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Computerized Decision Support for Blood Clot Prevention (DC-eALERT Trial)

N/A
Recruiting
Led By Gregory Piazza, MD, MS
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since the intervention involves an electronic alert rather than medication, there are no direct side effects from it. However, medications prescribed due to the alert may carry their own risks which will vary depending on individual patient health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Frequency of prescription of extended-duration post-discharge thromboprophylaxis.
Secondary study objectives
Frequency of all-cause mortality at 90 days
Frequency of all-cause rehospitalization at 90 days
Frequency of major bleeding (as defined by the ISTH bleeding classification system) at 90 days from randomization.
+1 more
Other study objectives
Medication adherence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AlertExperimental Treatment1 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 AlertActive Control1 Intervention
No notification to the provider.

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,666 Previous Clinical Trials
11,841,224 Total Patients Enrolled
12 Trials studying Venous Thromboembolism
179,182 Patients Enrolled for Venous Thromboembolism
Portola PharmaceuticalsIndustry Sponsor
28 Previous Clinical Trials
12,196 Total Patients Enrolled
1 Trials studying Venous Thromboembolism
7,513 Patients Enrolled for Venous Thromboembolism
Gregory Piazza, MD, MSPrincipal InvestigatorBWH
5 Previous Clinical Trials
12,970 Total Patients Enrolled

Media Library

Electronic alert Clinical Trial Eligibility Overview. Trial Name: NCT03728166 — N/A
Venous Thromboembolism Research Study Groups: Alert, No Alert
Venous Thromboembolism Clinical Trial 2023: Electronic alert Highlights & Side Effects. Trial Name: NCT03728166 — N/A
Electronic alert 2023 Treatment Timeline for Medical Study. Trial Name: NCT03728166 — N/A
~59 spots leftby Nov 2025
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