Decision Aid Tool for Atrial Fibrillation

Recruiting at 1 trial location

Overseen By Meghan Reading Turchioe, PhD, MPH, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Asymptomatic AF, Severe cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to assist individuals with atrial fibrillation (AF), a heart condition causing an irregular heartbeat, in making informed decisions about undergoing a procedure called ablation. The shared decision-making tool presents common symptom patterns after ablation to facilitate collaborative decision-making between patients and doctors. The trial aims to determine if using this tool increases patients' confidence and satisfaction with their decisions. Individuals experiencing irregular heartbeats with symptoms and scheduled for an ablation consultation at NewYork-Presbyterian Hospital may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve decision-making tools for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this decision aid tool is safe for use in shared decision-making?

Research has shown that shared decision-making tools are generally safe. These tools enable patients and doctors to collaborate on informed treatment choices by providing clear information about the benefits and risks of different options.

Studies indicate that patients appreciate these tools for offering clear evidence and reducing uncertainty about treatment outcomes. No reports of negative effects from using these decision aids exist. They are well-received and focus on helping patients make choices that align with their values and priorities. Overall, these tools are considered safe and helpful for informed decision-making. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for atrial fibrillation, like medications or procedures such as ablations, focus on controlling heart rhythm or rate. However, this new approach uses a shared decision-making tool that helps patients actively participate in their treatment choices during consultations for an atrial fibrillation ablation. Researchers are excited because it empowers patients, potentially leading to better satisfaction and outcomes by aligning medical decisions closely with individual preferences and values. This tool represents a shift from a purely medical focus to a more personalized and collaborative treatment strategy.

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

Research has shown that tools for shared decision-making can help patients make better health choices. In this trial, participants will use a shared decision-making tool during their consultation for atrial fibrillation ablation. One study found that these tools improved decision-making for patients considering catheter ablation, a procedure for irregular heartbeats. The tool uses pictures to explain common symptoms after heart surgery, helping patients know what to expect. Another study showed that these tools enhance communication between patients and doctors, leading to more informed decisions. Overall, these tools aim to reduce uncertainty and increase satisfaction with treatment choices. ^{2 4 5 6 7}

Who Is on the Research Team?

Meghan Reading Turchioe, PhD, MPH, RN

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 with symptomatic, paroxysmal atrial fibrillation who are considering catheter ablation at NewYork-Presbyterian Hospital. They must be able to give informed consent. Those with terminal illnesses, asymptomatic AF, major psychiatric conditions or severe cognitive impairment cannot participate.

Inclusion Criteria

I have symptoms of atrial fibrillation.

Willing/able to provide informed consent

I have an appointment at NYP to talk about a procedure to treat heart rhythm problems.

Exclusion Criteria

I have atrial fibrillation but no symptoms.

Concomitant terminal illness that would preclude participation

You have a serious mental illness.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consultation and Decision-making

Participants view a shared decision-making tool during consultation for atrial fibrillation ablation

1 visit

1 visit (in-person)

Follow-up

Participants are monitored for decisional conflict, decision regret, and satisfaction with their decision

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Shared decision-making tool

Trial Overview The study tests a shared decision-making tool that uses visual aids to show common symptoms after heart rhythm surgery (ablation). It aims to see if this helps patients make decisions about their treatment and measures how satisfied they are with those decisions.

How Is the Trial Designed?

Group I: Shared decision-making tool Experimental Treatment 1 Intervention

Participants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

The Integrated Decision Aid (IDeA) significantly improved patients' knowledge about their personalized stroke risk, increasing it by nearly four times compared to usual care, based on a study involving 66 patients and 6 clinicians.

Patients experienced reduced uncertainty in their decision-making regarding stroke prevention options, indicating that the IDeA is an effective tool for enhancing patient understanding and engagement in their care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized, Electronic Health Record-Integrated Decision Aid for Stroke Prevention in Atrial Fibrillation: A Small Cluster Randomized Trial and Qualitative Analysis of Efficacy and Acceptability. Schott, SL., Berkowitz, J., Dodge, SE., et al.[2021]

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]

In a study of 1006 patients with newly diagnosed atrial fibrillation, about half reported that their oral anticoagulant treatment decisions were made solely by their healthcare provider, indicating limited shared decision-making (SDM) in treatment choices.

Patients who understood their treatment options for oral anticoagulants and rhythm control were over two times more likely to engage in shared decision-making, suggesting that improving patient education could enhance their involvement in treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shared decision-making in atrial fibrillation: patient-reported involvement in treatment decisions. Ali-Ahmed, F., Pieper, K., North, R., et al.[2021]

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]

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 new decision aid (DA) tool for patients with atrial fibrillation (AF) has been developed to help them understand their specific risks for stroke and bleeding when considering oral anticoagulant (OAC) treatments, based on a comprehensive review of literature and patient feedback.

The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices about their treatment options, although further research is needed to test its effectiveness in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. Kaiser, K., Cheng, WY., Jensen, S., et al.[2018]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11262844/

Implementation of a Patient Decision Aid for Atrial ... Shared decision-making (SDM) is a method for a patient and physician to cooperatively consider a diagnostic or therapeutic option, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10111971/

Replace uncertainty with information - PubMed Central - NIH We aimed to measure decision quality and describe decision-making processes among patients and clinicians involved in decision-making around catheter ablation ...

3. withpower.com withpower.com/trial/phase-atrial-fibrillation-7-2022-752e9

Decision Aid Tool for Atrial Fibrillation · Info for Participants Trial Overview The study tests a shared decision-making tool that uses visual aids to show common symptoms after heart rhythm surgery (ablation). It aims to see ...

4. frontiersin.org frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2022.1086652/full

Designing for patient decision-making In this Brief Research Report, we describe the development and preliminary evaluation of an interactive decision-making aid for patients with AF.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00151-8/fulltext?rss=yes

Development and validation of risk stratification and shared ... This study aimed to develop a shared decision-making tool that aids in risk stratification and guides radiofrequency catheter ablation (RFCA) decisions for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36031860/

'Replace uncertainty with information': shared decision ... Patients reported preferences for an interactive, web-based decision aid that clearly presents evidence regarding outcomes using data, ...

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(22)01365-0/fulltext

PO-712-06 DEVELOPMENT OF AN INTERACTIVE ... Decision aids provide information about treatment options, harms and benefits, and alignment with values and priorities during shared decision-making (SDM).