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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
≥40 years of age, hospitalized for acute medical illness (heart failure, respiratory failure, infectious disease, rheumatic disease, or ischemic stroke), have reduced mobility, not prescribed thromboprophylaxis at hospital discharge, and have one additional risk factor for VTE: Age ≥60, Prior VTE, History of cancer
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
DC-eALERT Trial 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.Check my eligibility
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.See study design
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.
DC-eALERT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
DC-eALERT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of prescription of extended-duration post-discharge thromboprophylaxis.
Secondary outcome measures
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 moreOther outcome measures
Medication adherence
DC-eALERT 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.
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Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,477 Total Patients Enrolled
13 Trials studying Deep Vein Thrombosis
481,151 Patients Enrolled for Deep Vein Thrombosis
Portola PharmaceuticalsIndustry Sponsor
28 Previous Clinical Trials
12,196 Total Patients Enrolled
Gregory Piazza, MD, MSPrincipal InvestigatorBWH
5 Previous Clinical Trials
12,970 Total Patients Enrolled
1 Trials studying Deep Vein Thrombosis
10,000 Patients Enrolled for Deep Vein Thrombosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I was given medication to prevent blood clots when I left the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Alert
- Group 2: No Alert
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is this research project being supported by participants?
"Indeed, the information available on clinicaltrials.gov verifies that this trial is presently accepting applications from patients. The study was initially advertised on February 1st 2019 and has most recently been revised on April 5th 2022. 400 individuals are being recruited at one site for participation in the experiment."
Answered by AI
Is there still an opportunity to participate in this research endeavor?
"Affirmative. Clinicaltrials.gov data reveals that this medical study, which was originally posted on February 1st 2019, is actively recruiting. This evaluation requires 400 test subjects from a single trial site."
Answered by AI
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