Multi-Center Human Alert Trial to Prevent DVT and PE - Full Text View

Purpose

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.

Condition	Intervention
Pulmonary Embolism Deep Vein Thrombosis Cancer Surgery	Behavioral: Human Alert

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients

Resource links provided by NLM:

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Clinically diagnosed DVT and/or PE [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
Hemorrhagic events [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]

Enrollment:	2496
Study Start Date:	March 2006
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Alert Physicians alerted about their high risk patients who are not receiving any VTE prophylaxis.	Behavioral: Human Alert 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.
No Alert Physicians not alerted about their high risk patients who are not receiving any VTE prophylaxis.	Behavioral: Human Alert 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.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409136

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Locations

United States, Arizona
AZ Pulmonary Specialists, Ltd
Scottsdale, Arizona, United States, 85258
United States, California
Long Beach VA Hospital
Long Beach, California, United States, 90822
University of California - Irvine
Orange, California, United States, 92868
University of California - Davis
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06850
William W. Backus Hospital
Norwich, Connecticut, United States, 06360
United States, District of Columbia
Washington Hospital Center
Washington DC, District of Columbia, United States, 20010
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Emory-Crawford Long Hospital
Atlanta, Georgia, United States, 30308
United States, Maryland
Franklin Square Hospital
Baltimore, Maryland, United States, 21237
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
North Shore Medical Center
Salem, Massachusetts, United States, 01970
United States, Michigan
Henry Ford Hospital K15
Detroit, Michigan, United States, 48202
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65212
United States, New York
North Shore University Hospital
Great Neck, New York, United States, 11030
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, South Carolina
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84103
United States, Wisconsin
United Hospital System
Kenosha, Wisconsin, United States, 53143

Sponsors and Collaborators

Brigham and Women's Hospital

Sanofi

Investigators

Principal Investigator:

Samuel Z. Goldhaber, MD

Brigham and Women's Hospital

More Information

Additional Information:

North American Thrombosis Forum This link exits the ClinicalTrials.gov site

Publications:

Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. Review. No abstract available.

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.

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.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Apr 13.

Responsible Party:	Samuel Z. Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00409136 History of Changes
Other Study ID Numbers:	2005-P-002527
Study First Received:	December 7, 2006
Last Updated:	January 29, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Alert
Deep Vein Thrombosis
Pulmonary Embolism

Venous Thromboembolism
Prophylaxis
Anticoagulation

Additional relevant MeSH terms:

Embolism
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Embolism and Thrombosis

Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013