Decision Aid Tool for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Meghan Reading Turchioe, PhD, MPH, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Columbia University

Disqualifiers: Asymptomatic AF, Severe cognitive impairment, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study is a single-group feasibility study evaluating decision aid visualizations which display common post-ablation symptom patterns as a tool for shared decision-making. The specific aim of the clinical trial is to evaluate the feasibility of putting the visualizations into clinical practice (n=75). The hypothesis is that patients will report low decisional conflict and decision regret and high satisfaction with their decision about whether to undergo an ablation or not.

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 data supports the effectiveness of the shared decision-making tool for atrial fibrillation treatment?

Research shows that using a shared decision-making tool for atrial fibrillation can significantly reduce patients' uncertainty and improve satisfaction with their treatment choices. A study found that patients using the tool experienced less decisional conflict compared to those receiving usual care, indicating that the tool helps patients feel more confident and satisfied with their treatment decisions. ^{1 2 3 4 5}

Is the decision aid tool for atrial fibrillation safe for humans?

The research does not provide specific safety data for the decision aid tool, but it focuses on improving decision-making and patient knowledge, which suggests it is generally safe for use in humans. ^{1 3 6 7 8}

How does the Decision Aid Tool for Atrial Fibrillation differ from other treatments for this condition?

The Decision Aid Tool for Atrial Fibrillation is unique because it focuses on shared decision-making, helping patients and clinicians collaboratively choose the best treatment plan based on individual preferences and goals. Unlike traditional treatments, this tool uses interactive elements like videos and quizzes to reduce decisional conflict and improve patient satisfaction. ^{1 2 3 4 9}

Research Team

Meghan Reading Turchioe, PhD, MPH, RN

Principal Investigator

Columbia University

Eligibility Criteria

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 am 18 years old or older.

Able to read and speak English

I have symptoms of atrial fibrillation.

Exclusion Criteria

I have atrial fibrillation but no symptoms.

Concomitant terminal illness that would preclude participation

You have a serious mental illness.

Trial Timeline

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)

Treatment Details

Interventions

• Shared decision-making tool (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Katrina Armstrong

Columbia University

Chief Executive Officer

MD from Johns Hopkins University, MS in Epidemiology from Harvard School of Public Health

Dr. Katrina Armstrong

Columbia University

Chief Medical Officer

MD from Harvard Medical School

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Dr. Robert Min

Weill Medical College of Cornell University

Chief Executive Officer since 2024

MD, MBA

Dr. Adam R. Stracher

Weill Medical College of Cornell University

Chief Medical Officer since 2024

MD

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Dr. Jessica Gill

National Institute of Nursing Research (NINR)

Chief Medical Officer since 2023

PhD in Nursing from Johns Hopkins University

Dr. Shannon Zenk

National Institute of Nursing Research (NINR)

Chief Executive Officer since 2020

PhD in Urban Planning and Policy Development from Rutgers University

Findings from Research

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

'Replace uncertainty with information': shared decision-making and decision quality surrounding catheter ablation for atrial fibrillation. [2023]

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

The ENHANCE-AF clinical trial to evaluate an atrial fibrillation shared decision-making pathway: Rationale and study design. [2022]

3. Switzerland 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Shared decision-making in atrial fibrillation: patient-reported involvement in treatment decisions. [2021]

6. England 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. [2018]

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

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. [2021]

9. 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]