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)

Hospital Moinhos de Vento1,650 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,650

Conditions

Delirium

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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).

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

Antipsychotic use among ICU patients

Need of antipsychotic use during ICU stay

Time frame: 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

Need of mechanical restraints among ICU patients during ICU stay

Time frame: 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

Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay.

Time frame: During the first 7 days following patient enrollment.

Unplanned loss of invasive devices among ICU patients

Unplanned loss of venous catheter, tube feeding or urinary catheter

Time frame: 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

Days alive and free of mechanical ventilation during ICU stay.

Time frame: During the first 7 days following patient enrollment.

Any ICU-acquired infection among ICU patients

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

Time frame: 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

Pneumonia acquired after 48 hours of ICU admission.

Time frame: 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

Bloodstream infection acquired after 48 hours of ICU admission.

Time frame: 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

Urinary tract infection acquired after 48 hours of ICU admission.

Time frame: 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

Length of ICU stay in days

Time frame: 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

rates of all-cause mortality during hospital stay

Time frame: 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

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

Time frame: 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

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

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

Satisfaction among among family members

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

Time frame: 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

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

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.

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.

Any adverse event related to ICU visitation

Any adverse event possible related to the ICU visitation model

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

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)

Overview

Conditions

Interventions

Eligibility

Locations (33)

Outcomes

Primary Outcomes

Secondary Outcomes