• Regis Goulart Rosa, Maicon Falavigna, Caroline Cabral Robinson, Daiana Barbosa da Silva, Renata Kochhann, Rafaela Moraes de Moura, Mariana Martins Siqueira Santos, Daniel Sganzerla, Natalia Elis Giordani, Cláudia Eugênio, Tarissa Ribeiro, Alexandre Biasi Cavalcanti, Fernando Bozza, Azevedo Luciano Cesar Pontes LCP Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, Brazil., Flávia Ribeiro Machado, Salluh Jorge Ibrain Figueira JIF Department of Critical Care, Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil., Pellegrini José Augusto Santos JAS Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil., Rafael Barberena Moraes, Taís Hochegger, Alexandre Amaral, Teles José Mario Meira JMM Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Brazil., Lucas Gobetti da Luz, Mirceli Goulart Barbosa, Daniella Cunha Birriel, Iris de Lima Ferraz, Vandack Nobre, Helen Martins Valentim, Livia Corrêa E Castro, Duarte Péricles Almeida Delfino PAD Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Brazil. , Rogério Tregnago, Barilli Sofia Louise Santin SLS Intensive Care Unit, Hospital Conceição, Porto Alegre, Brazil., Nilton Brandão, Alberto Giannini, Cassiano Teixeira, and ICU Visits Study Group Investigators and the BRICNet.
• Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
• BMJ Open. 2018 Apr 13; 8 (4): e021193.

IntroductionFlexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals.Methods And AnalysisA cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals.Ethics And DisseminationThe study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through conferences and peer-reviewed journals.Trial RegistrationNCT02932358.© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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