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Completed

NCT Number: NCT04993807

Data-driven SDM to Reduce Symptom Burden in AF

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Irving Medical Center, New York, United States

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About this study

Atrial fibrillation (AF) is the most common heart rhythm disorder, and nearly 90% of patients experience symptoms such as shortness of breath that directly impair their health-related quality of life (HRQoL). Catheter ablation is a minimally invasive, surgical procedure that is routinely performed to treat AF and associated symptoms with the goal of improving HRQOL, but also carries potentially serious risks. Shared decision-making (SDM), in which treatment decisions are aligned based on high quality evidence and patient values and goals of care, is a widely encouraged practice for navigating complex healthcare decisions such as these. However, SDM around rhythm and symptom management does not routinely occur due to a lack of detailed evidence about symptom improvement post-ablation, and a lack of decision aids to communicate evidence to patients. The overarching goal of this award is to create an interactive patient decision aid composed of established evidence from clinical trials together with novel "real world" evidence about symptom improvement post ablation mined from electronic health records (EHRs).

The investigators propose to use "real-world evidence" drawn from electronic health records (EHRs) to characterize post-ablation symptom patterns, and display them in decision-aid visualizations to support shared decision-making (SDM). In this project, the investigators will first use natural language processing (NLP) and machine learning (ML) to extract and analyze symptom data from narrative notes in EHRs. The investigators will also employ a rigorous, user-centered design protocol created during the Principal Investigator's post-doctoral work to develop decision-aid visualizations. In the clinical trial, the investigators will evaluate the feasibility of implementing these interactive decision-aid visualizations in clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of paroxysmal AF according to International Classification of Diseases, Tenth Revision (ICD-10)
  • Scheduled consultation at NewYork-Presbyterian Hospital (NYP) to discuss catheter ablation
  • Symptomatic AF at baseline
  • Age 18 years and older
  • Able to read and speak English
  • Willing/able to provide informed consent

Exclusion criteria

  • Asymptomatic AF
  • Severe cognitive impairment
  • Major psychiatric illness
  • Concomitant terminal illness that would preclude participation

Treatment and study plan

Shared decision-making tool

Other

Participants will use an interactive web page intended to aid patient decision-making (i.e., a decision aid) while undergoing consultation for atrial fibrillation ablation.

Primary outcomes

  1. Decisional conflict assessed using the Decisional Conflict Scale

    Time frame: Baseline

    Conflict about the decision to undergo atrial fibrillation will be assessed using the Decisional Conflict Scale on a scale of 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  2. Decision regret assessed using the Decisional Regret Scale

    Time frame: 12 weeks

    Regret about the decision to undergo atrial fibrillation will be assessed using the Decision Regret Scale on a scale of 0 (no decision regret) to 100 (extremely high decision regret).

  3. Decision satisfaction assessed using the Satisfaction with Decision Scale

    Time frame: 12 weeks

    Satisfaction about the decision to undergo atrial fibrillation will be assessed using the Satisfaction with Decision Scale on a scale of 1 (low satisfaction) to 5 (high satisfaction).

Secondary outcomes

  1. Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS)

    Time frame: 12 weeks

    The severity of atrial fibrillation symptoms after an ablation will be assessed using the AFSS on a scale of 0 (no symptom burden) to 35 (extremely high symptom burden).

  2. Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire

    Time frame: 12 weeks

    Health-related quality of life after an ablation will be assessed using the AFEQT on a scale of 0 (complete disability) to 100 (high quality of life).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Data-driven Shared Decision-Making (SDM) to Reduce Symptom Burden in Atrial Fibrillation (AF)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2021
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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