Mechanism of a Flexible ICU Visiting Policy for Anxiety Symptoms Among Family Members in Brazil: A Path Mediation Analysis in a Cluster-Randomized Clinical Trial

OBJECTIVES: To investigate whether the effect of a flexible ICU visiting policy that includes flexible visitation plus visitor education on anxiety symptoms of family members is mediated by satisfaction and involvement in patient care. DESIGN: We embedded a multivariable path mediation analysis within a cluster-randomized crossover trial as a secondary analysis of The ICU Visits Study (ClinicalTrials.gov number: NCT02932358). SETTING: Thirty-six medical-surgical ICUs in Brazil. PATIENTS: Closest relatives of adult ICU patients. INTERVENTIONS: Flexible visitation (12 hr/d) supported by family education or usual restricted visitation (median, 1.5 hr/d). MEASUREMENTS AND MAIN RESULTS: Overall, 863 family members were assessed (mean age, 44.7 yr; women, 70.1%). Compared with the restricted visitation ( n = 436), flexible visitation ( n = 427) resulted in better mean anxiety scores (6.1 vs 7.8; mean difference, –1.78 [95% CI, –2.31 to –1.22]), as well as higher standardized scores of satisfaction (67% [95% CI, 55–79]) and involvement in patient care (77% [95% CI, 64–89]). The mediated effect of flexible visitation on mean anxiety scores through each incremental sd of satisfaction and involvement in patient care were –0.47 (95% CI, –0.68 to –0.24) and 0.29 (95% CI, 0.04–0.54), respectively. Upon exploratory analyses, emotional support, helping the ICU staff to understand patient needs, helping the patient to interpret ICU staff instructions, and patient reorientation were the domains of involvement in patient care associated with increased anxiety. CONCLUSIONS: A flexible ICU visiting policy reduces anxiety symptoms among family members and appears to work by increasing satisfaction. However, increased participation in some activities of patient care as a result of flexible visitation was associated with higher severity of anxiety symptoms.