Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention (ENHANCE-AF)

• ClinicalTrials.gov Identifier: NCT04096781
• Recruitment Status: Completed
• First Posted: September 20, 2019
• Last Update Posted: October 6, 2022
• Sponsor: Stanford University
• Collaborators: American Heart Association; East Carolina University; Ochsner Health System; The Cleveland Clinic; The Cooper Health System
• Information provided by (Responsible Party): Paul Wang, Stanford University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation; Atrial Flutter; Stroke; Cardiac; Heart Failure; Arrhythmia	Behavioral: SDMT; Behavioral: Usual Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1001 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
• Actual Study Start Date: December 18, 2019
• Actual Primary Completion Date: June 23, 2022
• Actual Study Completion Date: August 17, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Shared Decision Making Tool (SDMT)	Behavioral: SDMT; 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.
Active Comparator: Usual Care	Behavioral: Usual Care; The participants will receive usual care.

Outcome Measures

Primary Outcome Measures :

1. Decisional Conflict Scale [ Time Frame: 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 :

1. Decisional Conflict Scale (16 items) [ Time Frame: 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
2. Decision Regret Scale (5 items) [ Time Frame: 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
3. Weighted composite outcome scale according to patient preference [ Time Frame: 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
4. Preparation for Decision Making Scale (10 items) [ Time Frame: 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
5. Utah-Stanford Atrial Fibrillation Knowledge Assessment [ Time Frame: 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
6. Quality of Communication (Based on CAHPS Clinician & Group Survey) [ Time Frame: Visit 1 (Post Clinic Visit) ]
   CAHPS 3-item modified version
7. Atrial Fibrillation Severity Scale (AFSS) [ Time Frame: 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
8. Collaborative Agreement on Decision [ Time Frame: Visit 1 (Post Clinic Visit) ]
   Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported
9. Clinician Satisfaction of the Decision Aid: Physician Survey [ Time Frame: Visit 1 (Post Clinic Visit) ]
   Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making
10. Patient Satisfaction of the Decision Aid: Patient Survey [ Time Frame: Visit 1 (Post Clinic Visit) ]
    Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making
11. Length of Visit at visit 1 (clinician) [ Time Frame: Visit 1 (Post Clinic Visit) ]
    Compare treatment arm on the length of visit
12. Anticoagulant Choice (Patient follow up questions on Anticoagulant use) [ Time Frame: 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
13. Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use) [ Time Frame: 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
14. 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 ]
    Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
15. Death [ Time Frame: Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled ]
    Incidence of Death

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University

Palo Alto, California, United States, 94305

Sponsors and Collaborators

Stanford University

American Heart Association

East Carolina University

Ochsner Health System

The Cleveland Clinic

The Cooper Health System

Investigators

• Principal Investigator: Paul J Wang, MD; Stanford University
• Principal Investigator: Randall S Stafford, MD; Stanford University

More Information

• Responsible Party: Paul Wang, Professor of Medicine (Cardiovascular Medicine), Stanford University Medical Center, Stanford University
• ClinicalTrials.gov Identifier: NCT04096781
• Other Study ID Numbers: 50864
• First Posted: September 20, 2019
• Last Update Posted: October 6, 2022
• Last Verified: October 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Atrial Fibrillation; Atrial Flutter; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Pathologic Processes