Background In the treatment of coronary heart disease, secondary prevention goals are still often unmet and poor adherence to prescribed drugs has been suggested as one of the reasons. We aimed to investigate whether pharmaceutical care by a pharmacist at the cardiology clinic trained in motivational interviewing improves clinical outcomes and patient adherence. Methods This was a prospective, randomized, controlled, outcomes-blinded trial designed to compare pharmaceutical care follow-up with standard care. After standard follow-up at the cardiology clinic, patients in the intervention group were seen by a clinical pharmacist two to five times as required over seven months. Pharmacists were trained to use motivational interviewing in the consultations and they tailored their support to each patient’s clinical needs and beliefs about medicines. The primary study end-point was the proportion of patients who reached the treatment goal for low-density lipoprotein cholesterol by 12 months after discharge. The key secondary outcome was patient adherence to lipid-lowering therapy at 15 months after discharge, and other secondary outcomes were the effects on patient adherence to other preventive drugs, systolic blood pressure, disease-specific quality of life, and healthcare use. Results 316 patients were included. The proportion of patients who reached the target for low-density lipoprotein cholesterol were 37.0% in the intervention group and 44.2% in the control group (P = .263). More intervention than control patients were adherent to cholesterol-lowering drugs (88 vs 77%; P = .033) and aspirin (97 vs 91%; P = .036) but not to beta-blocking agents or renin–angiotensin–aldosterone system inhibitors. Conclusions Our intervention had no positive effects on risk factors for CHD, but it increased patient adherence. Further investigation of the intervention process is needed to explore the difference in results between patient adherence and medication effects. Longer follow-up of healthcare use and mortality will determine if the increased adherence per se eventually will have a meaningful effect on patient health. Trial registration: ClinicalTrials.gov NCT02102503, 03/04/2014 retrospectively registered.

BackgroundTrials of complex interventions are often criticized for being difficult to interpret because the effects of apparently similar interventions vary across studies dependent on context, targeted groups, and the delivery of the intervention. The Motivational Interviewing and Medication Review in Coronary heart disease (MIMeRiC) trial is a randomized controlled trial (RCT) of an intervention aimed at improving pharmacological secondary prevention. Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development of interventions, including descriptions of how the intervention is assumed to work, how this theory informed the process evaluation, and how the process evaluation relates to the outcome evaluation.ObjectiveThis paper aims to describe how the intervention was designed and developed. The aim of the process evaluation is to better understand how and why the intervention in the MIMeRiC trial was effective or not effective.MethodsThe research questions for evaluating the process are based on the conceptual model of change processes assumed in the intervention and will be analyzed by qualitative and quantitative methods. Quantitative data are used to evaluate the medication review in terms of drug-related problems, to describe how patients’ beliefs about medicines are affected by the intervention, and to evaluate the quality of motivational interviewing. Qualitative data will be used to analyze whether patients experienced the intervention as intended, how cardiologists experienced the collaboration and intervention, and how the intervention affected patients’ overall experience of care after coronary heart disease.ResultsThe development and piloting of the intervention are described in relation to the theoretical framework. Data for the process evaluation will be collected until March 2018. Some process evaluation questions will be analyzed before, and others will be analyzed after the outcomes of the MIMeRiC RCT are known.ConclusionsThis paper describes the framework for the design of the intervention tested in the MIMeRiC trial, development of the intervention from the pilot stage to the complete trial intervention, and the framework and methods for the process evaluation. Providing the protocol of the process evaluation allows prespecification of the processes that will be evaluated, because we hypothesize that they will determine the outcomes of the MIMeRiC trial. This protocol also constitutes a contribution to the new field of process evaluations as made explicit in health services research and clinical trials of complex interventions.

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Objectives Clinical outcomes in the secondary prevention of cardiovascular disease depend on the patients’ adherence to prescribed medicines. Motivational interviewing (MI) is a patient-centred approach used to change different health behaviours. The objective of this pilot study was to explore the impact of a clinical pharmacist's consultation on beliefs about medicines and self-reported medication adherence among patients with coronary heart disease (CHD). Methods CHD-patients participating in a prevention programme at the Kalmar County Hospital were randomised to control or intervention. The intervention consisted of a medication review focused on cardiovascular drugs, and a semistructured interview based on MI-approach, with a follow-up phone call 2 weeks later. The intervention was conducted by a clinical pharmacist at the cardiology unit 3 months postdischarge. Primary outcome measures were the results from the Beliefs about Medicines-Specific (BMQ-S) and the 8-Item Morisky Medication Adherence Scale (MMAS-8) 2 weeks after intervention. Results 21 enrolled patients (11 intervention) all completed to follow-up. MMAS-8 was very similar in the intervention and control groups. In BMQ-S the intervention group had a mean (SD) necessity score of 21 (4) and a concern score of 12 (6), corresponding results in the control group were 21 (3) and 10 (5). However, since there was a difference in BMQ-S at baseline, seven intervention patients shifted towards more positive beliefs compared with two control patients. Conclusions No difference was found in adherence and beliefs at follow-up. However, after consultation, a larger proportion of patients changed towards more positive beliefs compared with control.