Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention

Study Overview
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Brief Summary
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A multi-center, randomized controlled 2-arm trial comparing the effectiveness of an innovative shared decision-making pathway and usual care for Atrial Fibrillation Stroke Prevention

Detailed Description
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This study will test to see if a new type of decision-making process tool, called a Shared Decision Making Pathway, can make a difference in decreasing the risk of stroke due to a condition called Atrial Fibrillation (AFib.) This online tool is designed to help doctors and patients decide together on treatment options for AFib.

Official Title
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Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention

Conditions
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Atrial Fibrillation, Atrial Flutter, Stroke, Cardiac, Heart Failure, Arrhythmia

Intervention / Treatment
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* Behavioral: SDMT
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 y/o Non-valvular atrial fibrillation or atrial flutter (AFib) CHA2DS2-VASc stroke score of: Men: 1 or more Women: 2 or more Able to consent in English or Spanish (if resources allow) and follow study instructions Exclusion Criteria: Moderate to severe mitral stenosis Mechanical valve replacement Absolute contraindication to anticoagulation (Based on clinician judgment) Indication for anticoagulation therapy for a condition other than atrial fibrillation Left atrial appendage exclusion (by surgery or device placement) At the clinical discretion of the investigator

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Shared Decision-Making pathway focused on a digital shared decision-making tool (SDMT) that is augmented by a clinician tool and an optional lay coach
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shared Decision Making Tool (SDMT)<br> | Behavioral: SDMT<br>* The intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making.<br>|
| Active Comparator: Usual Care<br> | Behavioral: Usual Care<br>* The participants will receive usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale | The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80 | Visit 2 (1-month follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict Scale (16 items) | The Decisional Conflict Scale is a 16 Item scale on whether the participants have enough information to make a clear decision. Each item scored from 1-5, where 1 indicates clarity and 5 indicates confusion, with total score ranging from 16-80 | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Decision Regret Scale (5 items) | Decision Regret Scale, is scored from 1-5, where 1 indicates they made the right decision and 5 indicates they made the wrong decision. This scale ranges from 5-25 | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Weighted composite outcome scale according to patient preference | Patient-selected weighted composite outcome scale is a composite scale to consider both decisional conflict and decisional regret scales simultaneously according to the priority based on the survey of 100 potential participants. The rationale for this endpoint is to consider not only the preference of majority patients (73%) but also the minority (27%) participants who prefer the decisional regret scale | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Preparation for Decision Making Scale (10 items) | Preparation for Decision Making scale assesses a patient's perception of how useful a decision aid or other decision support intervention is in preparing the respondent to communicate with their practitioner at a consultation focused on making a health decision | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Utah-Stanford Atrial Fibrillation Knowledge Assessment | Newly developed assessment for this study to record Atrial Fibrillation Knowledge | Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Quality of Communication (Based on CAHPS Clinician & Group Survey) | CAHPS 3-item modified version | Visit 1 (Post Clinic Visit) | 
| Atrial Fibrillation Severity Scale (AFSS) | The University of Toronto Atrial Fibrillation Severity Scale (AFSS) is a questionnaire designed for patients with AFib. It consists of 19 items combined into 3 parts to capture total AF burden, health care utilization, and the severity of AFib related symptoms | Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up) | 
| Collaborative Agreement on Decision | Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported | Visit 1 (Post Clinic Visit) | 
| Clinician Satisfaction of the Decision Aid: Physician Survey | Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making | Visit 1 (Post Clinic Visit) | 
| Patient Satisfaction of the Decision Aid: Patient Survey | Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making | Visit 1 (Post Clinic Visit) | 
| Length of Visit at visit 1 (clinician) | Compare treatment arm on the length of visit | Visit 1 (Post Clinic Visit) | 
| Anticoagulant Choice (Patient follow up questions on Anticoagulant use) | Decision on anticoagulation choice as assessed by patient follow up questions | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use) | Persistence and adherence to anticoagulation among participants selecting anticoagulation, as assessed by Patient follow up questions | Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 
| Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus | Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus | Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled | 
| Death | Incidence of Death | Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled |