BPA Tool for Stroke Prevention in Atrial Fibrillation

(SUPPORT-AF IV Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision support tool, Best Practice Advisory (BPA), to assist doctors in prescribing blood thinners for patients with atrial fibrillation (AF), a heart condition that increases stroke risk. The trial aims to determine if this tool boosts the number of patients who start and continue these medications. It compares doctors using the tool with those who do not. Suitable participants have been diagnosed with AF and have visited a primary care or heart specialist in the past year. As an unphased trial, this study allows patients to contribute to innovative research that could enhance treatment strategies for AF.

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 prior data suggests that this clinical decision support tool is safe for stroke prevention in atrial fibrillation?

Research shows that a best practice advisory (BPA) in electronic health records can help doctors prescribe blood-thinning medication more effectively for patients with atrial fibrillation (AF). Studies have found that incorporating a BPA into decision-making tools for AF has improved medication use in primary care settings.

The BPA is a digital tool, not a medication, so it doesn't have side effects like a drug might. Instead, it reminds doctors to follow guidelines when prescribing blood thinners, which are crucial for preventing strokes in AF patients.

No negative effects or safety issues have been reported from using the BPA tool itself. This suggests it is safe to use, as it primarily offers guidance rather than direct medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the best practice advisory (BPA) tool for stroke prevention in atrial fibrillation because it offers a new approach to managing patient care. Unlike traditional treatments that rely on medications like anticoagulants, the BPA tool focuses on enhancing clinical decision-making by providing timely, evidence-based recommendations to healthcare providers. This method aims to improve the consistency and quality of care, potentially leading to better patient outcomes by ensuring that best practices are followed more diligently.

What evidence suggests that this BPA tool is effective for stroke prevention in atrial fibrillation?

Research has shown that a best practice advisory (BPA) can enhance blood-thinning treatment for patients with atrial fibrillation (AF). One study with 562 patients demonstrated that adding a BPA to a decision-making tool significantly improved treatment outcomes. More patients received the appropriate blood-thinning medication, crucial for stroke prevention. In this trial, participants in the intervention arm will receive the BPA to assist doctors in following guidelines that reduce stroke risk in AF patients. Overall, using a BPA increases the likelihood that patients will receive the correct treatment to protect against strokes. ^{1 2 5 6 7}

Who Is on the Research Team?

Alok Kapoor, MD

Principal Investigator

UMass Chan Medical School

Are You a Good Fit for This Trial?

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 have not seen a heart specialist or primary care provider for AF or atrial flutter in the last year.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(23)00191-0/fulltext

Can a best practice advisory improve anticoagulation ... A BPA added to an AF decision support tool improved anticoagulation therapy among AF patients in a primary care academic health system setting.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37579873/

Can a best practice advisory improve anticoagulation ... Results: Among 562 patients with a minimum follow-up of 3 months, addition of a BPA to the AFDST resulted in significant improvement in ...

3. journal-of-cardiology.com journal-of-cardiology.com/article/S0914-5087(23)00191-0/pdf

Can a best practice advisory improve anticoagulation ... The primary outcome was effectiveness of the BPA measured by change to “appropriate thromboprophylaxis” (treatment with the highest QALYs ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04099485

EHR-Embedded Decision Support to Prevent Stroke in ... ... Effectiveness Study to Evaluate Atrial Fibrillation Decision-Support Tool (AFDST) vs. AFDST with addition of best practice advisory (BPA) and semi-automated ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10867001/

Atrial fibrillation: stroke prevention - PMC Evidence-based management of AF patients following the ABC integrated care pathway has been associated with a lower risk of stroke and other adverse events.

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.120.049768

Stroke Prevention in Atrial Fibrillation | Circulation We summarize the major advances in stroke prevention for patients with atrial fibrillation during the past 30 years and focus on novel diagnostic and treatment ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870325000390

Impact of a clinical atrial fibrillation risk estimation tool on ... The intervention consisted of an electronic health record (EHR)-based best-practice advisory (BPA) alert which calculated and displayed 5-year risk of AF. We ...