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

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
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

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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