TOPPS: Toronto Thromboprophylaxis Patient Safety Initiative

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Completed
• CT.gov ID: NCT01869075
• Collaborator: North York General Hospital (Other), Michael Garron Hospital (Other), Trillium Health Centre (Other), Lakeridge Health Corporation (Other), York Central Hospital, Ontario (Other), Scarborough General Hospital (Other), Markham Stouffville Hospital (Other)
• Enrollment: 1,895
• Location: 1
• Arms: 6
• Duration (Months): 32
• Patients Per Site Per Month: 59.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism	Other: Knowledge Translation (KT) toolkit	N/A

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

• Study Type: Interventional
• Actual Enrollment: 1895 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Health Services Research
• Official Title: Toronto Thromboprophylaxis Patient Safety Initiative (TOPPS): A Cluster Randomized Trial
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Other: 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; Other Names: AMI - Knowledge Translation (KT) toolkit MGS - Knowledge Translation (KT) toolkit HFS - Knowledge Translation (KT) toolkit
No Intervention: AMI - Usual Care Usual care
Experimental: MGS - Knowledge Translation Toolkit Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff	Other: 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; Other Names: AMI - Knowledge Translation (KT) toolkit MGS - Knowledge Translation (KT) toolkit HFS - Knowledge Translation (KT) toolkit
No Intervention: MGS - Usual Care Usual Care
Experimental: HFS - Knowledge Translation Toolkit Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff	Other: 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; Other Names: AMI - Knowledge Translation (KT) toolkit MGS - Knowledge Translation (KT) toolkit HFS - Knowledge Translation (KT) toolkit
No Intervention: HFS - Usual Care Usual Care

Outcome Measures

Primary Outcome Measures

1. Percentage of Patients Prescribed Appropriate VTE Prophylaxis [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• age at least 18 years

• at risk for VTE

Exclusion Criteria:

• on therapeutic anticoagulation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

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

Investigators

• Principal Investigator: William H Geerts, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

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. Review.

• Responsible Party: Artemis Diamantouros, KT Pharmacist, Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT01869075
• Other Study ID Numbers: 019-2006
• First Posted: Jun 5, 2013
• Last Update Posted: Sep 23, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Artemis Diamantouros, KT Pharmacist, Sunnybrook Health Sciences Centre: Quality Improvement; Patient Safety; Knowledge Translation
• Additional relevant MeSH terms: Thromboembolism; Venous Thromboembolism

Study Results

Participant Flow

Recruitment Details	Recruitment of study sites not individual patients.
Pre-assignment Detail	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
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	418	0	416	0	341
COMPLETED	0	418	0	416	0	341
NOT COMPLETED	0	0	0	0	0	0
Period Title: Phase 0 (Baseline)
STARTED	45	75	45	75	30	90
COMPLETED	45	75	45	75	30	90
NOT COMPLETED	0	0	0	0	0	0
Period Title: Phase 0 (Baseline)
STARTED	90	30	75	45	75	45
COMPLETED	90	30	75	45	75	45
NOT COMPLETED	0	0	0	0	0	0

Baseline Characteristics

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
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 Participants	0	341	0	416	0	418	1175
Age, Customized (participants) [Number]
18 years and older	341 Infinity	416 122%	418 Infinity	1175 282.5%
Sex: Female, Male (Count of Participants)
Female	NA NaN	NA NaN	NA NaN	NA NaN
Male	NA NaN	NA NaN	NA NaN	NA NaN

Outcome Measures

1. Primary Outcome

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.

Outcome Measure Data

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
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
Measure Participants	135	105	120	120	105	135
Number [percentage of patients]	64	62	67	54	85	76

Adverse Events

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.
Arm/Group Title	AMI - Knowledge Translation Toolkit		AMI - Usual Care		MGS - Knowledge Translation Toolkit		MGS - Usual Care		HFS - Knowledge Translation Toolkit		HFS - Usual Care
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/105 (0%)		0/120 (0%)		0/120 (0%)		0/105 (0%)		0/135 (0%)
Other (Not Including 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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/135 (0%)		0/105 (0%)		0/120 (0%)		0/120 (0%)		0/105 (0%)		0/135 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.