Periodic Reporting for period 2 - EHRA - PATHS (Addressing multimorbidity in elderly atrial fibrillation patients through interdisciplinary, tailored, patient-centered care pathways)
Periodo di rendicontazione: 2022-10-01 al 2024-03-31
Atrial fibrillation (AF) disease affects 7.8% of people ≥65 years old worldwide, and it is often associated with multimorbidity and polypharmacy. AF has a significant economic and societal impact on patients and healthcare systems. As a consequence, there is need for optimised AF disease management. The EU-funded EHRA-PATHS project aims to create innovative systematic care methods to address multimorbidity in elderly AF patients. The project will further describe multimorbidity, polypharmacy and sex differences using clinical data registries. EHRA-PATHS will also perform European needs assessment research to detect unmet needs and advance new software-supported patient care methods to identify, manage and monitor multimorbidity and polypharmacy in elderly AF patients.
The aim of the EHRA-PATHS project is to create well founded, innovative systematic care pathways to tackle multimorbidity in elderly AF patients. We hypothesize that such a well-structured, interdisciplinary, and patient-tailored care program is feasible throughout all healthcare systems in Europe, and effective to optimize outcomes. There are 5 objectives:
1. Further characterize multimorbidity, polypharmacy and sex differences in AF patients by means of clinical data registries.
2. Perform a European needs assessment study to map current clinical practice and identify unmet needs concerning multimorbid AF patient management.
3. Devise and implement new software-supported interdisciplinary, patient-centred care pathways to detect, manage, and follow-up on multimorbidity and polypharmacy in elderly AF patients with a focus on each patient’s unique profile.
4. A two-part clinical evaluation study (RCT) with initial base mapping followed by a cluster randomised controlled trial to evaluate the newly developed holistic care paths with predefined key performance indicators. The RCT will be performed in multiple EU countries, across different health care systems. A cost-utility analysis will be included.
5. Disseminate the insights, care pathways and implementation strategy from this project to patients, physicians, hospitals, other healthcare providers and regulatory authorities.
The aim of the EHRA-PATHS project is to create well founded, innovative systematic care pathways to tackle multimorbidity in elderly AF patients. We hypothesize that such a well-structured, interdisciplinary, and patient-tailored care program is feasible throughout all healthcare systems in Europe, and effective to optimize outcomes. There are 5 objectives:
1. Further characterize multimorbidity, polypharmacy and sex differences in AF patients by means of clinical data registries.
2. Perform a European needs assessment study to map current clinical practice and identify unmet needs concerning multimorbid AF patient management.
3. Devise and implement new software-supported interdisciplinary, patient-centred care pathways to detect, manage, and follow-up on multimorbidity and polypharmacy in elderly AF patients with a focus on each patient’s unique profile.
4. A two-part clinical evaluation study (RCT) with initial base mapping followed by a cluster randomised controlled trial to evaluate the newly developed holistic care paths with predefined key performance indicators. The RCT will be performed in multiple EU countries, across different health care systems. A cost-utility analysis will be included.
5. Disseminate the insights, care pathways and implementation strategy from this project to patients, physicians, hospitals, other healthcare providers and regulatory authorities.
WP1 which required finalization and homogenization of three different datasets from the EORP registry and contractual agreements on data sharing, started with some delay. The extensive analysis of the baseline characteristics of 22,163 patients with AF in these datasets confirms the multitude and extent of comorbidities and polypharmacy in patients with AF. Patients with AF ≥65 years old have an average of 4-5 comorbidities. Cluster-analysis was performed indicating three main groups of elderly AF patients, with different clinical profiles and needs. Further analysis of these datasets is ongoing to evaluate which comorbidities impact most on the prognosis of AF patients, characterization of specific treatment patterns and guideline-adherent management, the magnitude and impact of polypharmacy, and on regional disparities throughout Europe. In addition, the analyses of the comorbidity clusters are ongoing, to provide more information on the prevailing comorbidity cluster and the most common cluster-specific treatment patterns.
WP2 confirmed through a survey of >330 physicians and allied professionals in 29 European countries the important unmet need for tools and structures to map comorbidities and for referral of patients with AF to other specialties for proper management. The lack of integrated care models and organizational issues were mentioned by almost half as major barriers for effective referral, despite the fact that 40% of patients with AF need such multidisciplinary approach. A total of 30 patients from five European countries have been interviewed in WP2 to learn more about their perspective on comorbidity management. Together with meetings with the Patient Advisory Board, these have provided important input to the consortium concerning the phrasing of questions for the tools developed in WP3 and 4, terminology to describe patients and their conditions, and educational aspects. Patients stress the fact that in their mindset, there is no comorbidities and fragmentation of conditions: they need an holistic approach that guides them through the labyrinth of interdisciplinary care.
In WP3, the whole consortium converged on 22 comorbidities of importance in patients with AF. Working groups of 2 consortium partners first developed clinical pathways to assess these comorbidities, focusing on a simple but comprehensive approach. In the second phase, groups of 3-4 partners further optimized these care pathways. Action triggers have been defined that should trigger work-up for a possible comorbidity; process focus points in comorbidity evaluation have been defined; as well as key performance indicators for effective management of these comorbidities within a 6 months’ timeframe. The second of two Delphi rounds reached consensus on most care pathways. The few outstanding issues were resolved through deliberation between the concerned specialists within the consortium. The finalized pathways were passed for implementation in the software tool in WP4.
In WP4, the software tool was developed in collaboration with a professional third-party. In an initial discovery phase, the major requirements for the software were defined, including its user interface, conformity of a development framework to abide with the medical device regulation if needed for wide release in the future, and integration possibilities within existing electronic medical record systems. Based on these requirements, a software development company (Qompium) was selected via a tender procedure. The development process was performed in different steps. The consortium partners had the opportunity to test different versions of the software tool. The software tool was finalised for use in the RCT (WP5) in the first week of March 2024.
The pathways and software tool developed in WP3/4 will be evaluated for their effectiveness and cost-utility in the RCT of WP5. The start of the study was planned for the second half of 2023 but was delayed due to delays in administrative processes. The study started in March 2024 and is currently recruiting in 2 out of 14 countries.
We provide continuous communication on the results of the EHRA-PATHS consortium, including a dedicated website, newsletters, tweets and other social media messages, publications in scientific journals, lectures at scientific meetings, and occasional press releases on significant activities. A network is set up between all the communication departments of all consortium partners. The Communication and Dissemination Strategy Plan is regularly updated.
WP2 confirmed through a survey of >330 physicians and allied professionals in 29 European countries the important unmet need for tools and structures to map comorbidities and for referral of patients with AF to other specialties for proper management. The lack of integrated care models and organizational issues were mentioned by almost half as major barriers for effective referral, despite the fact that 40% of patients with AF need such multidisciplinary approach. A total of 30 patients from five European countries have been interviewed in WP2 to learn more about their perspective on comorbidity management. Together with meetings with the Patient Advisory Board, these have provided important input to the consortium concerning the phrasing of questions for the tools developed in WP3 and 4, terminology to describe patients and their conditions, and educational aspects. Patients stress the fact that in their mindset, there is no comorbidities and fragmentation of conditions: they need an holistic approach that guides them through the labyrinth of interdisciplinary care.
In WP3, the whole consortium converged on 22 comorbidities of importance in patients with AF. Working groups of 2 consortium partners first developed clinical pathways to assess these comorbidities, focusing on a simple but comprehensive approach. In the second phase, groups of 3-4 partners further optimized these care pathways. Action triggers have been defined that should trigger work-up for a possible comorbidity; process focus points in comorbidity evaluation have been defined; as well as key performance indicators for effective management of these comorbidities within a 6 months’ timeframe. The second of two Delphi rounds reached consensus on most care pathways. The few outstanding issues were resolved through deliberation between the concerned specialists within the consortium. The finalized pathways were passed for implementation in the software tool in WP4.
In WP4, the software tool was developed in collaboration with a professional third-party. In an initial discovery phase, the major requirements for the software were defined, including its user interface, conformity of a development framework to abide with the medical device regulation if needed for wide release in the future, and integration possibilities within existing electronic medical record systems. Based on these requirements, a software development company (Qompium) was selected via a tender procedure. The development process was performed in different steps. The consortium partners had the opportunity to test different versions of the software tool. The software tool was finalised for use in the RCT (WP5) in the first week of March 2024.
The pathways and software tool developed in WP3/4 will be evaluated for their effectiveness and cost-utility in the RCT of WP5. The start of the study was planned for the second half of 2023 but was delayed due to delays in administrative processes. The study started in March 2024 and is currently recruiting in 2 out of 14 countries.
We provide continuous communication on the results of the EHRA-PATHS consortium, including a dedicated website, newsletters, tweets and other social media messages, publications in scientific journals, lectures at scientific meetings, and occasional press releases on significant activities. A network is set up between all the communication departments of all consortium partners. The Communication and Dissemination Strategy Plan is regularly updated.
Based on our current experience in the progression of WP4 and WP5, the consortium partners and involved countries in the clinical trial acquire more knowledge and hands-on-experience with the European Medical Device Regulation and ethical approval process to use the EHRA-PATHS software tool in a clinical trial in their country. An additional goal, that is beyond the state of the art of the initial prescribed project, is that the study team of UZA will try to systematically map these experiences which will lead to additional insights that we will try to report on during RP3.