Computerized Decision Support for Stroke Prevention in Atrial Fibrillation
(AF-ALERT3 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a computerized decision support system to help doctors prescribe blood thinners more effectively for people with atrial fibrillation (irregular heartbeat) to prevent strokes. The system alerts doctors if a patient with atrial fibrillation is at risk for a stroke and not on blood thinners. It aims to increase adherence to guidelines for stroke prevention. This trial might suit individuals with atrial fibrillation who haven't been prescribed blood thinners and have stroke risk factors. As an unphased trial, participation could contribute to improving future care for atrial fibrillation patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already on anticoagulant therapy.
What prior data suggests that this computerized decision support is safe for stroke prevention in atrial fibrillation?
Research has shown that computerized decision support (CDS) systems are generally well-accepted by healthcare providers and patients. These systems help doctors make decisions by following clinical guidelines. Studies have demonstrated that CDS can improve how doctors prescribe treatments, ensuring that patients with atrial fibrillation (AF) receive appropriate care to prevent strokes.
Regarding safety, CDS poses no direct risks to patients. The system does not involve taking medication or undergoing procedures; it provides recommendations to healthcare providers. Essentially, CDS guides doctors in choosing the best treatment based on each patient’s specific needs.
Previous research has not reported any direct negative effects from using these systems. The main goal is to enhance decision-making, indirectly supporting patient safety by promoting the best available treatment options.12345Why are researchers excited about this trial?
Researchers are excited about the computerized decision support system because it aims to enhance stroke prevention in patients with atrial fibrillation (AF) by directly integrating into healthcare providers' workflows. Unlike standard treatments, such as prescribing anticoagulants based on clinical judgment alone, this system provides real-time alerts to clinicians, highlighting patients at risk and offering immediate access to FDA-approved anticoagulation options. This approach not only streamlines decision-making but could also improve adherence to evidence-based guidelines, potentially reducing stroke incidents more effectively than current practices.
What evidence suggests that this computerized decision support is effective for stroke prevention in atrial fibrillation?
This trial will compare the effectiveness of computerized decision support (CDS) tools in stroke prevention for patients with atrial fibrillation (AF). Research has shown that CDS tools help doctors follow guidelines for prescribing blood thinners. In this trial, participants at sites with the "Alert" arm will receive on-screen electronic alerts to assist in prescribing the right medications. Previous studies found that using CDS increases the likelihood of doctors prescribing the correct medications and aids in making better treatment choices for AF patients. Overall, these tools simplify adherence to best practices, potentially leading to improved stroke prevention.12367
Who Is on the Research Team?
Gregory Piazza, MD, MS
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for patients with atrial fibrillation, a heart condition that increases the risk of stroke. It aims to improve how often doctors prescribe blood thinners to prevent strokes in these patients. The study will take place in community medical centers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Implementation of computerized decision support (CDS) strategy to improve stroke prevention in AF among ambulatory care patients
Follow-up
Participants are monitored for prescription of anticoagulation and major bleeding events
Extension
Long-term monitoring for major adverse cardiovascular events and bleeding risk management
What Are the Treatments Tested in This Trial?
Interventions
- Computerized Decision Support
Trial Overview
The trial is testing an alert-based computerized decision support system designed to help doctors follow guidelines on prescribing blood thinners more consistently. This system also assesses and manages bleeding risks associated with treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
For Alert cluster sites, an on-screen electronic alert will be issued during the outpatient clinical encounter that notifies the provider that his or her patient is at risk for stroke due to AF, and that there is no order for anticoagulation. Clinicians who receive the computer alert will have three options: 1) access an order template of United States (US) Food and Drug Administration (FDA)-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence-based clinical practice guidelines to learn more about stroke prevention in AF, or 3) continue with order entry after providing an explanation for why anticoagulation was not prescribed.
For No Alert cluster sites, no computerized alert notification will be issued to providers.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Janssen, LP
Industry Sponsor
Joaquin Duato
Janssen, LP
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen, LP
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Published Research Related to This Trial
Citations
Computerized clinical decision support to improve stroke ...
We assessed whether computerized clinical decision support (CDS) would enable guideline-based antithrombotic therapy for AF patients in primary care.
Computerized clinical decision support to improve stroke ...
We assessed whether computerized clinical decision support (CDS) would enable guideline-based antithrombotic therapy for AF patients in primary care.
Computerized Decision Support to Prevent Stroke in Atrial ...
The primary efficacy outcome will be determined by review of the Electronic Health Record (EHR) medication documentation for prescription of anticoagulation by ...
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We have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic ...
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