$5 million award from PCORI and AHA establishes center to support better-informed AFib treatment decisions

WASHINGTON, D.C. — A new research center will produce and test decision aids to help people with atrial fibrillation (AFib) more readily make choices with their doctors about their treatment options, thanks to a $5 million funding award. The Patient-Centered Outcomes Research Institute (PCORI) and American Heart Association (AHA) announced the selection of the research team and home for the center today.

The award was made through the organizations' joint initiative to enhance shared decision making on this common heart condition. The initiative establishes an AHA-PCORI Decision-making and Choices to Inform Dialogue and Empower AFib patients (DECIDE) Center.

The AHA-PCORI DECIDE Center will be based at the University of Utah will undertake two projects supported by this award. The center, which the awardees have named STEP UP-AF, will first develop and refine two types of decision aids, one that people with AFib would use on their own before a visit with their doctor and one that they would use with their doctor during a visit.

Then, through comparative effectiveness research (CER), the center will assess the decision tools’ abilities, when used individually and together, to promote better-informed and more-productive shared decisions between patients and clinicians. These decisions would be about the use of oral blood-thinning drugs to prevent stroke and which of these drugs would best align with the patients’ goals and preferences.

AHA estimates that as of 2010, at least 6.1 million Americans had AFib, an irregular heartbeat that can lead to stroke and other heart-related complications. Taking blood-thinning drugs reduces the risk of stroke associated with AFib, but, as with any medication, carries the potential for risks and side effects.

“Shared decision making tools can be very useful in helping patients, their families and their clinicians better understand and discuss how to balance the benefits and risks of their treatment options,” said PCORI Executive Director Joe Selby, MD, MPH. “We’re pleased to join with the AHA in making this award to this research team, which will significantly advance a patient-centered, collaborative approach to heart healthcare decision making through CER.”

“The studies taking place at the PCORI-AHA DECIDE Center will strengthen the relationship between clinician and patient and empower patients to make the best treatment decisions based on their specific needs,” said American Heart Association CEO Nancy Brown. “AFib is the most common heart arrythmia and we have tremendous confidence that this Center will substantially improve patient outcomes.”

The award was made jointly by PCORI and AHA. PCORI invested $2.75 million and the AHA provided $2.5 million, underwritten by AHA supporters David and Stevie Spina. The center involves several leading experts in decision science and clinical translation. Angela Fagerlin, PhD, professor and chair of population health sciences at University of Utah Health, will direct the center. Victor Montori, MD, professor of medicine at the Mayo Clinic, will lead the effort to appraise existing decision aids for AFib and refine or develop new ones. Elissa Ozanne, PhD, associate professor of population health sciences at Utah Health, will lead the comparative effectiveness analyses of the aids.

The PCORI-AHA DECIDE Center is part of AHA’s AFib Strategically Focused Research Network, which AHA announced the launch of today. This network, composed of six research centers, provides a mechanism to enhance the understanding of the causes, biology, pathophysiology and epidemiology of AFib, and to develop more effective ways to treat it and prevent risks such as stroke, ultimately improving patient outcomes.