Your browser doesn't support javascript.
loading
Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study).
Rosa, Regis Goulart; Falavigna, Maicon; Robinson, Caroline Cabral; da Silva, Daiana Barbosa; Kochhann, Renata; de Moura, Rafaela Moraes; Santos, Mariana Martins Siqueira; Sganzerla, Daniel; Giordani, Natalia Elis; Eugênio, Cláudia; Ribeiro, Tarissa; Cavalcanti, Alexandre Biasi; Bozza, Fernando; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain Figueira; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Hochegger, Taís; Amaral, Alexandre; Teles, José Mario Meira; da Luz, Lucas Gobetti; Barbosa, Mirceli Goulart; Birriel, Daniella Cunha; Ferraz, Iris de Lima; Nobre, Vandack; Valentim, Helen Martins; Corrêa E Castro, Livia; Duarte, Péricles Almeida Delfino; Tregnago, Rogério; Barilli, Sofia Louise Santin; Brandão, Nilton; Giannini, Alberto; Teixeira, Cassiano.
Afiliação
  • Rosa RG; Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Falavigna M; Institute for Education and Research, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Robinson CC; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • da Silva DB; Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Kochhann R; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • de Moura RM; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Santos MMS; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Sganzerla D; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Giordani NE; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Eugênio C; Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Ribeiro T; Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Cavalcanti AB; Research Institute, HCor, São Paulo, Brazil.
  • Bozza F; Department of Critical Care, Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil.
  • Azevedo LCP; Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, Brazil.
  • Machado FR; Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.
  • Salluh JIF; Department of Critical Care, Instituto D'Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil.
  • Pellegrini JAS; Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
  • Moraes RB; Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
  • Hochegger T; Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.
  • Amaral A; Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Brazil.
  • Teles JMM; Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Brazil.
  • da Luz LG; Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Barbosa MG; Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.
  • Birriel DC; Intensive Care Unit, Pavilhão Pereira Filho, Centro Histórico, Porto Alegre, Brazil.
  • Ferraz IL; Intensive Care Unit, Hospital de Urgência e Emergência de Rio Branco, Rio Branco, Brazil.
  • Nobre V; Intensive Care Unit, Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.
  • Valentim HM; Intensive Care Unit, Hospital Mãe de Deus, Porto Alegre, Brazil.
  • Corrêa E Castro L; Intensive Care Unit, Hospital Regional do Baixo Amazonas, Santarém, Brazil.
  • Duarte PAD; Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Brazil.
  • Tregnago R; Intensive Care, Hospital Universitário do Oeste do Paraná, Cascavel, Brazil.
  • Barilli SLS; Intensive Care Unit, Hospital Tacchini, Bento Gonçalves, Brazil.
  • Brandão N; Intensive Care Unit, Hospital Conceição, Porto Alegre, Brazil.
  • Giannini A; Department of Internal Medicine, School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil.
  • Teixeira C; Unit of Pediatric Anesthesia and Intensive Care, Ospedale dei Bambini - ASST Spedali Civili, Brescia, Italy.
BMJ Open ; 8(4): e021193, 2018 04 13.
Article em En | MEDLINE | ID: mdl-29654049
INTRODUCTION: Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. METHODS AND ANALYSIS: A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals. ETHICS AND DISSEMINATION: The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through conferences and peer-reviewed journals. TRIAL REGISTRATION: NCT02932358.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Visitas a Pacientes / Delírio / Relações Familiares / Unidades de Terapia Intensiva Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans País/Região como assunto: America do sul / Brasil Idioma: En Ano de publicação: 2018 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Visitas a Pacientes / Delírio / Relações Familiares / Unidades de Terapia Intensiva Tipo de estudo: Clinical_trials / Prognostic_studies / Risk_factors_studies Limite: Adult / Humans País/Região como assunto: America do sul / Brasil Idioma: En Ano de publicação: 2018 Tipo de documento: Article