• Daniel Sganzerla, Cassiano Teixeira, Caroline Cabral Robinson, Renata Kochhann, Mariana Martins Siqueira Santos, Rafaela Moraes de Moura, Mirceli Goulart Barbosa, Daiana Barbosa da Silva, Tarissa Ribeiro, Cláudia Eugênio, Daniel Schneider, Débora Mariani, Rodrigo Wiltgen Jeffman, Fernando Bozza, Alexandre Biasi Cavalcanti, Azevedo Luciano Cesar Pontes LCP Intensive Care Unit, Hospital Sírio-Libanês, Rua Dona Adma Jafet, 91, Bela Vista, São Paulo, SP, 01308-050, Brazil., Flávia Ribeiro Machado, Jorge Ibrain Salluh, Pellegrini José Augusto Santos JAS Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Rua Ramiro Barcelos, 2350, Santa Cecília, Porto Alegre, RS, 90035-903, Rafael Barberena Moraes, Lucas Petri Damiani, da Silva Nilton Brandão NB Department of Internal Medicine, School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Rua Sarmento Leite, 24, Maicon Falavigna, and Regis Goulart Rosa.
• Research Projects Office, Hospital Moinhos de Vento (HMV), Rua Ramiro Barcelos, 910, Moinhos de Vento, Porto Alegre, RS, 90035-001, Brazil.
• Trials. 2018 Nov 19; 19 (1): 636.

BackgroundMost adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals.Methods/DesignThe ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data.DiscussionThis a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field.Trial RegistrationClinicalTrials.gov, NCT02932358 . Registered on 11 October 2016.

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