Periodic Reporting for period 2 - IMA-cRCT (Effectiveness and cost-effectiveness of the Initial Medication Adherence intervention: cluster randomized controlled trial and economic model)
Berichtszeitraum: 2022-07-01 bis 2023-12-31
Non-initiation is prevalent in prescriptions issued in primary care, and this behaviour is associated with poorer clinical outcomes and higher productivity lossess and costs to the healthcare system.
The Initial Medication Adherence cluster randomised trial (IMA-cRCT) aims to demonstrate that providing patients with better information and involving them in the decisions regarding their treatment has a positive effect on their health and consequently, on the health system. This study is being conducted on primary care patients with cardiovascular risk and/or diabetes who require a new treatment. Some primary care physicians, nurses and community pharmacists in Catalonia received training improve their skills for informing patients and making a shared decision about their treatment. The study will provide information on the training’s impact on the use of medication and if it produces an improvement in patient’s health.
The Initial Medication Adherence cluster randomised trial (IMA-cRCT) aims to demonstrate that providing patients with better information and involving them in the decisions regarding their treatment has a positive effect on their health and consequently, on the health system. This study is being conducted on primary care patients with cardiovascular risk and/or diabetes who require a new treatment. Some primary care physicians, nurses and community pharmacists in Catalonia received training improve their skills for informing patients and making a shared decision about their treatment. The study will provide information on the training’s impact on the use of medication and if it produces an improvement in patient’s health.
The IMA intervention is a multidisciplinary intervention that involves GPs, nurses and pharmacists and promotes shared decision-making between the patient and professional at the time of a new prescription in primary care. A pilot study was carried out to assess the feasibility and acceptability of implementing the intervention in clinical practice. This study helped to identify strengths and weaknesses and refine the IMA intervention and its evaluation design prior to the definitive IMA-cRCT.
As part of the IMA-cRCT study, 24 primary care centres (PCC) in Catalonia (Spain) were randomly assigned to the intervention and control group, and community pharmacies in the catchment areas of the intervention PCC were invited to participate. Healthcare professionals in the intervention group were trained on the IMA intervention as well as they were provided with technical support tools. These professionals applied the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment. The follow-up period will last until September 2023 and all study variables will be collected from patient electronic health records. Effectiveness and short-term cost-effectiveness analyses will be conducted once the observation period is over. Long-term cost-effectiveness will be assessed using a predictive model constructed using data from all Catalan patients who had a new prescription for cardiovascular disease and diabetes treatments between 2012 and 2013.
Alongside the cRCT, a mixed-methods process evaluation including quantitative and qualitative methods was conducted to assess implementation and to explore professionals’ and patients’ experiences. Quantitative data collection methods included data extraction from the intervention operative records and professional feedback questionnaires, whereas qualitative data collection involved interviews and field diaries. Quantitative and qualitative data were analysed separately and triangulated to produce robust results.
From the beginning of this project, results have been disseminated, including those of the pilot study, the optimisation of the IMA intervention, and the protocols of the cRCT and process evaluation to scientific audiences and decision-makers and managers of the Catalan Health System. In the last months, the preliminary results of the implementation process and professionals’ and patients’ experiences have been disseminated to scientific audiences as well as decision-makers of the Catalan Health System.
All the tasks were completed in the expected timing, with the exception of the field work, that was delayed 3 months due to the COVID-19 pandemic (as described in section ‘Technical challenges’).
As part of the IMA-cRCT study, 24 primary care centres (PCC) in Catalonia (Spain) were randomly assigned to the intervention and control group, and community pharmacies in the catchment areas of the intervention PCC were invited to participate. Healthcare professionals in the intervention group were trained on the IMA intervention as well as they were provided with technical support tools. These professionals applied the intervention to all patients who receive a new prescription for cardiovascular disease or diabetes treatment. The follow-up period will last until September 2023 and all study variables will be collected from patient electronic health records. Effectiveness and short-term cost-effectiveness analyses will be conducted once the observation period is over. Long-term cost-effectiveness will be assessed using a predictive model constructed using data from all Catalan patients who had a new prescription for cardiovascular disease and diabetes treatments between 2012 and 2013.
Alongside the cRCT, a mixed-methods process evaluation including quantitative and qualitative methods was conducted to assess implementation and to explore professionals’ and patients’ experiences. Quantitative data collection methods included data extraction from the intervention operative records and professional feedback questionnaires, whereas qualitative data collection involved interviews and field diaries. Quantitative and qualitative data were analysed separately and triangulated to produce robust results.
From the beginning of this project, results have been disseminated, including those of the pilot study, the optimisation of the IMA intervention, and the protocols of the cRCT and process evaluation to scientific audiences and decision-makers and managers of the Catalan Health System. In the last months, the preliminary results of the implementation process and professionals’ and patients’ experiences have been disseminated to scientific audiences as well as decision-makers of the Catalan Health System.
All the tasks were completed in the expected timing, with the exception of the field work, that was delayed 3 months due to the COVID-19 pandemic (as described in section ‘Technical challenges’).
As part of this project, training for professionals on the principles of SDM and leaflets and a website as decision aids have been designed to assess professionals at the time of a new prescription. The process evaluation has provided knowledge about the implementation and integration of the IMA intervention into routine clinical practice and has allowed us to identify contextual barriers and facilitators to take into account before translating it into the whole primary care setting. Additionally, we have collected data on the costs of implementing the IMA intervention to inform decision-makers and calculate the resources needed to sustain it. Since January 2021 we have been in contact with decision-makers and managers of the Catalan Health System to facilitate translation into the whole primary care context as well as adapted to other pathologies and treatments after the cRCT and if the intervention is cost-effective. A novel methodology has been used as part of the economic evaluation, a mathematical model constructed using Real Worl Data and its methodological publication that is being written at the moment and might inform future research.