400 Participants Needed

Computerized Decision Support for Blood Clot Prevention

(DC-eALERT Trial)

GP
CE
SZ
Overseen BySamuel Z Goldhaber, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death compared with short-duration enoxaparin. Obstacles to integration of these data in the hospitalized Medical Service patient population, including failure to identify at-risk patients, educational gaps in strategies for VTE prevention after discharge, and medication nonadherence, can be overcome with alert-based computerized decision support. This study is a single-center, 400-patient, randomized controlled trial of an EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase prescription of extended-duration post-discharge thromboprophylaxis and decrease symptomatic VTE in high-risk patients hospitalized with medical illness.Specific Aim #1: To determine the impact of electronic alert-based CDS (EPIC Best Practice Advisory \[BPA\]) on prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.Specific Aim #2: To estimate the impact of electronic alert-based CDS (EPIC BPA) on the frequency of symptomatic VTE in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.

Who Is on the Research Team?

GP

Gregory Piazza, MD, MS

Principal Investigator

BWH

Are You a Good Fit for This Trial?

This trial is for hospitalized patients over 40 with acute medical conditions like heart or respiratory failure, infections, rheumatic disease, or stroke. They must have limited mobility and not be on blood clot prevention meds after leaving the hospital. Additional risk factors such as being over 60, previous clots, or a cancer history are also required.

Inclusion Criteria

I am over 40, hospitalized for a serious illness, have limited mobility, not on blood clot prevention meds, and have another risk factor for blood clots.

Exclusion Criteria

I was given medication to prevent blood clots when I left the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

An EPIC Electronic Health Record (EHR) Best Practice Advisory (BPA) will identify patients hospitalized with medical illness who are not ordered for extended-duration, post-discharge thromboprophylaxis 48 hours after admission.

48 hours
In-hospital monitoring

Post-discharge Thromboprophylaxis

Participants receive extended-duration post-discharge thromboprophylaxis with oral betrixaban for 35 to 42 days.

5-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including review of Electronic Health Record at 90 days from randomization.

90 days

What Are the Treatments Tested in This Trial?

Interventions

  • Electronic alert
Trial Overview The study tests an electronic alert system designed to remind doctors to prescribe meds that prevent blood clots after high-risk patients leave the hospital. The goal is to see if this tech increases prescriptions and reduces cases of deep vein thrombosis and other clot-related issues post-discharge.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: AlertExperimental Treatment1 Intervention
Group II: No AlertActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Portola Pharmaceuticals

Industry Sponsor

Trials
29
Recruited
12,600+
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