The OPTIMIZE trial: Rationale and design of a randomized controlled trial of motivational enhancement therapy to improve adherence to statin medication.
Statins are a class of medications that are particularly effective for lowering cholesterol and reducing cardiovascular morbidity and mortality. Despite a range of benefits, non-adherence to statin medication is prevalent with 50% to 75% of patients failing to adhere to treatment within the first 2-years. A previous review on interventions to improve adherence to cholesterol lowering medication concluded that rigorous trials were needed with emphasis on the patient's perspective and shared decision making. Motivational interviewing (MInt) is a promising patient-centered approach for improving adherence in patients with chronic diseases. This manuscript describes the rational and design of a randomized controlled trial (RCT) testing the efficacy of MInt in improving adherence to statin medication.



Patients filling their first statin prescription will be recruited to complete a 6-month observation run-in period (phase-1) after which medication possession ratio (MPR) will be assessed. Patients meeting criteria for non-adherence (MPR≤60%) will be invited to participate in the trial. 336 non-adherent new statin users will undergo a fasting lipid panel, complete baseline questionnaires, and be randomly allocated to receive four sessions of adherence education delivered using MInt (EdMInt) or to an education control (EC) delivered at 3-month intervals. Final assessments will occur 12-months after the first EdMInt or EC session. The primary outcome is change in MPR adherence to statin medication from baseline to 12-months. Secondary outcomes include within-patient change in self-reported medication adherence, stage of change and self-efficacy for medication adherence, motivation to adhere to statin medication, and lipid profile.
Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada.
Joshua A
JA
Rash
Department of Psychology, University of Quebec at Montreal (UQAM), CP 8888, Succursale Centre-Ville, Montreal, QC, H3C 3P8, Canada; Montreal Behavioral Medicine Centre (MBMC), Research Centre, Hopital du Sacre-Coeur de Montreal, 5400 Gouin Blvd West, J-3145, Montreal, QC, H2J 1C5, Canada.
Kim L
KL
Lavoie
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Ronald J
RJ
Sigal
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
David J T
DJ
Campbell
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Cardiac Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Braden J
BJ
Manns
Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada; Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
Marcello
M
Tonelli
Department of Psychology, University of Calgary, 2500 University Drive N.W., Calgary, AB, Canada. Electronic address: t.s.campbell@ucalgary.ca.
Tavis S
TS
Campbell
D004311:Double-Blind Method; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D055118:Medication Adherence; D009042:Motivation; D062405:Motivational Interviewing / Q000379:methods*; D018802:Patient-Centered Care
D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors
Adherence; Compliance; Medication; Motivational interviewing; Randomized controlled trial; Statin