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

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.

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).

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.

Sistema de resposta rápida (SRR): como funciona e qual sua importância no contexto hospitalar / Rapid response system (RRS): how it works and its importance in the hospital context

Objetivos: Pretende-se contextualizar o surgimento e implementação dos Sistemas de Resposta Rápida (SRR) em hospitais terciários, trazendo aspectos históricos e organizacionais, com uma visão geral da composição e funcionamento dos SRRs, explicando a estrutura em braços de atuação (o braço aferente que identifica pacientes em risco e o braço eferente (conhecido como time de resposta rápida) que atua para melhorar o desfecho deste paciente). Aborda-se ainda o contexto regional, com uma apresentação da experiência de centros nacionais e as dificuldades de implementação. Métodos: as buscas basearam-se em duas plataformas, PubMed (NCBI) e Google Scholar. Focou-se em artigos publicados nos últimos 5 anos e utilizou-se tanto palavras chave em inglês quanto em português. As buscas foram realizadas em maio de 2018. Resultados: a busca revelou que ainda existe muita discordância na literatura sobre o SRR, existindo poucos estudos randomizados controlados, o que dificulta a elaboração de metanálises sobre o tema, apesar de os estudos mais recentes identificarem impactos positivos dos SRRs tanto em mortalidade quanto em organização hospitalar. Conclusões: apesar de ainda não existir uma unanimidade na literatura sobre todos os aspectos do SRR, existem dados de redução de desfechos negativos e de melhoria da assistência ao paciente crítico. Discutimos ainda a implementação do SRR no Brasil e boa evidência de sucesso.

Objective: This article intends to bring to light the context of the onset and implementation of the Rapid Response System (RRS) in tertiary hospitals around the globe, presenting historic and organizational aspects. We also present the arms structure of the SRR actuation (the afferent arm that is responsible for identifying at risk patients and the efferent or effector arm (best known as the rapid response team (RRT)) that acts to improve the patient outcome). This text was based on the most recent studies in the literature and in classics texts of the area. Our objective is to present a general vision of the composition and the operation of the RRS, besides the impact on the routine in the hospital. We also discuss the national context by presenting the experience in regional centers and the difficulties of RRS implementation. Methods: searches were conducted using two platforms, PubMed (NCBI) and Google Scholar. We focused on articles published in the last 5 years and both English (total of 984 articles) and Portuguese (total of 82 articles) keywords were used. Searches were conducted on May 2018. Results: our research revealed that there is still much disagreement in the literature regarding RRT, with few randomized case control studies, which dificults the elaboration of meta-analysis upon the subject, although some recent studies show positive impact of RRS both on mortality rates and hospital organization. Conclusions: although there is no unanimity in the literature about all of the aspects of RRS, recent data reveals benefits regarding reduction of negative outcomes and assistance for the critical patients . We found discrepancies between RRT's formats and discussed its implications in the assistential context. We also present articles that support the implementation of this system in Brazilian hospitals with a good success expectancy.