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  • 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)

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Intensive care
Protocol
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)
  1. Regis Goulart Rosa1,
  2. Maicon Falavigna2,
  3. Caroline Cabral Robinson3,
  4. Daiana Barbosa da Silva1,
  5. Renata Kochhann3,
  6. Rafaela Moraes de Moura3,
  7. Mariana Martins Siqueira Santos3,
  8. Daniel Sganzerla3,
  9. Natalia Elis Giordani3,
  10. Cláudia Eugênio1,
  11. Tarissa Ribeiro1,
  12. Alexandre Biasi Cavalcanti4,
  13. Fernando Bozza5,
  14. Luciano Cesar Pontes Azevedo6,
  15. Flávia Ribeiro Machado7,
  16. Jorge Ibrain Figueira Salluh5,
  17. José Augusto Santos Pellegrini8,
  18. Rafael Barberena Moraes8,
  19. Taís Hochegger8,
  20. Alexandre Amaral9,
  21. José Mario Meira Teles9,
  22. Lucas Gobetti da Luz1,
  23. Mirceli Goulart Barbosa3,
  24. Daniella Cunha Birriel10,
  25. Iris de Lima Ferraz11,
  26. Vandack Nobre12,
  27. Helen Martins Valentim13,
  28. Livia Corrêa e Castro14,
  29. Péricles Almeida Delfino Duarte15,16,
  30. Rogério Tregnago17,
  31. Sofia Louise Santin Barilli18,
  32. Nilton Brandão19,
  33. Alberto Giannini20,
  34. Cassiano Teixeira1
  35. The ICU Visits Study Group Investigators and the BRICNet
    1. 1 Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil
    2. 2 Institute for Education and Research, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil
    3. 3 Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil
    4. 4 Research Institute, HCor, São Paulo, Brazil
    5. 5 Department of Critical Care, Instituto D’Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, Brazil
    6. 6 Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, Brazil
    7. 7 Department of Anesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil
    8. 8 Intensive Care Unit, Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil
    9. 9 Intensive Care Unit, Hospital de Urgências de Goiânia, Goiânia, Brazil
    10. 10 Intensive Care Unit, Pavilhão Pereira Filho, Centro Histórico, Porto Alegre, Brazil
    11. 11 Intensive Care Unit, Hospital de Urgência e Emergência de Rio Branco, Rio Branco, Brazil
    12. 12 Intensive Care Unit, Hospital das Clínicas, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
    13. 13 Intensive Care Unit, Hospital Mãe de Deus, Porto Alegre, Brazil
    14. 14 Intensive Care Unit, Hospital Regional do Baixo Amazonas, Santarém, Brazil
    15. 15 Intensive Care Unit, Hospital do Câncer de Cascavel, Cascavel, Brazil
    16. 16 Intensive Care, Hospital Universitário do Oeste do Paraná, Cascavel, Brazil
    17. 17 Intensive Care Unit, Hospital Tacchini, Bento Gonçalves, Brazil
    18. 18 Intensive Care Unit, Hospital Conceição, Porto Alegre, Brazil
    19. 19 Department of Internal Medicine, School of Medicine, Universidade Federal de Ciências da Saúde de Porto Alegre (UFCSPA), Porto Alegre, Brazil
    20. 20 Unit of Pediatric Anesthesia and Intensive Care, Ospedale dei Bambini - ASST Spedali Civili, Brescia, Italy
    1. Correspondence to Dr. Regis Goulart Rosa; regis.rosa{at}hmv.org.br

    Abstract

    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.

    • delirium
    • family
    • health personnel
    • critical care
    • intensive care unit

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2017-021193

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      Footnotes

      • Contributors RGR, CT and DBdS developed the main study intervention (FFVM). RGR, CT and MF developed the original concept of this study. RGR, MF, NB, ABC, FB, LCPA, FRM, JIFS, JASP, RBM and CT contributed to study design. RGR, LGdL and CT wrote the first draft of the paper, and MF, NB, ABC, FB, LCPA, FRM, JIFS, JASP, RBM, CCR, RK, RMdM, MMSS, DS, NEG, CE, TR, TH, AA, JMMT, MGB, DCB, IdLF, VN, HMV, LCeC, PADD, RT, SLSB and AG revised the first draft. The final manuscript was reviewed by all the authors. All authors read and approved the final manuscript.

      • Funding The present study was funded by the Brazilian Ministry of Health through the Program of Institutional Development of the Brazilian Unified Health System (PROADI-SUS).

      • Competing interests None declared.

      • Patient consent Not required.

      • Ethics approval This study will be conducted according to the resolution no 466/12 of the Brazilian National Health Council (http://bvsms.saude.gov.br/bvs/saudelegis/cns/2013/res0466_12_12_2012.html). The study protocol has been approved by the Research Ethics Committee of the coordinating site (approval number: CAAE 57717516.3.1001.5330) and the research ethics committees of all participant institutions (online supplementary file 3).

      • Provenance and peer review Not commissioned; externally peer reviewed.

      • Collaborators Hospital de Urgência e Emergência de Rio Branco (AC): Gigliane Maria Angelim de Albuquerque, Márcia Odília Marçal Vasconcelos and Edna Lopes Monteiro. Hospital Geral do Estado (AL): Vania Peixoto Ticianeli and Lucia Regina Arana Leite. Fundação Hospital Adriano Jorge (AM): Ivaneide Teixeira Barbosa, Henri Horstmann, Eliane Aparecida Peixoto Paulo and Enio Barreto. Hospital Geral Clériston Andrade (BA): Paulo Henrique Panelli Ferreira, Lúcio Couto de Oliveira Júnior, Daniela Cunha de Oliveira, Katia Santana Freitas and Eduardo da Silva Oliveira. Incardio – Santa Casa de Misericórdia de Feira de Santana (BA): Patrick Sampaio, Deise Freitas Casaes, Rosa Maria Rios Santana Cordeiro, André Raimundo Franca Guimarães and Ananda Catharina Azevedo Silva. Hospital Estadual de Urgência e Emergência do Espírito Santo (ES): Jander Fornaciari Pissinate, Lucas da Silva Lima, Letícia Sales Araújo, Albano Siqueira Muniz, Wallace Kadratz Klemz, Layla Cavallieri das Neves, Ana Cláudia Freitas Ferraz, Lucas Dornelas Freitas Machado e Silva, Leandro de Oliveira Ferreira and Ivens Guimarães Soares. Hospital de Urgências de Goiânia (GO): Ana Paula Menezes, Marco Antônio Castilho, Durval Pedroso, Janaynna Silva, Lilian Siqueira Costa Correia Pádua, Marco Antônio Castilho, Aline Dias Martins, Julia de Paula Oliveira, Rosangela Fernandes de Oliveira and Luciana Mendonça Carvalho. Hospital das Clínicas da Universidade Federal de Minas Gerais (MG): Christiane de Freitas Mourão Helt Mantuano Pereira, Ronan de Souza and Ana Carolina de Oliveira Paiva. Santa Casa de Misericórdia de São João Del Rei (MG): Jorge Luiz da Rocha Paranhos, Adilson de Carvalho Meireles, Iany Grinésia da Silva and Leonardo José de Oliveira Santos. Hospital Metropolitano de Urgência e Emergência de Ananindeua (PA): Norma Assunção, Viviane Ferreira Paes Monteiro, Giselle Cesar da Silva and Rafaella Ferreira. Hospital Regional do Baixo Amazonas (PA): Marli Sarmento da Silva, Denis Vasconcelos, Renê Augusto Gonçalves e Silva and Antonio Carlos Alves Siva. Hospital Alberto Urquiza Wanderley (PB): Ciro Leite Mendes, Sérgio Luz and Erick Albuquerque. Hospital Universitário Alcides Carneiro (PB): Amanda Manuella Dantas Nobre, Elzilene Costa Araujo Germano, Mayra Ferreira Nascimento, Cybele Cristina Cavalcante Lucena and André Luiz Diniz Costa. Hospital Universitário Lauro Wanderley (PB): Lucrecia Maria Bezerra, Igor Mendonça do Nascimento, Adriana Coutinho Leite, Marcia Abath Aires de Barros and Maria José de Vasconcelos. Hospital Agamenon Magalhães (PE): Marcos Gallindo, Alexandre Roque da Silva, Claudia Raquel Alcantara Manzi and Deyse Queiroz Nogueira. Hospital Universitário da Universidade Federal do Vale do São Francisco (PE): Kátia Regina de Oliveira, Saulo Bezerra Xavier, Rosivania Castro Figueiredo Ribeiro and Ademir Jose de Vlieger Junior. Hospital Universitário da Universidade Federal do Piauí (PI): Rejane Martins Prestes, Danyelle Alves Vieira, Laís Sousa Santos, Francisco Eduardo Viana Brito, Murilo Moura Lima and Elisana Andreia Ferreira Moura. Hospital do Câncer de Cascavel (PR): Raysa Cristina Schmidt and Delmiro Becker. Hospital Universitário do Oeste do Paraná (PR): Lizandra Oliveira Ayres, Gisele Yumi Hoshino and Amaury Cezar Jorge. Hospital Geral de Nova Iguaçu (RJ): Alexander Oliveira Sodré, Tennyson Pereira de Oliveira, Letícia Alves Pereira Entrago, Thiago Matos Barcellos, Cid Leite Vilela and Osvaldo Marques Barros da Silva. Hospital Deoclécio Marques de Lucena (RN): Alessandro da Silva Dantas, José André de Anchieta Monteiro, Pollyanna Iracema Peixoto Gouveia Gomes de Brito, Patrícia Manuella Melo de Oliveira Magalhães and Cleide Medeiros da Silva. Fundação Saúde Pública São Camilo de Esteio (RS): Luciana Caccavo Miguel, Carolina Karnopp, Patrícia Bonatto and Elisabeth Borba da Rosa. Hospital Ana Nery (RS): William Rutzen, Ricardo da Silveira Bastos and Clébio Barreto Teixeira. Hospital Conceição (RS): Wagner Luis Nedel, William Victor Lissa Dalprá, Raquel Lazzari, Andreia Specht and Carla Silva Lincho. Hospital da Cidade de Passo Fundo (RS): Janaína Pilau, Priscila Tonial Foscarini, Juliane Disegna Fraporti and Elsa Zanette Tallamini. Hospital de Clínicas de Porto Alegre (RS): Amanda Andrade Forni, Paula Jordana Pereira dos Santos, Aloma Luz da Silva, Giovana Getelina Ferreira, Maria Renata Pereira dos Santos, Ana Paula Melo Carvalho, Thais Dos Santos Donato Schmitz and Rita Gigliola Gomes Prieb. Hospital Don Vicente Scherer (RS): Edison Moraes Rodrigues Filho, Alexandre Formighieri de Mello, Raquel Hohenreuther and Ruth Susin. Hospital Mãe de Deus (RS): Andrea Beck, Eduarda Cristina Martins, Fabrícia Cristina Hoff, Lilian da Fe Silveira, Adriana Oliveira Prestes, Hígia Pires Pizzato, Fábio Rosa and Rafael Cremonese. Hospital Montenegro (RS): Moreno Calcagnotto dos Santos, Ana Flávia Gallas Leivas, José Pettine and Lourenço Dobrinsky. Hospital Santa Cruz (RS): Rafael Botelho Foernges, Andreia Schubert de Carvalho, Roberto Ritter de Souza and Vanessa Cardoso. Hospital Santa Rita (RS): Andre Peretti Torelly, Martha Hadrich and Gabriele Lobato Marins. Hospital São Lucas da PUCRS (RS): Sérgio Baldisserotto, Brenda Santos, Fernanda Bettega, Guilherme Barcellos and Catia Daiane Souza Silveira. Hospital Tacchini (RS): Carla Flores, Juliana Giacomazzi, Samanta da Costa and Danieli Madruga de Souza. Pavilhão Pereira Filho (RS): Elisiane Gouveia da Silva, Luana Oliveira da Silva, Clarisa Vargas Xis and Taiani Vargas. Hospital Dona Helena (SC): Milton Caldeira Filho, Fabiana Efting Mohr, Kethe de Oliveira Souza, Raquel Souza de Aguiar and Micheli Coral Arruda. Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto (SP): Wilson Jose Lovato, Julia Batista de Carvalho, Maria Aline Sprioli, Rodrigo Barbosa Cerantola, Tânia Mara Gomes and Janaína de Oliveira Perez. Hospital do Coração (SP): Vinícius Avellar Werneck, Rosianne de Vasconcelos, Rafael Trevizoli Neves and Danielle Penha Dassi.