A User-Centered Designed Anticoagulation Shared Decision Making Tool for Stroke Prevention in Atrial Fibrillation

Atrial fibrillation (AF) is the most common cardiac arrhythmia and has a two- to five-fold increased risk of stroke in this population. Oral anticoagulation (OAC) therapy, while recommended, is not prescribed in up to 70 percent of those with AF, despite those patients being at a higher risk of death, higher risk of stroke, and lower risk of bleeding compared to those treated with anticoagulants.

Balancing the risks of stroke versus bleeding requires a personalized approach. The American College of Cardiology and the American Health Association’s clinical performance measures for AF identify shared decision making (SDM) of OAC therapy as a quality metric; however, neither provides a standardized and understandable method to demonstrate the risks versus benefits of the therapy in these patients. Overestimating bleeding risk is a common reason for not providing anticoagulation in AF, with providers being more likely to underestimate stroke risk versus bleeding risk. This research developed an SDM support application for OAC in AF that presents the risk tradeoffs of anticoagulation versus risk of stroke using visual representation.

The specific aims of the research were as follows:

• Use user-centered design principles to design a decision support tool that clarifies the relevant risk tradeoffs for anticoagulation in AF for patients and providers.
• Develop a SDM support application for the anticoagulation decision in AF.
• Demonstrate the comparative efficacy of the decision support tool in increasing patient knowledge of the risk tradeoffs during SDM for anticoagulation in AF.

Patients and physicians reviewed prototypes of the proposed tool and provided feedback via two rounds of interviews. The research team created the tool and evaluated its impact in a randomized controlled trial of three groups with 673 participants: the “Standard Group” that used standard written communication, a “Visual Group” that used a visual representation of relevant probabilities, and the “Visual+Value Group” that used the new decision support tool combining visual displays with value clarification.

Participants in both the “Visual” and “Visual+Value” groups were more confident about their use of OACs than the control group. However, the two groups using visuals were less likely to choose oral anticoagulation when compared to standard education, and the Visual+Values Group did not demonstrate a difference in comparison to the Visual Group. The researchers plan to implement the tool into clinical practice to support SDM between patients and provider.