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 Overview
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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.

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

Conditions
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Delirium

Intervention / Treatment
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* Other: Flexible Family Visitation Model (FFVM)
* Other: Restrictive Family Visitation Model (RFVM)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flexible Family Visitation Model (FFVM)<br>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)<br>* Visitation to ICU patients allowed during the period of 12 consecutive hours per day.<br>|
| Active Comparator: Restrictive Family Visitation Model (RFVM)<br>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)<br>* Visitation to ICU patients allowed during intermittent periods according local ICU regulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During ICU stay (from enrollment until ICU discharge, or death or a maximum of 30 days of follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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 | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intensive care units, Delirium, Cross infection, Mortality, Length of stay, Burnout, Professional, Depression, Anxiety