Work package 1 deals with the management of the project, both from the administrative and scientific perspectives. The main objectives are to liaise with the European Commission and put in place adequate consortium coordination and communication platform. Additionally, activities also include ensuring a quality assurance system and the management of ethical issues in the project with the support of the Ethical Committee.
• Coordination activities, project management
• Development and usage of a quality assurance system
• Consideration of ethical concerns in the project
Work package 2 focuses on the dissemination and exploitation of the project objectives, its phases of work, the activities themselves and the results.
One of its key objectives is to coordinate and support all of the consortium partners in disseminating information about the Project. This includes ensuring appropriate governance of the content of dissemination materials (such as author acknowledgements and approvals for the release interim or final foreground), tracking the progress of dissemination activities and maintaining records to include in annual dissemination report. A complementary objective is to ensure that the project reaches all relevant stakeholders with coordinated and reinforcing messages, through the most suitable channels.
This work package is also concerned with sustainable exploitation of the project results. In some cases, this will mean the adoption of its results by industry, for example through products that incorporate C3 Cloud interfaces or components. In other cases, this will mean the promotion of specific partner or multi partner results as commercial products or open source products.
Finally, this work package also needs to ensure that the health ICT industry is well prepared for the innovations that C3 Cloud will help to enable, which might have positive implications for the evolution of complimentary products and services that take advantage of better enabled person-centred care for patients with multiple conditions.
• Coordination of project dissemination and communication activities
• Identification of business and market opportunities, and providing exploitation plans
Work package was responsible for the design of the technical architecture of C3-Cloud. WP3 involved identification of relevant literature and state-of-the-art in the subject (Task 3.1), elicit, collate, categorise and document the requirements for the ICT part of C3-cloud with input from prospective users (Task 3.2), and finally construct a conceptual design for the C3-Cloud architecture (Task 3.3), which will be implemented by subsequent work packages. The outputs of WP3, in conjunction with those of WP7 will be used to create the various application modules for C3-Cloud. WP3 has produced and submitted all deliverables on time and according to the proposal’s specifications.
Current WP activities focus on Task 3.4, which is responsible with facilitating co-production in C3-Cloud, with its stakeholders. Following initial research and plans for co-production, Task 3.4 is at present documenting the co-production processes that has and will be taking place throughout the process.
WP4 is responsible of the Patient Pathway and Organisational Model Development & Change Management. The main objectıves of this WP are:
i. to provide guidance for and development of new patient pathways and corresponding personalised care plans (Task 4.1),
ii. the development of adaptive organisational models for improved delivery of patient-centred integrated care (Task 4.2) and
iii. the elaboration of guidelines for smooth management of changes in models of care delivery (Task 4.3).
Current activities are focused to both Tasks 4.1 (New Patient Pathways and corresponding care plans) and 4.3 (Change Management).
WP6 is responsible of the Interoperability Middleware design and development. The provided solution must address technical, semantic and privacy/security interoperability challenges to seamlessly integrate with the existing health care, social care and home/community care information systems for enabling patient-centric interoperable care coordination in an informed manner with the involvement of all stakeholders. WP6 has three main objectives that are splitted in three tasks. All tasks have the same 10 months duration.
Task 6.1 has the objective to define FHIR C3-Cloud profiles and technical interoperability implementation guidelines, to develop open source toolkits (TIS) implementing the guidelines and the integration of the open source toolkits with pilot sites: OSAKI, RJH, SWFT
Task 6.2 has the objective to design a semantic interoperability platform that will enable common understanding of clinical data and resolve semantic mismatches due the use of different terminology systems between pilot sites and C3-Cloud top-level components
Task 6.3 has the objective to implement the security and privacy components that are common for all pilot sites and detailed analysis of the pilot site specific security and privacy systems
WP6 started in month 9 (1 January 2017) and has ended in month 18 (31 October 2017). All technical solutions for technical and semantic interoperability as well as security solutions have been developed. Specific interfaces have been also developed to provide demonstration of the activities of C3-Cloud the middleware layer. The three demonstrators have been described and documented in the finalized three deliverables of the period.
D6.1: C3-Cloud Technical Interoperability Implementation Guidelines and Open Source Toolkits (TIS). The main achievements were to set a data dictionary template to cover pilot sites data, to identify the set of FHIR C3-Cloud profiles relevant to the data dictionary and to set the toolkit for the integration with the patient data sources in C3-Cloud, including OSAKI, RJH and SWFT.
D6.2: Semantic Interoperability Platform (SIS). The main achievements were to design structural mappings from local formats to FHIR profiles to realize format conversion, to develop a semantic mapper based on a mappings resource (including dedicated C3-Cloud mappings) for the conversion of local value sets to terminology standards and for the update and management of the mappings resource itself. The semantic mapper is a web service that can be queried directly by other components or the C3-Cloud administrator.
D6.3: Privacy Protection and Security within the C3-Cloud Architecture (SPS). The main achievements were to agree on the concrete integration method with each pilot site taking into account their constraints and specific access control rules were defined, to integrate the SPS server with the C3-Cloud FHIR repository and to integrate the C3DP with the SPS Server.
The WP6 has successfully ended. Work in continuing in the context of the task 7.4 dealing with the Integration of all the technical components implemented in WP6 (TIS, SIS and SPS) before deployment at the pilot sites. Moreover, integration of SPS with the relevant security systems used at the pilot sites is an ongoing work within the scope of WP8.
WP7 is a complex work package with several important objectives to be achieved starting in month 5 and completing in month 26 of the overall C3-Cloud duration:
• Identification of the evidence based clinical guideline definitions and flowcharts for individual chronic conditions
• Implementation of several clinical decision support modules to be used by Personalised Care Plan Development Platform and the Coordinated Care and Cure Delivery Platform
• Development of the Personalised Care Plan Development Platform
• Development of the Coordinated Care and Cure Delivery Platform
• Integration of all the technical components implemented in WP5, WP6 and WP7 before deployment at the pilot sites
WP7 has been very active in this period with technical specification and software implementation activities.
In the first year of the project, Task 7.1 leader ORU and three pilot sites OSAKIDETZA, RJH and SWFT have studied NICE clinical guidelines for the four major C3-Cloud diseases Type 2 Diabetes (T2D), Heart Failure (HF), Renal Failure (HF) and Depression (Dp) in detail and developed in total 43 logical flowcharts that model the clinical recommendations from the NICE text documents. National deviations on top of the NICE recommendations have been considered as well.
Task 7.2 is responsible for implementation of CDS services to be utilised while managing personalised care plans of a patient. As this task relies heavily on clinical content, WARWICK coordinated and led scoping and planning of this task and refining of the task requirements. WARWICK also coordinated discussion with external service providers for potential collaboration. To facilitate discussion and integration, SRDC has developed a readily implementable technical specification of T2D CDS services based on detailed analysis of D7.1 flowcharts and corresponding guideline definitions. Then, SRDC has implemented the full set of CDS services for T2D complying with the CDS Hooks specification and in Node.js for testing purposes. INSERM and WARWICK are developing detailed technical specification for RF, HF and Dp. As of October 2017, CAMBIO has implemented 3 out of 7 CDS services for T2D complying with the CDS Hooks specification and in GDL2, which will be the ones used in real pilot operation in C3-Cloud.
KG has coordinated OSAKIDETZA, RJH and SWFT to develop specification of clinical guideline reconciliation rules for all 2, 3 and 4 disease combinations, which is another major achievement in Task 7.2. In total, 52 reconciliation rules have been identified and specified in detail. SRDC, INSERM and WARWICK are incorporating the reconciliation rules into the CDSM technical specification.
SRDC has been working in tasks 7.3 and 7.4 together to implement the Coordinated Care and Cure Delivery Platform (C3DP) and its sub-component Personalised Care Plan Development Platform (PCPDP). Although there is more time for the completion of these tasks, the care plan management functionalities specified during the requirements analysis and design phases have already been completed to a great extent. As of October 2017, the full set of CRUD functionalities are implemented for HL7 FHIR STU3 based personalised care plan and related resources (e.g. goal, activity, condition, care team, observation, questionnaire, etc.). Messaging module, event and real-time notification mechanism have also been implemented in C3DP.
Significant integration work has also been achieved within the scope of Task 7.4. First of all, a complete and realistic storyboard including all the patient & care plan data and all interactions among involved C3-Cloud software components has been developed to facilitate development and integration activities among C3-Cloud partners. As of October 2017, PEP is integrated with the C3-Cloud FHIR Repository and hence can get care plan data and push patient provided data. Event API integration is achieved both ways. C3DP is integrated with 3 CDS services implemented by CAMBIO and 7 CDS services implemented by SRDC. C3DP is integrated with the default C3-Cloud Identity Provider (IdP). Integration of the SPS Authorization Manager with the C3-Cloud FHIR Repository is also completed. IdP integration with pilot sites OSAKIDETZA and RJH is in progress. In the interoperability layer, integration of Technical Interoperability Suite (TIS) with the Semantic Interoperability Suite (SIS) and with the C3-Cloud FHIR Repository is in progress. C3-Cloud technical partners have been working hard to realise all integration tasks before the end of Task 7.4.
WP8 is responsible of the C3-Cloud Pilot application development and deployment. WP8 involves the definition of the requirements and the detailed design of the C3-Cloud pilot application (Task 8.1), the design (Task 8.2) and finally the deployment and operation of the C3-Cloud pilot application to real life settings (Task 8.3).
During the first 18 months of the project, the work of this WP has been focused on the 8.1 and 8.2 Tasks. Current activities are focused on the preparation of the deployment and operation of the pilot application (Task 8.3). Following the information described in D8.2, Task 8.3 is working further on addressing the technical requirements of C3-Cloud components according to the deployment options in the three pilot sites.
Work Package 9 is responsible for the evaluation of the C3-Cloud components and pilot application. This is a complex undertaking due to the manifold aspects, clinical, technical and organisational that need to be taken into consideration.
The first 12 months of the project have therefore seen a concentration on planning and preparation. It is essential that this preparatory phase be undertaken thoroughly so that the evaluation methodology will be fit for purpose and the results as accurate and appropriate as possible. The objective addressed within this period was the defining of an approach that is able to predict and model the impact of the application when implemented at scale. In addition, criteria were defined with regard to subject selection, inclusion criteria, enrollment plans and ethical approval.