Arrhythmia, Atrial Fibrillation, Atrial Flutter, Cardiac, Heart Failure, Stroke
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALSDMT
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.
BEHAVIORALUsual Care
The participants will receive usual care.
Sponsors
American Heart Association
East Carolina University
Ochsner Health System
The Cleveland Clinic
The Cooper Health System
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | Visit 2 (1-month follow-up) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decision Regret Scale (5 items) | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 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 |
| Weighted composite outcome scale according to patient preference | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 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 |
| Preparation for Decision Making Scale (10 items) | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 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 |
| Utah-Stanford Atrial Fibrillation Knowledge Assessment | Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | Newly developed assessment for this study to record Atrial Fibrillation Knowledge |
| Quality of Communication (Based on CAHPS Clinician & Group Survey) | Visit 1 (Post Clinic Visit) | CAHPS 3-item modified version |
| Atrial Fibrillation Severity Scale (AFSS) | Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up) | 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 |
| Collaborative Agreement on Decision | Visit 1 (Post Clinic Visit) | Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported |
| Decisional Conflict Scale (16 items) | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | 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 |
| Patient Satisfaction of the Decision Aid: Patient Survey | Visit 1 (Post Clinic Visit) | Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making |
| Length of Visit at visit 1 (clinician) | Visit 1 (Post Clinic Visit) | Compare treatment arm on the length of visit |
| Anticoagulant Choice (Patient follow up questions on Anticoagulant use) | Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | Decision on anticoagulation choice as assessed by patient follow up questions |
| Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use) | Visit 2 (1-month follow up), Visit 3 (6-month follow-up) | Persistence and adherence to anticoagulation among participants selecting anticoagulation, as assessed by Patient follow up questions |
| Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus | Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled | Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus |
| Death | Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled | Incidence of Death |
| Clinician Satisfaction of the Decision Aid: Physician Survey | Visit 1 (Post Clinic Visit) | Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making |
Countries
United States
Outcome results
None listed