Delirium
Conditions
Keywords
Intensive care units, Delirium, Cross infection, Mortality, Length of stay, Burnout, Professional, Depression, Anxiety
Brief 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.
Interventions
OTHERFlexible Family Visitation Model (FFVM)
Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
OTHERRestrictive Family Visitation Model (RFVM)
Visitation to ICU patients allowed during intermittent periods according local ICU regulation.
Sponsors
Ministry of Health, Brazil
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Delirium among ICU patients | 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
| Measure | Time frame | Description |
|---|---|---|
| Daily hazard of delirium among ICU patients | 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). |
| Need of mechanical restraints among ICU patients | 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 |
| Coma-free days at day 7 among ICU patients | During the first 7 days following patient enrollment. | Days alive and free of coma (Richmond Agitation Sedation Scale -4 or -5) during ICU stay. |
| Unplanned loss of invasive devices among ICU patients | 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 |
| Mechanical ventilation-free days at day 7 among ICU patients | During the first 7 days following patient enrollment. | Days alive and free of mechanical ventilation during ICU stay. |
| Any ICU-acquired infection among ICU patients | 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. |
| ICU-acquired pneumonia among ICU patients | 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. |
| ICU-acquired bloodstream infection among ICU patients | 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. |
| Antipsychotic use among ICU patients | 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 |
| ICU length of stay among ICU patients | 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 |
| All-cause hospital mortality among ICU patients | 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 |
| Symptoms of anxiety among family members | 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 |
| Symptoms of depression among family members | 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 |
| Satisfaction among among family members | 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 |
| Prevalence of Burnout Syndrome among ICU professionals | 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 |
| 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. | Satisfaction with the current ICU visiting policy among ICU professionals |
| Any adverse event related to ICU visitation | 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 |
| ICU-acquired urinary tract infection among ICU patients | 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. |
Countries
Brazil
Outcome results
None listed