Effectiveness and cost-effectiveness of the Initial Medication Adherence intervention: a cluster randomised control trial, economic model and process evaluation(IMA-cRCT).

BACKGROUND. Nowadays 10% of the prescriptions for chronic treatments prescribed in Catalonia are not initiated. This behaviour of no initiation has a negative impact on the population health and health expenditure. HYPOTHESIS. The Initial Medication Adherence intervention (IMA) is effective and efficient to improve initiation, secondary adherence, and clinical outcomes in patients receiving treatment for the prevention and/or treatment of cardiovascular disease and diabetes. Its implementation in clinical practice in primary care centres and community pharmacies is feasible. OBJECTIVE. Evaluate the effectiveness, cost-effectiveness and feasibility of the IMA intervention, compared to the usual treatment, through a cluster randomized controlled trial complemented by a process evaluation and an economic modelling study. METHODOLOGY. Intervention hybrid design that includes a cluster randomized control trial (clinical trial) with a process evaluation, and a Markov model. The IMA intervention is a shared decision-making intervention based on the theoretical model of non-initiation. The clinical trial will be conducted in 34 primary care centres, which will be randomly assigned to the control or intervention group, and the community pharmacies of the reference area of the primary care centres in the intervention group. The professionals of the intervention group will receive training in non-initiation, shared decision-making and the IMA intervention. These professionals will apply the IMA intervention on all patients who receive a first prescription of a new treatment for cardiovascular disease and diabetes during the study period (January-July 2022). To carry out a process evaluation and understand the components of the intervention that influence the results; we will collect data on the implementation, the mechanism of impact and the context of the intervention. A Markov model that considers adherence as a dynamic process will be built, it will be informed with the clinical trial data and data from previous studies to assess long-term cost-effectiveness. EXPECTED RESULTS. The study will provide evidence on the IMA intervention as well as on a new methodology for developing and evaluating complex interventions in the future. APPLICABILITY AND RELEVANCE. The results of the study will be disseminated among stakeholders, including decision-makers, health professionals and patient groups, to facilitate transferability to clinical practice.