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Completed

NCT Number: NCT04096781

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmia Arrhythmias, Cardiac Atrial Flutter Brain Diseases Cardiac Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Heart Diseases Heart Failure Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SDMT

Behavioral

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.

Usual Care

Behavioral

The participants will receive usual care.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • American Heart Association
  • East Carolina University
  • Ochsner Health System
  • The Cleveland Clinic
  • The Cooper Health System

Registry information

Acronym: ENHANCE-AF

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Sep 20, 2019
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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