Effectiveness and cost-effectiveness of an intervention to improve Initial Medication Adherence to treatments for cardiovascular diseases and diabetes in primary care: study protocol for a pragmatic cluster randomised controlled trial and economic model (the IMA-cRCT study)

Abstract

Background Between 2 and 43% of patients who receive a new prescription in PC do not initiate their treatments. Non-initiation is associated with poorer clinical outcomes, more sick leave and higher costs to the healthcare system. Existing evidence suggests that shared decision-making positively impacts medication initiation. The IMA-cRCT assesses the effectiveness of the IMA intervention in improving adherence and clinical parameters compared to usual care in patients with a new treatment for cardiovascular disease and diabetes prescribed in PC, and its cost-effectiveness, through a cRCT and economic modelling. Methods The IMA intervention is a shared decision-making intervention based on the Theoretical Model of Non-initiation. A cRCT will be conducted in 24 PC teams in Catalonia (Spain), randomly assigned to the intervention group (1:1), and community pharmacies in the catchment areas of the intervention PC teams. Healthcare professionals in the intervention group will apply the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment (no other prescription from the same pharmacological group in the previous 6 months). All the study variables will be collected from real-world databases for the 12 months before and after receiving a new prescription. Effectiveness analyses will assess impact on initiation, secondary adherence, cardiovascular risk, clinical parameters and cardiovascular events. Cost-effectiveness analyses will be conducted as part of the cRCT from a healthcare and societal perspective in terms of extra cost per cardiovascular risk reduction and improved adherence; all analyses will be clustered. Economic models will be built to assess the long-term cost-effectiveness of the IMA intervention, in terms of extra cost for gains in QALY and life expectancy, using clinical trial data and data from previous studies. Discussion The IMA-cRCT represents an innovative approach to the design and evaluation of behavioural interventions that use the principles of complex interventions, pragmatic trials and implementation research. This study will provide evidence on the IMA intervention and on a new methodology for developing and evaluating complex interventions. The results of the study will be disseminated among stakeholders to facilitate its transferability to clinical practice. Trial registration ClinicalTrials.gov, NCT05026775. Registered 30th August 2021.

Complex multidisciplinary intervention to improve Initial Medication Adherence to cardiovascular disease and diabetes treatments in primary care (the IMA-cRCT study): mixed-methods process evaluation protocol

“…52 Details of how informed consent will be obtained by simplified means are described somewhere else. 35 Participation in the process evaluation is entirely voluntary. As approved by the CEIm, all healthcare professionals participating in the process evaluation will have signed an informed consent prior to the trial commencement agreeing to have feedback questionnaires sent by mail and to take part in an interview if invited to do so towards the end of the trial.…”

“…Full details on the cRCT setting are provided elsewhere. 35 The IMA-cRCT will recruit 24 PC centres, around 300 professionals and 4000 patients. 35 The sampling strategy of the process evaluation is conditioned by the cluster sampling design of the cRCT and is detailed below.…”

“…Full details of the dissemination strategy are outlined in the main trial protocol. 35 Unitat de Suport a la Recerca Regió Metropolitana Sud, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina (IDIAPJGol), Barcelona, Catalunya, Spain…”

“…Detailed cRCT methods (ClinicalTrials.gov, NCT05026775) are described elsewhere. 35 The trial is being conducted in 24 PC centres in Catalonia (May 2022–September 2023), randomised to the control (usual care) or the intervention group (the IMA intervention), as well as community pharmacies in the area covered by PC centres of the intervention group. Professionals in the intervention group were trained on the IMA intervention and will apply it to all patients receiving a new prescription for lipid-lowering medication, antihypertensive medication, antiplatelet medication and/or antidiabetic medication during the study period (7 months).…”

“…Professionals in the intervention group were trained on the IMA intervention and will apply it to all patients receiving a new prescription for lipid-lowering medication, antihypertensive medication, antiplatelet medication and/or antidiabetic medication during the study period (7 months). 35 The primary outcome of the trial is the rate of initiation. Secondary outcomes include other measures of adherence (implementation and persistence), clinical outcomes and cost-effectiveness.…”