Assessment of the Effectiveness, Socio-Economic Impact and Implementation of a Digital Solution for Patients with Advanced Chronic Diseases: The ADLIFE Study Protocol.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

"It depends on the people!" - A qualitative analysis of contextual factors, prior to the implementation of digital health innovations for chronic condition management, in a German integrated care network.

Objective: Integrated care and digital health technology interventions are promising approaches to coordinate services for people living with chronic conditions, across different care settings and providers. The EU-funded ADLIFE project intends to provide digitally integrated personalized care to improve and maintain patients' health with advanced chronic conditions. This study conducted a qualitative assessment of contextual factors prior to the implementation of the ADLIFE digital health platforms at the German pilot site. The results of the assessment are then used to derive recommendations for action for the subsequent implementation, and for evaluation of the other pilot sites. Methods: Qualitative interviews with healthcare professionals and IT experts were conducted at the German pilot site. The interviews followed a semi-structured interview guideline, based on the HOT-fit framework, focusing on organizational, technological, and human factors. All interviews were audio recorded, transcribed, and subsequently analysed following qualitative content analysis. Results: The results of the 18 interviews show the interviewees' high openness and motivation to use new innovative digital solutions, as well as an apparent willingness of cooperation between different healthcare professionals. Challenges include limited technical infrastructure and large variability of software to record health data, lacking standards and interfaces. Conclusions: Considering contextual factors on different levels is critical for the success of implementing innovations in healthcare and the transfer into other settings. In our study, the HOT-fit framework proved suitable for assessing contextual factors, when implementing IT innovations in healthcare. In a next step, the methodological approach will be transferred to the six other European pilot sites, participating in the project, for a cross-national assessment of contextual factors.

An Integrated Care Platform System (C3-Cloud) for Care Planning, Decision Support, and Empowerment of Patients With Multimorbidity: Protocol for a Technology Trial.

BACKGROUND: There is an increasing need to organize the care around the patient and not the disease, while considering the complex realities of multiple physical and psychosocial conditions, and polypharmacy. Integrated patient-centered care delivery platforms have been developed for both patients and clinicians. These platforms could provide a promising way to achieve a collaborative environment that improves the provision of integrated care for patients via enhanced information and communication technology solutions for semiautomated clinical decision support. OBJECTIVE: The Collaborative Care and Cure Cloud project (C3-Cloud) has developed 2 collaborative computer platforms for patients and members of the multidisciplinary team (MDT) and deployed these in 3 different European settings. The objective of this study is to pilot test the platforms and evaluate their impact on patients with 2 or more chronic conditions (diabetes mellitus type 2, heart failure, kidney failure, depression), their informal caregivers, health care professionals, and, to some extent, health care systems. METHODS: This paper describes the protocol for conducting an evaluation of user experience, acceptability, and usefulness of the platforms. For this, 2 "testing and evaluation" phases have been defined, involving multiple qualitative methods (focus groups and surveys) and advanced impact modeling (predictive modeling and cost-benefit analysis). Patients and health care professionals were identified and recruited from 3 partnering regions in Spain, Sweden, and the United Kingdom via electronic health record screening. RESULTS: The technology trial in this 4-year funded project (2016-2020) concluded in April 2020. The pilot technology trial for evaluation phases 3 and 4 was launched in November 2019 and carried out until April 2020. Data collection for these phases is completed with promising results on platform acceptance and socioeconomic impact. We believe that the phased, iterative approach taken is useful as it involves relevant stakeholders at crucial stages in the platform development and allows for a sound user acceptance assessment of the final product. CONCLUSIONS: Patients with multiple chronic conditions often experience shortcomings in the care they receive. It is hoped that personalized care plan platforms for patients and collaboration platforms for members of MDTs can help tackle the specific challenges of clinical guideline reconciliation for patients with multimorbidity and improve the management of polypharmacy. The initial evaluative phases have indicated promising results of platform usability. Results of phases 3 and 4 were methodologically useful, yet limited due to the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov NCT03834207; https://clinicaltrials.gov/ct2/show/NCT03834207. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/21994.

Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country.

BACKGROUND: Older patients with multimorbidity have complex health and social care needs, associated with elevated use of health care resources. The aim of this study is to evaluate the impact of CareWell integrated care model for older patients with multimorbidity in the Basque Country. METHODS: The CareWell program for older patients with multimorbidity, based on the coordination between health providers, home-based care and patient empowerment, supported by information and communication technology tools. The program was deployed in four healthcare areas in the Basque Country. The control group was formed by two organizations in which the program had not been deployed and regular care procedures were applied. Participants, older patients (aged ≥65) with two or more chronic conditions (at least one being chronic obstructive pulmonary disease, chronic heart failure, or diabetes mellitus), categorized as complex according to a risk stratification algorithm, were followed up to 12 months. The impact of the program on the use of health resources, clinical effectiveness, and satisfaction was evaluated using a mixed-method approach. Semi-structured interviews were performed to assess satisfaction with the newly deployed model and mixed regression models to measure the effect of the intervention throughout the follow-up period. RESULTS: Two hundred patients were recruited (101 intervention and 99 control), mostly males (63%) with a mean age of 79 years and age-adjusted Charlson Comorbidity Index of 9.7 on average. Relevant differences between the groups were observed for all dimensions. In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased. Clinical changes were also observed, such as a decrease in the body mass index and blood glucose levels. The satisfaction level was high for all stakeholders. CONCLUSION: The implementation of CareWell integrated care model changed the profile of health resource utilization, strengthening the key role of primary care and reducing the number of emergency visits and hospitalizations. The satisfaction with this model of care was high. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03042039 . Registered 3 February 2017 - Retrospectively registered.

Localisation, Personalisation and Delivery of Best Practice Guidelines on an Integrated Care and Cure Cloud Architecture: The C3-Cloud Approach to Managing Multimorbidity.

BACKGROUND: C3-Cloud is an integrated care ICT infrastructure offering seamless patient-centered approach to managing multimorbidity, deployed in three European pilot sites. Challenge: The digital delivery of best practice guidelines unified for multimorbidity, customized to local practice, offering the capability to improve patient personalization and benefit. METHOD: C3-Cloud has adopted a co-production approach to developing unified multimorbidity guidelines, by collating and reconciling best practice guidelines for each condition. Clinical and technical teams at pilot sites and the C3-Cloud consortium worked in tandem to create the specification and technical implementation. RESULTS: C3-Cloud offers CDSS for diabetes, renal failure, depression and congenital heart failure, with over 300 rules and checks that deliver four best practice guidelines in parallel, customized for each pilot site. CONCLUSIONS: The process provided a traceable, maintainable and audited digitally delivered collated and reconciled guidelines.

Impact Assessment of an Innovative Integrated Care Model for Older Complex Patients with Multimorbidity: The CareWell Project.

OBJECTIVES: To evaluate the impact in terms of use of health services, clinical outcomes, functional status, and patient's satisfaction of an integrated care program, the CareWell program, for complex patients with multimorbidity, supported by information and communication technology platforms in six European regions. DATA SOURCES: Primary data were used and the follow-up period ranged between 8 and 12 months. STUDY DESIGN: A quasi-experimental study, targeting chronic patients aged 65 or older, with 2 or more conditions - one of them necessarily being diabetes, congestive heart failure or congestive obstructive pulmonary disease. The intervention group received the integrated care program and the control group received usual care. Generalized mixed regression models were used. DATA COLLECTION: Data were obtained from individual interviews and electronic clinical records. PRINCIPAL FINDINGS: Overall, 856 patients were recruited (475 intervention and 381 control). In the intervention group, the number of visits to emergency rooms was significantly lower, and the number of visits to the general practitioners and primary care nurses was higher than in the control group. CONCLUSION: The CareWell program resulted in improvements in the use of health services, strengthening the role of PC as the cornerstone of care provision for complex patients with multimorbidity.

User-Centered Design of the C3-Cloud Platform for Elderly with Multiple Diseases - Functional Requirements and Application Testing.

The number of patients with multimorbidity has been steadily increasing in the modern aging societies. The European C3-Cloud project provides a multidisciplinary and patient-centered "Collaborative Care and Cure-system" for the management of elderly with multimorbidity, enabling continuous coordination of care activities between multidisciplinary care teams (MDTs), patients and informal caregivers (ICG). In this study various components of the infrastructure were tested to fulfill the functional requirements and the entire system was subjected to an early application testing involving different groups of end-users. MDTs from participating European regions were involved in requirement elicitation and test formulation, resulting in 57 questions, distributed via an internet platform to 48 test participants (22 MDTs, 26 patients) from three pilot sites. The results indicate a high level of satisfaction with all components. Early testing also provided feedback for technical improvement of the entire system, and the paper points out useful evaluation methods.

A Collaborative Platform for Management of Chronic Diseases via Guideline-Driven Individualized Care Plans.

Older age is associated with an increased accumulation of multiple chronic conditions. The clinical management of patients suffering from multiple chronic conditions is very complex, disconnected and time-consuming with the traditional care settings. Integrated care is a means to address the growing demand for improved patient experience and health outcomes of multimorbid and long-term care patients. Care planning is a prevalent approach of integrated care, where the aim is to deliver more personalized and targeted care creating shared care plans by clearly articulating the role of each provider and patient in the care process. In this paper, we present a method and corresponding implementation of a semi-automatic care plan management tool, integrated with clinical decision support services which can seamlessly access and assess the electronic health records (EHRs) of the patient in comparison with evidence based clinical guidelines to suggest personalized recommendations for goals and interventions to be added to the individualized care plans. We also report the results of usability studies carried out in four pilot sites by patients and clinicians.

Safety assessment of chronic oral exposure to iron oxide nanoparticles.

Iron oxide nanoparticles with engineered physical and biochemical properties are finding a rapidly increasing number of biomedical applications. However, a wide variety of safety concerns, especially those related to oral exposure, still need to be addressed for iron oxide nanoparticles in order to reach clinical practice. Here, we report on the effects of chronic oral exposure to low doses of γ-Fe2O3 nanoparticles in growing chickens. Animal observation, weight, and diet intake reveal no adverse signs, symptoms, or mortality. No nanoparticle accumulation was observed in liver, spleen, and duodenum, with feces as the main excretion route. Liver iron level and duodenal villi morphology reflect the bioavailability of the iron released from the partial transformation of γ-Fe2O3 nanoparticles in the acid gastric environment. Duodenal gene expression studies related to the absorption of iron from γ-Fe2O3 nanoparticles indicate the enhancement of a ferric over ferrous pathway supporting the role of mucins. Our findings reveal that oral administration of iron oxide nanoparticles is a safe route for drug delivery at low nanoparticle doses.

A novel Real Time micro PCR based Point-of-Care device for Salmonella detection in human clinical samples.

Our POC (Point of Care) device is intended to be a diagnostic tool for routine use in the clinical sector. The validation of the whole procedure, including bacterial genomic DNA isolation and the Real Time detection of Salmonella spp., was conducted on 29 clinical stool samples that had been diagnosed with Salmonella spp. by a routine culture technique. The entire process was achieved in a single microfluidic chip within 35 min. In comparison to the culture reference method that is used in the clinical laboratories, this new device performed well in regards to the analytical parameters of sensitivity, specificity and accuracy. Therefore, the POC device reported in this study proved to be very appropriate for the fully integrated analysis system. To the best of our knowledge, this is the first work to report the sample preparation and followed by Real Time PCR (Polymerase Chain Reaction) on a single 2.5 µl chamber chip for the detection of Salmonella spp. bacteria in stool samples.

The SmartBioPhone, a point of care vision under development through two European projects: OPTOLABCARD and LABONFOIL.

This paper describes how sixteen partners from eight different countries across Europe are working together in two EU projects focused on the development of a point of care system. This system uses disposable Lab on a Chips (LOCs) that carry out the complete assay from sample preparation to result interpretation of raw samples. The LOC is either embedded in a flexible motherboard with the form of a smartcard (Labcard) or in a Skinpatch. The first project, OPTOLABCARD, extended and tested the use of a thick photoresit (SU-8) as a structural material to manufacture LOCs by lamination. This project produced several examples where SU-8 microfluidic circuitry revealed itself as a viable material for several applications, such as the integration on chip of a Polymerase Chain Reaction (PCR) that includes sample concentration, PCR amplification and optical detection of Salmonella spp. using clinical samples. The ongoing project, LABONFOIL, is using two results of OPTOLABCARD: the sample concentration method and the capability to fabricate flexible and ultra thin LOCs based on sheets instead of wafers. This rupture from the limited and expensive wafer surface heritage allows the development of a platform where LOCs are big enough to include all the sample preparation subcomponents at a low price. These LOCs will be used in four point of care applications: environment, food, cancer and drug monitoring. The user will obtain the results of the tests by connecting the Labcard/Skinpatch reader to a very popular interface (a smartphone), creating a new instrument namely "The SmartBioPhone". All standard smartphone capabilities will be at the disposal of the point of care instrument by a simple click. In order to guarantee the future mass production of these LOCs, the project will develop a large dry film equipment where LOCs will be fabricated at a low cost.