Clinical trial NCT02932358: 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
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Keywords: Intensive care units
Delirium
Cross infection
Mortality
Length of stay
Burnout, Professional
Depression
Anxiety
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2016-10-13
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Incidence of Delirium among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Secondary outcomes:
measure: Daily hazard of delirium among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: Antipsychotic use among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: Need of mechanical restraints among ICU patients
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
measure: Coma-free days at day 7 among ICU patients
timeFrame: During the first 7 days following patient enrollment.
measure: Unplanned loss of invasive devices among ICU patients
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
measure: Mechanical ventilation-free days at day 7 among ICU patients
timeFrame: During the first 7 days following patient enrollment.
measure: Any ICU-acquired infection among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: ICU-acquired pneumonia among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: ICU-acquired bloodstream infection among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: ICU-acquired urinary tract infection among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: ICU length of stay among ICU patients
timeFrame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
measure: All-cause hospital mortality among ICU patients
timeFrame: During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
measure: Symptoms of anxiety among family members
timeFrame: IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
measure: Symptoms of depression among family members
timeFrame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
measure: Satisfaction among among family members
timeFrame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
measure: Prevalence of Burnout Syndrome among ICU professionals
timeFrame: 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.
measure: Satisfaction with the current ICU visiting policy among ICU professionals
timeFrame: It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.
measure: Any adverse event related to ICU visitation
timeFrame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Other outcomes:
Locations:
city: Rio Branco
country: Brazil
facility: Hospital de Urgência e Emergência de Rio Branco
state: AC
city: Manaus
country: Brazil
facility: Fundação Hospital Adriano Jorge
state: AM
city: Feira De Santana
country: Brazil
facility: Hospital Geral Clériston Andrade
state: BA
city: Feira De Santana
country: Brazil
facility: Hospital INCARDIO
state: BA
city: Goiânia
country: Brazil
facility: Hospital de Urgências de Goiânia
state: Goias
city: Belo Horizonte
country: Brazil
facility: Hospital das Clínicas da Universidade Federal de Minas Gerais
state: MG
city: São João Del Rei
country: Brazil
facility: Santa Casa de Misericórdia de São João Del Rei
state: MG
city: Santarém
country: Brazil
facility: Hospital Regional do Baixo Amazonas
state: PA
city: Campina Grande
country: Brazil
facility: Hospital Universitário Alcides Carneiro
state: PB
city: João Pessoa
country: Brazil
facility: Hospital Universitário Lauro Wanderley
state: PB
city: Petrolina
country: Brazil
facility: Hospital Universitário de Petrolina
state: PE
city: Recife
country: Brazil
facility: Hospital Agamenom Magalhães
state: PE
city: Teresina
country: Brazil
facility: Hospital Universitário da Universidade Federal do Piauí
state: PI
city: Cascavel
country: Brazil
facility: Hospital do Caâncer de Cascavel (UOPECCAN)
state: PR
city: Cascavel
country: Brazil
facility: Hospital Universitário do Oeste do Paraná (UNIOESTE)
state: PR
city: Nova Iguaçú
country: Brazil
facility: Hospital Geral de Nova Iguaçú
state: RJ
city: Parnamirim
country: Brazil
facility: Hospital Deoclécio Marques de Lucena
state: RN
city: Bento Gonçalves
country: Brazil
facility: Hospital Tacchini
state: RS
city: Esteio
country: Brazil
facility: Hospital São Camilo de Esteio
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Dom Vicente Scherer
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mãe de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceiçaão
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Santa Rita
state: RS
city: Porto Alegre
country: Brazil
facility: Pavilhão Pereira Filho
state: RS
city: Santa Cruz Do Sul
country: Brazil
facility: Hospital Ana Nery
state: RS
city: Santa Cruz Do Sul
country: Brazil
facility: Hospital Santa Cruz
state: RS
city: Joinville
country: Brazil
facility: Hospital Dona Helena
state: SC
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Coração (HCor)
state: SP
city: João
country: Brazil
facility: Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
city: Montenegro
country: Brazil
facility: Hospital Montenegro
Study officials:
affiliation: Hospital Moinhos de Vento
name: Regis Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.