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Multi-Screen Electronic Alert for Venous Thromboembolism Prevention


N/A
18 Years
N/A
Not Enrolling
Both
Deep Vein Thrombosis, Pulmonary Embolism, Cancer

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Trial Information

Multi-Screen Electronic Alert for Venous Thromboembolism Prevention


Background and Significance:

Scope of the Problem: VTE is the third most common cardiovascular disease (heart attack and
stroke are more common) but is the most preventable medical problem among patients
hospitalized with other illnesses. DVT often causes chronic venous insufficiency, a
potentially disabling and painful condition that lowers the quality of life. Acute PE may
cause death or disabling chronic thromboembolic pulmonary hypertension. After discharge
from a short-term hospital stay, one study reported that the incidence of DVT was 48 per
100,000 and the incidence of PE (with or without DVT) was 23 per 100,000.9 In addition, the
incidence of VTE increases dramatically with age.10-11 Clinical manifestations of DVT often
include swelling, pain, and extremity discoloration and may lead to PE. Manifestations of
PE may include dyspnea, pleuritic pain, cough, and hemoptysis or may be asymptomatic.12-13
The 28-day mortality rate for a first VTE event is alarmingly high, approximately 11%.14 In
addition, 3-month mortality rates for PE have been reported as high as 17%.15 However,
appropriate prophylaxis—using anticoagulants, mechanical measures, or both anticoagulants
plus mechanical measures—can prevent most episodes of VTE16. For example, mechanical
measures as simple as "low tech" and inexpensive graduated compression stockings can reduce
VTE rates.16a, 16b, 16c

Burden to Patients: VTE is associated with complications including recurrence of DVT or PE,
chronic thromboembolic pulmonary hypertension, death, or the subsequent development of
post-thrombotic syndrome. The risk of VTE recurrence is greatest within 6-12 months after
the first event and continues for at least 10 years,17 and is a risk factor for death after
PE.18 The post-thrombotic syndrome can have devastating effects on the patients' quality of
life and is associated with venous hypertension that may cause pain, edema, skin changes,
varicose veins, and skin ulcers. Valve dysfunction, which can lead to venous hypertension,
is most often caused by a previous DVT.19 The cumulative incidence of the development of
postthrombotic syndrome after a VTE event is high: 17% at one year, 23% at 2 years, and 29%
at 8 years, with 30% of these cases classified as severe.20

Burden to Society: Direct medical costs to the United States health care system related to
VTE events and complications approximate at least $600 million annually. Bullano and
colleagues21 estimate that managed care plans pay a median of $3,131 per incident DVT,
$6,424 per incident PE, and $12,200 for a DVT plus PE combination event. A 2004 registry of
5,451 patients with ultrasound-confirmed DVT at 183 institutions in the United States
revealed that DVT led to hospitalization in 80% of those diagnosed as outpatients. Those
initially diagnosed with DVT as inpatients remained hospitalized for a median of 12 days.7

Role of computerized healthcare delivery systems:

The use of computerized physician order entry (CPOE) is growing and is currently utilized in
about 10% of U.S. Hospitals.22 When linked with clinical decision support, it provides a
unique and important tool to improve ordering decisions, thereby reducing medication errors,
transcribing errors, decreasing the frequency of adverse drug events, and increasing
compliance with evidence-based clinical guidelines.23 This leads to overall improved patient
care. There is growing recognition of the importance and utility of CPOE technology, and
currently, there is a concerted effort nation-wide to implement it in all hospitals and
private practices. CPOE programs provide an excellent platform to increase the
implementation of clinical practice guidelines, thereby changing physician behavior.

At Brigham and Women's Hospital, we have developed an electronic alert system, which is
integrated with the CPOE system but functions independently. We have created risk score
criteria by which the system determines the risk of DVT or PE for a particular patient. All
the information needed to accomplish this risk assessment is stored in the computer system,
allowing the process to run in an automated fashion. The system according to present
criteria determines whether to generate an alert. To do this, the system checks for the
existence of current orders for prophylaxis, using the Brigham and Women's Hospital CPOE
system. The presence of medication class orders for anticoagulants or general care orders
for mechanical prophylaxis prevents the computer from issuing an alert. We will enhance
this computerized system to produce a series of alerts that provide more information related
to prescription or omission of thromboprophylaxis. We aim to test this new system in our
proposed study.

At Brigham and Women's Hospital, we also leverage the use of the multiple outpatient
electronic medical records and inpatient CPOE systems to facilitate the process of
medication reconciliation before, during, and after the hospital stay. This system
aggregates medication data from electronic medical records (EMR) and CPOE systems so that
clinicians can efficiently generate an accurate pre-admission medication list. Information
collected with the use of this application subsequently supports the writing of admission
and discharge orders by physicians, performance of admission assessment by nurses, and
reconciliation of inpatient orders by pharmacists. Medication histories are thus seamlessly
transferred during transition of care from inpatient admission to discharge to home,
rehabilitation, or skilled nursing facilities. This efficient system will allow us to
carefully document the use or omission of thromboprophylaxis orders. Furthermore, for 90
day follow-up, we will be able to track thromboprophylaxis prescriptions after hospital
discharge by using a combination of the Brigham and Women's Hospital's pharmacy's electronic
outpatient prescription reconciliation program and Partners' internally developed EMR, the
Longitudinal Medical Record.

The Longitudinal Medical Record is used by our outpatient clinics to record clinical visit
information such as history, notes, problems, medications, and allergies, and provides
inpatient and outpatient test results, including imaging tests and laboratory blood tests,
from 7 Partners-affiliated institutions: Brigham and Women's Hospital, Massachusetts
General Hospital, Dana Farber Cancer Institute, Newton Wellesley Hospital, North Shore
Medical Center, Faulkner Hospital, and Spaulding Rehabilitation Hospital. The Longitudinal
Medical Record is especially useful for following patients who might undergo evaluation for
a new problem, such as sudden onset of shortness of breath, at a suburban hospital such as
Newton Wellesley Hospital, after a prior hospitalization at Brigham and Women's Hospital for
treatment of a complicated medical illness with a high risk of VTE. In our 2005 randomized
trial of electronic alerts for VTE prophylaxis,8 we relied upon the Longitudinal Medical
Record to achieve 94% follow-up at 90 days of all patients enrolled at Brigham and Women's
Hospital.

Between 2000 and 2004, we developed a computer generated alert system for VTE prophylaxis
and tested it in a large randomized controlled trial at Brigham and Women's Hospital. The
system was linked to the patient database, identifying patients at high risk for VTE
(defined as ≥ 4 score points and shown in Table 1) who were not receiving prophylaxis.
High-risk patients not receiving VTE prophylaxis were randomized to an intervention group in
which their physicians received an electronic alert or a control group in which physicians
were not alerted. Patients in the intervention group experienced a 41% reduction in the
incidence of symptomatic VTE events within 90 days, without an increase in the risk of major
or minor bleeding. However, prophylactic measures were prescribed for only 33.5% of the
patients in the intervention group. For the remaining patients (66.5%), we were surprised
that physicians declined to implement the suggested intervention, initiation of VTE
prophylaxis.

There is still considerable scope for electronic methodology and technology to increase
prophylaxis rates and reduce the rates of VTE. Therefore, we will focus these new study
initiatives on improving our current methods and strategies to further reduce the incidence
of VTE.

Significance of our proposed studies:

Our projects will address several gaps in our understanding of the issues related to
implementation of VTE prophylaxis in hospitalized patients. We aim to identify subgroups in
the hospitalized population that are at especially high risk for VTE. An improved and novel
automated electronic alerting system will facilitate this identification. Our new alert
system will be much more rigorous than our prior protocol. The new alert will have three
sequential screens rather than the single alert screen that we had in the prior version.

This computerized system will identify hospitalized patients at high risk for VTE and will
analyze their records to determine whether they have received thromboprophylaxis orders. If
the system identifies any high-risk patient who does not have orders for thromboprophylaxis,
then a series of prompts will be issued to the ordering physician. The physician whose
patient is at risk for VTE will be requested to institute prophylaxis. If the automated
request is not followed, a series of alerts will query reasons for withholding preventive
measures. Further prompts will lead to centralized computer-generated ordering of graduated
compression stockings, unless the physician opts out and unselects this order. Important
elements in the alerts include an up-to-date selection of pharmacological agents, doses
based on renal clearance, and the documentation of reasons for withholding prophylaxis by
the ordering physician.

We will follow all high-risk patients whose physicians received an alert. We will determine
whether within 90 days, the patient has developed symptomatic DVT or PE. The Longitudinal
Medical Record will facilitate follow-up after hospital discharge.

Through the use of this novel alert system, we will identify patients at high risk for VTE,
maximize the implementation of VTE prophylaxis, learn the rationale for physicians'
withholding anticoagulant or mechanical prophylaxis in some high-risk patients, and test
whether this novel electronic intervention reduces clinically important episodes of PE and
DVT. The success of this program will provide a useful model for dissemination of VTE
preventive strategies nationwide and worldwide.


Inclusion Criteria:



- Hospitalized patients at Brigham and Women's Hospital from medical and surgical
services who are 18 yrs old or older and are at a moderate to high risk for venous
thromboembolism (VTE)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Venous Thromboembolism and Bleeding Events

Outcome Time Frame:

90 Days

Safety Issue:

No

Principal Investigator

Samuel Z Goldhaber, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

2006-P-002346

NCT ID:

NCT00550082

Start Date:

July 2007

Completion Date:

November 2009

Related Keywords:

  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Cancer
  • Anticoagulation
  • High-Risk
  • Deep Vein Thrombosis
  • Pulmonary Embolism
  • Surgery
  • Embolism
  • Pulmonary Embolism
  • Thrombosis
  • Venous Thrombosis
  • Venous Thromboembolism

Name

Location

Brigham and Women's Hospital Boston, Massachusetts  02115