Design, implementation and usability analysis of patient empowerment in ADLIFE project via patient reported outcome measures and shared decision making.

INTRODUCTION: This paper outlines the design, implementation, and usability study results of the patient empowerment process for chronic disease management, using Patient Reported Outcome Measurements and Shared Decision-Making Processes. BACKGROUND: The ADLIFE project aims to develop innovative, digital health solutions to support personalized, integrated care for patients with severe long-term conditions such as Chronic Obstructive Pulmonary Disease, and/or Chronic Heart Failure. Successful long-term management of patients with chronic conditions requires active patient self-management and a proactive involvement of patients in their healthcare and treatment. This calls for a patient-provider partnership within an integrated system of collaborative care, supporting self-management, shared-decision making, collection of patient reported outcome measures, education, and follow-up. METHODS: ADLIFE follows an outcome-based and patient-centered approach where PROMs represent an especially valuable tool to evaluate the outcomes of the care delivered. We have selected 11 standardized PROMs for evaluating the most recent patients' clinical context, enabling the decision-making process, and personalized care planning. The ADLIFE project implements the "SHARE approach' for enabling shared decision-making via two digital platforms for healthcare professionals and patients. We have successfully integrated PROMs and shared decision-making processes into our digital toolbox, based on an international interoperability standard, namely HL7 FHIR. A usability study was conducted with 3 clinical sites with 20 users in total to gather feedback and to subsequently prioritize updates to the ADLIFE toolbox. RESULTS: User satisfaction is measured in the QUIS7 questionnaire on a 9-point scale in the following aspects: overall reaction, screen, terminology and tool feedback, learning, multimedia, training material and system capabilities. With all the average scores above 6 in all categories, most respondents have a positive reaction to the ADLIFE PEP platform and find it easy to use. We have identified shortcomings and have prioritized updates to the platform before clinical pilot studies are initiated. CONCLUSIONS: Having finalized design, implementation, and pre-deployment usability studies, and updated the tool based on further feedback, our patient empowerment mechanisms enabled via PROMs and shared decision-making processes are ready to be piloted in clinal settings. Clinical studies will be conducted based at six healthcare settings across Spain, UK, Germany, Denmark, and Israel.

Cost-utility analysis of the UPRIGHT intervention promoting resilience in adolescents.

BACKGROUND: As mental health in adulthood is related to mental status during adolescence, school-based interventions have been proposed to improve resilience. The objective of this study was to build a simulation model representing the natural history of mental disorders in childhood, adolescence and youth to estimate the cost-effectiveness of the UPRIGHT school-based intervention in promoting resilience and mental health in adolescence. METHODS: We built a discrete event simulation model fed with real-world data (cumulative incidence disaggregated into eight clusters) from the Basque Health Service database (609,381 individuals) to calculate utilities (quality-adjusted life years [QALYs]) and costs for the general population in two scenarios (base case and intervention). The model translated changes in the wellbeing of adolescents into different risks of mental illnesses for a time horizon of 30 years. RESULTS: The number of cases of anxiety was estimated to fall by 5,125 or 9,592 and those of depression by 1,269 and 2,165 if the effect of the intervention lasted 2 or 5 years respectively. From a healthcare system perspective, the intervention was cost-effective for all cases considered with incremental cost-utility ratios always lower than €10,000/QALY and dominant for some subgroups. The intervention was always dominant when including indirect and non-medical costs (societal perspective). CONCLUSIONS: Although the primary analysis of the trial did not did not detect significant differences, the UPRIGHT intervention promoting positive mental health was dominant in the economic evaluation from the societal perspective. Promoting resilience was more cost-effective in the most deprived group. Despite a lack of information about the spillover effect in some sectors, the economic evaluation framework developed principally for pharmacoeconomics can be applied to interventions to promote resilience in adolescents. As prevention of mental health disorders is even more necessary in the post-coronavirus disease-19 era, such evaluation is essential to assess whether investment in mental health promotion would be good value for money by avoiding costs for healthcare providers and other stakeholders.

Incidence of mental disorders in the general population aged 1-30 years disaggregated by gender and socioeconomic status.

PURPOSE: The objective of this study was to estimate the incidence and age of onset of mental disorders diagnosed by gender and socioeconomic status (SES) in children, adolescents, and young adults up to 30 years of age in the whole population of the Basque Country (Spain). METHODS: All mental health diagnoses documented in Basque Health Service records from 1 January 2003 to 31 December 2018, were classified into eight clusters: anxiety, attention deficit hyperactivity disorder (ADHD), conduct disorders, depression, psychosis/personality disorders, substance use, eating disorders, and self-harm. We calculated incidence and cumulative incidence for each cluster, disaggregated by gender, and socioeconomic status (SES). Poisson regression analyses were performed. RESULTS: Overall, 9,486,853 person-years of observation were available for the 609,281 individuals included. ADHD and conduct disorders were diagnosed in the first decade, anxiety and depression disorders in the second and third decades, and psychosis/personality and substance use in the third. The cumulative incidence at 18 years of age for any type of disorder was 15.5%. The group with low SES had a statistically significantly higher incidence of all eight clusters. The incidence of ADHD, conduct disorders, depression, psychosis/personality disorders, and substance use was higher in males and that of anxiety, eating disorders and self-harm was higher in females. CONCLUSIONS: The incidence of mental disorders is high among children, adolescents, and young adults in the Basque Country underlining the need for preventive interventions. Marked differences by gender and SES highlight mental health inequalities, especially for depression and psychosis in low SES males.

Incorporating Budget Impact Analysis in the Implementation of Complex Interventions: A Case of an Integrated Intervention for Multimorbid Patients within the CareWell Study.

OBJECTIVES: To develop a framework for the management of complex health care interventions within the Deming continuous improvement cycle and to test the framework in the case of an integrated intervention for multimorbid patients in the Basque Country within the CareWell project. METHODS: Statistical analysis alone, although necessary, may not always represent the practical significance of the intervention. Thus, to ascertain the true economic impact of the intervention, the statistical results can be integrated into the budget impact analysis. The intervention of the case study consisted of a comprehensive approach that integrated new provider roles and new technological infrastructure for multimorbid patients, with the aim of reducing patient decompensations by 10% over 5 years. The study period was 2012 to 2020. RESULTS: Given the aging of the general population, the conventional scenario predicts an increase of 21% in the health care budget for care of multimorbid patients during the study period. With a successful intervention, this figure should drop to 18%. The statistical analysis, however, showed no significant differences in costs either in primary care or in hospital care between 2012 and 2014. The real costs in 2014 were by far closer to those in the conventional scenario than to the reductions expected in the objective scenario. The present implementation should be reappraised, because the present expenditure did not move closer to the objective budget. CONCLUSIONS: This work demonstrates the capacity of budget impact analysis to enhance the implementation of complex interventions. Its integration in the context of the continuous improvement cycle is transferable to other contexts in which implementation depth and time are important.

Scaling-Out Digitally Enabled Integrated Care in Europe Through Good Practices Transfer: The JADECARE Study.

Introduction: The absence of a coordinated approach to health and social care compromises the ability of health systems to provide universal, equitable, high-quality, and financially sustainable care. Transferring evidence-based practices focused on digitally-enabled integrated care to new contexts can overcome this challenge if implementation is satisfactory. This paper presents the scaling-out methodology that JADECARE has designed to spread effective innovative practices across Europe. Methodology: The scaling-out methodology pretends to guide the Next Adopters in the transfer and adoption of practices, whereas increasing their implementation capacity and providing an evaluation framework to assess impact and success. Discussion: JADECARE scaling-out effort is based on guiding principles found in the literature such as the balance between fidelity to the original practice and the degree of adaptation required to fit the new context, the need for capacity building in implementation to bridge the gap between research and routine practice and the focus on explaining why, for whom and in what circumstances an intervention works. Conclusion: The JADECARE scaling-out methodology is theory-driven and pragmatic and aims to facilitate the transfer of complex interventions across different contexts.

Socioeconomic and gender inequalities in mental disorders among adolescents and young adults.

BACKGROUND: Socioeconomic status (SES) and gender play a key role in mental health. The objective of this study was to assess socioeconomic and gender mental health inequalities in adolescents and young adults using a population-based registry. MATERIALS AND METHODS: We conducted a lifetime follow-up study of all residents in the Basque Country between 1 and 30 years old (n=609,381) as of 31 December 2018. Primary care, specialized outpatient, and hospital care records were searched for diagnoses. SES was assessed based on household income. We estimated disaggregated lifetime prevalence of substance use, behaviour, anxiety, depression, psychosis, and attention deficit hyperactivity disorder. The local Institute of Statistics validated the mortality data. The likelihood of risks was estimated using logistic regression. RESULTS: Overall, 96,671 individuals (15.9%) had a diagnosed mental disorder, with clear gradients by gender and SES. Females of medium-to-high SES had the lowest prevalence of all mental disorders, except anxiety and depression. This group was followed by males of the same SES and females of low SES, while the highest prevalence of mental disorders was observed in low-SES males. The lower income categories had higher risks of psychiatric admission (adjusted odds ratio [AOR]: 3.64 for females; 6.66 for males) and death (AOR: 5.42). People with a mental health diagnosis had higher mortality (AOR: 2.38). CONCLUSIONS: Our work evidenced important SES and gender inequalities in the mental health and premature mortality of adolescents and young adults, findings that should drive the development and implementation of early preventive interventions.

Interoperability Architecture of the ADLIFE Patient Empowerment Platform.

Chronic diseases introduce challenges for the patients to manage the changing requirements of the disease. Patient empowerment activities are a critical component to assist patients in their long-term care journey. In order to be effective, patient empowerment tools need to be well-integrated with the chronic disease management tools used at the clinical sites. This paper explores and analyzes the exploitation of HL7 FHIR to design and implement an interoperable patient empowerment platform that can be seamlessly integrated with external chronic disease management and Electronic Health Record (EHR) systems.

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 of stratification on the effectiveness of a comprehensive patient-centered strategy for multimorbid patients.

OBJECTIVE: The objective of this work was to assess the effectiveness of a population-level patient-centered intervention for multimorbid patients based on risk stratification for case finding in 2014 compared with the baseline scenario in 2012. DATA SOURCE: Clinical and administrative databases. STUDY DESIGN: This was an observational cohort study with an intervention group and a historical control group. A propensity score by a genetic matching approach was used to minimize bias. Generalized linear models were used to analyze relationships among variables. DATA COLLECTION: We included all eligible patients at the beginning of the year and followed them until death or until the follow-up period concluded (end of the year). The control group (2012) totaled 3558 patients, and 4225 patients were in the intervention group (2014). PRINCIPAL FINDING: A patient-centered strategy based on risk stratification for case finding and the implementation of an integrated program based on new professional roles and an extensive infrastructure of information and communication technologies avoided 9 percent (OR: 0.91, CI: 0.86-0.96) of hospitalizations. However, this effect was not found in nonprioritized groups whose probability of hospitalization increased (OR: 1.19, CI = 1.09-1.30). CONCLUSIONS: In a before-and-after analysis using propensity score matching, a comprehensive, patient-centered, integrated care intervention was associated with a lower risk of hospital admission among prioritized patients, but not among patients who were not prioritized to receive the intervention.

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.