Periodic Reporting for period 3 - AFFIRMO (ATRIAL FIBRILLATION INTEGRATED APPROACH IN FRAIL, MULTIMORBID, AND POLYMEDICATED OLDER PEOPLE)
Periodo di rendicontazione: 2024-05-01 al 2025-04-30
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.
The AFFIRMO project develops and validates a patient-centred, stratified care pathway for older patients with multimorbidity, including atrial fibrillation (AF). Significant progress during this reporting period have been made in the conduction of the randomised controlled trial (RCT). A total of 66 sites have activated, surpassing the original target of 50. The recruitment goal for the RCT was 1,250 patients, with each of the 50 centres aiming to enrol 25 individuals. The first patient was recruited on April 11, 2024, and the final participant on January 31, 2025, with a total of 1,260 patients enrolled, balanced across the two randomisation groups (626 in Usual Care clusters, 634 in iABC clusters).
Overall, the AFFIRMO project is advancing steadily, with major milestones reached in trial conduct, participant recruitment, event validation, and data monitoring. These developments lay a strong foundation for assessing the impact of the holistic and systematic care approach on reducing hospitalisations and improving patient outcomes.
Further progress has also been made in refining the healthcare cost modelling framework for atrial fibrillation (AF) management across different disease clusters. With these updates, AFFIRMO is now well-positioned to finalise the economic assessment and provide actionable insights into optimising healthcare costs for multimorbid elderly patients across Europe.
In conclusion, the AFFIRMO project is progressing steadily, achieving key milestones in the completion of the randomized clinical trial to evaluate the effectiveness on clinical and health economic outcomes.
Overall, the AFFIRMO project is advancing steadily, with major milestones reached in trial conduct, participant recruitment, event validation, and data monitoring. These developments lay a strong foundation for assessing the impact of the holistic and systematic care approach on reducing hospitalisations and improving patient outcomes.
Further progress has also been made in refining the healthcare cost modelling framework for atrial fibrillation (AF) management across different disease clusters. With these updates, AFFIRMO is now well-positioned to finalise the economic assessment and provide actionable insights into optimising healthcare costs for multimorbid elderly patients across Europe.
In conclusion, the AFFIRMO project is progressing steadily, achieving key milestones in the completion of the randomized clinical trial to evaluate the effectiveness on clinical and health economic outcomes.
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.
AFFIRMO has already produced many good results at this midway point of the project. The progress made and the experiences gathered so far strongly indicate that the project is on track to achieve its projected impact upon completion.
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.
AFFIRMO has already produced many good results at this midway point of the project. The progress made and the experiences gathered so far strongly indicate that the project is on track to achieve its projected impact upon completion.