With a $5 million grant from the Patient-Centered Outcomes Research Institute (PCORI) and the American Heart Association, University of Utah Health is leading a center to develop and test tools that spur constructive conversations between health care providers and patients. Specifically, the decision aids will help patients with atrial fibrillation (AFib) and their providers navigate the complex options available for treating the condition so they can reach a decision together.

For patients who are used to taking their doctor’s word for it, playing an active role in making health care decisions may take some getting used to. But Angie Fagerlin, chair of population health sciences at University of Utah Health, says it is worth it.

“If people don’t feel engaged in the decision-making process they are less likely to see the benefits of treatments. Instead they may see them as a hassle and not fill their prescriptions or take the medications,” says Fagerlin, director of the center, called the Decision-making and Choices to Inform Dialogue and Empower AFib patients (DECIDE) Center. The research studies will be carried out in collaboration with the Mayo Clinic.

Decisions, decisions

Understanding complex medical information could be a challenge for anyone but negotiating the myriad treatments for AFib stands out as a particularly tough nut to crack.

About 6 million Americans have the condition, an irregular heartbeat that increases risk for debilitating strokes. Taking blood thinning medications lessens that risk but at a cost. Patients on blood thinners bleed easily and more often – it could take multiple bandages to control bleeding from a small cut. Another worry is how to mitigate bleeding in a more serious situation such as a car accident.

“You are placing people on a relatively dangerous drug in order to reduce the risk for blood clots but sometimes you need blood clots,” says co-investigator Daniel Witt, professor and chair of pharmacotherapy at U of U Health. “The key is to find the right balance.”

But taking anticoagulants or not could be just one of many decisions patients with AFib face.

If they decide to take drugs, then there is the choice of what kind. Common foods and medications like antibiotics can interfere with the most common anticoagulant, warfarin, and patients must undergo frequent blood testing to monitor efficacy. Newer oral anticoagulants have fewer restrictions but increase risk for bleeding, are much more expensive and the increased cost is often not covered by insurance.

Tools developed through the study will lay out this information in an easy to understand way so patients and providers can decide on the best option. Fagerlin points out that even though providers are experts in the medical complexities, only patients know what their lives are like day in and day out. Rural residents may not be able to drive long distances for routine blood tests, others may not be able to afford high-priced treatments.

“This approach is expected to increase the number of patients who receive effective therapy for preventing stroke, and thereby improve outcomes in heart disease,” says co-investigator Elissa Ozanne, associate professor in Population Health Sciences at U of U Health.

The team will develop two types of decision support tools. One will be accessible at home or inthe waiting room so that patients can prepare for their clinic visit ahead of time. A second will facilitate conversation between patient and provider during the visit.

Clinical trials testing each tool independently and together, will be carried out at the University of Utah, Mayo Clinic and at additional sites. The investigators anticipate enrolling 1200 patients into the trial.

“What we hope in the end is to answer important questions. What is the best way to support patients in a way that fits the patient and makes sense intellectually, factually, and emotionally?” says co-investigator Juan Pablo Brito, medical director of the Shared Decision Making National Resource Center and investigator of the Knowledge and Evaluation Research Unit at the Mayo Clinic. “We think this this will be the beginning of a new era of shared decision making.”

Brito anticipates that what they learn through this study will help patients with other conditions talk through decisions with their providers.