Italian quality assurance in mental health.

Since the radical changes in Italian mental health law in the 1970s, quality assurance models have gained consensus as the most suitable service assessment tool. In the 1990s, the whole Italian National Health System changed into a corporate model, and an accreditation system was implemented.The Italian Association for Quality and Accreditation in Mental Health (Associazione Italiana per la Qualità e l'Accreditamento in Salute Mentale [QUASM]) was founded in 1984, and since then, it offers consultation and support for Mental Health Departments and Regional Governments to help them to develop psychiatric programs, self-evaluation, educational programs, and professional peer-model accreditation. The QUASM accreditation manual has now gone through several revisions, the last in 2008. Until 2008, QUASM was successful in promoting quality and facilitating both institutional and professional accreditation. However, radical changes triggered by financial crisis have jeopardized quality assurance implementation. Nowadays, the challenge for QUASM is to maintain quality and accreditation geared to excellence against prevailing leveling trends.

Patterns of referral in first-episode schizophrenia and ultra high-risk individuals: results from an early intervention program in Italy.

PURPOSE: This study set out to investigate the patterns of referral in a sample (n = 206) of patients having first-time access to an Italian comprehensive program that targets the early detection of and early intervention on subjects at the onset of psychosis. The primary goal of the study was to investigate the duration of untreated illness (DUI) and/or the duration of untreated psychosis (DUP) in the sample since the implementation of the program. METHOD: Data on pathways of referrals prospectively collected over a 11-year period, from 1999 to 2010; data referred to patients from a defined catchment area, and who met ICD-10 criteria for a first episode of a psychotic disorder (FEP) or were classified to be at ultra-high risk of psychosis (UHR) according to the criteria developed by the Personal Assessment and Crisis Evaluation (PACE) Clinic in Melbourne. Changes over time in the DUI and DUP were investigated in the sample. RESULTS: Referrals increased over time, with 20 subjects enrolled per year in the latter years of the study. A large majority of patients contacted a public or private mental health care professional along their pathway to treatment, occurring more often in FEP than in UHR patients. FEP patients who had contact with a non-psychiatric health care professional had a longer DUP. Over time, DUP and DUI did not change in FEP patients, but DUI increased, on average, in UHR patients. CONCLUSIONS: The establishment of an EIP in a large metropolitan area led to an increase of referrals from people and agencies that are not directly involved in the mental health care system; over time, there was an increase in the number of patients with longer DUI and DUP than those who normally apply for psychiatric services.

The mental health system in Lombardy, Italy: access to services and patterns of care.

PURPOSE: The psychiatric reform in Italy devolved to the regions the responsibility of implementing community psychiatric care. The aim of this paper is to evaluate the mental health system in Lombardy by assessing changes in accessibility and patterns of care occurred between 1999 and 2009. METHODS: Data on mental health services were collected through the regional mental health information system and analyzed in terms of treated prevalence, treated incidence, continuity of care and packages of care. RESULTS: Both treated incidence and treated prevalence in Lombardy increased between 1999 and 2009. There was an increasing access to psychiatric services of people with a better social integration. Incidence of schizophrenic and personality disorders decreased and that of affective and neurotic disorders increased dramatically, while increase in prevalence concerned all diagnostic groups. The percentage of patients in continuous care remained stable and was generally low. The majority of cases, even those with schizophrenia, are cared for on outpatient basis. The percentage of patients receiving integrated multiprofessional care declined. Rates of admission to inpatient services remained low and within the inpatient sector a shift from hospital towards residential care emerged, with decreasing hospital utilization and an increase in size of patient population entering community residences. Treatment gap is still a problem in schizophrenic disorders. CONCLUSIONS: The Lombardy mental health system is strongly based on community care. However, it is reaching a turning point and it needs to be improved in some key areas: the shifting balance towards the care of common mental disorders, in the absence of resource allocations targeted to severely mentally ill, may hinder the system ability to deal with more disabled people. A focus on early intervention and an improvement of continuity of care for people with severe mental disorder, by strengthening community teams, is a priority.

Measuring clinical change in routine mental health care: differences between first time and longer term service users.

OBJECTIVE: The aims were to assess the feasibility of routinely collecting outcome data in everyday mental health services across Italy and to evaluate clinical change in a cohort of patients stratified by illness duration. METHOD: A prevalence sample of patients attending nine Italian community mental health services (CMHS) was assessed over one year with the Health of the Nation Outcome Scales (HoNOS). The patients were classified on the basis of the duration of their contact with services. Clinical outcome was evaluated taking into account parameters of reliable and clinically significant change (RCSC). Predictors of change included clinical and socio-demographic characteristics at first assessment and six month reliable improvement. RESULTS: 2059 patients were evaluated with only 3% attrition at follow up; 22% of first time and about 7% of longer term users achieved reliable improvement at one year. First contacts had a better outcome than longer term users and significant differences were seen at both group and individual level. Reliable improvement at six months was the best predictor of clinical improvement at one year for the whole cohort. CONCLUSION: The study demonstrated the feasibility of routine outcome assessment and gave an expected and realistic picture of the one-year outcome of a representative sample of patients attending a group of Italian CMHS. RCSC showed potential utility as a means of communicating with clinicians and decision makers.

Burnout among psychiatrists in Milan: a multicenter survey.

OBJECTIVES: This study evaluated the prevalence of job burnout and estimated psychiatric morbidity and job satisfaction among psychiatrists in Milan. Also investigated were the contributions of personal and environmental factors to burnout. METHODS: Data were gathered via a cross-sectional, descriptive, multicenter survey. All psychiatrists working in departments of psychiatry within the Italian Public Health System in Milan were invited to participate, and an overall response rate of 70% (N=81) was achieved. The Maslach Burnout Inventory, the 12-item General Health Questionnaire, a job satisfaction measure, and a study-specific questionnaire were used in the assessments. RESULTS: Psychiatrists showed high levels of emotional exhaustion and depersonalization. Main sources of stress were related to work environment. According to regression models, the variable that most predicted burnout was a low level of job satisfaction. CONCLUSIONS: Data suggested that psychiatrists had higher levels of burnout than other physicians employed in general medical settings and confirmed that job satisfaction could have a protective role.

Rationale and design of an independent randomised controlled trial evaluating the effectiveness of aripiprazole or haloperidol in combination with clozapine for treatment-resistant schizophrenia.

BACKGROUND: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study. METHODS/DESIGN: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome. DISCUSSION: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.

[Management of violent behaviour and rapid tranquillisation during acute psychotic episode: discrepancy between routine practice and evidence. The SIEP-DIRECT'S Project]. / La gestione dei comportamenti violenti e della sedazione rapida durante l'episodio psicotico acuto: discrepanze fra pratica clinica ed evidenze. Il Progetto SIEP-DIRECT'S.

AIMS: To evaluate the quality of acute psychiatric care concerning the management of violent behaviour and rapid tranquilization. METHODS: Data concerning 13 indicators, drawn from NICE recommendations, were collected in 19 Departments of Mental Health, in the frame of the SIEP-DIRECT'S Project, to evaluate the implementation of NICE recommendations in Italian Mental Health Services. RESULTS: In about two thirds of Departments of Mental Health (DMHs) professionals were trained in the management of violent behaviour, while written procedures existed only in one fourth of DMHs. About a half of the professionals working in Psychiatric Wards in General Hospital were trained in rapid tranquilization, while procedures on this topic are practically absent and specific care for monitoring intensively the heavily sedated patient was not frequent. CONCLUSIONS: Management of violent behaviour and rapid tranquilization are two critical areas in the care performed by Psychiatric Wards in General Hospital. Training on these topics is more frequent than implementation of procedures. NICE recommendations and SIEP indicators are useful tools for improving the quality of acute psychiatric care.

Does community care work? A model to evaluate the effectiveness of mental health services.

The aim of this paper is to evaluate the effectiveness of community Mental Health Departments in Lombardy (Italy), and analyse the eventual differences in outcome produced by different packages of care. The survey was conducted in 2000 on 4,712 patients treated in ten Mental Health Departments. Patients were assessed at least twice in a year with HoNOS (Health of the Nation Outcome Scales). Data on treatment packages were drawn from the regional mental health information system, which includes all outpatient and day-care contacts, as well as general hospital and inpatient admissions provided by Mental Health Departments. Multilevel growth models were used for outcomes statistical analysis, expressed in terms of change of the total HoNOS score. On the whole, Mental Health Departments were effective in reducing HoNOS scores. The main predictor of improvement was treatment, while length of care, gender and diagnosis were weaker predictors. After severity adjustment, some packages of care proved more effective than others. Appropriate statistical methods, comprehensive treatment descriptions and routine outcome assessment tools are needed to evaluate the effectiveness of community mental health services in clinical settings.

[Residential facilities and day centres in mental health. Is there any difference?]. / Strutture residenziali e semiresidenziali nei servizi di salute mentale. Dove sta la differenza?

AIMS: We wanted to investigate to what extent and in what characteristics the patients cared in the psychiatric residential facilities (RF) were similar to those in the day-centres (DC), and whether 6-month improvements in the two settings were comparable. METHODS: We described 141 patients admitted to the RF and 180 in DC of three mental health service networks in Milan and near Milan. They were evaluated again after six months. RESULTS: In both groups, we identified subgroups of more intensive treatment: 45% of those in residential treatment were in high intensity rehabilitation facilities, and those who followed a residential program of >12 hours/week were 53%. The mean duration of treatment in the residential treatment was 40 months (SD 55.7) and in DC 49.6 months (49.3). The two groups differed in the overall scores of the HoNOS, but differences emerged in the subscales relative to daily life activities and living conditions. Among those in RF, about half had a house, versus 99% among those in DC. After six months, clinically significant modifications were small in both groups. CONCLUSIONS: Residential patients had more needs than DC patients. It is possible that some of the residential patients might be treated with intensive DC program, but the absence of a home for the majority of residential facilities patients makes this unlikely.

Estimating the prevalence of severe mental illness in mental health services in Lombardy (Italy).

Although many countries' policies give Severe Mental Illness (SMI) priority inside Mental Health Services, researches assessing the prevalence of SMI in Mental Health Services according to operational criteria are still few. The aim of this is paper is to define annual SMI treated prevalence, describing socio-demographic and clinical characteristics, patterns of care and treatment costs of SMI and non-SMI patients. SMI prevalence in 10 Departments of Mental Health of the Lombardy Region (Italy) was assessed in 2000 by applying criteria concerning both severity, measured through HoNOS (Health of the Nation Outcome Scales), and utilisation patterns in the previous year. Annual SMI prevalence was equal to 3.1 cases per 1,000 inhabitants aged over 14; SMI patients' costs were 5.5 times higher than those of non-SMI patients ($5,183 versus $939 per year) and patterns of care were different. The variables predicting the SMI status were diagnosis, presence of paid employment, duration of service contact, care packages delivered in 2000 and severity of some HoNOS items (self harm, drug abuse, cognitive problems, delusions, other symptoms, relationships, activities of daily living and housing). The use of the combined criteria of severity and intensity of contact with mental health services in the previous year seems to be able to define severely ill patients adequately.

Assessing reliable and clinically significant change on Health of the Nation Outcome Scales: method for displaying longitudinal data.

OBJECTIVE: Many authors recommended that reliable and clinically significant change (RCSC) should be calculated when reporting results of interventions. To test the reliability of the Health of the Nation Outcome Scales (HoNOS) in identifying RCSC, we applied the Jacobson and Truax model to two HoNOS assessments in a large group of people evaluated in 10 community mental health services in Lombardy, Italy, in 2000. METHOD: The HoNOS was administered to 9817 patients; of these, 4759 (48%) were re-assessed. Reliable change (RC) was calculated using Cronbach's alpha (alpha), as a parameter of the reliability of the measure. Clinical significance cut-offs were calculated using a classification of severity based on HoNOS items. RESULTS: In the whole sample, the clinical improvement cut-off was 11 and the remission cut-off was 5. Considering the severe patients, the clinical improvement cut-off was 12. The RC index calculated on the whole group and on the subgroup of severe patients indicated that eight-point and seven-point changes, respectively, were needed to be confident that a real change had occurred. Longitudinal changes were depicted on two-dimensional graphs as examples of reporting RCSC on HoNOS total scores in a routine data collection: 91.6% of the whole sample (4361) was stable, 5.6% (269) improved and 1.8% (129) worsened. CONCLUSION: Our study proposes a methodological framework for computing RCSC normative data on a widely used outcome scale and for identifying different degrees of clinical change.