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Data-driven SDM to Reduce Symptom Burden in AF

Primary Purpose

Atrial Fibrillation, Patient Engagement

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared decision-making tool
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Shared Decision-Making (SDM), Symptom Burden, Decisional Conflict, Decision Regret, Decision Satisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Cornell Medicine
  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Shared decision-making tool

Arm Description

Participants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation.

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
July 27, 2021
Last Updated
August 28, 2023
Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04993807
Brief Title
Data-driven SDM to Reduce Symptom Burden in AF
Official Title
Data-driven Shared Decision-Making (SDM) to Reduce Symptom Burden in Atrial Fibrillation (AF)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Patient Engagement
Keywords
Shared Decision-Making (SDM), Symptom Burden, Decisional Conflict, Decision Regret, Decision Satisfaction

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a single arm feasibility study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shared decision-making tool
Arm Type
Experimental
Arm Description
Participants in this arm will view a shared decision-making tool while they are undergoing consultation to have an atrial fibrillation ablation.
Intervention Type
Other
Intervention Name(s)
Shared decision-making tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Decisional conflict assessed using the Decisional Conflict Scale
Description
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).
Time Frame
Baseline
Title
Decision regret assessed using the Decisional Regret Scale
Description
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).
Time Frame
12 weeks
Title
Decision satisfaction assessed using the Satisfaction with Decision Scale
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Post-ablation symptom burden assessed using the Atrial Fibrillation severity Scale (AFSS)
Description
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).
Time Frame
12 weeks
Title
Post-ablation health-related quality of life assessed using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) questionnaire
Description
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).
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meghan Reading Turchioe, PhD, MPH, RN
Phone
212-305-1557
Email
mr3554@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghan Reading Turchioe, PhD, MPH, RN
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
07030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jyotishman Pathak, PhD, FACMI
Email
jyp2001@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jyotishman Pathak, PhD, FACMI
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Reading Turchioe, PhD, MPH, RN
Phone
212-305-1557
Email
mr3554@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Maxim Topaz, PhD, RN
Email
mt3315@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Meghan Reading Turchioe, PhD, MPH

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified individual participant data (IPD) will be available to other researchers upon reasonable request after Data Use Agreements have been executed.
IPD Sharing Time Frame
Beginning 3 years and ending 5 years following publication.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal and have completed Data Use Agreements.

Learn more about this trial

Data-driven SDM to Reduce Symptom Burden in AF

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