Background
Trial overview
Inclusion criteria | Exclusion criteria | |
---|---|---|
Cluster | Adult medical-surgical ICUs of public and philanthropic hospitals with at least six beds; restrictive policy of ICU visiting hours (< 4.5 h/day) | Structural or organizational impediments to flexible family visitation, according to the Brazilian resolution of minimal operational requirements for ICUsa |
Patients | ICU patients aged ≥18 years | Coma (RASS − 4 or − 5) lasting > 96 h from the moment of first evaluation for recruitment; delirium at baseline (positive CAM-ICU); cerebral death; aphasia; severe hearing deficit; predicted ICU length of stay < 48 h; exclusive palliative treatment at ICU admission; unavailability of a family member to participate in the flexible family visits; unlikelihood to survive > 24 h; prisoner status; readmission to the ICU after enrollment in the study |
Family members | Closest family member of a patient enrolled in the study | Family members who do not speak Portuguese or have serious difficulty in answering the self-applied questionnaires (e.g., due to illiteracy or severe visual or hearing limitations); having another family member already enrolled in the study |
ICU professionals | Bedside ICU professionals (physicians, nurses, nursing technicians, and physiotherapists) who assist patients during daytime for at least 20 h/week at the enrolled ICU | ICU professionals who have a planned leave of absence of > 15 days during phase 1 of the study |
Statistical analysis plan
Overall principles
Handling of missing data
Definition of analysis sets
Statistical analyses
Patient flow
Adherence to study interventions
Baseline characteristics
FFVM | RFVM | |
---|---|---|
Patients | ||
Age, years: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Age ≥ 65 years: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Female gender: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Charlson comorbidity index: median (IQR) | xx.x (xx.x-xx.x) | xx.x (xx.x-xx.x) |
History of dementia: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Hazardous alcohol consumption:a n/total n (%) | x/x (xx.x) | x/x (xx.x) |
ICU admission type | ||
Medical: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Emergency surgery: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Elective surgery: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
PRE-DELIRIC score: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
APACHE-II score:b mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
SOFA score:b mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Mechanically ventilated: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Use of vasopressor: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Use of corticosteroids: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Use of parenteral sedative:b n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Use of benzodiazepine:b n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Use of opioid:b n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Indwelling central venous catheter: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Urinary catheter: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Family members | ||
Age, years: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Female gender: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Years of education: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Household income, USD: median (IQR) | xx.x (xx.x-xx.x) | xx.x (xx.x-xx.x) |
Unemployed: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Living with care recipient: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Surrogate decision maker: n/total n (%) | x/x (xx.x) | x/x(xx.x) |
History of anxiety: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
History of depression: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
ICU professionals | ||
Age, years: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Female gender: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Type of ICU professional | ||
Physician: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Nurse: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Nurse technician: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Physiotherapist: n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Years of experience in ICU: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Hours of work per week: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Number of patients per professional | ||
Physician: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Nurse: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Nurse technician: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Physiotherapist: mean (SD) | xx.x (xx.x) | xx.x (xx.x) |
Burnout syndrome at baseline:c n/total n (%) | x/x (xx.x) | x/x (xx.x) |
Inter-rater reliability of the CAM-ICU
Primary outcome
Outcomes | FFVM | RFVM | Type of effect estimate | Effect estimate (CI) | p valuea |
---|---|---|---|---|---|
Primary | |||||
Cumulative incidence of delirium:b n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Secondary | |||||
Patients | |||||
Daily hazard of delirium:b mean (SD) | xx.x (xx.x) | xx.x (xx.x) | HR | x.xx (x.xx-x.xx)** | x.xx |
Any ICU-acquired infection:c n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Proportion of ventilator free-days: mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)** | x.xx |
ICU length of stay: mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)** | x.xx |
Hospital mortality: n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)** | x.xx |
Family members | |||||
HADS anxiety score: mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)*** | x.xx |
HADS depression score: mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)*** | x.xx |
CCFNI satisfaction score: mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)*** | x.xx |
ICU professionals | |||||
Burnout syndrome:d n/total n (%) | x/x (xx.x) | x/x (xx.x) | PR | x.xx (x.xx-x.xx)* | x.xx |
Tertiary | |||||
Patients | |||||
Need for antipsychotic agents: n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Need for mechanical restraints: n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Unplanned loss of invasive devices: n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Proportion of coma-free days: mean (SD) | xx.x (xx.x) | xx. (xx.x) | MD | x.xx (x.xx-x.xx)* | x.xx |
ICU-acquired pneumonia:c n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
ICU-acquired UTI:c n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
ICU-acquired BSI:c n/total n (%) | x/x (xx.x) | x/x (xx.x) | RR | x.xx (x.xx-x.xx)* | x.xx |
Family members | |||||
Self-perception of involvement in patient care | |||||
Score:e mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)* | x.xx |
ICU professionals | |||||
Satisfaction of ICU professionals with the ICU visiting policy score:f mean (SD) | xx.x (xx.x) | xx.x (xx.x) | MD | x.xx (x.xx-x.xx)* | x.xx |