Low awareness and the often-asymptomatic nature of heart valve diseases contribute to the underdiagnosis and undertreatment of these potentially fatal conditions. Heart valve disease affects 2.5 percent of the population. For people with severe aortic stenosis, only half undergo valve replacement, and, without repair or replacement, only 20 percent survive five years. While the United States is moving toward patient-centered health care, true patient-centered care can only happen with evidence resulting from patient engagement in patient-centered outcomes research (PCOR) overall, and in comparative effectiveness research (CER) specifically. Yet much of the research around heart valve disease fails to consider patient preferences and challenges. This gap in patient engagement bears out in the clinical setting. Heart Valve Voice (HVV) will build a vibrant heart valve disease community of individuals and stakeholder organizations that represent patients, caregivers, and public and private researchers and payers; and act as a hub in connecting them to cultivate PCOR along the entire research and dissemination process. HVV will build the infrastructure for patients to discuss, plan for, and participate in PCOR. Many have little understanding about PCOR, how to participate, and what the expectations are, and stakeholders are engaging in research without sufficient patient input. Training will include education about current challenges in heart valve disease research, an overview of the Pipeline to Proposal project work, existing opportunities in PCOR and CER projects at federal agencies, PCORI, and local research centers, and hands-on training exercises to familiarize training participants with understanding how to interpret research studies, understand clinical trials, and outline and pursue engagement plans.
The project will include curriculum development and training for up to 50 patients and family caregivers to understand and participate in PCOR in heart valve disease, including in advisory roles at federal agencies, PCORI, local CER projects, and other public and private organizations.
Heart Valve Voice US also will create at least four materials, including fact sheets, videos, and blog posts to increase awareness about challenges in heart valve disease, encourage patients to become more involved, and to indicate what to expect when participating on patient advisory boards, in research, and in other forms of patient engagement. HVV will use the materials as part of the curriculum and will also disseminate them to its members.
HVV will provide the necessary support to ensure that patients play an integral role in developing the curriculum, participating in the training sessions, and in developing important relationships with stakeholders in the heart valve disease community. Patients and caregivers will have important roles in this project from the beginning. They will participate on the steering committee to ensure they are at the center of discussions when developing content and format. They will be actively involved in creating the curriculum and also in delivering key components during the training. Following the first training session, the project team will collect patient and caregiver feedback so that the team can adequately and appropriately adjust the curriculum moving forward.