SDM for Stroke Prevention in Atrial Fibrillation (SDM4Afib)

Mayo Clinic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Behavioral: Decision Aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02905032

1R01HL131535 (U.S. NIH Grant/Contract)

16-005409

Details and patient eligibility

About

The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

Full description

The goal of this study is to determine the extent to which the Anticoagulation Choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.

Enrollment: 1,186 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Clinician Inclusion Criteria:

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

Patient Inclusion Criteria:

• ≥ 18 years of age
• Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women)
• Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent

Patient Exclusion Criteria:

• Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,186 participants in 2 patient groups

Standard Care

No Intervention group

Description:

Observations in clinical encounter via video, audio or observational notes.

Standard Care + Decision Aid

Active Comparator group

Description:

Observation of clinical encounter using the decision aid via video, audio, or observational notes.

Treatment:

Behavioral: Decision Aid