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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)

Trials. 2018;19(1):1-10 DOI 10.1186/s13063-018-3006-8

 

Journal Homepage

Journal Title: Trials

ISSN: 1745-6215 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Medicine (General)

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS


Daniel Sganzerla (Research Projects Office, Hospital Moinhos de Vento (HMV))

Cassiano Teixeira (Intensive Care Unit, HMV. Rua Ramiro Barcelos)

Caroline Cabral Robinson (Research Projects Office, Hospital Moinhos de Vento (HMV))

Renata Kochhann (Research Projects Office, Hospital Moinhos de Vento (HMV))

Mariana Martins Siqueira Santos (Research Projects Office, Hospital Moinhos de Vento (HMV))

Rafaela Moraes de Moura (Research Projects Office, Hospital Moinhos de Vento (HMV))

Mirceli Goulart Barbosa (Research Projects Office, Hospital Moinhos de Vento (HMV))

Daiana Barbosa da Silva (Intensive Care Unit, HMV. Rua Ramiro Barcelos)

Tarissa Ribeiro (Intensive Care Unit, HMV. Rua Ramiro Barcelos)

Cláudia Eugênio (Intensive Care Unit, HMV. Rua Ramiro Barcelos)

Daniel Schneider (Research Projects Office, Hospital Moinhos de Vento (HMV))

Débora Mariani (Research Projects Office, Hospital Moinhos de Vento (HMV))

Rodrigo Wiltgen Jeffman (Research Projects Office, Hospital Moinhos de Vento (HMV))

Fernando Bozza (Department of Critical Care, Instituto D’Or de Pesquisa e Ensino (IDOR))

Alexandre Biasi Cavalcanti (HCor Research Institute)

Luciano Cesar Pontes Azevedo (Intensive Care Unit, Hospital Sírio-Libanês)

Flávia Ribeiro Machado (Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP))

Jorge Ibrain Salluh (HCor Research Institute)

José Augusto Santos Pellegrini (Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA))

Rafael Barberena Moraes (Institute for Education and Research, HMV)

Lucas Petri Damiani (HCor Research Institute)

Nilton Brandão da Silva (Department of Internal Medicine, School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA))

Maicon Falavigna (Institute for Education and Research, HMV)

Regis Goulart Rosa (Intensive Care Unit, HMV. Rua Ramiro Barcelos)

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 15 weeks

 

Abstract | Full Text

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.