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Improving Venous Thromboembolism Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01304108
First received: July 9, 2010
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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%.


Condition Intervention Phase
Venous Thromboembolism
Delivery of Health Care
Quality Improvement
 Other: VTE-P Tollgate
Other: BLAZE Pop up
Other: Usual Care
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Spreading and Improving DVT Prophylaxis at Mayo Clinic (DVT-P-Spread)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • % of in patients with an appropriate VTE prophylaxis plan [ Time Frame: Baseline to 1 month ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Clinically significant complications of VTE-P anticoagulant therapy [ Time Frame: baseline to 1 month ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 3000
Study Start Date: January 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Order Set
Insertion of VTE-P Order Set "tollgate" in all active admission and transfer orders.
 Other: VTE-P Tollgate
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.
 Other: BLAZE Pop up
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
 Other: Usual Care
No addition to the baseline system for care

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.

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inpatients with age > 17 years old

Exclusion Criteria:

  • Outpatients
  • Inpatients with age less than or equal to 17 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304108

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Timothy Morgenthaler, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Timothy Morgenthaler, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01304108     History of Changes
Other Study ID Numbers: 09-006359
Study First Received: July 9, 2010
Last Updated: February 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Venous Thromboembolism
Delivery of Health Care
Quality Improvement
Evidence-Based Practice

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 16, 2013