Periodic Reporting for period 1 - AFFIRMO (ATRIAL FIBRILLATION INTEGRATED APPROACH IN FRAIL, MULTIMORBID, AND POLYMEDICATED OLDER PEOPLE) Reporting period: 2021-05-01 to 2022-10-31 Summary of the context and overall objectives of the project Worldwide healthcare systems are challenged by the growing number of persons living with multiple (≥2)chronic conditions (i.e. multimorbidity) and their complex healthcare needs. Current medical practice has traditionally focused on individual diseases, but fails to show effectiveness in the care of patients with multimorbidity, who often receive fragmented, incomplete, and sometimes harmful treatments. The goal of AFFIRMO is to validate the effectiveness of a patient-centred, stratified care pathway for older patients with multimorbidity (including atrial fibrillation as one of the conditions), with the aim of facilitating a multi-disciplinary, shared decision-making process. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Multimorbidity clusters have been identified using registry data and reported according to plan. Seven homogeneous groups of multimorbid individuals with atrial fibrillation have been defined and characterized: 1) neuropsychiatric disease, 2) complex multimorbidity, 3) eye disease 4) musculoskeletal disease 5) metabolic disease 6) cardiovascular disease and 7) unspecific pattern. In addition, predictors of lack of drug indication among patients with atrial fibrillation has been identified and the risk and types of potentially inappropriate prescribing has been investigated. A systematic review on inappropriate prescribing among patients with atrial fibrillation is in progress.As part of the preparation for the upcoming randomized clinical trial of the new patient care model, an empowerment tool box with educational material for patients have been developed, translated and nearly completely evaluated by patients and clinicians. In addition, three separate surveys have been undertaken to ascertain the experience of living with (patients and caregivers) or managing multimorbidity (patients, caregivers, healthcare professionals) and patient/caregiver needs. The surveys are conducted in five countries (Denmark, Italy, Spain, Romania, UK). Furthermore, development of the digital platform, which is to be used in the new care patient model, is well underway. So far, the High-level requirements document, Data Management Plan, Software Requirements Specification and Interactive prototypes has all been submitted as planned. Software development is currently ongoing. Early development has focused on linking the platform to the eCRF and building the onboarding process. The platform has been built to support local languages for each of the six countries involved in the trial. Each feature of the platform will be provided to the Affirmo team as a shippable product for early and regular feedback; this is a core principle of Agile software development. At this point there is a risk to delivery of the digital platform with the finer details of requirements still being confirmed.The study protocol as well as baseline and follow-up CRF for the AFFIRMO trial has been completed. The trial will run as cluster randomized trial including 1200 patients from 6 countries. Clinical sites have been identified and included (6 sites in Denmark, 8 in Romania and Serbia, 10 in Spain and Bulgaria (2 sites as back-up), 16 in Italy (6 as back-up)). The regulatory package, which is to be used when obtaining approvals for conducting the trial in the individual countries, is near complete, primarily awaiting documentation of the digital platform.Finally, work have begun in preparation for the health economics analyses of the new patient care model. An UK prototype where the data is already available is used for better enabling us to explore data requirements for making the model easily portable to other populations. Inputs to the data collection forms have been provided to inform cost calculations and facilitate the exploration of the cost effectiveness of the trial, projecting it into the future. A modeller is in place and has started to work on code adaptation. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) AFFIRMO continues to be committed on delivering impact on the following dimensions (all in line with the original grant agreement):Health:New patient-oriented care pathways for the management of older patients with multimorbidity and polypharmacy are developed and tested. AFFIRMO will develop a comprehensive, multidisciplinary assessment for the management older patients with multimorbidity and AF. The holistic approach will consider both clinical needs and patient preferences. The integrated approach will be implemented and scientifically tested in clinical practice through development of a digital framework.Scientific:The evidence provided by the AFFIRMO trial will have the scientific validity to contribute to clinical guidelines at national and international levels. The challenge of ageing populations with increasing levels and complexity of morbidity combined with a paucity of randomized clinical trials on how best to provide efficient and respectful care for these patients will ensure a potential major impact of a successful AFFIRMO trial as it may form basis for subsequent studies on other morbidity clusters.Training:Surveys, qualitative interviews and focus groups will allow us to identify needs and key quality performance indicators for use in planning and monitoring the effectiveness of healthcare interventions aimed at improving the management of older patients with multimorbidity. Involvement of healthcare professionals from primary and secondary care across 6 European countries in the AFFIRMO trial will ensure widespread dissemination of knowledge and experience with the AFFIRMO concept. This will facilitate subsequent implementation of this integrated care approach in routine clinical settings. Social:The empowerment process implemented in AFFIRMO will likely have an important social impact by providing a better understanding of medical conditions and possible treatment options, whilst improving communication between healthcare professionals and increasing the ability of patients to make informed, shared decisions.Technological:The digital platform aims to realize the benefits of the AFFIRMO project by utilizing technology built specifically for older users with co-morbidities. The modular design will enable future development and addition of new features and will be achieved with a strict focus on the protection of patient data. This will enable the platform to be scaled across many different diseases and to support increasing numbers of patients. Cultural:AFFIRMO will delineate a new care pathway for the optimal management of older patients with multimorbidity that is trans-sectoral, cost-effective and equitable. The model proposed in the AFFIRMO could be also adopted to a wide spectrum of clusters of chronic diseases not including atrial fibrillation. The active engagement of scientific societies, as well as a patient association combined with the active exploitation and dissemination of the results will foster the cultural background for this approach.Economic:The care pathway proposed in the AFFIRMO has the ambition to improve the treatment of patients leading to a reduction in health and societal costs. At this still rather early stage of the project, the impact of AFFIRMO cannot be expected to anything than limited, however, the progress of the project and experiences gathered so far do not give us any reason to expect that project will not have the projected impact when completed. AFFIRMO logo
