NCT02932358.

Trial name or title	Effectiveness and safety of a flexible family visitation model for delirium prevention in the ICU Country: Brazil
Methods	A cluster‐randomized, cross‐over trial, multicentre
Participants	Adult ICU patients, visitors and ICU workers, expected, n = 1650 participants
Interventions	Intervention Other: flexible family visitation model (FFVM) (12 consecutive hours per day) Control Restrictive family visitation model (RFVM) (intermittent visits according to local ICU regulation)
Outcomes	Incidence of delirium (from enrolment until ICU discharge, or death or a maximum of 30 days of follow‐up) Delirium‐free days Days alive and free of delirium during ICU stay Antipsychotic use Rates of antipsychotic use Need of mechanical restraints Unplanned removal of invasive devices, venous catheter, tube feeding or urinary catheter Mechanical ventilation‐free days Days alive and free of mechanical ventilation ICU‐acquired infection Pneumonia or bloodstream infection or urinary tract infection acquired after 48 hours of ICU admission ICU‐acquired pneumonia Pneumonia acquired after 48 hours of ICU admission ICU‐acquired bloodstream infection Bloodstream infection acquired after 48 hours of ICU admission Urinary tract infection after 48 hours of ICU admission Any ICU‐acquired multi‐drug resistant infection Pneumonia or bloodstream infection or urinary tract infection due to multi‐drug resistant bacteria acquired after 48 hours of ICU admission ICU length of stay All‐cause hospital mortality (from enrolment until hospital discharge, or death or a maximum of 30 days of follow‐up) Symptoms of anxiety among ICU visitors Symptoms of anxiety or depression among ICU visitors Satisfaction among ICU visitors Incidence of burnout syndrome symptoms among ICU workers (Maslach Burnout Inventory) and any adverse event related to ICU visitation Assessed by confusion assessment method for the ICU 2 times per day
Starting date	January 2017
Contact information	Regis G Rosa MD, PHD , regisgoulartrosa@gmail.com
Notes	Outcomes are aimed at visitors and ICU workers as well as ICU patients A wash‐out period is planned: after randomization of ICUs to either an RFVM or to an FFVM as the initial intervention and enrolment of 25 ICU patients and 25 family members; there will be a 30‐day period without patient or family member recruitment to avoid spill‐over. After this period, each ICU will be assigned to an intervention contrary to that initially received until the enrolment of 25 more ICU patients and 25 family members. Study number: NCT02932358 Status: recruiting Contact with author: emailed June 2016. The study has completed the recruitment of about 60% of the target population and analysis of the impact of a flexible family visitation model on delirium prevention is realistic by the end of February 2018.