Periodic Reporting for period 2 - RELIEF (RECOVERING LIFE WELLBEING THROUGH PAIN SELF-MANAGEMENT TECHNIQUES INVOLVING ICTs)
Okres sprawozdawczy: 2017-04-01 do 2021-03-31
RELIEF project aims at implementing a Pre-Commercial Procurement tender to find innovative ICT solutions that improve the self-management of chronic pain patients.
General Chronic Pain is a very common pathology suffered by more than 95 million of European (between 4%-10% of adult population), implying significant direct costs to healthcare systems (annually over 300bn euros in Europe); furthermore, inappropriate and ineffective management and treatment generates repetitive visits to primary care physicians, and referrals to specialists. Although nowadays there are clinics specialised in diagnosing and treating patients with chronic pain, not everybody can access to these specialized pain clinics and services; also the type of service may vary significantly.
In this regard, clinicians need to work in collaboration with patients to identify the optimal therapy. It is also critical that patients receive treatment as soon as possible. On the other hand, medical market of electronic devices is growing at a huge rate in the past few years, however only a few of them have been directly supervised by clinicians. Only little research has been done in the field of chronic pain management or self-management.
RELIEF was conceived with the response to cover these gaps and expanding the range and reach the quality of chronic pain self-management supporting people with chronic pain, their carers and their families.
In this sense, the project will aim at identifying solutions for chronic pain self-management through the development of a joined Pre Commercial Procurement.
The project has created a network of procuring organisations, from France, Sweden and Spain, with a common challenge and identified unmet needs that are going to launch and implement a Pre-Commercial Procurement (PCP) to buy research and development services to develop innovative solutions that solve this common challenge: How to improve the self-management of chronic pain patients using ICT.
General Chronic Pain is a very common pathology suffered by more than 95 million of European (between 4%-10% of adult population), implying significant direct costs to healthcare systems (annually over 300bn euros in Europe); furthermore, inappropriate and ineffective management and treatment generates repetitive visits to primary care physicians, and referrals to specialists. Although nowadays there are clinics specialised in diagnosing and treating patients with chronic pain, not everybody can access to these specialized pain clinics and services; also the type of service may vary significantly.
In this regard, clinicians need to work in collaboration with patients to identify the optimal therapy. It is also critical that patients receive treatment as soon as possible. On the other hand, medical market of electronic devices is growing at a huge rate in the past few years, however only a few of them have been directly supervised by clinicians. Only little research has been done in the field of chronic pain management or self-management.
RELIEF was conceived with the response to cover these gaps and expanding the range and reach the quality of chronic pain self-management supporting people with chronic pain, their carers and their families.
In this sense, the project will aim at identifying solutions for chronic pain self-management through the development of a joined Pre Commercial Procurement.
The project has created a network of procuring organisations, from France, Sweden and Spain, with a common challenge and identified unmet needs that are going to launch and implement a Pre-Commercial Procurement (PCP) to buy research and development services to develop innovative solutions that solve this common challenge: How to improve the self-management of chronic pain patients using ICT.
The RELIEF PCP project was initiated by developing a generic PCP process and documentation based on the PCP model created by the European Commission.
The consortium carried out a large European need analysis and co-creation process with the main stakeholders of the project. The RELIEF preparation stage included: literature review and study of the state of the art; organization of focus groups and individual interviews; publication of the Prior Information Notice; and organization of the Open Market Consultation activities.
Based on the information collected during the preparatory activities, the consortium worked in the preparation of the tender documents needed for launching the process through the RELIEF eTendering Platform.
Specific and detailed evaluation and monitoring methodologies were defined to carried out the three phases and guarantee an adequate execution of the work by the awarded contractors. No incidences were identified in Phase 1 and Phase 2. 17 offers were submitted in phase 1, 7 of which were awarded.
A preparation stage for Phase 2 was necessary to redefine the Tender process for Prototype Development. It took more time than expected and a 4-months extension of the project was needed. After the Call-off for Phase 2 ended, there were 7 offers submitted. The project awarded 4 suppliers for starting Phase 2.
The Phase 3 was divided in three phases: Local Adaptation, Pilot Test and Field Testing. It was carried out in the three sites of the buyer group: Spain, France and Sweden, with the objective of recruiting 120 patients, 40 per site. The procurers decided to design this phase as a clinical study in real-life conditions with patients.
The phase was planned to last for 10 months, although several deviations from this initial plan were needed. Some delays in all sites were due to the need of a longer time for the adaptation of the prototypes to the local sites and the improvement of the solutions during and after the pilot test. Besides, the field-testing started with an additional delay in France because of a late approval of the clinical protocol by the French committee. However, the main impact in the project execution was due to the COVID-19 pandemic and its consequences in the recruitment of patients that took longer than expected.
The pandemic also impacted in the number of patients recruited. The recruitment of patients stopped even though the objective of 120 patients was not reached. 102 patients were recruited and 95 of them successfully complete.
Through all the above activities, the project obtained two main results. On the one hand, the knowledge obtained from the implementation of the RELIEF PCP process. On the other hand, the eHealth solutions to empower patients with chronic pain.
Regarding the PCP experience, the consortium has acquired a very relevant knowledge about how to implement and carry out a PCP project. Related to the solutions developed in the project, they have demonstrated that they can work in a real-life environment, in a healthcare domain, although additional measures for their fine-tuning are needed.
Although the buyer group has planned some activities to support the exploitation, they will be implemented according to the final progress of the technologies in the market. At this moment, the most important issue is the option that the buyer group and contractors are analyzing regarding the use of the solutions for free for 1 year.
Several communication and dissemination activities has been carried out by using different. The last month of the project, the consortium organized the RELIEF Final Conference in which 52 stakeholders attended. Besides, the project has designed the RELIEF educational programme.
The consortium carried out a large European need analysis and co-creation process with the main stakeholders of the project. The RELIEF preparation stage included: literature review and study of the state of the art; organization of focus groups and individual interviews; publication of the Prior Information Notice; and organization of the Open Market Consultation activities.
Based on the information collected during the preparatory activities, the consortium worked in the preparation of the tender documents needed for launching the process through the RELIEF eTendering Platform.
Specific and detailed evaluation and monitoring methodologies were defined to carried out the three phases and guarantee an adequate execution of the work by the awarded contractors. No incidences were identified in Phase 1 and Phase 2. 17 offers were submitted in phase 1, 7 of which were awarded.
A preparation stage for Phase 2 was necessary to redefine the Tender process for Prototype Development. It took more time than expected and a 4-months extension of the project was needed. After the Call-off for Phase 2 ended, there were 7 offers submitted. The project awarded 4 suppliers for starting Phase 2.
The Phase 3 was divided in three phases: Local Adaptation, Pilot Test and Field Testing. It was carried out in the three sites of the buyer group: Spain, France and Sweden, with the objective of recruiting 120 patients, 40 per site. The procurers decided to design this phase as a clinical study in real-life conditions with patients.
The phase was planned to last for 10 months, although several deviations from this initial plan were needed. Some delays in all sites were due to the need of a longer time for the adaptation of the prototypes to the local sites and the improvement of the solutions during and after the pilot test. Besides, the field-testing started with an additional delay in France because of a late approval of the clinical protocol by the French committee. However, the main impact in the project execution was due to the COVID-19 pandemic and its consequences in the recruitment of patients that took longer than expected.
The pandemic also impacted in the number of patients recruited. The recruitment of patients stopped even though the objective of 120 patients was not reached. 102 patients were recruited and 95 of them successfully complete.
Through all the above activities, the project obtained two main results. On the one hand, the knowledge obtained from the implementation of the RELIEF PCP process. On the other hand, the eHealth solutions to empower patients with chronic pain.
Regarding the PCP experience, the consortium has acquired a very relevant knowledge about how to implement and carry out a PCP project. Related to the solutions developed in the project, they have demonstrated that they can work in a real-life environment, in a healthcare domain, although additional measures for their fine-tuning are needed.
Although the buyer group has planned some activities to support the exploitation, they will be implemented according to the final progress of the technologies in the market. At this moment, the most important issue is the option that the buyer group and contractors are analyzing regarding the use of the solutions for free for 1 year.
Several communication and dissemination activities has been carried out by using different. The last month of the project, the consortium organized the RELIEF Final Conference in which 52 stakeholders attended. Besides, the project has designed the RELIEF educational programme.
At this moment is difficult to determine the efficiency improvements in public services that the subcontractors' innovations deliver to the procurers. Main impacts on the efficiency of the healthcare services of the RELIEF solutions highlighted by contractors and expected by procurers are: Improvement of the clinical work, Improvement of the communication and strengthening the alliance between clinicians and patients, Improvement of treatment adherence, Reducing inappropriate medications and support to non-pharmaceutical strategies, and Increasing patients empowerment.
These impacts on the efficiency of the healthcare services have been analyzed through the clinical study developed in the phase 3 of the project. No evidence related to the potential of the ICT solutions to increase the patient’s empowerment, self-management, engagement and motivation for the treatment of chronic pain, was identified. However, the in-deep interviews, questionnaires and comments from patients and professionals using the solutions revealed other interesting information to take into account for determining the solutions’ impact.
In consequence, there are still some pending issues to resolve for making final conclusions. Both solutions need a further development, as well as a wider use to determine their real impact.
These impacts on the efficiency of the healthcare services have been analyzed through the clinical study developed in the phase 3 of the project. No evidence related to the potential of the ICT solutions to increase the patient’s empowerment, self-management, engagement and motivation for the treatment of chronic pain, was identified. However, the in-deep interviews, questionnaires and comments from patients and professionals using the solutions revealed other interesting information to take into account for determining the solutions’ impact.
In consequence, there are still some pending issues to resolve for making final conclusions. Both solutions need a further development, as well as a wider use to determine their real impact.