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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 3 - DeltaScan (Public private partnership to revolutionize delirium care in hospitals)

Teaser

Summary

Prolira, a high-tech SME, has formed a consortium with European academic hospitals and Key Opinion Leaders who together are revolutionizing delirium care.

This is necessary as delirium has severe consequences for patients (death, dementia, slower recovery), hospitals (organizational, time, costs), and society (costs â‰ˆ â‚¬173 billion).
Every year, at least 3 million Europeans are affected by acute brain failure (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

Proliraâ€™s DeltaScan is the worldâ€™s first objective device, based on EEG, to revolutionize delirium care in hospitals. The DeltaScan project has received funding from the European Unionâ€™s Horizon 2020 research and innovation program under grant agreement No 820555. In reporting period 3/5 the work results are as follows:

Technically, the first version of the full commercial DeltaScan Monitor and Patch are finished and CE-certified. Manufacturing of the DeltaScan system has commenced to sufficient levels for the international large-scale Clinical Evaluation Program and Proliraâ€™s first commercial customers.

Clinically, 13 hospital departments in The Netherlands, Germany and Belgium have started the control phase of the Clinical Evaluation Program of DeltaScan in 2019. As from January 2020, every month a pair of hospital departments will progress into the intervention phase. In the control phase they still continued their delirium care as usual (using paper checklists) and in the intervention phase they change fully to using DeltaScan for daily delirium detection and monitoring.

Commercially, Prolira has built a sales and clinical specialist team, to be present in the market and on medical congresses. As DeltaScan is very new and revolutionary, clinics ask for support in order to get this medical technology implemented correctly in routine care. Change management for entire nursing and physician teams at every customer location is important; especially the first ones need extra support, as it is important to create ambassadors. That is why we made e-learning modules in 2 languages, an instruction video in 3 languages, posters, pocket-cards and hands on trainings and built our own team of clinical application specialists, to be able to support and have sufficient presence in clinics that start using DeltaScan.

On communication and dissemination; Until now, Prolira staff has been visiting all Dutch hospitals, many German ones and some Belgian, English and Austrian ones, we have been present in the delirium research and Key Opinion Leader societies, and communicated through the project and Prolira website about the activities. Our consortium partners and Key Opinion Leaders (Prof Spies, G; Prof Slooter, NL; Prof Milisen, B) are publishing and presenting on and attending to many conferences continuously. Now that DeltaScan is commercially available and implementation in clinics is on its way, opportunities for communication and dissemination are growing.

Final results

Technically and clinically, at the end of the project, DeltaScan will reach TRL9, meaning DeltaScan was evaluated and tested heavily in clinical practice through the clinical program of the DeltaScan H2020 project. We expect positive patient outcomes in reducing the length of stay as well as demonstrating a positive health economics case from the consortiumâ€™s clinical programs.

Commercially, we will have become masters in implementing DeltaScan in routine hospital care, in such a way that customers are supported to efficiently and effectively use DeltaScan and to gain the clinical benefits from it. In this strategy, we really improve delirium care together with our customers. In addition, Prolira will become a viable, self-sustaining business generating jobs in the countries that we are active in, throughout the supply chain.

In society and amongst the clinical community, through our efforts, the consortium will have raised delirium awareness, trained and communicated that improving delirium care is worthwhile. Early detection and timely treatment of delirium can improve patient outcome and reduce the societal burden of delirium.