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DeliriumNCT02932358

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)

A study testing Flexible Family Visitation Model (FFVM) and Restrictive Family Visitation Model (RFVM) in people with Delirium, run by Hospital Moinhos de Vento at 33 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium
What is being tested?
Flexible Family Visitation Model (FFVM) and Restrictive Family Visitation Model (RFVM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,650 participants
Where
33 sitesBrazil
Study dates
28 Apr 2017to 22 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Brazil33 sites

  • Hospital das Clínicas da Universidade Federal de Minas Gerais

    Belo Horizonte, Minas Gerais

  • Hospital Tacchini

    Bento Gonçalves, Rio Grande do Sul

  • Hospital Universitário Alcides Carneiro

    Campina Grande, Paraíba

  • Hospital do Caâncer de Cascavel (UOPECCAN)

    Cascavel, Paraná

  • Hospital Universitário do Oeste do Paraná (UNIOESTE)

    Cascavel, Paraná

  • Hospital São Camilo de Esteio

    Esteio, Rio Grande do Sul

  • Hospital Geral Clériston Andrade

    Feira de Santana, Estado de Bahia

  • Hospital INCARDIO

    Feira de Santana, Estado de Bahia

  • Hospital de Urgências de Goiânia

    Goiânia, Goiás

  • Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)

    João Monlevade

  • Hospital Universitário Lauro Wanderley

    João Pessoa, Paraíba

  • Hospital Dona Helena

    Joinville, Santa Catarina

  • Fundação Hospital Adriano Jorge

    Manaus, Amazonas

  • Hospital Montenegro

    Montenegro

  • Hospital Geral de Nova Iguaçú

    Nova Iguaçu, Rio de Janeiro

  • Hospital Deoclécio Marques de Lucena

    Parnamirim, Rio Grande do Norte

  • Hospital da Cidade de Passo Fundo

    Passo Fundo, Rio Grande do Sul

  • Hospital Universitário de Petrolina

    Petrolina, Pernambuco

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital Dom Vicente Scherer

    Porto Alegre, Rio Grande do Sul

  • Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul

  • Hospital Nossa Senhora da Conceiçaão

    Porto Alegre, Rio Grande do Sul

  • Hospital Santa Rita

    Porto Alegre, Rio Grande do Sul

  • Pavilhão Pereira Filho

    Porto Alegre, Rio Grande do Sul

  • Hospital Agamenom Magalhães

    Recife, Pernambuco

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto

    Ribeirão Preto, São Paulo

  • Hospital de Urgência e Emergência de Rio Branco

    Rio Branco, Acre

  • Hospital Ana Nery

    Santa Cruz do Sul, Rio Grande do Sul

  • Hospital Santa Cruz

    Santa Cruz do Sul, Rio Grande do Sul

  • Hospital Regional do Baixo Amazonas

    Santarém, Pará

  • Santa Casa de Misericórdia de São João Del Rei

    São João del Rei, Minas Gerais

  • Hospital do Coração (HCor)

    São Paulo, São Paulo

  • Hospital Universitário da Universidade Federal do Piauí

    Teresina, Piauí

Other trials in Brazil

About this 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

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
Being tested
Flexible Family Visitation Model (FFVM), Restrictive Family Visitation Model (RFVM)
Keywords
Intensive care units, Delirium, Cross infection, Mortality, Length of stay, Burnout, Professional, Depression, Anxiety
Medical subject headings
Delirium, Cross Infection, Burnout, Professional, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexible Family Visitation Model (FFVM)Other

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

  • Restrictive Family Visitation Model (RFVM)Other

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

Study groups in NCT02932358
Study groupRoleWhat they receive
Flexible Family Visitation Model (FFVM)Active comparatorIn 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.
Receives: Other: Flexible Family Visitation Model (FFVM)
Restrictive Family Visitation Model (RFVM)Active comparatorIn 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.
Receives: Other: Restrictive Family Visitation Model (RFVM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (18)

  1. 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).

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

  2. Antipsychotic use among ICU patients

    Need of antipsychotic use during ICU stay

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

  3. Need of mechanical restraints among ICU patients

    Need of mechanical restraints among ICU patients during ICU stay

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

  4. 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.

    Measured: During the first 7 days following patient enrollment.

  5. Unplanned loss of invasive devices among ICU patients

    Unplanned loss of venous catheter, tube feeding or urinary catheter

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

  6. Mechanical ventilation-free days at day 7 among ICU patients

    Days alive and free of mechanical ventilation during ICU stay.

    Measured: During the first 7 days following patient enrollment.

  7. Any ICU-acquired infection among ICU patients

    Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.

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

  8. ICU-acquired pneumonia among ICU patients

    Pneumonia acquired after 48 hours of ICU admission.

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

  9. ICU-acquired bloodstream infection among ICU patients

    Bloodstream infection acquired after 48 hours of ICU admission.

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

  10. ICU-acquired urinary tract infection among ICU patients

    Urinary tract infection acquired after 48 hours of ICU admission.

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

  11. ICU length of stay among ICU patients

    Length of ICU stay in days

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

  12. All-cause hospital mortality among ICU patients

    rates of all-cause mortality during hospital stay

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

  13. Symptoms of anxiety among family members

    symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale

    Measured: IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

  14. Symptoms of depression among family members

    symptoms of depression among family members measured by the Hospital Anxiety and Depression scale

    Measured: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

  15. Satisfaction among among family members

    Rates of patient's families satisfaction measured by the critical care family needs inventory

    Measured: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.

  16. Prevalence of Burnout Syndrome among ICU professionals

    Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory

    Measured: 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.

  17. Satisfaction with the current ICU visiting policy among ICU professionals

    Satisfaction with the current ICU visiting policy among ICU professionals

    Measured: It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.

  18. Any adverse event related to ICU visitation

    Any adverse event possible related to the ICU visitation model

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Oct 2016 (estimated)
  2. Study start28 Apr 2017
  3. Primary completion22 Jun 2018
  4. Study completion22 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
1,650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02932358
Sponsor's protocol ID
ICU Visits
Status last verified
Nov 2018
First submitted
11 Oct 2016
Last updated
23 Nov 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

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.

    PubMed 29654049

  • 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.

    PubMed 30454019

  • 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.

    PubMed 39172240

  • 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.

    PubMed 33870915

  • 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.

    PubMed 31310297

Questions about this trial

What is this clinical trial studying?

A study testing Flexible Family Visitation Model (FFVM) and Restrictive Family Visitation Model (RFVM) in people with Delirium, run by Hospital Moinhos de Vento at 33 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Delirium among ICU patients (time frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02932358, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2018.

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