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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).

ABSTRACT: INTRODUCTION:Flexible 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 ANALYSIS:A 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 DISSEMINATION:The 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 REGISTRATION:NCT02932358.

SUBMITTER: Rosa RG

PROVIDER: S-EPMC5905750 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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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).

Rosa Regis Goulart RG Falavigna Maicon M Robinson Caroline Cabral CC da Silva Daiana Barbosa DB Kochhann Renata R de Moura Rafaela Moraes RM Santos Mariana Martins Siqueira MMS Sganzerla Daniel D Giordani Natalia Elis NE Eugênio Cláudia C Ribeiro Tarissa T Cavalcanti Alexandre Biasi AB Bozza Fernando F Azevedo Luciano Cesar Pontes LCP Machado Flávia Ribeiro FR Salluh Jorge Ibrain Figueira JIF Pellegrini José Augusto Santos JAS Moraes Rafael Barberena RB Hochegger Taís T Amaral Alexandre A Teles José Mario Meira JMM da Luz Lucas Gobetti LG Barbosa Mirceli Goulart MG Birriel Daniella Cunha DC Ferraz Iris de Lima IL Nobre Vandack V Valentim Helen Martins HM Corrêa E Castro Livia L Duarte Péricles Almeida Delfino PAD Tregnago Rogério R Barilli Sofia Louise Santin SLS Brandão Nilton N Giannini Alberto A Teixeira Cassiano C

BMJ open 20180413 4

<h4>Introduction</h4>Flexible 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 professi ...[more]

PMID: 29654049

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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.

Project description:BackgroundIn the intensive care unit (ICU), critical illness delirium occurs in the context of multiple comorbidities, multi-organ failure, and invasive management techniques, such as mechanical ventilation, sedation, and lack of sleep. Delirium is characterized by an acute confusional state defined by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. The long-term cognitive and psychosocial function of patients that experience delirium in the ICU is of crucial interest because preliminary data suggest a strong association between ICU-related delirium and long-term cognitive impairment.ObjectiveThe aim of this study is to explore the relationship between delirium in the ICU and adverse outcomes by following mechanically ventilated patients for one year following their discharge from the ICU and collecting data on their long-term cognition and psychosocial function.MethodsThis study will be conducted by enrolling patients in two tertiary ICUs in Australia. We aim to recruit 200 patients who have been mechanically ventilated for more than 24 hours. Data will be collected at the following three time points: (1) at discharge where they will be administered the Mini-Mental State Examination (MMSE); (2) at 6 months after discharge from the ICU discharge where the Impact of Events Scale Revised (IES-R) and the Telephone Inventory for Cognitive Status (TICS) tests will be administered; and (3) at 12 months after discharge from the ICU where the patients will be administered the TICS and IES-R tests, as well as the Informant Questionnaire for Cognitive Decline in the Elderly (IQCODE). The IQCODE will be administered to their "person responsible" or the significant other of the patient.ResultsLong-term cognition and psychosocial function will be the primary outcome of this study. Mortality will also be investigated as a secondary outcome. Active enrollment will take place until the end of September 2016 and data collection will conclude at the end of September 2017. The analysis and results are expected to be available by March 2018.ConclusionDelirium during mechanical ventilation has been linked to longer ICU and hospital stays, higher financial burdens, increased risks of long-term cognitive impairment (ie, dementia), poor functional outcomes and quality of life, and decreased survival. However, delirium during mechanical ventilation in the ICU is not well understood. This study will advance our knowledge of the comprehensive, long-term effects of delirium on cognitive and psychosocial function.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616001116415; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371216 (Archived by WebCite at http://www.webcitation.org/ 6nfDkGTcW).

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.

Project description:ObjectivesThe pathophysiology of delirium is complex and incompletely understood. Inflammation is hypothesized to be integral to its development due to effects on blood brain barrier integrity, facilitation of leukocyte extravasation into brain parenchyma, and propagation of neuroinflammation. Septic shock is the prototypical condition associated with ICU delirium; however, the relative contribution of resultant hypotension and systemic inflammation to the development of delirium is unknown.DesignThis was a prospective exploratory study.SettingA multidisciplinary ICU at an academic medical center in Phoenix, AZ.PatientsCritically ill patients older than or equal to 18 years old admitted to the ICU.InterventionsNone.Measurements and main resultsScreening for delirium was performed using the Confusion Assessment Method for the ICU tool. The levels of C-C motif ligand 2 (CCL2), C-C motif ligand 3, C-X-C motif chemokine ligand 1, C-X-C motif chemokine ligand 10, and interleukin-8 were measured in serum samples obtained within 12 hours of ICU admission. Univariate and multivariate analyses were performed to assess the association of delirium with patient data pertaining to hospital course, laboratory values, vital signs, medication administration, and levels of the aforementioned chemokines. Forty-one of 119 patients (34.5%) in the study cohort developed ICU delirium. Each chemokine studied was associated with delirium on univariate analyses; however, CCL2 was the only chemokine found to be independently associated with the development of delirium on multivariable analysis. The association of increased CCL2 levels with delirium remained robust in various models controlling for age, presence of shock, Sequential Organ Failure Assessment score, Acute Physiology and Chronic Health Evaluation IV score, mean arterial pressure at presentation, lowest mean arterial pressure, and total opioid, midazolam, propofol, and dexmedetomidine exposure.ConclusionsThe demonstrated relationship between CCL2 and delirium suggests this chemokine may play a role in the development of delirium and warrants further investigation.

Project description:OBJECTIVES:The aim of this study was to explore the experiences of doctors and nurses caring for patients with delirium in the intensive care unit (ICU) and to describe the process of delirium management. SETTING:This study was performed in 5 ICUs located within 4 hospitals in Madrid (Spain). PARTICIPANTS:Purposeful sampling was performed which included (1) doctors and nurses working in ICUs, (2) with >1 year experience in the ICU and (3) clinical experience with delirium. 38 professionals participated (19 doctors, 19 nurses), including 22 women and 16 men. The total mean age was 39 years. DESIGN:A qualitative study using focus groups. METHODS:7 focus groups were held to collect data: 3 nurse focus groups, 3 doctor focus groups and 1 mixed focus group. Each group comprised 6-10 participants. A semistructured questions guide was used. Thematic analysis methods were used to analyse the data. RESULTS:3 themes were identified: (1) the professional perspective on delirium; (2) implementing pharmacological and non-pharmacological treatment for delirium and (3) work organisation in the ICU. The professionals regarded patients with delirium with uncertainty, and felt they were often underdiagnosed and poorly managed. Doctors displayed discrepancies regarding pharmacological prescriptions and decision-making. The choice of medication was determined by experience. Nurses felt that, for many doctors, delirium was not considered a matter of urgency in the ICU. Nurses encountered difficulties when applying verbal restraint, managing sleep disorders and providing early mobilisation. The lack of a delirium protocol generates conflicts regarding what type of care management to apply, especially during the night shift. A degree of group pressure exists which, in turn, influences the decision-making process and patient care. CONCLUSIONS:Patients with delirium represent complex cases, requiring the implementation of specific protocols. These results serve to improve the process of care in patients with delirium.

Dataset Information

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).

Publications

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).

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