Funds awarded by the Patient-Centered Outcomes Research Institute
Karen Sepucha, PhD from Massachusetts General Hospital (MGH) and Sammy Elmariah, MD from University of California, San Francisco (UCSF) have been approved for a $5.6 million funding award by the Patient-Centered Outcomes Research Institute (PCORI) to study shared decision making for aortic valve replacement decisions.
Aortic stenosis is a common disease, present in more than 20% of elderly adults, and causes significant morbidity and mortality. Without a valve replacement, only half of symptomatic patients will survive two years. Clinical guidelines recommend shared decision making to select the best approach to valve replacement. In this project, Drs. Sepucha and Elmariah will work with eight sites across the country to identify effective strategies to achieve shared decision making and thereby ensure high quality, patient-centered decisions about aortic valve replacement.
“Treatment for many patients with severe aortic stenosis can be done with either a transcatheter or surgical approach, and helping patients understand the tradeoffs can be challenging. This study will examine the impact of tools and training to help heart valve teams put shared decision making into practice.” Dr. Sammy Elmariah, co-Principal Investigator and Chief, Interventional Cardiology and Medical Director, Cardiac Catheterization Laboratory at UCSF.
The study will use patient decision aids developed by the American College of Cardiology and evidence-based skills training for clinicians developed by the MGH team. The multidisciplinary study team includes heart valve clinic leadership, cardiac surgeons, interventional cardiologists, nurses, geriatric medicine physicians, decision scientists, statisticians, and implementation scientists. Ms. Susan Strong of Heart Valve Voice US will oversee engagement of patient partners to help with the design and conduct of the study. In addition, an advisory group with representatives from professional societies, regulatory organizations, and key stakeholder groups will provide strategic advice and input on the study.
“We have a large team of co-investigators, patient partners and advisors to help us make sure the study generates new knowledge that will significantly improve the care and experience of patients.” – Dr. Karen Sepucha, co-Principal Investigator and Director, MGH Health Decision Sciences Center.
The study, titled “Promoting Shared Decision Making for Decisions about Treatment of Severe Aortic Stenosis,” was selected for PCORI funding through a highly competitive review process in which patients, clinicians and other stakeholders joined clinical scientists to evaluate the proposals. Applications were assessed for scientific merit, how well they will engage caregivers and other stakeholders and their methodological rigor among other criteria. The study award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better informed healthcare decisions.
Click here to read more about the award.
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