Health care reforms of relevance to chronic disease

The 1978 Law 833, which established the SSN, constituted a fundamental reform of the Italian health care system. It has made possible policy-setting at national level, including the regular development of a three-year national health plan (Piano Sanitario Nazionale), a key instrument at national level, which sets out the national health strategy and defines health care objectives and targets (Lo Scalzo et al., 2009). The reform also introduced prevention and rehabilitation as essential activities of the health system. It further introduced local health authorities (Unità Sanitarie Locali, USLs), which were made responsible for hospitals. In 1992, Law 502 transformed the USLs into local public enterprises (ASLs), equipping them with considerable administrative and financial independence from local government. At the same time, the system underwent a gradual process of decentralization, with regions being assigned organizational and operative responsibilities that previously were the responsibility of national authorities.

Subsequent reforms included the 1999 Law 229, which introduced monitoring and evaluation systems for ALSs, hospitals and physicians. It also extended the autonomy granted to regions in managing and financing the range of services they provide to their citizens, including home and residential care. Regional competences and powers were further strengthened by the 2001 Constitutional Law 3, which (partially) increased the degree of financial autonomy within the framework of minimum standards in welfare services. More recent reform efforts have progressively afforded regions almost total financial autonomy, with 2009 legislation (Law 42) requiring central government to enact legislation, by May 2010, to guarantee the fiscal autonomy of regional institutions (Lega, Sargiacomo & Ianni, 2010; Ferré et al., 2014). It also introduced accountability mechanisms and expenditure control systems, using economic and administrative incentives and sanctions tied to predetermined indicators of economic efficiency.

Current legal, regulatory and policy frameworks

Population ageing is a key concern in Italy, where the proportion of those aged 65 and over is among the highest in the Organisation for Economic Co-operation and Development (OECD) countries (OECD, 2010). Yet, policies addressing chronic and age-related diseases have only been introduced relatively recently. This includes the 1998–2000 national health plan, which, within its overarching framework to strengthen health care quality in the SSN, set out a number of measures of relevance for chronic diseases, with one of its five objectives aimed at promoting healthy behaviour and lifestyles (Lo Scalzo et al., 2009). Other measures included enhancing the cooperation of providers across health and social care with legislative decree 299/1999 establishing the relevant regulatory framework to promote better integration of the two sectors. These provisions were further strengthened by the 2003–2005 national health plan, which set the target of achieving a higher level of integration between health and social services, including through significant reorganization (Ministero della Salute, 2003). The most recent national health plan 2011–2013 confirmed the emphasis of integration across sectors (Ferré et al., 2014).

At the same time, a 2003 agreement by the state-regions joint commission emphasized the need for ‘active prevention’, with a subsequent operational plan Piano Nazionale Prevenzione Attiva 2004–2006 (‘national plan for active prevention’) specifying that ‘active prevention’ can be understood also in the context of disease management as a means to reduce the risk of disabling or fatal complications, with a particular focus on diabetes (Ministero della Salute, 2004). It identifies the key components of disease management to include a computerized monitoring system; involvement of multidisciplinary professionals and institutions in treatment; and active patient participation in the management of the disease through education and support provided by primary health care services networks. The subsequent national plan for prevention (Piano Nazionale della Prevenzione, PNP) 2005–2007 established national priorities in the field of prevention. It further strengthened activities in relation to diabetes as part of a wider strategy to prevent cardiovascular diseases, along with cancer screening, immunization and the prevention of injuries; measures were to be coordinated by the Centro Nazionale per la Prevenzione e il Controllo delle Malattie (National Centre for Disease Prevention and Control) (Ministero della Salute, 2005). Among other things, the plan required regions to adopt measures to reduce complications arising from diabetes and to increase patient adherence to treatment, making specific reference to DMPs. Each of the 20 regions has responded to the plan by enacting regional laws and regulations for meeting the plan’s targets.

Following extension of the targets set out in the PNP 2005–2007, first to 2008 and then to 2009, with only few modifications, a new three-year prevention plan was eventually published in 2010, covering the period 2010–2012 (Ministero della Salute, 2010). It confirmed diabetes management as a priority for regional and local authorities, and supported the development of the IGEA (Integration, Management and Treatment for Diabetes; Integrazione, Gestione e Assistenza per la Malattia Diabetica) project described below.

Parallel developments included the adoption of the 2006 WHO Regional Office for Europe’s ‘Gaining health’ strategy for the prevention and control of noncommunicable diseases, within the Guadagnare Salute programme (2007) (Ministero della Salute, 2007). It focused on the prevention of common risk factors such as tobacco and alcohol use, lack of physical activity and poor diet, while also promoting the reorganization of health care services in line with the principles of disease management. It emphasized primary care over secondary care and patient engagement in the Italian health care system. In addition, to support the monitoring of population health and health behaviours, the Ministry of Health commissioned the development of a system for the ongoing surveillance of major behavioural risk factors and preventive measures for noncommunicable diseases, the ‘Passi’ system (Progressi delle Aziende Sanitarie per la Salute in Italia, ‘Progress by Local Health Units Towards a Healthier Italy’) (Baldissera et al., 2011). The system involves an ongoing nationwide collection of data using a standardized questionnaire. It covers almost all of the country’s ASLs and comprehensively monitors the health status, behaviours and preventive measures among the adult Italian population.

IGEA – Integrazione, Gestione e Assistenza per la Malattia Diabetica

IGEA is a national strategy to support the implementation of disease management for type 2 diabetes at the regional level (Istituto Superiore di Sanità, 2014). It was developed in 2006, following the identification of diabetic complications as a priority intervention area by the 2004–2006 national prevention plan. The definition of disease management adopted by IGEA follows that proposed by the United States Centers for Disease Control and Prevention, referring to an ‘organized, proactive, multicomponent approach to health care delivery’ which integrates care along the spectrum of the disease and its complications (Maggini, 2009).

At the national level, the key actors involved in the development of the programme and the evaluation of regional performance were the National Centre for Disease Prevention and Control and the National Institute of Health (Istituto Superiore di Sanità, ISS). Regional government agencies are responsible for the coordination and implementation of the programme, acting as a link between central government agencies, regional governments and the ASLs (Istituto Superiore di Sanità, 2014).

The overall objective of IGEA is to improve the quality of care, placing the patient at the centre of the care process (Maggini, 2009). It has developed a series of tools to support the regions in the gradual implementation of disease management for people with diabetes, taking account of geographic differences while ensuring that interventions are uniform. The main strategies promoted within the IGEA project involve elements of self-management support, delivery system design, decision support and clinical information systems.

• Self-management support involves access to a structured diabetes education programme provided by trained staff (specialists, nurses and GPs), the active involvement of patients in developing a care plan and the provision of self-management tools and routine assessments of problems and accomplishments. Particular attention is given to social determinants of health (ethnicity and socioeconomic factors), thus including socio-cultural mediators.
• Delivery system design includes the use of integrated care pathways involving multidisciplinary health care teams and case management for patients with complex needs. A specialist nurse develops care or treatment plans that are tailored to the needs of individual patients. Teams bring together a range of professionals, including endocrinologists and other specialists involved in the treatment of diabetic complications; these include nurses, dieticians, podologists, psychologists and pharmacists. Team composition varies in accordance with individual patients’ needs.
• Decision support involves evidence-based guidelines for the management of type 2 diabetes developed by the ISS for use within IGEA (‘Recommendations’ (Istituto Superiore di Sanità, 2007)). It also includes provider training, which is in two stages, a training-the-trainers stage at national and regional level and individual provider education. The programme not only targets diabetes management and communication training, but also promotes multiprofessional teamwork and communication among health professionals, people with diabetes and other relevant stakeholders. Periodic meetings seek to inform training and develop further disease management practice. A methodological guide to assist trainers’ teams and software to support the evaluation of training programmes have been developed (Istituto Superiore di Sanità, 2014). Participation in training is voluntary, however, and those who partake receive education credits (Educazione Continua in Medicina, ECM).
• Clinical information systems include the development of paper-based or electronic registries of enrolled patients, using administrative and ad hoc data collection. The format of registries varies among regions. For example, the Piedmont region uses a disease registry that only includes general information on enrolled patients while other regions sought to implement diabetes registries capturing detailed clinical information. A document, ‘The information system’ sets out principles for the development of information systems as a means to harmonize the various regional experiences and as the basis for future activities of the IGEA project (Istituto Superiore di Sanità, 2008).

In addition, regional governments periodically present the results of the project to representatives of patient organizations. Patient representatives are also involved in the earlier stages of training activities in each region, which set out the overall design of the project to adapt it to the local epidemiological and organizational features. Furthermore, patient representatives were members of the multidisciplinary working group based on the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) (Schünemann et al., 2008) methodology, which was specifically created to design the programme and outline the guidelines for its implementation in the single regions.

Disease management as implemented within IGEA is funded from usual sources, that is, within the Italian SSN. Because diabetic complications were identified as national priority in the 2004–2006 national prevention plan, and because the 2005–2007 national prevention plan made specific reference to regional projects, IGEA financing was complemented by national and regional funds earmarked for prevention and allocated by the Interministerial Committee for Economic Planning (Comitato Interministeriale per la Programmazione Economica, CIPE).

As noted above, a core component of disease management as implemented within IGEA is the use of multidisciplinary teams; this also includes the formation of provider networks spanning the different levels of care, namely primary care (GPs) as the first point of contact for patients enrolling in the programme, and secondary and tertiary care (hospitals), as well as administrative structures (ASLs and regions). Patients join upon invitation by their GP, following diagnosis according to national guidelines. The participation of providers in regional projects is principally voluntary although some regions have introduced financial incentives for GPs whose patients sign up for the relevant DMP (for example, Piedmont). Other regions have made it a requirement for GPs to provide a minimum dataset (for example, Abruzzi). Again other regions have not introduced any specific incentives or requirements for GPs participating in disease management activities within IGEA (for example, Campania). Non-financial incentives for GPs and other providers to participate include networking, information sharing, access to guidelines and peer pressure.

Although the IGEA project was developed in 2006, the implementation of DMPs at the regional level has been a gradual process and patient enrolment is ongoing. In addition, a number of local health agencies have already had DMPs in operation; one of the goals of IGEA is to harmonize existing projects by ensuring that general guidelines are made available and that certain minimum requirements are being met. For this reason, it is difficult to provide precise figures on the number of residents covered by IGEA.

Overall programme implantation has been advancing, albeit at slow pace. Where it has been fully embraced, GP participation rates have reached up to 100%, for example within several local health agencies (ASLs) in Piedmont and Emilia-Romagna regions, and one ASL in Sardinia. At the beginning of 2010, just over 1900 GPs in Piedmont were reported to have participated in the programme, equating to about 60% of GPs and covering about 50 000 patients, corresponding to 30% of the entire diabetes population in the region. There was an expectation that because IGEA has been promoted by governmental agencies, representing national and regional authorities, and because it is financed from public sources that GP participation would eventually reach 100%.

Dalla medicina d’attesa alla sanità d’iniziativa project, Tuscany

Concern about population ageing and the rising burden of chronic conditions prompted the regional government in Tuscany, in its Regional Health Plan 2008–2010 to set out a three-year strategy for the development of a new organizational approach to health care, emphasizing proactive patient care (Regione Toscana, 2008). Described as Dalla medicina d’attesa alla sanità d’iniziativa (‘From On-Demand to Proactive Primary Care’), the new approach was to be built on the principles of the expanded Chronic Care Model (Barr et al., 2003; Regione Toscana, 2009a), with care pathways developed for five conditions in the first instance: moderate to severe hypertension, diabetes mellitus, congestive heart failure, COPD and stroke, with possible extension to Parkinson’s disease, dementia, severe chronic degenerative osteopathy and rheumatoid arthritis.

The strategy essentially constituted a structural reform of the regional health system in Tuscany, with implementation in two stages, an initial phase (from January 2010) and full implementation following evaluation of the initial phase, from January 2011 (Regione Toscana, 2009a). The key components of the approach involve elements of self-management support, delivery system design, decision support and clinical information systems.

• Self-management support involves access to education and counselling on aspects of the disease, including lifestyle and behaviours, recognizing the symptoms of complications and handling emergency situations, together with instruction in self-monitoring activities. Patients and their carers are actively engaged in developing the care plan with their GP, the nurse and, depending on the patient’s level of need, a specialist; they have to sign up to the plan (giving informed consent) when commencing treatment, and provide feedback or suggestions to the GP or nurse throughout the process. This includes regular assessments by the nurse of problems and needs. Where necessary, patients will have access to devices such as postural and physical aids for stroke patients. Patients’ quality of life and satisfaction with or experience of the programme is monitored regularly. Those with special needs as identified by age or socioeconomic status might also be supported by specifically trained social workers who will coordinate further support, such as nursing care or free aid tools, as required.
• Delivery system design includes the use of clinical pathways for each of the five conditions and delivery by multiprofessional teams (‘modules’). Each team meets periodically for organizational audits with the community health doctor at the local health agency assigned to it for regular updates on progress. Staff roles are clearly defined with flow charts describing checkpoints and actions to be taken at the occurrence of any event, which may also include involving of nonhealth professionals such as social workers. The team is led by the GP responsible for the team’s clinical activities; she/he sets up specialist assessments specific to a patient’s medical needs, with the staff nurse playing a key role in case management and counselling. Care plans are tailored to individual patient’s needs, and involve continuous controls and assessments by the team.
• Decision support involves the use of international and scientific guidelines to inform the development of clinical pathways and a comprehensive programme of peer education, targeting all professionals involved in the general delivery of the programme as well as single groups of professionals on specific issues, followed by an evaluation at completion. Each medical team (‘module’) includes specialists in disciplines appropriate for the patient’s needs; these are called upon at specific points along the clinical pathways, but can also be referred to when necessary by the nurse, the GP and the patient. Nurses are trained in case management and counselling techniques specifically for the project.
• Clinical information systems include paper-based or electronic databases using administrative data provided by the community health doctor at the ASL. They also monitor the performance of the practice team in regular meetings, based on predefined process and success indicators which are specific to the area of activity of team members. Information is shared among team members and recorded on the lead GP’s electronic filing system, where it can be made available for subsequent reference; team members without Internet connections are provided with this by the region. An electronic booking system is in place to support continuity of care, maximize appropriateness and comfort and minimize patient drop-out; among other things it identifies content of follow-up and the responsible team member.

A core component of the programme is the use of multiprofessional teams (‘modules’), led by a GP and including all GPs involved in the treatment of enrolled patients, supported by a community health doctor at the local health agency. The team always includes a specifically trained nurse who acts as the patient’s first point of contact. The team may also include specialists and allied health professionals; its composition will vary in accordance with the patient’s chronic condition, involving for example a cardiologist, dietician, rehabilitation specialist and social worker for patients with heart failure; or diabetologist, cardiologist, podologist, psychologist or psychiatrist, dietician and physiotherapist for diabetes patients.

The ‘From On-Demand to Proactive Primary Care’ project was funded from usual sources, namely from within the Italian SSN, with regional regulations stipulating a total allocation of resources to project implementation of €8 883 000 over a period of three years (Regione Toscana, 2009b). The participation of GPs is principally voluntary; participating GPs qualified for financial incentives determined by the level of involvement (namely, whether they coordinate teams or participate through enrolling patients into the programme) and the achievement of objectives. Payment of the fee is conditional on meeting certain criteria, such as adherence to the programme as assessed by process indicators (20%), submission of electronic register data for patients for each of the five conditions targeted by the programme (20%), attainment of intermediate outcome measures for a given condition (30%) and final outcome indicators for that condition (30%) (Regione Toscana, 2009a). Assessment of goal achievement is performed for each team; each GP participating in the team is allocated, in accordance with the above criteria, a part of the maximum reimbursement proportional to the number of patients enrolled in the programme. Thus, GPs coordinators are eligible for a maximum annual payment of €1500 if the number of patients enrolled with the team is lower or equal to 15 000, and €2250 if the number is higher than 15 000. GPs who participate but do not act as coordinators are entitled to an annual fee of €4.5 per patient per year.

As noted above, project implementation was in two stages, with the initial start-up and pilot phase in 2010 involving the establishment of approximately 50 modules (teams) covering about 500 000 residents and initially targeting patients with diabetes and heart failure, with the subsequent addition of further modules and extending coverage to the remaining three conditions (COPD; stroke; hypertension). By April 2012 and following further extension, the programme covered some 106 modules and a total of 1.2 million (or 38%) of the resident population, with just over 1000 GPs (about one third of all GPs in the region) participating in the programme (Ruggeri, 2014). Building on this programme, Tuscany is currently embarking on a wider primary care reform which places the extended chronic care model at its centre, anticipated to cover 100% of the Tuscan population in 2015 (Quotidianosanità.it, 2013).

Leonardo pilot project, Apulia

The Leonardo programme for disease and care management was developed during a three year public–private partnership agreement, initiated in 2004, between Pfizer pharmaceutical company and the regional government of Apulia (Pfizer, 2014a). Designed as a pilot study for a new approach to chronic illness care, its objective was to improve the quality and effectiveness of health care for those with chronic conditions, including type 1 and type 2 diabetes, chronic heart failure and high cardiovascular risk. It targeted GPs to facilitate systematic integration into the existing organizational framework set by ASLs.

Leonardo was based on the principles of patient self-management, individualized care plans, case management and the use of electronic information systems, building on the components set out by the Chronic Care Model (Wagner et al., 1999). Its main purpose was to assess the feasibility of implementing an approach developed in the United States for use in the context of the Italian health care system. The project involved elements of self-management support, delivery system design, decision support and clinical information systems.

• Self-management support involves access to patient education based on the ‘eight priorities’ approach defined by Lorig (2001). It uses a care manager, who is usually a specialist nurse trained in counselling techniques and communications skills, with an emphasis on the psychological aspects of assistance in breaking old habits and forming new ones. The care manager guides the patient through the different stages of raising self-awareness (pre-contemplation, contemplation, determination, action, maintenance). Assessment of patient needs is systematic, with the care manager scheduling meetings with the patient, in person or by telephone, to discuss needs and conditions at care initiation and follow-up, introducing modifications to the plan in accordance to the individual patient’s needs.
• Delivery system design includes the use of the aforementioned care manager, who works with the GP to deliver the individual patient’s care plan. Staff roles are clearly defined, with the care manager assessing the patient’s needs and potential problems while the GP is responsible for treatment and supervising the care manager. Staff meets regularly, at intervals determined by the severity of the patient’s condition as assessed by the level of care intensity required. Flow charts describe the activities set out in the care plan and medicines management is a core component of the plan.
• Decision support involves the use of evidence-based principles of care management and scoring systems (for example, the New York Heart Association (NYHA) scoring system for heart failure) built-in specifically designed software (see below) and the training of staff, with care managers trained in counselling and communication techniques and GPs in the use of programme software. Access to specialist expertise is available where required.
• Clinical information systems includes access to a specifically designed software, InformaCare^TM, developed by Pfizer, which provided the IT platform for the project. Its features include reminders for providers to enable periodical assessments, diagnostic tests and treatments; data collection on process and outcome indicators for performance assessment; continuous monitoring of progress and information sharing. An electronic booking system is in place, as well as a preferential option for specialist consultations.

Leonardo disease and care management was designed to supplement the current practice of patient care by introducing a care manager who, in collaboration with the GP, works with patients in the doctor’s office, the patient’s home or via telephone. A public–private initiative, it was funded jointly, with contributions that included non-financial resources, such as the InformaCare^TM software. Funds were set aside in the Apulia region’s budget for GPs, including both a lump sum at the beginning of the project to incentivize participation, and a variable payment at the end, its volume determined by performance, as assessed using process and outcome indicators.

Overall, the project involved 85 GPs in the Apulia region (about 2.5% of GPs practising in the region), working with some 30 care managers, and covering just under 1160 patients for a project lasting 18 months at the local health agency ASL di Lecce (Pfizer, 2014a).

Raffaello project, Marche and Abruzzi

The Raffaello project was a research project designed to assess the effectiveness of an innovative model of patient care for the prevention of cardiovascular diseases on the basis of disease and care management in general practice (Pfizer, 2014b). It was launched in 2007, developed by the Marche and Abruzzo regional health agencies with support from the central Ministry of Health and Pfizer pharmaceutical company. Its introduction was informed, in part, by the Leonardo project described earlier, which also involved Pfizer.

Similar to the Leonardo disease and care management programme, Raffaello’s core feature was the use of a care manager, a qualified nurse who supports the patient along the care pathway. The project involved elements of self-management support, delivery system design, decision support and clinical information systems.

• Self-management support involves the active participation of patients in devising their care plan and in the decision-making process. Patients have access to a care manager who carries out counselling (‘coaching’) and follow-up activities by telephone, in the doctor’s office or in the patient’s home; the mode is determined in accordance with the individual patient’s needs. Patients also have access to information material on the disease, lifestyle, and to services available in the geographical area.
• Delivery system design includes the use of a care manager, who works with the GP to deliver an individual patient’s care plan. This ‘personalized health plan’ is tailored to the needs of the patient and developed through collaboration between the care manager, the GP and the patient. Staff roles are clearly defined with the GP managing the clinical–therapeutic component of the health plan, and the care manager overseeing it. The project further applies the principles of case finding through measures of primary prevention, screening of asymptomatic patients at risk for cardiovascular diseases, and treatment of patients with a history of cardiovascular diseases who are thus at high risk for complications.
• Decision support involves provider education, including a training-the-trainers component as well as individual provider training for both GPs and care managers, with the latter specifically educated in professional skills. An additional stage was added later to identify and address any problems that may have arisen following initial training (in three- to six-month intervals, starting from March 2008). Access to specialist expertise and experience is mentioned in the project, but while specialists are consulted and their opinions considered in developing and modifying the health plan, they do not play an active role in the team. Before programme launch, the simulation instrument DEOS (Discrete Event Object-Oriented) was used for a preliminary evaluation of the impact of the processes of disease and care management on the existing organization, and to support decisions in improving the interventions.
• Clinical information systems include the use of a software specifically developed for care managers, enabling regular reminders for GPs of scheduled tests and appointments; facilitating communication between patient and staff members and ensuring adherence to evidence-based guidelines; and the evaluation of clinical outcomes. Similar software has yet to be integrated into the current information systems available to GPs.

The core feature of the Raffaello disease and care management programme was a collaborative relationship between the patient, the care manager and the GP, which places the patient at the centre of the care process. A public–private initiative, it was jointly funded by various actors, including regional health care funds complemented by additional funds from the Italian Ministry of Health’s ‘Special Programmes’ fund and co-financed by Pfizer, Italy.

Designed as a scientific project, the Raffaello project was limited to a defined group of patients recruited for participation, a total of 900 patients in the regions of Marche and Abruzzi, with 16 clusters of GPs participating in the experimental arm of the study (see below).