Periodic Reporting for period 2 - STARS (Empowering Patients by Professional Stress Avoidance and Recovery Services)
Période du rapport: 2018-04-01 au 2022-06-30
Stress, experienced by patients during the clinical care path, has an enormous economic burden on the current health care systems and the quality of life of the patient and caregivers. Scientific studies have demonstrated undeniably the relation between stress and an increase of complications during surgery, a higher mortality after surgical interventions and an increased number of re-hospitalization. Also, the effect of (pre-operative) stress on recovery-time after surgery has been investigated thoroughly, concluding that not only the average time of stay in the hospital increased largely, but the return to daily routine was delayed as well. Also, it has been scientifically proven that wound healing suffers significantly from stress. All these issues lead to a considerate reduction of the quality of life of the patient during the patient journey. These scientific studies are in line with the experience of the clinical experts of STARS.
Still, the scientific evidence on stress reduction in controlled patient groups through interventions is quite extensive: Stress reduction is being achieved by education of the patient about the surgical procedures and their risks, providing information about the next step in the patient journey, novel communication techniques to consult clinical expertise, training the patient to be calm (e.g. mindfulness), distracting the patient (e.g. video experience while entering the operation theatre), personalizing his/her surroundings (e.g. through music) and timely monitoring by clinical experts.
This procurement is for R&D services to develop solutions to tackle the following challenge:
To develop a resilient, ground-breaking, beyond state-of-the-art technology solution to reduce stress, experienced by the patient, as early as in the preclinical phase, proceeding through hospitalization until discharge, in a continuous and personalised manner by combining the scientifically proven interventions (e.g. education, information, communication, distraction, personalization and monitoring) with the empowerment of patients by allowing them to actively influence the process by expressing their state of mind and needs.
Still, the scientific evidence on stress reduction in controlled patient groups through interventions is quite extensive: Stress reduction is being achieved by education of the patient about the surgical procedures and their risks, providing information about the next step in the patient journey, novel communication techniques to consult clinical expertise, training the patient to be calm (e.g. mindfulness), distracting the patient (e.g. video experience while entering the operation theatre), personalizing his/her surroundings (e.g. through music) and timely monitoring by clinical experts.
This procurement is for R&D services to develop solutions to tackle the following challenge:
To develop a resilient, ground-breaking, beyond state-of-the-art technology solution to reduce stress, experienced by the patient, as early as in the preclinical phase, proceeding through hospitalization until discharge, in a continuous and personalised manner by combining the scientifically proven interventions (e.g. education, information, communication, distraction, personalization and monitoring) with the empowerment of patients by allowing them to actively influence the process by expressing their state of mind and needs.
The preparatory phase consisted out of a thorough needs assessment and state-of-the-art analysis by the buyers group. Then followed a period of open communication between the buyers group and the market (industries, companies, or public-private consortia), during the so-called open market consultation, which were organised at five different locations and have been visited by over 81 individuals from 65 different legal entities. At the end of this preparatory phase, the call for tender was published on the EU TED (Tender Electronic Daily) website and widely advertised to reach any potentially interested industrial partner in Europe.
We received 21 bids in response to the call for tender. After careful evaluation, 6 bids were selected to start in phase 1. In this phase, suppliers had to deliver a solution design and demonstrate the feasibility of their proposed concept. Outcomes included a clear and feasible plan on how to develop the solution successfully as well as a preliminary business plan. The solution needed to include evidence that it meets the requirements outlined in the PCP challenge. To do so, the suppliers interacted with the buyers group to obtain a good understanding of the needs of the different hospitals and their professionals and patients. After assessment of the phase 1 results, successful bidders were invited to participate in phase 2.
After careful evaluation of the offers for phase 2, 4 contractors were selected and had to develop and submit the prototypes of the solution for evaluation in lab conditions to demonstrate that the solution meets the requirements of the PCP challenge. This development was done on an iterative basis by supplying intermediate reports and regular contact with the buyers group. At the end of phase 2, a prototype demonstration was planned to be conducted in Maastricht University, where every supplier would set up lab conditions and environment for their solution. Unfortunately, due the Covid pandemic and the related restrictions, the lab testing had to be performed online. After assessing the results of phase 2, successful bidders were invited to participate in phase 3.
Again, after evaluation of the phase 3 offers, 2 contractors were selected to deliver a limited set of first products and/or services for field-testing at each location of the buyers group. In summary, the results show that the solutions from contractors Evidenze and Adhera Health both have promising functionalities in an integrated and innovative app. Both solutions have their specific strengths and points to improve, but overall they incorporated a holistic approach that combines stress assessment, educational content and stress reduction activities according to our requirements in the call for tender. From the field tests, we concluded that due to the small sample size, we were not able to show statistical significant beneficial effects on clinical and non-clinical patient outcomes. However, usability analyses showed that the solutions have a high potential to increase satisfaction for patients and health care professionals and are promising to reduce stress in surgical patients.
We received 21 bids in response to the call for tender. After careful evaluation, 6 bids were selected to start in phase 1. In this phase, suppliers had to deliver a solution design and demonstrate the feasibility of their proposed concept. Outcomes included a clear and feasible plan on how to develop the solution successfully as well as a preliminary business plan. The solution needed to include evidence that it meets the requirements outlined in the PCP challenge. To do so, the suppliers interacted with the buyers group to obtain a good understanding of the needs of the different hospitals and their professionals and patients. After assessment of the phase 1 results, successful bidders were invited to participate in phase 2.
After careful evaluation of the offers for phase 2, 4 contractors were selected and had to develop and submit the prototypes of the solution for evaluation in lab conditions to demonstrate that the solution meets the requirements of the PCP challenge. This development was done on an iterative basis by supplying intermediate reports and regular contact with the buyers group. At the end of phase 2, a prototype demonstration was planned to be conducted in Maastricht University, where every supplier would set up lab conditions and environment for their solution. Unfortunately, due the Covid pandemic and the related restrictions, the lab testing had to be performed online. After assessing the results of phase 2, successful bidders were invited to participate in phase 3.
Again, after evaluation of the phase 3 offers, 2 contractors were selected to deliver a limited set of first products and/or services for field-testing at each location of the buyers group. In summary, the results show that the solutions from contractors Evidenze and Adhera Health both have promising functionalities in an integrated and innovative app. Both solutions have their specific strengths and points to improve, but overall they incorporated a holistic approach that combines stress assessment, educational content and stress reduction activities according to our requirements in the call for tender. From the field tests, we concluded that due to the small sample size, we were not able to show statistical significant beneficial effects on clinical and non-clinical patient outcomes. However, usability analyses showed that the solutions have a high potential to increase satisfaction for patients and health care professionals and are promising to reduce stress in surgical patients.
Based on the internet research, patents database, OMC’s and experts’ opinion, STARS has identified innovation gaps for their uncovered functionalities, such as:
1. No resilient support tool that enables continuous support during the entire patient journey.
2. No (or very little) patient empowerment in the current solutions. All solutions are supply-driven and not patient-centered.
3. Lack of adequate intelligence in the solutions based on medically validated information and the personalized situation of the patient.
It was found that in Europe some examples of stressful surgical interventions, such as hip replacements occur approximately 21 million times per year, prostatectomy 2.7 million times per year and bypass operations 5 million times each year (source: http://ec.europa.eu/eurostat). These indications however do not cover the full market of the solution of STARS, because many more indications could potentially be included. If STARS were to obtain only 2% of the market of patients, elective for surgery, the solution would still be applied to several millions of patients each year.
If STARS were to reduce the length of stay with 20%, an enormous saving could be achieved. Furthermore, it is expected that the number and time for direct contacts with health care as well as the number of complementary medical examinations will be reduced, which is important for the hospitals with the ageing work force. It is expected that the number of re-admissions to hospital and ICU (estimated costs per readmission are € 6.000) will be reduced. Another important cost-aspect for the hospitals is the readmission to the hospital after clinical discharge. Health insurance companies define that a new treatment is started if the number of days exceeds 30 between the original discharge and the new hospital admission. But if time is shorter, the readmission will be regarded as a continuation of the original treatment with no or less coverage by the health insurance.
1. No resilient support tool that enables continuous support during the entire patient journey.
2. No (or very little) patient empowerment in the current solutions. All solutions are supply-driven and not patient-centered.
3. Lack of adequate intelligence in the solutions based on medically validated information and the personalized situation of the patient.
It was found that in Europe some examples of stressful surgical interventions, such as hip replacements occur approximately 21 million times per year, prostatectomy 2.7 million times per year and bypass operations 5 million times each year (source: http://ec.europa.eu/eurostat). These indications however do not cover the full market of the solution of STARS, because many more indications could potentially be included. If STARS were to obtain only 2% of the market of patients, elective for surgery, the solution would still be applied to several millions of patients each year.
If STARS were to reduce the length of stay with 20%, an enormous saving could be achieved. Furthermore, it is expected that the number and time for direct contacts with health care as well as the number of complementary medical examinations will be reduced, which is important for the hospitals with the ageing work force. It is expected that the number of re-admissions to hospital and ICU (estimated costs per readmission are € 6.000) will be reduced. Another important cost-aspect for the hospitals is the readmission to the hospital after clinical discharge. Health insurance companies define that a new treatment is started if the number of days exceeds 30 between the original discharge and the new hospital admission. But if time is shorter, the readmission will be regarded as a continuation of the original treatment with no or less coverage by the health insurance.