Periodic Reporting for period 5 - DeltaScan (Public private partnership to revolutionize delirium care in hospitals) Reporting period: 2020-10-01 to 2021-06-30 Summary of the context and overall objectives of the project Prolira, a high-tech SME, has formed a consortium with European academic hospitals and Key Opinion Leaders to revolutionizing delirium care.This is necessary as delirium has severe consequences for patients (death, dementia, slower recovery), hospitals (organizational, time, costs), and society (costs ≈ €173 billion).Every year, at least 3 million Europeans are affected by delirium, especially hospitalized elderly and patients in ICU. And, the size of this problem will grow with our aging society. Delirium is an acute failure of the brain. Each day of delirium increases the risk of dementia or dying.Prolira has created a new vital sign monitor based on portable electroencephalography (EEG) technology: DeltaScan. Nurses can use it during bedside checks to scan brain activity for delirium. This simple step is as important as measuring blood pressure.Currently, nurses are only equipped with subjective checklists to detect delirium, leaving the majority of cases undetected, and untreated. With DeltaScan, delirium is detected more often and earlier, benefiting patients, hospitals, and society.Our medical consortium partners wish to implement DeltaScan into routine care, evaluating the effects and capturing the benefits. This project covers clinical testing, which is an absolute requirement for market acceptance. It is a straight road to becoming the Gold Standard in delirium detection and being included in clinical guidelines. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Prolira’s DeltaScan is the world’s first objective device, based on EEG, to measure delirium in hospitals. The DeltaScan project has received funding from the EC's Horizon 2020 research and innovation program under grant agreement No 820555. Technically, the first version of the full commercial DeltaScan Monitor and Patch are finished and CE certified. In 2020, Prolira has upgraded the CE-certification as well as the Quality Management System to the latest and novel EU MDR level as part of the first set of companies to achieve this in Europe. In January 2021, we were able to extend the CE-certificate with the indication for acute encephalopathy, next to delirium. The relation between acute encephalopathy and delirium is perfectly described by Key Opinion Leaders (KOLs) in these two videos: “Management of acute encephalopathy/delirium” (https://vimeo.com/561376290/16bb109105) and “Innovation: using EEG in acute encephalopathy/delirium management” (https://vimeo.com/544938759/984a254196)Clinically, and together with our consortium partners and KOLs (Prof Slooter, NL; Prof Spies, DE; Prof Milisen, BE), one large scale validation study for device performance was executed, showing strong performance (>85% overall diagnostic accuracy) of DeltaScan for acute encephalopathy (a.k.a. delirium) in a hospital wide study population of 434 patients. An international evaluation study with the purpose to evaluate DeltaScan in daily practice was severely hampered by the COVID-19 pandemic, which made it not possible to reach the required inclusion numbers in the intervention phase of the study. Study sites did however get a good introduction to DeltaScan and most continue to use DeltaScan because of their participation in the study.Commercially, Prolira has built a direct sales and clinical specialist team in The Netherlands and closed contracts with Orion Pharma for sales in the German market, and with Habel Medizintechnik for distribution in the Austrian market. This provides us with a strong presence in these target markets. In addition, we have developed a full set of marketing materials (leaflets, congress stand, posters, information packs, videos, and an on-demand webinar) to support the sales teams. In addition, we developed a customer-focused Cost Benefit Calculator (with a health economics specialist), that enables calculating the cost-benefit for the use of the DeltaScan device for each customer individually.On clinical support, we developed a support package to help customers to implement DeltaScan into routine use. The package contains of a Department Scan, DeltaScan Academy (extensive training using e-learning modules, training videos, and hands-on training materials), Integration with Electronic Health Records (EHR), and the DeltaScan Dashboard (using EHR-data of the customer to show the benefits of using DeltaScan). We gained a lot of experience and know-how on stimulating change on the floor of our customers, ensuring that entire nursing and physician teams adapt to actively using DeltaScan and improving patient care.On communication and dissemination; 1) the consortium has been present in the delirium research and Key Opinion Leader societies, and communicated plans and results at dedicated European and American medical congresses. 2) The clinical program results in multiple peer-reviewed articles, for example, Hut et al., 2021, EEG and clinical assessment in delirium and acute encephalopathy, Psychiatry and Clinical Neuroscience. DeltaScan is becoming more and more known in the delirium research world. 3) Prolira has set up a digital awareness campaign, regularly communicating about DeltaScan, new insights, and project results through LinkedIn and other digital media. We have also developed an on-demand webinar, which is part of the campaign as well, and features different Key Opinion Leaders. 4) During the project, we have set up extensive activities to directly communicate product offering, clinical benefits, and project results to relevant clinics. Hundreds of visits were executed to clinics in Prolira’s target countries (NL, DE, AT, UK, and USA). Through these direct activities (next to events and digital channels), we build on a presence of DeltaScan in the market. 5) Visiting medical device tradeshows such as Medica (DE) and Advamed (USA) has supported Prolira to grow as a company, gain industry experience, and expand our network with multiple contacts, who we started to work with thereafter. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) Technically and clinically, DeltaScan reached TRL9, meaning DeltaScan was evaluated and tested heavily in clinical practice through the clinical program of the DeltaScan H2020 project. The diagnostic performance has shown consistent good results in different clinical studies. DeltaScan is now implemented in different hospital departments, meaning we gain insights about the clinical benefits by working closely with our customers. Soon, outside the project, we expand on the initial good clinical experiences by pooling real-world data from multiple customers to quantify the expected positive patient outcomes in reducing the length of stay as well as demonstrating the positive health economics case.In clinical support, we will become masters in implementing DeltaScan in routine hospital care, in such a way that customers are supported to use DeltaScan efficiently and effectively and to gain the clinical benefits from it. In this strategy, we really improve delirium care together with our customers.Commercially, Prolira will become a viable, self-sustaining business generating jobs by focusing on 5 key the countries that we selected to become commercially successful (NL, DE, AT, UK, and USA).In society and amongst the clinical community, through our efforts, the project consortium has raised delirium awareness, and communicated that improving delirium care is possible and valuable. Early detection and timely treatment of delirium can improve patient outcome and reduce the societal burden of delirium. The technology explained (https://vimeo.com/544938759/984a254196) The problem and the solution (https://vimeo.com/561376290/16bb109105) DeltaScan® in action (https://youtu.be/nULIaUjtcJ8) DeltaScan® on national news (https://youtu.be/JWAw3BCAURo) Customer video on delirium (https://youtu.be/1DSBZ_UUa1E)
