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

Regis Goulart Rosa, Maicon Falavigna, Daiana Barbosa da Silva, Daniel Sganzerla, Mariana Martins Siqueira Santos, Renata Kochhann, Rafaela Moraes de Moura, Cláudia Severgnini Eugênio, Tarissa da Silva Ribeiro Haack, Mirceli Goulart Barbosa, Caroline Cabral Robinson, Daniel Schneider, Débora Mariani de Oliveira, Rodrigo Wiltgen Jeffman, Alexandre Biasi Cavalcanti, Flávia Ribeiro Machado, Luciano Cesar Pontes Azevedo, Jorge Ibrain Figueira Salluh, José Augusto Santos Pellegrini, Rafael Barberena Moraes, Rafael Botelho Foernges, Andre Peretti Torelly, Lizandra de Oliveira Ayres, Pericles Almeida Delfino Duarte, Wilson José Lovato, Patrick Harrison Santana Sampaio, Lúcio Couto de Oliveira Júnior, Jorge Luiz da Rocha Paranhos, Alessandro da Silva Dantas, Pollyanna Iracema Peixoto Gouveia Gomes de Brito, Eliane Aparecida Peixoto Paulo, Marcos Antônio Cavalcanti Gallindo, Janaina Pilau, Helen Martins Valentim, José Mario Meira Teles, Vandack Nobre, Daniella Cunha Birriel, Livia Corrêa E Castro, Andréia Martins Specht, Gregory Saraiva Medeiros, Tulio Frederico Tonietto, Emersom Cicilini Mesquita, Nilton Brandão da Silva, Jeffrey E Korte, Luciano Serpa Hammes, Alberto Giannini, Fernando Augusto Bozza, Cassiano Teixeira
JAMA: the Journal of the American Medical Association 2019 July 16, 322 (3): 216-228

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: Identifier: NCT02932358.


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