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    Date Issued2021 (1)2016 (2)Author
    Hill, Nicholas S. (3)
    Lindenauer, Peter K. (3)Stefan, Mihaela S. (3)Goldberg, Robert J. (2)Kent, David M. (2)View MoreUMass Chan AffiliationDepartment of Quantitative Health Sciences (2)Department of Population and Quantitative Health Sciences (1)Medicine at UMCMS-Baystate (1)Document TypeJournal Article (3)Keywordnoninvasive ventilation (2)Respiratory Tract Diseases (2)asthma (1)Clinical Epidemiology (1)clinical trial (1)View MoreJournalAnnals of the American Thoracic Society (1)Chest (1)Trials (1)

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    Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

    Stefan, Mihaela S.; Pekow, Penelope S.; Shea, Christopher M.; Hughes, Ashley M.; Hill, Nicholas S.; Steingrub, Jay S.; Farmer, Mary Jo S.; Hess, Dean R.; Riska, Karen L.; Clark, Taylar A.; et al. (2021-12-16)
    BACKGROUND: There is strong evidence that noninvasive ventilation (NIV) improves the outcomes of patients hospitalized with severe COPD exacerbation, and NIV is recommended as the first-line therapy for these patients. Yet, several studies have demonstrated substantial variation in NIV use across hospitals, leading to preventable morbidity and mortality. In addition, prior studies suggested that efforts to increase NIV use in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, our initial project aimed to compare two educational strategies: online education (OLE) and interprofessional education (IPE), which targets complex team-based care in NIV delivery. Due to the impact of the COVID-19 pandemic on recruitment and planned intervention, we had made several changes in the study design, statistical analysis, and implementation strategies delivery as outlined in the methods. METHODS: We originally proposed a two-arm, pragmatic, cluster, randomized hybrid implementation-effectiveness trial comparing two education strategies to improve NIV uptake in patients with severe COPD exacerbation in 20 hospitals with a low baseline rate of NIV use. Due to logistical constrains and slow recruitment, we changed the study design to an opened cohort stepped-wedge design with three steps which will allow the institutions to enroll when they are ready to participate. Only the IPE strategy will be implemented, and the education will be provided in an online virtual format. Our primary outcome will be the hospital-level risk-standardized NIV proportion for the period post-IPE training, along with the change in rate from the period prior to training. Aim 1 will compare the change over time of NIV use among patients with COPD in the step-wedged design. Aim 2 will explore the mediators' role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and effectiveness. Finally, in Aim 3, through interviews with providers, we will assess the acceptability and feasibility of the educational training. CONCLUSION: The changes in study design will result in several limitation. Most importantly, the hospitals in the three cohorts are not randomized as they enroll based on their readiness. Second, the delivery of the IPE is virtual, and it is not known if remote education is conducive to team building. However, this study will be among the first to test the impact of IPE in the inpatient setting carefully and may generalize to other interventions directed to seriously ill patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04206735 . Registered on December 20, 2019.
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    Outcomes of Noninvasive and Invasive Ventilation in Patients Hospitalized with Asthma Exacerbation

    Stefan, Mihaela S.; Nathanson, Brian H.; Lagu, Tara; Priya, Aruna; Pekow, Penelope S.; Steingrub, Jay; Hill, Nicholas S.; Goldberg, Robert J.; Kent, David M.; Lindenauer, Peter K. (2016-07-01)
    RATIONALE: Little is known about the effectiveness of noninvasive ventilation for patients hospitalized with asthma exacerbation. OBJECTIVES: To assess clinical outcomes of noninvasive (NIV) and invasive mechanical ventilation (IMV) and examine predictors for NIV use in patients hospitalized with asthma. METHODS: This was a retrospective cohort study at 97 U.S. hospitals using an electronic medical record database. We developed a hierarchical regression model to identify factors associated with the choice of initial ventilation and used the Laboratory Acute Physiological Score to adjust for differences in the severity of illness. We assessed the outcomes of patients treated with initial NIV or IMV in a propensity-matched cohort. MEASUREMENTS AND MAIN RESULTS: Among 13,930 subjects, 73% were women and 54% were white. The median age was 53 years. Overall, 1,254 patients (9%) required ventilatory support (NIV or IMV). NIV was the initial ventilation method for 556 patients (4.0%) and IMV for 668 (5.0%). Twenty-six patients (4.7% of patients treated with NIV) had to be intubated (NIV failure). The in-hospital mortality was 0.2, 2.3, 14.5, and 15.4%, and the median length of stay was 2.9, 4.1, 6.7, and 10.9 days among those not ventilated, ventilated with NIV, ventilated with IMV, and with NIV failure, respectively. Older patients were more likely to receive NIV (odds ratio, 1.06 per 5 yr; 95% confidence interval [CI], 1.01-1.11), whereas those with higher acuity (Laboratory Acute Physiological Score per 5 units: odds ratio, 0.85; 95% CI, 0.82-0.88) and those with concomitant pneumonia were less likely to receive NIV. In a propensity-matched sample, NIV was associated with a lower inpatient risk of dying (risk ratio, 0.12; 95% CI, 0.03-0.51) and shorter lengths of stay (4.3 d less; 95% CI, 2.9-5.8) than IMV. CONCLUSIONS: Among patients hospitalized with asthma exacerbation and requiring ventilatory support (NIV or IMV), more than 40% received NIV. Although patients successfully treated with NIV appear to have better outcomes than those treated with IMV, the low rate of NIV failure suggests that NIV was being used selectively in a lower risk group. The increased risk of mortality for patients who fail NIV highlights the need for careful monitoring to avoid possible delay in intubation.
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    Hospitals' Patterns of Use of Noninvasive Ventilation in Patients With Asthma Exacerbation

    Stefan, Mihaela S.; Nathanson, Brian H.; Priya, Aruna; Pekow, Penelope; Lagu, Tara; Steingrub, Jay; Hill, Nicholas S.; Goldberg, Robert J.; Kent, David M.; Lindenauer, Peter K. (2016-03-01)
    BACKGROUND: Limited data are available on the use of noninvasive ventilation in patients with asthma exacerbations. The objective of this study was to characterize hospital patterns of noninvasive ventilation use in patients with asthma and to evaluate the association with the use of invasive mechanical ventilation and case fatality rate. METHODS: This cross-sectional study used an electronic medical record dataset, which includes comprehensive pharmacy and laboratory results from 58 hospitals. Data on 13,558 patients admitted from 2009 to 2012 were analyzed. Initial noninvasive ventilation (NIV) or invasive mechanical ventilation (IMV) was defined as the first ventilation method during hospitalization. Hospital-level risk-standardized rates of NIV among all admissions with asthma were calculated by using a hierarchical regression model. Hospitals were grouped into quartiles of NIV to compare the outcomes. RESULTS: Overall, 90.3% of patients with asthma were not ventilated, 4.0% were ventilated with NIV, and 5.7% were ventilated with IMV. Twenty-two (38%) hospitals did not use NIV for any included admissions. Hospital-level adjusted NIV rates varied considerably (range, 0.4-33.1; median, 5.2%). Hospitals in the highest quartile of NIV did not have lower IMV use (5.4% vs 5.7%), but they did have a small but significantly shorter length of stay. Higher NIV rates were not associated with lower risk-adjusted case fatality rates. CONCLUSIONS: Large variation exists in hospital use of NIV for patients with an acute exacerbation of asthma. Higher hospital rates of NIV use does not seem to be associated with lower IMV rates. These results indicate a need to understand contextual and organizational factors contributing to this variability.
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