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

Abstract

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.

Psychological distress and morbidity of family members experiencing virtual visiting in intensive care during COVID-19: an observational cohort study

“…In a cohort of 88 family members experiencing COVID-19 visiting restrictions in a single French ICU, Cattelan and colleagues report prevalence rates of anxiety and depression measured using the Hospital Anxiety Depression Scale (HADS) at 83% and 73%, respectively [ 13 ]. In the aforementioned trial of flexible in-person visiting, moderate-to-severe anxiety, again measured using the HADS, was found in 64% of participants [ 33 ]. Reasons for the lower levels of psychological morbidity detected in our study are unclear.…”

The Impact of Randomized Family-Centered Interventions on Family-Centered Outcomes in the Adult Intensive Care Unit: A Systematic Review

“…Participant sample size ranged from 10 to 1295 with 3 studies including more than 1000 family participants. 18,44,45 Changes in family-centered outcomes stratified by intervention category are displayed in Supplemental Figure 1.…”

An integrated review: connecting Covid-era hospital visiting policies to family engagement

“…Seven studies include a survey in their design (12,25,27,33,36,38,46). The review includes randomized control trials (22,41), retrospective comparative studies (20,26,31,38,43,47), observational studies (29, 40), and a regression discontinuity and time to event design (24). There are qualitative studies with semi-structured interviews (21, 30,45).…”

“…These articles add to the body of evidence that supports the benefits of family engagement. Five articles connect the policy and domains to patient and family satisfaction (12,20,22,41,46).…”