Effectiveness and Safety of a Flexible Family Visitation Model for Delirium Prevention in Adult Intensive Care Units: a Cluster-randomized, Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,650
- 试验地点
- 33
- 主要终点
- Incidence of Delirium among ICU patients
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Flexible Family Visitation Model (FFVM)
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.
干预措施: Flexible Family Visitation Model (FFVM) (Other)
Restrictive Family Visitation Model (RFVM)
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.
干预措施: Restrictive Family Visitation Model (RFVM) (Other)
结局指标
主要结局
Incidence of Delirium among ICU patients
时间窗: 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.
次要结局
- 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))
- 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 mechanical restraints among ICU patients(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(During the first 7 days following patient enrollment.)
- 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))
- Mechanical ventilation-free days at day 7 among ICU patients(During the first 7 days following patient enrollment.)
- 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))
- 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))
- 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 depression among family members(On the day of patient discharge from ICU, or death or a maximum of 30 days of follow-up.)
- 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))
- 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))
- 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))
- 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))
- Satisfaction among among family members(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(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(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(During ICU stay (from randomization until ICU discharge, or death, or a maximum of 30 days of follow-up))