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Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01869075
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : September 23, 2014
Last Update Posted : September 23, 2014
Sponsor:
Collaborators:
North York General Hospital
Toronto East General Hospital
Trillium Health Centre
Lakeridge Health Corporation
York Central Hospital, Ontario
Scarborough General Hospital
Markham Stoufville Hospital
Information provided by (Responsible Party):
Artemis Diamantouros, Sunnybrook Health Sciences Centre

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition Venous Thromboembolism
Intervention Other: Knowledge Translation (KT) toolkit
Enrollment 1895
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.
Arm/Group Title AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Hide Arm/Group Description

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

Usual care provided at the hospital

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

Usual care provided at the hospital

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

Usual care provided at the hospital
Period Title: Phase 0 (Baseline)
Started 0 [1] 418 0 [1] 416 0 [1] 341
Completed 0 418 0 416 0 341
Not Completed 0 0 0 0 0 0
[1]
Phase 0 was the baseline phase. No intervention had been started.
Period Title: Phase 1
Started 45 [1] 75 [1] 45 [1] 75 [1] 30 [1] 90 [1]
Completed 45 75 45 75 30 90
Not Completed 0 0 0 0 0 0
[1]
Each phase of the study collected data on a unique set of patients.
Period Title: Phase 2
Started 90 [1] 30 [1] 75 [1] 45 [1] 75 [1] 45 [1]
Completed 90 30 75 45 75 45
Not Completed 0 0 0 0 0 0
[1]
Participants included in phase 2 of the study were not enrolled in phase 1. Each is a unique phase.
Arm/Group Title AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care Total
Hide Arm/Group Description

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

Usual care as provided at the hospital.

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

Usual Care as provided at the hospital.

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

Usual Care as provided at the hospital. Total of all reporting groups
Overall Number of Baseline Participants 0 341 0 416 0 418 1175
Hide Baseline Analysis Population Description
Baseline data collection was conducted to establish baseline rates of appropriate prophylaxis. Baseline patients were not included in the active phases of the study.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
18 years and older Number Analyzed 0 participants 341 participants 0 participants 416 participants 0 participants 418 participants 1175 participants
341 416 418 1175
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 341 participants 0 participants 416 participants 0 participants 418 participants 1175 participants
Female NA [1]  NA [1]  NA [1]  NA [2] 
Male NA [1]  NA [1]  NA [1]  NA [2] 
[1]
Gender of participants was not collected
[2]
Total not calculated because data are not available (NA) in one or more arms.
1.Primary Outcome
Title Percentage of Patients Prescribed Appropriate VTE Prophylaxis
Hide 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.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Hide Arm/Group Description:

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

Usual care as provided at the hospital

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

Usual Care as provided at the hospital

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

Usual Care as provided at the hospital
Overall Number of Participants Analyzed 135 105 120 120 105 135
Measure Type: Number
Unit of Measure: percentage of patients
64 62 67 54 85 76
Time Frame At one point in time at phase 1 and phase 2. Phase 1 and 2 were approx 1 year apart. Adverse events were only captured if they occured in the participants in the audit sample during their hospital admission.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Hide Arm/Group Description

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

Usual care as provided at the hospital

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

Usual Care as provided at the hospital

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

Usual Care as provided at the hospital
All-Cause Mortality
AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/105 (0.00%)   0/120 (0.00%)   0/120 (0.00%)   0/105 (0.00%)   0/135 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
AMI - Knowledge Translation Toolkit AMI - Usual Care MGS - Knowledge Translation Toolkit MGS - Usual Care HFS - Knowledge Translation Toolkit HFS - Usual Care
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/135 (0.00%)   0/105 (0.00%)   0/120 (0.00%)   0/120 (0.00%)   0/105 (0.00%)   0/135 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Artemis Diamantouros
Organization: Sunnybrook HSC
Phone: 416-480-6100 ext 3654
Responsible Party: Artemis Diamantouros, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01869075     History of Changes
Other Study ID Numbers: 019-2006
First Submitted: April 3, 2013
First Posted: June 5, 2013
Results First Submitted: August 11, 2014
Results First Posted: September 23, 2014
Last Update Posted: September 23, 2014