Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF)

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: Encounter Decision Aid; Other: Patient Decision Aid

Study type: Interventional

Funder types: Other

Identifiers

NCT04357288

IRB_00124127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,117 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient Participants -

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)

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 -

Inclusion Criteria:

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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1,117 participants in 4 patient groups

Patient Decision Aid

Experimental group

Description:

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.

Treatment:

Other: Patient Decision Aid

Encounter Decision Aid

Experimental group

Description:

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.

Treatment:

Other: Encounter Decision Aid

Patient & Encounter Decision Aids

Experimental group

Description:

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

Treatment:

Other: Patient Decision Aid

Other: Encounter Decision Aid

Standard Care

No Intervention group

Description:

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