Baltaxe et al. BMC Health Services Research (2019) 19:370 https://doi.org/10.1186/s12913-019-4174-2 STUDY PROTOCOL Open Access Evaluation of integrated care services in Catalonia: population-based and service- based real-life deployment protocols Erik Baltaxe1,2*, Isaac Cano1,2, Carmen Herranz1,3, Anael Barberan-Garcia1,2, Carme Hernandez1,2, Albert Alonso1,2, María José Arguis1,2, Cristina Bescos4, Felip Burgos1,2, Montserrat Cleries5, Joan Carles Contel6, Jordi de Batlle7,2, Kamrul Islam8, Rachelle Kaye9, Maarten Lahr10, Graciela Martinez-Palli1,2, Felip Miralles11, Montserrat Moharra12, David Monterde13, Jordi Piera14, José Ríos15,16, Nuria Rodriguez12, Reut Ron9, Maureen Rutten-van Mölken17,18, Tomas Salas12, Sebastià Santaeugenia6,19, Helen Schonenberg4, Oscar Solans6, Gerard Torres7,2, Eloisa Vargiu11, Emili Vela5 and Josep Roca1,2* Abstract Background: Comprehensive assessment of integrated care deployment constitutes a major challenge to ensure quality, sustainability and transferability of both healthcare policies and services in the transition toward a coordinated service delivery scenario. To this end, the manuscript articulates four different protocols aiming at assessing large-scale implementation of integrated care, which are being developed within the umbrella of the regional project Nextcare (2016–2019), undertaken to foster innovation in technologically-supported services for chronic multimorbid patients in Catalonia (ES) (7.5 M inhabitants). Whereas one of the assessment protocols is designed to evaluate population-based deployment of care coordination at regional level during the period 2011–2017, the other three are service-based protocols addressing: i) Home hospitalization; ii) Prehabilitation for major surgery; and, iii) Community-based interventions for frail elderly chronic patients. All three services have demonstrated efficacy and potential for health value generation. They reflect different implementation maturity levels. While full coverage of the entire urban health district of Barcelona- Esquerra (520 k inhabitants) is the main aim of home hospitalization, demonstration of sustainability at Hospital Clinic of Barcelona constitutes the core goal of the prehabilitation service. Likewise, full coverage of integrated care services addressed to frail chronic patients is aimed at the city of Badalona (216 k inhabitants). Methods: The population-based analysis, as well as the three service-based protocols, follow observational and experimental study designs using a non-randomized intervention group (integrated care) compared with a control group (usual care) with a propensity score matching method. Evaluation of cost-effectiveness of the interventions using a Quadruple aim approach is a central outcome in all protocols. Moreover, multi-criteria decision analysis is explored as an innovative method for health delivery assessment. The following additional dimensions will also be addressed: i) Determinants of sustainability and scalability of the services; ii) Assessment of the technological support; iii) Enhanced health risk assessment; and, iv) Factors modulating service transferability. (Continued on next page) * Correspondence: baltaxe@clinic.cat; jroca@clinic.cat 1 Hospital Clinic de Barcelona, Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Universitat de Barcelona, Barcelona, Spain Full list of author information is available at the end of the article © The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 2 of 11 (Continued from previous page) Discussion: The current study offers a unique opportunity to undertake a comprehensive assessment of integrated care fostering deployment of services at regional level. The study outcomes will contribute refining service workflows, improving health risk assessment and generating recommendations for service selection. Trials registration: NCT03130283 (date released 04/06/2018), NCT03768050 (date released 12/05/2018), NCT03767387 (date released 12/05/2018). Keywords: Chronic patients, Integrated care services, Multimorbidity, Service transferability, Home hospitalization, Prehabilitation, Digital tools, Implementation science, Risk assessment, Multi-criteria decision analysis Background contributed to the generation of a series of general rec- Core elements of integrated care (IC) are connectivity, ommendations on evaluation of IC with focus on service alignment and collaboration within and between the transferability across geographical sites aimed at foster- cure and care sectors. The goal is to enhance quality of ing regional scalability [4, 10]. It is of note, however, that care and quality of life, consumer satisfaction and system application of these recommendations for a comprehen- efficiency for patients suffering from chronic disorders, sive assessment of deployment of IC services in real-life that need multiple services, providers and settings in scenarios is clearly an unmet need. different levels of care [1–3]. Useful approaches [4] have The current manuscript aims to describe a structured identified two main systemic levels (i.e. horizontal and evaluation framework (Fig. 1) that articulates four com- vertical) at which integration of health and social care prehensive assessment protocols covering both vertical sectors can occur. Horizontal integration links community- and horizontal levels of integration. One assessment based services while vertical integration brings together protocol reports a population-based assessment of out- specialized and primary care under one functional (or comes from past and current Catalan Health Plans, structural) management umbrella through shared care 2011–2015 [11] and 2016–2020 [12], respectively, agreements framed into well-defined service workflows. whereas the other three assessment protocols address Since early 2000’s, large scale implementation of IC is the deployment of specific IC services during the period being strongly promoted by relevant international agen- 2017–2018, namely: i) Home hospitalization [13]; ii) Pre- cies and governments [5, 6] because of its high potential habilitation of candidates for major surgery [14]; and, iii) to effectively address the healthcare and societal chal- Community-based advanced care service for frail elderly lenges generated by population ageing and unhealthy [15, 16]. The ultimate aim of the research is to explore lifestyles. However, several aspects implicit in the transi- the application of innovative evaluation strategies [4] for tion towards real care coordination scenarios, must be IC services deployed in real-life settings. To this end, a taken into account and properly solved to ensure adop- comprehensive evaluation of outcomes following a Quad- tion. First, since IC services are applied to complex ruple Aim approach [17, 18], deployment strategies and patients and in evolving settings, the need for flexible maturity of implementation will be performed within each standardization of the interventions, as well as changes of the four assessment protocols of the study. in the roles of patients and health professionals is a The Catalan Health Care System dispenses services for must. Second, the coordination between several stake- 7.5 inhabitants, providing universal coverage through a holders and/or healthcare tiers often requires profound tax-based system. Administratively, it is composed by a organizational adaptations which, in turn, involve the single public payer and multiple service providers pub- need for novel business models and reimbursement licly or privately owned. Since 2006, the implementation incentives to drive management change. Last but not of IC services in one of the four healthcare sectors in least, quickly evolving digital technologies are facilitating the city of Barcelona (520 k inhabitants) was instituted coordination and personalization of care, as well as com- by the Hospital Clinic of Barcelona (HCB), a tertiary plex data management, but extensive adoption of digital university hospital [19], adopting the Chronic Care health supporting IC needs to be accelerated. Model as the conceptual reference [20, 21]. Moreover, All of the above factors contribute to explain the diffi- the subsequent Health Plans for Catalonia after 2011, culties encountered in the process of standardization of have addressed the deployment challenges by giving pri- IC assessment. Over the past several years, evaluation of ority to new modalities of healthcare delivery for chronic well-established IC programs, alongside pilot experi- patient care including empowerment of patients and ences, has been undertaken in several countries with carers. To date, clear examples of clinical effectiveness mixed results [7–9]. Overall, these experiences have have been produced for the three IC services presented Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 3 of 11 Fig. 1 The figure depicts the main elements of the structured evaluation framework that articulates the four assessment protocols described in the current report. The proposed comprehensive assessment of integrated care services includes their impact at population level. A core component of the assessment protocols includes the identification of Key Performance Indicators (KPI) useful for long-term follow-up of health services after adoption encompassing three dimensions: health outcomes, processes and structure in this report: Home hospitalization [13, 22, 23], preha- those same outcomes allowing standardized comparisons bilitation [14] and community-based services for frail between seemingly dissimilar IC programmes. Moreover, patients [9]. It is expected that lessons learned from the engagement of health professionals, the fourth pillar of implementation of the four protocols reported in the the Quadruple Aim approach, will be assessed using the current manuscript will foster regional scalability and questionnaires currently applied in [34], aiming at asses- sustainability of IC services in Catalonia. Moreover, it is sing main drivers of large-scale deployment of IC also expected that the recommendations generated by services in 5 European regions. these deployments in real-life settings will significantly The current assessment protocols also aim to separately contribute to facilitate transferability and comparability establish key factors that modulate the success of IC ser- of IC services at international level. The context in vice deployments in order to identify their potential for which these four assessment protocols will take place is transferability to other sites. To this end, we will use described in [11] and [19]. standard implementation science tools [28, 29, 35, 36] to answer the questions delineated in the third column of Methods Table 2, as well as to report the results of the implementa- The four protocols (Table 1) follow observational and tion process following standards for reporting implemen- experimental non-randomized study designs. In all cases, tation studies (StaRI) [28]. This will allow us to identify comparability between the intervention group and the facilitators, barriers, solutions and critical success factors control group will be achieved using a propensity score during the course of the implementation process with matching (PSM) [24, 25] method, as described in detail relevant implications for analysis of service transferability. below. The common methodology for assessing health- It must be highlighted that collaborative tools and meth- value generation of the interventions in each protocol odologies were applied for the implementation of the will follow a Quadruple Aim approach [17, 18] consider- three service-oriented studies. The process incorporates ing pre-defined variables for: i) Health and well-being; ii) co-design elements, with participation of different stake- Experience with care; iii) Operational costs; and, iv) holders, including patients, following a Plan-Do-Study- Health professionals’ engagement, as summarized in the Act (PDSA) iterative cycles approach [37] adapted to the second column of Table 2. It is of note that the characteristics of each assessment protocol, as summa- outcomes of the three first dimensions (Triple Aim rized below. Last, but not least, the maturity of the ecosys- approach) [26, 27, 30] will be assessed both separately tem in which the service is being deployed will be and jointly. The later will consist of a multi-criteria deci- assessed following the twelve-dimension measurement sion analysis (MCDA) recently developed [31, 32] and protocol described in [4] and summarized in the fourth currently applied in 17 selected IC programs from 8 column of Table 2. European countries [33]. The MCDA approach broadens It is assumed that the three assessment categories the scope of the evaluation taking into account patient depicted in Fig. 1 and in Table 2: i) Outcomes, ii) De- health reported outcomes and stakeholders’ views on ployment strategies, and, iii) Maturity level, will provide Table 1 Main characteristics of the four assessment protocols Protocol Aims Study design & Intervention group Comparator group Expected outputs Measurements (1) Population- (1.1) Impact of (1.1) Case control study (1.1 and 1.2) Residents living in the (1.1 and 1.2) Residents living in the other 3 (1.1a) Health value generation of based study integrated care on matching registry data healthcare district of Barcelona-Esquerra healthcare districts of Barcelona (~ 400 k integrated care cost-effectiveness using PSM methods (n = 516 K inhabitants) inhabitants each), as well as the entire (2011–2017) (Additional region of Catalonia (n = 7.5 M inhabitants) file 1: Table S1) (1.2) Enhanced health (1.2) Fixed cohort study (1.1b) Enhanced Key Performance risk assessment and Indicators (KPI) for long-term service selection assessment of integrated care (1.2) Proposal for health risk Baltaxe et al. BMC Health Services Research assessment for service selection (2) Home (2.1) Assessment of (2.1) Prospective controlled (2.1) All patients admitted to the home (2.1) Patients admitted to conventional (2.1a) Health value generation of hospitalization hospital avoidance and cohort study using PSM hospitalization directly from the emergency hospitalization directly from the emergency the service; expanded HDA using early hospital discharge methods (2017–2018) room (n = 800 patients). Study of a deeply department of the same hospital (n = 800 MCDA (n = 200). Factors at district level (Additional file 2: Table S2) characterized subset (triple aim approach) patients). Study of a deeply characterized modulating success of the of 200 patients. This subset will be used to subset (triple aim approach) of 200 patients. implementation strategy. (2019) 19:370 (2.2) Recommendations (2.2) Observational mixed- generate (2.2). This subset will be used to generate (2.2). for shared-care agree methods study combining (2.1b) KPI for service assessment ments between network and cluster specialized and analyses with qualitative (2.2) Strategies for enhanced interactions between specialized- community-based care methodologies community-based care. (3) (3.1) Sustainability (3.1) Prospective controlled (3.1) All candidates for major surgery at (3.1) Candidates for major surgery at HCB (3.1a) Health value generation of Prehabilitation (cost-effectiveness of cohort study using PSM HCB receiving prehabilitation (n = 500) receiving usual care in the same hospital prehabilitation at HCB prehabilitation at HCB methods (2016–2018) (n = 250) (Additional file 3: Table S3) (3.2) Recommendations (3.2) Randomized (3.2) Candidates for major surgery at HCB (3.1b) KPI for service assessment for transition toward a controlled trial to assess receiving peri-operative care (n = 60) regional peri-operative peri-operative care care program (3.3) Enhanced (3.3) Fixed cohort study (3.3) All surgical patients in the last 5 years (3.2) Candidates for major surgery at HCB (3.2) Cost-effectiveness of peri- pre-operative risk at HCB receiving usual care (n = 60) operative care and strategies assessment for regional deployment. (3.3) Risk assessment tool for personalized prehabilitation (4) Frail elderly (4.1) Assessment of (4.1) Prospective controlled (4.1) Individuals enrolled in BSA integrated care (4.1) Individuals living in Badalona receiving (4.1a) Cost-effectiveness of the patients community-based cohort study using PSM programs for frail elderly that includes: i) Early usual care: i) After hospital discharge service; and, expanded HDA integrated care services methods (2018) Discharge support (n = 144); ii) Long-term (n = 144), ii) At home (n = 566); and, iii) using MCDA (n = 250). Factors for frail patients at BSA (Additional file 4: Table S4) home-based support services (n = 566) and iii) Living at geriatric residences (n = 920) modulating success of the Geriatric residences care (n = 920) implementation strategy. (4.1b) KPI for service assessment Abbreviations: HDA Health Delivery Assessment, MCDA Multi-Criteria Decision Analysis, HCB Hospital Clinic de Barcelona, PSM Propensity Score Matching, KPI Key Performance Indicators for service long-term assessment after the deployment phase, BSA Badalona Serveis Asssistencials Page 4 of 11 Table 2 Three main assessment dimensions: effects of the intervention, determinants of success of implementation and maturity of integration Study Protocol Outcomes of the intervention [26, 27] Deployment strategies [28, 29] Maturity level [4] (1) Population- Mortality, general practitioner visits, community-nurse visits, A. What are the possible factors Assessment of the twelve dimensions of the based cumulative days per year admitted in hospital, emergency and agents responsible for good Maturity Model for Integrated Care, both at health department visits, all hospital admissions, potentially avoidable implementation of a health system and health services levels, promoted by the hospitalizations, multiple drug prescription, needs for social intervention? European Innovation Partnership for Active Baltaxe et al. BMC Health Services Research support, costs per patient per year (Additional file 1: Table S1) B. What are the possible factors and Healthy Ageing, following the instructions for enhancing or expanding reported in reference (4). These twelve (2) Home Health Mortality rate 30/90 days after discharge, place a given health intervention? dimensions are: hospitalization and well-being of death, avoidable hospital admissions, total C. What describes the context in 1. Readiness to Change bed days, 12 months before admission (hospital which implementation occurs? 2. Structure & Governance and community resources); 30-day after discharge D. What describes the main factors 3. Information & eHealth Services (hospital and community resources), transitional influencing implementation in a 4.Standardization& Simplification (2019) 19:370 care strategies (palliative care, primary care or given context? 5. Finance & Funding hospital care) To be assessed using a mixed methods 6. Removal of Inhibitors Patient Person centeredness, continuity of care (Additional file 2: approach: combining qualitative and 7. Population Approach experience Table S2) quantitative methods 8. Citizen Empowerment 9. Evaluation Methods Costs Operational costs 10. Breadth of Ambition (3) Health and Cumulative hospital days of stay, intensive care unit length 11. Innovation Management Prehabilitation well-being of stay, number of complications per patient, costs from the 12. Capacity Building perspective of the hospital including inpatient services, diagnostic procedures, pharmaceutical consumption and blood products consumption, aerobic capacity, physical activity, psychological status, health status (Additional file 3: Table S3) Costs Operational costs (4) Frail elderly Health and Mortality rate, avoidable hospital admissions, total bed days, 30-day well-being readmissions, number of ER visits in the month, physical functioning, psychological well-being, social relationships & participation, enjoyment of life, resilience, autonomy Patient Person centeredness, continuity of care, burden of medication, experience burden of informal caregiving (Additional file 4: Table S4) Costs Operational costs Page 5 of 11 Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 6 of 11 the basis for identification of general, and service- 2011. The information is updated every 6 months. It specific, key performance indicators (KPI) useful for provides a basis for cost analyses of the use of healthcare long-term follow-up of IC services after the initial de- resources, pharmacy consumption, and prevalence of ployment period, taking into account outcomes, pro- key health problems. The CHSS feeds the regional cesses and structure [38]. population-based risk stratification tool named Adjusted The assessment protocols will combine three different Morbidity Groups (GMA) that complies with the follow- data sources. First, registry data obtained from the ing characteristics: i) A population health approach; ii) Catalan Health Surveillance System (CHSS) [16, 39, 40], No licensing constraints; iii) Open source computational as briefly described below. Second, individual data ex- algorithms; and, iv) The adjusted morbidity grouper re- tracted from the electronic healthcare records from pri- lies mostly on statistical criteria, as opposed to other mary care and specialized care. Third, data derived from tools that include expert-based coefficients, thus facili- prospectively applied standardized questionnaires to pa- tating quick transferability to other territories [39, 42]. tients, health professionals and managers (Additional file 1: Table S1, Additional file 2: Table S2, Additional file 3: Table S3 and Additional file 4: Table S4). The challenges Assessment protocols involved in the combination of different datasets used in Assessment protocol 1: population-based analysis these four assessment protocols have been overcome This protocol will take into consideration the entire within the framework of the recent EU General Data population of healthcare users in Catalonia. The health Protection Regulation (GDPR) [41]. system in Catalonia (7.5 M inhabitants) has three organ- The CHSS includes updated registries from primary isational levels, with the seven health regions at the top care, hospital-related events (e.g. hospitalization, emer- level (Fig. 2). Each region includes several geographical gency room and specialized outpatient visits), pharmacy, areas called health districts, second level, covering both mental health, socio-sanitary services, respiratory ther- specialised and primary care needs of the population. apies, dialysis, outpatient rehabilitation and non-urgent The third level corresponds to clusters of primary care transport of all citizens living in Catalonia (7.5 M) since centres within each healthcare district. The region has a Fig. 2 The figure displays the seven health regions of Catalonia. The urban area of Barcelona (1.8 million citizens) has four health districts. The South-Eastern healthcare sector of the Barcelona city, which encompasses 520 k inhabitants, is Barcelona-Esquerra (AISBE). Taken from the Catalan Health Service (CatSalut) website. https://catsalut.gencat.cat/ca/coneix-catsalut/transparencia/territori/informacio-cartografica/mapes/ This is a public access image. Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 7 of 11 total of 369 primary care units covering approximately from HCB during a one-year period (October 2017–Oc- 20 k citizens, on average, each of them. tober 2018) (n = 1146), approximately 70% of the Integration of health and social services in the entire patients were admitted to HH directly from the emer- Catalonia is being promoted under the umbrella of the gency room. A subset of the patients admitted to HH five-year regional health plans. Key goals in terms of de- directly from the emergency room throughout the study ployment of the integrated model were established dur- period will be assessed separately (n = 200). ing the 2011–2015 Plan [11] and consolidation of the The characteristics of the intervention have recently program is expected during the 2016–2020 period [12]. been described by Hernandez et al. [13] in terms of im- The Integrated Health District in Barcelona-Esquerra plementation strategy, outcomes and costs during the (AISBE) (n = 520 k inhabitants) [19] is the intervention deployment of the service in a real-life setting during the district and includes HCB as reference centre, two gen- years 2006–2015. During the period 2017–2018, the eral hospitals and 19 primary care centres run by differ- programme was expanded to 48 beds per day to cover ent healthcare providers. Since mid-2000s, AISBE has the entire AISBE health district. deployed, and continuously developed, IC services for The principal objective of this protocol is to assess chronic patients across healthcare tiers [9, 19]. Deploy- hospital avoidance and early hospital discharge at health ment of IC services in AISBE is based on the hypothesis district level. Moreover, the approach aims to generate that an appropriate transfer of selected care complexities recommendations for shared-care agreements between from hospital-based to community-based care, within an specialized and community-based care after discharge to IC scenario, can increase healthcare value generation ensure safe transitional care strategies. both at provider and at health system levels. The main The assessment protocol will consist of a prospective characteristics and achievements of technologically- controlled cohort study wherein patients admitted to supported IC services evaluated and adopted in AISBE HH directly from the emergency room (intervention) have been reported elsewhere [8, 9, 14, 16, 19, 43]. (n = 800) will be compared with conventional hospital- The main objective of this assessment protocol is the isation (control) (n = 800). The control group will in- analysis of health-value generation of IC in Catalonia clude patients admitted to conventional hospitalization (Table 1). An ancillary aim is to enhance health risk directly from the emergency room of the same hos- assessment for clinical purposes and service selection, pital (HCB). PSM will be used for comparability pur- taking into account the population-based risk assess- poses using age, sex, GMA, socioeconomic status, ment tool, (i.e. GMA), as reported in [39]. For the prin- number of hospitalisations during the previous year cipal objective, health-related outcomes in AISBE will be and polypharmacy as matching variables. As described compared using a case-control design with three other above, a sub-group of 200 consecutive patients re- healthcare districts of the city of Barcelona (approxi- cruited on a voluntary basis, admitted through the mately 400 k inhabitants each), and the entire region emergency department during the study period, from (7.5 M inhabitants), considered as control areas. A PSM each arm (HH and conventional hospitalization) will method will used for comparability purposes using age, be also thoroughly characterized using a set of stan- sex, health-risk grading based on GMA [39, 42], and dardized questionnaires [26, 27, 30], as depicted in socioeconomic status as matching variables. Compari- Tables 2 and Additional file 2: Table S2. It is of note sons between intervention and controls will be done on that these two well defined sub-groups of 200 patients a yearly basis for the period 2011–2017. Key specific each (n = 400) will also constitute a single fixed cohort aspects of the assessment protocol are summarized in for later analysis on the interactions between special- Additional file 1: Table S1. ized and community-based care using network and Health risk assessment and service selection will cluster analyses alongside qualitative methodologies. address enrichment of the predictive role of standard clinical information using population-based health risk Assessment protocol 3: Prehabilitation service assessment (GMA grading) and patient self-tracked in- This is a preventive intervention targeted at high risk formation obtained through the regional personal health candidates for major surgical procedures carried out pre- folder in Catalonia (La Meva Salut). Evaluation of result- operatively aiming at reducing complications and enhan- ing clinical predictive modelling (Table 1) will be based cing postoperative recovery. It combines: i) Motivational on fixed cohort study designs with 1 year follow-up, as interviewing; ii) High-intensity endurance exercise train- already reported in [40]. ing; iii) Promotion of physical activity; iv) Nutritional supplementation; and; v) Psychological support. Assessment protocol 2: home hospitalization (HH) The intervention is currently deployed as a main- The intervention group to be analysed will include all stream service at HCB in several types of major surger- the patients admitted to HH and early discharge service ies. During fall 2017, three multidisciplinary workshops Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 8 of 11 using a design-thinking approach were carried out to The study protocol will consist of a prospective controlled refine the service workflow and to explore the potential cohort study wherein each intervention group will be com- for service scalability. The outcomes of the co-design pared with the corresponding usual care group (controls, 1: process provided a robust background for the design of 1 ratio) (n = 1630 in each arm), using propensity score a future personalized perioperative care service at matching. Age, sex, GMA, socioeconomic status, number regional level covering three phases: prehabilitation, in- of hospitalisations during the previous year and polyphar- patient care, and post-discharge rehabilitation. macy will be used as matching variables. The patients from The current assessment protocol aims to assess cost- the usual care group will be recruited during the study effectiveness of prehabilitation as a mainstream service period in the same area. A subset of 250 patients from in the ongoing deployment at HCB, as well as to gener- each control and intervention groups will be thoroughly ate a roadmap for regional scalability of the service. It is characterized using a set of standardized questionnaires planned as a prospective controlled cohort study includ- [26, 27, 30], as depicted in Additional file 4; Table S4. ing 500 consecutive patients undertaking prehabilitation, as the intervention group, and patients following stand- Additional elements toward enhancement of IC services ard care before surgery, in the same hospital (i.e. HCB), All four assessment protocols will also integrate the as the control group (2:1 intervention to control ratio). following dimensions described below. The patients will be included from the following type of surgeries: major digestive surgery (n = 525), lung volume Enhanced risk assessment & service selection reduction (n = 30), radical cystectomy (n = 30), major The 2011–2015 Catalan Health Plan extensively imple- cardiovascular surgery (n = 165). Study groups will be mented a case finding system classifying high risk made comparable using PSM with the following match- chronic patients into two different categories based on ing variables: type of surgery, age, sex, American Society defined criteria and primary care physician judgement: i) of Anaesthesiologists index and GMA grading. Patients’ Complex chronic patients (CCP, approximately 3% of clinical outcomes will be assessed at baseline, pre- the population); and, ii) Patients with less than 12 surgery and 30 days after surgery. The primary outcome months expected life survival (Advanced Care Disease, will be cost-effectiveness, meaning reduced hospital stay ACD, approximately 1% of the population). The latter and early re-admissions. Secondary outcome variables will category of patients consists of citizens with advanced include number of complications per patient, healthcare chronic diseases and/or with oncological problems being use, aerobic capacity, physical activity and psychological potential candidates for palliative care. and health status. The specificities of the assessment Since 2015, the population-based risk stratification protocol are summarized in Additional file 3: Table S3. tool (i.e. GMA) primarily used for health policy pur- poses, has been extensively implemented in primary Assessment protocol 4: community-based care for the frail care. The clinical workstation currently displays the elderly GMA grading of the patient being attended by the The assessment protocol will evaluate three types of spe- health professionals, without specific connections with cific interventions during the period from 1st January to the patient’s care plan. The current assessment protocols 31th December 2018: i) Early discharge service (n = 144) offer an opportunity to explore enhanced clinical risk which includes acute patients admitted to the medical assessment modalities aiming at facilitating preventive and/or surgical hospital wards and promptly discharged strategies, improving service selection and providing to receive home-based post-acute care and/or rehabilita- clinical decision support. To this end, the assessment tion; ii) Home-based Case Management service (n = 566) protocols will elaborate and evaluate novel approaches which includes complex chronic patients or patients re- to health risk assessment following the orientations ceiving long-term care by a case management nurse; described in [39, 40, 42]. and, iii) Geriatric residences service (n = 920) will in- clude patients receiving acute support, post-acute or Assessment of technological support continued care for elderly people living in geriatric resi- The three service-oriented assessment protocols will dences. It will be conducted by Badalona Serveis Assis- assess acceptability, usability and value generation of tencials (BSA), an IC service provider located in the city digital tools supporting the different services with focus of Badalona (216 K inhabitants) in the North-Eastern on personal health systems, and collaborative adaptive part of the Barcelona Metropolitan Area. case management (ACM). Since these key supporting The current assessment protocol, summarized in technologies are required to be integrated with provider- Additional file 4: Table S4, aims to assess cost-effectiveness specific and regional health information systems for a of these three interventions for frail patients, as well as to large-scale implementation in the region (i.e., Catalonia), generate a roadmap for regional scalability of the service. the protocols will be built upon the regional digital Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 9 of 11 health framework [44] (Additional file 5: Figure S1). assess implementation of IC services, as indicated Table Specifically, two personal health systems for patient self- 2, third column. management at community level are being tested: i) MyPathway® (http://mypathway.healthcare); and, ii) CONNECARE Self-Management System (SMS) [45]. Discussion The former is a secure digital communications channel The current document provides the core information on connecting patients to clinicians and services. It is a a framework applicable for the evaluation of large-scale browser and app-based commercial application to use deployment of IC services in Catalonia. The approach on phones, tablets and PCs. The SMS is a prototype relies on the use of assessment of shared interventions, application to use on smartphones that allow patients’ within well-defined service workflows, that have been self-tracking, monitoring by health care professionals previously tested in terms of efficacy and potential for and bi-directional messaging to improve the patients’ value generation. The three assessment categories treatment and encourage them in following it. depicted in Table 2: i) Value generation of IC services The assessment protocols also consider ACM as key following standard and novel approaches, i.e. MCDA; ii) supporting technology [46–48] to enhance collaborative Deployment strategies; and, iii) Maturity level of the eco- work among health professionals and patients them- system for implementation will provide the basis for a selves (actively participating in his/her healthcare via the comprehensive evaluation of IC and should contribute above personal health systems). To this end, an ACM to the identification of KPIs useful for long-term follow- process based on the Camunda® open-source platform up after IC service adoption (Fig. 1). (https://camunda.org) was selected to support process Observational and experimental non-randomized con- workflow specification, case management and decision trolled cohort study designs using PSM have been automation. The ACM process engine is aimed at pro- adopted, instead of randomized controlled trials, as a viding the required process engine functionality to pragmatic option to assess events in a real-life setting current hospital information systems. [52, 53] The assessment protocols also take into account Acceptability (by means of 3 Likert scales alongside a the role of digital health as enabling tools supporting dif- net promoter score) [49] and usability (by means of the ferent strategic aspects of care coordination, namely: ser- System Usability Scale - SUS) [50] of MyPathway® and/ vice scalability, service evaluation and personalization or SMS will be assessed by patients (at patient discharge through enhanced service selection, as described in [39]. from the protocols), and of ACM process engine (i.e. We believe that the current regional context in Catalo- Camunda®) by healthcare professionals. Moreover, as- nia facilitates full alignment between the Catalan Health sessment of consolidated implementation of the digital Plan 2016–2020 [12] and the ongoing Nextcare program health tools supporting each of the four assessment pro- [54] aiming at fostering innovation of digitally-supported tocols will be done using the mini-MAST tool [51] healthcare services for chronic patients with multimor- (Additional file 6: Annex S1). bid conditions. It is of note that Nextcare acts as an umbrella program wherein three EU projects with simi- lar timeframes converge covering complementary facets Co-design activities of IC implementation, namely: i) CONNECARE [45], Deployment of the Catalan Health Plans involves a addressing enhanced digital support of IC services; ii) highly structured co-design system ensuring follow-up SELFIE [33], exploring novel modalities of health deliv- and continuous improvement of the different implemen- ery assessment like multi-criteria decision analysis; and, tation initiatives. Likewise, the deployment of IC within iii) ACT@Scale [34], analysing key factors that modulate AISBE has a well-defined structure of committees at dif- large scale deployment of IC services. All in all, the sce- ferent levels ensuring refinement of the implementation nario described facilitates the progressive expansion of the processes, as described in detail in [19]. Moreover, two results of the assessment protocols to analyses of other IC of the EU projects supporting the current assessment services (i.e. non-invasive home-based ventilation, cardio- protocols [34, 45] have built-in co-design protocols ap- pulmonary rehabilitation of chronic patients, etc.) and to plying collaborative tools and methodologies following a distinct healthcare districts toward achievement of effect- PDSA (Plan, Do, Study, Act) approach [37]. The PDSA ive full regional deployment of care coordination. cycles are a systematic series of steps for gaining valu- Real-life assessment of IC services using the proposed able learning and knowledge for the continual improve- implementation research methodologies will contribute ment of a product or process. All in all, the different to quantify health value generation of care coordination. levels of co-design activities alluded to above provide in- The approach should also contribute to generating rec- formation for undertaking a mixed-methods approach ommendations for transferability of the services facilitat- combining quantitative and qualitative methodologies to ing outcomes comparability across sites. Baltaxe et al. BMC Health Services Research (2019) 19:370 Page 10 of 11 Additional files Biomedical Network Research in Respiratory Diseases (CIBERES), Madrid, Spain. 3CAPSBE. Consorci d’Atenció Primaria de Salut. Barcelona Esquerra, Barcelona, Spain. 4Royal Philips Netherlands BV acting through Philips Additional file 1: Table S1. Population-based protocol. (DOCX 26 kb) Homecare, Boeblingen, Germany. 5Area d’Atenció Sanitària, Servei Català de Additional file 2: Table S2. Home Hospitalization protocol. (DOCX 35 kb) la Salut, Barcelona, Catalonia, Spain. 6Chronic Care Program. Ministry of Additional file 3: Table S3. Prehabilitation protocol. (DOCX 28 kb) Health, Generalitat de Catalunya, Barcelona, Catalonia, Spain. 7Respiratory Department, Institut de Recerca Biomedica (IRBLeida), Lleida, Spain. Additional file 4: Table S4. Three interventions addressed to frail 8 Department of Economics, University of Bergen, Bergen, Norway. 9Assuta complex chronic patients. (DOCX 35 kb) Medical Centers, Tel Aviv-Yafo, Israel. 10Department of Epidemiology, Additional file 5: Figure S1- Digital health framework in Catalonia (IS3). University of Groningen, University Medical Center Groningen, Groningen, (DOCX 75 kb) the Netherlands. 11Eurecat. Technological Center of Catalonia, Barcelona, Additional file 6: Annex 1 - Method for ASsessment of Telemedicine Catalunya, Spain. 12Agència de Qualitat i Avaluació Sanitàries de Catalunya (mini-MAST). (DOCX 22 kb) (AQuAS), Barcelona, Catalonia, Spain. 13Institut Català de la Salut, Serveis Centrals, Barcelona, Catalonia, Spain. 14Badalona Serveis Assistencials (BSA), Badalona, Catalonia, Spain. 15Medical Statistics Core Facility, Institut Abbreviations d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) and Hospital ACD: Advanced care disease; ACM: Adaptive case management; AISBE: The Clinic, Barcelona, Spain. 16Biostatistics Unit, Faculty of Medicine, Universitat Integrated Health District in Barcelona-Esquerra; BSA: Badalona Serveis Autònoma de Barcelona, Barcelona, Spain. 17School of Health Policy and Assistencials; CCP: Complex chronic patients; CHSS: Catalan Health Management, Erasmus University Rotterdam, Rotterdam, the Netherlands. Surveillance System; GDPR: General data protection regulation; 18 Institute for Medical Technology Assessment, Erasmus University GMA: Adjusted morbidity groups; HCB: Hospital Clinic of Barcelona; Rotterdam, Rotterdam, the Netherlands. 19Central Catalonia Chronicity HDA: Health delivery assesment; IC: integrated care; KPI: Key performance Research Group (C3RG), University of Vic – Central University of Catalonia, indicator; MCDA: multi-criteria decision analysis; PDSA: Plan-Do-Study-Act; 08500 Vic, Spain. PSM: Propensity score matching; SMS: Self-managemet system; StaRI: Standards for reporting implementation studies Received: 20 February 2019 Accepted: 20 May 2019 Acknowledgments We gratefully acknowledge all the Catalonian teams participating in the several protocols presented in the paper, including those working in the References Hospital Clinic in Barcelona, BSA in Badalona, AQuAS, CatSalut, ICS and 1. Spreeuwenberg C, Kodner DL. Integrated care: meaning, logic, appplications Eurecat. Also, we would like to thank all the consortia members of the and implications - a discussion paper. Int J Integr Care. 2002;2:1–6. different EU projects: SELFIE, CONNECARE and ACT@Scale, contributing to 2. Lewis R, Rosen R, Godwin N, Dixon J. Where next for integrated care the current initiative. organisations in the English NHS? London: The Nuffield Trust; 2010. 3. Goodwin N, Alonso A. Understanding integrated care: the role of Authors’ contributions information and communication technology. In: Meyer I, Muller S, All authors have read and approved the manuscript. EB, JR2, IC, AB-G, CH1, Kubitschke L, editors. Achieving effective integrated e-care beyond the silos. CH2 and FB developed the comprehensive framework for IC evaluation and IGI Global; 2014. p. 63–88. drafted this paper. AA, M-JA, CB, MC, J-CC, JdB, KI, RK, ML, GM-P, FM, MM, 4. Expert Group on Health Systems Performance Assessment. Blocks - tools DM, JP, JR1, NR, RR, MRvM, TS, SS, HS, OS, GT, EV1 and EV2 critically reviewed and methodologies to assess integrated care in Europe. 2017. Available and generated relevant inputs to this paper. All authors read and approved from: https://ec.europa.eu/health/sites/health/files/systems_performance_ the final manuscript. assessment/docs/2017_blocks_en_0.pdf%0Ahttp://www.journals.cambridge. org/abstract_S1041610215000137%0Ahttp://www.euro.who.int/__data/ assets/pdf_file/0005/322475/Integrated-care-models-over Funding 5. Araujo de Carvalho I, Epping-Jordan J, Pot AM, Kelley E, Toro N, This work was supported by the European Union’s Horizon 2020 Research Thiyagarajan JA, et al. Organizing integrated health-care services to meet and Innovation Programme (under grant agreements n° GA-689802 CONNE- older people’s needs. Bull World Health Organ. 2017;95:756–63. CARE and GA-634288 SELFIE), the European Union’s Health Programme 6. 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