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NCT Number: 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)

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Urgência e Emergência de Rio Branco, Rio Branco, Acre, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

Sponsors and collaborators

Lead sponsor

Hospital Moinhos de Vento

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 13, 2016
Registry last updated
Nov 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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