NCT00853463

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,515

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

Geographic Reach
1 country

22 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

First Submitted

Initial submission to the registry

February 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

11 months

First QC Date

February 26, 2009

Last Update Submit

May 31, 2011

Conditions

Keywords

Pulmonary EmbolismDeep Vein ThrombosisProphylaxisVenous thromboembolismPreventionMedical patients

Outcome Measures

Primary Outcomes (1)

  • Clinically diagnosed DVT and/or PE

    90 days after discharge

Secondary Outcomes (2)

  • Mortality

    30 and 90 days

  • Hemorrhagic events

    30 and 90 days

Study Arms (2)

No Alert

NO INTERVENTION

The responsible physician of a patient randomized to the control arm will not be contacted regarding the increased VTE risk of the patient.

Alert

OTHER

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

Interventions

AlertBEHAVIORAL

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

Also known as: "Alert"
Alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Long Beach VA Healthcare System

Long Beach, California, 90822, United States

Location

UC Irvine

Orange, California, 92868, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Denver VA Medical Center

Denver, Colorado, 80262, United States

Location

William Backus Hospital

Norwich, Connecticut, 06360, United States

Location

Medstar Research Frankin Square Hospital

Baltimore, Maryland, 21237, United States

Location

Washington County Hospital

Hagerstown, Maryland, 21740, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

North Shore Medical Center

Salem, Massachusetts, 01970, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

University of Missouri- Columbia

Columbia, Missouri, 65212, United States

Location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

Location

Lovelace Medical Center

Albuquerque, New Mexico, 87102, United States

Location

Albany Medical Center

Albany, New York, 12208, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Indiana Regional Medical Center

Indiana, Pennsylvania, 15701, United States

Location

Thomas Jefferson Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Washington Hospital

Washington, Pennsylvania, 15301, United States

Location

Presbyterian Hospital Texas Health

Dallas, Texas, 75231, United States

Location

University of Utah Hospital Medical Center

Salt Lake City, Utah, 84132, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84143, 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
  • Spencer FA, Lessard D, Emery C, Reed G, Goldberg RJ. Venous thromboembolism in the outpatient setting. Arch Intern Med. 2007 Jul 23;167(14):1471-5. doi: 10.1001/archinte.167.14.1471.

    PMID: 17646600BACKGROUND

MeSH Terms

Conditions

Pulmonary EmbolismVenous ThrombosisVenous Thromboembolism

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosisThromboembolism

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Samuel Z Goldhaber, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2009

First Posted

March 2, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

May 1, 2011

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations