Aortic stenosis is a common heart disease, affecting more than 20 percent of older adults, and causes significant symptoms such as chest pain, shortness of breath, and fainting, which limit everyday activities. Once symptoms develop, aortic stenosis portends a dismal prognosis unless the aortic valve is replaced. Without aortic valve replacement (AVR), only half of patients will survive one to two years. Many patients being considered for aortic valve replacement have the option of either an open surgical approach (SAVR) or a minimally invasive transcatheter approach (TAVR). Both TAVR and SAVR provide a significant survival benefit over medications, but the options differ on recovery time, complication rates and long-term durability.
Clinical practice guidelines for aortic stenosis emphasize the need for shared decision making (SDM) to individualize the decision based on clinical and imaging evaluation, risk assessment, and the patient’s goals and expectations. The guidelines do not provide specifics on how to implement SDM and studies find routine care often falls short of the SDM ideal. One significant feature in this clinical setting is a mandate from the Centers for Medicare and Medicaid Services that requires evaluation by a multidisciplinary heart valve team, including both a cardiac surgeon and interventional cardiologist, as a condition for payment for TAVR. The mandate reinforces clinical guidelines that recommend SDM; however, the impact of the heart valve team strategy on the quality of decisions and implementation of SDM has not been studied.
This study will aim to determine the comparative effectiveness of a multicomponent intervention—patient decision aids plus clinician training—to the heart valve team alone. This study will engage eight diverse sites in a pragmatic stepped wedge randomized trial. In this type of trial, each site will start in the usual care period. The research team will track outcomes using surveys of patients. Then sites will be randomly assigned to switch to the intervention period where they will have formal SDM training and will provide patients educational decision aids as part of routine care. The research team will continue to track outcomes using surveys of patients in the intervention period.
The primary outcome is determining whether patients were meaningfully engaged in these significant decisions (Aim 1). Further, the study will examine how well sites are able to deliver the patient decision aids as part of routine care and how many clinicians participated in the training course (Aim 2). The team will look at the impact of these interventions in vulnerable populations, including those with low health literacy and low socioeconomic status and racial or ethnic minorities. The team will also explore the factors that might influence these results, such as the level of teamwork, the organization of the clinic, and the overall health of patients (Aim 3). The project will take advantage of the novel regulatory context of a mandated team-based, multispecialty evaluation for patients considering TAVR.
The findings will be important to patients who are facing this decision, to clinicians and heart valve clinics that need to integrate SDM into routine care, and to policy makers who may want to promote SDM for new medical technologies.
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.