Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,895
- Locations
- 2
- Primary Endpoint
- Percentage of Patients Prescribed Appropriate VTE Prophylaxis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age at least 18 years
- •at risk for VTE
Exclusion Criteria
- •on therapeutic anticoagulation
Arms & Interventions
AMI - Usual Care
Usual care
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: Knowledge Translation (KT) toolkit (Other)
MGS - Knowledge Translation Toolkit
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Intervention: Knowledge Translation (KT) toolkit (Other)
MGS - Usual Care
Usual Care
HFS - Knowledge Translation Toolkit
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Intervention: Knowledge Translation (KT) toolkit (Other)
HFS - Usual Care
Usual Care
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Artemis Diamantouros
KT Pharmacist
Sunnybrook Health Sciences Centre