Multi-Center Human Alert Trial to Prevent DVT and PE

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00409136

Collaborator

Sanofi (Industry)

2,496

Enrollment

Locations

Duration (Months)

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Embolism Deep Vein Thrombosis Cancer Surgery	Behavioral: Human Alert

Detailed 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:

Cancer
Prior VTE
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:

Advanced age (> 70 years of age)
Obesity (Body Mass Index > 29)
Bed rest
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.

Study Design

Study Type:

Observational

Actual Enrollment :

2496 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Physician Alerts to Prevent DVT and Pulmonary Embolism in Hospitalized Patients

Study Start Date :

Mar 1, 2006

Actual Primary Completion Date :

Aug 1, 2008

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Clinically diagnosed DVT and/or PE [90 days]

Secondary Outcome Measures

Mortality [30 and 90 days]
Hemorrhagic events [30 and 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	AZ Pulmonary Specialists, Ltd	Scottsdale	Arizona	United States	85258
2	Long Beach VA Hospital	Long Beach	California	United States	90822
3	University of California - Irvine	Orange	California	United States	92868
4	University of California - Davis	Sacramento	California	United States	95817
5	University of Colorado Health Sciences Center	Denver	Colorado	United States	80262
6	Norwalk Hospital	Norwalk	Connecticut	United States	06850
7	William W. Backus Hospital	Norwich	Connecticut	United States	06360
8	Washington Hospital Center	Washington DC	District of Columbia	United States	20010
9	Florida Hospital	Orlando	Florida	United States	32803
10	Emory-Crawford Long Hospital	Atlanta	Georgia	United States	30308
11	Franklin Square Hospital	Baltimore	Maryland	United States	21237
12	Washington County Hospital	Hagerstown	Maryland	United States	21740
13	Lahey Clinic	Burlington	Massachusetts	United States	01805
14	North Shore Medical Center	Salem	Massachusetts	United States	01970
15	Henry Ford Hospital K15	Detroit	Michigan	United States	48202
16	St. Joseph Mercy Hospital	Ypsilanti	Michigan	United States	48197
17	University of Missouri	Columbia	Missouri	United States	65212
18	North Shore University Hospital	Great Neck	New York	United States	11030
19	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma	United States	73104
20	Thomas Jefferson Hospital	Philadelphia	Pennsylvania	United States	19107
21	Washington Hospital	Washington	Pennsylvania	United States	15301
22	Spartanburg Regional Medical Center	Spartanburg	South Carolina	United States	29303
23	Presbyterian Hospital of Dallas	Dallas	Texas	United States	75231
24	LDS Hospital	Salt Lake City	Utah	United States	84103
25	University of Utah Medical Center	Salt Lake City	Utah	United States	84132
26	United Hospital System	Kenosha	Wisconsin	United States	53143