Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study)

Rosa, Régis Goulart; Falavigna, Maicon; Robinson, Caroline Cabral; Silva, Daiana Barbosa da; Kochhann, Renata; Moura, Rafaela Moraes de; Santos, Mariana Martins Siqueira; Sganzerla, Daniel; Giordani, Natalia Elis; Eugênio, Cláudia Severgnini; Ribeiro, Tarissa; Cavalcanti, Alexandre Biasi; Bozza, Fernando A.; Azevedo, Luciano César Pontes; Machado, Flávia Ribeiro; Salluh, Jorge I.; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Hochegger, Taís; Amaral, Alexandre Alcides Bezerra do; Teles, José; Luz, Lucas Gobetti da; Barbosa, Mirceli Goulart; Birriel, Daniella Cunha; Ferraz, Iris de Lima; Nobre, Vandack; Valentim, Helen Martins; Castro, Livia Corrêa e; Duarte, Péricles Almeida Delfino; Tregnago, Rogério; Barilli, Sofia Louise Santin; Brandão, Nilton; Giannini, Alberto; Teixeira, Cassiano

doi:10.1136/bmjopen-2017-021193

Cited by 25 publications

(17 citation statements)

References 41 publications

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“…Details of trial rationale and methods have been reported previously. 14 The ICU Visits study was conducted from April 2017 to July 2018 in 36 mixed Brazilian ICUs after approval by institutional review boards of all centers. All participating ICU clinicians provided written informed consent for study participation.…”

Section: Methodsmentioning

confidence: 99%

Association of Burnout With Depression and Anxiety in Critical Care Clinicians in Brazil

et al. 2020

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IMPORTANCEIt is unclear whether burnout, anxiety, and depression constitute the same or different constructs. Better understanding of these constructs is important for diagnosis and treatment for intensive care unit (ICU) clinicians. OBJECTIVE To determine the associations and distinctiveness of burnout, depression, and anxiety in a sample of ICU clinicians. DESIGN, SETTING, AND PARTICIPANTS This cross-sectional study used baseline data from the ICU Visits Study, a cluster-randomized crossover clinical trial conducted from April 2017 to July 2018 in 36 mixed public and private nonprofit ICUs in Brazil. ICU clinicians, including day-shift physicians, nurses, nurse technicians, and physiotherapists working in an ICU at least 20 hours per week, were enrolled. Data were analyzed from December 27, 2019, to October 10, 2020. MAIN OUTCOMES AND MEASURES The main outcome measures were burnout, depression, and anxiety measured with the Maslach Burnout Inventory (MBI; range, 0-6, with high scores indicating more burnout) and the Hospital Depression and Anxiety Scale (HADS; range, 0-3, with higher scores indicating more depression or anxiety). Internal consistencies were satisfactory. RESULTS The total sample included 715 ICU clinicians (median [interquartile range] age, 34.8 [30.2-39.3] years; 520 [72.7%] women), including 96 physicians (13.4%), 159 nurses (22.2%), 358 nurse technicians (50.1%), and 102 physiotherapists (14.3%). Clinicians reported low levels of emotional exhaustion (mean [SD] score, 1.84 [1.18]), depersonalization (mean [SD] score, 0.98 [1.03]), and personal accomplishment (mean [SD] score, 5.05 [0.87]) on the MBI, and similarly low levels of depression (mean [SD] score, 0.54 [0.40]) and anxiety (mean [SD] score, 0.70 [0.45]) on the HADS.Confirmatory factor analyses consistently showed improved fit separating latent burnout dimensions from depression and anxiety. An exploratory graph analysis combining gaussian graphical model with clustering algorithms for weighted networks suggested 3 clusters, with distinct burnout, anxiety, and depression clusters. This structure was confirmed using a bootstrap with 1000 random samples, in which the 3-cluster solution emerged in 625 samples (62.5%). Both latent variable loadings and network statistics suggested 3 key indicators (ie, feeling burned out from work, worrying thoughts, and reverse-scored reporting feeling cheerful) that can be used for short screening instruments. CONCLUSIONS AND RELEVANCEThese findings suggest that burnout and clinical symptoms of depression and anxiety were empirically distinct in a large sample of ICU clinicians, highlighting the importance of screening for burnout and clinical symptoms to allow fast access to adequate support and treatment in health professionals at high risk of burnout.

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Section: Methodsmentioning

confidence: 99%

Association of Burnout With Depression and Anxiety in Critical Care Clinicians in Brazil

et al. 2020

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“…Moreover, according to other studies, family members feel relaxed and less anxious if they visit their patients in the intensive care units. 29,66 Therefore, it is necessary to implement some strategies to reduce the limitations of ICU visiting policies and increase the presence of family members at the patient's bedside to enhance their communication and participation in patient care. This is because visitation based on a very strict and limited policy, such as the current visitation policies commonly practiced, 13,59,61,67 seems to be inefficient in meeting the needs of the ICU patients and their families.…”

Section: Discussionmentioning

confidence: 99%

“…13,27 Some other studies have shown that ICU nurses perceive patients' visits as a source of increased workload and burnout. 28,29 Disorganization of patient care and more interruptions due to the extended presence of families in the ICU are the other reasons for adhering strict visiting policy in intensive care units. 30 There is also concern that with open visitation policy, stress of family members will increase because of feeling to be obligated to stay in the ICU.…”

Section: Introductionmentioning

confidence: 99%

Effect of Programmed Family Presence in Coronary Care Units on Patients’ and Families’ Anxiety

et al. 2020

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Introduction: Hospitalization of patients in the intensive care units always has negative consequences such as anxiety and concern for patients and their families. This study aimed to investigate the effect of programmed family presence in intensive care units on patients’ and families’ anxiety. Methods: This was a quasi-experimental study conducted in Iran. The eligible patients and a member of their families were assigned into two groups (N = 80) through convenience sampling. The family members in the experimental group were allowed to attend twice a day for 15 minutes in a planned way beside the patient and contribute to their clinical primary care. In the control group, the family members had a strict limitation to visit their patients based on the usual policy. Anxiety in both groups at the beginning and on the third day of patient’s admission was measured, using Spielberger’s questionnaire. The data were analyzed with SPSS version13. Results: The mean score of anxiety in the control group did not show significant difference in patients and in families, however it had decreased significantly in the experimental group after the intervention for both patients and families. The results showed that mean differences between the two groups was statistically significant in patients and families. Conclusion: The planned presence of the family of patients in coronary care unit (CCU) played a crucial role in reducing the anxiety of patients and their family. Furthermore, it is recommended that strategies of visiting policy in intensive care units (ICUs) should be revised and the possibility be provided for the families’ planned presence and participation in the patient care.

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“…The ICU Visits Study is a cluster-randomized, crossover trial comparing an FFVM (12 consecutive ICU visiting hours per day) with an RFVM (< 4.5 ICU visiting hours per day) in Brazilian adult ICUs. The study background, design, rationale, eligibility criteria, and sample size have been previously published [ 10 ]. In brief, mixed adult ICUs of public and private philanthropic hospitals with a restrictive policy of ICU visiting hours (< 4.5 h/day) are randomly assigned to either an FFVM or RFVM in a 1:1 ratio until the recruitment and follow-up of 25 patients (phase 1) (Fig.…”

Section: Trial Overviewmentioning

confidence: 99%

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)

Sganzerla

Teixeira²,

Robinson

et al. 2018

Trials

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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.

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Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study)

Cited by 25 publications

References 41 publications

Association of Burnout With Depression and Anxiety in Critical Care Clinicians in Brazil

Association of Burnout With Depression and Anxiety in Critical Care Clinicians in Brazil

Effect of Programmed Family Presence in Coronary Care Units on Patients’ and Families’ Anxiety

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)

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