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BACKGROUND: Intensive care medicine continues to improve, with advances in technology and care provision leading to improved patient survival. However, this has not been matched by similar advances in ICU bedspace design. Environmental factors including excessive noise, suboptimal lighting, and lack of natural lights and views can adversely impact staff wellbeing and short- and long-term patient outcomes. The personal, social, and economic costs associated with this are potentially large. The ICU of the Future project was conceived to address these issues. This is a mixed-method project, aiming to improve the ICU bedspace environment and assess impact on patient outcomes. Two innovative and adaptive ICU bedspaces capable of being individualised to patients' personal and changing needs were co-designed and implemented. The aim of this study is to evaluate the effect of an improved ICU bedspace environment on patient outcomes and operational impact. METHODS: This is a prospective multi-component, mixed methods study including a randomised controlled trial. Over a 2-year study period, the two upgraded bedspaces will serve as intervention beds, while the remaining 25 bedspaces in the study ICU function as control beds. Study components encompass (1) an objective environmental assessment; (2) a qualitative investigation of the ICU environment and its impact from the perspective of patients, families, and staff; (3) sleep investigations; (4) circadian rhythm investigations; (5) delirium measurements; (6) assessment of medium-term patient outcomes; and (7) a health economic evaluation. DISCUSSION: Despite growing evidence of the negative impact the ICU environment can have on patient recovery, this is an area of critical care medicine that is understudied and commonly not considered when ICUs are being designed. This study will provide new information on how an improved ICU environment impact holistic patient recovery and outcomes, potentially influencing ICU design worldwide. TRIAL REGISTRATION: ACTRN12623000541606. Registered on May 22, 2023. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385845&isReview=true .
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Unidades de Cuidados Intensivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Estudios Prospectivos , Factores de Tiempo , Lechos , Resultados de Cuidados Críticos , Ambiente de Instituciones de Salud , Arquitectura y Construcción de Hospitales , Cuidados Críticos/métodosRESUMEN
BACKGROUND: ICU outcomes are continuing to improve. However, this has not been matched by similar improvements of the ICU bedspace environment, which can detrimentally impact on patient outcomes. Excessive sound and noise, especially, has been linked with adverse and potentially preventable patient outcomes and staff errors. There are many sources of sound in the ICU, with alarms from bedside equipment frequently listed as a main source. The number of alarms is increasing in parallel with the introduction of new and more sophisticated technologies to monitor and support patients. However, most alarms are not accurate or critical and are commonly ignored by staff. OBJECTIVE: The objective of this study was to evaluate the impact of a sound reduction bundle on sound levels, number of alarms, and patients' experience and perceived quality of sleep in the ICU. METHODS: This was a pre-post, quasi-experimental study investigating the impact of three study interventions implemented sequentially (staff education, visual warnings when sound levels exceeded the preset levels, and monitor alarm reconfigurations). Effects of staff education were evaluated using pre-education and post-education questionnaires, and the impact on patients was evaluated via self-report questionnaires. A sound-level monitor was used to evaluate changes in sound levels between interventions. Alarm audits were completed before and after alarm reconfiguration. RESULTS: Staff knowledge improved; however, sound levels did not change across interventions. The number of monthly monitor alarms reduced from 600,452 to 115,927. No significant differences were found in patients' subjective rating of their experience and sleep. CONCLUSION: The interventions did not lead to a sound-level reduction; however, there was a large reduction in ICU monitor alarms without any alarm-related adverse events. As the sources of sound are diverse, multidimensional interventions, including staff education, alarm management solutions, and environmental redesign, are likely to be required to achieve a relevant, lasting, and significant sound reduction.
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Alarmas Clínicas , Unidades de Cuidados Intensivos , Ruido , Humanos , Masculino , Femenino , Encuestas y Cuestionarios , Persona de Mediana Edad , AdultoRESUMEN
OBJECTIVES: Following a user-centred redesign and refinement process of an electronic delirium screening tool (eDIS-MED), further accuracy assessment was performed prior to anticipated testing in the clinical setting. METHODS: Content validity of each of the existing questions was evaluated by an expert group in the domains of clarity, relevance and importance. Questions with a Content Validity Index (CVI) <0.80 were reviewed by the development group for potential revision. Items with CVI <0.70 were discarded. Next, face validity of the entirety of the tests was conducted and readability measured. RESULTS: A panel of five clinical experts evaluated the test battery comprising eDIS-MED. The content validity process endorsed 61 items. The overall scale CVI was 0.92. Eighty-eight per cent of the responses with regard to question relevancy, usefulness and appropriateness were positive. The questions were deemed fifth grade level and very easy to read. CONCLUSIONS: A revised electronic screening tool was shown to be accurate according to an expert group. A clinical validation study is planned.
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Delirio , Aplicaciones Móviles , Valor Predictivo de las Pruebas , Humanos , Delirio/diagnóstico , Reproducibilidad de los Resultados , ComprensiónRESUMEN
BACKGROUND: As advancements in critical care medicine continue to improve Intensive Care Unit (ICU) survival rates, clinical and research attention is urgently shifting toward improving the quality of survival. Post-Intensive Care Syndrome (PICS) is a complex constellation of physical, cognitive, and mental dysfunctions that severely impact patients' lives after hospital discharge. This review provides a comprehensive and multi-dimensional summary of the current evidence and practice of exercise therapy (ET) during and after an ICU admission to prevent and manage the various domains of PICS. The review aims to elucidate the evidence of the mechanisms and effects of ET in ICU rehabilitation and highlight that suboptimal clinical and functional outcomes of ICU patients is a growing public health concern that needs to be urgently addressed. MAIN BODY: This review commences with a brief overview of the current relationship between PICS and ET, describing the latest research on this topic. It subsequently summarises the use of ET in ICU, hospital wards, and post-hospital discharge, illuminating the problematic transition between these settings. The following chapters focus on the effects of ET on physical, cognitive, and mental function, detailing the multi-faceted biological and pathophysiological mechanisms of dysfunctions and the benefits of ET in all three domains. This is followed by a chapter focusing on co-interventions and how to maximise and enhance the effect of ET, outlining practical strategies for how to optimise the effectiveness of ET. The review next describes several emerging technologies that have been introduced/suggested to augment and support the provision of ET during and after ICU admission. Lastly, the review discusses future research directions. CONCLUSION: PICS is a growing global healthcare concern. This review aims to guide clinicians, researchers, policymakers, and healthcare providers in utilising ET as a therapeutic and preventive measure for patients during and after an ICU admission to address this problem. An improved understanding of the effectiveness of ET and the clinical and research gaps that needs to be urgently addressed will greatly assist clinicians in their efforts to rehabilitate ICU survivors, improving patients' quality of survival and helping them return to their normal lives after hospital discharge.
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BACKGROUND: Our understanding of post-ICU recovery is influenced by which patients are selected to study and treat. Many studies currently list an ICU length of stay of at least 24, 48, or 72 h as an inclusion criterion. This may be driven by established evidence that prolonged time in an ICU bed and prolonged ventilation can complicate post-ICU rehabilitation. However, recovery after short ICU stays still needs to be explored. METHODS: This is a secondary analysis from the tracking outcomes post-intensive care (TOPIC) study. One hundred and thirty-two participants were assessed 6-months post-ICU discharge using standardised and validated self-report tools for physical function, cognitive function, anxiety, depression and post-traumatic stress disorder (with clinically significant impairment on any tool being considered a complicated recovery). Routinely collected data relating to the ICU stay were retrospectively accessed, including length of stay and duration of mechanical ventilation. Patients with short ICU stays were intentionally included, with 77 (58%) participants having an ICU length of stay < 72 h. RESULTS: Of 132 participants, 40 (30%) had at least one identified post-ICU impairment 6 months after leaving ICU, 22 (17%) of whom had an ICU length of stay < 72 h. CONCLUSION: Many patients with an ICU length of stay < 72 h are reporting post-ICU impairment 6 months after leaving ICU. This is a population often excluded from studies and interventions. Future research should further explore post-ICU impairment among shorter stays.
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Ansiedad , Enfermedad Crítica , Humanos , Estudios Retrospectivos , Unidades de Cuidados IntensivosRESUMEN
BACKGROUND: Electronic delirium-screening tools are an emergent area of research. OBJECTIVE: The objective of this study was to summarise the development and performance characteristics of electronic screening tools in delirium. METHODS: Searches were conducted in Pubmed, Embase, and CINAHL Complete databases to identify electronic delirium-screening tools. RESULTS: Five electronic delirium-screening tools were identified and reviewed. Two were designed for and tested within a medical setting, and three were applied to intensive care. Adaptive design features, such as skip function to reduce test burden, were variably integrated into instrument design. All tools were shown to have acceptable psychometric properties, but validation studies were largely incomplete. CONCLUSIONS: Electronic delirium-screening tools are an exciting area of development and may offer hope for improved uptake of delirium screening.
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Delirio , Tamizaje Masivo , Psicometría , Delirio/diagnóstico , Humanos , Tamizaje Masivo/métodosRESUMEN
BACKGROUND: ICU survival is improving. However, many patients leave ICU with ongoing cognitive, physical, and/or psychological impairments and reduced quality of life. Many of the reasons for these ongoing problems are unmodifiable; however, some are linked with the ICU environment. Suboptimal lighting and excessive noise contribute to a loss of circadian rhythms and sleep disruptions, leading to increased mortality and morbidity. Despite long-standing awareness of these problems, meaningful ICU redesign is yet to be realised, and the 'ideal' ICU design is likely to be unique to local context and patient cohorts. To inform the co-design of an improved ICU environment, this study completed a detailed evaluation of the ICU environment, focussing on acoustics, sound, and light. METHODS: This was an observational study of the lighting and acoustic environment using sensors and formal evaluations. Selected bedspaces, chosen to represent different types of bedspaces in the ICU, were monitored during prolonged study periods. Data were analysed descriptively using Microsoft Excel. RESULTS: Two of the three monitored bedspaces showed a limited difference in lighting levels across the day, with average daytime light intensity not exceeding 300 Lux. In bedspaces with a window, the spectral power distribution (but not intensity) of the light was similar to natural light when all ceiling lights were off. However, when the ceiling lights were on, the spectral power distribution was similar between bedspaces with and without windows. Average sound levels in the study bedspaces were 63.75, 56.80, and 59.71 dBA, with the single room being noisier than the two open-plan bedspaces. There were multiple occasions of peak sound levels > 80 dBA recorded, with the maximum sound level recorded being > 105 dBA. We recorded one new monitor or ventilator alarm commencing every 69 s in each bedspace, with only 5% of alarms actioned. Acoustic testing showed poor sound absorption and blocking. CONCLUSIONS: This study corroborates other studies confirming that the lighting and acoustic environments in the study ICU were suboptimal, potentially contributing to adverse patient outcomes. This manuscript discusses potential solutions to identified problems. Future studies are required to evaluate whether an optimised ICU environment positively impacts patient outcomes.
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Unidades de Cuidados Intensivos , Calidad de Vida , Humanos , Ruido/efectos adversos , Iluminación , LuzRESUMEN
BACKGROUND: Intensive Care survival continues to improve, and the number of ICU services is increasing globally. However, there is a growing awareness of the detrimental impact of the ICU environment on patients, families, and staff. Excessive noise and suboptimal lighting especially have been shown to adversely impact physical and mental recovery during and after an ICU admission. Current ICU designs have not kept up with advances in medical technology and models of care, and there is no current 'gold-standard' ICU design. Improvements in ICU designs are needed to optimise care delivery and patient outcomes. METHODS: This manuscript describes a mixed-methods, multi-staged participatory design project aimed at redesigning and implementing two innovative ICU bedspaces. Guided by the action effect method and the consolidated framework for implementation research, the manuscript describes the processes taken to ensure the patient-centred problems were properly understood, the steps taken to develop and integrate solutions to identified problems, and the process of implementation planning and rebuilding in a live ICU. RESULTS: Two innovative ICU bedspaces were rebuilt and implemented. They feature solutions to address all identified problems, including noise reduction, optimisation of lighting, access to nature via digital solutions, and patient connectivity and engagement, with solutions developed from various specialty fields, including IT improvements, technological innovations, and design and architectural solutions. Early evaluation demonstrates an improved lighting and acoustic environment. CONCLUSIONS: Optimising the ICU bedspace environment and improving the lighting and acoustic environment is possible. The impact on patient outcomes needs to be evaluated.
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Cuidados Críticos , Unidades de Cuidados Intensivos , Humanos , Cuidados Críticos/métodos , Pacientes , Ruido , HospitalizaciónRESUMEN
AIM: To address the need for additional education in the management of mental illness in the critical care setting by providing a broad overview of the interrelationship between critical illness and mental illness. The paper also offers practical advice to support critical care staff in managing patients with mental illness in critical care by discussing two hypothetical case scenarios involving aggressive and disorganised behaviour. People living with mental illness are over-represented among critically unwell patients and experience worse outcomes, contributing to a life expectancy up to 30 years shorter than their peers. Strategic documents call for these inequitable outcomes to be addressed. Staff working in intensive care units (ICUs) possess advanced knowledge and specialist skills in managing critical illness but have reported limited confidence in managing patients with comorbid mental illness. DESIGN & METHODS: A discursive paper, drawing on clinical experience and research of the authors and current literature. RESULTS: Like all people, patients with mental illnesses draw on their cognitive, behavioural, social and spiritual resources to cope with their experiences during critical illness. However, they may have fewer resources available due to co-morbid mental illness, a history of trauma and social disadvantage. By identifying and sensitively addressing patients' underlying needs in a trauma-informed way, demonstrating respect and maximising patient autonomy, staff can reduce distress and disruptive behaviours and promote recovery. Caring for patients who are distressed and/or display challenging behaviours can evoke strong and unpleasant emotional responses. Self-care is fundamental to maintaining a compassionate approach and effective clinical judgement. Staff should be enabled to accept and acknowledge emotional responses and access support-informally with peers and/or through formal mechanisms as needed. Organisational leadership and endorsement of the principles of equitable care are critical to creation of the environment needed to improve outcomes for staff and patients. RELEVANCE TO CLINICAL PRACTICE: ICU nurses hold an important role in the care of patients with critical illnesses and are ideally placed to empower, advocate for and comfort those patients also living with mental illness. To perform these tasks optimally and sustainably, health services have a responsibility to provide nursing staff with adequate education and training in the management of mental illnesses, and sufficient formal and informal support to maintain their own well-being while providing this care. PATIENT AND PUBLIC INVOLVEMENT: This paper is grounded in accounts of patients with mental illness and clinicians providing care to patients with mental illness in critical care settings but there was no direct patient or public contribution.
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Enfermedad Crítica , Trastornos Mentales , Humanos , Enfermedad Crítica/terapia , Trastornos Mentales/terapia , Cuidados Críticos , Pacientes , ComorbilidadRESUMEN
BACKGROUND: Up to 80% of Intensive Care Unit patients experience physical, cognitive, and/or psychological complications post-discharge, known as 'Post Intensive Care Syndrome' (PICS). Early diagnosis and intervention are a priority, but while current post-intensive care follow-up processes endorse a multidisciplinary model, incorporating a psychiatric consultation has not been studied. METHODS: A pilot, open-label randomised controlled trial was developed by a multidisciplinary team to evaluate the feasibility and acceptability of incorporating a psychiatric review into an existing post-ICU clinic. The study will run for 12 months and aim to recruit 30 participants. Inclusion criteria for participants: a) ICU admission greater than 48 hours, b) no cognitive impairment that prevents participation, c) ≥ 18 years old, d) residing in Australia, e) fluent in English, f) able to provide GP information, and g) likely to be contactable in 6 months. Patient recruitment will be at Redcliffe Hospital, Queensland, Australia, and will involve patients attending the Redcliffe post intensive care clinic. Participants will be allocated to intervention or control using block randomisation and allocation concealment. Participants allocated to the control arm will receive the standard cares provided by the clinic, which involves an unstructured interview about their ICU experience and a battery of surveys about their psychological, cognitive, and physical function. Those allocated to the intervention arm will receive these same cares as well as an appointment with a psychiatrist for a single session intervention. The psychiatric intervention will involve a comprehensive review, including comorbid disorders, substance use, suicidal ideation, psychosocial stressors, social/emotional supports. Psychoeducation and initial treatment will be provided as indicated and recommendations given to the patient and their GP about how to access ongoing care. In addition to surveys conducted as part of standard clinic cares, all participants will complete additional questionnaires about their history, hospital experience, mental and physical health as well as employment circumstances. All participants will be followed up 6 months after their appointment and will be invited to complete follow-up questionnaires about their mental and physical health, as well as health service use and employment circumstances. The trial has been registered with ANZCTR (ACTRN12622000894796). RESULTS: To evaluate the feasibility and acceptability of the intervention to the patient population. Differences between groups will be assessed using an independent samples t-test. Resource requirements to administer the intervention will be evaluated by reporting the mean duration of the EPARIS assessment and approximate cost per patient to provide this service. To estimate the effect size of any treatment effects, changes in secondary outcome measures between baseline and 6 months will be compared between intervention and control groups using Analysis of Covariance regression. As this is a pilot, we will not use p-values or test a null hypothesis, but will give confidence intervals. CONCLUSIONS: This protocol provides a pragmatic evaluation of the acceptability of introducing early psychiatric assessment into an existing post-ICU follow-up process, and if considered acceptable will inform future research into the efficacy and generalisability of the intervention. The strengths of EPARIS are the prospective, longitudinal design with a control population, and its use of validated post-ICU outcome measures.
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Cuidados Posteriores , Alta del Paciente , Humanos , Adolescente , Proyectos Piloto , Estudios Prospectivos , Derivación y Consulta , Cuidados Críticos , Ensayos Clínicos Controlados Aleatorios como Asunto , Literatura de Revisión como AsuntoRESUMEN
BACKGROUND: Delirium is a common, yet underdiagnosed neuropsychiatric complication of intensive care unit (ICU) admission, associated with significant mortality and morbidity. Delirium can be difficult to diagnose, with gold standard assessments by a trained specialist being impractical and rarely performed. To address this, various tools have been developed, enabling bedside clinicians to assess for delirium efficiently and accurately. However, the performance of these tools varies depending on factors including the assessor's training. To address the shortcomings of current tools, electronic tools have been developed. AIMS AND OBJECTIVES: The aims of this validation study are to assess the feasibility, acceptability, and generalisability of a recently developed and pilot-tested electronic delirium screening tool (eDIS-ICU) and compare diagnostic concordance, sensitivity, and specificity between eDIS-ICU, Confusion Assessment Method for the ICU (CAM-ICU), and the Diagnostic and Statistical Manual of Mental Disorders - 5th edition (DSM-V) gold standard in diverse ICU settings. METHODS: Seven hundred participants will be recruited across five sites in three countries. Participants will complete three assessments (eDIS-ICU, CAM-ICU, and DSM-V) twice within one 24-h period. At each time point, assessments will be completed within one hour. Assessments will be administered by three different people at any given time point, with the assessment order and assessor for eDIS-ICU and CAM-ICU randomly allocated. Assessors will be blinded to previous and concurrent assessment results. RESULTS: The primary outcome is comparing diagnostic sensitivity of eDIS-ICU and CAM-ICU against the DSM-V. RELEVANCE TO CLINICAL PRACTICE: This protocol describes a definitive validation study of an electronic diagnostic tool to assess for delirium in the ICU. Delirium remains a common and difficult challenge in the ICU and is linked with multiple neurocognitive sequelae. Various challenges to routine assessment mean many cases are still unrecognised or misdiagnosed. An improved ability for bedside clinicians to screen for delirium accurately and efficiently will support earlier diagnosis, identification of underlying cause(s) and timely treatments, and ultimately improved patient outcomes. CLINICAL TRIAL REGISTRATION NUMBER: This study was prospectively registered on the Australian New Zealand Clinical Trials Registry (ANZCTR) on 8th February 2022 (ACTRN12622000220763).
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Delirio , Humanos , Delirio/diagnóstico , Australia , Unidades de Cuidados Intensivos , Evaluación de Resultado en la Atención de Salud , Nueva ZelandaRESUMEN
BACKGROUND: Workplace violence comprises abuse, assaults, threats, and harassment. Reaching epidemic proportions in healthcare, workplace violence compromises staff and patient safety and service efficiency and effectiveness. Although workplace violence is a nontrivial problem in intensive care, little is known about circumstances in which violence occurs in this setting. OBJECTIVE: The objective of this study was to describe and reflect upon aggression towards staff in the intensive care unit (ICU) from the perspectives of staff members. METHODS: We investigated workplace violence in a qualitative study with data collected from semistructured interviews with 19 staff members of a 10-bed ICU, analysed using a framework approach. FINDINGS: All participants reported witnessing or experiencing physical and/or verbal aggression. While acknowledging that 'any patient' could become aggressive, participants differentiated 'any patients admitted for treatment of somatic illnesses' from 'dangerous' patients and interpreted violence differently dependent on characteristics of perpetrators. 'Dangerousness' was associated with patients who had a comorbid mental illness. Aggression of 'dangerous patients' was construed as intentional and/or 'normal aberrant' behaviour for the individual. Staff reported feeling ill-prepared to work effectively with this cohort and having difficulty responding empathically. Mental health services were considered 'responsible' for managing patients' drug use, personality, and psychiatric problems. CONCLUSION: Perceived knowledge and skill deficits, as well as stigma when engaging with certain subpopulations, contribute to workplace violence in the ICU setting. ICU staff members seek education and support to improve management of patients and reduce risk of violence. However, effectiveness depends on robust service and organisational commitment and strategies to promote workplace health and safety.
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Agresión , Violencia Laboral , Humanos , Agresión/psicología , Pacientes , Lugar de Trabajo/psicología , Cuidados CríticosRESUMEN
The purpose of this study is to establish the diagnostic sensitivity of Endothelin-1 for risk stratification and screening of clinical vasospasm after subarachnoid hemorrhage.This is a multicentre, observational study, correlating daily blood Endothelin-1 with clinical variables. Binary logistic regression used to examine if Endothelin-1 levels could be used to predict clinical vasospasm. Bivariate modelling used to explore associations between patient characteristics and vasospasm. A Receiver Operating Curve used to explore cut-off values for Endothelin-1. Sensitivity and specificity was used to validate the cut-point found in the pilot study. A total of 96 patients were enrolled over two years. Median Endothelin-1 was higher for patients who experienced clinical vasospasm except for day-5, where median endothelin for patients without vasospasm was higher (3.6 IQR = 5.3), compared to patients with vasospasm (3.3 IQR = 8.5) although differences were not significant. The Receiver Operating Curve analysis confirmed that day-5 Endothelin-1 was not a good indicator of vasospasm, with an area under the curve of 0.506 (95% CI: 0.350-0.663, p = 0.938). The levels of Endothelin-1 in blood do not discriminate patients who may develop symptomatic vasospasm. The high variability in Endothelin-1 levels, aligns with the pathophysiological variability of most biomarkers, decreasing their ability to predict a clinical event.
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Hemorragia Subaracnoidea , Vasoespasmo Intracraneal , Método Doble Ciego , Endotelina-1 , Humanos , Proyectos Piloto , Vasoespasmo Intracraneal/diagnóstico , Vasoespasmo Intracraneal/etiologíaRESUMEN
BACKGROUND: Critically ill patients are more likely to survive intensive care than ever before due to advances in treatment. However, a proportion subsequently experiences post-intensive care syndrome (PICS) incurring substantial personal, social, and economic costs. PICS is a debilitating set of physical, psychological, and cognitive sequelae but the size and characteristics of the affected population have been difficult to describe, impeding progress in intensive care rehabilitation. AIMS AND OBJECTIVES: The aim of this protocol is to describe recovery after admission to intensive care unit (ICU) and the predictors, correlates, and patient-reported outcomes for those experiencing PICS. The study will support the development of screening, diagnostic, and outcome measures to improve post-ICU recovery. DESIGN: A prospective, multi-site observational study in three ICUs in Brisbane, Australia. Following consent, data will be collected from clinical records and using validated self-report instruments from 300 patients, followed up at 6 weeks and 6 months post ICU discharge. METHODS: TOPIC is a prospective, multi-site observational study using self-report and clinical data on risk factors, including comorbidities, and outcomes. Data will be collected with consent from hospital records and participants 6 weeks and 6months post ICU discharge. RESULTS: The main outcome measures will be self-reported physical, cognitive, and psychological function 6 weeks and 6 months post-ICU discharge. RELEVANCE TO CLINICAL PRACTICE: This protocol provides a methodological framework to measure recovery and understand PICS. Data analysis will describe characteristics associated with recovery and PICS. The subsequent prediction and screening tools developed then aim to improve the effectiveness of post-ICU prevention and rehabilitation through more targeted screening and prediction and found a program of research developing a more tailored approach to PICS.
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Cuidados Críticos , Calidad de Vida , Cuidados Críticos/psicología , Enfermedad Crítica/psicología , Humanos , Unidades de Cuidados Intensivos , Estudios Observacionales como Asunto , Estudios ProspectivosRESUMEN
BACKGROUND: There is limited evidence on interventions to minimise weight gain at clozapine commencement. We compared the effect of adjunctive metformin versus placebo at clozapine initiation. METHODS: People with schizophrenia commencing on clozapine were randomised to either metformin or placebo for 24 weeks. The primary outcome was difference in the change of body weight. Secondary outcomes included comparative rates of weight gain of more than 5%, overall weight gain/loss, and differences in metabolic and psychosis outcomes. RESULTS: The study was closed prematurely in March 2020 due to COVID-19 restrictions. Ten participants were randomised to each of the metformin and placebo groups. Eight metformin group and five placebo group participants completed the trial and were included in the analysis. The study was insufficiently powered to detect difference between the metformin and placebo groups for the primary outcome of change in weight (0.09 kg vs 2.88 kg, p = 0.231). In terms of secondary outcomes, people in the metformin group were significantly less likely to gain >5% of their body weight (12.5% vs 80%, p = 0.015) and were more likely to lose weight (37.5% vs 0% p = 0.024) compared to placebo. There was no difference between the groups in terms of adverse drug reactions (ADRs). CONCLUSION: While limited by the forced premature closure of the trial due to COVID19, the findings from this randomised controlled trial are promising. Clozapine and metformin co-commencement may be a promising treatment to prevent clozapine-associated weight gain, especially given the low rates of ADRs associated with metformin. This supports the consideration of use of metformin to prevent weight gain in people initiated on clozapine; however, further studies are needed to confirm this finding. TRIAL REGISTRATION: ACTRN12617001547336.
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INTRODUCTION: Delirium, a common complication of an intensive care unit (ICU) admission, is inconsistently diagnosed by clinicians. Current screening tools require specialist expertise and/or training. Some are time-consuming to administer, and reliability in routine clinical practice is questionable. An innovative app designed to enable efficient and sensitive screening for delirium without specialist training (eDIS-ICU) has recently been described. This pilot study compared the eDIS-ICU against the reference standard expert assessment using DSM-V (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria and the Confusion Assessment Method for the ICU (CAM-ICU). METHODS: In this prospective, single-centre pilot study, a convenience sample of 29 ICU patients were recruited at a tertiary referral hospital between November 2018 and August 2019. After obtaining written consent, demographic and clinical data were collected, and the patients were screened for delirium using eDIS-ICU and CAM-ICU by two clinician researchers in random order. The patients were also assessed for presence of delirium independently by an expert clinician using a structured interview to diagnose as per DSM-V criteria. The results of screening and diagnosis were tabulated to allow comparison of screening tools against diagnosis; sensitivity and specificity of the tools were calculated. RESULTS: Seven participants were diagnosed with delirium as per DSM-V criteria. The eDIS-ICU tool correctly identified six of these participants compared with two identified by CAM-ICU. The sensitivity of the eDIS-ICU tool was 86% (95% confidence interval [CI] = 81.5-100.0) compared with 29% (95% CI = 5.1-69.7) for CAM-ICU (p < 0.05), and the specificity was 73% (95% CI = 81.5-100.0) versus 96% (95% CI = 75.1-99.8), respectively. CONCLUSION: The simple and novel eDIS-ICU delirium screening tool was noninferior to the CAM-ICU in detecting delirium as per DSM-V criteria. A definitive validation study is warranted.
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Delirio , Aplicaciones Móviles , Delirio/diagnóstico , Humanos , Unidades de Cuidados Intensivos , Proyectos Piloto , Estudios Prospectivos , Reproducibilidad de los ResultadosRESUMEN
BACKGROUND: The intensive care environment and experiences during admission can negatively impact patient and family outcomes and can complicate recovery both in hospital and after discharge. While their perspectives based on intimate experiences of the environment could help inform design improvements, patients and their families are typically not involved in design processes. Rather than designing the environment around the needs of the patients, emphasis has traditionally been placed on clinical and economic efficiencies. OBJECTIVE: The main objective was to inform design of an optimised intensive care bedspace by developing an understanding of how patients and their families experience the intensive care environment and its impact on recovery. METHODS: A qualitative descriptive study was conducted with data collected in interviews with 17 intensive care patients and seven family members at a large cardiothoracic specialist hospital, analysed using a framework approach. RESULTS: Participants described the intensive care as a noisy, bright, confronting and scary environment that prevented sleep and was suboptimal for recovery. Bedspaces were described as small and cluttered, with limited access to natural light or cognitive stimulation. The limited ability to personalise the environment and maintain connections with family and the outside world was considered especially problematic. CONCLUSIONS: Intensive care patients described features of the current environment they considered problematic and potentially hindering their recovery. The perspective of patients and their families can be utilised by researchers and developers to improve the design and function of the intensive care environment. This can potentially improve patient outcomes and help deliver more personalised and effective care to this vulnerable patient population and their families.
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Enfermedad Crítica , Unidades de Cuidados Intensivos , Australia , Cuidados Críticos , Familia , Humanos , Investigación CualitativaRESUMEN
BACKGROUND: While the impact of the intensive care environment on patients' experiences and outcomes has been extensively studied, relatively little research has examined the impact on clinicians and their provision of care in the intensive care unit (ICU). Understanding staff experience and views about the environment is needed to optimise the ICU environment, patient outcomes and staff wellbeing. OBJECTIVE: The objective of this study was to inform design of an optimised intensive care bedspace by describing clinicians' views about the current environment, including experience, impact on performance of clinical duties, and experience and outcomes of patients and family members. METHODS: A pragmatic, qualitative descriptive study was conducted, with data collected in focus groups and interviews with 30 intensive care clinicians at a large cardiothoracic specialist hospital and analysed using the framework approach. RESULTS: Participants acknowledged that the busy and noisy ICU provided a suboptimal healing environment for patients, was confronting for visiting families and exposed clinicians to risk of psychological injury. The bedspace, described as small and cluttered, hindered provision of clinical care of various kinds and contributed to an increased risk of staff physical injuries. Participants noted that the bland, sterile environment, devoid of natural light and views of the outside world, negatively affected both staff and patients' mood and motivation. Aware of the potential benefits of natural light, cognitive stimulation and visually appealing environments for patients and families, clinicians were frustrated by their inability to personalise the bedspace. Some participants, while acknowledging the importance of family contact for patients, were concerned about the impact of visitors on care delivery, particularly within already crowded bedspaces, suggesting restrictions on visiting. CONCLUSIONS: Intensive care clinicians perceive that the current intensive care environment is suboptimal for patients, their families and staff and may contribute to suboptimal patient outcomes. The intensive care bedspaces need to be redesigned to ensure they are built around the needs of the people using them. Optimisation is dependent on engaging all stakeholders in future design processes.