Computerized Decision Support for Stroke Prevention in Atrial Fibrillation

(AF-ALERT3 Trial)

Not yet recruiting at 1 trial location

Overseen By Benjamin Peterson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Anticoagulants

Disqualifiers: Low CHA2DS2VASc score, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 90 days

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. ^{1 2 3 4 5}

Why 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. ^{1 2 3 6 7}

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

I have been diagnosed with atrial fibrillation or flutter.

My stroke risk score is 2 or higher.

My stroke risk score is 3 or higher.

Exclusion Criteria

I am currently taking medication to prevent blood clots.

My stroke risk score is less than 2.

My stroke risk score is 2 or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Implementation of computerized decision support (CDS) strategy to improve stroke prevention in AF among ambulatory care patients

90 days

Ongoing outpatient clinical encounters

Follow-up

Participants are monitored for prescription of anticoagulation and major bleeding events

6 months

Extension

Long-term monitoring for major adverse cardiovascular events and bleeding risk management

6 months

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?

Group I: Alert Experimental Treatment 1 Intervention

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.

Group II: No Alert Active Control 1 Intervention

For No Alert cluster sites, no computerized alert notification will be issued to providers.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Janssen, LP

Industry Sponsor

Trials

169

Recruited

329,000+

Founded

1953

Headquarters

Beerse, Belgium

Known For

Mental Health Therapies

Top Products

Imodium, Remicade, Invega, Procrit

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

A review of 7 studies found that decision aids for stroke prevention in atrial fibrillation significantly improved patient knowledge and involvement in treatment choices, while also reducing decisional conflict.

Despite their effectiveness, none of the evaluated decision aids are currently accessible for clinical use, highlighting a gap in resources that could help patients make informed choices about their treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability of patient decision aids for stroke prevention in atrial fibrillation: A systematic review. O'Neill, ES., Grande, SW., Sherman, A., et al.[2018]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38685464

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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0002870324001030

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.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06355986

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 ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35081360/

Electronic health record-embedded decision support to ... We have designed a study to implement and evaluate the effectiveness of an Atrial Fibrillation Decision Support Tool (AFDST) embedded within our electronic ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.028562

Randomized Clinical Trial to Evaluate an Atrial Fibrillation ... This multicenter randomized clinical trial demonstrated the beneficial effects of our novel SDM pathway in reducing decisional conflict ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40768761/

Electronic Clinical Decision Support System for Stroke Risk ... This study highlights the challenges and opportunities in managing AF-related stroke risk in mental health settings.

7. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-025-02905-y

Effect of a clinical decision support system for non-valvular ... Computer algorithms-powered clinical decision support systems (CDSS) are assisting physicians in making timely, accurate, and customized ...