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The impact of COVID-19 monoclonal antibodies on clinical outcomes: A retrospective cohort study

Nagler, Arielle R; Horwitz, Leora I; Jones, Simon; Petrilli, Christopher M; Iturrate, Eduardo; Lighter, Jennifer L; Phillips, Michael; Bosworth, Brian P; Polsky, Bruce; Volpicelli, Frank M; Dapkins, Isaac; Viswanathan, Anand; François, Fritz; Kalkut, Gary
DISCLAIMER/CONCLUSIONS:In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE/OBJECTIVE:Despite progress in the treatment of coronavirus disease 2019 (COVID-19), including the development of monoclonal antibodies (mAbs), more clinical data to support the use of mAbs in outpatients with COVID-19 is needed. This study is designed to determine the impact of bamlanivimab, bamlanivimab/etesevimab, or casirivimab/imdevimab on clinical outcomes within 30 days of COVID-19 diagnosis. METHODS:A retrospective cohort study was conducted at a single academic medical center with 3 campuses in Manhattan, Brooklyn, and Long Island, NY. Patients 12 years of age or older who tested positive for COVID-19 or were treated with a COVID-19-specific therapy, including COVID-19 mAb therapies, at the study site between November 24, 2020, and May 15, 2021, were included. The primary outcomes included rates of emergency department (ED) visit, inpatient admission, intensive care unit (ICU) admission, or death within 30 days from the date of COVID-19 diagnosis. RESULTS:A total of 1,344 mAb-treated patients were propensity matched to 1,344 patients with COVID-19 patients who were not treated with mAb therapy. Within 30 days of diagnosis, among the patients who received mAb therapy, 101 (7.5%) presented to the ED and 79 (5.9%) were admitted. Among the patients who did not receive mAb therapy, 165 (12.3%) presented to the ED and 156 (11.6%) were admitted (relative risk [RR], 0.61 [95% CI, 0.50-0.75] and 0.51 [95% CI, 0.40-0.64], respectively). Four mAb patients (0.3%) and 2.64 control patients (0.2%) were admitted to the ICU (RR, 01.51; 95% CI, 0.45-5.09). Six mAb-treated patients (0.4%) and 3.37 controls (0.3%) died and/or were admitted to hospice (RR, 1.61; 95% CI, 0.54-4.83). mAb therapy in ambulatory patients with COVID-19 decreases the risk of ED presentation and hospital admission within 30 days of diagnosis.
PMID: 36242772
ISSN: 1535-2900
CID: 5361302

Early Results from SARS-CoV-2 PCR testing of Healthcare Workers at an Academic Medical Center in New York City

Nagler, Arielle R; Goldberg, Eric R; Aguero-Rosenfeld, Maria E; Cangiarella, Joan; Kalkut, Gary; Monahan, Carolyn Rooke; Cerfolio, Robert J
COVID-19 RT-PCR employee-testing was implemented across NYU Langone. Over eight-weeks, 14,764 employees were tested: 33% of symptomatic employees, 8% of asymptomatic employees reporting COVID-19 exposure, 3% of employees returning to work were positive. Positivity rates declined over time possibly reflecting the importance of community transmission and efficacy of PPE.
PMID: 32594114
ISSN: 1537-6591
CID: 4503762

Comparison of Payment Margins Between the Bundled Payments for Care Improvement Initiative and the Comprehensive Care for Joint Replacement Model Shows a Marked Reduction for a Successful Program

Padilla, Jorge A; Gabor, Jonathan A; Kalkut, Gary E; Pazand, Lily; Zuckerman, Joseph D; Macaulay, William; Bosco, Joseph A; Slover, James D
BACKGROUND:The Comprehensive Care for Joint Replacement (CJR) model was implemented to address the 2 most commonly billed inpatient surgical procedures, total hip arthroplasty and total knee arthroplasty. The primary purpose of this study was to review the economic implications of 1 institution's mandatory involvement in the CJR in comparison with prior involvement in the Bundled Payments for Care Improvement (BPCI) initiative. METHODS:The mean cost per episode of care was calculated using our institution's historical data. The target prices, projected savings or losses per episode of care, and projected annual savings for both BPCI and CJR were established and were comparatively analyzed. RESULTS:The CJR target prices will decrease in comparison with BPCI target prices by 24.0% for Medicare Severity-Diagnosis Related Group (MS-DRG) 469 without fracture, 22.8% for MS-DRG 469 with fracture, 26.1% for MS-DRG 470 without fracture, and 27.7% for MS-DRG 470 with fracture, resulting in a reduction in savings per episode of care by 92.8% for MS-DRG 469 without fracture, 166.0% for MS-DRG 469 with fracture, 94.9% for MS-DRG 470 without fracture, and 61.7% for MS-DRG 470 with fracture. Our institution's projected annual savings under CJR will decrease by 83.3%. CONCLUSIONS:These results suggest that the margin for savings in the CJR will be substantially reduced compared with the margin for savings in the BPCI. In hospitals that had previously devoted resources, these will have far less impact in the CJR, and hospitals new to the CJR that have not made these investments previously will require even greater resources for developing cost reduction and quality control strategies to remain financially solvent. LEVEL OF EVIDENCE/METHODS:Economic Level IV. See Instructions for Authors for a complete description of levels of evidence.
PMID: 31567678
ISSN: 1535-1386
CID: 4116002

Ninety-Day Readmissions of Bundled Valve Patients: Implications for Healthcare Policy

Koeckert, Michael S; Grossi, Eugene A; Vining, Patrick F; Abdallah, Ramsey; Williams, Mathew R; Kalkut, Gary; Loulmet, Didier F; Zias, Elias A; Querijero, Michael; Galloway, Aubrey C
OBJECTIVE:Medicare's Bundle Payment for Care Improvement(BPCI) Model 2 groups reimbursement for valve surgery into 90-day episodes of care(EOC) which include operative costs, inpatient stay, physician fees, post-acute care, and readmissions up to 90 days post-procedure. We analyzed our BPCI patients' 90-day outcomes to understand the late financial risks and implications of the bundle payment system for valve patients. METHODS:All BPCI valve patients from 10/2013 (start of risk-sharing phase) through 12/2015 were included. Readmissions were categorized as early (≤30 days) or late (31-90 days). Data were collected from institutional databases as well as Medicare claims. RESULTS:Analysis included 376 BPCI valve patients: 202 open and 174 transcatheter aortic valves (TAVR). TAVR patients were older (83.6 vs 73.8 years; p=0.001) and had higher STS predicted risk (7.1% vs 2.8%; p=0.001). Overall, 18.6% of patients (70/376) had one-or-more 90-day readmission, and total claims was on average 51% greater for these patients. Overall readmissions were more common among TAVR patients (22.4%(39/174) vs 15.3%(31/202),p=0.052) as was late readmission. TAVR patients had significantly higher late readmission claims, and early readmission was predictive of late readmission for TAVR patients only (p=0.04). CONCLUSION/CONCLUSIONS:Bundled claims for a 90-day episode of care are significantly increased in patients with readmissions. TAVR patients represent a high-risk group for late readmission, possibly a reflection of their chronic disease processes. Being able to identify patients at highest risk for 90-day readmission and the associated claims will be valuable as we enter into risk-bearing EOC agreements with Medicare.
PMID: 30102970
ISSN: 1532-9488
CID: 3236652

Improving hospital venous thromboembolism prophylaxis with electronic decision support

Bhalla, Rohit; Berger, Matthew A; Reissman, Stan H; Yongue, Brandon G; Adelman, Jason S; Jacobs, Laurie G; Billett, Henny; Sinnett, Mark J; Kalkut, Gary
BACKGROUND: Venous thromboembolism (VTE) disease prophylaxis rates among medical inpatients have been noted to be <50%. OBJECTIVE: Our objective was to evaluate the effectiveness and safety of a computerized decision support application to improve VTE prophylaxis. DESIGN: Observational cohort study. SETTING: Academic medical center. PATIENTS: Adult inpatients on hospital medicine and nonmedicine services. INTERVENTION: A decision support application designed by a quality improvement team was implemented on medicine services in September 2009. MEASUREMENTS: Effectiveness and safety parameters were compared on medicine services and nonmedicine (nonimplementation) services for 6-month periods before and after implementation. Effectiveness was evaluated by retrospective information system queries for rates of any VTE prophylaxis, pharmacologic VTE prophylaxis, and hospital-acquired VTE incidence. Safety was evaluated by queries for bleeding and thrombocytopenia rates. RESULTS: Medicine service overall VTE prophylaxis increased from 61.9% to 82.1% (P < 0.001), and pharmacologic VTE prophylaxis increased from 59.0% to 74.5% (P < 0.001). Smaller but significant increases were observed on nonmedicine services. Hospital-acquired VTE incidence on medicine services decreased significantly from 0.65% to 0.42% (P = 0.008) and nonsignificantly on nonmedicine services. Bleeding rates increased from 2.9% to 4.0% (P < 0.001) on medicine services and from 7.7% to 8.6% (P = 0.043) on nonmedicine services, with nonsignificant changes in thrombocytopenia rates observed on both services. CONCLUSIONS: An electronic decision support application on inpatient medicine services can significantly improve VTE prophylaxis and hospital-acquired VTE rates with a reasonable safety profile. Journal of Hospital Medicine 2013;8:115-120. (c) 2012 Society of Hospital Medicine.
PMID: 23184857
ISSN: 1553-5592
CID: 248472

Understanding and preventing wrong-patient electronic orders: a randomized controlled trial

Adelman, Jason S; Kalkut, Gary E; Schechter, Clyde B; Weiss, Jeffrey M; Berger, Matthew A; Reissman, Stan H; Cohen, Hillel W; Lorenzen, Stephen J; Burack, Daniel A; Southern, William N
ObjectiveTo evaluate systems for estimating and preventing wrong-patient electronic orders in computerized physician order entry systems with a two-phase study.Materials and methodsIn phase 1, from May to August 2010, the effectiveness of a 'retract-and-reorder' measurement tool was assessed that identified orders placed on a patient, promptly retracted, and then reordered by the same provider on a different patient as a marker for wrong-patient electronic orders. This tool was then used to estimate the frequency of wrong-patient electronic orders in four hospitals in 2009. In phase 2, from December 2010 to June 2011, a three-armed randomized controlled trial was conducted to evaluate the efficacy of two distinct interventions aimed at preventing these errors by reverifying patient identification: an 'ID-verify alert', and an 'ID-reentry function'.ResultsThe retract-and-reorder measurement tool effectively identified 170 of 223 events as wrong-patient electronic orders, resulting in a positive predictive value of 76.2% (95% CI 70.6% to 81.9%). Using this tool it was estimated that 5246 electronic orders were placed on wrong patients in 2009. In phase 2, 901 776 ordering sessions among 4028 providers were examined. Compared with control, the ID-verify alert reduced the odds of a retract-and-reorder event (OR 0.84, 95% CI 0.72 to 0.98), but the ID-reentry function reduced the odds by a larger magnitude (OR 0.60, 95% CI 0.50 to 0.71).Discussion and conclusionWrong-patient electronic orders occur frequently with computerized provider order entry systems, and electronic interventions can reduce the risk of these errors occurring.
PMID: 22753810
ISSN: 1067-5027
CID: 176006

Improving primary percutaneous coronary intervention performance in an urban minority population using a quality improvement approach

Bhalla, Rohit; Yongue, Brandon G; Currie, Brian P; Greenberg, Mark A; Myrie-Weir, Jacqueline; Defino, Maryrose; Esses, David; Menegus, Mark A; McAllen, Susan J; Monrad, E Scott; Galhotra, Sanjay; Kalkut, Gary
It has been well established that there are racial and ethnic disparities in cardiovascular care. Quality improvement initiatives have been recommended to proactively address these disparities. An initiative was implemented to improve timeliness of and access to primary percutaneous coronary intervention (PCI) procedures among myocardial infarction patients at an academic medical center serving a predominantly minority population. The effort was part of a national quality improvement collaborative focused on improving cardiovascular care for Hispanic/Latino and African American/ black populations. The proportion of primary PCI procedures performed within 90 minutes improved significantly from 17% in the first quarter of 2006 to 93% in the fourth quarter of 2008 (P < .001). There were no significant differences in the frequency with which Hispanic/Latino or African American/black patients received primary PCI therapy in comparison to nonmembers of these groups. Quality improvement techniques can improve the quality of and access to acute cardiovascular care for minority populations.
PMID: 20484661
ISSN: 1062-8606
CID: 176007

Could Medicare readmission policy exacerbate health care system inequity?

Bhalla, Rohit; Kalkut, Gary
The Centers for Medicare & Medicaid Services recently started publicly reporting hospital readmission rates. Health care reform proposals include readmission provisions as vehicles to promote care coordination and achieve savings. Current approaches ascribe variability in hospital readmission primarily to differences in patient medical risk and hospital performance. These approaches do not adequately account for the effect of patient sociodemographic and community factors that influence health care utilization and outcomes. The evidence base on cost-effective and generalizable care management techniques to reduce readmission is still evolving. Although readmission-related policies may prove to be a transformational force in health care reform, their incorrect application in facilities serving vulnerable communities may increase health care system inequity. Policy options can mitigate this potential.
PMID: 19949133
ISSN: 0003-4819
CID: 176008

Caring for VIPs in the hospital: the ethical thicket

Dubler, Nancy Neveloff; Kalkut, Gary E
PMID: 17180823
ISSN: 1565-1088
CID: 176009

Antiretroviral therapy: an update for the non-AIDS specialist

Kalkut, Gary
PURPOSE OF REVIEW: The treatment of HIV infection has been transformed by the introduction of highly active antiretroviral therapy. For patients who respond and can tolerate lifelong therapy, HIV infection may become a chronic disease requiring long-term ambulatory care follow-up. The current management of antiretrovirals is increasingly complex because of the large number of agents, wide spectrum of toxicities, adherence issues, and drug interactions. This review summarizes the currently available agents, recommended and alternative combinations, commonly encountered adverse events, and viral resistance issues. RECENT FINDINGS: Twenty antiretroviral medications are commercially available in the United States. Six new agents have been introduced since 2000, including one drug in a novel class of HIV fusion inhibitors. The adverse effects of antiretrovirals are well characterized and include lactic acidosis related to nucleoside reverse transcription inhibitors; metabolic and body habitus changes, primarily attributed to protease inhibitors; and concern about the long-term vascular consequences of elevated lipids and insulin resistance associated with treatment. The recommended antiretroviral therapy by an expert panel as of October 2004 is summarized. SUMMARY: The benefits of antiretroviral therapy are clear: reduced morbidity and mortality related to advanced HIV infection. Managing antiretroviral therapy, along with their adverse effects and drug interactions, is complex. Modern treatment mandates a thorough understanding of the agents. Consultation with an HIV-experienced clinician should be considered in most circumstances.
PMID: 16093800
ISSN: 1040-8746
CID: 176010