Discharge ALERT: Quality Improvement Initiative

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00853463
First received: February 26, 2009
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

Brigham and Women's Hospital will coordinate a Quality Improvement Initiative at other hospitals that focuses on whether physician notification prior to discharge of high risk VTE patients will reduce the incidence of VTE after hospital discharge.


Condition Intervention
Pulmonary Embolism
Deep Vein Thrombosis
Prophylaxis
Venous Thromboembolism
Prevention
Behavioral: Alert

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Multi-centered Discharge Alert to Prevent DVT and PE at Hospital Discharge

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Clinically diagnosed DVT and/or PE [ Time Frame: 90 days after discharge ] [ 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: 2515
Study Start Date: April 2009
Study Completion Date: May 2011
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Alert
The responsible physician of a patient randomized to the control arm will not be contacted regarding the increased VTE risk of the patient.
Alert
The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders
Behavioral: Alert
The responsible physician will be notified that: 1) his or her patient is at high risk for VTE and 2) VTE prophylaxis should be considered in the Discharge orders
Other Name: "Alert"

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years of age
  • Planned discharge within 48 hours
  • Cumulative VTE risk score at least 4
  • Patients from Medical Services

Exclusion Criteria:

  • VTE risk score <4
  • Patients <18 years of age
  • Full anticoagulation therapy planned upon discharge, i.e., atrial fibrillation, mechanical heart valve, venous thromboembolism treatment, etc.
  • Patient is admitted to a non-medical service, i.e., surgical service, orthopedics, obstetrics/gynecology, neurology, psychiatry, or other non-medical service
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00853463

Locations
United States, California
Long Beach VA Healthcare System
Long Beach, California, United States, 90822
UC Irvine
Orange, California, United States, 92868
UC Davis
Sacramento, California, United States, 95817
United States, Colorado
Denver VA Medical Center
Denver, Colorado, United States, 80262
United States, Connecticut
William Backus Hospital
Norwich, Connecticut, United States, 06360
United States, Maryland
Medstar Research Frankin Square Hospital
Baltimore, Maryland, United States, 21237
Washington County Hospital
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
North Shore Medical Center
Salem, Massachusetts, United States, 01970
United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Missouri
University of Missouri- Columbia
Columbia, Missouri, United States, 65212
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New Mexico
Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
United States, New York
Albany Medical Center
Albany, New York, United States, 12208
North Shore University Hospital
Manhasset, New York, United States, 11030
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Pennsylvania
Indiana Regional Medical Center
Indiana, Pennsylvania, United States, 15701
Thomas Jefferson Hospital
Philadelphia, Pennsylvania, United States, 19107
Washington Hospital
Washington, Pennsylvania, United States, 15301
United States, Texas
Presbyterian Hospital Texas Health
Dallas, Texas, United States, 75231
United States, Utah
Intermountain Medical Center
Salt Lake City, Utah, United States, 84143
University of Utah Hospital Medical Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Brigham and Women's Hospital
Sanofi
Investigators
Principal Investigator: Samuel Z Goldhaber, MD Brigham and Women's Hospital
  More Information

Publications:
Responsible Party: Samuel Goldhaber, MD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00853463     History of Changes
Other Study ID Numbers: 2008-P-001083
Study First Received: February 26, 2009
Last Updated: May 31, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Pulmonary Embolism
Deep Vein Thrombosis
Prophylaxis
Venous thromboembolism
Prevention
Medical patients

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014