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Data-driven SDM to Reduce Symptom Burden in AF

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04993807
Enrollment
75
Registered
2021-08-06
Start date
2024-03-25
Completion date
2025-08-20
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Patient Engagement

Keywords

Shared Decision-Making (SDM), Symptom Burden, Decisional Conflict, Decision Regret, Decision Satisfaction

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Columbia University
Lead SponsorOTHER
National Institute of Nursing Research (NINR)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

This is a single arm feasibility study.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflict assessed using the Decisional Conflict ScaleBaselineConflict 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).
Decision regret assessed using the Decisional Regret Scale12 weeksRegret 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).
Decision satisfaction assessed using the Satisfaction with Decision Scale12 weeksSatisfaction 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

MeasureTime frameDescription
Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS)12 weeksThe 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).
Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire12 weeksHealth-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).

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMeghan Reading Turchioe, PhD, MPH, RN

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026