Digitalisation in proximity health care services in Italy: an analysis upon possible different trajectories and the key role of both GPs and patients Open Access

Governments are constantly looking for a way to improve the quality and efficiency of health systems (Armitage et al., 2009), but the different ways for optimisation, such as cost control and quality management, have been challenged by several tensions (Johansen et al., 2018). Moreover, the COVID-19 health crisis challenged this ongoing progression, clarifying that the determination of the post-pandemic is in our hands (Katzourakis, 2022), as the reset of the public sector system after COVID-19 has been deemed the “hardest challenge of the century” (OECD, 2021a). Particularly, within public healthcare systems, the pandemic had two important effects. First, it led to a positive change in the esteem of public health services and the respect of medical research (Bargain and Aminjonov, 2020). The COVID-19 crisis is indeed contributing to requesting a tailored assessment of the value-based healthcare creation (Teisberg et al., 2020), necessitating the involvement of professionals, organisations and public institutions in charge of the service supply, together with an active role by the patients (Antonucci et al., 2023). Secondly, the pandemic led to an increased use of digital tools, thus transforming our working arrangements as well as our interactions (Berardi et al., 2022), and it was also a “booster” of innovation in the whole public sector (Agostino et al., 2020; Cepiku et al., 2021; Sancino et al., 2021) and in healthcare in particular (Leite et al., 2020).

To overcome the difficulties for the actual implementation of the needed changes, a great role has been allocated to information and communication technologies (ICTs) and to digitalisation (Mergel et al., 2019). The use of ICT resources in healthcare has been growing since the 2000s (Criswell and Parchman, 2002), given that digitalisation can lead to cost savings (Silva et al., 2003), time savings (d’Hemecourt, 2001; Rothschild et al., 2002), error reduction (Grasso et al., 2002; Barrett et al., 2004) and improvement of medical practice (Lapinsky et al., 2001; Schoonenboom and Johnson, 2017). Nowadays digitalisation of healthcare constitutes a central component of pervasive healthcare and represents an important instrument to increase health promotion, disease prevention, provision of care and monitoring (Gagnon et al., 2016).

Notwithstanding the profound dissemination of ICTs and digitalisation within the healthcare sector, it is not clear yet how public budgets are allocated and what the real results of related policies are. For instance, while new e-health paradigms are rapidly developing in the sector, several issues prevent them from being the “new normal”, such as security, privacy, design, performance efficiency, heterogeneity, interoperability regulatory and legal aspects (Aceto et al., 2018). Furthermore, while the potential of digitalisation is being more and more acknowledged in healthcare (e.g. Odone et al., 2019), there is a paucity of specific studies related to primary care, a setting deemed essential to answer the challenges Europe is currently dealing with (Kringos et al., 2015).

Relatedly, our research question is: which are the enablers and barriers in implementing national policies aimed at digitalising (public) primary care?

We propose the Italian primary care system as case study (Yin, 2014) for at least two reasons. First, primary care in the Italian National Health System (INHS) is undergoing a radical change after the COVID-19 pandemic, which has underscored the weaknesses of previous policies (Garattini et al., 2022). Although in the functioning of the INHS, General Practitioners (GPs) are a pillar at the local level, several shortcomings impede them from fully deploying their potential (Garattini et al., 2022). The opportunity is therefore favourable to explore reform trajectories and speculate on possible outcomes that could interest at least the whole of Europe (Odone et al., 2019).

Second, INHS could benefit from a huge amount of public budget specifically devoted to implementing an adequate digitalisation. The Italian Plan of investments of the European Union (EU) Programme Next Generation EU, Mission 6 of the National Recovery and Resilience Plan (M6-PNRR) allocates approximately €15.6bn to support asset investments in proximity assistance and telemedicine, having 8.6bn for disseminating telemedicine and strengthening the healthcare system’s information and digital tools (PNRR, 2021). We moreover found that, at least in the last 3 decades, this is the first time in which such an important needed reform does not include the lack of financial resources. This raises relevant questions on how funds are spent, which interventions are planned and how digital development is really impacting upon the delivery of services. As an example of top-down policy implementation (Kaiser, 2020) in a three-tier public service decentralised at the regional level (Garattini et al., 2022), our case offers useful insights in circumstances of large-scale reforms.

To achieve our research aim, we decided to use a qualitative approach, starting from a document analysis, to then run semi-structured interviews with highly qualified experts and finally manage two focus groups with GPs in order to understand which are the distances, and thus which are the problems, in the actual implementation of a digitalised system at the level of proximity caring. In our case, GPs are among the key health professionals to interviewee, since they are called to exert a pivotal role in the renewed Italian primary care system (Garattini et al., 2022).

The paper is organised as follows: The next paragraph illustrates the theoretical background; paragraph 3 describes the context and methods of our research; paragraph 4 synthesises findings; paragraph 5 presents the discussion and the final one presents the conclusion.

Healthcare systems, especially public ones, ought to reform themselves completely, disrupting the “in-hospital” paradigm of service providing by placing primary health care at the centre of their caring system, being thus able to both manage any sudden surge of demand and to maintain continuity of care for all (OECD, 2021b). Basic pillars should be the integration of care among sectors (Raus et al., 2020) and continuity of chronic care and community-based health services (Rosen et al., 2011). Nevertheless, the way to achieve these targets is not easy to settle (Nicholson et al., 2017).

This is particularly true in countries with public national health services which have been the object, in the last decades, of reforms inspired by new public management (NPM) theories and principles (Cairney, 2002) whose effectiveness, in such a unique context as healthcare, has been contested (Andrews et al., 2019). NPM reforms would have failed to deliver their promises (Simonet, 2015). Especially since the new millennium, we are witnessing a worsening of public health services rather than their increase in efficiency and effectiveness. Particularly, public services reforms inspired by NPM saw a business-driving equation, which assumes that production costs can be reduced without affecting consumption (Osborne et al., 2014). On the contrary, in the production of public services such as healthcare – in which production and consumption are simultaneous, intangible, heterogeneous and inseparable (Moeller, 2010) – the reduction of production costs directly affects service quality. This approach is leading to a fragmentation of health services, thus resulting in a continuously changing health system which is becoming more complex and thus impersonal but, most of all, not always able to respond to citizens’ needs and sometimes even difficult to manage (Jackson et al., 2010).

Indeed, the request for healthcare services is changing significantly because the ageing of the population, especially in industrialised countries, is increasing patients with multi-pathological chronic conditions (Hajat and Stein, 2018). Moreover, more patients are now well informed, thus requesting better and tailored healthcare services according to advancements in medical knowledge (Parker, 2006). This request for more and better services has to deal with financial sustainability, which is leading to a decrease in the availability of public sources (Gabutti et al., 2017). Therefore, public healthcare systems ought to change to improve both quality and efficiency, as well as equity and appropriateness (Zaadoud et al., 2021).

A way by which healthcare systems, all around the world, are attempting to improve is digitalisation (Odone et al., 2019). As ways of innovation, the digitalisation of the health system and the implementation of telemedicine services could contribute directly toward achieving (1) better health outcomes, (2) improved patient experience, (3) lower costs and (4) improved clinician experience (Bodenheimer and Sinsky, 2014). Relatedly, all healthcare systems took a path characterised by the growing presence of virtual components in care pathways, thus leading to an irreversible change in health services provision (Mann et al., 2020; Wosik et al., 2020). Digitalisation had a great acceleration during COVID-19 crisis (Shachar et al., 2020), and many researchers are investigating the consequences of the COVID-19 pandemic as a “booster” of innovation, both of services and strategies (Cepiku et al., 2021), especially linked with digitalisation and telemedicine (Agostino et al., 2020; Leite et al., 2020). Telemedicine saves both patients and healthcare providers’ time as well as the cost of the treatment. Furthermore, due to its fast and advantageous characteristics, it can streamline the workflow of hospitals and clinics, thus being able to create a win-win situation (Haleem et al., 2021). Remote communication will continue to improve diagnostic medicine (Marques and Ferreira, 2020).

Considering that previous studies focused on the technological advances for digital transformation and their use in healthcare (Mauro et al., 2024; Marques and Ferreira, 2020; Odone et al., 2019), on their impact on public value co-creation (Marsilio and Mastrodascio, 2024) or on the digital readiness of future physicians (Marsilio et al., 2024), we decided to investigate how health systems are fostering the implementation of new e-health paradigms and digital tools through targeted health policies. Paradoxically, a huge problem in the health sector is not innovation per se, but the dissemination of innovative concepts (Berwick, 2003). Service innovation in healthcare implies new forms of logistics, advice and reporting, and it is successful only if it can satisfy users’ needs (Flessa and Huebner, 2021). The so-called promoters play a fundamental role in this sense: they are key persons who allow the implementation of the change, contributing to overcoming its barriers (Gemünden et al., 2007). They can do that because they know “how things work” and thus comprehend the innovation and perceive its perspectives (Goduscheit, 2014).

Literature on health policy has already highlighted several dynamics that influence its implementation. With reference to e-health, Ross et al. (2016) synthesised several factors: taking into account complexity, adaptability, compatibility and cost; including stakeholders and implementation champions; allocating sufficient financial and legislative support; addressing standards for technology (issues of interoperability, security and privacy); planning implementation for organisational readiness; training and education for all the actors involved and ongoing monitoring, evaluation and adaptation of systems. They call for external governmental policies and incentives (financial incentives, reimbursement and pay-for-performance initiatives) aimed at enacting the implementation of e-health at the local level (organisational and health professional). These findings echo a review upon change factors in primary care, in which authors explored external contexts, organisational and professional levels, as well as the intervention dimension itself (Lau et al., 2015). The external context was found as an effective activator to extend the telemedicine applications. Furthermore, fitting with local or national agendas, appropriate regulator frameworks, codes of practice at local level and financial and non-financial incentives could favour change and its sustainability over time. However, more research would be needed to advance the understanding of how these and other factors work together to influence its implementation.

All the above considered, we aimed at understanding patterns of policy implementation at the intersection between digitalisation, primary care and health policy, focusing both on GPs, as key actors of change and patients, as beneficiaries of the reforms. We choose primary care since – despite its growing relevance to overcome current challenges that healthcare systems are facing around the world (WHO, 2018) – it is an under-investigated setting with reference to public budgeting and policy design and implementation. Moreover, previous literature underlined the need to deepen the understanding of the dynamics among factors, and we tried to unveil the answers of interested parties to the reform.

Accordingly, we decided to analyse the ongoing modifications of the Italian public health system, looking at it to unveil current issues in implementing reforms in primary care. Reforms that have been implemented allocating a huge public budget disseminate digitalisation practices throughout new care settings able to integrate care with other areas (secondary and tertiary settings). The next section presents the context of analysis and illustrates the chosen methods.

Healthcare systems, and public ones in particular, require nowadays a reform focused on primary care, as highlighted by the frame of reference on primary care by the EU Commission in 2014 (EC, 2014) and by the 2018 Astana Declaration by the World Health Organisation (WHO, 2018). Yet, adjustments in public healthcare systems seem to be insoluble, especially considering their persistent resistance to reforms (Broerse and Grin, 2017; Dickinson and Pierre, 2016; Fineberg, 2012).

All these aspects are particularly significant in Italy, being, together with Japan, the country with the most aged population and with the necessity to modify accordingly its public National Health Service (Mazzola et al., 2016). And this should be done in a setting which has great disparities among the territories in terms of quality and expenses (Garattini et al., 2022).

The INHS is a public, highly decentralised system (Giulio et al., 2022). The central government set the national policies and allocated funding to each regional healthcare system. The regional level is responsible for healthcare financing, planning and organisation at the local level. Within every region, few local health authorities (LHAs) promote public health and deliver health services, providing them directly or purchasing them from other providers. They are directly accountable to the healthcare regional system to which they belong. Health professionals can be appointed to lead units (hospitals, health districts, operating units, etc.), and they are accountable to the LHA. In this context, because of the COVID-19 crisis, the Central Government devoted, within the PNNR, a specific mission to health, envisaging more equal, modern and digitalised health services.

Regarding ICT, digitalisation and telemedicine, before the pandemic, the INHS had “simply” formally transposed national guidelines, launched in 2014, as a first attempt to give a “glossary” in a common national scheme (Bobini et al., 2023). Since the COVID-19 crisis, several regions (being INHS governed at the regional level) launched specific norms and regulatory statements to activate tele-examinations as interaction at a distance between medical doctor (MD) and patient (Bobini et al., 2023). Indeed, during pandemic peaks, the local branches of INHS reacted promptly through a community co-production approach (Cepiku et al., 2021). This innovation was in line with the PNRR Mission 6, devoted to primary care reorganisation, innovation and implementation (M6-PNRR). It foresaw, among others, “Telemedicine to better support to patients”, allocating 1B€ (1.2.3 M6-PNRR), divided into 250 M€ to implement a national platform for telemedicine and 750 M€ to design and implement regional projects of telemedicine (Ministerial Decree 01/04/2022). Meanwhile, with Law 25/2022 (which modified previous Legislative Decrees), the National Agency for Regional Health Services (AGENAS) was attributed the further role of National Agency for Digital Health (ASD), thus ratifying an evolution also in the governance of the regional health systems.

Considering both the relevance and especially the multipurpose nature of our investigation, we decided to construct it using a qualitative approach (Creswell, 2009), through two different phases.

In the first one we conducted a desk analysis upon both primary sources (laws, rules, regulations, etc.) and secondary ones (preliminary possible published studies and grey literature regarding the digitalisation and telemedicine within the reforms of the INHS as stated in the PNRR). The aim of this first part of the analysis was to investigate the design, expectations, first realisations and preliminary analysis.

In the second phase, in line with the qualitative explorative case sampling (Patton, 2002a, b), we explored the potential impact of digitalisation and telemedicine within their real-life context by gathering information from knowledgeable key informants, that is, well-situated and competent people involved in critical issues (Yin, 2014). Particularly, at this further stage of investigation, we conducted exploratory targeted qualitative interviews (Bailey, 1987) with privileged witnesses, who were able to offer insights as experts in the area (Weiss, 1995).

Within a larger, still ongoing, research on community care homes in Italy, we had the possibility to interview personnel belonging to two different Italian regions and to four different Local Public Health Territorial Services (ASL), gathering data from different settings.

Considering the specific inner aspects of our investigation, we looked for proper helpful privileged witnesses able to give information rather than being representative of a sample, considering that we were not running a questionnaire, but we had semi-structured interviews (Gill, 2020). Particularly, we looked for centred interviewees to frame the first stage of this research phase in the scheme of purposeful sampling (Suri, 2011). Therefore, we looked for interviewees from whom we could learn a great deal about issues of central importance in our inquiry, because the collected information had to generate insights and in-depth understanding (useful also for the second stage of this research phase) rather than empirical generalisations (Patton, 2002).

In particular, we interviewed – with an average of about 20 min for each interview – the following, as shown in Table 1:

Moreover, after the above-reported first stage of interviewees, we conducted two focus groups with nine GPs who were representatives of the different categories and unions. In this way, we could have a representation of the whole spectrum of ideas, positions and judgements of all the different categories representing GPs at the negotiation table for the developing of the reform.

The choice to run a focus group with GPs lies in the fact that, in Italy, they are independent contractors (paid by the public system) who act as gatekeepers to higher levels of care. Apart from receiving direct care, patients have access to specific public health services after receiving prescriptions from their own GP (de Belvis et al., 2022). Patients can freely choose a GP (and paediatricians for their children) among those enrolled in their municipality, being only limited by capacity constraints (no more than 1,500 registered patients for each GP).

Both interviews and focus groups were conducted in the interviewers’ and interviewees’ native language (Italian). The first focus group – devoted to collect general information on the innovation and the situation of the services – was held in January 2024 and lasted 85 min, while the second – specifically focused upon some aspects about telemedicine which came out after the deepening of our investigation – was held in May 2024 and lasted 40 min.

We developed the theoretical rationales for the interview protocol and the focus group by drawing on themes regarding literature on community health services facilities (Winpenny et al., 2016), innovative healthcare systems (Flessa and Huebner, 2021) and digitalisation (Mergel et al., 2019). Particularly, following the path developed by Srinivasan and Chandwani (2014) in analysing managers’ role in an evolving health organisation domain, and considering also the research by Mergel et al. (2019) on the relevance of processes of digital transformation within public service organisations, we defined a proper semi-structured questionnaire based on the following questions, coherently with our research aim:

1. How is the public health sector evolving or changing?

2. What is the extent of digital readiness in your organisation?

3. What is the mindset toward digital transformation?

4. Is there a lack of the skills needed to move toward digital transformation?

5. How is your organisation digitally transforming its public service delivery?

When appropriate, during the interviews, we proposed further questions. The transcriptions of the records were analysed through a content analysis approach (Bauer and Gaskell, 2000), which was developed through deductive thematic analysis, guided by theoretically driven coding (Braun and Clarke, 2006).

Particularly, from the works by services facilities by Winpenny et al. (2016) and by Srinivasan and Chandwani (2014), we enucleated the following main themes: (1) facility type, (2) expected outcomes, (3) staffing, (4) collaboration and networking among services and (5) patient-centredness.

The verbatim of the interviews were analysed separately by two researchers looking for the above-reported enucleated themes. Accordingly, we extracted and analysed contents belonging to each label. The results from each evaluation were then compared to trace for inter-rater reliability, particularly looking for a common unique shared decision in cases, which were found as not corresponding. We opted not to use any specific computer-assisted software, but we defined a common scheme for the researchers within the writing software, avoiding the use of any artificial intelligence generative scheme. The content analysis results were then translated into English and finally reanalysed for the redaction of this work.

In reporting our findings, we divide this section into two parts. We firstly illustrate the results coming from the document analysis, namely those corresponding to the design and intention of policy makers. We then report on those regarding the analysis of the interviews and the focus groups that are the considerations by the actual promoters of innovation. Indeed, our investigation intended to take into account the possible gaps between the planning of an innovation in health services delivering and its actual implementation. Particularly, we addressed the crucial role of the promoters of the change, that is, the personnel working in public territorial health services, as illustrated hereafter.

According to the results of our desk analysis, the ongoing reform stems from a strategic health innovation ecosystem, a complex network in which key players are the Central Government, the National Agency for Regional Health Services (AGENAS), all the Regional Healthcare Systems, the LHAs, the health professionals and the citizens. Indeed, as reported above, within the M6-PNRR panorama – devoted to the primary care reorganisation, innovation and implementation – the measure “Telemedicine to better support patients” is foreseen, among the others. Moreover, AGENAS now has the further role of National Agency for Digital Health (ASD), thus ratifying an evolution also in the national governance of the regional public health systems. The aim of the reform is to improve local assistance in primary and intermediate care through technological and digital modernisation (Anessi Pessina et al., 2021). These measures of transformation aim at the definition of a strategic vision of telemedicine, starting from the broader definition of regional strategies on digital health and governance of the relevant ecosystem (Boscolo et al., 2023). There is a clear determination for the adoption and renewal of information systems in healthcare facilities to modernise and standardise the information systems in use, where also the territory (perhaps for the first time so explicitly) is at the heart of these reforms (Boscolo and Longo, 2023).

Within the preliminary act in the agreements between the national government and the different regions, in December 2020, there were clarified both rights and responsibilities of the involved parties (which should be homogeneous within the national territory), stating that (Conferenza Stato Regioni, 2020):

1. The doctor is responsible for deciding in which situations teleconsultations can be employed in favour of the patient;

2. During the teleconsultation it must always be guaranteed the ability to exchange, on real-time clinical data, medical reports, images, audio and video and

3. The activation of the service requires a prior intention of the patient that must be preceded by adequate information so that the patient is aware and well informed about the visit methods, advantages, risks and protection of his/her personal data.

Moreover, an important aspect has been the clear definition, at the national level, of the different telemedicine ICT-supported interventions and care, both by a single specialist and by a team. Indeed, the INHS defined the following “glossary” of interventions (Bobini et al., 2023) as synthesised in Table 2:

In synthesis, according to what has been planned by the policymakers, the programme “Telemedicine to better support patients” within M6 of the PNRR can really be considered an important strategic health innovation ecosystem, especially if we consider that innovation ecosystems in healthcare can be seen as the full potential, given by new technologies, to tackle unmet needs (Javaid and Haleem, 2019).

In the following sub-sections, we illustrate what emerged from the analysis of the considered items about the relevance of the personnel role in developing and implementing this innovation, highlighting distances and gaps among the involved parties within the governance process of this change.

The design of healthcare facilities is a multifaceted process, which should involve different stakeholders, aiming at aligning operational, clinical and organisational objectives. It should indeed be considered the dynamic and complex nature of healthcare itself and the necessity of finding an equilibrium capable of both improving population health and reducing costs, trying also to improve staff work life (Halawa et al., 2020).

Our results show a misalignment between what was stated at the level of infrastructure creation and the real implementation of the reform by what should be the promoters of the change. All the interviewed people perceive the roles as “detached” from the ongoing reform inspired by the PNRR. GP2, in the first focus group, even affirmed that “there continue to be parallel tracks, and we do not know how to interact properly”. On the other hand, by the side of the service managers, the strategical importance of preliminary analysis of present pathologies has been underlined in order to have different planning in different realities, thus being in line with the impossibility of implementing a telemedicine service if not tailored according to pathologies (Medolla, 2021) to then obviously tailor a value-based intervention for any specific case. An example in this case was given by the following statement by ID2, “Yes, I know, it is easy for her (referring to ID5); she is an oculist, but how could you think we might develop telemonitoring with people with psychiatric disorders?”

Lastly, we also found huge differences among the different territories involved in our investigation, showing that there are different stages of implementation given by the fact that there were different starting points, even within the territories of the same region. In one case local services were already experimenting with what they called a “unique medical electronic record”, that is, a virtual record that allows all interested parties to have a clear illustration of the actual medical situation of each patient, independently from the specialists that might have to intervene according to both previous and ongoing pathologies. On the contrary, in all the other investigated cases – nevertheless, the system appears to be implemented at the 90% at least in 19 of the 21 territorial systems (AGID, 2024) – there was not even a clear notion of it.

This item really resulted as a contested one. A first great misunderstanding came out from the different indications given to “outcome”, particularly showing the different interpretations between the proper vision of the clinicians (patients’ health) and those of the policymakers (effectiveness of the digitalisation). Indeed, our analysis was planned in terms of achievement of intended impacts, according to the foreseen innovation, thus considering aspects such as the extent of goals, level of accessibility by the target population and the efficiency in the implementation (World Bank, 2003). On the contrary, by the side of our interviewees, the indication was given properly to health outcomes that are the consequences brought by the treatment of a health condition or as a result of an interaction with the healthcare system (Lee and Leung, 2014).

This misalignment can be seen as an indicator of the fact that, even if covering managerial roles, health personnel are keen on medical results for patients and see digitalisation and telemedicine per se as tools. On the contrary, by a proper budgeting allocation on innovation and digitalisation, the policymaking side sees outcomes within the general management of health services (e.g. cost reduction, time reduction, etc.) including the achievement of its aims, as a secondary component.

Therefore, after appropriate clarifications, important indications came out. The first important one, on which all the interviewees agreed, is that digitalisation and telemedicine are opportunities, but much will depend on how the PNRR innovation will be actually implemented. By the side of the managers, it has been highlighted that there is a necessity for a “different vision” in terms of local health services, where digitalisation and telemedicine might be the drivers of the change, not the change. All agreed on the great opportunities for monitoring and caring of patients with chronic diseases, which now have, in too many cases, several periodical occurrences of risky acute phases due to a lack of daily monitoring, caring and prevention assistance. Nevertheless, our respondents, especially the GPs, manifested scepticism. A scepticism, which we discovered, was based on their past and present experience within the INHS scheme, as clearly illustrated in the following descriptions of the items staffing and, especially, collaboration among services.

The aspect regarding staffing was easy to be decrypted from our content analysis, but, at the same time, it was really a worrying one. The knowledge needed to deliver digitalised and telemedicine assistance is complex, collective, and organisationally embedded, where non-didactic training (e.g. joint clinical sessions, case-based discussions, and in-person, whole-team and on-the-job training) covers a fundamental role (Greenhalgh et al., 2023). Unfortunately, this is not happening at all in the ongoing process inspired by the PNRR. Both during the interviews with the managers, and especially within the second focus group with the GPs, it clearly came out that not even information is given, let alone training.

We discovered that no GP was aware that the electronic health record was already at their disposal and that they could exchange information. All the interviewed persons had notions about telemedicine, but none was able to give even a basic definition of the different components as given by the ministry, as reported in 4.1 (e.g. no clear idea about the difference between telerehabilitation and telemonitoring, no idea about the process for a tele-examination, etc.). They actually had no information about the implementation of the system, as stated by GP3, who, during the second focus group, affirmed, “We are ill-informed, we have no capabilities, we don’t know”. We discovered a kind of strange misalignment: there are technical resources and funds to increase them, but there is nothing on personnel.

Moreover, most of the respondents also highlighted a possible digital divide within the aged personnel, but most of all a lack of experience. GP7 summed up by declaring, “Before starting a battle, you have to know what forces you have, and it is not sufficient to have tools; you need personnel”.

In order to be effective, a telemedicine system should take care of the quality of (1) health information, (2) the electronic health record system and (3) the telehealth service (Zhang and Saltman, 2022). The ongoing reform does recognise the importance of planning and implementing a health innovation ecosystem but seems to forget the importance of telehealth service quality. Indeed, this third aspect highlights that health providers should offer the same level of care and follow the same treatment guidelines for telehealth services as with in-person visits and ensure that their practices are compliant with applicable regulations (Zhang and Saltman, 2022). According to our investigation, this is not happening.

While on one hand all the respondents agreed on the relevance of having the possibility of teleconsultations and telemonitoring, thus having a discussion among different specialists, even from distant sites, on the other hand they see it as a utopia, not even as a dream. Apart from the lack of retraining (as reported in the previous point), the great issue which emerged was the dichotomy between the ongoing running bureaucratic system and the idealised planned telemedicine reform inspired by the PNRR. GP3 affirmed, “It would be great to have the possibility to interact at a distance with specialists for a teleconsultation, but do you know that now, if we want to prescribe home assistance, we still have to fill out specific forms which are given to us on printed paper? What are you talking about? We dream of simplification but we still have bureaucracy”. GP7 stated, “We’d like to exchange information, but the daily reality is that there are no specific protocols and especially no knowledge on the side of the personnel, and I’m referring to administrative ones. I saw screens left open with all sensible data while none were working in that specific moment!” Moreover, most of the respondents highlighted that “one thing is to work in urbanised areas; another is to assist people in internal ones (especially near mountains) where you need more the possibility of having a teleconsultation, but you don’t even have a stable connection”.

But the greatest unexpected issue regarded the system interoperability. We discovered that, apart from the already known differences in terms of software among the regions, there was also different software among the realities insisting on the same territory. GP5 stated, “They talk about the possibility of having interaction among the territories, but then my organisation (referring to one of his GPs) suggested good management software, then the ASL (the territorial autonomous administrative branch of the INHS) has another one and the region another one! To account for our work and to allow the analysis of epidemiological data, a good spreadsheet was more than enough. On the contrary, we have to be linked to three licensed software providers! Where is the connection? How could we do networking?”

In considering this final item, we started our investigation having in mind the EU Commission definition, which sees it as “putting users'” needs at the centre when determining which public services should be provided and how they should be delivered (EC, 2020). On the contrary, we found that the respondents, and GPs in particular, were considering it from a completely different point of view.

They highlighted the necessity of, in some sense, “educating the patients”. Indeed, there were made affirmations such as GP5: “Their expectations, in such a free-of-charge public system as the Italian one, made the system inefficient. In several cases there are excessive requests”; GP3: “It is a cultural aspect. With the improper use of the Internet, a kind of ‘self-diagnosis’ is growing. And if you tell them they don’t need that medical examination, they tell you that you don’t know your work”, and GP7: “You are talking about monitoring at a distance, but do you know that we spent hours answering telephone calls that ask what to do if they have a cold or cough”. At the beginning, it was not clear to us why they were describing these situations while talking about telemedicine, but then we understood that they were all incipient cases to then conclude, “Can you imagine a patient to use a device to be monitored at a distance?” In other words, all the respondents wanted to highlight that it is not sufficient to retrain health personnel, but you need to do it, especially with users. Moreover, they clarified that telemonitoring might be really helpful for chronic diseases, but most of the people needing it are old, and therefore, digital divide is an issue. GP7: “They call me on the telephone because they forgot the posology … How could you think I might interact with them if SMS is the only way to remotely transmit information, and only a few of them can use WhatsApp?” and GP4 added, “And those who can use it are a problem. They send pictures of the results of their self-monitoring of blood pressure, being worried. On the contrary, in the majority of the cases, this is due to an incorrect use of the machine. Could you imagine them having constant telemonitoring tools?”

Our investigation into the digitalisation reform of proximity healthcare services reveals a complex interplay among factors influencing the implementation of public policies. Building upon existing systematic reviews of implementation and implementation science frameworks, notably those by Ross et al. (2016) and Lau et al. (2015), we now offer a portrait of the enablers and barriers to the digitalisation of public primary care in circumstances of an ongoing major reform.

Our findings provide empirical evidence of the interconnections between external support and other factors in implementing e-health while changing the primary care system. First, financial support within a national policy framework is a potent activator of change. This finding aligns with both the “outer setting” construct of the Consolidated Framework for Integrating Research (CFIR) (Ross et al., 2016) and the “external context” dimension of the primary care implementation framework (Lau et al., 2015). However, according to our analysis, while the transformation by AGENAS concerning digitalisation is ongoing and the different software by the companies has been developed, there is yet no investment in workers' capabilities, first of all the GPs. The ongoing PNRR reform, concerning digitalisation and telemedicine, is therefore facing a significant challenge, which we term a “double track”. This “double track” exposes a significant mismatch between the design of national digitalisation policies and their actual application within the healthcare system’s existing organisational and professional settings. Despite an unprecedented allocation of financial and legislative backing, this inherent discrepancy creates a gap between policy aims and real-world implementation. On one side, the technical components are set to be fully implemented, while on the other, health personnel do not seem fully involved in the change, risking the reform’s success. Furthermore, bureaucracy, the continued use of “paper form” prescriptions, interoperability issues, the existence of different software across and even within territories and infrastructure barriers (such as the lack of stable connection in internal areas) are all contextualised examples of typical barriers in implementing policies. These issues directly relate to the point emphasised by both Lau et al. (2015) and Ross et al. (2016), which suggests that the “fit” between the intervention and its context is vital for successful implementation. We offered empirical evidence for their hypothesis, as especially asked by Lau et al. (2015).

Thus, if it can be assumed that legislation, policies and funds are necessary to promote change, we contend that they are not a sufficient condition. Our case confirms that organisational and professional disengagement interfere with the implementation of the plans, as organisational readiness is low and competencies are not built to sustain change (Lau et al., 2015; Ross et al., 2016). As stemmed from the regional healthcare systems covered by our study, there was inadequate preparation among healthcare professionals, and there were no established forms of experimentation with hospital-community integration. Therefore, not only did the organisational readiness of existing structures seem to be very low, but other experiences on which to build the new – and digitalised – primary care systems were entirely lacking.

Differently from the above analysed literature, we stress another important factor, which we found in the need of “educating/training” also patients, also revealing the importance of creating a co-production scheme for developing a really effective digitalised system. The commitment and active participation of patients represents indeed a prerequisite for obtaining high adherence, but if users are culturally not keen in contributing to the process, the potential of digitalisation remains unexploited. New policies should be designed, without underestimating the role of education and training as well, thanks to a wider use of co-production approaches (Cepiku et al., 2021), whose solutions could be further adapted at the point of use, according to the characteristics of the end user and/or the setting.

Our findings also showed other relevant details about the ongoing implementation of the reform. It seems to be a “great misunderstanding” between clinicians (focused on “patients’ health” and outcome) and policymakers (focused on “effectiveness of the digitalisation”, like cost/time reduction), highlighting a possible misalignment between priorities. Lau et al. (2015), for example, noted “no data” for relative priority about the implementation climate in their CFIR construct analysis. We offer concrete evidence to understand this less explored factor.

We also provided significant empirical depth to the concept of contextual fit and readiness, illustrating the practical challenges of achieving national standardisation in a decentralised system. Adaptability to local features is a known factor, but we unveiled different starting points in the regional systems, even within the territories of the same region, highlighting the scale and persistence of an uneven implementation despite the top-down national policy.

Further, our results are in line with the paradox according to which a huge problem in the health sector is not innovation per se, but the dissemination of innovative concepts (Berwick, 2003). The so-called promoters cover a fundamental role in this sense: they are key persons who allow the implementation of the change, contributing to overcoming its barriers (Gemünden et al., 2007). Accordingly, policymakers should design policies by first identifying key change agents. To design new plans, they should also raise the competences of different stakeholders for achieving common important outcomes (Arribas-Ibar et al., 2021). However, according to our results, the above-reported issues have not been taken into account by the ongoing reform, thus leading to the risk of spending PNRR money to implement a telemedicine system which no users are aware of but few health personnel know, while specific education in digital health and telemedicine is needed (Marsilio et al., 2024). Integration of telemedicine in clinical practices is possible only by understanding healthcare professionals’ expectations and concerns about adopting the new technology (Bernuzzi et al., 2024).

According to previous literature, further research is needed to deepen understanding of how enablers and barriers work together to influence implementation. Our case study allowed us to uncover patterns and trajectories of change within a renewed primary care (public) system. Change was driven by a new regulatory framework and health policy aimed at guiding primary services through digitalisation and telemedicine. Previous literature emphasised the importance of considering e-health implementation factors, particularly complexity, adaptability, compatibility and cost, stakeholders and change agents’ involvement, financial and legislative support, technological standards, organisational readiness, training and education, as well as ongoing monitoring, evaluation and adaptation (Ross et al., 2016). External context has been identified as a strong activator of telemedicine (Lau et al., 2015).

Analysing the Italian primary care system, mainly public, we were able to isolate some factors from others. In the ongoing reform, unprecedented financial and legislative support was given to realise the change, confirming its relevance to activate e-health paradigms in new settings and services. Further, we could focus on stakeholders’ and change agents’ involvement, as it emerged as one of the main barriers to policy implementation. We advanced previous literature, offering a portrait that deepens the understanding of how this factor works (together with others) in facilitating or hampering implementation (Lau et al., 2015), especially in the context of a (public) healthcare system.

Our results, although they cannot be fully generalised, confirm that a full reflection of a strategic nature aimed at defining the objectives to be pursued through the implementation of telemedicine is still immature (Bobini et al., 2023). However, notwithstanding the small number of interviews and the number of involved professionals in the focus group, we offer a richer portrait of how contextual factors influence implementation (Bate et al., 2014).

Resonating with Watt et al.'s (2005, p. 10) policies “that do not address the organisational, professional and social contexts are unlikely to achieve successful implementation. Political objectives alone, however well intentioned, are inadequate to change practice. When barriers to policy implementation exist in any of these contexts, the policy may fail to meet its objectives”. Our analysis demonstrates that the fit between the intervention (digitalisation and telemedicine) and the context (a decentralised public health system) should be designed by aligning stakeholders’ values and objectives (especially involving health professionals and end-users) as well as understanding the degree of infrastructural development of different geographical areas and the development of lines of services.

Further research is needed. Comparative studies among different healthcare settings (secondary and tertiary care) and systems (intercountry comparison) could be useful to confirm our findings or highlight other issues in the design and implementation of policy-driven digital healthcare reforms, considering social, professional and organisational contexts (Watt et al., 2005). Other studies could explore specific cultural factors and resistance patterns that hinder the adoption of digital healthcare tools among end-users, and other studies are needed to find strategies for better engagement of healthcare staff in digital initiatives. Finally, longitudinal studies of the implementation of such reforms could offer deeper insights on criticalities and the way to solve them.

Ministerial Decree 01/04/2022 interventi e i sub-interventi di investimento del Piano Nazionale di Ripresa e Resilienza (PNRR) a titolarità del Ministero della salute Available at https://www.trovanorme.salute.gov.it/norme/renderNormsanPdf?anno=2022&codLeg=86969&parte=1%20&serie=null (last accessed, Apr. 2024).

Law 25/2022 (2022) Conversione in legge, con modificazioni, del decreto-legge 27 gennaio 2022, n. 4, recante misure urgenti in materia di sostegno alle imprese e agli operatori economici, di lavoro, salute e servizi territoriali, connesse all’emergenza da COVID-19, nonche’ per il contenimento degli effetti degli aumenti dei prezzi nel settore elettrico, Italian Parliament. Available at https://def.finanze.it/DocTribFrontend/getAttoNormativoDetail.do?ACTION=getArticolo&id={1F40749E-77F0-41A6-AADC-9E2BBB58EDE6}&codiceOrdinamento=600000000000000&articolo=Allegato (Last accessed Apr. 2024).

The authors wish to thank Dr Pierpaolo Arquilla for his valuable help in allowing the possibility of organising the focus groups with the GPs of ASL 3.