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)

November 21, 2018 updated by: Hospital Moinhos de Vento

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1650

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • João, Brazil
        • Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
      • Montenegro, Brazil
        • Hospital Montenegro
    • AC
      • Rio Branco, AC, Brazil
        • Hospital de Urgência e Emergência de Rio Branco
    • AM
      • Manaus, AM, Brazil
        • Fundação Hospital Adriano Jorge
    • BA
      • Feira De Santana, BA, Brazil
        • Hospital Geral Clériston Andrade
      • Feira De Santana, BA, Brazil
        • Hospital INCARDIO
    • Goias
      • Goiânia, Goias, Brazil
        • Hospital de Urgências de Goiânia
    • MG
      • Belo Horizonte, MG, Brazil
        • Hospital das Clinicas da Universidade Federal de Minas Gerais
      • São João Del Rei, MG, Brazil
        • Santa Casa de Misericórdia de São João del Rei
    • PA
      • Santarém, PA, Brazil
        • Hospital Regional do Baixo Amazonas
    • PB
      • Campina Grande, PB, Brazil
        • Hospital Universitário Alcides Carneiro
      • João Pessoa, PB, Brazil
        • Hospital Universitário Lauro Wanderley
    • PE
      • Petrolina, PE, Brazil
        • Hospital Universitário de Petrolina
      • Recife, PE, Brazil
        • Hospital Agamenom Magalhaes
    • PI
      • Teresina, PI, Brazil
        • Hospital Universitário da Universidade Federal do Piauí
    • PR
      • Cascavel, PR, Brazil
        • Hospital do Caâncer de Cascavel (UOPECCAN)
      • Cascavel, PR, Brazil
        • Hospital Universitário do Oeste do Paraná (UNIOESTE)
    • RJ
      • Nova Iguaçú, RJ, Brazil
        • Hospital Geral de Nova Iguaçu
    • RN
      • Parnamirim, RN, Brazil
        • Hospital Deoclécio Marques de Lucena
    • RS
      • Bento Gonçalves, RS, Brazil
        • Hospital Tacchini
      • Esteio, RS, Brazil
        • Hospital São Camilo de Esteio
      • Passo Fundo, RS, Brazil
        • Hospital da cidade de Passo Fundo
      • Porto Alegre, RS, Brazil
        • Hospital Mae de Deus
      • Porto Alegre, RS, Brazil
        • Hospital de clinicas de Porto Alegre
      • Porto Alegre, RS, Brazil
        • Hospital Dom Vicente Scherer
      • Porto Alegre, RS, Brazil
        • Hospital Nossa Senhora da Conceiçaão
      • Porto Alegre, RS, Brazil
        • Hospital Santa Rita
      • Porto Alegre, RS, Brazil
        • Pavilhão Pereira Filho
      • Santa Cruz Do Sul, RS, Brazil
        • Hospital Ana Nery
      • Santa Cruz Do Sul, RS, Brazil
        • Hospital Santa Cruz
    • SC
      • Joinville, SC, Brazil
        • Hospital Dona Helena
    • SP
      • Ribeirão Preto, SP, Brazil
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
      • São Paulo, SP, Brazil
        • Hospital do Coração (HCOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
Other: Flexible Family Visitation Model (FFVM)
Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
Active Comparator: 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.
Other: Restrictive Family Visitation Model (RFVM)
Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Daily hazard 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)
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).
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Antipsychotic use among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Need of antipsychotic use during ICU stay
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
Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Need of mechanical restraints among ICU patients during ICU stay
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
Time Frame: During the first 7 days following patient enrollment.
Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.
During the first 7 days following patient enrollment.
Unplanned loss of invasive devices among ICU patients
Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Unplanned loss of venous catheter, tube feeding or urinary catheter
During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Mechanical ventilation-free days at day 7 among ICU patients
Time Frame: During the first 7 days following patient enrollment.
Days alive and free of mechanical ventilation during ICU stay.
During the first 7 days following patient enrollment.
Any ICU-acquired infection among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission.
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired pneumonia among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Pneumonia acquired after 48 hours of ICU admission.
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired bloodstream infection among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Bloodstream infection acquired after 48 hours of ICU admission.
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU-acquired urinary tract infection among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Urinary tract infection acquired after 48 hours of ICU admission.
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
ICU length of stay among ICU patients
Time Frame: During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
Length of ICU stay in days
During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up)
All-cause hospital mortality among ICU patients
Time Frame: During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
rates of all-cause mortality during hospital stay
During hospital stay (from enrollment until hospital discharge, or death or a maximum of 30 days of follow-up)
Symptoms of anxiety among family members
Time Frame: IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
symptoms of anxiety among family members measured by the Hospital Anxiety and Depression scale
IOn the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Symptoms of depression among family members
Time Frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
symptoms of depression among family members measured by the Hospital Anxiety and Depression scale
On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Satisfaction among among family members
Time Frame: On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Rates of patient's families satisfaction measured by the critical care family needs inventory
On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.
Prevalence of Burnout Syndrome among ICU professionals
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.
Prevalence of Burnout Syndrome among ICU workers measured by the Maslach Burnout Inventory
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.
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.
Satisfaction with the current ICU visiting policy among ICU professionals
It will be measured between the 15th and 30th days of the period in which no patient will be enrolled.
Any adverse event related to ICU visitation
Time Frame: During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)
Any adverse event possible related to the ICU visitation model
During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Moinhos de Vento

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regis Rosa, MD, PhD, Hospital Moinhos de Vento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 22, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICU Visits

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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