Data-driven SDM to Reduce Symptom Burden in AF

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993807
• Other study ID #: AAAU2028
• Secondary ID: K99NR01912419-11
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: Meghan Reading Turchioe, PhD, MPH, RN
• Phone: 212-305-1557
• Email: mr3554[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Patient Engagement

Intervention

Other:
• Shared decision-making tool
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.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York
United States	Weill Cornell Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS)	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).	12 weeks
Secondary	Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire	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).	12 weeks