| Author | Sganzerla, Daniel | |
| Author | Teixeira, Cassiano | |
| Author | Robinson, Caroline Cabral | |
| Author | Kochhann, Renata | |
| Author | Santos, Mariana Martins Siqueira | |
| Author | Moura, Rafaela Moraes de | |
| Author | Barbosa, Mirceli Goulart | |
| Author | Silva, Daiana Barbosa da | |
| Author | Ribeiro, Tarissa | |
| Author | Eugênio, Cláudia | |
| Author | Schneider, Daniel | |
| Author | Mariani, Débora | |
| Author | Jeffman, Rodrigo Wiltgen | |
| Author | Bozza, Fernando A. | |
| Author | Cavalcanti, Alexandre Biasi | |
| Author | Azevedo, Luciano Cesar Pontes | |
| Author | Machado, Flávia Ribeiro | |
| Author | Salluh, Jorge Ibrain | |
| Author | Pellegrini, José Augusto Santos | |
| Author | Moraes, Rafael Barberena | |
| Author | Damiani, Lucas Petri | |
| Author | Silva, Nilton Brandão da | |
| Author | Falavigna, Maicon | |
| Author | Rosa, Regis Goulart | |
| Access date | 2019-07-08T12:26:25Z | |
| Available date | 2019-07-08T12:26:25Z | |
| Document date | 2018 | |
| Citation | SGANZERLA, Daniel et al. Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU visits study). Trials, v. 19, p. 1-10, 2018. | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/33874 | |
| Description | Fernando Bozza. Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Documento produzido em parceria ou por autor vinculado à Fiocruz, mas não consta a informação no documento. | pt_BR |
| Language | eng | pt_BR |
| Publisher | BMC | pt_BR |
| Rights | open access | pt_BR |
| Title | Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU visits study) | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1186/s13063-018-3006-8 | |
| Abstract | Background: Most 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/design: The 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. Discussion: This 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. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Instituto D’Or de Pesquisa e Ensino. Department of Critical Care. Rio de Janeiro, RJ, Brazil. | pt_BR |
| Affilliation | HCor Research Institute. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Hospital Sírio-Libanês. Intensive Care Unit. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Universidade Federal de São Paulo. Department of Anesthesiology, Pain and Intensive Care. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | HCor Research Institute. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Hospital de Clínicas de Porto Alegre. Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Institute for Education and Research. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | HCor Research Institute. São Paulo, SP, Brazil. | pt_BR |
| Affilliation | Universidade Federal de Ciências da Saúde de Porto Alegre. Department of Internal Medicine, School of Medicine. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Institute for Education and Research. Porto Alegre, RS, Brazil. | pt_BR |
| Affilliation | Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil. | pt_BR |
| Subject | Critical care | pt_BR |
| Subject | Delirium | pt_BR |
| Subject | Cross infection | pt_BR |
| Subject | Family | pt_BR |
| Subject | Personal satisfaction | pt_BR |
| Subject | Anxiety | pt_BR |
| Subject | Depression | pt_BR |
| Subject | Health personnel | pt_BR |
| Subject | Burnout | pt_BR |
| e-ISSN | 1745-6215 | |
