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Toronto Thromboprophylaxis Patient Safety Initiative

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01869075
Acronym
TOPPS
Enrollment
1895
Registered
2013-06-05
Start date
2006-07-31
Completion date
2009-03-31
Last updated
2014-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Quality Improvement, Patient Safety, Knowledge Translation

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.

Interventions

OTHERKnowledge 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

Sponsors

North York General Hospital
CollaboratorOTHER
Michael Garron Hospital
CollaboratorOTHER
Trillium Health Centre
CollaboratorOTHER
Lakeridge Health Corporation
CollaboratorOTHER
York Central Hospital, Ontario
CollaboratorOTHER
Scarborough General Hospital
CollaboratorOTHER
Markham Stouffville Hospital
CollaboratorOTHER
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* age at least 18 years * at risk for VTE

Exclusion criteria

* on therapeutic anticoagulation

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Patients Prescribed Appropriate VTE ProphylaxisEnd 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.

Countries

Canada

Participant flow

Recruitment details

Recruitment of study sites not individual patients.

Pre-assignment details

After site enrolment, baseline data was collected for all sites in order to establish sample size for phases 1 and 2.

Participants by arm

ArmCount
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 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
0
AMI - Usual Care
Usual care as provided at the hospital.
341
MGS - Knowledge Translation Toolkit
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff 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
0
MGS - Usual Care
Usual Care as provided at the hospital.
416
HFS - Knowledge Translation Toolkit
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff 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
0
HFS - Usual Care
Usual Care as provided at the hospital.
418
Total1,175

Baseline characteristics

CharacteristicAMI - Usual CareMGS - Usual CareHFS - Usual CareTotal
Age, Customized
18 years and older
341 participants416 participants418 participants1175 participants
Sex: Female, Male
Female
NA ParticipantsNA ParticipantsNA ParticipantsNA Participants
Sex: Female, Male
Male
NA ParticipantsNA ParticipantsNA ParticipantsNA Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 1350 / 1050 / 1200 / 1200 / 1050 / 135
serious
Total, serious adverse events
0 / 1350 / 1050 / 1200 / 1200 / 1050 / 135

Outcome results

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.

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

Population: The number of participants in the analysis was 720. In phase 1, there were 360 patients included and in phase 2, an additional 360 patients were included. The outcomes by end of study (end of phase 2) are reported. The patients in control (usual care) and intervention (Knowledge Translation toolkit) were compared.

ArmMeasureValue (NUMBER)
AMI - Knowledge Translation ToolkitPercentage of Patients Prescribed Appropriate VTE Prophylaxis64 percentage of patients
AMI - Usual CarePercentage of Patients Prescribed Appropriate VTE Prophylaxis62 percentage of patients
MGS - Knowledge Translation ToolkitPercentage of Patients Prescribed Appropriate VTE Prophylaxis67 percentage of patients
MGS - Usual CarePercentage of Patients Prescribed Appropriate VTE Prophylaxis54 percentage of patients
HFS - Knowledge Translation ToolkitPercentage of Patients Prescribed Appropriate VTE Prophylaxis85 percentage of patients
HFS - Usual CarePercentage of Patients Prescribed Appropriate VTE Prophylaxis76 percentage of patients

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026