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.