SDM for Stroke Prevention in Atrial Fibrillation

Mayo Clinic1,186 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

1,186

Conditions

Atrial Fibrillation

Interventions

Decision AidBEHAVIORAL

Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Alabama

Birmingham, Alabama, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Park Nicollet Health Partners

Saint Louis Park, Minnesota, United States

Outcomes

Primary Outcomes

Number of Clinician Satisfied Encounters

The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.

Time frame: 1 month

Number of Clinician Recommendation

The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.

Time frame: 1 month

Secondary Outcomes

Number of Participants With Anticoagulant Medication Use

The number of subjects who chose to start or continue receive an anticoagulant medication.

Time frame: 12 months

Patient Involvement

Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement.

Data from ClinicalTrials.gov

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