Venous ThromboembolismTOPPSNCT01869075
Toronto Thromboprophylaxis Patient Safety Initiative
A study testing Knowledge Translation (KT) toolkit in people with Venous Thromboembolism, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Knowledge Translation (KT) toolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,895 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2006to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age at least 18 years
- at risk for VTE
Who cannot join
- on therapeutic anticoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
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.
Read the 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.
- Conditions
- Venous Thromboembolism
- Being tested
- Knowledge Translation (KT) toolkit
- Keywords
- Quality Improvement, Patient Safety, Knowledge Translation
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge Translation (KT) toolkitOther
Also called AMI - Knowledge Translation (KT) toolkit, MGS - Knowledge Translation (KT) toolkit, HFS - 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
| Study group | Role | What they receive |
|---|---|---|
| AMI - Knowledge Translation toolkit | Experimental | AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Receives: Other: Knowledge Translation (KT) toolkit |
| AMI - Usual Care | No intervention | Usual care |
| MGS - Knowledge Translation Toolkit | Experimental | Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff Receives: Other: Knowledge Translation (KT) toolkit |
| MGS - Usual Care | No intervention | Usual Care |
| HFS - Knowledge Translation Toolkit | Experimental | Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff Receives: Other: Knowledge Translation (KT) toolkit |
| HFS - Usual Care | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of study (end of phase 2) - measured over duration of hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startJul 2006
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,895 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- North York General Hospital, Michael Garron Hospital, Trillium Health Centre, Lakeridge Health Corporation, York Central Hospital, Ontario, Scarborough General Hospital, Markham Stouffville Hospital
- Responsible party
- Principal investigator, Artemis Diamantouros, Sunnybrook Health Sciences Centre
- Investigators
- William H Geerts, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869075
- Sponsor's protocol ID
- 019-2006
- Acronym
- TOPPS
- Status last verified
- Sep 2014
- First submitted
- 3 Apr 2013
- Last updated
- 23 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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. doi: 10.1378/chest.126.3_suppl.338S.
PubMed 15383478
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01869075
- Acronym / sponsor ID
- TOPPS / 019-2006
- Conditions
- Venous Thromboembolism
- Keywords
- Quality Improvement, Patient Safety, Knowledge Translation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,895 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- North York General Hospital, Michael Garron Hospital, Trillium Health Centre, Lakeridge Health Corporation, York Central Hospital, Ontario, Scarborough General Hospital, Markham Stouffville Hospital
- Study start
- Jul 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 23 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AMI - Knowledge Translation toolkit | Experimental | Other: Knowledge Translation (KT) toolkitAMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff |
| AMI - Usual Care | No intervention | –Usual care |
| MGS - Knowledge Translation Toolkit | Experimental | Other: Knowledge Translation (KT) toolkitKnowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff |
| MGS - Usual Care | No intervention | –Usual Care |
| HFS - Knowledge Translation Toolkit | Experimental | Other: Knowledge Translation (KT) toolkitKnowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff |
| HFS - Usual Care | No intervention | –Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age at least 18 years
- at risk for VTE
Key exclusion criteria (1 listed)
- on therapeutic anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge Translation (KT) toolkitAlso: AMI - Knowledge Translation (KT) toolkit, MGS - Knowledge Translation (KT) toolkit, HFS - Knowledge Translation (KT) toolkitKT 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 | AMI - Knowledge Translation toolkit, HFS - Knowledge Translation Toolkit, MGS - Knowledge Translation Toolkit |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15383478Geerts 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. doi: 10.1378/chest.126.3_suppl.338S.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William H Geerts, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge Translation (KT) toolkit in people with Venous Thromboembolism, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Prescribed Appropriate VTE Prophylaxis (time frame: End of study (end of phase 2) - measured over duration of hospital stay.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01869075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2014.