The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial: rationale and design of a multi-center pragmatic randomized clinical trial of hepatitis C screening in emergency departments.

BACKGROUND: Early identification of HCV is a critical health priority, especially now that treatment options are available to limit further transmission and provide cure before long-term sequelae develop. Emergency departments (EDs) are important clinical settings for HCV screening given that EDs serve many at-risk patients who do not access other forms of healthcare. In this article, we describe the rationale and design of The Determining Effective Testing in Emergency Departments and Care Coordination on Treatment Outcomes (DETECT) for Hepatitis C (Hep C) Screening Trial. METHODS: The DETECT Hep C Screening Trial is a multi-center prospective pragmatic randomized two-arm parallel-group superiority trial to test the comparative effectiveness of nontargeted and targeted HCV screening in the ED with a primary hypothesis that nontargeted screening is superior to targeted screening when identifying newly diagnosed HCV. This trial will be performed in the EDs at Denver Health Medical Center (Denver, CO), Johns Hopkins Hospital (Baltimore, MD), and the University of Mississippi Medical Center (Jackson, MS), sites representing approximately 225,000 annual adult visits, and designed using the PRECIS-2 framework for pragmatic trials. When complete, we will have enrolled a minimum of 125,000 randomized patient visits and have performed 13,965 HCV tests. In Denver, the Screening Trial will serve as a conduit for a distinct randomized comparative effectiveness trial to evaluate linkage-to-HCV care strategies. All sites will further contribute to embedded observational studies to assess cost effectiveness, disparities, and social determinants of health in screening, linkage-to-care, and treatment for HCV. DISCUSSION: When complete, The DETECT Hep C Screening Trial will represent the largest ED-based pragmatic clinical trial to date and all studies, in aggregate, will significantly inform how to best perform ED-based HCV screening. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04003454 . Registered on 1 July 2019.

Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial.

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown. Objective: To compare strategies for HIV screening when integrated into usual ED practice. Design, Setting, and Participants: This randomized clinical trial included patients visiting EDs at 4 US urban hospitals between April 2014 and January 2016. Patients included were ages 16 years or older, not critically ill or mentally altered, not known to have an HIV positive status, and with an anticipated length of stay 30 minutes or longer. Data were analyzed through March 2021. Interventions: Consecutive patients underwent concealed randomization to either nontargeted screening, enhanced targeted screening using a quantitative HIV risk prediction tool, or traditional targeted screening as adapted from the Centers for Disease Control and Prevention. Screening was integrated into clinical practice using opt-out consent and fourth-generation antigen-antibody assays. Main Outcomes and Measures: New HIV diagnoses using intention-to-treat analysis, absolute differences, and risk ratios (RRs). Results: A total of 76 561 patient visits were randomized; median (interquartile range) age was 40 (28-54) years, 34 807 patients (51.2%) were women, and 26 776 (39.4%) were Black, 22 131 (32.6%) non-Hispanic White, and 14 542 (21.4%) Hispanic. A total of 25 469 were randomized to nontargeted screening; 25 453, enhanced targeted screening; and 25 639, traditional targeted screening. Of the nontargeted group, 6744 participants (26.5%) completed testing and 10 (0.15%) were newly diagnosed; of the enhanced targeted group, 13 883 participants (54.5%) met risk criteria, 4488 (32.3%) completed testing, and 7 (0.16%) were newly diagnosed; and of the traditional targeted group, 7099 participants (27.7%) met risk criteria, 3173 (44.7%) completed testing, and 7 (0.22%) were newly diagnosed. When compared with nontargeted screening, targeted strategies were not associated with a higher rate of new diagnoses (enhanced targeted and traditional targeted combined: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.7; 95% CI, 0.30 to 1.56; P = .38; and enhanced targeted only: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.70; 95% CI, 0.27 to 1.84; P = .47). Conclusions and Relevance: Targeted HIV screening was not superior to nontargeted HIV screening in the ED. Nontargeted screening resulted in significantly more tests performed, although all strategies identified relatively low numbers of new HIV diagnoses. Trial Registration: ClinicalTrials.gov Identifier: NCT01781949.

Predicting probability of perirectal colonization with carbapenem-resistant Enterobacteriaceae (CRE) and other carbapenem-resistant organisms (CROs) at hospital unit admission.

BACKGROUND: Targeted screening for carbapenem-resistant organisms (CROs), including carbapenem-resistant Enterobacteriaceae (CRE) and carbapenemase-producing organisms (CPOs), remains limited; recent data suggest that existing policies miss many carriers. OBJECTIVE: Our objective was to measure the prevalence of CRO and CPO perirectal colonization at hospital unit admission and to use machine learning methods to predict probability of CRO and/or CPO carriage. METHODS: We performed an observational cohort study of all patients admitted to the medical intensive care unit (MICU) or solid organ transplant (SOT) unit at The Johns Hopkins Hospital between July 1, 2016 and July 1, 2017. Admission perirectal swabs were screened for CROs and CPOs. More than 125 variables capturing preadmission clinical and demographic characteristics were collected from the electronic medical record (EMR) system. We developed models to predict colonization probabilities using decision tree learning. RESULTS: Evaluating 2,878 admission swabs from 2,165 patients, we found that 7.5% and 1.3% of swabs were CRO and CPO positive, respectively. Organism and carbapenemase diversity among CPO isolates was high. Despite including many characteristics commonly associated with CRO/CPO carriage or infection, overall, decision tree models poorly predicted CRO and CPO colonization (C statistics, 0.57 and 0.58, respectively). In subgroup analyses, however, models did accurately identify patients with recent CRO-positive cultures who use proton-pump inhibitors as having a high likelihood of CRO colonization. CONCLUSIONS: In this inpatient population, CRO carriage was infrequent but was higher than previously published estimates. Despite including many variables associated with CRO/CPO carriage, models poorly predicted colonization status, likely due to significant host and organism heterogeneity.

Hospital Surge Capacity: A Web-Based Simulation Tool for Emergency Planners.

The National Center for the Study of Preparedness and Catastrophic Event Response (PACER) has created a publicly available simulation tool called Surge (accessible at http://www.pacerapps.org) to estimate surge capacity for user-defined hospitals. Based on user input, a Monte Carlo simulation algorithm forecasts available hospital bed capacity over a 7-day period and iteratively assesses the ability to accommodate disaster patients. Currently, the tool can simulate bed capacity for acute mass casualty events (such as explosions) only and does not specifically simulate staff and supply inventory. Strategies to expand hospital capacity, such as (1) opening unlicensed beds, (2) canceling elective admissions, and (3) implementing reverse triage, can be interactively evaluated. In the present application of the tool, various response strategies were systematically investigated for 3 nationally representative hospital settings (large urban, midsize community, small rural). The simulation experiments estimated baseline surge capacity between 7% (large hospitals) and 22% (small hospitals) of staffed beds. Combining all response strategies simulated surge capacity between 30% and 40% of staffed beds. Response strategies were more impactful in the large urban hospital simulation owing to higher baseline occupancy and greater proportion of elective admissions. The publicly available Surge tool enables proactive assessment of hospital surge capacity to support improved decision-making for disaster response. (Disaster Med Public Health Preparedness. 2018;12:513-522).

The Effect of Medicaid Expansion on Utilization in Maryland Emergency Departments.

STUDY OBJECTIVE: A proposed benefit of expanding Medicaid eligibility under the Patient Protection and Affordable Care Act (ACA) was a reduction in emergency department (ED) utilization for primary care needs. Pre-ACA studies found that new Medicaid enrollees increased their ED utilization rates, but the effect on system-level ED visits was less clear. Our objective was to estimate the effect of Medicaid expansion on aggregate and individual-based ED utilization patterns within Maryland. METHODS: We performed a retrospective cross-sectional study of ED utilization patterns across Maryland, using data from Maryland's Health Services Cost Review Commission. We also analyzed utilization differences between pre-ACA (July 2012 to December 2013) uninsured patients who returned post-ACA (July 2014 to December 2015). RESULTS: The total number of ED visits in Maryland decreased by 36,531 (-1.2%) between the 6 quarters pre-ACA and the 6 quarters post-ACA. Medicaid-covered ED visits increased from 23.3% to 28.9% (159,004 additional visits), whereas uninsured patient visits decreased from 16.3% to 10.4% (181,607 fewer visits). Coverage by other insurance types remained largely stable between periods. We found no significant relationship between Medicaid expansion and changes in ED volume by hospital. For patients uninsured pre-ACA who returned post-ACA, the adjusted visits per person during 6 quarters was 2.38 (95% confidence interval 2.35 to 2.40) for those newly enrolled in Medicaid post-ACA compared with 1.66 (95% confidence interval 1.64 to 1.68) for those remaining uninsured. CONCLUSION: There was a substantial increase in patients covered by Medicaid in the post-ACA period, but this did not significantly affect total ED volume. Returning patients newly enrolled in Medicaid visited the ED more than their uninsured counterparts; however, this cohort accounted for only a small percentage of total ED visits in Maryland.

Risk of Acute Kidney Injury After Intravenous Contrast Media Administration.

STUDY OBJECTIVE: The study objective was to determine whether intravenous contrast administration for computed tomography (CT) is independently associated with increased risk for acute kidney injury and adverse clinical outcomes. METHODS: This single-center retrospective cohort analysis was performed in a large, urban, academic emergency department with an average census of 62,179 visits per year; 17,934 ED visits for patients who underwent contrast-enhanced, unenhanced, or no CT during a 5-year period (2009 to 2014) were included. The intervention was CT scan with or without intravenous contrast administration. The primary outcome was incidence of acute kidney injury. Secondary outcomes included new chronic kidney disease, dialysis, and renal transplantation at 6 months. Logistic regression modeling and between-groups odds ratios with and without propensity-score matching were used to test for an independent association between contrast administration and primary and secondary outcomes. Treatment decisions, including administration of contrast and intravenous fluids, were examined. RESULTS: Rates of acute kidney injury were similar among all groups. Contrast administration was not associated with increased incidence of acute kidney injury (contrast-induced nephropathy criteria odds ratio=0.96, 95% confidence interval 0.85 to 1.08; and Acute Kidney Injury Network/Kidney Disease Improving Global Outcomes criteria odds ratio=1.00, 95% confidence interval 0.87 to 1.16). This was true in all subgroup analyses regardless of baseline renal function and whether comparisons were made directly or after propensity matching. Contrast administration was not associated with increased incidence of chronic kidney disease, dialysis, or renal transplant at 6 months. Clinicians were less likely to prescribe contrast to patients with decreased renal function and more likely to prescribe intravenous fluids if contrast was administered. CONCLUSION: In the largest well-controlled study of acute kidney injury following contrast administration in the ED to date, intravenous contrast was not associated with an increased frequency of acute kidney injury.

Association of a Clinical Practice Guideline With Blood Culture Use in Critically Ill Children.

Importance: Sepsis and septic shock are common and, at times, fatal in pediatrics. Blood cultures are often obtained when clinicians suspect sepsis, yet are low-yield with a false-positive rate up to 50%. Objectives: To determine whether a novel, 2-part, clinical practice guideline could decrease the rates of total blood cultures and cultures collected from central venous catheters in critically ill children and to examine the effect of the guideline on patient outcomes. Design, Setting, and Participants: A retrospective cohort study was performed to determine the effect of a new clinical practice guideline on blood culture practices in a 36-bed, combined medical/surgical pediatric intensive care unit of an urban, academic, tertiary care center from April 1, 2013, to March 31, 2015. All patients admitted to the pediatric intensive care unit with length of stay of 4 hours or more were evaluated (4560 patient visits: 2204 preintervention, 2356 postintervention visits). Interventions: Two documents were developed: (1) fever/sepsis screening checklist and (2) blood culture decision algorithm. Clinicians consulted these documents when considering ordering blood cultures and for guidance about the culture source. Main Outcomes and Measures: Primary outcome was the total number of blood cultures collected per 100 patient-days. Results: Of the 2204 children evaluated before the intervention, 1215 were male (55.1%); median (interquartile range) age was 5 (1-13) years. Postintervention analysis included 2356 children; 1262 were male (53.6%) and median (interquartile range) age was 6 (1-13) years. A total of 1807 blood cultures were drawn before the intervention during 11 196 patient-days; 984 cultures were drawn after the intervention during 11 204 patient-days (incidence rate, 16.1 vs 8.8 cultures per 100 patient-days). There was a 46.0% reduction after the intervention in the blood culture collection rate (incidence rate ratio, 0.54; 95% CI, 0.50-0.59). After the intervention, there was an immediate 25.0% reduction in the rate of cultures per 100 patient-days (95% CI, 4.2%-39.7%; P = .02) and a sustained 6.6% (95% CI, 4.7%-8.4%; P < .001) monthly decrease in the rate of cultures per 100 patient-days. Significantly fewer cultures were collected from central venous catheters after vs before the intervention (389 [39.5%] vs 1321 [73.1%]; P < .001). Rates of episodes defined as suspected infection and suspected septic shock decreased significantly after the intervention, but patients meeting these criteria underwent cultures at unchanged frequencies before vs after the intervention (52.1% vs 47.0%, P = .09, compared with 56.7% vs 55.0%, P = .75). In-hospital mortality (45 [2.0] vs 37 [1.6]; P = .23) and hospital readmissions (107 [4.9] vs 103 [4.4]; P = .42) were unchanged after the intervention. Conclusions and Relevance: A systematic approach to blood cultures decreased the total number of cultures and central venous catheter cultures, without an increase in rates of mortality, readmission, or episodes of suspected infection and suspected septic shock.

Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation.

OBJECTIVE: To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). METHODS: The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. RESULTS: The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. DISCUSSION: The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients' risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. CONCLUSION: Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support.

Medication waste reduction in pediatric pharmacy batch processes.

OBJECTIVES: To inform pediatric cart-fill batch scheduling for reductions in pharmaceutical waste using a case study and simulation analysis. METHODS: A pre and post intervention and simulation analysis was conducted during 3 months at a 205-bed children's center. An algorithm was developed to detect wasted medication based on time-stamped computerized provider order entry information. The algorithm was used to quantify pharmaceutical waste and associated costs for both preintervention (1 batch per day) and postintervention (3 batches per day) schedules. Further, simulation was used to systematically test 108 batch schedules outlining general characteristics that have an impact on the likelihood for waste. RESULTS: Switching from a 1-batch-per-day to a 3-batch-per-day schedule resulted in a 31.3% decrease in pharmaceutical waste (28.7% to 19.7%) and annual cost savings of $183,380. Simulation results demonstrate how increasing batch frequency facilitates a more just-in-time process that reduces waste. The most substantial gains are realized by shifting from a schedule of 1 batch per day to at least 2 batches per day. The simulation exhibits how waste reduction is also achievable by avoiding batch preparation during daily time periods where medication administration or medication discontinuations are frequent. Last, the simulation was used to show how reducing batch preparation time per batch provides some, albeit minimal, opportunity to decrease waste. CONCLUSIONS: The case study and simulation analysis demonstrate characteristics of batch scheduling that may support pediatric pharmacy managers in redesign toward minimizing pharmaceutical waste.