Data-driven SDM to Reduce Symptom Burden in AF

NCT04993807 | Completed

• 3 other identifiers: AAAU2028K99NR01912419-11021059
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

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.

Conditions

Atrial Fibrillation; Patient Engagement

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Decisional conflict assessed using the Decisional Conflict Scale

  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).

  Baseline

• Decision regret assessed using the Decisional Regret Scale

  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).

  12 weeks

• Decision satisfaction assessed using the Satisfaction with Decision Scale

  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).

  12 weeks

Secondary Outcomes (2)

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

  12 weeks

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

  12 weeks

Study Arms (1)

Shared decision-making tool

EXPERIMENTAL

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

Other: Shared decision-making tool

Interventions

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.

Shared decision-making tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Weill Cornell Medicine

New York, New York, 07030, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Reading Turchioe M, Shamnath A, Slotwiner D, Zhao Y, Saluja D, Goldbarg S, Kim J, Varosy P, Biviano A. Evaluating a digital decision aid for atrial fibrillation rhythm control in a hybrid implementation-effectiveness trial. NPJ Digit Med. 2026 Mar 6. doi: 10.1038/s41746-026-02405-y. Online ahead of print.

  PMID: 41792400 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Patient Participation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Meghan Reading Turchioe, PhD, MPH, RN

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Nursing

Model Details: This is a single arm feasibility study.

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 6, 2021
• Study Start: March 25, 2024
• Primary Completion: June 20, 2025
• Study Completion: August 20, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 3 years and ending 5 years following publication.
• Access Criteria: Researchers who provide a methodologically sound proposal and have completed Data Use Agreements.

Locations

US (2)