Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter randomized and controlled Italian study.

OBJECTIVE: Families of ICU patients have a pressing need for information: they find themselves suddenly in a complex technical environment often because of a life-threatening illness of a loved one. Some evidence suggests that specific communication tools (like websites or brochures) could improve the experience of ICU families. DESIGN: Randomized, multicenter, stepped wedge trial for large-scale assessment of the effectiveness of a multitasking intervention to improve communication with families of critically ill patients. MAIN OUTCOME: correct understanding of the prognosis. SECONDARY OUTCOMES: correct understanding of medical treatments, prevalence of anxiety, depression and post-traumatic stress symptoms in the first ICU week. Prevalence of PTSD 6 months from ICU discharge. Empathy and burnout among ICU staff. Prevalence of refusals for tissues/organ donation, and medical claims. SUBJECTS: 2100 ICU relatives of critically ill patients. INTERVENTIONS: The intervention employs specific tools especially designed to raise the correctness of information and to improve the quality of communication: a website presenting the ICU world and justifying the relatives' emotions, with a webpage specifically dedicated to each participating ICU; a standard brochure; eight posters for the families' waiting room and a signboard for the ICU door. MEASUREMENTS AND MAIN RESULTS: The study plans to assess these materials in up to 300 Italian ICUs that will participate, according to a five waves program, each one with randomized starting order. This way the effect of the intervention will be evaluated simultaneously. CONCLUSION: This is an educational study, aiming to spread good medical practices, while also verifying their real effectiveness in a large number of ICUs. TRIAL REGISTRATION NUMBER: NCT03438175.

Neurological assessment with validated tools in general ICU: multicenter, randomized, before and after, pragmatic study to evaluate the effectiveness of an e-learning platform for continuous medical education.

BACKGROUND: International guidelines recommend systematic assessment of pain, agitation/sedation and delirium with validated scales for all ICU patients. However, these evaluations are often not done. We have created an e-learning training platform for the continuous medical education, and assessed its efficacy in increasing the use of validated tools by all medical and nursing staff of the participating ICUs during their daily practice. METHODS: Multicenter, randomized, before and after study. The eight participating centers were randomized in two groups, and received training at different times. The use of validated tools (Verbal Numeric Rating or Behavioral Pain Scale for pain; Richmond Agitation-Sedation Scale for agitation; Confusion Assessment Method for the ICU for delirium) was evaluated from clinical data recorded in medical charts during a week, with follow-up up to six months after the training. All the operators were invited to complete a questionnaire, at baseline and after the training. RESULTS: Among the 374 nurses and physicians involved, 140 (37.4%) completed at least one of the three courses. The assessment of pain (38.1 vs. 92.9%, P<0.01) and delirium (0 vs. 78.6%, P<0.01) using validated tools significantly increased after training. Observation in the follow-up showed further improvement in delirium monitoring, with no signs of extinction for pain and sedation/agitation measurements. CONCLUSIONS: This e-learning program shows encouraging effectiveness, and the increase in the use of validated tools for neurological monitoring in critically ill patients lasts over time.

A family information brochure and dedicated website to improve the ICU experience for patients' relatives: an Italian multicenter before-and-after study.

PURPOSE: Good communication between ICU staff and patients' relatives may reduce the occurrence of post-traumatic stress disorder, anxiety or depression, and dissatisfaction with clinicians. An information brochure and website to meet relatives' needs were designed to explain in technical yet simple terms what happens during and after an ICU stay, to legitimize emotions such as fear, apprehension, and suffering, and to improve cooperation with relatives without increasing staff workload. The main outcomes were improved understanding of prognosis and procedures, and decrease of relatives' anxiety, depression, and stress symptoms. METHODS: In this prospective multicenter before-and-after study, a self-administered questionnaire was used to investigate relatives' understanding of prognosis, treatments, and organ dysfunction, families' satisfaction, and symptoms of anxiety, depression, and post-traumatic stress. RESULTS: A total of 551 relatives received questionnaires in nine Italian ICUs; 332 (60%) responded, 144 before and 179 after implementation of the brochure and website. Of the 179 relatives who responded after, 131 (73%) stated they had read the brochure and 34 (19%) reported viewing the website. The intervention was associated with increased correct understanding of the prognosis (from 69 to 84%, p = 0.04) and the therapeutic procedures (from 17 to 28%, p = 0.03). Multivariable analysis, together with non-modifiable factors (relative's gender, education level, relationship to patient, and patient status at ICU discharge), showed the intervention to be significantly associated with a lower incidence of post-traumatic stress symptoms (Poisson coefficient = -0.29, 95% CI -0.52/-0.07). The intervention had no effect on the prevalence of symptoms of anxiety and depression. CONCLUSION: An information brochure and website designed to meet relatives' needs improved family members' comprehension and reduced their prevalence of stress symptoms.

Enteral vs. intravenous ICU sedation management: study protocol for a randomized controlled trial.

BACKGROUND: A relevant innovation about sedation of long-term Intensive Care Unit (ICU) patients is the 'conscious target': patients should be awake even during the critical phases of illness. Enteral sedative administration is nowadays unusual, even though the gastrointestinal tract works soon after ICU admission. The enteral approach cannot produce deep sedation; however, it is as adequate as the intravenous one, if the target is to keep patients awake and adapted to the environment, and has fewer side effects and lower costs. METHODS/DESIGN: A randomized, controlled, multicenter, single-blind trial comparing enteral and intravenous sedative treatments has been done in 12 Italian ICUs. The main objective was to achieve and maintain the desired sedation level: observed RASS = target RASS ± 1. Three hundred high-risk patients were planned to be randomly assigned to receive either intravenous propofol/midazolam or enteral melatonin/hydroxyzine/lorazepam. Group assignment occurred through online minimization process, in order to balance variables potentially influencing the outcomes (age, sex, SAPS II, type of admission, kidney failure, chronic obstructive pulmonary disease, sepsis) between groups. Once per shift, the staff recorded neurological monitoring using validated tools. Three flowcharts for pain, sedation, and delirium have been proposed; they have been designed to treat potentially correctable factors first, and, only once excluded, to administer neuroactive drugs. The study lasted from January 24 to December 31, 2012. A total of 348 patients have been randomized, through a centralized website, using a specific software expressly designed for this study. The created network of ICUs included a mix of both university and non-university hospitals, with different experience in managing enteral sedation. A dedicated free-access website was also created, in both Italian and English, for continuous education of ICU staff through CME courses. DISCUSSION: This 'educational research' project aims both to compare two sedative strategies and to highlight the need for a profound cultural change, improving outcomes by keeping critically-ill patients awake. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov #NCT01360346.

The importance of spirituality in supportive care.

BACKGROUND: It has been shown that the pineal gland plays a fundamental role in mediating either the spiritual perception or the anticancer immunity by stimulating the endogenous production of anticancer cytokine interleukin (IL)-2. OBJECTIVE: The present study was performed to evaluate the impact of a spiritual approach consisting of Kriya Yoga program alone or in association with melatonin (MLT) or low-dose IL-2 plus MLT on the survival time in a group of metastatic cancer patients with life expectancy less than 1 year. MATERIALS AND METHODS: A case-control study was carried out in 240 patients (M/F: 146/94; median age: 62 years, range: 34-71, suffering from non-small-cell lung cancer or gastrointestinal tumors) who were subdivided into 6 groups of 40 patients, treated with supportive care alone as a control group, supportive care plus Yoga, MLT alone, MLT plus Yoga, inteleukin-2 plus MLT, or IL-2 plus MLT plus Yoga. RESULTS: The best results in terms of increased survival time were obtained by the association between neuroimmunotherapy with MLT plus IL-2 and Yoga program (2 years), which was significantly longer with respect to that achieved by supportive care alone, Yoga alone, or IL-2 plus MLT alone (1 year). CONCLUSIONS: This study would suggest that a spiritual therapeutic approach may improve the survival time of untreatable metastatic solid tumor patients.