NCT01304108

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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2010

Completed
8 months until next milestone

First Posted

Study publicly available on registry

February 25, 2011

Completed
Last Updated

February 25, 2011

Status Verified

February 1, 2011

Enrollment Period

1.3 years

First QC Date

July 9, 2010

Last Update Submit

February 24, 2011

Conditions

Keywords

Venous ThromboembolismDelivery of Health CareQuality ImprovementEvidence-Based Practice

Outcome Measures

Primary Outcomes (1)

  • % 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

Secondary Outcomes (1)

  • Clinically significant complications of VTE-P anticoagulant therapy

    baseline to 1 month

Study Arms (3)

Order Set

EXPERIMENTAL

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

Other: VTE-P Tollgate

Clinical Decision Support Pop-up

EXPERIMENTAL

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

Other: BLAZE Pop up

Usual Care

ACTIVE COMPARATOR

Usual care, without the experimental additions

Other: Usual Care

Interventions

Add VTE-P tollgate order set that requires a decision regarding VTE-P for every patient admitted or transferred in our hospital system

Order Set

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.

Clinical Decision Support Pop-up

No addition to the baseline system for care

Usual Care

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients with age \> 17 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Timothy Morgenthaler, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 9, 2010

First Posted

February 25, 2011

Study Start

January 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 25, 2011

Record last verified: 2011-02

Locations