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Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications.

ABSTRACT: In critically ill patients, acute respiratory distress syndrome (ARDS) and ventilator-associated conditions (VACs) are associated with increased mortality, survivor morbidity and healthcare resource utilisation. Studies conclusively demonstrate that initial ventilator settings in patients with ARDS, and at risk for it, impact outcome. No studies have been conducted in the emergency department (ED) to determine if lung-protective ventilation in patients at risk for ARDS can reduce its incidence. Since the ED is the entry point to the intensive care unit for hundreds of thousands of mechanically ventilated patients annually in the USA, this represents a knowledge gap in this arena. A lung-protective ventilation strategy was instituted in our ED in 2014. It aims to address the parameters in need of quality improvement, as demonstrated by our previous research: (1) prevention of volutrauma; (2) appropriate positive end-expiratory pressure setting; (3) prevention of hyperoxia; and (4) aspiration precautions.The lung-protective ventilation initiated in the emergency department (LOV-ED) trial is a single-centre, quasi-experimental before-after study testing the hypothesis that lung-protective ventilation, initiated in the ED, is associated with reduced pulmonary complications. An intervention cohort of 513 mechanically ventilated adult ED patients will be compared with over 1000 preintervention control patients. The primary outcome is a composite outcome of pulmonary complications after admission (ARDS and VACs). Multivariable logistic regression with propensity score adjustment will test the hypothesis that ED lung-protective ventilation decreases the incidence of pulmonary complications.Approval of the study was obtained prior to data collection on the first patient. As the study is a before-after observational study, examining the effect of treatment changes over time, it is being conducted with waiver of informed consent. This work will be disseminated by publication of full-length manuscripts, presentation in abstract form at major scientific meetings and data sharing with other investigators through academically established means.NCT02543554.

SUBMITTER: Fuller BM

PROVIDER: S-EPMC4838728 | biostudies-other | 2016 Apr

REPOSITORIES: biostudies-other

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Project description:ImportanceMaternal emergency department (ED) use before or during pregnancy is associated with worse obstetrical outcomes, for reasons including preexisting medical conditions and challenges in accessing health care. It is not known whether maternal prepregnancy ED use is associated with higher use of the ED by their infant.ObjectiveTo study the association between maternal prepregnancy ED use and risk of infant ED use in the first year of life.Design, setting, and participantsThis population-based cohort study included all singleton livebirths in all of Ontario, Canada, from June 2003 to January 2020.ExposuresAny maternal ED encounter within 90 days preceding the start of the index pregnancy.Main outcomes and measuresAny infant ED visit up to 365 days after the index birth hospitalization discharge date. Relative risks (RR) and absolute risk differences (ARD) were adjusted for maternal age, income, rural residence, immigrant status, parity, having a primary care clinician, and number of prepregnancy comorbidities.ResultsThere were 2 088 111 singleton livebirths; the mean (SD) maternal age was 29.5 (5.4) years, 208 356 (10.0%) were rural dwelling, and 487 773 (23.4%) had 3 or more comorbidities. Among singleton livebirths, 206 539 mothers (9.9%) had an ED visit within 90 days before the index pregnancy. ED use in the first year of life was higher among infants whose mother had visited the ED before pregnancy (570 per 1000) vs those whose mother had not (388 per 1000) (RR, 1.19 [95% CI, 1.18-1.20]; ARD, 91.1 per 1000 [95% CI, 88.6-93.6 per 1000]). Compared with mothers without a prepregnancy ED visit, the RR of infant ED use in the first year was 1.19 (95% CI, 1.18-1.20) if its mother had 1 prepregnancy ED visit, 1.18 (95% CI, 1.17-1.20) following 2 visits, and 1.22 (95% CI, 1.20-1.23) after at least 3 maternal visits. A low-acuity maternal prepregnancy ED visit was associated with an adjusted odds ratio (aOR) of 5.52 (95% CI, 5.16-5.90) for a low-acuity infant ED visit, which was numerically higher than the pairing of a high-acuity ED use between mother and infant (aOR, 1.43, 95% CI, 1.38-1.49).Conclusions and relevanceIn this cohort study of singleton livebirths, prepregnancy maternal ED use was associated with a higher rate of ED use by the infant in the first year of life, especially for low-acuity ED use. This study's results may suggest a useful trigger for health system interventions aimed at reducing some ED use in infancy.

Project description:IntroductionDue to hospital crowding, mechanically ventilated patients are increasingly spending hours boarding in emergency departments (ED) before intensive care unit (ICU) admission. This study aims to evaluate the association between time ventilated in the ED and in-hospital mortality, duration of mechanical ventilation, ICU and hospital length of stay (LOS).MethodsThis was a multi-center, prospective, observational study of patients ventilated in the ED, conducted at three academic Level I Trauma Centers from July 2011 to March 2013. All consecutive adult patients on invasive mechanical ventilation were eligible for enrollment. We performed a Cox regression to assess for a mortality effect for mechanically ventilated patients with each hour of increasing LOS in the ED and multivariable regression analyses to assess for independently significant contributors to in-hospital mortality. Our primary outcome was in-hospital mortality, with secondary outcomes of ventilator days, ICU LOS and hospital LOS. We further commented on use of lung protective ventilation and frequency of ventilator changes made in this cohort.ResultsWe enrolled 535 patients, of whom 525 met all inclusion criteria. Altered mental status without respiratory pathology was the most common reason for intubation, followed by trauma and respiratory failure. Using iterated Cox regression, a mortality effect occurred at ED time of mechanical ventilation > 7 hours, and the longer ED stay was also associated with a longer total duration of intubation. However, adjusted multivariable regression analysis demonstrated only older age and admission to the neurosciences ICU as independently associated with increased mortality. Of interest, only 23.8% of patients ventilated in the ED for over seven hours had changes made to their ventilator.ConclusionIn a prospective observational study of patients mechanically ventilated in the ED, there was a significant mortality benefit to expedited transfer of patients into an appropriate ICU setting.

Project description:Recent health policy changes have focused efforts on reducing emergency department (ED) visits as a way to reduce costs and improve quality of care. This was a systematic review of interventions based outside the ED aimed at reducing ED use.This study was designed as a systematic review. We reviewed the literature on interventions in five categories: patient education, creation of additional non-ED capacity, managed care, prehospital diversion, and patient financial incentives. Studies written in English, with interventions administered outside of the ED, and a comparison group where ED use was an outcome, were included. Two independent reviewers screened search results using MEDLINE, Cochrane, OAIster, or Scopus. The following data were abstracted from included studies: type of intervention, study design, population, details of intervention, effect on ED use, effect on non-ED health care use, and other health and financial outcomes. Quality of individual articles was assessed using Grading of Recommendations Assessment, Development, and Evaluation (GRADE) guidelines.Of 39 included studies, 34 were observational and five were randomized controlled trials. Two of five studies on patient education found reductions in ED use ranging from 21% to 80%. Out of 10 studies of additional non-ED capacity, four showed decreases of 9% to 54%, and one a 21% increase. Both studies on prehospital diversion found reductions of 3% to 7%. Of 12 studies on managed care, 10 had decreases ranging from 1% to 46%. Nine out of 10 studies on patient financial incentives found decreases of 3% to 50%, and one a 34% increase. Nineteen studies reported effect on non-ED use with mixed results. Seventeen studies included data on health outcomes, but 13 of these only included data on hospitalizations rather than morbidity and mortality. Seven studies included data on cost outcomes. According to the GRADE guidelines, all studies had at least some risk of bias, with four moderate quality, one low quality, and 34 very low quality studies.Many studies have explored interventions based outside the ED to reduce ED use in various populations, with mixed evidence. Approximately two-thirds identified here showed reductions in ED use. The interventions with the greatest number of studies showing reductions in ED use include patient financial incentives and managed care, while the greatest magnitude of reductions were found in patient education. These findings have implications for insurers and policymakers seeking to reduce ED use.

Project description:ImportanceSuicide is a leading cause of deaths in the United States. Although the emergency department (ED) is an opportune setting for initiating suicide prevention efforts, ED-initiated suicide prevention interventions remain underdeveloped.ObjectiveTo determine whether an ED-initiated intervention reduces subsequent suicidal behavior.Design, setting, and participantsThis multicenter study of 8 EDs in the United States enrolled adults with a recent suicide attempt or ideation and was composed of 3 sequential phases: (1) a treatment as usual (TAU) phase from August 2010 to December 2011, (2) a universal screening (screening) phase from September 2011 to December 2012, and (3) a universal screening plus intervention (intervention) phase from July 2012 to November 2013.InterventionsScreening consisted of universal suicide risk screening. The intervention phase consisted of universal screening plus an intervention, which included secondary suicide risk screening by the ED physician, discharge resources, and post-ED telephone calls focused on reducing suicide risk.Main outcomes and measuresThe primary outcome was suicide attempts (nonfatal and fatal) over the 52-week follow-up period. The proportion and total number of attempts were analyzed.ResultsA total of 1376 participants were recruited, including 769 females (55.9%) with a median (interquartile range) age of 37 (26-47) years. A total of 288 participants (20.9%) made at least 1 suicide attempt, and there were 548 total suicide attempts among participants. There were no significant differences in risk reduction between the TAU and screening phases (23% vs 22%, respectively). However, compared with the TAU phase, patients in the intervention phase showed a 5% absolute reduction in suicide attempt risk (23% vs 18%), with a relative risk reduction of 20%. Participants in the intervention phase had 30% fewer total suicide attempts than participants in the TAU phase. Negative binomial regression analysis indicated that the participants in the intervention phase had significantly fewer total suicide attempts than participants in the TAU phase (incidence rate ratio, 0.72; 95% CI, 0.52-1.00; P = .05) but no differences between the TAU and screening phases (incidence rate ratio, 1.00; 95% CI, 0.71-1.41; P = .99).Conclusions and relevanceAmong at-risk patients in the ED, a combination of brief interventions administered both during and after the ED visit decreased post-ED suicidal behavior.

Project description:IntroductionSedation is a cornerstone therapy in the management of patients receiving mechanical ventilation and is highly influential on outcome. Early sedation depth appears especially influential, as early deep sedation is associated with worse outcome when compared with light sedation. Our research group has shown that patients receiving mechanical ventilation in the emergency department (ED) are exposed to deep sedation commonly, and ED sedation depth is impactful on intensive care unit (ICU) care and clinical outcomes. While extensive investigation has occurred for patients in the ICU, comparatively little data exist from the ED. Given the influence that ED sedation seems to carry, as well as a lack of ED-based sedation trials, there is significant rationale to investigate ED-based sedation as a means to improve outcome.Methods and analysisThis is a multicentre (n=3) prospective, before-and-after pilot trial examining the feasibility of implementing targeted sedation in the immediate postintubation period in the ED. A cohort of 344 patients receiving mechanical ventilation in ED will be included. Feasibility outcomes include: (1) participant recruitment; (2) proportion of Richmond Agitation-Sedation Scale (RASS) scores in the deep sedation range; (3) reliability (agreement) of RASS measurements performed by bedside ED nurses; and (4) adverse events. The proportion of deep sedation measurements before and after the intervention will be compared using the χ2 test. Logistic regression will be used to compare before-and-after differences, adjusting for potential confounders. The inter-rater correlation coefficient will be used to assess paired observations between a study team member and bedside ED nurses, and to describe reliability of RASS measurements.Ethics and disseminationThe Human Research Protection Office at Washington University in St. Louis School of Medicine has approved the study. The publication of peer-reviewed manuscripts and the presentation of abstracts at scientific meetings will be used to disseminate the work.RegistrationClinicalTrials.gov identifier NCT04410783; Pre-results.

Project description:BackgroundPatients with opioid use disorder (OUD) frequently present to the emergency department (ED) after overdose, or seeking treatment for general medical conditions, their addiction, withdrawal symptoms, or complications of injection drug use, such as soft tissue infections. ED-initiated buprenorphine has been shown to be effective in increasing patient engagement in treatment compared with brief intervention with a facilitated referral or referral alone. However, adoption into practice has lagged behind need. To address this implementation challenge, we are evaluating the impact of implementation facilitation (IF) on the adoption of ED-initiated buprenorphine for OUD into practice.MethodsThis protocol describes a study that is being conducted through the National Institute on Drug Abuse's Center for the Clinical Trials Network. A hybrid type III effectiveness-implementation study design is used to evaluate the effectiveness of a standard educational dissemination strategy versus IF on implementation (primary) and effectiveness (secondary) outcomes in four urban, academic EDs. Sites start with a standard 60-min "Grand Rounds" educational intervention describing the prevalence of ED patients with OUD, the evidence for opioid agonist treatment and for innovative interventions with ED-initiated buprenorphine; followed by a 1-year baseline evaluation period. Using a modified stepped wedge design, sites are randomly assigned to the IF intervention which is guided by the Promoting Action on Research Implementation in Health Services (PARiHS) framework to assess evidence, context, and facilitation-related factors impacting the adoption of ED-initiated buprenorphine. During the 6 months of IF through the 1-year IF evaluation period, external facilitators work with local stakeholders to tailor and refine a bundle of activities to meet the site's needs. The primary analyses compare the baseline evaluation period to the IF evaluation period (n = 120 patients with untreated OUD enrolled during each period) on (1) rates of provision of ED-initiated buprenorphine by ED providers with referral for ongoing medication (implementation outcome) and (2) rates of patient engagement in addiction treatment on the 30th day after the ED visit (effectiveness outcome). Finally, we will perform a cost-effectiveness analysis (CEA) to determine if the effectiveness benefits are worth the additional costs.DiscussionResults will generate novel information regarding the impact of IF as a strategy to promote ED-initiated buprenorphine.Trial registrationClinicalTrials.gov NCT03023930 first posted 1/10/2017, https://clinicaltrials.gov/ct2/show/NCT03023930?term=0069&rank=1.

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Lung-protective ventilation initiated in the emergency department (LOV-ED): a study protocol for a quasi-experimental, before-after trial aimed at reducing pulmonary complications.

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