Abstract
Background: Lipid-lowering therapy, particularly with hydroxymethylglutaryl-CoA reductase inhibitors (statins), has been shown to significantly reduce morbidity and mortality in patients with and without known coronary artery disease; however adherence is poor particularly among racial/ethnic minorities. Motivational interviewing (MINT) is a patient centered intervention that has been shown to improve self-management through behavior change. Purpose: The aim is to determine if a call center-based motivational interviewing intervention is more effective than usual care at increasing long term adherence to statins (12 months) among minority subjects. Methods: Using a randomized design we will compare usual care and MINT. We will include adult black and Hispanic subjects enrolled in a large health benefits company who were newly started in a statin. We will recruit diabetic and non-diabetic subjects to evaluate the impact of MINT in these two distinct populations. We will identify eligible subjects from a large administrative database using a previously validated algorithm. The primary outcome will be medication adherence measured using pharmacy claims as the medication possession ratio. We will define adequate adherence as 80% refill over a period of a year. Our goal is to recruit 800 minority subjects and to have an equal distribution of Black, Hispanics, diabetics and non-diabetics. Conclusions: The study will evaluate a non-traditional but scalable intervention to curtail the epidemic of lack of adherence to statin therapy.
Highlights
Lipid-lowering therapy, with hydroxymethylglutaryl-CoA reductase inhibitors, has been shown to significantly reduce morbidity and mortality in patients with and without known coronary artery disease; adherence is poor among racial/ethnic minorities
Minorities have a higher prevalence of cardiovascular risk factors [5] and are even less likely to use statins when prescribed [6,7,8]
This may be related to the presence of additional barriers to adherence such as social, financial, environmental, behavioral and cultural factors; traditional medical models for managing Cardiovascular Disease (CVD) have met with limited success in minority populations
Summary
Lipid-lowering therapy, with hydroxymethylglutaryl-CoA reductase inhibitors (statins), has been shown to significantly reduce morbidity and mortality in patients with and without known coronary artery disease; adherence is poor among racial/ethnic minorities. Adherence to Hydroxymethylglutaryl-CoA reductase inhibitors (statins) is low in spite of significantly decreasing the risk of cardiovascular events and mortality in patients with hypercholesterolemia [1]. Increasing evidence suggests that nontraditional approaches maybe effective in these groups Such approaches most typically involve culturally tailored behavioral interventions led by counselors, pharmacists, or lay health educators [9]. This approach may be useful for improving adherence to statins, which seems to require appropriate communication, understanding and follow up [4]. Most patients that discontinue temporarily statins due to adverse events, tolerate well statins long term when rechallenged [10], highlighting the importance of helping patients make informed health decisions when concerns arise
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