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)

NCT02932358 | Completed

• 1 other identifier: ICU Visits
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 33

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.

Conditions

Delirium

Keywords

Intensive care units; Delirium; Cross infection; Mortality; Length of stay; Burnout, Professional; Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Daily hazard of delirium among ICU patients

  During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)

• Antipsychotic use among ICU patients

  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

  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

  During the first 7 days following patient enrollment.

• Unplanned loss of invasive devices among ICU patients

  During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

Study Arms (2)

Flexible Family Visitation Model (FFVM)

ACTIVE COMPARATOR

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)

Restrictive Family Visitation Model (RFVM)

ACTIVE COMPARATOR

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)

Interventions

Flexible Family Visitation Model (FFVM) OTHER

Visitation to ICU patients allowed during the period of 12 consecutive hours per day.

Flexible Family Visitation Model (FFVM)

Restrictive Family Visitation Model (RFVM) OTHER

Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

Restrictive Family Visitation Model (RFVM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead
• Ministry of Health, Brazil: collaborator

Study Sites (33)

Hospital de Urgência e Emergência de Rio Branco

Rio Branco, Acre, Brazil

Location

Fundação Hospital Adriano Jorge

Manaus, Amazonas, Brazil

Location

Hospital Geral Clériston Andrade

Feira de Santana, Estado de Bahia, Brazil

Location

Hospital INCARDIO

Feira de Santana, Estado de Bahia, Brazil

Location

Hospital de Urgências de Goiânia

Goiânia, Goiás, Brazil

Location

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

Santa Casa de Misericórdia de São João Del Rei

São João del Rei, Minas Gerais, Brazil

Location

Hospital do Caâncer de Cascavel (UOPECCAN)

Cascavel, Paraná, Brazil

Location

Hospital Universitário do Oeste do Paraná (UNIOESTE)

Cascavel, Paraná, Brazil

Location

Hospital Universitário Alcides Carneiro

Campina Grande, Paraíba, Brazil

Location

Hospital Universitário Lauro Wanderley

João Pessoa, Paraíba, Brazil

Location

Hospital Regional do Baixo Amazonas

Santarém, Pará, Brazil

Location

Hospital Universitário de Petrolina

Petrolina, Pernambuco, Brazil

Location

Hospital Agamenom Magalhães

Recife, Pernambuco, Brazil

Location

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, Brazil

Location

Hospital Geral de Nova Iguaçú

Nova Iguaçu, Rio de Janeiro, Brazil

Location

Hospital Deoclécio Marques de Lucena

Parnamirim, Rio Grande do Norte, Brazil

Location

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Location

Hospital São Camilo de Esteio

Esteio, Rio Grande do Sul, Brazil

Location

Hospital da Cidade de Passo Fundo

Passo Fundo, Rio Grande do Sul, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Dom Vicente Scherer

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Nossa Senhora da Conceiçaão

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Santa Rita

Porto Alegre, Rio Grande do Sul, Brazil

Location

Pavilhão Pereira Filho

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Ana Nery

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Location

Hospital Santa Cruz

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Location

Hospital Dona Helena

Joinville, Santa Catarina, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Location

Hospital do Coração (HCor)

São Paulo, São Paulo, Brazil

Location

Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)

João Monlevade, Brazil

Location

Hospital Montenegro

Montenegro, Brazil

Location

Related Publications (5)

• 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.

  PMID: 29654049 BACKGROUND

• 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.

  PMID: 30454019 BACKGROUND

• de Souza JMB, Miozzo AP, da Rosa Minho Dos Santos R, Mocellin D, Rech GS, Trott G, Estivalete GPM, Sganzerla D, de Souza D, Rosa RG, Teixeira C. Long-term effects of flexible visitation in the intensive care unit on family members' mental health: 12-month results from a randomized clinical trial. Intensive Care Med. 2024 Oct;50(10):1614-1621. doi: 10.1007/s00134-024-07577-3. Epub 2024 Aug 22.

  PMID: 39172240 DERIVED

• 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.

  PMID: 33870915 DERIVED

• 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.

  PMID: 31310297 DERIVED

MeSH Terms

Conditions

Delirium; Cross Infection; Burnout, Professional; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Regis Rosa, MD, PhD

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 13, 2016
• Study Start: April 28, 2017
• Primary Completion: June 22, 2018
• Study Completion: June 22, 2018
• Last Updated: November 23, 2018

Record last verified: 2018-11

Locations

BR (33)