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| ID | Type | Description | Link |
|---|---|---|---|
| K99NR019124 | U.S. NIH Grant/Contract | View source | |
| 19-11021059 | Other Identifier | Weill Cornell Medicine |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meghan Reading Turchioe, PhD, MPH, RN | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 07030 | United States | ||
| Columbia University Irving Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41792400 | Derived | 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;9(1):326. doi: 10.1038/s41746-026-02405-y. |
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De-identified individual participant data (IPD) will be available to other researchers upon reasonable request after Data Use Agreements have been executed.
Beginning 3 years and ending 5 years following publication.
Researchers who provide a methodologically sound proposal and have completed Data Use Agreements.
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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This is a single arm feasibility study.
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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 |
| New York |
| New York |
| 10032 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |