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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-28

Study Completion Date

2018-06-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Flexible Family Visitation Model (FFVM)

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Restrictive Family Visitation Model (RFVM)

Intervention Type OTHER

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

Interventions

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Flexible Family Visitation Model (FFVM)

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

Intervention Type OTHER

Restrictive Family Visitation Model (RFVM)

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regis Rosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento

Locations

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Hospital de Urgência e Emergência de Rio Branco

Rio Branco, Acre, Brazil

Site Status

Fundação Hospital Adriano Jorge

Manaus, Amazonas, Brazil

Site Status

Hospital Geral Clériston Andrade

Feira de Santana, Estado de Bahia, Brazil

Site Status

Hospital INCARDIO

Feira de Santana, Estado de Bahia, Brazil

Site Status

Hospital de Urgências de Goiânia

Goiânia, Goiás, Brazil

Site Status

Hospital das Clínicas da Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Santa Casa de Misericórdia de São João Del Rei

São João del Rei, Minas Gerais, Brazil

Site Status

Hospital do Caâncer de Cascavel (UOPECCAN)

Cascavel, Paraná, Brazil

Site Status

Hospital Universitário do Oeste do Paraná (UNIOESTE)

Cascavel, Paraná, Brazil

Site Status

Hospital Universitário Alcides Carneiro

Campina Grande, Paraíba, Brazil

Site Status

Hospital Universitário Lauro Wanderley

João Pessoa, Paraíba, Brazil

Site Status

Hospital Regional do Baixo Amazonas

Santarém, Pará, Brazil

Site Status

Hospital Universitário de Petrolina

Petrolina, Pernambuco, Brazil

Site Status

Hospital Agamenom Magalhães

Recife, Pernambuco, Brazil

Site Status

Hospital Universitário da Universidade Federal do Piauí

Teresina, Piauí, Brazil

Site Status

Hospital Geral de Nova Iguaçú

Nova Iguaçu, Rio de Janeiro, Brazil

Site Status

Hospital Deoclécio Marques de Lucena

Parnamirim, Rio Grande do Norte, Brazil

Site Status

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, Brazil

Site Status

Hospital São Camilo de Esteio

Esteio, Rio Grande do Sul, Brazil

Site Status