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.

Show Detailed Description

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

Show 26 Study Locations

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 23, 2013