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The American Heart Association and PCORI are excited to announce a major step in a multiyear partnership to identify and fund cardiovascular health research that will make a difference in patients’ lives.
The AHA-PCORI Decision-making and Choices to Inform Dialogue and Empower AFib Patients (DECIDE) Center will develop, adapt, and test decision aids to help people with atrial fibrillation (AFib) make better-informed treatment choices with their doctors, thanks to $5 million in funding jointly awarded by our two organizations. AHA and PCORI announced last week that the University of Utah would house the center and carry out the research in collaboration with the Mayo Clinic.
AHA estimates that as of 2010, more than 6 million Americans had AFib, an irregular heartbeat that can lead to stroke and other heart-related complications. Taking blood-thinning medication greatly reduces the risk of stroke associated with AFib, but, as with any drug, these treatments have risks. Shared decision making provides patients information on the benefits and harms associated with treatment options, and then engages patients in a decision-making process with their clinician that reflects their values. We’re very excited to be supporting a project on such a high-burden topic with great potential for improvement for patients.
Patients Helped Identify Priority Topics
In late 2015, AHA and PCORI first partnered on a project to identify questions about cardiovascular health and disease and that could be approached by clinical comparative effectiveness research (CER). We started by crowdsourcing questions and decisional dilemmas about heart disease from patients and their caregivers, to identify the most important ones that were also feasible for us to address.
The response highlighted concerns among patients and other stakeholders about how best to treat and prevent stroke, particularly when associated with AFib. We know that blood-thinning medications, or anticoagulants, can prevent strokes related to AFib, but we also know that many patients aren’t prescribed anticoagulants or they aren’t taking them. There are also downsides to these blood thinners, including out-of-pocket costs; dietary restrictions; and, most importantly, increased bleeding risk. We wanted to fund a project that would figure out how to make sure patients, their family caregivers, and their doctors have the best information and tools to make treatment decisions based on their individual goals and priorities.
For the next phase of our collaboration, in 2017, AHA and PCORI requested research proposals about shared decision making in the treatment of AFib. Research has shown that when patients use decision aids to facilitate shared decision making, they gain knowledge and clarity about their values and preferences around their treatment decisions. Decision aids—nonbiased, informational tools—help patients and those who care for them better understand their treatment options.
Refining Shared Decision Making Tools’ Effectiveness
We announced the awardee—the University of Utah, working with the Mayo Clinic—this month. This DECIDE Center will develop, test, and deliver shared decision making tools for clinicians and patients to use together to determine which treatment options should provide the desired outcomes for each patient. But what does that actually entail?
Emphasizing Shared Decision Making in Cardiovascular Health Care
Researchers will survey existing decision aids for patients diagnosed with AFib. They will take content from the best options and adapt it to form two decision aids with the same information but varying delivery styles. One decision aid will be for patients to use before they visit their clinicians, and the other will be for patients and their clinicians to use together during an office visit. While both kinds of aids have been shown to improve aspects of shared decision making, no studies have yet compared the effectiveness of the two delivery types against one another for treating AFib.
In the next phase of the project, the research team will conduct a multisite randomized trial to compare the two types of decision aids.
The research team will score which approach does the best job at improving a patient’s knowledge about their options and clarity about their decision, as well as enhancing the communication between patient and clinician. Secondary outcomes will include patients’ use of blood thinners. An optimal shared decision making approach could improve outcomes of millions of patients.
The PCORI-AHA DECIDE Center is part of AHA’s larger AFib Strategically Focused Research Network. This network, composed of six research centers, establishes a mechanism to enhance the understanding of AFib and to develop more-effective ways to treat it and prevent risks such as stroke, ultimately improving patient outcomes.
AHA and PCORI are excited to be collaborating again to fund research that is central to both organizations’ missions, and more importantly, fills a critical research gap that will help millions of patients with AFib across the country.
Editor's note: At the time that this blog post was published, Diane E. Bild, MD, MPH served as associate director in the Clinical Effectiveness and Decision Science program.
December 2, 2018, 12:43 PM
Comment by Patricia Nadraus,
Will the PDA's developed take into account an individual's cognitive status, frailty status, health literacy status and identify their preference for involvement in SDM? Thank You.
November 28, 2018, 10:41 PM
Comment by PCORI,
Hi, Mr. Mage. The study has not begun enrolling patients yet. When it does, a good way to get involved would be to contact the researchers at the University of Utah.
November 28, 2018, 10:37 PM
Comment by PCORI,
Hi Joan, thanks for your comment. We currently don’t have any studies directly related to this topic and recommend you talk to your physician about what treatment option is best for you.
August 3, 2018, 4:39 PM
Comment by Tom Mage,
As a person with Afib, I am interested in both the trial and the study.
August 3, 2018, 4:05 PM
Comment by joan,
Is there a study being done or already done re pros and cons of defibrillators? I've been reading that having defib kick in can be very painful, but even worse often leads to a long slow uncomfortable, at best, road to death vs a quick death from cardiac arrest. Anything I might read about this decision? Thank you, joan, age 77.
July 26, 2018, 9:29 PM
Comment by PCORI,
Thank you for your comments, Mr. Holzberg, Ms. Graham, and Cliff. Mr. Holzberg, the study has not begun enrolling patients yet. When it does, a good way to get involved would be to contact the researchers at the University of Utah. Ms. Graham, while treatment of stroke is an important topic, this study focuses on preventing stroke with those with AFib. Treatment options for a new stroke would have to be evaluated in a different study. And finally, Cliff, the benefits and harms of anticoagulation depend on a person's individual risk factors for stroke (a possible consequence of the AFib) and for bleeding (a possible consequence of the anticoagulants). These factors will vary from person to person, and people will have different preferences about how to manage those risks. The goal of the study is to help individuals understand the risks and weigh them in the context of their own preferences. For information about treatment options, you may visit AHA’s website.
July 25, 2018, 8:13 PM
Comment by Cliff,
As a chronic AFIB person, apparently a major study revealed no net benefit between anticoagulants, e.g. including warfarin and xeralto, or ablation surgery when compared with no drugs or surgery at all! I hope your study will address this also.
July 25, 2018, 3:53 PM
Comment by Stephanie Graham,
What about the use of mechanical thrombectomy for urgent treatment of strokes?
July 25, 2018, 3:43 PM
Comment by Roger Holzberg,
How does a person with Afib become a part of the trial and study?
July 5, 2018, 9:27 PM
Comment by PCORI,
Hello Dr. Berger. Thank you for your questions. The study will have a usual care (control) arm and an arm using both decision aids (DAs), but will not have an arm with an economic incentive. The DAs have not yet been developed, so we cannot speak directly to the content. The DAs are intended to facilitate shared decision-making and to help patients make an evidence-based choice about the use of anticoagulants for the treatment of atrial fibrillation.
July 3, 2018, 5:57 PM
Comment by Lawrence Berge…,
Will the trial include:
- a third arm utilizing both decision-making tools?
- a non-intervention comparison arm?
- include an arm involving an economic incentive (dramatically lower-cost of DOAGs) likely to increase individual's adherence to the use of anticoagulants?
- discussion of lifestyle changes (e.g., quit smoking, weight loss, dietary changes, stress reduction) likely to reduce the frequency of afib episodes and/or stroke risk?
- discussion of economic factors in decision making?
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