Multi-Center Human Alert Trial to Prevent DVT and PE

Cancer Clinical Trial

Official title:

Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00409136
• Other study ID #: 2005-P-002527
• Status: Completed
• Phase: N/A
• First received: December 7, 2006
• Last updated: January 29, 2009
• Start date: March 2006
• Est. completion date: August 2008

Study information

• Verified date: January 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Background Information and Rationale for the Study:

Venous thromboembolism (VTE) is often avoidable in hospitalized patients because proven prevention strategies have been established for patients at risk. North American and European prophylaxis guidelines have been widely disseminated. However, despite intensive educational efforts, VTE prevention remains underutilized.

At Brigham and Women's Hospital, we undertook a comprehensive program aimed at increasing the frequency of VTE prophylaxis in high risk patients. This novel strategy required: 1) devising a risk score that reliably and quickly identified patients at high risk of VTE, and 2) conducting a randomized controlled trial in which high risk patients without prophylaxis were randomized into an intervention or control group. The intervention group's physicians received a single alert explaining that the patient was at high risk, was not receiving prophylaxis, and urged that prophylaxis be selected from a template of available pharmacological and mechanical options. In contrast, the control group's physicians received no alert.

Each of 8 common risk factors was weighted according to a point scale. At least 4 score points were required to be deemed at "high risk" for VTE.

3 of the 8 risk factors were considered major and were assigned a score of 3 points each:

1. Cancer

2. Prior VTE

3. Hypercoagulability

One of the 8 risk factors, surgery, was considered intermediate and was assigned a score of 2.

4 of the 8 risk factors were considered minor and were assigned a score of 1 point each:

1. Advanced age (> 70 years of age)

2. Obesity (Body Mass Index > 29)

3. Bed rest

4. Hormone replacement therapy or oral contraceptives

There were 2,506 patients in the randomized controlled trial of a computer alert: 1255 in the intervention group and 1251 in the control group. The incidence of symptomatic VTE at 90 days was high: 8.2% in the control group. This high incidence validates the 8 risk factor and point score methodology.

The intervention group had an overall 41% reduction in VTE, without any increase in major bleeding. There was a 60% reduction in the incidence of symptomatic pulmonary embolism.

Identification of Patients at Risk for Venous Thromboembolism (VTE):

A VTE risk profile will be computed for each hospitalized patient using 8 common risk factors. Each risk factor is weighted according to a point score. To be included in this trial, the point score must equal or exceed 4 points.

Minor (Low) Risk Factors (1 POINT each):

• Advanced Age (>70 years of age)

• Obesity (BMI >29, or the presence of the word "obesity" in admission exam notes)

• Bed rest / Immobility (not related to surgery)

• Female Hormone Replacement Therapy or Oral Contraceptives

Intermediate Risk Factor (2 POINTS each):

· Major Surgery (> 60 minutes)

Major (High) Risk Factors (3 POINTS each):

• Cancer (active)

• Prior VTE

• Hypercoagulability

Increased VTE risk is defined as a cumulative VTE risk score 4, so that patients with at least 1 major risk factor (cancer, prior VTE, or hypercoagulability) plus at least 1 additional intermediate risk factor (major surgery or bed rest) or minor risk factor (advanced age, obesity, or hormone replacement therapy/oral contraceptives) become eligible. In the absence of a major risk factor, patients with 1 intermediate risk factor plus at least 2 minor risk factors become eligible.

Screening for Venous Thromboembolism Prophylaxis:

If the cumulative VTE risk score is ³4, orders are reviewed to detect ongoing mechanical or pharmacological prophylactic measures. Mechanical prophylactic measures include graduated compression stockings and intermittent pneumatic compression devices. Pharmacological prophylactic measures include unfractionated heparin, enoxaparin, dalteparin, fondaparinux, tinzaparin, and warfarin.

Randomization:

Randomization Envelopes containing the statement "ALERT" (Intervention) or "NO ALERT" (Control) will be provided by Harvard Clinical Research Institute (HCRI), to randomize patients who meet all inclusion criteria.

The intervention is informing the responsible physician that: 1) his or her patient is at high risk for VTE, 2) is not receiving prophylaxis, and 3) VTE prophylaxis is recommended. For control patients, VTE prevention guidelines are available, but no specific prompt is provided to use them.

Follow Up:

Ninety-day follow-up is performed in all study patients by medical record review and through contact with the subject's Primary Care Physician.

Data Collection and Study Endpoints:

The primary endpoint is clinically diagnosed DVT or PE at 90 days. Safety endpoints include total mortality and hemorrhagic events at 30 and 90 days, respectively. We define major bleeding as intracranial, intraocular, retroperitoneal, pericardial, or bleeding that requires surgical intervention or that resulted in a hemoglobin loss greater than 3 g/l.

DVT is diagnosed if there is loss of vein compressibility by ultrasound or a filling defect by CT scan or by conventional contrast venography. PE is diagnosed by a positive contrast chest CT scan, a high-probability ventilation perfusion scan, or conventional pulmonary angiogram.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2496
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cancer
• Deep Vein Thrombosis
• Embolism
• Pulmonary Embolism
• Surgery
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
United States	Emory-Crawford Long Hospital	Atlanta	Georgia
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Lahey Clinic	Burlington	Massachusetts
United States	University of Missouri	Columbia	Missouri
United States	Presbyterian Hospital of Dallas	Dallas	Texas
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Henry Ford Hospital K15	Detroit	Michigan
United States	North Shore University Hospital	Great Neck	New York
United States	Washington County Hospital	Hagerstown	Maryland
United States	United Hospital System	Kenosha	Wisconsin
United States	Long Beach VA Hospital	Long Beach	California
United States	Norwalk Hospital	Norwalk	Connecticut
United States	William W. Backus Hospital	Norwich	Connecticut
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of California - Irvine	Orange	California
United States	Florida Hospital	Orlando	Florida
United States	Thomas Jefferson Hospital	Philadelphia	Pennsylvania
United States	University of California - Davis	Sacramento	California
United States	North Shore Medical Center	Salem	Massachusetts
United States	LDS Hospital	Salt Lake City	Utah
United States	University of Utah Medical Center	Salt Lake City	Utah
United States	AZ Pulmonary Specialists, Ltd	Scottsdale	Arizona
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Washington Hospital	Washington	Pennsylvania
United States	Washington Hospital Center	Washington DC	District of Columbia
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

Goldhaber SZ, Turpie AG. Prevention of venous thromboembolism among hospitalized medical patients. Circulation. 2005 Jan 4;111(1):e1-3. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically diagnosed DVT and/or PE		90 days	No
Secondary	Mortality		30 and 90 days	No
Secondary	Hemorrhagic events		30 and 90 days	No

External Links

•   North American Thrombosis Forum