Atrial FibrillationNCT04993807
Data-driven SDM to Reduce Symptom Burden in AF
A study testing Shared decision-making tool in people with Atrial Fibrillation and Patient Engagement, run by Columbia University at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Patient Engagement
- What is being tested?
- Shared decision-making tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2024to 20 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Asymptomatic AF
- Severe cognitive impairment
- Major psychiatric illness
- Concomitant terminal illness that would preclude participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Weill Cornell Medicine
New York, New York, 07030
Columbia University Irving Medical Center
New York, New York, 10032
About this study
Official title: Data-driven Shared Decision-Making (SDM) to Reduce Symptom Burden in Atrial Fibrillation (AF)
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.
Read the 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.
- Conditions
- Atrial Fibrillation, Patient Engagement
- Being tested
- Shared decision-making tool
- Keywords
- Shared Decision-Making (SDM), Symptom Burden, Decisional Conflict, Decision Regret, Decision Satisfaction
- Medical subject headings
- Atrial Fibrillation, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared decision-making toolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Shared decision-making tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline 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).
Measured: Baseline
Two Week 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).
Measured: 2 weeks
Baseline Decision Self-Efficacy Score Assessed Using the Decision Self-Efficacy Scale
The Decision Self-Efficacy Scale ranges from 0-100; higher indicates more self-efficacy.
Measured: Baseline
Two Week Decision Self-efficacy Assessed Using the Decisional Self-Efficacy Scale
The Decision Self-Efficacy Scale ranges from 0-100; higher indicates more self-efficacy.
Measured: 2 weeks
Secondary outcomes (2)
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).
Measured: 12 weeks
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start25 Mar 2024
- Primary completion20 Jun 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm feasibility study.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Meghan Turchioe, Columbia University
- Investigators
- Meghan Reading Turchioe, PhD, MPH, RN, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993807
- Sponsor's protocol ID
- AAAU2028
- Other IDs
- K99NR019124, 19-11021059
- Status last verified
- Sep 2026
- First submitted
- 27 Jul 2021
- Last updated
- 15 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be available to other researchers upon reasonable request after Data Use Agreements have been executed.
Publications
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.
PubMed 41792400
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-driven Shared Decision-Making (SDM) to Reduce Symptom Burden in Atrial Fibrillation (AF)
- ClinicalTrials.gov ID
- NCT04993807
- Acronym / sponsor ID
- AAAU2028
- Conditions
- Atrial Fibrillation, Patient Engagement
- Keywords
- Shared Decision-Making (SDM), Symptom Burden, Decisional Conflict, Decision Regret, Decision Satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 6 Aug 2021 (actual)
- Results
- Posted 15 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Shared decision-making tool | Experimental | Other: Shared decision-making toolParticipants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Asymptomatic AF
- Severe cognitive impairment
- Major psychiatric illness
- Concomitant terminal illness that would preclude participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared decision-making toolParticipants will use an interactive web page intended to aid patient decision-making (i.e., a decision aid) while undergoing consultation for atrial fibrillation ablation. | Other | Shared decision-making tool |
Primary outcome
Baseline Decisional Conflict Assessed Using the Decisional Conflict Scale
Time frame: 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).
Two Week Decisional Conflict Assessed Using the Decisional Conflict Scale
Time frame: 2 weeks
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 Self-Efficacy Score Assessed Using the Decision Self-Efficacy Scale
Time frame: Baseline
The Decision Self-Efficacy Scale ranges from 0-100; higher indicates more self-efficacy.
Two Week Decision Self-efficacy Assessed Using the Decisional Self-Efficacy Scale
Time frame: 2 weeks
The Decision Self-Efficacy Scale ranges from 0-100; higher indicates more self-efficacy.
2 secondary outcomes
Post-ablation Symptom Burden Assessed Using the Atrial Fibrillation Severity Scale (AFSS)
Time frame: 12 weeks
Post-ablation Health-related Quality of Life Assessed Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41792400Reading 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be available to other researchers upon reasonable request after Data Use Agreements have been executed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Reading Turchioe, PhD, MPH, RN principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared decision-making tool in people with Atrial Fibrillation and Patient Engagement, run by Columbia University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Decisional Conflict Assessed Using the Decisional Conflict Scale (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.