[Skip to Content]
[Skip to Content Landing]
Original Investigation
Caring for the Critically Ill Patient
July 16, 2019

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

Regis Goulart Rosa, MD, PhD1,2,3; Maicon Falavigna, MD, PhD2; Daiana Barbosa da Silva, RN, MSc1,2; et al Daniel Sganzerla, BSc2; Mariana Martins Siqueira Santos, MSc2; Renata Kochhann, PhD2; Rafaela Moraes de Moura, PHAR2; Cláudia Severgnini Eugênio, RN, MSc1,2; Tarissa da Silva Ribeiro Haack, RN1,2; Mirceli Goulart Barbosa, MSc2; Caroline Cabral Robinson, PhD2; Daniel Schneider, BSc2; Débora Mariani de Oliveira, BSc2; Rodrigo Wiltgen Jeffman, MD2; Alexandre Biasi Cavalcanti, MD, PhD3,4; Flávia Ribeiro Machado, MD, PhD3,5; Luciano Cesar Pontes Azevedo, MD, PhD3,6; Jorge Ibrain Figueira Salluh, MD, PhD3,7; José Augusto Santos Pellegrini, MD, PhD8; Rafael Barberena Moraes, MD, PhD8; Rafael Botelho Foernges, MD9; Andre Peretti Torelly, MD10; Lizandra de Oliveira Ayres, RN11; Pericles Almeida Delfino Duarte, MD, PhD11,12; Wilson José Lovato, MD13; Patrick Harrison Santana Sampaio, MD14; Lúcio Couto de Oliveira Júnior, MD15; Jorge Luiz da Rocha Paranhos, MD16; Alessandro da Silva Dantas, MD17; Pollyanna Iracema Peixoto Gouveia Gomes de Brito, PT17; Eliane Aparecida Peixoto Paulo, RN18; Marcos Antônio Cavalcanti Gallindo, MD19; Janaina Pilau, MD, PhD20; Helen Martins Valentim, MD21; José Mario Meira Teles, MD22; Vandack Nobre, MD, PhD3,23; Daniella Cunha Birriel, MD24; Livia Corrêa e Castro, MD25; Andréia Martins Specht, RN, MSc26; Gregory Saraiva Medeiros, MD, MSc1,2; Tulio Frederico Tonietto, MD1; Emersom Cicilini Mesquita, MD, PhD7; Nilton Brandão da Silva, MD, PhD27; Jeffrey E. Korte, MD, PhD28; Luciano Serpa Hammes, MD, PhD2; Alberto Giannini, MD29; Fernando Augusto Bozza, MD, PhD3,7,30; Cassiano Teixeira, MD, PhD1,3; for the ICU Visits Study Group Investigators and the Brazilian Research in Intensive Care Network (BRICNet)
Author Affiliations
  • 1Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil
  • 2Research Projects Office, HMV, Porto Alegre, Rio Grande do Sul, Brazil
  • 3Brazilian Research in Intensive Care Network (BRICNet), São Paulo, São Paulo
  • 4HCor Research Institute, São Paulo, São Paulo, Brazil
  • 5Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, São Paulo, Brazil
  • 6Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, São Paulo, Brazil
  • 7Department of Critical Care, Instituto D’Or de Pesquisa e Ensino, Rio de Janeiro, Rio de Janeiro, Brazil
  • 8Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil
  • 9Intensive Care Unit, Hospital Santa Cruz, Santa Cruz do Sul, Rio Grande do Sul, Brazil
  • 10Intensive Care Unit, Hospital Santa Rita, Porto Alegre, Rio Grande do Sul, Brazil
  • 11Intensive Care Unit, Hospital Universitário do Oeste do Paraná, Cascavel, Paraná, Brazil
  • 12Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Paraná, Brazil
  • 13Intensive Care Unit, Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil
  • 14Intensive Care Unit, Santa Casa de Misericórdia de Feira de Santana, Feira de Santana, Bahia, Brazil
  • 15Intensive Care Unit, Hospital Geral Clériston Andrade, Feira de Santana, Bahia, Brazil
  • 16Intensive Care Unit, Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Minas Gerais, Brazil
  • 17Intensive Care Unit, Hospital Regional Doutor Deoclécio Marques de Lucena, Parnamirim, Rio Grande do Norte, Brazil
  • 18Intensive Care Unit, Fundação Hospital Adriano Jorge, Manaus, Amazonas, Brazil
  • 19Intensive Care Unit, Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil
  • 20Intensive Care Unit, Hospital da Cidade, Passo Fundo, Rio Grande do Sul, Brazil
  • 21Intensive Care Unit, Hospital Mãe de Deus, Porto Alegre, Rio Grande do Sul, Brazil
  • 22Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Goiânia, Brazil
  • 23Intensive Care Unit, Hospital das Clínicas, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil
  • 24Intensive Care Unit, Pavilhão Pereira Filho, Porto Alegre, Rio Grande do Sul, Brazil
  • 25Intensive Care Unit, Hospital Regional do Baixo Amazonas, Santarém, Pará, Brazil
  • 26Intensive Care Unit, Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande do Sul, Brazil
  • 27School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil
  • 28Department of Public Health Sciences, Medical University of South Carolina, Charleston
  • 29Unit of Pediatric Anesthesia and Intensive Care, Ospedale dei Bambini—ASST Spedali Civili, Brescia, Italy
  • 30Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Rio de Janeiro, Brazil
JAMA. 2019;322(3):216-228. doi:10.1001/jama.2019.8766
Visual Abstract.
Visual Abstract.
Flexible Family Visitation and Delirium in ICU Patients
Flexible Family Visitation and Delirium in ICU Patients
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

×