Improving Venous Thromboembolism Prophylaxis

Venous Thromboembolism Clinical Trial

Official title:

Spreading and Improving DVT Prophylaxis at Mayo Clinic (DVT-P-Spread)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304108
• Other study ID #: 09-006359
• Status: Completed
• Phase: Phase 4
• First received: July 9, 2010
• Last updated: February 24, 2011
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: February 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Inpatients with age > 17 years old

Exclusion Criteria:

• Outpatients

• Inpatients with age less than or equal to 17 years old

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Delivery of Health Care
• Quality Improvement
• Thromboembolism
• Venous Thromboembolism

Intervention

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
• 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.
• Usual Care
No addition to the baseline system for care

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of in patients with an appropriate VTE prophylaxis plan	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	Yes
Secondary	Clinically significant complications of VTE-P anticoagulant therapy	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	Yes