search
Back to results

Improving Venous Thromboembolism Prophylaxis

Primary Purpose

Venous Thromboembolism, Delivery of Health Care, Quality Improvement

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VTE-P Tollgate
BLAZE Pop up
Usual Care
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Venous Thromboembolism focused on measuring Venous Thromboembolism, Delivery of Health Care, Quality Improvement, Evidence-Based Practice

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inpatients with age > 17 years old

Exclusion Criteria:

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

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Order Set

Clinical Decision Support Pop-up

Usual Care

Arm Description

Insertion of VTE-P Order Set "tollgate" in all active admission and transfer orders.

Deploy rules-based pop-up that reminds ordering clinicians when patients do not have an active VTE-P plan.

Usual care, without the experimental additions

Outcomes

Primary Outcome Measures

% 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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 9, 2010
Last Updated
February 24, 2011
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT01304108
Brief Title
Improving Venous Thromboembolism Prophylaxis
Official Title
Spreading and Improving DVT Prophylaxis at Mayo Clinic (DVT-P-Spread)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Delivery of Health Care, Quality Improvement
Keywords
Venous Thromboembolism, Delivery of Health Care, Quality Improvement, Evidence-Based Practice

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order Set
Arm Type
Experimental
Arm Description
Insertion of VTE-P Order Set "tollgate" in all active admission and transfer orders.
Arm Title
Clinical Decision Support Pop-up
Arm Type
Experimental
Arm Description
Deploy rules-based pop-up that reminds ordering clinicians when patients do not have an active VTE-P plan.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Usual care, without the experimental additions
Intervention Type
Other
Intervention Name(s)
VTE-P Tollgate
Intervention Description
Add VTE-P tollgate order set that requires a decision regarding VTE-P for every patient admitted or transferred in our hospital system
Intervention Type
Other
Intervention Name(s)
BLAZE Pop up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
No addition to the baseline system for care
Primary Outcome Measure Information:
Title
% of in patients with an appropriate VTE prophylaxis plan
Description
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.
Time Frame
Baseline to 1 month
Secondary Outcome Measure Information:
Title
Clinically significant complications of VTE-P anticoagulant therapy
Description
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.
Time Frame
baseline to 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inpatients with age > 17 years old Exclusion Criteria: Outpatients Inpatients with age less than or equal to 17 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Morgenthaler, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Improving Venous Thromboembolism Prophylaxis

We'll reach out to this number within 24 hrs