Data-driven SDM to Reduce Symptom Burden in AF
- Conditions
- Atrial FibrillationPatient Engagement
- Interventions
- Other: Shared decision-making tool
- Registration Number
- NCT04993807
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 75
- 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
- Asymptomatic AF
- Severe cognitive impairment
- Major psychiatric illness
- Concomitant terminal illness that would preclude participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Shared decision-making tool Shared decision-making tool Participants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation.
- Primary Outcome Measures
Name Time Method Decision satisfaction assessed using the Satisfaction with Decision Scale 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).
Decision regret assessed using the Decisional Regret Scale 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).
Decisional conflict assessed using the Decisional Conflict Scale 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).
- Secondary Outcome Measures
Name Time Method Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS) 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).
Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire 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).
Trial Locations
- Locations (2)
Weill Cornell Medicine
🇺🇸New York, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States