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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a computerized alert system to help doctors prevent dangerous blood clots in high-risk patients after hospital discharge. The electronic alert reminds healthcare providers to prescribe extended blood clot prevention medication to at-risk patients not already receiving it. Suitable candidates for this trial include those hospitalized with conditions like heart failure or respiratory issues, who have mobility issues, and are not prescribed blood clot prevention medicine upon discharge.

As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions that could enhance patient safety and outcomes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on patients who are not prescribed blood clot prevention medication at hospital discharge.

What prior data suggests that this computerized decision support tool is safe for use in hospitalized patients?

Studies have shown that computerized decision support systems, such as electronic alerts, are generally safe and easy to use. These systems assist doctors in making better decisions by notifying them of important patient needs. Research indicates these alerts can reduce medical errors and improve patient safety by reminding doctors to prevent blood clots in high-risk patients.

One study used electronic alerts in hospitals to promote blood clot prevention. The alerts helped doctors remember to prescribe treatments that lower the risk of blood clots without causing harm. No major safety issues were reported, suggesting that electronic alerts safely enhance patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the computerized decision support system for blood clot prevention because it leverages technology to directly assist healthcare providers in making real-time decisions. Unlike traditional methods where doctors rely on their memory or manual checks, this system sends an on-screen alert to notify providers about a patient's increased risk of venous thromboembolism (VTE) after discharge. This alert prompts the provider to consider extended-duration thromboprophylaxis, offering options for easy ordering from a template, or access to evidence-based guidelines. By integrating seamlessly into existing workflows, this innovative approach could enhance patient care and reduce the incidence of blood clots more effectively than current practices.

What evidence suggests that this electronic alert is effective for preventing VTE?

Research has shown that electronic alert systems can lower the risk of dangerous blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE). In this trial, participants in the "Alert" arm will receive an on-screen electronic alert that notifies the provider about the increased risk for VTE after discharge and the indication for thromboprophylaxis. One study found that using these alerts in hospitals cut the risk of blood clots by half. Another study demonstrated that these alerts helped doctors assess the risk of blood clots more effectively and encouraged timely treatment. Specifically, patients who received these alerts were 35% less likely to develop blood clots compared to before the alerts were used. This evidence suggests that computerized alerts can effectively remind healthcare providers to prescribe preventive treatments, potentially reducing the chances of blood clots in high-risk patients. ^{1 3 4 5 6}

Who Is on the Research Team?

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?

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+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839599

AI-Driven Clinical Decision Support to Reduce Hospital ... An additional study found that electronic alerts for VTE prophylaxis had minimal impact on clinically significant outcomes.⁵ In the present ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12125021/

A clinical decision support tool for improving venous ... An integrated electronic alert system linked to a CPOE-based VTE risk assessment order set within an eMMS significantly improved VTE risk ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1538783622069768

Economic impact of an electronic alert system to prevent ... Results:E‐alerts achieved a sustained reduction of the incidence of in‐hospital VTE, OR 0.50 (95% CI, 0.29–0.84), the impact being especially significant in ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa041533

Electronic Alerts to Prevent Venous Thromboembolism ... We hypothesized that the use of a computer-alert program to encourage prophylaxis might reduce the frequency of deep-vein thrombosis among high-risk ...

5. journals.lww.com journals.lww.com/jhqonline/fulltext/2015/07000/computerized_clinical_decision_support_to_prevent.2.aspx

Computerized Clinical Decision Support to Prevent Venous... Compared to baseline, patients benefitting from VTE CDS were 35% less likely to have a VTE. VTE CDS utilization achieved 78.4% patients assessed within 24 hr ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2902769/

Computerized Decision Support for the Cardiovascular ... Computerized decision support improves patient safety by reducing medical errors, alerting providers to abnormal test results, and suggesting prophylactic ...