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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,001
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.
The participants will receive usual care.
Stanford University
Palo Alto, California, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Cooper University Hospital
Camden, New Jersey, United States
East Carolina University
Greenville, North Carolina, United States
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
Time frame: Visit 2 (1-month follow-up)
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
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Visit 1 (Post Clinic Visit)
Length of Visit at visit 1 (clinician)
Compare treatment arm on the length of visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled
Death
Incidence of Death
Time frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled