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)

Sganzerla, Daniel; Teixeira, Cassiano; Robinson, Caroline Cabral; Kochhann, Renata; Santos, Mariana Martins Siqueira; Moura, Rafaela Moraes de; Barbosa, Mirceli Goulart; Silva, Daiana Barbosa da; Ribeiro, Tarissa; Eugênio, Cláudia; Schneider, Daniel; Mariani, Débora; Jeffman, Rodrigo Wiltgen; Bozza, Fernando; Cavalcanti, Alexandre Biasi; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Damiani, Lucas Petri; Silva, Nilton Brandão da; Falavigna, Maicon; Rosa, Regis Goulart

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)

Detalhes bibliográficos
Autor(a) principal:	Sganzerla, Daniel
Data de Publicação:	2018
Outros Autores:	Teixeira, Cassiano, Robinson, Caroline Cabral, Kochhann, Renata, Santos, Mariana Martins Siqueira, Moura, Rafaela Moraes de, Barbosa, Mirceli Goulart, Silva, Daiana Barbosa da, Ribeiro, Tarissa, Eugênio, Cláudia, Schneider, Daniel, Mariani, Débora, Jeffman, Rodrigo Wiltgen, Bozza, Fernando, Cavalcanti, Alexandre Biasi, Azevedo, Luciano Cesar Pontes, Machado, Flávia Ribeiro, Salluh, Jorge Ibrain, Pellegrini, José Augusto Santos, Moraes, Rafael Barberena, Damiani, Lucas Petri, Silva, Nilton Brandão da, Falavigna, Maicon, Rosa, Regis Goulart
Tipo de documento:	Artigo
Idioma:	eng
Título da fonte:	Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo:	https://www.arca.fiocruz.br/handle/icict/33874
Resumo:	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.

Metadados do item

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spelling	Sganzerla, DanielTeixeira, CassianoRobinson, Caroline CabralKochhann, RenataSantos, Mariana Martins SiqueiraMoura, Rafaela Moraes deBarbosa, Mirceli GoulartSilva, Daiana Barbosa daRibeiro, TarissaEugênio, CláudiaSchneider, DanielMariani, DéboraJeffman, Rodrigo WiltgenBozza, FernandoCavalcanti, Alexandre BiasiAzevedo, Luciano Cesar PontesMachado, Flávia RibeiroSalluh, Jorge IbrainPellegrini, José Augusto SantosMoraes, Rafael BarberenaDamiani, Lucas PetriSilva, Nilton Brandão daFalavigna, MaiconRosa, Regis Goulart2019-07-08T12:26:25Z2019-07-08T12:26:25Z2018SGANZERLA, 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.https://www.arca.fiocruz.br/handle/icict/3387410.1186/s13063-018-3006-81745-6215Fernando 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.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Research Projects Office. Porto Alegre, RS, Brazil.Instituto D’Or de Pesquisa e Ensino. Department of Critical Care. Rio de Janeiro, RJ, Brazil.HCor Research Institute. São Paulo, SP, Brazil.Hospital Sírio-Libanês. Intensive Care Unit. São Paulo, SP, Brazil.Universidade Federal de São Paulo. Department of Anesthesiology, Pain and Intensive Care. São Paulo, SP, Brazil.HCor Research Institute. São Paulo, SP, Brazil.Hospital de Clínicas de Porto Alegre. Intensive Care Unit. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Institute for Education and Research. Porto Alegre, RS, Brazil.HCor Research Institute. São Paulo, SP, Brazil.Universidade Federal de Ciências da Saúde de Porto Alegre. Department of Internal Medicine, School of Medicine. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Institute for Education and Research. Porto Alegre, RS, Brazil.Hospital Moinhos de Vento. Intensive Care Unit. Porto Alegre, RS, Brazil.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.engBMCStatistical 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)info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleCritical careDeliriumCross infectionFamilyPersonal satisfactionAnxietyDepressionHealth personnelBurnoutinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; 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dc.title.pt_BR.fl_str_mv	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)
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)
spellingShingle	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) Sganzerla, Daniel Critical care Delirium Cross infection Family Personal satisfaction Anxiety Depression Health personnel Burnout
title_short	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)
title_full	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)
title_fullStr	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)
title_full_unstemmed	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)
title_sort	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)
author	Sganzerla, Daniel
author_facet	Sganzerla, Daniel Teixeira, Cassiano Robinson, Caroline Cabral Kochhann, Renata Santos, Mariana Martins Siqueira Moura, Rafaela Moraes de Barbosa, Mirceli Goulart Silva, Daiana Barbosa da Ribeiro, Tarissa Eugênio, Cláudia Schneider, Daniel Mariani, Débora Jeffman, Rodrigo Wiltgen Bozza, Fernando Cavalcanti, Alexandre Biasi Azevedo, Luciano Cesar Pontes Machado, Flávia Ribeiro Salluh, Jorge Ibrain Pellegrini, José Augusto Santos Moraes, Rafael Barberena Damiani, Lucas Petri Silva, Nilton Brandão da Falavigna, Maicon Rosa, Regis Goulart
author_role	author
author2	Teixeira, Cassiano Robinson, Caroline Cabral Kochhann, Renata Santos, Mariana Martins Siqueira Moura, Rafaela Moraes de Barbosa, Mirceli Goulart Silva, Daiana Barbosa da Ribeiro, Tarissa Eugênio, Cláudia Schneider, Daniel Mariani, Débora Jeffman, Rodrigo Wiltgen Bozza, Fernando Cavalcanti, Alexandre Biasi Azevedo, Luciano Cesar Pontes Machado, Flávia Ribeiro Salluh, Jorge Ibrain Pellegrini, José Augusto Santos Moraes, Rafael Barberena Damiani, Lucas Petri Silva, Nilton Brandão da Falavigna, Maicon Rosa, Regis Goulart
author2_role	author author author author author author author author author author author author author author author author author author author author author author author
dc.contributor.author.fl_str_mv	Sganzerla, Daniel Teixeira, Cassiano Robinson, Caroline Cabral Kochhann, Renata Santos, Mariana Martins Siqueira Moura, Rafaela Moraes de Barbosa, Mirceli Goulart Silva, Daiana Barbosa da Ribeiro, Tarissa Eugênio, Cláudia Schneider, Daniel Mariani, Débora Jeffman, Rodrigo Wiltgen Bozza, Fernando Cavalcanti, Alexandre Biasi Azevedo, Luciano Cesar Pontes Machado, Flávia Ribeiro Salluh, Jorge Ibrain Pellegrini, José Augusto Santos Moraes, Rafael Barberena Damiani, Lucas Petri Silva, Nilton Brandão da Falavigna, Maicon Rosa, Regis Goulart
dc.subject.en.pt_BR.fl_str_mv	Critical care Delirium Cross infection Family Personal satisfaction Anxiety Depression Health personnel Burnout
topic	Critical care Delirium Cross infection Family Personal satisfaction Anxiety Depression Health personnel Burnout
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.
publishDate	2018
dc.date.issued.fl_str_mv	2018
dc.date.accessioned.fl_str_mv	2019-07-08T12:26:25Z
dc.date.available.fl_str_mv	2019-07-08T12:26:25Z
dc.type.status.fl_str_mv	info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv	info:eu-repo/semantics/article
format	article
status_str	publishedVersion
dc.identifier.citation.fl_str_mv	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.
dc.identifier.uri.fl_str_mv	https://www.arca.fiocruz.br/handle/icict/33874
dc.identifier.doi.none.fl_str_mv	10.1186/s13063-018-3006-8
dc.identifier.eissn.none.fl_str_mv	1745-6215
identifier_str_mv	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. 10.1186/s13063-018-3006-8 1745-6215
url	https://www.arca.fiocruz.br/handle/icict/33874
dc.language.iso.fl_str_mv	eng
language	eng
dc.rights.driver.fl_str_mv	info:eu-repo/semantics/openAccess
eu_rights_str_mv	openAccess
dc.publisher.none.fl_str_mv	BMC
publisher.none.fl_str_mv	BMC
dc.source.none.fl_str_mv	reponame:Repositório Institucional da FIOCRUZ (ARCA) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ
instname_str	Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str	FIOCRUZ
institution	FIOCRUZ
reponame_str	Repositório Institucional da FIOCRUZ (ARCA)
collection	Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv	https://www.arca.fiocruz.br/bitstream/icict/33874/1/license.txt https://www.arca.fiocruz.br/bitstream/icict/33874/2/ve_Sganzerla_Daniel_etal_INI_2018.pdf https://www.arca.fiocruz.br/bitstream/icict/33874/3/ve_Sganzerla_Daniel_etal_INI_2018.pdf.txt
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bitstream.checksumAlgorithm.fl_str_mv	MD5 MD5 MD5
repository.name.fl_str_mv	Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv	repositorio.arca@fiocruz.br
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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)

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