Digital Biomarkers for Supporting Transitional Care Decisions: Protocol for a Transnational Feasibility Study
Authors: Petsani Despoina , Ahmed Sara , Petronikolou Vasileia , Kehayia Eva , Alastalo Mika , Santonen Teemu , Merino-Barbancho Beatriz , Cea Gloria , Segkouli Sofia , Stavropoulos Thanos G , Billis Antonis , Doumas Michael , Almeida Rosa , Nagy Enikő , Broeckx Leen , Bamidis Panagiotis , Konstantinidis Evdokimos 
Published: November 2021

Background
Virtual Health and Wellbeing Living Lab Infrastructure is a Horizon 2020 project that aims to harmonize Living Lab procedures and facilitate access to European health and well-being research infrastructures. In this context, this study presents a joint research activity that will be conducted within Virtual Health and Wellbeing Living Lab Infrastructure in the transitional care domain to test and validate the harmonized Living Lab procedures and infrastructures. The collection of data from various sources (information and communications technology and clinical and patient-reported outcome measures) demonstrated the capacity to assess risk and support decisions during care transitions, but there is no harmonized way of combining this information.

Objective
This study primarily aims to evaluate the feasibility and benefit of collecting multichannel data across Living Labs on the topic of transitional care and to harmonize data processes and collection. In addition, the authors aim to investigate the collection and use of digital biomarkers and explore initial patterns in the data that demonstrate the potential to predict transition outcomes, such as readmissions and adverse events.

Methods
The current research protocol presents a multicenter, prospective, observational cohort study that will consist of three phases, running consecutively in multiple sites: a cocreation phase, a testing and simulation phase, and a transnational pilot phase. The cocreation phase aims to build a common understanding among different sites, investigate the differences in hospitalization discharge management among countries, and the willingness of different stakeholders to use technological solutions in the transitional care process. The testing and simulation phase aims to explore ways of integrating observation of a patient’s clinical condition, patient involvement, and discharge education in transitional care. The objective of the simulation phase is to evaluate the feasibility and the barriers faced by health care professionals in assessing transition readiness.

Results
The cocreation phase will be completed by April 2022. The testing and simulation phase will begin in September 2022 and will partially overlap with the deployment of the transnational pilot phase that will start in the same month. The data collection of the transnational pilots will be finalized by the end of June 2023. Data processing is expected to be completed by March 2024. The results will consist of guidelines and implementation pathways for large-scale studies and an analysis for identifying initial patterns in the acquired data.

Conclusions
The knowledge acquired through this research will lead to harmonized procedures and data collection for Living Labs that support transitions in care.

International Registered Report Identifier (IRRID)
PRR1-10.2196/34573