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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)

Primary Purpose

Delirium

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Flexible Family Visitation Model (FFVM)
Restrictive Family Visitation Model (RFVM)
Sponsored by
Hospital Moinhos de Vento
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Intensive care units, Delirium, Cross infection, Mortality, Length of stay, Burnout, Professional, Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Urgência e Emergência de Rio Branco
  • Fundação Hospital Adriano Jorge
  • Hospital Geral Clériston Andrade
  • Hospital INCARDIO
  • Hospital de Urgências de Goiânia
  • Hospital das Clínicas da Universidade Federal de Minas Gerais
  • Santa Casa de Misericórdia de São João Del Rei
  • Hospital Regional do Baixo Amazonas
  • Hospital Universitário Alcides Carneiro
  • Hospital Universitário Lauro Wanderley
  • Hospital Universitário de Petrolina
  • Hospital Agamenom Magalhães
  • Hospital Universitário da Universidade Federal do Piauí
  • Hospital do Caâncer de Cascavel (UOPECCAN)
  • Hospital Universitário do Oeste do Paraná (UNIOESTE)
  • Hospital Geral de Nova Iguaçú
  • Hospital Deoclécio Marques de Lucena
  • Hospital Tacchini
  • Hospital São Camilo de Esteio
  • Hospital da Cidade de Passo Fundo
  • Hospital de Clínicas de Porto Alegre
  • Hospital Dom Vicente Scherer
  • Hospital Mãe de Deus
  • Hospital Nossa Senhora da Conceiçaão
  • Hospital Santa Rita
  • Pavilhão Pereira Filho
  • Hospital Ana Nery
  • Hospital Santa Cruz
  • Hospital Dona Helena
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
  • Hospital do Coração (HCor)
  • Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
  • Hospital Montenegro

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Flexible Family Visitation Model (FFVM)

Restrictive Family Visitation Model (RFVM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Antipsychotic use among ICU patients
Need of antipsychotic use during ICU stay
Need of mechanical restraints among ICU patients
Need of mechanical restraints among ICU patients during ICU stay
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.
Unplanned loss of invasive devices among ICU patients
Unplanned loss of venous catheter, tube feeding or urinary catheter
Mechanical ventilation-free days at day 7 among ICU patients
Days alive and free of mechanical ventilation during ICU stay.
Any ICU-acquired infection among ICU patients
Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.
ICU-acquired pneumonia among ICU patients
Pneumonia acquired after 48 hours of ICU admission.
ICU-acquired bloodstream infection among ICU patients
Bloodstream infection acquired after 48 hours of ICU admission.
ICU-acquired urinary tract infection among ICU patients
Urinary tract infection acquired after 48 hours of ICU admission.
ICU length of stay among ICU patients
Length of ICU stay in days
All-cause hospital mortality among ICU patients
rates of all-cause mortality during hospital stay
Symptoms of anxiety among family members
symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale
Symptoms of depression among family members
symptoms of depression among family members measured by the Hospital Anxiety and Depression scale
Satisfaction among among family members
Rates of patient's families satisfaction measured by the critical care family needs inventory
Prevalence of Burnout Syndrome among ICU professionals
Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory
Satisfaction with the current ICU visiting policy among ICU professionals
Satisfaction with the current ICU visiting policy among ICU professionals
Any adverse event related to ICU visitation
Any adverse event possible related to the ICU visitation model

Full Information

First Posted
October 11, 2016
Last Updated
November 21, 2018
Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT02932358
Brief Title
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)
Official Title
Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 28, 2017 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Moinhos de Vento
Collaborators
Ministry of Health, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium
Keywords
Intensive care units, Delirium, Cross infection, Mortality, Length of stay, Burnout, Professional, Depression, Anxiety

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The following interventions will be evaluated in the present study: restrictive family visitation model (intermittent visits according to local ICU regulation) and flexible family visitation model (12 consecutive hours per day). The unit of of concealed randomization is the ICU to minimize the risk of contamination, given that we intend to apply the intervention to the whole ICU multidisciplinary team. We will randomize ICUs to either an RFVM or to an FFVM as the initial intervention (T1). After enrollment of 25 ICU patients, there will be a 30-day period without recruitment to avoid contamination bias. After this period, each ICU will be assigned to an intervention contrary to that which initially receive (T2) until the enrollment of more 25 ICU patients.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1650 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flexible Family Visitation Model (FFVM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Restrictive Family Visitation Model (RFVM)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Flexible Family Visitation Model (FFVM)
Intervention Description
Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
Intervention Type
Other
Intervention Name(s)
Restrictive Family Visitation Model (RFVM)
Intervention Description
Visitation to ICU patients allowed during intermittent periods according local ICU regulation.
Primary Outcome Measure Information:
Title
Incidence of Delirium among ICU patients
Description
Incidence of delirium will be verified by trained intensive care professionals with the confusion assessment method for the ICU 2 times per day.
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary Outcome Measure Information:
Title
Daily hazard of delirium among ICU patients
Description
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).
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
Antipsychotic use among ICU patients
Description
Need of antipsychotic use during ICU stay
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
Need of mechanical restraints among ICU patients
Description
Need of mechanical restraints among ICU patients during ICU stay
Time Frame
During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Title
Coma-free days at day 7 among ICU patients
Description
Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.
Time Frame
During the first 7 days following patient enrollment.
Title
Unplanned loss of invasive devices among ICU patients
Description
Unplanned loss of venous catheter, tube feeding or urinary catheter
Time Frame
During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Title
Mechanical ventilation-free days at day 7 among ICU patients
Description
Days alive and free of mechanical ventilation during ICU stay.
Time Frame
During the first 7 days following patient enrollment.
Title
Any ICU-acquired infection among ICU patients
Description
Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
ICU-acquired pneumonia among ICU patients
Description
Pneumonia acquired after 48 hours of ICU admission.
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
ICU-acquired bloodstream infection among ICU patients
Description
Bloodstream infection acquired after 48 hours of ICU admission.
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
ICU-acquired urinary tract infection among ICU patients
Description
Urinary tract infection acquired after 48 hours of ICU admission.
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
ICU length of stay among ICU patients
Description
Length of ICU stay in days
Time Frame
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Title
All-cause hospital mortality among ICU patients
Description
rates of all-cause mortality during hospital stay
Time Frame
During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
Title
Symptoms of anxiety among family members
Description
symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale
Time Frame
IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Title
Symptoms of depression among family members
Description
symptoms of depression among family members measured by the Hospital Anxiety and Depression scale
Time Frame
On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Title
Satisfaction among among family members
Description
Rates of patient's families satisfaction measured by the critical care family needs inventory
Time Frame
On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Title
Prevalence of Burnout Syndrome among ICU professionals
Description
Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory
Time Frame
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.
Title
Satisfaction with the current ICU visiting policy among ICU professionals
Description
Satisfaction with the current ICU visiting policy among ICU professionals
Time Frame
It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.
Title
Any adverse event related to ICU visitation
Description
Any adverse event possible related to the ICU visitation model
Time Frame
During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regis Rosa, MD, PhD
Organizational Affiliation
Hospital Moinhos de Vento
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Urgência e Emergência de Rio Branco
City
Rio Branco
State/Province
AC
Country
Brazil
Facility Name
Fundação Hospital Adriano Jorge
City
Manaus
State/Province
AM
Country
Brazil
Facility Name
Hospital Geral Clériston Andrade
City
Feira De Santana
State/Province
BA
Country
Brazil
Facility Name
Hospital INCARDIO
City
Feira De Santana
State/Province
BA
Country
Brazil
Facility Name
Hospital de Urgências de Goiânia
City
Goiânia
State/Province
Goias
Country
Brazil
Facility Name
Hospital das Clínicas da Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
MG
Country
Brazil
Facility Name
Santa Casa de Misericórdia de São João Del Rei
City
São João Del Rei
State/Province
MG
Country
Brazil
Facility Name
Hospital Regional do Baixo Amazonas
City
Santarém
State/Province
PA
Country
Brazil
Facility Name
Hospital Universitário Alcides Carneiro
City
Campina Grande
State/Province
PB
Country
Brazil
Facility Name
Hospital Universitário Lauro Wanderley
City
João Pessoa
State/Province
PB
Country
Brazil
Facility Name
Hospital Universitário de Petrolina
City
Petrolina
State/Province
PE
Country
Brazil
Facility Name
Hospital Agamenom Magalhães
City
Recife
State/Province
PE
Country
Brazil
Facility Name
Hospital Universitário da Universidade Federal do Piauí
City
Teresina
State/Province
PI
Country
Brazil
Facility Name
Hospital do Caâncer de Cascavel (UOPECCAN)
City
Cascavel
State/Province
PR
Country
Brazil
Facility Name
Hospital Universitário do Oeste do Paraná (UNIOESTE)
City
Cascavel
State/Province
PR
Country
Brazil
Facility Name
Hospital Geral de Nova Iguaçú
City
Nova Iguaçú
State/Province
RJ
Country
Brazil
Facility Name
Hospital Deoclécio Marques de Lucena
City
Parnamirim
State/Province
RN
Country
Brazil
Facility Name
Hospital Tacchini
City
Bento Gonçalves
State/Province
RS
Country
Brazil
Facility Name
Hospital São Camilo de Esteio
City
Esteio
State/Province
RS
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo
City
Passo Fundo
State/Province
RS
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Dom Vicente Scherer
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Mãe de Deus
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceiçaão
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Santa Rita
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Pavilhão Pereira Filho
City
Porto Alegre
State/Province
RS
Country
Brazil
Facility Name
Hospital Ana Nery
City
Santa Cruz Do Sul
State/Province
RS
Country
Brazil
Facility Name
Hospital Santa Cruz
City
Santa Cruz Do Sul
State/Province
RS
Country
Brazil
Facility Name
Hospital Dona Helena
City
Joinville
State/Province
SC
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
City
Ribeirão Preto
State/Province
SP
Country
Brazil
Facility Name
Hospital do Coração (HCor)
City
São Paulo
State/Province
SP
Country
Brazil
Facility Name
Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
City
João
Country
Brazil
Facility Name
Hospital Montenegro
City
Montenegro
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
Citations:
PubMed Identifier
29654049
Citation
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.
Results Reference
background
PubMed Identifier
30454019
Citation
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.
Results Reference
background
PubMed Identifier
33870915
Citation
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.
Results Reference
derived
PubMed Identifier
31310297
Citation
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.
Results Reference
derived

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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)

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