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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04096781
Recruitment Status : Recruiting
First Posted : September 20, 2019
Last Update Posted : May 5, 2020
Sponsor:
Collaborators:
American Heart Association
Boston University
East Carolina University
Ochsner Health System
The Cleveland Clinic
Information provided by (Responsible Party):
Paul Wang, 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

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 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: Single (Outcomes Assessor)
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
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


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.




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: Baseline, 1-month follow up, 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: Baseline, 1-month follow up, 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. Patient-selected weighted composite outcome scale [ Time Frame: Baseline, 1-month follow up, 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: Baseline, 1-month follow up, 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, 1-month follow up, 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: Baseline ]
    CAHPS 3-item modified version

  7. Atrial Fibrillation Severity Scale (AFSS) [ Time Frame: Baseline, 1-month follow up, 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: Baseline ]
    Developed by the University of Utah to assess the Collaborative Agreement (1. Patient Reported Outcome 2) Clinician Reported 3) Electronic Health Record

  9. Clinician Satisfaction of the Decision Aid: Physician Survey [ Time Frame: Baseline ]
    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: Baseline ]
    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: Baseline ]
    Compare treatment arm on the length of visit

  12. Anticoagulant Choice and Persistence (Patient follow up questions on Anticoagulant use) [ Time Frame: Baseline, 1-month follow up, 6-month follow-up ]
    Decision on anticoagulation choice as assessed by patient follow up questions

  13. Anticoagulation Persistence (Patient follow up questions on Anticoagulant use) [ Time Frame: 1-month follow up, 6-month follow-up ]
    Persistence 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: 1-month follow up, 6-month follow-up, Unscheduled ]
    Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus

  15. Death [ Time Frame: 1-month follow up, 6-month follow-up, Unscheduled ]
    Incidence of Death



Information from the National Library of Medicine

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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: 2 or more
    • Women: 3 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096781


Contacts
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Contact: Paul J Wang, MD (650) 723-9363 pjwang@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Katie DeSutter    650-725-4151    ksutter@stanford.edu   
Sponsors and Collaborators
Stanford University
American Heart Association
Boston University
East Carolina University
Ochsner Health System
The Cleveland Clinic
Investigators
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Principal Investigator: Paul J Wang, MD Stanford University
Principal Investigator: Randall S Stafford, MD Stanford University
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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    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Atrial Fibrillation
Atrial Flutter
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Heart Diseases
Arrhythmias, Cardiac
Pathologic Processes