Impact of a Patient Decision Aid for Treatment of Aortic Stenosis

This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).

The pilot trial will enroll patients who are coming in to see a valve specialist (cardiac surgeon or interventional cardiologist) to discuss treatment options for aortic stenosis. The study will recruit patients at Massachusetts General Hospital or at the University of Colorado Health Heart and Vascular Center, Anschutz Medical in Denver, Colorado and randomly assign them to usual care arm or decision aid arm. The decision aid will be given to the participant in clinic at the time of their appointment. Patient participants in both arms will be asked to complete a short survey after the visit. The survey will assess knowledge, treatment preference, shared decision making (SDM), and decisional conflict. Analyses will compare the two arms on these outcomes to generate preliminary data on impact of the intervention.

Participants in this arm will receive the patient decision aid, titled "Treatment Choices for Aortic Stenosis" to review.

A decision aid, titled "Treatment Choices for Aortic Stenosis," produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis.

Patients will complete 6 multiple choice knowledge items and a total knowledge score (0-100%) will be created by summing the number of correct responses and dividing by the number of items.

Items from the SDM Process survey will be summed to create a total score (0-4) with higher scores indicating more shared decision making.

The 4 item SURE scale will measure decisional conflict and the percent with the top score (4 out of 4) will be reported

The 3 item Collaborate scale will be scored and the percent receiving the top score (27 out of 27) will be reported

Inclusion Criteria: Adults 18-85 years only English speaking Severe aortic stenosis, defined as an aortic valve area < 1 cm2 Never had AVR or who had previous AVR > 6 months previous Patients perceived by the clinician to be at low or intermediate risk for SAVR Exclusion Criteria: Concomitant disease of another heart valve or the aorta that required either transcatheter or surgical intervention

Information about the data sets will be on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH)/ Mass General Brigham policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board (IRB) requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.