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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial Registration</p> <p><b>Clincaltrials.gov Identifier</b>: NCT00395915</p

Developing mentorship in clinical practice:psychometrics properties of the Mentors’ Competence Instrument

Abstract Clinical placements are an important part of nursing education to developing nursing students’ competencies. In enhancing clinical learning, to focus on mentors’ competences is pivotal as they are the main role models and experts in guiding. This study is validated the Italian version of the Mentors’ Competence Instrument. A sampling frame of 648 mentors was involved. The final sample included 291 mentors (response rate 45%). Confirmatory Factor Analysis was performed. Fit indices were also calculated to evaluate validity. The scale demonstrated optimal fit indexes and its validity was confirmed by psychometrical testing. In detail, Root Mean Square Error of Approximation is 0.058, Standardized Root Mean Residual is 0.046, Comparative Fit Index is 0.893 and Tucker-Lewis Index 0.886. Cronbach’s alpha ranges from 0.77 to 0.95 among factors. This is the first validation of the scale performed in a different country from the original study. The performed psychometric testing showed that the scale is valid and reliable, as well as consistent with the theoretical structure reported for a different national context. This scale can be beneficial for comparing mentors’ competencies across different clinical learning environments and could be used to build a broader model of mentors’ competencies

Mentors’ competence in mentoring nursing students in clinical practice:detecting profiles to enhance mentoring practices

Abstract Aims: To describe the mentoring competence of clinical practice nurse mentors and identify different mentor profiles. Design: Cross-sectional research design, secondary analysis. Methods: An international, cross-sectional study design was performed in five European countries. A total of 1 604 mentors from 33 healthcare organizations participated in the study between 2016–2019. The Mentors’ Competence Instrument (MCI), which includes seven sub-dimensions and 44 items, was used to collect data. K-means cluster and binary regression analyses were performed to detect mentor profiles and determine how various factors affect competence, respectively. Results: The K-means cluster analysis identified three distinct profiles: A (n = 926); B (n = 566); and C (n = 85). The profiles showed significantly different values (p &lt; 0.001) across all seven areas of mentoring competence. In comparison with the other profiles, nurses in profile A were older, had more work experience and were more probably to have completed mentoring-specific training

Development and testing of an evidence-based model of mentoring nursing students in clinical practice

Abstract Background: Mentoring in clinical settings is an important factor in the development of nursing students’ professional knowledge and competences, but more knowledge of mentors’ current and required competences is needed to improve nursing students’ clinical learning. Objectives: This study aimed to develop and test an evidence-based model of mentoring nursing students in clinical practice. Design: An international cross-sectional survey coordinated in five European countries: Finland, Italy, Lithuania, Slovenia and Spain. Methods: Mentors, 4980 registered nurses working in both primary and specialist healthcare organizations, were invited to participate in the study during 2016—2019. The final sample consisted of 1360 mentors (mean age 41.9 ± 11). Data were collected with background questions and the Mentor Competence Instrument. The instrument was psychometrically validated then the data were used to construct a Structural Equation Model (SEM) with Full Imputation Maximum Likelihood (FIML) estimation. Results: All of six hypotheses were verified. In summary: mentors’ characteristics related to their motivation and reflection are positively related to mentoring practices in the workplace, which (together with constructive feedback) are positively related to and foster goal-orientation in students’ clinical learning and student-centered evaluation. All parameters in the SEM model were significant and the model’s fit indexes were verified (RMSEA = 0.055; SRMR = 0.083; CFI = 0.914, TLI = 0.909). Conclusion: Our evidence-based modeling confirms the research hypotheses about mentorship, and identifies focal competences for designing mentors’ education to improve students’ clinical learning and establish a common European mentoring model. Mentorship is important for both healthcare organizations and educational systems to enhance students’ clinical competences, professional growth and commitment to the nursing profession and organizational environments