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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SUBMITTER: Sganzerla D
PROVIDER: S-EPMC6245900 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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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 Daniel D Teixeira Cassiano C Robinson Caroline Cabral CC Kochhann Renata R Santos Mariana Martins Siqueira MMS de Moura Rafaela Moraes RM Barbosa Mirceli Goulart MG da Silva Daiana Barbosa DB Ribeiro Tarissa T Eugênio Cláudia C Schneider Daniel D Mariani Débora D Jeffman Rodrigo Wiltgen RW Bozza Fernando F Cavalcanti Alexandre Biasi AB Azevedo Luciano Cesar Pontes LCP Machado Flávia Ribeiro FR Salluh Jorge Ibrain JI Pellegrini José Augusto Santos JAS Moraes Rafael Barberena RB Damiani Lucas Petri LP da Silva Nilton Brandão NB Falavigna Maicon M Rosa Regis Goulart RG
Trials 20181119 1
<h4>Background</h4>Most 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 prev ...[more]
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Project description:IntroductionFlexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals.Methods and analysisA cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals.Ethics and disseminationThe study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through conferences and peer-reviewed journals.Trial registrationNCT02932358.
| S-EPMC5905750 | biostudies-literature
Project description:ImportanceThe effects of intensive care unit (ICU) visiting hours remain uncertain.ObjectiveTo determine whether a flexible family visitation policy in the ICU reduces the incidence of delirium.Design, setting and participantsCluster-crossover randomized clinical trial involving patients, family members, and clinicians from 36 adult ICUs with restricted visiting hours (<4.5 hours per day) in Brazil. Participants were recruited from April 2017 to June 2018, with follow-up until July 2018.InterventionsFlexible visitation (up to 12 hours per day) supported by family education (n = 837 patients, 652 family members, and 435 clinicians) or usual restricted visitation (median, 1.5 hours per day; n = 848 patients, 643 family members, and 391 clinicians). Nineteen ICUs started with flexible visitation, and 17 started with restricted visitation.Main outcomes and measuresPrimary outcome was incidence of delirium during ICU stay, assessed using the CAM-ICU. Secondary outcomes included ICU-acquired infections for patients; symptoms of anxiety and depression assessed using the HADS (range, 0 [best] to 21 [worst]) for family members; and burnout for ICU staff (Maslach Burnout Inventory).ResultsAmong 1685 patients, 1295 family members, and 826 clinicians enrolled, 1685 patients (100%) (mean age, 58.5 years; 47.2% women), 1060 family members (81.8%) (mean age, 45.2 years; 70.3% women), and 737 clinicians (89.2%) (mean age, 35.5 years; 72.9% women) completed the trial. The mean daily duration of visits was significantly higher with flexible visitation (4.8 vs 1.4 hours; adjusted difference, 3.4 hours [95% CI, 2.8 to 3.9]; P < .001). The incidence of delirium during ICU stay was not significantly different between flexible and restricted visitation (18.9% vs 20.1%; adjusted difference, -1.7% [95% CI, -6.1% to 2.7%]; P = .44). Among 9 prespecified secondary outcomes, 6 did not differ significantly between flexible and restricted visitation, including ICU-acquired infections (3.7% vs 4.5%; adjusted difference, -0.8% [95% CI, -2.1% to 1.0%]; P = .38) and staff burnout (22.0% vs 24.8%; adjusted difference, -3.8% [95% CI, -4.8% to 12.5%]; P = .36). For family members, median anxiety (6.0 vs 7.0; adjusted difference, -1.6 [95% CI, -2.3 to -0.9]; P < .001) and depression scores (4.0 vs 5.0; adjusted difference, -1.2 [95% CI, -2.0 to -0.4]; P = .003) were significantly better with flexible visitation.Conclusions and relevanceAmong patients in the ICU, a flexible family visitation policy, vs standard restricted visiting hours, did not significantly reduce the incidence of delirium.Trial registrationClinicalTrials.gov Identifier: NCT02932358.
| S-EPMC6635909 | biostudies-literature
Project description:Delirium is a primary adverse event in ventilated patients who receive long-term monosedative treatment. Sequential sedation may reduce these adverse effects. This study evaluated risk factors for delirium in sequential sedation patients.A total of 141 patients who underwent sequential sedation were enrolled. Delirium was diagnosed using Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) scale. Univariate and multivariate Cox proportional hazards regressions were used to predict risk factors.Older age (?51) (RR = 2.432, 95% CL 1.316-4.494, p = 0.005), higher SOFA score (?14) (RR = 2.022, 95% CL 1.076-3.798, p = 0.029), regular smoking (RR = 2.366, 95% CL 1.277-4.382, p = 0.006), and higher maintenance dose of midazolam (RR = 1.052, 95% CL 1.000-1.107, p = 0.049) and fentanyl (RR = 1.045, 95% CL 1.019-1.072, p = 0.001) when patients met sequential criteria, were independent risk factors of delirium. Sequential sedation with dexmedetomidine (RR = 0.448, 95% CL 0.209-0.963, p = 0.040) was associated with a lower risk of delirium.Older age, higher SOFA score, regular smoking, and higher maintenance dose of midazolam and fentanyl when patients met sequential criteria were independent risk factors of delirium in sequential sedation patients. Sequential sedation with dexmedetomidine reduced risk of delirium.
| S-EPMC5684530 | biostudies-literature
Project description:BackgroundDelirium is a brain dysfunction syndrome, which children have a higher incidence. At present, there have been more and more studies and reports on delirium in paediatric intensive care unit, but there are some differences in the risk factor results among different studies. To better manage delirium, this study was performed.ObjectiveTo integrate and clarify the risk factors for delirium in paediatric intensive care unit.MethodsCNKI, CBMdisc, Wanfang Data Knowledge Service Platform, VIP, PubMed, Embase, Cochrane Library, JBI and PsycInfo were searched for relevant literature. The study subjects were patients in PICU and literature was included according to the PICOS principle. Literature screening and risk of bias assessment were mainly completed by two researchers, and RevMan 5.3 software and Stata software were used for data analysis. The GRADE systerm was used to assess the quality of evidence.ResultsA total of 10 studies were included, all in English, involving 4343 children. Within the GRADE system, 4 indicators were scored A, 1 indicators were scored B, and 3 indicators were scored C regarding evidence levels. Three studies analysed the influence of developmental delay on the occurrence of delirium in PICU, total sample size of which was 1823, and the results showed that the combined effect was statistically significant [OR = 3.34, 95%CI(2.46-4.53), Z = 7.75, P<0.001]; Five studies analysed the effects of mechanical ventilation on the occurrence of delirium in PICU, sample size of which was 1562, and the results showed that the combined effect was statistically significant [OR = 4.11, 95%CI(3.13-5.40), Z = 10.16, P<0.001]; Two studies analysed the effects of benzodiazepines on children developing delirium, sample size of which was 1635, and the results showed that the combined effect was statistically significant [OR = 5.05, 95%CI(3.65-6.97), Z = 9.83, P<0.001]; Two studies analysed the effects of anticholinergic drug use on children developing delirium in PICU, sample size of which was 1703, and the results suggested the combined effect was statistically significant [OR = 5.04, 95%CI (3.62-7.00), Z = 9.63, P<0.001]; Two studies compared the same age period, sample size of which was 1724 and the results showed that children 2-5 years old has a 48% incidence rate of delirium relative to children younger than 2 years old, and the combined effect was statistically significant [OR = 0.48, 95%CI(0.25-0.92), Z = 2.22, P = 0.030], children 5-13 years old has a 39% incidence rate of delirium relative to children younger than 2 years old, and the combined effect was statistically significant [OR = 0.39, 95%CI(0.26-0.59), Z = 4.43, P<0.001]. Two studies analysed the effects of PICU LOS on children developing delirium and the combined effect of PICU LOS on the occurrence of delirium in children in PICU was statistically significant [OR = 1.10, 95%CI(1.05-1.15), Z = 4.07, P<0.001].ConclusionDevelopmental delay, mechanical ventilation, benzodiazepine use, anticholinergic use, age and PICU length of stay are independent risk factors for delirium in children in PICU. However, only a few articles were included in this study, which may lead to a certain bias and affect the analysing results. More large-sample, multicentre studies should be conducted to further explore and clarify the independent influencing factors of delirium in children in PICU and to provide guidance for clinical practice.
| S-EPMC9269883 | biostudies-literature
Project description:IntroductionDelirium is a disturbance of attention and awareness that represents a change from baseline mental status. Accurate diagnosis of delirium is of paramount importance to improving the management of pediatric delirium in the intensive care unit. Despite ongoing education, inconsistencies in delirium assessments occur. Here, we aimed to determine the extent of the problem and increase compliance with delirium assessments.MethodsWe collected preintervention data to assess baseline compliance of delirium assessments in the Pediatric Intensive Care Unit (PICU) and Pediatric Cardiac Intensive Care Unit (PCICU) at Monroe Carell Jr Children's Hospital at Vanderbilt in November 2020. We executed 2 Plan-Do-Study-Act cycles with different interventions and collected data after each and approximately 1 year after the interventions. The first intervention consisted of virtual lectures on delirium assessments for the nursing staff. The second intervention included an educational handout and a new electronic medical record documentation tool.ResultsFive hundred five individual nurse-patient encounters were assessed and collected throughout the project. The mean compliance of delirium documentation before the interventions was 52.5%. Target compliance after interventions was 70%. Mean compliance was 70% after cycle 1, 78% after cycle 2, and 86% in March 2022.ConclusionsUsing pre- and postintervention data from chart reviews and nurse interviews regarding delirium screenings, we found that interventions targeting nurse education and EMR flowsheet improved compliance with delirium assessment and documentation in the PICU and PCICU. Future work should focus on assessing the clinical implications of this project in diagnosing and treating delirium.
| S-EPMC9278948 | biostudies-literature
Project description:RationaleIntensive care unit (ICU) delirium is highly prevalent and a potentially avoidable hospital complication. The current cost of ICU delirium is unknown.ObjectivesTo specify the association between the daily occurrence of delirium in the ICU with costs of ICU care accounting for time-varying illness severity and death.Research designWe performed a prospective cohort study within medical and surgical ICUs in a large academic medical center.SubjectsWe analyzed critically ill patients (N=479) with respiratory failure and/or shock.MeasuresCovariates included baseline factors (age, insurance, cognitive impairment, comorbidities, Acute Physiology and Chronic Health Evaluation II Score) and time-varying factors (sequential organ failure assessment score, mechanical ventilation, and severe sepsis). The primary analysis used a novel 3-stage regression method: first, estimation of the cumulative cost of delirium over 30 ICU days and then costs separated into those attributable to increased resource utilization among survivors and those that were avoided on the account of delirium's association with early mortality in the ICU.ResultsThe patient-level 30-day cumulative cost of ICU delirium attributable to increased resource utilization was $17,838 (95% confidence interval, $11,132-$23,497). A combination of professional, dialysis, and bed costs accounted for the largest percentage of the incremental costs associated with ICU delirium. The 30-day cumulative incremental costs of ICU delirium that were avoided due to delirium-associated early mortality was $4654 (95% confidence interval, $2056-7869).ConclusionsDelirium is associated with substantial costs after accounting for time-varying illness severity and could be 20% higher (∼$22,500) if not for its association with early ICU mortality.
| S-EPMC6200340 | biostudies-literature
Project description:BackgroundSince the publication of the 2018 Clinical Guidelines about sedation, analgesia, delirium, mobilization, and sleep deprivation in critically ill patients, no evaluation and adequacy assessment of these recommendations were studied in an international context. This survey aimed to investigate these current practices and if the COVID-19 pandemic has changed them.MethodsThis study was an open multinational electronic survey directed to physicians working in adult intensive care units (ICUs), which was performed in two steps: before and during the COVID-19 pandemic.ResultsWe analyzed 1768 questionnaires and 1539 (87%) were complete. Before the COVID-19 pandemic, we received 1476 questionnaires and 292 were submitted later. The following practices were observed before the pandemic: the Visual Analog Scale (VAS) (61.5%), the Behavioral Pain Scale (BPS) (48.2%), the Richmond Agitation Sedation Scale (RASS) (76.6%), and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) (66.6%) were the most frequently tools used to assess pain, sedation level, and delirium, respectively; midazolam and fentanyl were the most frequently used drugs for inducing sedation and analgesia (84.8% and 78.3%, respectively), whereas haloperidol (68.8%) and atypical antipsychotics (69.4%) were the most prescribed drugs for delirium treatment; some physicians regularly prescribed drugs to induce sleep (19.1%) or ordered mechanical restraints as part of their routine (6.2%) for patients on mechanical ventilation; non-pharmacological strategies were frequently applied for pain, delirium, and sleep deprivation management. During the COVID-19 pandemic, the intensive care specialty was independently associated with best practices. Moreover, the mechanical ventilation rate was higher, patients received sedation more often (94% versus 86.1%, p < 0.001) and sedation goals were discussed more frequently in daily rounds. Morphine was the main drug used for analgesia (77.2%), and some sedative drugs, such as midazolam, propofol, ketamine and quetiapine, were used more frequently.ConclusionsMost sedation, analgesia and delirium practices were comparable before and during the COVID-19 pandemic. During the pandemic, the intensive care specialty was a variable that was independently associated with the best practices. Although many findings are in accordance with evidence-based recommendations, some practices still need improvement.
| S-EPMC8815719 | biostudies-literature
Project description:Since the lockdown because of the pandemic, family members have been prohibited from visiting their loved ones in hospital. While it is clearly complicated to implement protocols for the admission of family members, we believe precise strategic goals are essential and operational guidance is needed on how to achieve them. Even during the pandemic, we consider it a priority to share strategies adapted to every local setting to allow family members to enter intensive care units and all the other hospital wards.
| S-EPMC8171999 | biostudies-literature
Project description:ObjectiveTo report the statistical analysis plan (first version) for the Balanced Solutions versus Saline in Intensive Care Study (BaSICS).MethodsBaSICS is a multicenter factorial randomized controlled trial that will assess the effects of Plasma-Lyte 148 versus 0.9% saline as the fluid of choice in critically ill patients, as well as the effects of a slow (333mL/h) versus rapid (999mL/h) infusion speed during fluid challenges, on important patient outcomes. The fluid type will be blinded for investigators, patients and the analyses. No blinding will be possible for the infusion speed for the investigators, but all analyses will be kept blinded during the analysis procedure.ResultsBaSICS will have 90-day mortality as its primary endpoint, which will be tested using mixed-effects Cox proportional hazard models, considering sites as a random variable (frailty models) adjusted for age, organ dysfunction and admission type. Important secondary endpoints include renal replacement therapy up to 90 days, acute renal failure, organ dysfunction at days 3 and 7, and mechanical ventilation-free days within 28 days.ConclusionThis manuscript provides details on the first version of the statistical analysis plan for the BaSICS trial and will guide the study's analysis when follow-up is finished.
| S-EPMC7853670 | biostudies-literature
Project description:ObjectivesTo develop and validate a delirium prediction model for adult intensive care patients and determine its additional value compared with prediction by caregivers.DesignObservational multicentre study.SettingFive intensive care units in the Netherlands (two university hospitals and three university affiliated teaching hospitals).Participants3056 intensive care patients aged 18 years or over.Main outcome measureDevelopment of delirium (defined as at least one positive delirium screening) during patients' stay in intensive care.ResultsThe model was developed using 1613 consecutive intensive care patients in one hospital and temporally validated using 549 patients from the same hospital. For external validation, data were collected from 894 patients in four other hospitals. The prediction (PRE-DELIRIC) model contains 10 risk factors-age, APACHE-II score, admission group, coma, infection, metabolic acidosis, use of sedatives and morphine, urea concentration, and urgent admission. The model had an area under the receiver operating characteristics curve of 0.87 (95% confidence interval 0.85 to 0.89) and 0.86 after bootstrapping. Temporal validation and external validation resulted in areas under the curve of 0.89 (0.86 to 0.92) and 0.84 (0.82 to 0.87). The pooled area under the receiver operating characteristics curve (n=3056) was 0.85 (0.84 to 0.87). The area under the curve for nurses' and physicians' predictions (n=124) was significantly lower at 0.59 (0.49 to 0.70) for both.ConclusionThe PRE-DELIRIC model for intensive care patients consists of 10 risk factors that are readily available within 24 hours after intensive care admission and has a high predictive value. Clinical prediction by nurses and physicians performed significantly worse. The model allows for early prediction of delirium and initiation of preventive measures. Trial registration Clinical trials NCT00604773 (development study) and NCT00961389 (validation study).
| S-EPMC3276486 | biostudies-literature