Long-Term Effects of Flexible Visitation in the ICU on Family Members' Mental Health: 12-Month Results from a Randomized Clinical Trial

Abstract Purpose To assess the effects of flexible ICU visitation on the one-year prevalences of posttraumatic stress, anxiety and depression symptoms among family members of critically ill patients. Methods This is a secondary analysis of a cluster-crossover randomized clinical trial that evaluated a flexible visitation model in the ICU (12 hours/day) compared to a restrictive visitation model (median 1.5 hours/day) in 36 Brazilian ICUs. In the present analysis, family members were assessed 12 months after inclusion in the study for the following outcomes: post-traumatic stress symptoms measured by the Impact Event Scale-6 and anxiety and depression symptoms measured by the Hospital Anxiety and Depression Scale. Results A total of 519 family members were analyzed (288 in the flexible visitation group and 231 in the restrictive visitation group). Three-hundred sixty-nine (71.1%) were women, and the mean age was 46.7 years. Compared to family members in the restrictive visitation group, family members in the flexible visitation group had a significantly lower prevalence of post-traumatic stress symptoms (21.0% vs. 30.5%; prevalence ratio [PR], 0.70; 95% confidence interval [CI], 0.54–0.92; p = 0.01). The prevalence of anxiety (28.9% vs. 33.2%; PR 0.92; 95% CI, 0.71–1.19; p = 0.54) and depression symptoms (19.2% vs. 25.0%; PR, 0.79; 95% CI, 0.61–1.04; p = 0.05) did not differ significantly between the groups. Conclusion Flexible ICU visitation, compared to the restrictive visitation, was associated with a significant reduction in the one-year prevalence of post-traumatic stress symptoms in family members. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02932358 Trial protocol: 10.1136/bmjopen-2017-021193