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)

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. Trial registration ClinicalTrials.gov, NCT02932358. Registered on 11 October 2016

Qualidade de vida pós-unidades de terapia intensiva: protocolo de estudo de coorte multicêntrico para avaliação de desfechos em longo prazo em sobreviventes de internação em unidades de terapia intensiva brasileiras

RESUMO Objetivo: Avaliar a prevalência de incapacidades físicas, cognitivas e psiquiátricas, fatores associados e sua relação com qualidade de vida em pacientes sobreviventes de internação em unidades de terapia intensiva brasileiras. Métodos: Um estudo de coorte prospectivo multicêntrico está sendo conduzido em dez unidades de terapia intensiva adulto clínico-cirúrgicas representativas das cinco regiões geopolíticas do Brasil. Pacientes com idade ≥ 18 anos que receberam alta das unidades de terapia intensiva participantes e permaneceram internados na unidade de terapia intensiva por 72 horas ou mais, nos casos de internação clínica ou cirúrgica de urgência, e por 120 horas ou mais, nos casos de internação cirúrgica eletiva, serão incluídos de forma consecutiva. Estes pacientes serão seguidos por 1 ano, por meio de entrevistas telefônicas estruturadas 3, 6 e 12 meses pós-alta da unidade de terapia intensiva. Dependência funcional, disfunção cognitiva, sintomas de ansiedade e depressão, sintomas de estresse pós-traumático, qualidade de vida relacionada à saúde, re-hospitalizações e mortalidade em longo prazo serão avaliados como desfechos. Discussão: O presente estudo tem o potencial de contribuir para o conhecimento a respeito da prevalência e dos fatores associados à síndrome pós-cuidados intensivos na população de pacientes adultos sobreviventes de internação em unidades de terapia intensiva brasileiras. Ademais, a associação entre síndrome pós-cuidados intensivos e qualidade de vida relacionada à saúde poderá ser estabelecida

Effect of flexible family visitation on delirium among patients in the Intensive Care Unit: the ICU visits randomized clinical trial

Fernando Augusto 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.Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil (Rosa, D. B. da Silva, Eugênio, Haack, Medeiros, Tonietto, Teixeira); Research Projects Office, HMV, Porto Alegre, Rio Grande do Sul, Brazil (Rosa, Falavigna, D. B. da Silva, Sganzerla, Santos, Kochhann, de Moura, Eugênio, Haack, Barbosa, Robinson, Schneider, de Oliveira, Jeffman, Medeiros, Hammes); Brazilian Research in Intensive Care Network (BRICNet), São Paulo, São Paulo (Rosa, Cavalcanti, Machado, Azevedo, Salluh, Nobre, Bozza, Teixeira); HCor Research Institute, São Paulo, São Paulo, Brazil (Cavalcanti); Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, São Paulo, Brazil (Machado); Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, São Paulo, Brazil (Azevedo); Department of Critical Care, Instituto D’Or de Pesquisa e Ensino, Rio de Janeiro, Rio de Janeiro, Brazil (Salluh, Mesquita, Bozza); Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Rio Grande do Sul, Brazil (Pellegrini, Moraes); Intensive Care Unit, Hospital Santa Cruz, Santa Cruz do Sul, Rio Grande do Sul, Brazil (Foernges); Intensive Care Unit, Hospital Santa Rita, Porto Alegre, Rio Grande do Sul, Brazil (Torelly); Intensive Care Unit, Hospital Universitário do Oeste do Paraná, Cascavel, Paraná, Brazil (Ayres, Duarte); Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Paraná, Brazil (Duarte); Intensive Care Unit, Hospital das Clínicas, Faculdade de Medicina de Ribeirão Preto, Ribeirão Preto, São Paulo, Brazil (Lovato); Intensive Care Unit, Santa Casa de Misericórdia de Feira de Santana, Feira de Santana, Bahia, Brazil (Sampaio); Intensive Care Unit, Hospital Geral Clériston Andrade, Feira de Santana, Bahia, Brazil (de Oliveira Júnior); Intensive Care Unit, Santa Casa de Misericórdia de São João Del Rei, São João Del Rei, Minas Gerais, Brazil (Paranhos); Intensive Care Unit, Hospital Regional Doutor Deoclécio Marques de Lucena, Parnamirim, Rio Grande do Norte, Brazil (Dantas, de Brito); Intensive Care Unit, Fundação Hospital Adriano Jorge, Manaus, Amazonas, Brazil (Paulo); Intensive Care Unit, Hospital Agamenon Magalhães, Recife, Pernambuco, Brazil (Gallindo); Intensive Care Unit, Hospital da Cidade, Passo Fundo, Rio Grande do Sul, Brazil (Pilau); Intensive Care Unit, Hospital Mãe de Deus, Porto Alegre, Rio Grande do Sul, Brazil (Valentim); Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Goiânia, Brazil (Meira Teles); Intensive Care Unit, Hospital das Clínicas, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil (Nobre); Intensive Care Unit, Pavilhão Pereira Filho, Porto Alegre, Rio Grande do Sul, Brazil (Birriel); Intensive Care Unit, Hospital Regional do Baixo Amazonas, Santarém, Pará, Brazil (Corrêa e Castro); Intensive Care Unit, Hospital Nossa Senhora da Conceição, Porto Alegre, Rio Grande do Sul, Brazil (Specht); School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Rio Grande do Sul, Brazil (N. B. da Silva); Department of Public Health Sciences, Medical University of South Carolina, Charleston (Korte); Unit of Pediatric Anesthesia and Intensive Care, Ospedale dei Bambini—ASST Spedali Civili, Brescia, Italy (Giannini); Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Rio de Janeiro, Brazil (Bozza).Submitted by Janaína Nascimento ([email protected]) on 2019-09-11T14:37:38Z No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5)Approved for entry into archive by Janaína Nascimento ([email protected]) on 2019-09-11T14:52:11Z (GMT) No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5)Made available in DSpace on 2019-09-11T14:52:11Z (GMT). No. of bitstreams: 1 ve_Rosa_Regis_etal_INI_2019.pdf: 616825 bytes, checksum: 2aae5be305137324e272a08cc32e9270 (MD5) Previous issue date: 2019Múltipla - Ver em Notas.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