Project Summary
What is the research about?
Atrial fibrillation, or AFib, occurs when the heart quivers or beats irregularly. AFib can lead to blood clots that can cause stroke or death. Taking blood thinners can help people with AFib reduce their risk of stroke. But these medicines have their own risks, such as increased bleeding.
In September 2017, PCORI awarded $2.75 million to support a $5 million partnership with the American Heart Association to improve shared decision making for treating AFib. Shared decision making is a process where patients and doctors work together to make healthcare decisions. In shared decision making, patients and their doctors often use a decision aid, which can help patients choose between two or more treatment options based on what is most important to them.
The Decision-Making and Choices to Inform Dialogue and Empower AFib Patients (DECIDE) Center supports efforts to develop, adapt, and test decision aids for AFib. Through the DECIDE Center, doctors, pharmacists, and researchers at the University of Utah and the Mayo Clinic are working together to
- Assess what has been done so far to develop decision aids for patients with AFib
- Identify decision aids already being used for AFib
- Adapt or develop decision aids that patients can use on their own before a doctor visit
- Develop encounter decision aids, which patients can use with their doctor
- Evaluate whether a patient decision aid, an encounter decision aid, both, or neither are effective in helping patients with AFib choose treatments to prevent stroke
- Train the next generation of scientists working in shared decision making
Who can this research help?
Results can help health systems or clinics considering ways to help patients better understand their treatment options and choose the treatment that works best for them.
What is the research team doing?
Working with six clinical sites, the research team is recruiting 1,200 patients with AFib. The team is assigning patients by chance to receive a patient decision aid or not, to use before their clinic visit. The team is assigning doctors by chance to use an encounter decision aid or not.
The research team is comparing four ways of working with patients to make decisions about AFib treatment:
- A patient decision aid only
- An encounter decision aid only
- A patient decision and encounter decision aid together
- Usual care without a decision aid
To study how patients and clinicians work together to make decisions, the research team is recording clinic visits. They are looking at how patients and clinicians use the decision aids, how they talk about the risks and benefits of treatments for AFib, and how they decide together which treatment to use. The team is reviewing patient records up to a year before and after the visit to see if patients took medicine to reduce stroke risk. They are also looking at whether patients had strokes and at other health problems.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 1,200 patients with AFib |
| Interventions/ Comparators |
|
| Outcomes |
Primary: shared decision making, patient decisional conflict, knowledge about AFib Secondary: decision regret, preparation for decision making, quality of communication, shared decision making, control preference, satisfaction with the decision aid, anti-clot treatment scale, collaborative agreement between clinician and patient, values tradeoff, minimizer/maximizer tendency, anticoagulation use, choice of anticoagulation agent, death, stroke, transient ischemic event, medicine adherence and persistence, INR (clotting) tests scheduled and obtained for patients choosing warfarin |
 |
1-year follow up for primary outcomes |
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Women
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.