- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304108
Improving Venous Thromboembolism Prophylaxis
February 24, 2011 updated by: Mayo Clinic
Spreading and Improving DVT Prophylaxis at Mayo Clinic (DVT-P-Spread)
Preventing the formation of blood clots in the veins so they do not injure leg veins or travel to the lungs, also called venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including The investigators own.
Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery.
Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P.
This project seeks to utilize the lessons learned from these two pilots along with known best practices for "spreading" to deploy methods that enhance VTE-P to the entire hospitalized population.
The investigators seek appropriate VTE-P rates exceeding 95%.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Venous thromboembolism prophylaxis (VTE-P) is an essential component of safe in-patient care, yet it is deployed sub-optimally in many hospitals, including our own.
Two prior VTE-P improvement projects were completed at Mayo Clinic hospitals, one in the Department of Medicine, and the other in selected divisions of the Department of Surgery.
Both projects resulted in marked improvement in the percentage of patients receiving appropriate VTE-P.
This project seeks to utilize the lessons learned from these two pilots along with known best practices for "spreading" to deploy methods that enhance VTE-P to the entire hospitalized population.
The investigators seek appropriate VTE-P rates exceeding 95%.
This began as a quality improvement project.
The investigators have taken baseline measures of VTE-P rates in our hospitals, intervened with various electronic prompts to use appropriate VTE-P, and have and will re-measure VTE-P rates.
The investigators intend to present and publish our methods and results so that lessons learned may be shared and applied elsewhere.
Study Type
Interventional
Enrollment (Actual)
3000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Inpatients with age > 17 years old
Exclusion Criteria:
- Outpatients
- Inpatients with age less than or equal to 17 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Order Set
Insertion of VTE-P Order Set "tollgate" in all active admission and transfer orders.
|
Add VTE-P tollgate order set that requires a decision regarding VTE-P for every patient admitted or transferred in our hospital system
|
|
Experimental: Clinical Decision Support Pop-up
Deploy rules-based pop-up that reminds ordering clinicians when patients do not have an active VTE-P plan.
|
Develop and deploy a rules-based popup that reminds prescribers interfacing with the orders system when a patient does not have an active VTE-P plan.
|
|
Active Comparator: Usual Care
Usual care, without the experimental additions
|
No addition to the baseline system for care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
% of in patients with an appropriate VTE prophylaxis plan
Time Frame: Baseline to 1 month
|
The investigators will measure the number of patients in a statistically valid random sample of hospitalized patients who have a VTE-prophylaxis plan consistent with current recommendations.
|
Baseline to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinically significant complications of VTE-P anticoagulant therapy
Time Frame: baseline to 1 month
|
The investigators will determine the rate of bleeding complications in inpatients using a statistically valid random sample of hospitalized patients.
The investigators will also determine the rate of procedure delays due to VTE-P related anticoagulation.
|
baseline to 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Timothy Morgenthaler, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
July 9, 2010
First Submitted That Met QC Criteria
February 24, 2011
First Posted (Estimate)
February 25, 2011
Study Record Updates
Last Update Posted (Estimate)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 24, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-006359
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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