Periodic Reporting for period 2 - GERONTE (Streamlined Geriatric and Oncological evaluation based on IC Technology for holistic patient-oriented healthcare management for older multimorbid patients)
Période du rapport: 2022-10-01 au 2024-03-31
Population is aging and the number of complex multimorbid patients to manage will increase sharply. Disease-centred approach is not appropriate to manage these patients. Change to a patient-centred approach will simplify
care pathways, secure management and treatment decision making and decrease healthcare costs. It will be a real breakthrough for daily practice with multiple impacts that must be quantified. GERONTE multimorbid patient-centred system proposes:
1) Coordination of management by a patient-tailored, interdisciplinary health professional consortium (HPC), including hospital- and home-based professionals, with a case manager;
2) Timely registration of symptoms and patient-reported outcomes at home through a web-based app for anticipation of avoidable adverse events;
3) Proposal of self-management guidelines according to intrinsic capacity evaluation by geriatrician for patient-driven improvement of independent living;
4) Structured collection of data from electronic health record into a dashboard made available to HPC members as well as patient and caregiver, thanks to its capacity to securely interoperate with all electronic health records including software managing medical data.
care pathways, secure management and treatment decision making and decrease healthcare costs. It will be a real breakthrough for daily practice with multiple impacts that must be quantified. GERONTE multimorbid patient-centred system proposes:
1) Coordination of management by a patient-tailored, interdisciplinary health professional consortium (HPC), including hospital- and home-based professionals, with a case manager;
2) Timely registration of symptoms and patient-reported outcomes at home through a web-based app for anticipation of avoidable adverse events;
3) Proposal of self-management guidelines according to intrinsic capacity evaluation by geriatrician for patient-driven improvement of independent living;
4) Structured collection of data from electronic health record into a dashboard made available to HPC members as well as patient and caregiver, thanks to its capacity to securely interoperate with all electronic health records including software managing medical data.
WP1 established which health care professionals should be involved in the HPC and how they should communicate with one another within the GerOnTe model, which existing multimorbidity data needed to be made available to the HPC and which symptoms and PROMs are relevant for real-time patient reporting during the patient trajectory and finally how intrinsic capacity/frailty and patient preferences should be assessed and reported to the HPC.
WP2 which worked on developing the tools for GerOnTe, achieved two deliverables. MyPL the technical partner of the consortium, with the participation of other partners and stakeholders, developed the Holis(TM) GV application with four modules (patients, caregivers, nurses, doctors) in English, Dutch and French on mobile devices and desktop. MYPL company was liquidated 30/01/2024 without delivering the app nor the source code although consortium members tested a preliminary version of the app. We consequently searched for other companies to develop the app and identified MyPatientSpace, an Irish company, that will deliver the full app by mid-June 2024.
WP3 is working on developing the methods for GerOnTe. It has already delivered a literature review on the cost-effectiveness of healthcare services for older multimorbid patients, the protocol for economic evaluation of GerOnTe, the definition of the protocol for business case in Geronte as well as the definition of a dashboard of indicators for the clinical trials.
The objective of WP4 is to perform two clinical trials, i.e. FRONE in France and TWOBE in Belgium and the Netherlands, in accordance with ethical and regulatory requirements. WP4 has already delivered the clinical trial methodology, the trial committees' charters, the statistical analysis plan for the studies and the first study approval packages for both FRONE and TWOBE (trial's protocols, registration number and ethics approval). It is now awaiting finalisation of the GerOnTe digital tool to launch the FRONE trial and start participant recruitment.
So far WP5 has delivered the evaluation process protocol for Geronte. It has aslo taken part in extensive consultation with partners, including a co-creation process for the design of the app, consultations with all partners sites, and participation in the Site Initiation Visits for the FRONE trial. An initial program theory is being developed, informed by a scoping review, which is in final draft form.
WP6 is working on stakeholder engagement to ensure that GerOnTe’s technology is both useful and usable for the target users. So far, WP6 developed a coordination strategy for stakeholders' engagement, a practical guidebook and tools for Focus Groups in WP1-5 and the report on the small-scale pilots. It was also involved in preparing the clinical trials, creating the first versions of the materials used for training, including manuals for the various trial participants and videos, used in WP4.
So far WP7 has delivered the projects personalized visual identity, a dedicated Website, Twitter and LinkedIn accounts as well as a brochure. WP7 has also worked on WP specific strategies and created internal and external newsletters.
The objective for WP8 is to ensure efficient and effective management of GerOnTe and to optimise the communication environment in which it is performed by the consortium. The WorkPackage achieved 5 deliverables (including DMP and EMP).
WP9 has delivered an ethics management plan, and has nominated an independent ethics advisor and an ethics manager The WorkPackage achieved three deliverables. D9.3 was updated with the second report from the independent ethics advisor. D9.2 will be updated M40 when myPatientSpace is included in the Consortium.
WP2 which worked on developing the tools for GerOnTe, achieved two deliverables. MyPL the technical partner of the consortium, with the participation of other partners and stakeholders, developed the Holis(TM) GV application with four modules (patients, caregivers, nurses, doctors) in English, Dutch and French on mobile devices and desktop. MYPL company was liquidated 30/01/2024 without delivering the app nor the source code although consortium members tested a preliminary version of the app. We consequently searched for other companies to develop the app and identified MyPatientSpace, an Irish company, that will deliver the full app by mid-June 2024.
WP3 is working on developing the methods for GerOnTe. It has already delivered a literature review on the cost-effectiveness of healthcare services for older multimorbid patients, the protocol for economic evaluation of GerOnTe, the definition of the protocol for business case in Geronte as well as the definition of a dashboard of indicators for the clinical trials.
The objective of WP4 is to perform two clinical trials, i.e. FRONE in France and TWOBE in Belgium and the Netherlands, in accordance with ethical and regulatory requirements. WP4 has already delivered the clinical trial methodology, the trial committees' charters, the statistical analysis plan for the studies and the first study approval packages for both FRONE and TWOBE (trial's protocols, registration number and ethics approval). It is now awaiting finalisation of the GerOnTe digital tool to launch the FRONE trial and start participant recruitment.
So far WP5 has delivered the evaluation process protocol for Geronte. It has aslo taken part in extensive consultation with partners, including a co-creation process for the design of the app, consultations with all partners sites, and participation in the Site Initiation Visits for the FRONE trial. An initial program theory is being developed, informed by a scoping review, which is in final draft form.
WP6 is working on stakeholder engagement to ensure that GerOnTe’s technology is both useful and usable for the target users. So far, WP6 developed a coordination strategy for stakeholders' engagement, a practical guidebook and tools for Focus Groups in WP1-5 and the report on the small-scale pilots. It was also involved in preparing the clinical trials, creating the first versions of the materials used for training, including manuals for the various trial participants and videos, used in WP4.
So far WP7 has delivered the projects personalized visual identity, a dedicated Website, Twitter and LinkedIn accounts as well as a brochure. WP7 has also worked on WP specific strategies and created internal and external newsletters.
The objective for WP8 is to ensure efficient and effective management of GerOnTe and to optimise the communication environment in which it is performed by the consortium. The WorkPackage achieved 5 deliverables (including DMP and EMP).
WP9 has delivered an ethics management plan, and has nominated an independent ethics advisor and an ethics manager The WorkPackage achieved three deliverables. D9.3 was updated with the second report from the independent ethics advisor. D9.2 will be updated M40 when myPatientSpace is included in the Consortium.
Geronte intends to progress beyond the state of the art in five areas:
Standardised data collection :
Geronte will define a core dataset for decision making and treatment as well as a baseline dataset on that need to be gathered from health records. GerOnTe self-reporting and self-management applications will focus on older patients with multimorbidity and cancer, who so far have been rarely included in trials testing such tools. Patient preferences will be accounted in a parallel process that will also feed the dataset, to ensure Holis is patient-centered.
ICT tool for data collection and presentation to the HPC:
GerOnTe research will provide the following innovations:
• feeding a data lake with structured, semi-structured and unstructured clinical data;
• clinical business intelligence by managing, in real time and automatically, multimorbid older cancer patients’ healthcare process;
• streaming analytics, using reports and QKPIs defined in WP3;
• a tool for data science and future machine learning capabilities;
• an easy to use platform for each stakeholder with positive user experience for better adoption.
Economic methods and QKPIs :
The GerOnTe project will develop an innovative, multi-disciplinary, comprehensive methodological framework for estimating the full costs of complex healthcare services/programs such as the GerOnTe model.
Two clinical trials in three countries :
Proof of concept will be done in two clinical trials (namely, FRONE & TWOBE) using a stepped wedge approach to demonstrate feasibility and quantify impact on stakeholders (patients, health professionals, hospitals, health authorities). Performance of two trials in two different health systems will increase the external validity of our demonstration. Endpoints will include patients’ perspectives as well as health professionals’ and health decision-makers’ perspectives, allowed by a comprehensive network of competences for performance of large-scale studies.
Realist evaluation of an e-health implementation :
GerOnTe will be one of the largest realist evaluations of an e-health implementation ever done. This unique data collection from FRONE and TWOBE will inform a number of high-quality outputs, and in particular a formal guide for the implementation of the GerOnTe intervention, and a worked business plan for scaling up the use of the technology and the model of care, and using both on a much wider scale. This will give a head start to innovators in other countries who are interested in following in the lead of GerOnTe.
Standardised data collection :
Geronte will define a core dataset for decision making and treatment as well as a baseline dataset on that need to be gathered from health records. GerOnTe self-reporting and self-management applications will focus on older patients with multimorbidity and cancer, who so far have been rarely included in trials testing such tools. Patient preferences will be accounted in a parallel process that will also feed the dataset, to ensure Holis is patient-centered.
ICT tool for data collection and presentation to the HPC:
GerOnTe research will provide the following innovations:
• feeding a data lake with structured, semi-structured and unstructured clinical data;
• clinical business intelligence by managing, in real time and automatically, multimorbid older cancer patients’ healthcare process;
• streaming analytics, using reports and QKPIs defined in WP3;
• a tool for data science and future machine learning capabilities;
• an easy to use platform for each stakeholder with positive user experience for better adoption.
Economic methods and QKPIs :
The GerOnTe project will develop an innovative, multi-disciplinary, comprehensive methodological framework for estimating the full costs of complex healthcare services/programs such as the GerOnTe model.
Two clinical trials in three countries :
Proof of concept will be done in two clinical trials (namely, FRONE & TWOBE) using a stepped wedge approach to demonstrate feasibility and quantify impact on stakeholders (patients, health professionals, hospitals, health authorities). Performance of two trials in two different health systems will increase the external validity of our demonstration. Endpoints will include patients’ perspectives as well as health professionals’ and health decision-makers’ perspectives, allowed by a comprehensive network of competences for performance of large-scale studies.
Realist evaluation of an e-health implementation :
GerOnTe will be one of the largest realist evaluations of an e-health implementation ever done. This unique data collection from FRONE and TWOBE will inform a number of high-quality outputs, and in particular a formal guide for the implementation of the GerOnTe intervention, and a worked business plan for scaling up the use of the technology and the model of care, and using both on a much wider scale. This will give a head start to innovators in other countries who are interested in following in the lead of GerOnTe.