Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

NCT ID: NCT04357288

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1117 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-16
• Study Completion Date: 2024-09-20

Brief Summary

This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and health outcomes for at-risk participants with Atrial Fibrillation (AF) at 6 study sites. We hypothesize the combination of the PDA and EDA will be more effective in promoting high-quality SDM and in adoption of and adherence to anticoagulation than either tool alone.

Detailed Description

Background Information:

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and it continues to grow in prevalence, afflicting an estimated 3 million Americans. While treatment of AF symptoms can be resource-intensive, another source of physical, social, and economic burden is thromboembolic stroke, the major cause of morbidity and mortality for both symptomatic and asymptomatic people with AF. People with AF must decide on a stroke prevention medication (typically, Warfarin or Oral Anti-Coagulants (OACs)).

Shared Decision Making (SD) is particularly useful when decisions, such as this, are value laden and complex. Models of SDM stress clear communication of the risks and benefits of all treatment options (including no treatment) to patients, who in turn need opportunities to share their treatment preferences, relevant values, and goals of care.

Decision aids are tools designed to support both people with AF and clinicians in SDM by 1) providing accurate, balanced information; 2) clarifying patients' values; and 3) improving SDM skills.

Two types of decision aids will be evaluated in the study: a patient-centered Patient Decision Aid (PDA) and an Encounter Decision Aid for collaborative use by the clinician and patient. The PDA is intended to help people with AF prepare for the medical visit with foundational understanding and questions. The EDA is intended to promote SDM between the clinician and person with AF.

Research Design & Methods:

Through a randomized controlled trial, our study will address whether the use of a PDA, and EDA, a combination of the 2, or usual care achieves the best SDM process and health outcomes. We will assess the comparative effectiveness of those 4 approaches in terms of their ability to affect the following outcomes: 1) SDM outcomes, including decisional conflict, knowledge, and quality of patient-clinician communication; and 2) health outcomes, including adoption rates of anticoagulation therapy, adherence to anticoagulation therapy regimen, bleeding, stroke/systemic embolism, and death. Data collection will include medical record review, survey completion, and video/audio recording of the clinician encounter.

Study sites:

Recruitment is planned to occur from 6 sites within the US.

Data Collection:

Self-reported outcomes from people with AF and clinicians will be collected at the end of each clinical encounter. In addition, clinicians will complete a survey that collects data on their demographics and practice characteristics.

Data from the medical record will be abstracted for all enrolled participants with AF to capture demographic, clinical, and medication prescription data.

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Patient Decision Aid

Participants in this arm will use the Patient Decision Aid (PDA), an online education tool about atrial fibrillation designed for patient use, prior to the encounter with their provider.

Group Type: EXPERIMENTAL

Patient Decision Aid

Intervention Type: OTHER

The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

Encounter Decision Aid

Participants in this arm will use the Encounter Decision Aid (EDA), an online educational tool about atrial fibrillation designed for patient-provider use, during the encounter with their provider.

Group Type: EXPERIMENTAL

Encounter Decision Aid

Intervention Type: OTHER

The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

Patient & Encounter Decision Aids

Participants in this arm will use both the PDA \& EDA as described above.

Group Type: EXPERIMENTAL

Patient Decision Aid

Intervention Type: OTHER

The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

Encounter Decision Aid

Intervention Type: OTHER

The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

Standard Care

Participants in this arm will receive standard care, that is they will not use either the PDA or EDA.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Patient Decision Aid

The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

Intervention Type: OTHER

Encounter Decision Aid

The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Adults (18 and older)

2. Are diagnosed with Atrial Fibrillation

3. Are aware they have been diagnosed with Atrial Fibrillation

4. Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)

1. All clinicians (MDs, NP/PAs, PharmDs, APPs, etc.) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion.

Exclusion Criteria

1. Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation

2. Have deficits in cognitive abilities or sensory input

3. Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.

Clinician Participants -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Heart Association

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Utah

OTHER

Sponsor Role: lead

Responsible Party

Elissa Ozanne

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elissa Ozanne, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Angela Fagerlin, PhD

Role: STUDY_DIRECTOR

University of Utah

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Northwestern University

Chicago, Illinois, United States

University of Michigan

Ann Arbor, Michigan, United States

The Mayo Clinic

Rochester, Minnesota, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Utah Health

Salt Lake City, Utah, United States

Countries

United States

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Other Identifiers

IRB_00124127

Identifier Type: -

Identifier Source: org_study_id