search
Back to results

Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS)

Primary Purpose

Venous Thromboembolism

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Knowledge Translation (KT) toolkit
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Venous Thromboembolism focused on measuring Quality Improvement, Patient Safety, Knowledge Translation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age at least 18 years
  • at risk for VTE

Exclusion Criteria:

  • on therapeutic anticoagulation

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Experimental

No Intervention

Arm Label

AMI - Knowledge Translation toolkit

AMI - Usual Care

MGS - Knowledge Translation Toolkit

MGS - Usual Care

HFS - Knowledge Translation Toolkit

HFS - Usual Care

Arm Description

AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

Usual care

Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff

Usual Care

Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff

Usual Care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2013
Last Updated
September 16, 2014
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
North York General Hospital, Michael Garron Hospital, Trillium Health Centre, Lakeridge Health Corporation, York Central Hospital, Ontario, Scarborough General Hospital, Markham Stouffville Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01869075
Brief Title
Toronto Thromboprophylaxis Patient Safety Initiative
Acronym
TOPPS
Official Title
Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
North York General Hospital, Michael Garron Hospital, Trillium Health Centre, Lakeridge Health Corporation, York Central Hospital, Ontario, Scarborough General Hospital, Markham Stouffville Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism
Keywords
Quality Improvement, Patient Safety, Knowledge Translation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1895 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMI - Knowledge Translation toolkit
Arm Type
Experimental
Arm Description
AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Arm Title
AMI - Usual Care
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
MGS - Knowledge Translation Toolkit
Arm Type
Experimental
Arm Description
Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff
Arm Title
MGS - Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
HFS - Knowledge Translation Toolkit
Arm Type
Experimental
Arm Description
Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff
Arm Title
HFS - Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Other
Intervention Name(s)
Knowledge Translation (KT) toolkit
Other Intervention Name(s)
AMI - Knowledge Translation (KT) toolkit, MGS - Knowledge Translation (KT) toolkit, HFS - Knowledge Translation (KT) toolkit
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Patients Prescribed Appropriate VTE Prophylaxis
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age at least 18 years at risk for VTE Exclusion Criteria: on therapeutic anticoagulation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William H Geerts, MD
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
15383478
Citation
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.
Results Reference
background

Learn more about this trial

Toronto Thromboprophylaxis Patient Safety Initiative

We'll reach out to this number within 24 hrs