Shared decision-making tool aids in AF-related stroke prevention: ENHANCE-AF
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CHICAGO — Compared with usual care, a shared decision-making pathway reduced decisional conflict associated with the use of anticoagulation for stroke prevention in atrial fibrillation at 1 month, according to the ENHANCE-AF study.
Current practices around stroke prevention for patients with AF often lead to a lack of patient satisfaction, therapy that is mismatched with patient preferences, wasted health care resources and preventable adverse outcomes, Paul J. Wang, MD, director of the Stanford Cardiac Arrhythmia Service and professor of medicine and bioengineering at Stanford University School of Medicine, said during a late-breaking science presentation at the American Heart Association Scientific Sessions.
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“Our hypothesis was that our novel, shared decision-making tool was more effective than usual care based on patient-selected outcomes,” Wang said.
Decrease in decisional conflict
In a randomized, comparative effectiveness trial, Wang and colleagues designed and evaluated a digital AF shared decision-making toolkit using a patient-centered design, available in English and Spanish. The toolkit included a brief animated video; interactive questions with answers; a quiz to check on understanding; a worksheet to be used by the patient during the encounter; and an online guide for clinicians. The study population included 1,001 English or Spanish speakers from five sites with nonvalvular AF and a CHA2DS2-VASc stroke score of 1 or greater for men or 2 or greater for women. The mean age of participants was 69 years; 40% were women and 16.9% were Black.
Researchers randomly assigned participants to the shared decision-making toolkit or to usual care. The primary endpoint was a validated 16-item Decisional Conflict Scale score at 1 month. Secondary outcomes included Decisional Conflict Scale at 6 months and the 10-item Decision Regret Scale score at 1 and 6 months.
The findings were simultaneously published in the Journal of the American Heart Association.
Within the cohort, half of participants had CHA2DS2-VASc scores of 3 or greater (men) or 4 or greater (women).
Researchers found that, for the primary endpoint at 1 month, the toolkit was associated with a clinically meaningful reduction in decisional conflict, with a 7-point difference in median scores (16.4 for usual care vs. 9.4 for shared decision-making; P = .007).
For the secondary endpoint of 1-month Decision Regret Scale score, the difference in median scores between arms was 5 points in the direction of less decisional regret (P = .078). Wang said the treatment effects lessened over time; the difference in medians was 4.7 points for Decisional Conflict Scale (P = .06) and 0 points for Decision Regret Scale (P = .35) at 6 months.
“At 1 month, our shared decision-making intervention resulted in a significant decrease in decisional conflict, improved preparation for decision-making and increased AF knowledge,” Wang said. “Our novel toolkit is now available for widespread use in clinical practice.”
Balancing stroke vs. bleeding risk
Discussing the ENHANCE-AF findings, Christine M. Albert, MD, MPH, FHRS, chair of the department of cardiology and the Lee and Harold Kapelovitz Distinguished Chair in Cardiology at the Smidt Heart Institute at Cedars-Sinai, said anticoagulation remains underutilized in part because it is a complex decision, depending on a clear understanding of the value patients place on the trade-offs between risk for stroke and risk for bleeding. Additionally, 50% of patients not initiated on oral anticoagulation therapy reported a lack of discussion with their physician regarding stroke prophylaxis.
“There is no free lunch — there is a risk for bleeding,” Albert said. “This has to be explained to patients. Those at the highest risk for stroke are often at the highest risk for bleeding. It is a complex decision for the physician sometimes. This requires education, which takes time.”
The multipronged decision aid in ENHANCE-AF showed benefit with significantly improved decisional conflict and regret scores despite low scores, suggesting minimal decisional conflict in both groups, Albert said.
“For the future, we hope [the researchers] will test this tool in populations with lower health literacy, evaluate the impact on longer-term compliance and determine whether the decision aid improves oral anticoagulation use in patients not on oral anticoagulants,” Albert said. “Ultimately, we will need larger-scale studies to determine whether these decision aids impact hard outcomes in AF.”
Reference:
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Wang PJ, et al. LBS.08: Treating atrial and supraventricular arrhythmias. Presented at: American Heart Association Scientific Sessions; Nov. 5-7, 2022; Chicago (hybrid meeting).
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