toronto East General Hospital, Trillium Health Centre, York Central Hospital, Ontario

Country where clinical trial is conducted

Canada, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No