Computerized Decision Support for Blood Clot Prevention

(DC-eALERT Trial)

Overseen By Samuel Z Goldhaber, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Thromboprophylaxis

Disqualifiers: Prescribed thromboprophylaxis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

400 Participants Needed

Trial Summary

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.

Research Team

Gregory Piazza, MD, MS

Principal Investigator

BWH

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Alert Experimental Treatment 1 Intervention

On-screen electronic alert that notifies the provider about the increased risk for VTE after discharge and indication for thromboprophylaxis will be issued 48 hours after admission. This first on-screen electronic alert will provide the clinician with the opportunity to consider extended-duration, post-discharge thromboprophylaxis and start any required processes for prior authorization or medication coverage. The provider then will be given on-screen options to either order thromboprophylaxis (betrixaban or low-molecular weight heparin for 35 days) from a "Extended-Duration VTE Prevention" order template, follow a link to evidence-based practice guidelines, or defer prescribing extended-duration, post-discharge thromboprophylaxis.

Group II: No Alert Active Control 1 Intervention

No notification to the provider.

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+