Computerized Decision Support for Stroke Prevention in Atrial Fibrillation

(AF-ALERT3 Trial)

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

2500 Participants Needed

Trial Summary

What is the purpose of this trial?

Atrial fibrillation (AF) is the most preventable cause of stroke. However, despite widely available risk stratification tools, numerous options for oral anticoagulation, and evidence-based practice guidelines, anticoagulation for stroke prevention in AF is consistently under-prescribed. In a pair of observational cohort analyses within the Mass General Brigham (MGB) health system, prescription of anticoagulation for stroke prevention in AF was less frequent in ambulatory clinic patients than in those who were hospitalized at the time of assessment (46.9% vs. 57.2%). Two single academic medical center randomized controlled trials demonstrated success for increasing adherence to guideline recommendations for stroke prevention in AF. To address the feasibility and impact of a computerized decision support (CDS) strategy in the non-tertiary care, community medical center setting, this study will involve a multicenter, cluster-randomized controlled trial of a more sophisticated CDS focused not only on implementation stroke prevention but also on bleeding risk assessment and management.

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 data supports the effectiveness of the treatment Computerized Decision Support for stroke prevention in atrial fibrillation?

Research shows that using a computerized decision support tool can help doctors follow guidelines better for preventing strokes in patients with atrial fibrillation, which means more patients get the right treatment to lower their stroke risk. ^{1 2 3 4 5}

Is the computerized decision support tool for stroke prevention in atrial fibrillation safe for humans?

The research articles do not provide specific safety data for the computerized decision support tool itself, but they focus on its role in helping manage treatment decisions for atrial fibrillation, which involves using established medications like warfarin and other anticoagulants that have known safety profiles. ^{1 3 6 7 8}

How is the Computerized Decision Support treatment for stroke prevention in atrial fibrillation different from other treatments?

The Computerized Decision Support treatment is unique because it integrates a decision-making tool into electronic health records to help healthcare providers follow guidelines for stroke prevention in patients with atrial fibrillation, aiming to improve the use of anticoagulant therapy and reduce undertreatment. ^{1 2 8 9 10}

Research Team

Gregory Piazza, MD, MS

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 Business School

Biljana Naumovic

Janssen, LP

Chief Medical Officer since 2023

MD from Belgrade University Medical School

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A clinical decision support tool for improving adherence to guidelines on anticoagulant therapy in patients with atrial fibrillation at risk of stroke: A cluster-randomized trial in a Swedish primary care setting (the CDS-AF study). [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical decision support for stroke prevention in atrial fibrillation (CDS-AF): Rationale and design of a cluster randomized trial in the primary care setting. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Application of a decision support tool for anticoagulation in patients with non-valvular atrial fibrillation. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Electronic alerts for ambulatory patients with atrial fibrillation not prescribed anticoagulation: A randomized, controlled trial (AF-ALERT2). [2023]

5. England pubmed.ncbi.nlm.nih.gov

An interrupted time series study of electronic health record clinical decision support for providers caring for patients with atrial fibrillation at increased stroke risk. [2023]

6. Poland pubmed.ncbi.nlm.nih.gov

Pilot of a Computerised Antithrombotic Risk Assessment Tool Version 2 (CARATV2.0) for stroke prevention in atrial fibrillation. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

Availability of patient decision aids for stroke prevention in atrial fibrillation: A systematic review. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Computerized Decision Support Systems on Management of Atrial Fibrillation: A Scoping Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Electronic health record-embedded decision support to reduce stroke risk in patients with atrial fibrillation - Study protocol. [2022]

10. England pubmed.ncbi.nlm.nih.gov

A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial. [2022]