Adherence to statin therapy cannot be bought, a randomized clinical trial found. After 12 months, there were no significant differences in low-density lipoprotein cholesterol (LDL-C) between patients who received financial incentives to take statins for 6 months and those who did not.
Six-month adherence to taking statins was better among people who received financial incentives, but this did not translate into longer-term results — namely, changes in LDL-C levels from baseline to 12 months, the primary outcome — that were different between intervention and control groups, reported Iwan Barankay, PhD, of University of Pennsylvania in Philadelphia, and colleagues in JAMA Network Open.
“Different financial incentives improved measured statin adherence but not LDL-C levels,” they wrote. “Although adherence was a secondary outcome here, and electronic pill bottle data are an improvement over self-reported adherence data or medication refill rates, our study reinforces the imperative to go beyond adherence and instead focus, as was done in this trial, on the health outcomes or validated surrogate outcomes of primary interest.”
In the study, patients were randomized to control (n=201) or one of three intervention groups. For people in the three intervention groups, adherence was rewarded with financial incentives for 6 months:
- The sweepstakes group had incentives for daily adherence.
- The deadline sweepstakes group had incentives that were reduced if participants opened the bottle only after a reminder.
- The sweepstakes plus deposit contract group split incentives between daily adherence and a monthly deposit reduced for each day of nonadherence.
Adherence at 6 months, defined as the proportion of 180 days with electronic pill bottle opening, was lowest for the control group at 0.69 (95% CI 0.66-0.72).
For the sweepstakes group, adherence was 0.84 (95% CI 0.81-0.87). For the deadline sweepstakes group it was 0.86 (95% CI 0.83-0.89), and for the sweepstakes plus deposit contract group it was 0.87 (95% CI 0.84-0.90<em>; P< .001 for each group versus control).
Months after the incentives ended, however, the groups showed similar changes in LDL-C. Mean LDL-C level reductions from baseline to 12 months were 33.6 mg/dL in the control group, 32.4 mg/dL in the sweepstakes group, 33.2 mg/dL in the deadline sweepstakes group, and 36.5 mg/dL in the sweepstakes plus deposit contract group (adjusted P > 0.99 for each group vs control).
There are more questions than answers in the study, noted Hayden Bosworth, PhD, of the Veterans Affairs Medical Center in Durham, North Carolina, in an accompanying editorial.
“Additional questions that may require further attention is the issue of delayed gratification,” Bosworth wrote. “Use of cholesterol as a focus is appropriate in the sense that individuals do not experience direct benefits from taking the medications, but on the other hand, it tends to be challenging to encourage an individual to adhere to a treatment with a long delay in gratification and subsequent long-term risk reduction.”
More work may be necessary “to better understand how closely tied a specific behavior needs to be to the reward and relevant context, and as Barankay and colleagues set out to answer, how long a behavior needs to be reinforced before it becomes a habit,” he added.
Prescribed medication nonadherence is common — as many as half of those with chronic disease deviate from their prescription — which affects both health outcomes and costs. A 2017 CDC review of nonadherence outlined intentional and unintentional patient factors including complex regimens, financial issues, beliefs about medication and disease, and side effects, as well as provider factors, including limited coordination of care and ineffective communication.
Barankay and colleagues conducted a four-group trial between August 2013 and July 2018, including 805 adults with elevated risk of cardiovascular disease, poor LDL-C control, and evidence of imperfect adherence to statin medication. Participants were recruited from employees at four companies served by a large national pharmacy benefits manager, beneficiaries of a large health plan, and the University of Pennsylvania Health System.
Mean age was 58.5 and 64.5% were women, with diabetes and cardiovascular disease rates of 63.9% and 33.9%, respectively. Average baseline LDL-C was 143.2 mg/dL. LDL-C levels were measured for 636 participants at 12 months.
Over the 6-month intervention period, all participants received daily reminders and had an electronic pill bottle that tracked compliance based on bottle opening, with those in the three intervention groups paid to do so.
Intervention and control participants had similar, salutary changes in LDL-C in the trial, the authors noted.
“Given that eligibility relied on suboptimal LDL-C levels recently measured in usual care, clinicians may already have been active in intensifying the dose or the type of statin and encouraging healthful behavior concurrent with the trial,” they wrote. “Mean reversion can also explain some of the LDL-C improvement.”
“Taken together, these observations suggest that although financial incentives did not reduce LDL-C levels in this population of patients, financial incentives could still be a useful intervention for patients with lower degrees of health engagement who do not use or have access to primary care,” they added. “This is especially possible because the effect of statins on LDL-C reduction at the start of medication regimens is substantial and well-documented.”
Limitations of the study included missing 12 month LDL-C values for about 21% of participants. Findings are for long-term statin users with partial adherence, which may limit generalizability regarding how those with a new statin prescription or those without routine care might respond to a similar intervention.
- There were no significant differences in low-density lipoprotein cholesterol (LDL-C) after 12 months between patients who received financial incentives to take statins for 6 months and patients who did not, a randomized clinical trial found.
- The findings point to the importance of directly measuring health outcomes, rather than simply adherence in trials aimed at improving health behaviors.
Paul Smyth, MD, Contributing Writer, BreakingMED™
This work was supported by CVS Health and a grant from the National Institutes of Health.
Barankay reported receiving research support from Humana outside the submitted work.
Bosworth reported receiving grants from Improved Patient Outcome, NovoNordisk, Otsuka, and Pharma Foundation; personal fees from Preventric Diagnostic and Novartis; and grants and personal fees from Sanofi outside the submitted work.
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