NCT00409136

Brief Summary

To evaluate physician response to human alerts that inform the clinician that his/her patient may be eligible for thromboprophylaxis. Medical records are reviewed to evaluate prescribing decision and to evaluate rates of venous thromboembolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2006

Typical duration for all trials

Geographic Reach
1 country

26 active sites

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

March 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 2, 2009

Status Verified

January 1, 2009

Enrollment Period

2.4 years

First QC Date

December 7, 2006

Last Update Submit

January 29, 2009

Conditions

Keywords

AlertDeep Vein ThrombosisPulmonary EmbolismVenous ThromboembolismProphylaxisAnticoagulation

Outcome Measures

Primary Outcomes (1)

  • Clinically diagnosed DVT and/or PE

    90 days

Secondary Outcomes (2)

  • Mortality

    30 and 90 days

  • Hemorrhagic events

    30 and 90 days

Study Arms (2)

Alert

Physicians alerted about their high risk patients who are not receiving any VTE prophylaxis.

Behavioral: Human Alert

No Alert

Physicians not alerted about their high risk patients who are not receiving any VTE prophylaxis.

Behavioral: Human Alert

Interventions

Human AlertBEHAVIORAL

An alert from study staff informing a physician that his/her patient is at high risk for DVT and/or PE, but is not receiving any prophylaxis.

AlertNo Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients that have a cumulative VTE risk score of 4 or more with no orders for prophylactic measures.

You may qualify if:

  • Patients \> 18 years of age
  • Cumulative VTE risk score \> 4
  • Absence of pharmacologic or mechanical prophylaxis orders
  • Patients from medical or surgical Services

You may not qualify if:

  • VTE risk score \<4
  • Current active pharmacologic or mechanical prophylaxis order
  • Patients from the Department of Neurology, Newborn Service, Rehab Units, and Neonatal Intensive Care Unit (NICU).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

AZ Pulmonary Specialists, Ltd

Scottsdale, Arizona, 85258, United States

Location

Long Beach VA Hospital

Long Beach, California, 90822, United States

Location

University of California - Irvine

Orange, California, 92868, United States

Location

University of California - Davis

Sacramento, California, 95817, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Norwalk Hospital

Norwalk, Connecticut, 06850, United States

Location

William W. Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Emory-Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

Franklin Square Hospital

Baltimore, Maryland, 21237, United States

Location

Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

North Shore Medical Center

Salem, Massachusetts, 01970, United States

Location

Henry Ford Hospital K15

Detroit, Michigan, 48202, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

North Shore University Hospital

Great Neck, New York, 11030, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Washington Hospital

Washington, Pennsylvania, 15301, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Presbyterian Hospital of Dallas

Dallas, Texas, 75231, United States

Location

LDS Hospital

Salt Lake City, Utah, 84103, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

United Hospital System

Kenosha, Wisconsin, 53143, United States

Location

Related Publications (5)

  • Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. doi: 10.1161/01.CIR.0000150393.51958.54. No abstract available.

    PMID: 15630031BACKGROUND
  • Goldhaber SZ, Dunn K, MacDougall RC. New onset of venous thromboembolism among hospitalized patients at Brigham and Women's Hospital is caused more often by prophylaxis failure than by withholding treatment. Chest. 2000 Dec;118(6):1680-4. doi: 10.1378/chest.118.6.1680.

    PMID: 11115458BACKGROUND
  • Goldhaber SZ, Tapson VF; DVT FREE Steering Committee. A prospective registry of 5,451 patients with ultrasound-confirmed deep vein thrombosis. Am J Cardiol. 2004 Jan 15;93(2):259-62. doi: 10.1016/j.amjcard.2003.09.057.

    PMID: 14715365BACKGROUND
  • Kucher N, Koo S, Quiroz R, Cooper JM, Paterno MD, Soukonnikov B, Goldhaber SZ. Electronic alerts to prevent venous thromboembolism among hospitalized patients. N Engl J Med. 2005 Mar 10;352(10):969-77. doi: 10.1056/NEJMoa041533.

    PMID: 15758007BACKGROUND
  • Piazza G, Rosenbaum EJ, Pendergast W, Jacobson JO, Pendleton RC, McLaren GD, Elliott CG, Stevens SM, Patton WF, Dabbagh O, Paterno MD, Catapane E, Li Z, Goldhaber SZ. Physician alerts to prevent symptomatic venous thromboembolism in hospitalized patients. Circulation. 2009 Apr 28;119(16):2196-201. doi: 10.1161/CIRCULATIONAHA.108.841197. Epub 2009 Apr 13.

Related Links

MeSH Terms

Conditions

Pulmonary EmbolismVenous ThrombosisNeoplasmsVenous Thromboembolism

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisThromboembolism

Study Officials

  • Samuel Z. Goldhaber, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2006

First Posted

December 8, 2006

Study Start

March 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 2, 2009

Record last verified: 2009-01

Locations