Poor Prescription Adherence After Acute MI Continues to Vex Researchers

Automated reminders combined with financial incentives and support from family and friends are not effective in motivating patients to adhere to prescribed medications after acute MI. In a new study, patients who received no extra encouragement to stick to their medication schedule had similar rehospitalization rates as those who received a multifaceted reminder strategy.

“The fact that this intervention had negative results is important in highlighting that some of the approaches we might expect to significantly improve adherence do not in the context of a health plan-based intervention for patients after AMI,” write Kevin G. Volpp, MD, PhD (University of Pennsylvania, Philadelphia, PA), and colleagues.

The researchers had hoped that by combining some promising approaches, such as electronic pill bottles and small, frequent financial rewards, patients would benefit in terms of a reduction in repeat cardiovascular events.

Sameer Bansilal, MD (Icahn School of Medicine at Mount Sinai, New York, NY), who was not involved in the study, told TCTMD he was not surprised by the results. While a few targeted interventions have been shown to improve surrogate outcomes such as blood pressure and cholesterol, even eliminating copayments for medication has not been shown to significantly impact hard CV outcomes.

“Fixing human behavior is sort of the Holy Grail of this type of research, and I don’t think anyone has come really close to it,” he said.

(Not Even) With a Little Help From Their Friends

For the HeartStrong trial, published online ahead of print earlier this week in JAMA Internal Medicine, 1,509 patients discharged with a diagnosis of acute MI and prescribed at least two daily medications (statin, aspirin, beta-blocker, or antiplatelet drug) were randomized to the reminder or no-reminder group. Patients in both groups received $25 for their participation.

Those randomized to the reminder group received an additional $25 for activating their electronic pill bottles. The bottles used a wireless communication system to report whether doses have been taken or missed. Other components of the reminder strategy were: daily lottery incentives with an approximately one in five chance of a $5 payout and a one in 100 chance of a $50 payout based on medication adherence the previous day; the option to enlist a friend or family member to support medication adherence who would be automatically notified if participants failed to use the electronic pill bottles two out of the three consecutive days; access to social work resources; and a hospital-based advisor to provide monitoring, feedback, and reinforce adherence.

Most patients in the reminder group (87.5%) activated their electronic pill bottles, and approximately 70% enlisted a friend or family member.

Over 12 months of follow-up, time to first readmission for a vascular event or death (the primary outcome) was similar between the two groups, as was the prespecified secondary outcome of time to first all-cause readmission. Similarly, time to first event (including observation stays and emergency department visits) did not differ.

In analyses looking at adherence, there were no differences between the reminder and no-reminder groups for adherence to any of the prescription medications or over-the-counter aspirin. Furthermore, a cost analysis showed similar rates of mean annual medical spending over the 12 months between the no-reminder and reminder groups ($29,811 vs $24,038; P = 0.15).

Does Anything Work?

Volpp and colleagues offer several explanations for why their intervention did not work. One may be that this type of strategy is not suited for patients with cardiovascular disease who are taking multiple medications.

“Perhaps the multiple medications required or use of electronic pill bottles makes adherence daunting,” they hypothesize. “Perhaps the goal of avoiding a subsequent AMI is maximally motivating, so that further efforts toward motivation are ineffective. Perhaps other patient concerns about potential adverse effects of these medications, such as impotence or fatigue, were not targeted by this engagement strategy.”

The researchers also suggest that at a mean of 41 days between discharge and study enrollment—due to insurance requirements—the intervention might have been timed too late for some patients. Another possibility is that despite improvements in technology, the electronic pill bottles may need more refining.

It’s just amazing how patients can figure out ways to zone out and not take their medications. Sameer Bansilal

To TCTMD, Bansilal said the authors may have been overly optimistic in expecting to see a large difference with the intervention, adding that a larger study population might have provided a better opportunity to see differences. He also questioned the value of the financial incentives, which were extremely small compared with what is offered to other patient populations in similar studies.

“It’s very difficult to say why this didn’t work,” Bansilal observed. “This is the challenge and what keeps people engaged in behavioral research. It’s just amazing how patients can figure out ways to zone out and not take their medications. If you had a heart attack and someone is trying to help you take your pill, that should be a powerful motivator, but [the data on these interventions] are abysmal.”

He also noted that more research is needed on racial and ethnic differences in motivational strategies. “I don’t believe we are going to find one ‘silver bullet’ that is right for everyone,” Bansilal said. “But we do know the motivators can be quite different.”

Another promising option, he added, is a polypill that combines several medications into a single dose. Simplifying a patient’s daily drug schedule may be an important next step. Polypills are currently being tested in Europe and India for effects on hard CV outcomes.

“As of now, that is one of our major investments in terms of improving medication adherence,” Bansilal noted.