The Design and Development, Usability Evaluation and Pilot Testing of a Patient Decision Aid for Individuals with Nonvalvular Atrial Fibrillation Considering Stroke Prevention Therapy in Atrial Fibrillation Management

Abstract

Background: Nonvalvular chronic atrial fibrillation (AF) is associated with a fivefold increase in the risk of stroke and accounts for 15-20% of strokes suffered annually by Canadians. This stroke risk can be reduced by 65% with stroke prevention therapies. However, due to the numerous therapeutic options available to patients for stroke prevention therapy in AF management, deciding which therapy is best for them is difficult and complex. The purpose of this program of research was to design, develop and evaluate an interactive, web-based patient decision aid to assist individuals newly diagnosed with AF make informed decisions, in-line with their personal preferences, about stroke prevention therapies. Methods: The approach of the dissertation was systematic, starting with a systematic review and including iterative prototype development and testing, user evaluations and the inclusion of patient and healthcare provider stakeholders. Results: This approach contends with the complexity of developing successful patient decision aids and the necessity for multiple studies and methods. The findings from the studies culminated in a polished decision aid that is consistent with the International Patient Decision Aids Standards’ most recent criteria, facilitates shared decision making between patients and their healthcare providers and is ready for future clinical study. Factors integral to the decision aid’s successful development included: (1) the user-centred design process; (2) its web app format and responsive mobile-first design; (3) personalization of evidence-based risk information for a patient’s self-reported risk factors; (4) the multi-stage formative evaluation that provided recommendations for design improvement and resulted in over 1,000 design changes; and (5) approval from AF and heart rhythm experts. Conclusion: This dissertation describes the end-to-end development and evaluation of an interactive web-based patient decision aid for individuals who are considering stroke prevention therapy for AF. Collectively, the multiple studies in this dissertation establish a foundation for exploring shared decision making between patients and their healthcare providers, contribute significantly to the domain of patient decision aids and set a new standard for future decision aid development. This new standard can be applied to all fields of medicine where patients are able to share in any decision-making necessary for their care.