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

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.

Motivational Interviewing and Medication Review in Coronary Heart Disease (MIMeRiC): Intervention Development and Protocol for the Process Evaluation

“…Guidelines for the development and evaluation of complex interventions have recently highlighted the need for better reporting of the development and evaluation of the intervention, including descriptions of how it is assumed to work, how these assumptions informed the process evaluation, and how the process evaluation relates to the outcomes evaluation [ 3 - 5 ]. The protocol for a randomized controlled trial (RCT) of a complex intervention aimed at improving pharmacological secondary prevention practice in coronary heart disease (CHD) is described in a separate paper, Motivational Interviewing and Medication Review in CHD (MIMeRiC) (forthcoming) [ 6 ]. In this paper, however, we describe the theoretical framework of the intervention, describe its development, and present the study protocol for our prespecified process evaluation, which will help explain the outcomes of the trial, inform about the generalizability of the trial’s results, and highlight barriers and facilitators that are important for successful implementation of the intervention.…”

“…On the basis of the adherence model by the WHO, the RAA as a more general model for predicting behavior, and our understanding of how prescribing treatment determines outcomes, we made a conceptual model of how the change processes of the intervention would act to change the outcomes we set out in our RCT [ 6 ]. The model in Multimedia Appendix 1 describes how the optimized outcomes follow from full adherence to the optimal treatment, and how the intervention acts by two methods to improve these variables.…”

“…Ethical approval has been obtained from the Regional Ethics Committee, Linköping (Dnr-2013/236-31). The trial (clinicaltrials.gov, NCT02102503) has been fully described in the forthcoming protocol [ 6 ]. Patients in the intervention group meet a clinical pharmacist at the cardiology clinic 2 to 5 times during the year after discharge depending on need, and problems with adherence or prescribing are solved in collaboration with the patient and/or the cardiologist.…”