Recommendations and Alerting for Delirium Alleviation in Real-Time (RADAR): Protocol for a pilot randomized controlled trial.
ABSTRACT: Background: Delirium is a common and serious complication of major surgery for older adults. Postoperative social and behavioral support (e.g., early mobilization, mealtime assistance) may reduce the incidence and impact of delirium, and these efforts are possible with proactive patient-care programs. This pilot trial tests the hypothesis that a multicomponent decision support system, which sends automated alerts and recommendations to patient-care programs and family members for high-risk patients, will improve the postoperative environment for neurocognitive and clinical recovery. Methods: This will be a randomized, controlled, factorial pilot trial at a large academic medical center. High-risk, non-cardiac surgery patients (?70 years old) will be recruited. Patients will be allocated to a usual care group (n=15), Hospital Elder Life Program (HELP)-based paging system (n=15), family-based paging system (n=15), or combined HELP- and family-based system (n=15). The primary outcome will be the presence of delirium, defined by positive long-form Confusion Assessment Method screening. Secondary outcomes will include additional HELP- and family-based performance metrics along with various neurocognitive and clinical recovery measures. Exploratory outcomes include the incidence of positive family-based delirium assessments post-discharge, 36-item Short Form Survey, PROMIS Cognitive Function Abilities Subset 4a, and 30-day readmission rates. Ethics and dissemination: This trial has received approval by the University of Michigan Medical Institutional Review Board (IRBMED). Dissemination plans include presentation at scientific conferences, publication in medical journals, and distribution via educational and news media. Registration: ClinicalTrials.gov Identifier NCT04007523, registered on 7/3/2019.
Project description:Introduction:Internship preparation should include curricula to hone key skills such as acute medical management and communication with consulting and interprofessional providers. Methods:To enhance these skills, we developed an interprofessional mock paging and consult curriculum incorporating direct observation and peer, faculty, and nursing feedback for fourth-year medical students entering medical internships. Our brief mock paging and consult curriculum was designed as part of a larger 2-week internship preparation course. Our curriculum was delivered in two 2-hour sessions by physician and nurse educators. Sessions were conducted in small groups, offering the opportunity for direct observation and feedback from faculty, nurse educators, and peers. Our curriculum was expanded from a pilot for 10-15 students to 60 students after 2 years of a successful pilot. Results:Mock paging and consult sessions were highly rated by medical students and resulted in significantly enhanced self-assessment of preparedness in key intern skills such as returning pages, interprofessional communication, calling a consult, and managing acute issues for cross-cover patients. Discussion:We have demonstrated the effectiveness of a brief, interprofessional mock paging and consult curriculum incorporating faculty, nurse educator, and peer feedback. The tenets of our curriculum can be widely adopted for other learner groups.
Project description:BACKGROUND:Delirium is associated with a significantly increased risk of postoperative morbidity and mortality. Furthermore, delirium has been associated with an increased risk of prolonged cognitive deficits and accelerated long-term cognitive decline. To date, experimental interventions for delirium have mainly focused on alternative pharmacologic and behavioral strategies in the postoperative period. Few studies have examined whether proactive strategies started before surgery can prevent delirium or reduce its sequelae. Neurocognitive training programs such as Lumosity have been shown to be effective in increasing cognitive performance in both elderly healthy volunteers and patients suffering from a myriad of acute and chronic medical conditions. When initiated in the preoperative period, such training programs may serve as interesting and novel patient-led interventions for the prevention of delirium and postoperative cognitive decline (POCD). We hypothesize that perioperative neurocognitive training is feasible in the older cardiac surgical population and are testing this hypothesis using a randomized controlled design. METHODS:The Prevention of Early Postoperative Decline (PEaPoD) study is a randomized, controlled trial with a target enrollment of 45 elderly cardiac surgical patients. Subjects will be randomized in a 1:1 ratio to undergo either at least 10 days of preoperative neurocognitive training, continued for 4 weeks postoperatively, or usual care control. The primary outcome, feasibility, will be assessed by study recruitment and adherence to protocol. Secondary outcomes will include potential differences in the incidence of postoperative in-hospital delirium and POCD up to 6 months, as determined by the Confusion Assessment Method and the Montreal Cognitive Assessment. DISCUSSION:PEaPoD will be the first trial investigating the use of perioperative cognitive training to potentially reduce delirium and POCD in the cardiac surgical population. Information gleaned from this feasibility study will prove valuable in designing future efficacy studies aimed at determining whether this low-risk, patient-led intervention can reduce serious postoperative morbidity. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02908464 . Registered on 21 September 2016.
Project description:BACKGROUND:Delirium affects 15% of hospitalised patients and is linked with poor outcomes, yet few pharmacological treatment options exist. One hypothesis is that delirium may in part result from exaggerated and/or prolonged stress responses. Dexmedetomidine, a parenterally-administered alpha2-adrenergic receptor agonist which attenuates sympathetic nervous system activity, shows promise as treatment in ICU delirium. Clonidine exhibits similar pharmacodynamic properties and can be administered orally. We therefore wish to explore possible effects of clonidine upon the duration and severity of delirium in general medical inpatients. METHODS/DESIGN:The Oslo Study of Clonidine in Elderly Patients with Delirium (LUCID) is a randomised, placebo-controlled, double-blinded, parallel group study with 4-month prospective follow-up. We will recruit 100 older medical inpatients with delirium or subsyndromal delirium in the acute geriatric ward. Participants will be randomised to oral clonidine or placebo until delirium free for 2 days (Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria), or after a maximum of 7 days treatment. Assessment of haemodynamics (blood pressure, heart rate and electrocardiogram) and delirium will be performed daily until discharge or a maximum of 7 days after end of treatment. The primary endpoint is the trajectory of delirium over time (measured by Memorial Delirium Assessment Scale). Secondary endpoints include the duration of delirium, use of rescue medication for delirium, pharmacokinetics and pharmacodynamics of clonidine, cognitive function after 4 months, length of hospital stay and need for institutionalisation. DISCUSSION:LUCID will explore the efficacy and safety of clonidine for delirium in older medical inpatients. TRIAL REGISTRATION:ClinicalTrials.gov NCT01956604. EudraCT Number: 2013-000815-26.
Project description:BACKGROUND:Patients in the intensive care unit (ICU) are known to be at increased risk of developing delirium, but the risk of subsequent neuropsychiatric disorders is unclear. We therefore sought to examine the association between the presence of delirium in the ICU and incident neuropsychiatric disorders (including depressive, anxiety, trauma-and-stressor-related, and neurocognitive disorders) post-ICU stay among adult medical-surgical ICU patients. METHODS:Retrospective cohort study utilizing clinical and administrative data from both inpatient and outpatient healthcare visits to identify the ICU cohort and diagnostic information 5 years prior to and 1 year post-ICU stay. Patients ??18?years of age admitted to one of 14 medical-surgical ICUs across Alberta, Canada, January 1, 2014-June 30, 2016, and survived to hospital discharge were included. The main outcome of interest was a new diagnosis of any neuropsychiatric disorder 1 year post-ICU stay. The exposure variable was delirium during the ICU stay identified through any positive delirium screen by the Intensive Care Unit Delirium Screening Checklist (ICDSC) during the ICU stay. RESULTS:Of 16,005 unique patients with at least one ICU admission, 4033 patients were included in the study of which 1792 (44%) experienced delirium during their ICU stay. The overall cumulative incidence of any neuropsychiatric disorder during the subsequent year was 19.7% for ICU patients. After adjusting for hospital characteristics using log-binomial regression, patients with delirium during the ICU stay had a risk ratio (RR) of 1.14 (95% confidence interval [CI] 0.98-1.33) of developing any neuropsychiatric disorder within 1 year post-ICU compared to those who did not experience delirium. Delirium was significantly associated with neurocognitive disorders (RR 1.59, 95% CI 1.08-2.35), but not depressive disorders (RR 1.16, 95% CI 0.92-1.45), anxiety (RR 1.16, 95% CI 0.92-1.47), and trauma-and-stressor-related (RR 0.82, 95% CI 0.53-1.28) disorders. CONCLUSIONS:The diagnosis of new onset of neurocognitive disorders is associated with ICU-acquired delirium. In this study, significant associations were not observed for depressive, anxiety, and trauma-and-stressor-related disorders.
Project description:BACKGROUND: The Hospital Elder Life Program (HELP) has been shown to be highly efficient and (cost-)effective in reducing delirium incidence in the USA. HELP provides multicomponent protocols targeted at specific risk factors for delirium and introduces a different view on care organization, with trained volunteers playing a pivotal role. The primary aim of this study is the quantification of the (cost-)effectiveness of HELP in the Dutch health care system. The second aim is to investigate the experiences of patients, families, professionals and trained volunteers participating in HELP. METHODS/DESIGN: A multiple baseline approach (also known as a stepped-wedge design) will be used to evaluate the (cost-) effectiveness of HELP in a cluster randomized controlled study. All patients aged 70 years and older who are at risk for delirium and are admitted to cardiology, internal medicine, geriatrics, orthopedics and surgery at two participating community hospitals will be included. These eight units are implementing the intervention in a successive order that will be determined at random. The incidence of delirium, the primary outcome, will be measured with the Confusion Assessment Method (CAM). Secondary outcomes include the duration and severity of delirium, quality of life, length of stay and the use of care services up to three months after hospital discharge. The experiences of patients, families, professionals and volunteers will be investigated using a qualitative design based on the grounded theory approach. Professionals and volunteers will be invited to participate in focus group interviews. Additionally, a random sample of ten patients and their families from each hospital unit will be interviewed at home after discharge. DISCUSSION: We hypothesize that HELP will reduce delirium incidence during hospital admission and decrease the duration and severity of delirium and length of hospital stays among these older patients, which will lead to reduced health care costs. The results of this study may fundamentally change our views on care organization for older patients at risk for delirium. The stepped-wedge design was chosen for ethical, practical and statistical reasons. The study results will be generalizable to the Dutch hospital care system, and the proven cost-effectiveness of HELP will encourage the spread and implementation of this program. TRIAL REGISTRATION: Netherlands Trial register: NTR3842.
Project description:INTRODUCTION:Delirium, an acute confusional state, affects up to 29% of acute inpatients aged 65 years and over. The Australian Delirium Clinical Care Standard (the Standard) contains evidence-based, multicomponent interventions, to identify and reduce delirium. This study aims to: (1) conduct a controlled, before-and-after study to assess the clinical effectiveness of the Standard to improve diagnosis and treatment of delirium; (2) conduct a cost-effectiveness study of implementing the Standard and (3) evaluate the implementation process. METHODS AND ANALYSIS:The study will use a controlled, preimplementation and postimplementation mixed-methods study design, including: medical record reviews, activity-based costing analysis and interviews with staff, patients and their family members. The study population will comprise patients 65 years and over, admitted to surgical, medical and intensive care wards in four intervention hospitals and one control hospital. The primary clinical outcome will be the incidence of delirium. Secondary outcomes include: length of stay, severity and duration of delirium, inhospital mortality rates, readmission rates and use of psychotropic drugs. Cost-effectiveness will be evaluated through activity-based costing analysis and outcome data, and the implementation process appraised through the qualitative results. ETHICS AND DISSEMINATION:Ethics approval has been received for two hospitals. Additional hospitals have been identified and ethics applications will be submitted once the tools in the pilot study have been tested.The results will be submitted for publication in peer-reviewed journals and presented to national and international conferences. Results seminars will provide a quality feedback mechanism for staff and health policy bodies.
Project description:INTRODUCTION:Delirium in critically ill adults is associated with prolonged hospital stay, increased mortality and greater cognitive and functional decline. Current practice guideline recommendations advocate the use of non-pharmacological strategies to reduce delirium. The routine use of scheduled haloperidol to treat delirium is not recommended given a lack of evidence regarding its ability to resolve delirium nor improve relevant short-term and longer-term outcomes. This study aims to evaluate the efficacy and safety of haloperidol for the treatment of delirium in adult critically ill patients to reduce days spent with coma or delirium. METHODS AND ANALYSIS:EuRIDICE is a prospective, multi-centre, randomised, double-blind, placebo-controlled trial. Study population consists of adult intensive care unit (ICU) patients without acute neurological injury who have delirium based on a positive Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the ICU (CAM-ICU) assessment. Intervention is intravenous haloperidol 2.5?mg (or matching placebo) every 8?hours, titrated daily based on ICDSC or CAM-ICU positivity to a maximum of 5?mg every 8?hours, until delirium resolution or ICU discharge. Main study endpoint is delirium and coma-free days (DCFD) up to 14 days after randomisation. Secondary endpoints include (1) 28-day and 1-year mortality, (2) cognitive and functional performance at 3 and 12 months, (3) patient and family delirium and ICU experience, (4) psychological sequelae during and after ICU stay, (4) safety concerns associated with haloperidol use and (5) cost-effectiveness. Differences in DCFDs between haloperidol and placebo group will be analysed using Poisson regression analysis. Study recruitment started in February 2018 and continues. ETHICS AND DISSEMINATION:The study has been approved by the Medical Ethics Committee of the Erasmus University Medical Centre Rotterdam (MEC2017-511) and by the Institutional Review Boards of the participating sites. Its results will be disseminated via peer-reviewed publication and conference presentations. TRIAL REGISTRATION:NCT03628391.
Project description:Purpose of ReviewWe present a focused review on postoperative delirium for anesthesiologists, encompassing clinical features, neuropathogenesis, and clinical identification and management strategies based on risk factors and current delirium treatments.Recent FindingsThe literature on postoperative delirium is dominated by non-experimental studies. We review delirium phenotypes, diagnostic criteria, and present standard nomenclature based on current literature. Disruption of cortical inhibition of complex information (CICI) may provide a framework to understand the neuropathogenesis of postoperative delirium, as well as risk factors and clinical modifiers in the perioperative period. We further divide risk factors into patient factors, surgical factors, and medical/pharmacological factors, and present specific considerations for each in the preoperative, intraoperative, and postoperative periods.SummaryPostoperative delirium is prevalent, poorly understood, and often missed with current screening techniques. Proper identification of risk factors is useful for perioperative interventions and can help tailor patient-specific management strategies.
Project description:Delirium is a neurocognitive syndrome arising from acute global brain dysfunction, and is prevalent in up to 42% of patients admitted to palliative care inpatient units. The symptoms of delirium and its associated communicative impediment invariably generate high levels of patient and family distress. Furthermore, delirium is associated with significant patient morbidity and increased mortality in many patient populations, especially palliative care where refractory delirium is common in the dying phase. As the clinical diagnosis of delirium is frequently missed by the healthcare team, the case for regular screening is arguably very compelling. Depending on its precipitating factors, a delirium episode is often reversible, especially in the earlier stages of a life-threatening illness. Until recently, antipsychotics have played a pivotal role in delirium management, but this role now requires critical re-evaluation in light of recent research that failed to demonstrate their efficacy in mild- to moderate-severity delirium occurring in palliative care patients. Non-pharmacological strategies for the management of delirium play a fundamental role and should be optimized through the collective efforts of the whole interprofessional team. Refractory agitated delirium in the last days or weeks of life may require the use of pharmacological sedation to ameliorate the distress of patients, which is invariably juxtaposed with increasing distress of family members. Further evaluation of multicomponent strategies for delirium prevention and treatment in the palliative care patient population is urgently required.
Project description:BACKGROUND:Delirium affects > 15% of hospitalised patients but is grossly underdetected, contributing to poor care. The 4 'A's Test (4AT, www.the4AT.com ) is a short delirium assessment tool designed for routine use without special training. The primary objective was to assess the accuracy of the 4AT for delirium detection. The secondary objective was to compare the 4AT with another commonly used delirium assessment tool, the Confusion Assessment Method (CAM). METHODS:This was a prospective diagnostic test accuracy study set in emergency departments or acute medical wards involving acute medical patients aged ≥ 70. All those without acutely life-threatening illness or coma were eligible. Patients underwent (1) reference standard delirium assessment based on DSM-IV criteria and (2) were randomised to either the index test (4AT, scores 0-12; prespecified score of > 3 considered positive) or the comparator (CAM; scored positive or negative), in a random order, using computer-generated pseudo-random numbers, stratified by study site, with block allocation. Reference standard and 4AT or CAM assessments were performed by pairs of independent raters blinded to the results of the other assessment. RESULTS:Eight hundred forty-three individuals were randomised: 21 withdrew, 3 lost contact, 32 indeterminate diagnosis, 2 missing outcome, and 785 were included in the analysis. Mean age was 81.4 (SD 6.4) years. 12.1% (95/785) had delirium by reference standard assessment, 14.3% (56/392) by 4AT, and 4.7% (18/384) by CAM. The 4AT had an area under the receiver operating characteristic curve of 0.90 (95% CI 0.84-0.96). The 4AT had a sensitivity of 76% (95% CI 61-87%) and a specificity of 94% (95% CI 92-97%). The CAM had a sensitivity of 40% (95% CI 26-57%) and a specificity of 100% (95% CI 98-100%). CONCLUSIONS:The 4AT is a short, pragmatic tool which can help improving detection rates of delirium in routine clinical care. TRIAL REGISTRATION:International standard randomised controlled trial number (ISRCTN) 53388093 . Date applied 30/05/2014; date assigned 02/06/2014.