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

Primary Purpose

Atrial Fibrillation, Atrial Flutter, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SDMT
Usual Care
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Shared Decision Making Tool (SDMT)

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Decisional Conflict Scale
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

Decisional Conflict Scale (16 items)
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)
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
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)
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
Newly developed assessment for this study to record Atrial Fibrillation Knowledge
Quality of Communication (Based on CAHPS Clinician & Group Survey)
CAHPS 3-item modified version
Atrial Fibrillation Severity Scale (AFSS)
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
Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported
Clinician Satisfaction of the Decision Aid: Physician Survey
Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making
Patient Satisfaction of the Decision Aid: Patient Survey
Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making
Length of Visit at visit 1 (clinician)
Compare treatment arm on the length of visit
Anticoagulant Choice (Patient follow up questions on Anticoagulant use)
Decision on anticoagulation choice as assessed by patient follow up questions
Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)
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
Incidence of Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
Death
Incidence of Death

Full Information

First Posted
September 9, 2019
Last Updated
October 4, 2022
Sponsor
Stanford University
Collaborators
American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, The Cooper Health System
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1. Study Identification

Unique Protocol Identification Number
NCT04096781
Brief Title
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
Acronym
ENHANCE-AF
Official Title
Engaging Patients to Help Achieve Increased Patient Choice and Engagement for AFib Stroke Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 18, 2019 (Actual)
Primary Completion Date
June 23, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
American Heart Association, East Carolina University, Ochsner Health System, The Cleveland Clinic, The Cooper Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Atrial Flutter, Stroke, Cardiac, Heart Failure, Arrhythmia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
1001 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shared Decision Making Tool (SDMT)
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
SDMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
The participants will receive usual care.
Primary Outcome Measure Information:
Title
Decisional Conflict Scale
Description
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
Time Frame
Visit 2 (1-month follow-up)
Secondary Outcome Measure Information:
Title
Decisional Conflict Scale (16 items)
Description
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
Time Frame
Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Decision Regret Scale (5 items)
Description
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
Time Frame
Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Weighted composite outcome scale according to patient preference
Description
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
Time Frame
Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Preparation for Decision Making Scale (10 items)
Description
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
Time Frame
Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Utah-Stanford Atrial Fibrillation Knowledge Assessment
Description
Newly developed assessment for this study to record Atrial Fibrillation Knowledge
Time Frame
Baseline, Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Quality of Communication (Based on CAHPS Clinician & Group Survey)
Description
CAHPS 3-item modified version
Time Frame
Visit 1 (Post Clinic Visit)
Title
Atrial Fibrillation Severity Scale (AFSS)
Description
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
Time Frame
Baseline, Visit 2 (1-month follow up), Visit 3(6-month follow-up)
Title
Collaborative Agreement on Decision
Description
Assess the collaborative agreement (1. Patient Reported Outcome 2) Clinician Reported
Time Frame
Visit 1 (Post Clinic Visit)
Title
Clinician Satisfaction of the Decision Aid: Physician Survey
Description
Clinician Satisfaction of the Decision Aid as assessed by a physician survey on shared decision making
Time Frame
Visit 1 (Post Clinic Visit)
Title
Patient Satisfaction of the Decision Aid: Patient Survey
Description
Patient Satisfaction of the Decision Aid as assessed by Patient survey on shared decision making
Time Frame
Visit 1 (Post Clinic Visit)
Title
Length of Visit at visit 1 (clinician)
Description
Compare treatment arm on the length of visit
Time Frame
Visit 1 (Post Clinic Visit)
Title
Anticoagulant Choice (Patient follow up questions on Anticoagulant use)
Description
Decision on anticoagulation choice as assessed by patient follow up questions
Time Frame
Visit 1 (Post Clinic Visit), Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Anticoagulation Persistence and adherence (Patient follow up questions on Anticoagulant use)
Description
Persistence and adherence to anticoagulation among participants selecting anticoagulation, as assessed by Patient follow up questions
Time Frame
Visit 2 (1-month follow up), Visit 3 (6-month follow-up)
Title
Stroke or TIA or Deep Venous Thrombosis or Pulmonary Embolus
Description
Incidence of 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
Title
Death
Description
Incidence of Death
Time Frame
Visit 2 (1-month follow up), Visit 3 (6-month follow-up), Unscheduled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul J Wang, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Randall S Stafford, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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