BPA Tool for Stroke Prevention in Atrial Fibrillation

(SUPPORT-AF IV Trial)

Recruiting at 1 trial location

Overseen By Alok Kapoor, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Must be taking: Anticoagulants

Disqualifiers: Left atrial appendage closure, hospice, pregnancy, prisoner, others

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

Compensation: Varies

Number of Visits: Unknown

5094 Participants Needed

Trial Summary

What is the purpose of this trial?

Six million Americans live with atrial fibrillation (AF), a heart rhythm abnormality that is a major risk factor for stroke and only half of those AF patients receive oral anticoagulation (AC). Within the context of an ongoing collaboration between two large learning health systems, the investigators propose to study the impact of a shared clinical decision support tool embedded within the electronic health record designed to enhance guideline-based AC prescription. The hypothesis the investigators are testing is that the number of AC starts in patients seen by intervention providers will be higher than in patients seen by control providers. Additionally, the investigators are testing the hypothesis that the risk of not persisting on AC will be higher in the patients of control providers compared with patients of intervention providers.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Best practice advisory (BPA) for stroke prevention in atrial fibrillation?

Research shows that using a best practice advisory (BPA) can help improve the use of anticoagulation (blood-thinning) treatments, which are known to reduce the risk of stroke in patients with atrial fibrillation. This approach addresses the gap in therapy use and supports better decision-making between patients and healthcare providers. ^{1 2 3 4 5}

Is the BPA tool for stroke prevention in atrial fibrillation safe for humans?

The safety of antithrombotic therapy, including new oral anticoagulants like dabigatran, is often assessed using risk tools that consider factors like age and previous bleeding. These tools help balance the risk of bleeding against the benefit of stroke prevention, but more integration of safety aspects is needed. ^{6 7 8 9 10}

How does the BPA Tool for Stroke Prevention in Atrial Fibrillation differ from other treatments?

The BPA Tool for Stroke Prevention in Atrial Fibrillation is unique because it is a decision support tool embedded within electronic health records to improve anticoagulation prescribing, addressing the underutilization of anticoagulation therapy in patients with atrial fibrillation. ^{3 11 12 13 14}

Research Team

Alok Kapoor, MD

Principal Investigator

UMass Chan Medical School

Eligibility Criteria

This trial is for adults with atrial fibrillation or flutter who've seen a primary care provider or heart specialist in the past year and have this condition noted in their health records. It's not for those under 18, pregnant women, prisoners, patients without an AF diagnosis, those with left atrial appendage closure, or hospice patients.

Inclusion Criteria

I am 18 or older with a diagnosis of atrial fibrillation or flutter and have seen a heart specialist or primary care provider in the last year.

I am 18 or older with a diagnosis of AF or atrial flutter and have seen a heart specialist in the last year.

Exclusion Criteria

You are currently in hospice care.

You haven't been diagnosed with atrial fibrillation or atrial flutter by a primary care provider or cardiovascular medicine specialist in the past year.

I am younger than 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Providers receive a best practice advisory (BPA) to enhance guideline-based AC prescription

12 months

Follow-up

Participants are monitored for initiation and persistence of oral anticoagulation use

12 months

Treatment Details

Interventions

• Best practice advisory (BPA)

Trial Overview The study tests if a decision support tool within electronic health records can increase prescription of oral anticoagulants (AC) to prevent strokes in AF patients. Providers are split into two groups: one uses the tool (intervention group), while the other doesn't (control group).

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Receive best practice advisory (BPA)

Group II: Control Active Control 1 Intervention

Does not receive best practice advisory (BPA)

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Findings from Research

A review identified 14 shared decision-making (SDM) tools for patients with atrial fibrillation (AF) considering stroke prevention, most of which provided current information but lacked practical considerations like cost.

While five of these tools showed small improvements in patient knowledge and reduced decisional conflict, their effectiveness in promoting high-quality SDM remains uncertain, highlighting the need for better user-centered development and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan. Torres Roldan, VD., Brand-McCarthy, SR., Ponce, OJ., et al.[2021]

A novel digital shared decision-making toolkit significantly reduced decisional conflict in patients with atrial fibrillation (AF) compared to usual care, with a notable 7-point difference in median scores at 1 month after implementation.

The toolkit, which included various patient-centered resources, was effective in helping patients make informed choices about oral anticoagulation, although the benefits in reducing decisional conflict and regret diminished over time, indicating the need for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. Wang, PJ., Lu, Y., Mahaffey, KW., et al.[2023]

References

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

Stroke prevention in patients with atrial fibrillation: disease burden and unmet medical needs. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Provider Specialty, Anticoagulation Prescription Patterns, and Stroke Risk in Atrial Fibrillation. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Can a best practice advisory improve anticoagulation prescribing to reduce stroke risk in patients with atrial fibrillation? [2023]

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

Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan. [2021]

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

Randomized Clinical Trial to Evaluate an Atrial Fibrillation Stroke Prevention Shared Decision-Making Pathway. [2023]

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

Dabigatran: comparison to warfarin, pathway to approval, and practical guidelines for use. [2015]

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

Atrial fibrillation and thromboembolism: a decade of progress in stroke prevention. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Aspirin in the Food and Drug Administration Adverse Event Reporting System: Missing Demographics and Underreporting. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Safe use of antithrombotics for stroke prevention in atrial fibrillation: consideration of risk assessment tools to support decision-making. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Appropriateness of Oral Anticoagulants for the Long-Term Treatment of Atrial Fibrillation in Older People: Results of an Evidence-Based Review and International Consensus Validation Process (OAC-FORTA 2016). [2018]

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

Use of Guidelines for Reducing Stroke Risk in Patients With Nonvalvular Atrial Fibrillation: A Review From a Latin American Perspective. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Stroke prevention in atrial fibrillation: comparison of recent international guidelines. [2021]

13. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Atrial Fibrillation: Stroke Prevention in Clinical Practice Physician]. [2019]

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

Development and validation of a decision aid for choosing among antithrombotic agents for atrial fibrillation. [2017]