Decision Support Tool for Atrial Fibrillation

Overseen By Larry Jackson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must be taking: Oral anticoagulants

Disqualifiers: Non-English speakers, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a decision support tool might assist patients with non-valvular atrial fibrillation (a heart condition causing irregular heartbeat) in understanding the risks and benefits of using oral anticoagulants (blood thinners) to reduce stroke risk. The researchers aim to determine if this tool can improve decision-making and increase anticoagulant use, particularly among Black patients. Participants will either use the Patient Decision Support Tool alongside regular doctor counseling or receive standard counseling alone. Suitable candidates include Black and White adults diagnosed with non-valvular atrial fibrillation who are consulting a doctor about starting blood thinners. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance patient decision-making and healthcare outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on starting oral anticoagulation for stroke prevention in patients with non-valvular atrial fibrillation.

What prior data suggests that this decision support tool is safe for patients with non-valvular atrial fibrillation?

Research shows that digital tools, like the one being tested, help people with atrial fibrillation make better decisions to prevent strokes. These tools enhance collaboration between patients and doctors in selecting treatments. Past studies have not linked these tools to any major negative side effects. They primarily aid patients in understanding their treatment options, leading to more informed health choices.

Overall, using these decision-support tools has shown promise in assisting patients without causing harm. No known safety concerns exist with these tools. They are designed to facilitate discussions between patients and doctors about the risks and benefits of different treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Support Tool for atrial fibrillation because it aims to enhance patient involvement in treatment decisions. Unlike traditional methods that rely solely on physician counseling, this tool provides a structured way for patients to understand the risks and benefits of oral anticoagulation therapy. By fostering shared decision-making between patients and doctors, the tool could lead to more personalized care and possibly better adherence to treatment plans. This approach empowers patients, potentially improving overall outcomes by aligning treatment choices with their personal values and preferences.

What evidence suggests that this decision support tool is effective for atrial fibrillation?

Research has shown that digital tools help patients feel more confident and informed when making treatment decisions. These tools also increase patients' understanding of their health conditions. In this trial, one group of participants will use a Patient Decision Support Tool alongside physician counseling to discuss the risks and benefits of systemic oral anticoagulation for atrial fibrillation (AF). Studies have explored how such tools assist patients and doctors in choosing the best ways to prevent strokes. Using these tools encourages shared decision-making, where patients and doctors collaborate to select the most suitable treatment. This approach aims to improve decision quality and may lead to more patients using recommended treatments like blood-thinning medications. ^{1 3 6 7 8}

Who Is on the Research Team?

Larry Jackson

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for Black and White adults over 18 with non-valvular atrial fibrillation (NVAF) who have a CHA2DS2-VASc score of at least 2, indicating a higher risk of stroke. They must be new patients at primary care or cardiology clinics considering starting oral anticoagulation but cannot participate if they can't speak English or provide informed consent.

Inclusion Criteria

I am starting oral anticoagulation treatment at a primary care or cardiology clinic.

I have been diagnosed with non-valvular atrial fibrillation.

You have a score of 2 or more on the CHA2DS2-VASc scale.

Exclusion Criteria

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use a patient decision support tool in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Patient Decision Support Tool

Trial Overview The study tests whether a patient decision support tool can improve the quality of decisions made by patients regarding the use of oral anticoagulants to prevent strokes in NVAF. It aims to see if this tool helps, especially among Black patients, and will assess its feasibility and acceptability.

How Is the Trial Designed?

Group I: Patient Decision Support Tool Experimental Treatment 1 Intervention

Patient decision support tool to be used in conjunction with physician counseling to discuss the risk and benefits of systemic oral anticoagulation.

Group II: Usual Healthcare Counseling Active Control 1 Intervention

Traditional physician counseling regarding the risk and benefits of systemic oral anticoagulation

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A study involving 15 patients with atrial fibrillation and 5 clinicians revealed that while patients experienced low decisional conflict and regret regarding catheter ablation, they felt under-informed and lacked agency in the decision-making process.

Patients expressed a strong preference for an interactive, web-based decision aid that provides clear evidence and personalized risk assessments, indicating a need for tools that enhance decision quality and patient engagement in treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation. Reading Turchioe, M., Mangal, S., Ancker, JS., et al.[2023]

Patient support programs (PSPs) were the only data source to contribute to a drug safety label change, indicating their potential value in monitoring safety, while market research programs and social media did not lead to any label changes.

Overall, the study found that traditional PSPs provided more reliable safety information compared to market research programs and social media, which had low completeness scores, suggesting that not all data sources are equally effective in enhancing the understanding of a product's safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety. Jokinen, J., Bertin, D., Donzanti, B., et al.[2020]

An interactive decision-making aid was developed for patients with atrial fibrillation (AF) using a user-centered design approach, incorporating feedback from both experts and AF patients.

Preliminary evaluations suggest that this decision aid, which includes visualizations, could effectively help patients make informed treatment decisions regarding their AF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing for patient decision-making: Design challenges generated by patients with atrial fibrillation during evaluation of a decision aid prototype. Fanio, J., Zeng, E., Wang, B., et al.[2023]

From 2011 to 2015, an estimated 145,490 emergency department visits annually in the U.S. were due to adverse events from antibiotics, highlighting a significant safety concern.

Allergic reactions were the leading cause of these visits, accounting for 74.3% of cases, with younger adults (ages 20-34) experiencing the highest rates of antibiotic-related adverse events compared to older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Estimates of Emergency Department Visits for Antibiotic Adverse Events Among Adults-United States, 2011-2015. Geller, AI., Lovegrove, MC., Shehab, N., et al.[2020]

The PROSPER Consortium aims to enhance safety reporting in healthcare by integrating patient-reported outcomes (PROs) into the assessment of adverse events, recognizing the importance of the patient's perspective in understanding treatment effects.

Despite advancements in technology and increased focus on patient involvement, current safety reporting still heavily relies on healthcare professionals, which can lead to under-reporting and discrepancies between patient experiences and clinician perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Banerjee, AK., Okun, S., Edwards, IR., et al.[2022]

The study highlights the inefficiency of manual management of serious adverse events (AEs) and reactions (ARs) in clinical trials, emphasizing the need for improved reporting systems.

A new data model has been developed to facilitate automatic code generation for a software tool designed to assist in the management of AE/AR data, potentially enhancing the efficiency and effectiveness of regulatory compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling an IT Support for Handling Serious Adverse Events in Clinical Trials. Fonck, S., Deserno, T.[2018]

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 proof-of-concept study using recurrent neural networks (RNNs) showed promise for automating the classification of adverse event (AE) terminology from FDA's FAERS and structured product labels (SPLs), which could improve regulatory efficiency.

The model performed well on SPL data, matching or exceeding conventional methods, but had mixed results on FAERS data, suggesting that more extensive data sets are needed for better generalization and validation of AE detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing Deep Learning for Detecting Adverse Drug Events in Structured and Unstructured Regulatory Drug Data Sets. Knisely, BM., Hatim, Q., Vaughn-Cooke, M.[2022]

The ENHANCE-AF trial is a multicenter, randomized controlled study involving 1,200 participants aimed at evaluating a new decision aid for shared decision making (SDM) in anticoagulation therapy for patients with atrial fibrillation (AF).

The primary outcome is to assess the Decisional Conflict Scale one month after the decision-making visit, with secondary outcomes including patient and clinician satisfaction, adherence to anticoagulation, and rates of major bleeding, death, stroke, or transient ischemic attack over a 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. Baykaner, T., Pundi, K., Lin, B., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11874357/

Use of digital patient decision-support tools for atrial ... Moderate certainty evidence suggests digital patient decision-support tools reduce decisional conflict, with low certainty evidence of knowledge improvement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11348720/

Randomized evaluation of decision support interventions ... The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04357288

Study Details | NCT04357288 | Randomized Evaluation of ... This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and ...

4. academic.oup.com academic.oup.com/eurheartj/article/45/Supplement_1/ehae666.3571/7839315

Implementation of digital patient decision support tools for ... To systematically review trials of digital patient decision-support tools for AF treatment decisions, focusing on factors influencing their ...

5. ahajournals.org ahajournals.org/doi/10.1161/circ.150.suppl_1.4139443

Abstract 4139443: Patient Decision Aids and Encounter ... Our study assessed the comparative effectiveness of PDAs and EDAs on SDM during AF clinical encounters where stroke prevention strategies were ...

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

Effect of a clinical decision support system for non-valvular ... Atrial fibrillation (AF) is one of the most common arrhythmia diseases with high risk of disability and mortality, greatly reducing the quality ...

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

Randomized Clinical Trial to Evaluate an Atrial Fibrillation ... We evaluated the effects of a novel patient‐clinician shared decision‐making (SDM) tool in reducing oral anticoagulation patient's decisional conflict as ...

8. 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.