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Empowering Patients by Professional Stress Avoidance and Recovery Services

Periodic Reporting for period 1 - STARS (Empowering Patients by Professional Stress Avoidance and Recovery Services)

Reporting period: 2017-01-01 to 2018-03-31

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.
A two days kick off meeting was organised in Maastricht at the beginning of the project in January 2017 to create awareness within the consortium about the STARS project. Furthermore, visits have been made by the coordinator to all five member of the buyers group during April and May 2017 for continuation.

The project management handbook was released in the beginning of 2017. It included the planning, meetings, communication and publicity plan but also information regarding the reporting period and financial guidelines. Furthermore, the roles within the consortium are described with the responsibilities and what to do in case of conflicts. The consortium agreement (DESCA) was finalized and signed by all partners the agreement In November 2017. Several meetings were organised between all members of the consortium and between the coordinator and the EU officer to discuss the progress of the project. Two amendments have been submitted to the EU. One is related to centralizing the budget for the PCP subcontract and the second one o change the reporting periods.

The needs assessment included the integration of 236 patients and over 90 professionals. A lot of results were found to reduce stress during the patient journey. The original goals of the proposal (stress measurement based on physiological parameters), the results of the extensive literature review and the translation of the results of the needs assessment were combined into the draft challenge brief. An EC informal review was used to strengthen the quality of the challenge brief. The final version was available late 2017 and used as input for the presentations for the Open Market Consultations.

Different channels have been used to promote the Open Market Consultations: the STARS website and the partners' websites. Another information channel to the industry was the publication of the PIN which contained the OMC schedule. OMC information has also been published on social media. Five OMC’s were organized in four different countries, Italy, Spain (2x), Germany and the Netherlands to have a two way dialog between the procurers group and the industry. The presentations as presented by the buyers group at the five OMC’s are published on the STARS web site.

The request for tender was based on the Challenge Brief, the outcomes of the open Market consultations, the art of the art and the regulatory environment.

The dissemination and communication plan was released as a guideline for the internal communication as well for the dissemination of the STARS project to external actors. The project website has been developed since the start of the project and has been launched since May 2017. The website will be continuously updated with new information.

An Ethics Board was established which included relevant independent expertise to monitor the ethical concerns in this project: Dr David Shaw (UM) and Dr Jacob Busch (Aarhus University). The ethics concerning project management was defined, ethics concerning patient selection for field testing in phase three was discussed and the ethical impact on society of the end-solution of STARS was debated.
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.

In case of a successful field testing of the solution, the consortium will design and seek funding for a large scale European ‘impact’ study.
Central image / concept STARS