Statistical analysis plan for a cluster-randomized crossover trial comparing the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units (the ICU Visits Study)

Abstract

BackgroundMost adult intensive care units (ICUs) worldwide adopt restrictive family visitation models (RFVMs). However, evidence, mostly from non-randomized studies, suggests that flexible adult ICU visiting hours are safe policies that can result in benefits such as prevention of delirium and increase in satisfaction with care. Accordingly, the ICU Visits Study was designed to compare the effectiveness and safety of a flexible family visitation model (FFVM) vs. an RFVM on delirium prevention among ICU patients, and also to analyze its potential effects on family members and ICU professionals.Methods/designThe ICU Visits Study is a cluster-randomized crossover trial which compares an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in 40 Brazilian adult ICUs. Participant ICUs are randomly assigned to either an FFVM or RFVM in a 1:1 ratio. After enrollment and follow-up of 25 patients, each ICU is crossed over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome is the cumulative incidence of delirium measured by the Confusion Assessment Method for the ICU. Secondary and tertiary outcomes include relevant measures of effectiveness and safety of ICU visiting policies among patients, family members, and ICU professionals. Herein, we describe all primary statistical procedures that will be used to evaluate the results and perform exploratory and sensitivity analyses of this study. This pre-specified statistical analysis plan was written and submitted without knowledge of the study data.DiscussionThis a priori statistical analysis plan aims to enhance the transparency of our study, facilitating unbiased analyses of ICU visit study data, and provide guidance for statistical analysis for groups conducting studies in the same field.Trial registrationClinicalTrials.gov, NCT02932358. Registered on 11 October 2016.

Effect of Flexible Family Visitation on Delirium Among Patients in the Intensive Care Unit

“…The trial protocol and statistical analysis plan have been published and are available in Supplement 1. 16,17…”

“…The primary hypothesis was that the flexible family visitation model would reduce the incidence of delirium among patients. The trial protocol and statistical analysis plan have been published and are available in Supplement 1 …”

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

“…We embedded a multivariable path mediation analysis within a cluster-randomized crossover trial as a secondary analysis of The ICU Visits Study (trial registration, NCT02932358). Details of the trial methods and primary results have been previously reported (9–11). Briefly, The ICU Visits Study was designed to assess the effects of a flexible ICU visiting policy supported by family education in comparison with standard restricted visitation defined by each ICU on patients’, family members’, and ICU clinicians’ outcomes at individual level.…”

“…The Critical Care Family Needs Inventory (CCFNI; score range, 43 [worst] to 172 [best]), which addresses satisfaction in proximity, information, reassurance, comfort, and support domains, was used to assess satisfaction (13). Patient care involvement was evaluated using a nine-question four-point Likert scale questionnaire (score range, 0 [no involvement] to 27 [maximum involvement]) developed for the present study by researchers and experts (11). This questionnaire summarizes the frequency of involvement in nine domains of patient care: hygiene (e.g., bath and brushing teeth), pain control (e.g., pain assessment and notification of degree of pain to the ICU staff), mobilization (e.g., sit-out-of-bed, sit-to-stand, and walking activities), feeding (assisting patients with eating and drinking), improving environment (e.g., bringing patient stuff [photos, drawings, books, magazines] to the ICU bed surroundings), helping ICU staff understand patient needs (e.g., participating in family conferences and multidisciplinary rounds), helping patient interpret ICU staff instructions (e.g., helping the patient to understand basic information about his/her health status and therapeutic plan), emotional support (e.g., showing empathy, and providing reassurance, acceptance, and encouragement), and reorientation (e.g., letting patient know where he/she is and why he/she is in the hospital) ( Supplemental Table 2 , http://links.lww.com/CCM/G375).…”