Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Protocol for a Randomized Controlled Trial Investigating Effects on Clinical Outcomes, Adherence, and Quality of Life

Abstract

BackgroundPreventive treatment goals for blood pressure and cholesterol levels continue to be unmet for many coronary patients. The effect of drug treatment depends on both its appropriateness and the patients’ adherence to the treatment regimen. There is a need for adherence interventions that have a measurable effect on clinical outcomes.ObjectiveThis study aims to evaluate the effects on treatment goals of an intervention designed to improve patient adherence and treatment quality in secondary prevention of coronary heart disease. A protocol for the prespecified process evaluation of the trial is published separately.MethodsThe Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a prospective, randomized, outcomes-blinded trial designed to compare individualized follow-up by a clinical pharmacist using motivational interviewing (MI) and medication review with standard follow-up. Patients were randomized to 2 groups after stratification according to their beliefs about medicines. After standard follow-up at the cardiology clinic, patients in the intervention group are seen individually by a clinical pharmacist 2 to 5 times as required over 7 months, at the clinic. The pharmacist reviews each patient’s medication and uses MI to manage any problems with prescribing and adherence. The primary study outcome is the proportion of patients who have reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. Secondary outcomes are the effects on patient adherence, systolic blood pressure, disease-specific quality of life, and health care use.ResultsThe protocol for this study was approved by the Regional Ethics Committee, Linköping, in 2013. Enrollment started in October 2013 and ended in December 2016 when 417 patients had been included. Follow-up data collection will conclude in March 2018. Publication of the primary and secondary outcome results from the MIMeRiC trial is anticipated in 2019.ConclusionsThe MIMeRiC trial will assess the effectiveness of an intervention involving medication reviews and individualized support. The results will inform the continued development of support for this large group of patients who use preventive medicines for lifelong treatment. The design of this adherence intervention is based on a theoretical framework and is the first trial of an intervention that uses beliefs about medicines to individualize the intervention protocol.Trial RegistrationClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy)

Effects of a pharmaceutical care intervention on clinical outcomes and patient adherence in coronary heart disease: the MIMeRiC randomized controlled trial

“…The participants were randomized in blocks of 10, stratified according to their attitudes to their heart medicines, as measured by the Beliefs about Medicines Questionnaire-Specific (BMQ-S) [ 12 , 13 ] after their standard care follow-up with the physician. Blinding to allocation was not possible due to the nature of the intervention (Additional file 1 ) [ 35 ].…”

“…The participants randomized to the intervention group received a follow-up program run by two clinical pharmacists in addition to standard care. Details of the intervention protocol and the associated theoretical framework have been previously described [ 35 , 36 ]. The mainstay of the intervention consisted of two appointments at the cardiac out-patient clinic with pharmacists trained in motivational interviewing and medication reviews (Additional file 1 ).…”

“…Data on LDL-C, systolic blood pressure, prescription refills, and number of healthcare contacts were obtained as a report from the EHR database . At 15 months post-discharge, participants were asked to complete the same questionnaires as those they completed at baseline; see study protocol for details [ 35 ].…”

“…The initial sample size calculation indicated that we would need 195 participants in each group to detect a shift in the proportion achieving the primary goal for LDL-C from 0.3 to 0.5 and a difference of 10% in the proportion of patients with refill adherence, with 80% power at a significance level of P = 0.05 (two-sided). Changed circumstances resulted in a new sample size calculation in 2016, see published protocol for details [ 35 ]. The new calculation was based on a shift in the proportion reaching the primary goal from 0.45 in the control group to our expectation of 0.6 in the intervention group.…”

“…The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial investigated whether individualized follow-up with motivational interviewing and medication review by a pharmacist at the cardiology clinic improves clinical outcomes and patient adherence [ 35 ]. The theoretical framework and the development and evaluation of this pharmaceutical care intervention have been described elsewhere [ 36 ].…”