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Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care UnitThe ICU Visits Randomized Clinical Trial

Educational Objective
To learn about flexible family visitation policies for intensive care units.
1 Credit CME
Key Points

Question  Does a policy that permits flexible family visitation in the intensive care unit (up to 12 hours per day), compared with standard restricted visitation defined by each intensive care unit (median, 1.5 hours per day; up to 4.5 hours per day), reduce the incidence of delirium among patients?

Findings  In this cluster-crossover randomized clinical trial that involved 1685 patients in the intensive care unit, the incidence of delirium was 18.9% in the flexible family visitation group compared with 20.1% in the standard restricted visitation group, a difference that was not statistically significant.

Meaning  Flexible family visiting hours did not significantly reduce the incidence of delirium among patients in the intensive care unit.

Abstract

Importance  The effects of intensive care unit (ICU) visiting hours remain uncertain.

Objective  To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium.

Design, Setting and Participants  Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018.

Interventions  Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation.

Main Outcomes and Measures  Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory).

Results  Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, −1.7% [95% CI, −6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, −0.8% [95% CI, −2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, −3.8% [95% CI, −4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, −1.6 [95% CI, −2.3 to −0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, −1.2 [95% CI, −2.0 to −0.4]; P = .003) were significantly better with flexible visitation.

Conclusions and Relevance  Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.

Trial Registration  ClinicalTrials.gov Identifier: NCT02932358

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Article Information

Corresponding Author: Regis Goulart Rosa, MD, PhD, Intensive Care Unit, Hospital Moinhos de Vento, Rua Ramiro Barcelos, 910, 3° andar, Porto Alegre, Rio Grande do Sul 90035-001, Brazil (regis.rosa@hmv.org.br).

Accepted for Publication: June 3, 2019.

Author Contributions: Drs Rosa and Teixeira had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Rosa, Falavigna, da Silva, Sganzerla, Santos, Robinson, Schneider, Jeffman, Cavalcanti, Machado, Azevedo, Salluh, Pellegrini, Moraes, Birriel, Tonietto, Brandão da Silva, Hammes, Giannini, Bozza, Teixeira.

Acquisition, analysis, or interpretation of data: Rosa, Falavigna, da Silva, Sganzerla, Santos, Kochhann, de Moura, Eugênio, Haack, Barbosa, Robinson, Schneider, de Oliveira, Jeffman, Cavalcanti, Azevedo, Pellegrini, Moraes, Foernges, Torelly, Ayres, Duarte, Lovato, Sampaio, de Oliveira Júnior, Paranhos, Dantas, de Brito, Paulo, Gallindo, Pilau, Valentim, Teles, Nobre, Birriel, e Castro, Specht, Medeiros, Tonietto, Mesquita, Brandão da Silva, Korte, Giannini, Teixeira.

Drafting of the manuscript: Rosa, Falavigna, Sganzerla, Santos, Robinson, Schneider, Moraes, Foernges, de Brito, Tonietto, Brandão da Silva, Teixeira.

Critical revision of the manuscript for important intellectual content: Rosa, Falavigna, da Silva, Sganzerla, Santos, Kochhann, de Moura, Eugênio, Haack, Barbosa, Schneider, de Oliveira, Jeffman, Cavalcanti, Machado, Azevedo, Salluh, Pellegrini, Moraes, Torelly, Ayres, Duarte, Lovato, Sampaio, de Oliveira Júnior, Paranhos, Dantas, Paulo, Gallindo, Pilau, Valentim, Teles, Nobre, Birriel, e Castro, Specht, Medeiros, Tonietto, Mesquita, Brandão da Silva, Korte, Hammes, Giannini, Bozza, Teixeira.

Statistical analysis: Rosa, Falavigna, Sganzerla, Schneider, Pellegrini, Brandão da Silva, Korte.

Obtained funding: Rosa, Falavigna, Hammes, Teixeira.

Administrative, technical, or material support: Rosa, da Silva, Sganzerla, Santos, Kochhann, de Moura, Eugênio, Haack, Barbosa, Robinson, Schneider, de Oliveira, Jeffman, Cavalcanti, Pellegrini, Moraes, Foernges, Torelly, Ayres, Duarte, Lovato, de Oliveira Júnior, Paranhos, Dantas, Paulo, Pilau, Valentim, Birriel, e Castro, Specht, Medeiros, Tonietto, Mesquita, Teixeira.

Supervision: Rosa, Falavigna, Sganzerla, Schneider, Salluh, Pellegrini, Foernges, Teles, Nobre, Birriel, Brandão da Silva, Hammes, Bozza, Teixeira.

Conflict of Interest Disclosures: Dr Falavigna reported receiving grants from Associação Hospitalar Moinhos de Vento and receiving other from HTAnalyze Economia e Gestão em Saúde. Dr Eugênio reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Barbosa reported grants from Associação Hospitalar Moinhos de Vento. Dr Pellegrini reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Torelly reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Ayres reported receiving grants from Hospital Moinhos de Vento. Dr Duarte reported receiving grants from SUS/Sistema Único de Saúde—Brazilian Health Ministry. Dr Lovato reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr de Oliveira Júnior reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Paranhos reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Dantas reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Paulo reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Pilau reported receiving grants from Associação Hospitalar Moinhos de Vento. Dr Castro reported receiving grants from Associação Hospitalar Moinhos de Vento. No other disclosures were reported.

Funding/Support: This study was funded by the Brazilian Ministry of Health through the Brazilian Unified Health System Institutional Development Program (PROADI-SUS).

Role of the Funder/Sponsor: The Brazilian Ministry of Health had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Group Information: The ICU Visits Group Investigators:Hospital de Urgência de Rio Branco (state of Acre): Íris de Lima Ferraz Siqueira, Gigliane Maria Angelim de Albuquerque, Edna Lopes Monteiro, Natasha Varjão Volpati, Tatiana Mendes Zerbini Leão. Hospital Geral do Estado Professor Osvaldo Brandão Vilela (Alagoas): Lucia Regina Arana Leite, Jullienne de Albuquerque Estevam, Fabiana Andrea da Silva Moreira, Maria Cleide de Abreu Torres, Larisse Simões Costa, Cristiane Caetano da Silva. Fundação Hospitalar Adriano Jorge (Amazonas): Kalil Emmanuel Oliveira, Alessandra de Sousa Resutto, Francisca Maria Nascimento da Cruz, Arlecy Moraes Do Carmo Martins, Oriana Wilkens Melo. Hospital Geral Clériston Andrade (Bahia): Paulo Henrique Panelli Ferreira, Daniela Cunha de Oliveira, Katia Santana Freitas, Eduardo da Silva Oliveira, João Victor Moraes de Melo, Maurício Gomes da Silva Serra. Santa Casa de Misericórdia de Feira de Santana (Bahia): Deise Freitas Casaes, Ananda Catharina Azevedo Silva, Rosa Maria Rios Santana, Maria Aparecida dos Santos Dantas. Hospital de Urgências de Goiânia (Goiás): Alexandre Amaral, Aline Dias Martins, Ana Paula Menezes, Lilian Siqueira Costa Correia Pádua, Marco Antonio Mendes Castilho Junior, Janaynna Rodrigues Silva, Carla Keit Aparecida Braz, Luciana Mendonça de Carvalho, Júlia de Paula Oliveira. Hospital das Clínicas da Universidade Federal de Minas Gerais (Minas Gerais): Christiane de Freitas Mourão Helt Mantuano Pereira, Ronan de Souza, Ana Carolina de Oliveira Paiva, Thiago Bragança Lana Silveira Ataíde. Santa Casa de Misericórdia de São João Del Rei (Minas Gerais): Adilson de Carvalho Meireles, Leonardo José de Oliveira Santos, Valéria Cristina Lima Coelho, Delmar Camelo de Oliveira, Iany Grinezia da Silva Wierman. Hospital Regional do Baixo Amazonas (Pará): Marden Junio Sousa Ferreira, Alline de Aguiar Cardoso Costa, Rodrigo Pedroso de Lima, Ilticiana Martins da Silva. Hospital Alberto Urquiza Wanderley (Paraíba): Igor Mendonça do Nascimento, Alana Maria Meireles Pereira, Rosilene Linhares de Souza Valentim, Karla Maria Duarte Silva Oliveira, Maria de Fátima Lima Serrano. Hospital Universitário Alcides Carneiro (Paraíba): Amanda Manuella Dantas Nobre, Iago Vieira Gomes, Cristiana Barbosa da Silva Gomes, Milena Késsia Tenório Leopoldino, Andrezza dos Santos Xavier Souto Maior. Hospital Universitário Lauro Wanderley (Paraíba): Lucrécia Maria Bezerra, Ciro Leite Mendes, Adriana Coutinho Leite, Márcia Abath Aires de Barros. Hospital do Câncer de Cascavel (Paraná): Delmiro Becker, Raysa Cristina Schmidt, Lucia Aparecida Daniel Lorencini, Audrey Regina Horochoski, Tatiane Borges da Silva Heidemann. Hospital Universitário do Oeste do Paraná (Paraná): Loide Ferreira Waldow, Renata de Souza Zaponi, Giseli Yumi Hoshino, Amaury Cezar Jorge, Itamar Regazzo Pedreschi Porto. Hospital Agamenom Magalhães (Pernambuco): Claudia Raquel Alcântara Manzi, Marçal Durval Paiva Junior, Marcelo Fiuza Chaves, Deyse Queiroz Nogueira. Hospital Universitário da Universidade Federal do Vale do São Francisco (Pernambuco): Kátia Regina de Oliveira, Maria Luciana Brasil de Lima Souza, Renata de Carvalho Gomes Prates, Saulo Bezerra Xavier. Hospital Universitário da Universidade Federal do Piauí (Piauí): Rejane Martins Prestes, Laís Sousa Santos de Almeida, Francisco Eduardo Viana Brito, Murilo Moura Lima, Francisco Magno Lima Alves, Tágora do Lago Santos, Carla Maria de Castro Dias e Silva, Martha Maria da Silva Batista. Hospital Geral de Nova Iguaçu (Rio de Janeiro): Alexander de Oliveira Sodré, Cid Leite Villela, Letícia Alves Pereira Entrago, Osvaldo Marques Barros da Silva, Thiago Matos Barcellos. Hospital Deoclécio Marques de Lucena (Rio Grande do Norte): Patrícia Manuella Melo de Oliveira Magalhães, Jose André de Anchieta Monteiro, Amanda Cristina Lima do Nascimento. Fundação Saúde Pública de Esteio (Rio Grande do Sul): Luciana Caccavo Miguel, Carolina Karnopp, Patrícia Bonatto, Juana Aracy Trindade Gómez, Cristiane Rolim Novakowski, Helton Lemos dos Reis. Hospital Ana Nery (Rio Grande do Sul): William Rutzen, Ricardo da Silveira Bastos, Clébio Barreto Teixeira, Vanessa Cargnelutti, Cassiele Daiane dos Santos. Hospital da Cidade de Passo Fundo (Rio Grande do Sul): Juliane Disegna Fraporti, Priscila Tonial Foscarini, Elsa Zanette Tallamini. Hospital de Clínicas de Porto Alegre (Rio Grande do Sul): Taís Hochegger, Thais Dos Santos Donato Schmitz, Rita Gigliola Gomes Prieb, Aloma Luz da Silva, Amanda Andrade Forni, Ana Paula Melo Carvalho, Giovana Getelina Ferreira, Letícia Gorski Simões Pires, Maria Renata Pereira dos Santos, Paula Jordana Pereira dos Santos. Hospital Dom Vicente Scherer (Rio Grande do Sul): Edison Moraes Rodrigues Filho, Alexandre Formighieri de Mello, Raquel Hohenreuther, Ruth Susin. Hospital Mãe de Deus (Rio Grande do Sul): Rafael Viegas Cremonese, Priscylla Souza Castro, Fabricia Cristina Hoff, Lilian da Fé Silveira, Eduarda Cristina Martins, Higia Pires Pizzato, Adriana Oliveira Prestes, Fabio Silva da Rosa, Andrea Diez Beck. Hospital Nossa Senhora da Conceição (Rio Grande do Sul): Carla Silva Lincho, Raquel Cristina Lazzari, Sofia Louise Santin Barilli, Wagner Luis Nedel, Henrique Saltz Netto, William Victor Lissa Dalpra. Hospital Montenegro (Rio Grande do Sul): José Pettine, Moreno Calcagnotto dos Santos, Ana Flávia Gallas Leivas, Lourenço Dobrinsky. Hospital Santa Cruz (Rio Grande do Sul): Andreia Schubert Carvalho, Roberta Veleda Rodrigues, Roberto Ritter de Souza, Katiuscia Brandenburg. Hospital Santa Rita (Rio Grande do Sul): Martha Hadrich, Alldren Silva de Souza, Caroline Fachini. Hospital Tacchini (Rio Grande do Sul): Rogério Tregnago, Carla Flores Braga, Juliana Giacomazzi, Samanta da Costa, Danieli Madruga de Souza. Pavilhão Pereira Filho (Rio Grande do Sul): Elisiane Gouveia da Silva, Luana Oliveira da Silva, Clarisa Vargas Xis. Hospital Dona Helena (Santa Catarina): Milton Caldeira Filho, Raquel Souza de Aguiar, Fabiana Efting Mohr, Kethe de Oliveira Souza, Micheli Coral Arruda. Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (São Paulo): Rodrigo Barbosa Cerantola, Julia Batista de Carvalho, Maria Aline Sprioli, Janaina de Oliveira Perez, Tania Mara Gomes. Hospital do Coração (São Paulo): Vinícius Avellar Werneck, Rosianne de Vasconcelos, Daniele Penha Dassi, Rafael Trevizoli Neves, Jorge Alcantara Farran.

Meeting Presentation: Presented in part at the 31st European Society of Intensive Care Medicine Congress; October 24, 2018; Paris, France.

Data Sharing Statement: See Supplement 3.

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