ObjectivesClinical outcomes in the secondary prevention of cardiovascular disease depend on the patients’ adherence to prescribed medicines. Motivational interviewing (MI) is a patient-centered approach used to change different health behaviors. 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).

MethodsCHD-patients participating in a prevention program at the Kalmar County Hospital were randomized to control or intervention. The intervention consisted of a medication review focused on cardiovascular drugs, and a semi-structured interview based on MI-approach, with a follow-up phone call two weeks later. The intervention was conducted by a clinical pharmacist at the cardiology unit three months post-discharge.

Primary outcome measures were the results from the Beliefs about medicines-Specific (BMQ-S) and the 8-Item Morisky Medication Adherence Scale (MMAS-8) two weeks after intervention.

Results21 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 to two control patients.

ConclusionNo difference was found in adherence and beliefs at follow-up. However, after consultation a larger proportion of patients changed towards more positive beliefs compared to control.

BACKGROUND: Preventive 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.

OBJECTIVE: This 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.

METHODS: The 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.

RESULTS: The 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.

CONCLUSIONS: The 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 REGISTRATION: ClinicalTrials.gov NCT02102503; https://clinicaltrials.gov/ct2/show/NCT02102503 (Archived by WebCite at http://www.webcitation.org/6x7iUDohy).

BACKGROUND: Trials 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.

OBJECTIVE: This 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.

METHODS: The 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.

RESULTS: The 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.

CONCLUSIONS: This 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.

Background: Living with coronary heart disease (CHD) usually means being prescribed several medications to help prevent new cardiac events. Using medicines for long-term conditions impacts on day-to-day life, and coping with medicines can be burdensome and can affect the quality of life. To enable better support of these patients, we need to understand their collective medicine-related experience. Purpose: The purpose of this study was to describe patients' medicine-related experience 1 year after the diagnosis of CHD. Patients and Methods: A qualitative, descriptive study using semi-structured interviews was conducted in 19 patients in their homes or at Linnaeus University, Sweden. Interviews were recorded and transcribed verbatim. Qualitative content analysis with an inductive approach was used. Results: Patients' experiences with using their medicines after diagnosis of CHD differed considerably. Some patients found handling the medicines and administering their treatment very easy, natural and straightforward, while others found that it was distressing or trouble-some, and influenced their lives extensively. There was a varied sense of personal responsibility about the treatment and use of medicines. The patients' experiences were classified into one of seven categories: a sense of security, unproblematic, learning to live with it, taking responsibility for it, somewhat uncertain, troublesome, or distressing. Participants in the study who expressed an unproblematic view of medicine taking also often revealed that they had dilemmas or uncertainties. Conclusion: Patients' medicine-related experiences after CHD vary greatly. The findings of this study highlight a need for more individualized support for patients using medicines for secondary prevention. The patients often needed better dialogue with healthcare providers to optimally manage their medicines. Medicine-related support for these patients should encompass various aspects of medicine-taking.

Background: In the treatment of coronary heart disease, secondary prevention goals are still often unmet and pooradherence 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 outcomesand 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 interventiongroup were seen by a clinical pharmacist two to fve times as required over seven months. Pharmacists were trainedto use motivational interviewing in the consultations and they tailored their support to each patient’s clinical needsand beliefs about medicines. The primary study end-point was the proportion of patients who reached the treatmentgoal for low-density lipoprotein cholesterol by 12 months after discharge. The key secondary outcome was patientadherence to lipid-lowering therapy at 15 months after discharge, and other secondary outcomes were the efectson patient adherence to other preventive drugs, systolic blood pressure, disease-specifc quality of life, and healthcareuse.

Results: 316 patients were included. The proportion of patients who reached the target for low-density lipoproteincholesterol were 37.0% in the intervention group and 44.2% in the control group (P=.263). More intervention thancontrol 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 efects on risk factors for CHD, but it increased patient adherence.Further investigation of the intervention process is needed to explore the diference in results between patient adherence and medication efects. Longer follow-up of healthcare use and mortality will determine if the increased adherence per se eventually will have a meaningful efect on patient health