IMPACT-AFib study shows a mailer not enough to increase blood thinner use in AF patients

If you want to change patient and provider behavior to improve a patient’s health, will an informational mailer make a difference? Not always, according to a new study co-authored by Duke Clinical Research Institute faculty.

A new paper published in JAMA Network Open co-authored by Duke Clinical Research Institute (DCRI) faculty found that an educational mailer sent to patients with atrial fibrillation (AF) and their clinicians was not effective in helping to increase the use of a treatment that could help those patients avoid a stroke.

Patients with AF are 5- to 7-times more likely to experience a stroke than non-AF patients, and strokes related to AF have higher morbidity and mortality than non-AF-related strokes. Taking oral anticoagulants (OACs) decreases stroke risk for these patients by approximately 70%. Although the FDA recommends OACs for AF patients at increased risk of stroke, only about half of these patients are treated with an OAC.

Insurance providers and health plans sometimes mail educational information directly to patients in attempts to improve the use of underused therapies. This method has shown some success when used to increase the use of β-blockers in heart attack patients, but it has not previously been tested for AF.

“It’s a very different patient population,” author Sean D. Pokorney, MD, MBA, Assistant Professor of Medicine and DCRI faculty member, said of the heart attack patients. “It’s an acutely ill patient who just went through a traumatic event, so maybe they need a β-blocker after they’ve had a heart attack, versus somebody who has had AF and likely had it for quite some time, and we’re trying to prevent something that hasn’t happened.”

Pokorney also noted that patients’ perceived risks of blood thinners may be deterring them from the treatment.

“I do think that there is an added challenge with engaging patients and helping them understand the value of preventing future events, especially when you’re talking about a medication that does have some risk with it,” Pokorney said. “The β-blockers don’t have a lot of associated risks. I would say that the blood thinners also don’t have a lot of risk with it, but they do increase the risk of bleeding, so there is risk-benefit with blood thinners, whereas it’s more just benefit with β-blockers.”

The report is a finding of the IMPACT-AFib trial, which ran from September 2017 to May 2019, and included more than 45,000 individuals with AF who fit the guidelines to be treated with OACs. Patients and their clinicians were randomly assigned to receive patient and clinician education materials in the mail either at the beginning of the study or after one year. The trial is a collaboration between researchers from health plans including Aetna, HealthCore/Anthem, Harvard Pilgrim Health Care, Humana, and Optum, along with the FDA, the Clinical Trials Transformation Initiative, the Harvard Pilgrim Health Care Institute, and the DCRI.

The trial found no meaningful differences in rates of OAC treatment for the patients regardless of whether they received the mailer at the beginning of the trial or one year in.

The authors acknowledged within the paper that the result “may be owing to the use of a single intervention when most studies showing success in guideline implementation have been multifaceted.”

The authors’ review of interventions targeting underuse of OACs for stroke prevention in AF patients found that provider education and persuasive elements such as comparing peer performance were the most successful.

The IMPACT-AFib trial builds on knowledge from the IMPACT-AF trial, which showed that a more comprehensive educational program for AF patients and providers in five low- and middle-income countries was effective in increasing the use of OACs.

“I think that what we’ve determined here is that more intensive interventions are needed,” Pokorney said. “Our next steps are focused on trying to engage members of the community and engage patients around this issue and also to build in systems of care with measurement and feedback for institutions to make sure they’re able to track their patients and able to treat them in the best way possible.”

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