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Updated: Jan 19, 2026

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Published on: September 25, 2021
Improving communication toward ICU families to facilitate understanding and reduce stress. Protocol for a multicenter
Giovanni Mistraletti1, Andrea Mezzetti2, Stefania Anania3
1Dipartimento di Fisiopatologia Medico-Chirurgica e dei Trapianti, Università degli Studi di Milano, Italy; SC Anestesia e Rianimazione, ASST Santi Paolo e Carlo, Ospedale San Paolo - Polo Universitario, Milano, Italy.
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.
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