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)
- Conditions
- Delirium
- Interventions
- Other: Flexible Family Visitation Model (FFVM)Other: Restrictive Family Visitation Model (RFVM)
- Registration Number
- NCT02932358
- Lead Sponsor
- Hospital Moinhos de Vento
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1650
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Flexible Family Visitation Model (FFVM) 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. Restrictive Family Visitation Model (RFVM) 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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
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.
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.
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
Trial Locations
- Locations (33)
Hospital Geral Clériston Andrade
🇧🇷Feira De Santana, BA, Brazil
Hospital de Urgência e Emergência de Rio Branco
🇧🇷Rio Branco, AC, Brazil
Fundação Hospital Adriano Jorge
🇧🇷Manaus, AM, Brazil
Hospital Universitário de Petrolina
🇧🇷Petrolina, PE, Brazil
Hospital Universitário do Oeste do Paraná (UNIOESTE)
🇧🇷Cascavel, PR, Brazil
Hospital do Caâncer de Cascavel (UOPECCAN)
🇧🇷Cascavel, PR, Brazil
Hospital Santa Rita
🇧🇷Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital Dom Vicente Scherer
🇧🇷Porto Alegre, RS, Brazil
Hospital Mãe de Deus
🇧🇷Porto Alegre, RS, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
🇧🇷Ribeirão Preto, SP, Brazil
Hospital Dona Helena
🇧🇷Joinville, SC, Brazil
Hospital Alberto Urquiza Wanderley (UNIMED João Pessoa)
🇧🇷João, Brazil
Hospital Universitário da Universidade Federal do Piauí
🇧🇷Teresina, PI, Brazil
Hospital Geral de Nova Iguaçú
🇧🇷Nova Iguaçú, RJ, Brazil
Hospital da Cidade de Passo Fundo
🇧🇷Passo Fundo, RS, Brazil
Hospital Agamenom Magalhães
🇧🇷Recife, PE, Brazil
Hospital INCARDIO
🇧🇷Feira De Santana, BA, Brazil
Hospital de Urgências de Goiânia
🇧🇷Goiânia, Goias, Brazil
Hospital Regional do Baixo Amazonas
🇧🇷Santarém, PA, Brazil
Hospital das Clínicas da Universidade Federal de Minas Gerais
🇧🇷Belo Horizonte, MG, Brazil
Santa Casa de Misericórdia de São João Del Rei
🇧🇷São João Del Rei, MG, Brazil
Hospital do Coração (HCor)
🇧🇷São Paulo, SP, Brazil
Hospital Montenegro
🇧🇷Montenegro, Brazil
Pavilhão Pereira Filho
🇧🇷Porto Alegre, RS, Brazil
Hospital Nossa Senhora da Conceiçaão
🇧🇷Porto Alegre, RS, Brazil
Hospital Ana Nery
🇧🇷Santa Cruz Do Sul, RS, Brazil
Hospital Santa Cruz
🇧🇷Santa Cruz Do Sul, RS, Brazil
Hospital Deoclécio Marques de Lucena
🇧🇷Parnamirim, RN, Brazil
Hospital Universitário Alcides Carneiro
🇧🇷Campina Grande, PB, Brazil
Hospital Universitário Lauro Wanderley
🇧🇷João Pessoa, PB, Brazil
Hospital Tacchini
🇧🇷Bento Gonçalves, RS, Brazil
Hospital São Camilo de Esteio
🇧🇷Esteio, RS, Brazil