Data-driven Shared Decision-Making (SDM) to Reduce Symptom Burden in Atrial Fibrillation (AF)
概览
- 阶段
- 不适用
- 干预措施
- Shared decision-making tool
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Columbia University
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Decision satisfaction assessed using the Satisfaction with Decision Scale
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Meghan Turchioe
Assistant Professor of Nursing
Columbia University
入排标准
入选标准
- •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
排除标准
- •Asymptomatic AF
- •Severe cognitive impairment
- •Major psychiatric illness
- •Concomitant terminal illness that would preclude participation
研究组 & 干预措施
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.
干预措施: Shared decision-making tool
结局指标
主要结局
Decision satisfaction assessed using the Satisfaction with Decision Scale
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- 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)