The burden deriving from non-communicable diseases (NDCs) and multi-morbidity is currently challenging the capacity of the Italian National Health System (NHS) to respond to the health needs of its rapidly aging population. A change in approach to the management of NCDs is needed, focusing on strengthening primary health care (PHC) and PHC professionals and on empowering individuals in managing their disease and preventing complications thus improving their quality of life. The current project has the goal of structuring and evaluating the effectiveness of an innovative multifactorial intervention, led by family nurses, aimed at improving self-care skills of chronic patients in their living environment and context. A multicenter randomized clinical trial will be carried out involving trained Family Health Nurses in the administration of an experimental intervention specifically developed for the purpose of the project, based on a literature review, consisting of the following elements: Information, Training, Accessibility, Care-givers, Assessment (ITACA). At least 148 patients will be enrolled will during their hospital admission and randomized 1:1 into control and experimental groups. The primary outcome will be the change in the levels of quality of life and self-care. Secondary outcomes measures will include mortality and hospital utilization (readmission rate - type and cause of admission, length of hospitalization - unplanned access of care - ER, GPs). Outcomes will be assessed both in the experimental and in the control group through repeated measures over the 12-months follow-up period (baseline, 1,3,6,12 months). The project will contribute to generating evidence on the effectiveness of a family nursing model for the global management of chronic diseases. Based on an assessment of its effectiveness, the ITACA intervention could be extended also to other care settings.
The association between the increasing prevalence of chronic diseases, the aging of the population, the increase in patient expectations and the pressing need to contain costs, leads to a growing demand for PHC services, long-term care and reforms that transfer assistance from hospitals to the community, ensuring quality and continuity of care.
Self-care support aims to learn patients to actively participate in the management of their chronic condition and is the systematic provision of supportive interventions by healthcare staff to increase patients¿ skills and confidence in managing their chronic disease, including regular assessment of progress and problems, goal setting, and problem-solving support. As such, self-care support must encompass more than merely a didactic, instructional program which mainly focuses on transfer of knowledge: even though self-care interventions often contain didactic strategies, the pivotal objective is to change behaviour, which is essential to boost a sequence of effects. For these reasons, self-care support complex interventions constitute the most updated version of interventions including a series of components designed to activate patient engagement.
For the first time in our country, this study will attempt to demonstrate the efficacy of a community-based complex intervention aimed at improving the condition of patients with chronic diseases. This will enhance public health and public health nursing knowledge, the two pillars closely linked in this project. In detail, the results will allow us:
- To strengthen the role of the Family Health Nurse: the Family Health Nurse has been introduced by the WHO European office since the beginning of 2000, when in the framework "HEALTH21 - Health for all in the 21st century" (WHO, 1998), one of the main strategies of action was the promotion of integrated health care services, primary health care-based and family/community-oriented. Target 19 of the plan identified the need to develop human resources for care, also through the establishment of two frontline PHC workers, the family doctor and the Family Health Nurse, who became the center of the network of PHC (WHO, 2006). In 2000, the Munich Declaration reiterated the importance of the Family Health Nurse approach within the context of effective PHC. Since then, Italy has made efforts to implement this figure and introduce it into the NHS, without reaching official ratification and regulation. After several pilot experiences in different Italian regions (Rocco, 2017) and the recent interest of the Ministry of Health, the time has finally come. This study will allow us to evaluate the efficacy of an intervention guided by this new professional figure and will lay the foundations for subsequent and broader efficacy assessments (HTA) to guarantee an evidence-based practice in PHC.
- To propose an intervention which would represent the synthesis of the recent research on self-care and the latest educational and technological strategies: self-care in recent years has been extensively studied in patients with chronic diseases, especially in terms of predictors. Among the main concepts that derived from the conceptual model of self-care, two emphasize the role of education and training: (1) the recognition of symptoms is the key to the success of self-care manangement; (2) self-care is higher in patients with more knowledge, skills, experience and compatible values. But also: (3) Adherence to treatment and especially the monitoring of symptoms are the predictors of much of the self-care process (Vellone, 2013). This means that education alone does not lead to positive health outcomes (Stromberg, 2003) and that it is necessary to use behavioral strategies to preserve these changes over time, such as close supervision and follow-up after discharge. Patient education with family involvement, counseling, virtual coaching and telephone contacts, combined with daily monitoring using the most modern telemedicine eHealth techniques can reduce the likelihood of poor compliance and/or promptly identify those conditions for which there is the need to undertake corrective treatments that can prevent clinical deterioration and hospitalization. This approach, used on a large scale, could have a major impact not only on the individual patient, but on the general reduction of preventable disease, cases of hospitalization, and eventually mortality.