Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit: The ICU Visits Randomized Clinical Trial

Abstract

Importance: The effects of intensive care unit (ICU) visiting hours remain uncertain.

Objective: To determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium.

Design, setting and participants: Cluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018.

Interventions: Flexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation.

Main outcomes and measures: Primary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory).

Results: Among 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation.

Conclusions and relevance: Among patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.

Trial registration: ClinicalTrials.gov Identifier: NCT02932358.

Figure 1.. Enrollment, Randomization, and Follow-up in the ICU Visits Study

ICU indicates intensive care unit. ^aICUs of public and private nonprofit hospitals from all 5 geopolitical regions of Brazil, all of which have participated in previous studies of the Brazilian Research in Intensive Care Network (BRICNet) or were recommended by the Brazilian Ministry of Health, were invited to participate in the trial. ^bAccording to the minimum requirements for the operation of ICUs in Brazil, which include multidisciplinary care (intensivist, nurse, nurse technician, and physiotherapist at minimum) and access to monitoring devices, organ support therapies, and specialty care services. ^cCauses of exclusion listed in eTable 2 in Supplement 2. ^dRichmond Agitation Sedation Scale score −4 or −5. Values range from −5 (unarousable) to +4 (combative); eg, a score of −4 indicates no response to voice but movement or eye opening in response to physical stimulation, and a score of −5 indicates no response to voice or physical stimulation. ^eAphasia or severe hearing deficit. ^fICU discharge, transfer, or end of cluster recruitment during the assessment of eligibility criteria. ^gIlliteracy or severe visual or hearing impairments. ^hData on causes of follow-up losses were not collected.

Figure 2.. Enrollment, Randomization, and Follow-up in the ICU Visits Study (Continued)

^aCauses of exclusion listed in eTable 2 in Supplement 2. ^bRichmond Agitation Sedation Scale score −4 or −5. Values range from −5 (unarousable) to +4 (combative); eg, a score of −4 indicates no response to voice but movement or eye opening in response to physical stimulation, and a score of −5 indicates no response to voice or physical stimulation. ^cAphasia or severe hearing deficit. ^dICU discharge, transfer, or end of cluster recruitment during the assessment of eligibility criteria. ^eIlliteracy or severe visual or hearing impairments. ^fData on causes of follow-up losses were not collected.

Figure 3.. Daily Mean Duration of Visits in Each Visitation Model

Daily mean duration of visits per patient is considered the length of stay of all visitors (whether they were family members) at the bedside of an enrolled patient. The box plot inner horizontal lines indicate median; boxes, interquartile range (25th and 75th percentiles); vertical whiskers, 1.5 interquartile range beyond the 25th and 75th percentiles; and dots, more extreme values.