Periodic Reporting for period 1 - EHRA - PATHS (Addressing multimorbidity in elderly atrial fibrillation patients through interdisciplinary, tailored, patient-centered care pathways)
Okres sprawozdawczy: 2021-04-01 do 2022-09-30
Atrial fibrillation (AF) disease affects 7.8% of people above 65 years old worldwide, and it will further increase as the population ages and predisposing factors become more prevalent. AF is often associated with multimorbidity and polypharmacy. It has a significant societal impact, and
economic burden on our healthcare systems. AF Guidelines indicate that there is a great need to optimize the management of AF patients to reduce the burden on patients, society, healthcare system and the economy.
The objectives are:
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 European cluster randomised controlled trial to evaluate the newly developed holistic care paths with predefined key performance indicators. 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.
economic burden on our healthcare systems. AF Guidelines indicate that there is a great need to optimize the management of AF patients to reduce the burden on patients, society, healthcare system and the economy.
The objectives are:
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 European cluster randomised controlled trial to evaluate the newly developed holistic care paths with predefined key performance indicators. 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.
Only WP1, which required finalization and homogenization of three different datasets from the EORP registry and contractual agreements on data sharing, started with some delay. Nevertheless, 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. 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.
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 (cf. Europace publication 2022). Also, patients are now being interviewed in this work package to learn more about their perspective on comorbidity management. Moreover, first meetings with the Patient Advisory Board have already 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.WP3 has identified 22 comorbidities of importance in patients with AF. Working groups of 2consortium partners first developed clinical pathways to assess these comorbidities, with a focus on a simple but comprehensive approach. In the second phase, the comorbidities were rearranged in groups of 3-4 partners to further optimize the care pathways. Action triggers have been defined that should trigger further 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 to reach consensus on all individual care pathways is almost finished. We have predefined a ≥80% consensus threshold from all consortium partners to finalize a pathway and move it over to implementation in the software tool in WP4. After round 1, 11 clinical care pathways could already be finalized.
In WP4 a discovery phase has defined the major requirements for the software, 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 tender has selected a software development company. The development process itself has already been started, and will be finalized by May 2023, integrating all finalized clinical care pathways from WP3. These pathways and software tool will then be evaluated for their effectiveness and cost-utility in the RCT of WP5.
In WP5: a pre-final study protocol, national coordinators in 13 countries have been defined, and potential clinical centers that will participate in the trial have been identified and are now being contacted. Also, the approval process of ethical committees and notified bodies have been initiated. The RCT is due to start in the second half of 2023, according to plan.
We provide continuous communication on the results, 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.
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. 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.
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 (cf. Europace publication 2022). Also, patients are now being interviewed in this work package to learn more about their perspective on comorbidity management. Moreover, first meetings with the Patient Advisory Board have already 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.WP3 has identified 22 comorbidities of importance in patients with AF. Working groups of 2consortium partners first developed clinical pathways to assess these comorbidities, with a focus on a simple but comprehensive approach. In the second phase, the comorbidities were rearranged in groups of 3-4 partners to further optimize the care pathways. Action triggers have been defined that should trigger further 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 to reach consensus on all individual care pathways is almost finished. We have predefined a ≥80% consensus threshold from all consortium partners to finalize a pathway and move it over to implementation in the software tool in WP4. After round 1, 11 clinical care pathways could already be finalized.
In WP4 a discovery phase has defined the major requirements for the software, 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 tender has selected a software development company. The development process itself has already been started, and will be finalized by May 2023, integrating all finalized clinical care pathways from WP3. These pathways and software tool will then be evaluated for their effectiveness and cost-utility in the RCT of WP5.
In WP5: a pre-final study protocol, national coordinators in 13 countries have been defined, and potential clinical centers that will participate in the trial have been identified and are now being contacted. Also, the approval process of ethical committees and notified bodies have been initiated. The RCT is due to start in the second half of 2023, according to plan.
We provide continuous communication on the results, 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.
We remain confident that the end result will be a user-friendly software package that can be plugged into different types of health care provision around Europe dealing with patients with AF. It will assist Healthcare providers (HCP) to evaluate the presence or absence of 22 comorbidities in such patients in a straightforward and effective way, and it will guide HCPs for further diagnostic work-up and in the management of the comorbidities defined.In this way, the EHRA-PATHS project will provide concrete implementation tools to HCPs (e.g. physicians, nurses) in Europe and beyond (since we have a Worldwide Advisory Board) for existing guidelines that now stress the importance of dealing with these comorbidities but without providing concrete ways on how to do that. This approach has the potential to reduce morbidity and mortality in AF patients, and to use healthcare resources in a much more cost-effective way. The RCT of WP5 will tell whether we successfully achieved that goal, which will serve as essential information to register the software as a medical device (according to Medical Device Regulation). Moreover, the RCT will provide health economic data for policy decision makers to develop appropriate reimbursement schemes for such enhanced care. Given the interviews of patients in WP2 and the active involvement of the Patient Advisory Board, we are confident that the tool developed will be tailored to the needs of patients. We have already received imported input from them on the phrasing of specific questions, on terminology used, and on general approaches, feedback that will definitely increase the impact on patients overall. By discussing our work and disseminating our findings, we already notice that we generate a heightened interest of HCP's in structuring their local care system to deal better with comorbidities in patients with AF, to set up more standardized referral pathways, and to improve education of patients and HCPs alike.