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Improving Adherence to Cholesterol Lowering Medications among Minority Populations in Florida: A Randomized Trial

Ana M Palacio, Leslie Hazel-Fernandez, Leonardo J Tamariz, Denise C Vidot, Claudia Uribe, Sylvia Desiree Garay, Hua Li and Olveen Carrasquillo

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.