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

Not Applicable

Completed

• Conditions: Atrial Fibrillation; Heart Failure; Arrhythmia; Atrial Flutter; Stroke; Cardiac
• Interventions: Behavioral: SDMT; Behavioral: Usual Care

• Registration Number: NCT04096781
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-09-09
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-20
• Study Start: 2019-12-18
• Primary Completion: 2022-06-23
• Study Completion: 2022-08-17
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-03
• Last Update Posted: 2024-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1001

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shared Decision Making Tool (SDMT)	SDMT	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Quality of Communication (Based on CAHPS Clinician & Group Survey)	Visit 1 (Post Clinic Visit)	CAHPS 3-item modified version
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
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
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
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
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
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
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
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
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

Trial Locations

Locations (5)

Stanford University; 🇺🇸 Palo Alto, California, United States

Cooper University Hospital; 🇺🇸 Camden, New Jersey, United States

Ochsner Medical Center; 🇺🇸 New Orleans, Louisiana, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States