The RELIEF Project Officer, Orestis Kalliantzidis of the Directorate-General for Communications Networks, Content and Technology (DG Connect) of European Commission, has presented the call and topic under which RELIEF was selected, as well as preliminary lessons learned from early H2020 PCPs in healthcare and the experience acquired in subsequent calls. Issues such as the relevance of the competition among suppliers to guarantee 1-2 successful solutions at the end, the need of bringing together multidisciplinary teams (clinical/IT/legal/finance/EC grants experts) or seek external expertise to ensure smooth implementation; were explained.

Ana Muñiz from Jaggaer, as coordinator of the project, has given an overview of the project execution and results. She explained the RELIEF PCP which started with a large European need analysis and co-creation process with the main stakeholders, very useful for the definition of the common challenges and needs. A review through the different PCP phases was done, explaining how the process from the request of tender was, with 17 offers were submitted, until the end of Phase 3 with the 2 remaining suppliers.

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EPIONE by Gnomon Informatics
(f.gonidis@gnomon.com.gr)

EPIONE solution consists of a mobile app for patients and a web dashboard for clinicians. Following a patient-centered approach, the patient mobile app facilitates chronic pain self-management, while the clinician’s dashboard allows remote personalized patient monitoring adopting evidence-based pain medicine guidelines.

The main features provided to patients include:

• • › Smart pain tracking
  • › A goal-oriented treatment plan including comprehensive organization of self-management activities
  • › A Personal Health Record including connection with EHR systems and a consent mechanism which allows patients to be in charge of their own health data
  • › Experiential learning episodes including virtual patients’ scenarios
  • › Community building tools
  • › Virtual coach to support medication non-adherence tracking

EPIONE offers clinicians the following features:

• • › A holistic pain assessment based on the biopsychosocial model
  • › Customization of treatment plans assigning individual goals to patients
  • › Patient triage based on serious side-effects, pain deterioration and psychological symptoms
  • › Visual progress monitoring based on validated assessment scales, continuous measurements from connected devices, such as trackers and treatment adherence monitoring
  • › Patient-Doctor communication via notifications and video consultation

Before their consultation with their clinician, the collection of patient’s pain status baseline and history is feasible through personalized questionnaires and the recording of medical history either manually by the patients themselves or by automatic population from hospital’s EHR systems.

During clinical encounters, clinicians have the option to assign a treatment plan to their patients, including different kind of activities, such as medication prescription, guidance for exercise, suggestions for education materials, tracking of important lifestyle and health parameters and referrals for exams or other healthcare specialities.

In daily life, EPIONE supports self-management of the pain condition in multiple ways. More specifically, a detailed daily agenda with a list of activities is documented for the patients with complex care needs to follow. Medication intake tracking and treatment plan progress tracking allows patients to stay informed and motivated, while a set of interactive educational scenarios aim at improving problem-solving skills of patients thus increasing their self-esteem and confidence in themselves to better self-manage their condition.

On the other hand, clinicians may follow-up their patients using visual graphs which may be configured on a patient level and can identify and compare multiple trends at the same time allowing the clinicians to test hypotheses around treatment, patient adherence levels and interference of the condition with daily life and patient mood.

A concise development plan has been devised to describe the required activities that will lead to the full market-ready version of the EPIONE solution. The activities are divided into 4 work packages.

• • › Enhancement of the EPIONE solution by improvements in the patients’ and HCP interface and the introduction of novel technologies (NLP, Machine Learning, etc)
  • › Further validation of the EPIONE solution through the development of new pilot activities in collaboration with the Lab of Medical Physics of the Aristotle University of Thessaloniki, and the publication of scientific articles
  • › Legal, Business and Operational readiness. The company is working on a commercialisation and licencing agreement, as well as an advanced the operational readiness and the customer support services
  • › Product and Company Certification. Gnomon is in the process of becoming Medical Device Regulation (MDR) certified

Access the EPIONE presentation recording
Access the EPIONE commercialization plan session recording

VR-RELIEF by Tech4Care
(info@tech4care.it)

This modular solution is composed by:

• • 1. A HARDWARE PLATFORM: a smartphone, optionally integrated with a compatible smartwatch and a VR-Headset.
  • 2. A MOBILE APP including features such as a Virtual Coach (DR. Relief), able to collect patients’ information directly from them, the clinicians and the integrated hardware (e.g. data from the smartwatch/wrist and the VR-Headset) and providing personalized reminders and feedbacks to enhance patients adherence to the treatment and monitoring the results. The App includes also a set of training contents and social community tools for patients’ training and self-management.
  • 3. A platform for clinicians to manage and profile the patients according to their clinical characteristics: data analysis allows the profiling of the patients, which will be the first step for the provision of (intelligent) personalized care.
  • 4. A library of VR applications for pain treatment, relaxation and rehabilitation, which can be used via a portable VR-headset.

The main target of customers identified in the VR-RELIEF business model, are those hospitals and out-patients facilities treating patients with Chronic Pain, interested in implementing a new telehealth system. The solution will be commercialized according to the SaaS model, which means that each clinic will pay a yearly fee depending on the volume of usage (fee including a fixed and a variable rate). The cost of use might increase in case the clinics request also to use of wearables. In such case, hardware can be provided on a lease agreement. The VR-RELIEF solution will be market-ready by the end of May 2021, after the finalization of the ISO certification procedures.

Tech4Care is currently working also in the re-development of the patients App. The improved version of the app is designed for a “stand-alone” use (i.e. without the clinician support and the VR-gear) and will be used by patients to self-manage their medication, track lifestyle and sleep, keep a log of the pain events, and a dashboard showing personal data. The plan is to release the app freely on App Store and Google Play. The App will generate revenues thanks to the sponsorship provided by Pharma industry (advanced negotiations in place). Also in this case, the release of the new version of the App is expected by the end of May 2021.

Last, the VR-component of VR-RELIEF has been included in ReLab a new, comprehensive telerehabilitation solution commercialized by Tech4Care which addresses several chronic conditions, including pain, stroke, Parkinson and Multiple Sclerosis. To improve the current hardware set-up, a new B2B agreement has been made with the manufacturing company PICO-VR. The launch of the new integrated solution is expected for October 2021.

Access the VR-Relief presentation recording.
Access the VR-Relief commercialization plan session recording.

Phase 3 of the RELIEF PCP consisted in testing both developed solutions in real life conditions through a clinical study, with patients from the three pain units from October 2019 until January 2021. The three procurers: SAS, RESAH and CCU identified collaborating hospitals and patients and have led the proof of concept. The primary aim of the clinical study was to evaluate if an ICT solution increases the patient’s empowerment and self-management in managing their pain condition. Secondary aims were to evaluate if an ICT solution increases adherence to treatment and how the patients and healthcare professionals experience the use of an ICT solution in the management of chronic pain.

An official Clinical Study Protocol was created and the field-testing consisted in a randomised, controlled, multicentre study with the overall objective to evaluate the clinical implications of using an ICT solution in clinical practice to support patients and healthcare providers in the management of chronic pain.

Even though the field testing was heavily impacted by the Covid-19 pandemic, patients were recruited in all three pilot sites and enough data was collected for analysis. In total, 95 patients completed the study successfully, 49 using one of the two solutions and 46 being in the control group. Both patients and healthcare professionals participating in the clinical study filled multiple questionnaires that allowed us to present the following results.

The primary endpoint of the study (evaluate the potential of the ICT solution to increase the patient’s empowerment, self-management, engagement and motivation for the treatment of chronic pain) was not met. In that respect the study was negative. However, in the patients’ interviews and questionnaires several positive aspects were captured. For instance, the patients appreciated the ability to monitor activities and sleeping patterns, and the access to self-management techniques and training recommendations. The functionality that was the most valued by participating physicians corresponds to the data collection before the first visit (medical history, treatments, …).

It is worth noting that even if the primary endpoint failed to show an effect, the patients scored reasonably high (2.7/4.0) on a similar question “What is your overall perception about the usefulness of the eHealth solutions to assist in making decisions on your own care?”.

The secondary endpoints (characterize the potential for an ICT-solution to improve management of chronic pain) showed no difference between the control group and the patients using the solutions. The system usability scale (SUS) score by the patients, is within the acceptability range of a technical solution. Obviously, there is a room for improvement, but we need to take into account that the field test was also the first time that these solutions were ever tested in real life situations.

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Very valuable point of view of procurers and contractors were shared. The questions asked by the moderator, Orestis Kalliantzidis, allowed going through the different PCP phases. Main lessons learnt and good practices identified were:

Phase 0 – Open Market Consultation

• • › The Phase 0 is the most important and critical Phase, often underestimated.
  • › It is essential to ensure the involvement of every stakeholder, especially the final users. it can also be interesting to consult experts from other organizations than the Buyers Group.
  • › Several Physical OMC Workshops (and eventually one online) have to be organized.

Phase 0 – Elaboration of the tender documents

• • › To centralise the PCP process in a lead procurer to simplify the management of the PCP.
  • › For contractors it is very useful to have information that allow understanding the patient journey.

Phase 1 – Feasibility Study

• • › It is important that the procurers involve staff with the necessary skills and experience.
  • › The workload and effort required for phase 1 in RELIEF indicates that the decision of awarding 7 solutions in phase 1 should be reconsidered.
  • › For contractors, the level of involvement of clinicians is fundamental, especially during the early design process, when the architecture of the solution is defined.

Phase 2 – Prototype development

• • › It is recommended to plan a demonstration/testing at the middle of Phase 2.
  • › Plan a testing at the end of the Phase 2 in order to validate the final version of the prototypes.

Phase 3 – Field Testing

• • › The gap between the lab testing and the field testing is too big, and it is necessary to plan an intermediate step or phase before phase 3 of the PCP.
  • › It is highly recommended do not plan a Clinical Trial for the Phase 3.
  • › It is important for procurers to commit the participation of a multidisciplinary team to carry out the field testing of the solutions
  • › For contractors, it is recommended that frequent follow-up training or information sessions are scheduled both with the patients and the HCPs.
  • › For contractors, a closer contact with users during the trial would have been very helpful.
  • › It will be beneficial for the contractors to include commercialization-related activities either in the end of Phase 3 or as a short follow-up Phase 4.

Based on those lessons and practices, the main recommendations presented were: For policy makers:

• • › Limit the participation in several PCP projects for a company.
  • › The PCP instrument could be divided into 4 phases instead of 3. An additional phase between the Prototyping phase (2) and the Field-testing phase (3) could be created.
  • › It could be very interesting to delete the tendering process between Phase 1 and Phase 2, and between Phase 2 and Phase 3. It would simplify a lot the process.

For public procurers:

• • › Reduce the number of contractors in Phase 2 and preferably in Phase 3.
  • › Ensure that you can involve a multidisciplinary team that includes all the necessary profiles
  • › Anticipate the tendering phase between each PCP Phase
  • › Small sample sizes at the pilot sites is a good idea. This was a sufficient number of end-users for the trial.

Access the session recording.