Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial (The ICU Visits Study)

Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial

A cluster-randomized crossover trial involving adult ICU patients, family members, and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with visiting hours <4.5 h/day will be randomly assigned to either a restrictive family visitation model (RFVM) (visits according to local policies) or a flexible family visitation model (FFVM) (visitation during 12 consecutive hours per day) at a 1:1 ratio. After enrollment 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 at day 7, any ICU-acquired infections, ICU length of stay, and all-cause hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of symptoms of burnout among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days at day 7, 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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Other: Flexible Family Visitation Model (FFVM); Other: Restrictive Family Visitation Model (RFVM)

• Study Type: Interventional
• Enrollment (Actual): 1650
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • João, Brazil
    • Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
  • Montenegro, Brazil
    • Hospital Montenegro
  • AC
    • Rio Branco, AC, Brazil
      • Hospital de Urgência e Emergência de Rio Branco
  • AM
    • Manaus, AM, Brazil
      • Fundação Hospital Adriano Jorge
  • BA
    • Feira De Santana, BA, Brazil
      • Hospital Geral Clériston Andrade
    • Feira De Santana, BA, Brazil
      • Hospital INCARDIO
  • Goias
    • Goiânia, Goias, Brazil
      • Hospital de Urgências de Goiânia
  • MG
    • Belo Horizonte, MG, Brazil
      • Hospital das Clinicas da Universidade Federal de Minas Gerais
    • São João Del Rei, MG, Brazil
      • Santa Casa de Misericórdia de São João del Rei
  • PA
    • Santarém, PA, Brazil
      • Hospital Regional do Baixo Amazonas
  • PB
    • Campina Grande, PB, Brazil
      • Hospital Universitário Alcides Carneiro
    • João Pessoa, PB, Brazil
      • Hospital Universitário Lauro Wanderley
  • PE
    • Petrolina, PE, Brazil
      • Hospital Universitário de Petrolina
    • Recife, PE, Brazil
      • Hospital Agamenom Magalhaes
  • PI
    • Teresina, PI, Brazil
      • Hospital Universitário da Universidade Federal do Piauí
  • PR
    • Cascavel, PR, Brazil
      • Hospital do Caâncer de Cascavel (UOPECCAN)
    • Cascavel, PR, Brazil
      • Hospital Universitário do Oeste do Paraná (UNIOESTE)
  • RJ
    • Nova Iguaçú, RJ, Brazil
      • Hospital Geral de Nova Iguaçu
  • RN
    • Parnamirim, RN, Brazil
      • Hospital Deoclécio Marques de Lucena
  • RS
    • Bento Gonçalves, RS, Brazil
      • Hospital Tacchini
    • Esteio, RS, Brazil
      • Hospital São Camilo de Esteio
    • Passo Fundo, RS, Brazil
      • Hospital da cidade de Passo Fundo
    • Porto Alegre, RS, Brazil
      • Hospital Mae de Deus
    • Porto Alegre, RS, Brazil
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, RS, Brazil
      • Hospital Dom Vicente Scherer
    • Porto Alegre, RS, Brazil
      • Hospital Nossa Senhora da Conceiçaão
    • Porto Alegre, RS, Brazil
      • Hospital Santa Rita
    • Porto Alegre, RS, Brazil
      • Pavilhão Pereira Filho
    • Santa Cruz Do Sul, RS, Brazil
      • Hospital Ana Nery
    • Santa Cruz Do Sul, RS, Brazil
      • Hospital Santa Cruz
  • SC
    • Joinville, SC, Brazil
      • Hospital Dona Helena
  • SP
    • Ribeirão Preto, SP, Brazil
      • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
    • São Paulo, SP, Brazil
      • Hospital do Coração (Hcor)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• For ICUs: medical-surgical ICUs of of public and philanthropic Brazilian hospitals with restricted visitation policies(<4.5 hours/day).
• For Patients: Age ≥ 18 years, admission to the intensive care unit.
• For Patient's Family Members: nearest relative of the ICU patient recruited in the study and consent to participate in the study.
• For ICU Workers: ICU workers that assist patients in the ICU during the daytime for at least 20 hours per week and consent to participate in the study.

Exclusion Criteria:

• For ICUs: ICUs with structural or organizational impediments to extended visitation.
• For Patients: Subjects with coma (Richmond Agitation Sedation Scale -4 or -5) lasting > 96 hours from the moment of first evaluation for recruitment, or delirium at the baseline (positive Confusion Assessment Method for ICU) will be excluded. Individuals with cerebral death, aphasia, severe hearing deficit, a prediction of ICU length of stay < 48 hours, exclusively palliative treatment, or without a familiar member able to participate in extended ICU visits and those who are prisioners, unlikely to survive >24hs, re-admitted to the ICU after enrolment in the study will also be excluded.
• For Patient's Family Members: Another ICU patient's relative enrolled in the study; family members who don't speak Portuguese; Difficulty to answer the self-administered questionnaires (e.g.: illiteracy)
• For ICU Workers: ICU workers who have a prediction of withdrawal of ICU care activities >15 days during the study will be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flexible Family Visitation Model (FFVM); In the FFVM, two or fewer family members will be allowed to visit the patient for up to 12 consecutive hours each day. In addition to family visitation, patients will be allowed to receive social visits in specific time intervals (according local ICU regulation). To have access to the FFVM, family members of ICU patients will have to attend a structured meeting at ICU in which they will receive orientations about the ICU environment, common ICU treatments, rehabilitation and basic infection control practices, multidisciplinary work at ICU and palliative treatment. Social visitors will not be required to attend the structured meeting.	Other: Flexible Family Visitation Model (FFVM); Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
Active Comparator: Restrictive Family Visitation Model (RFVM); In the RFVM, patients will be allowed to receive restricted visits according routine ICU practices, but respecting the maximum limit of 4.5 hours of visitation per day. Visitors will not be required to attend the structured meeting. The length of ICU visits will be similar to those of social visits in the FFVM.	Other: Restrictive Family Visitation Model (RFVM); Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Delirium among ICU patients	Incidence of delirium will be verified by trained intensive care professionals with the confusion assessment method for the ICU 2 times per day.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily hazard of delirium among ICU patients	The daily hazard of delirium will be analyzed using a joint survival model that accounts for the treatment effect on repeated daily indicator of delirium (Confusion Assessment Method for the ICU) within each patient and terminating event (death or discharge from the ICU).	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Antipsychotic use among ICU patients	Need of antipsychotic use during ICU stay	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Need of mechanical restraints among ICU patients	Need of mechanical restraints among ICU patients during ICU stay	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Coma-free days at day 7 among ICU patients	Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.	During the first 7 days following patient enrollment.
Unplanned loss of invasive devices among ICU patients	Unplanned loss of venous catheter, tube feeding or urinary catheter	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Mechanical ventilation-free days at day 7 among ICU patients	Days alive and free of mechanical ventilation during ICU stay.	During the first 7 days following patient enrollment.
Any ICU-acquired infection among ICU patients	Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired pneumonia among ICU patients	Pneumonia acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired bloodstream infection among ICU patients	Bloodstream infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired urinary tract infection among ICU patients	Urinary tract infection acquired after 48 hours of ICU admission.	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU length of stay among ICU patients	Length of ICU stay in days	During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
All-cause hospital mortality among ICU patients	rates of all-cause mortality during hospital stay	During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
Symptoms of anxiety among family members	symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale	IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Symptoms of depression among family members	symptoms of depression among family members measured by the Hospital Anxiety and Depression scale	On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Satisfaction among among family members	Rates of patient's families satisfaction measured by the critical care family needs inventory	On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Prevalence of Burnout Syndrome among ICU professionals	Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory	It will be measured in two moments: within 15 days prior to the first ICU intervention and between the 15th and 30th days of the period in which no patient will be enrolled.
Satisfaction with the current ICU visiting policy among ICU professionals	Satisfaction with the current ICU visiting policy among ICU professionals	It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.
Any adverse event related to ICU visitation	Any adverse event possible related to the ICU visitation model	During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Collaborators: Ministry of Health, Brazil
• Investigators: Principal Investigator: Regis Rosa, MD, PhD, Hospital Moinhos de Vento

Publications and helpful links

General Publications

• Rosa RG, Falavigna M, Robinson CC, da Silva DB, Kochhann R, de Moura RM, Santos MMS, Sganzerla D, Giordani NE, Eugenio C, Ribeiro T, Cavalcanti AB, Bozza F, Azevedo LCP, Machado FR, Salluh JIF, Pellegrini JAS, Moraes RB, Hochegger T, Amaral A, Teles JMM, da Luz LG, Barbosa MG, Birriel DC, Ferraz IL, Nobre V, Valentim HM, Correa E Castro L, Duarte PAD, Tregnago R, Barilli SLS, Brandao N, Giannini A, Teixeira C; ICU Visits Study Group Investigators and the BRICNet. 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). BMJ Open. 2018 Apr 13;8(4):e021193. doi: 10.1136/bmjopen-2017-021193.
• Sganzerla D, Teixeira C, Robinson CC, Kochhann R, Santos MMS, de Moura RM, Barbosa MG, da Silva DB, Ribeiro T, Eugenio C, Schneider D, Mariani D, Jeffman RW, Bozza F, Cavalcanti AB, Azevedo LCP, Machado FR, Salluh JI, Pellegrini JAS, Moraes RB, Damiani LP, da Silva NB, Falavigna M, Rosa RG. 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 Nov 19;19(1):636. doi: 10.1186/s13063-018-3006-8.
• Rosa RG, Pellegrini JAS, Moraes RB, Prieb RGG, Sganzerla D, Schneider D, Robinson CC, Kochhann R, da Silva DB, Amaral A, Prestes RM, Medeiros GS, Falavigna M, Teixeira C. Mechanism of a Flexible ICU Visiting Policy for Anxiety Symptoms Among Family Members in Brazil: A Path Mediation Analysis in a Cluster-Randomized Clinical Trial. Crit Care Med. 2021 Sep 1;49(9):1504-1512. doi: 10.1097/CCM.0000000000005037.
• Rosa RG, Falavigna M, da Silva DB, Sganzerla D, Santos MMS, Kochhann R, de Moura RM, Eugenio CS, Haack TDSR, Barbosa MG, Robinson CC, Schneider D, de Oliveira DM, Jeffman RW, Cavalcanti AB, Machado FR, Azevedo LCP, Salluh JIF, Pellegrini JAS, Moraes RB, Foernges RB, Torelly AP, Ayres LO, Duarte PAD, Lovato WJ, Sampaio PHS, de Oliveira Junior LC, Paranhos JLDR, Dantas ADS, de Brito PIPGG, Paulo EAP, Gallindo MAC, Pilau J, Valentim HM, Meira Teles JM, Nobre V, Birriel DC, Correa E Castro L, Specht AM, Medeiros GS, Tonietto TF, Mesquita EC, da Silva NB, Korte JE, Hammes LS, Giannini A, Bozza FA, Teixeira C; ICU Visits Study Group Investigators and the Brazilian Research in Intensive Care Network (BRICNet). Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial. JAMA. 2019 Jul 16;322(3):216-228. doi: 10.1001/jama.2019.8766.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 22, 2018

Study Registration Dates

• First Submitted: October 11, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): November 23, 2018
• Last Update Submitted That Met QC Criteria: November 21, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Mortality; Delirium; Cross infection; Intensive care units; Length of stay; Burnout, Professional
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: ICU Visits

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No