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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 (The ICU Visits Study)

NCT02932358 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1650

Last updated 2018-11-23

No results posted yet for this study

Summary

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.

Conditions

  • Delirium

Interventions

OTHER

Flexible Family Visitation Model (FFVM)

Visitation to ICU patients allowed during the period of 12 consecutive hours per day.

OTHER

Restrictive Family Visitation Model (RFVM)

Visitation to ICU patients allowed during intermittent periods according local ICU regulation.

Sponsors & Collaborators

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Moinhos de Vento

    lead OTHER

Principal Investigators

  • Regis Rosa, MD, PhD · Hospital Moinhos de Vento

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-28
Primary Completion
2018-06-22
Completion
2018-06-22

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02932358 on ClinicalTrials.gov