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Researching COVID to enhance recovery (RECOVER) pregnancy study: Rationale, objectives and design

Metz, Torri D; Clifton, Rebecca G; Gallagher, Richard; Gross, Rachel S; Horwitz, Leora I; Jacoby, Vanessa L; Martin-Herz, Susanne P; Peralta-Carcelen, Myriam; Reeder, Harrison T; Beamon, Carmen J; Chan, James; Chang, A Ann; Costantine, Maged M; Fitzgerald, Megan L; Foulkes, Andrea S; Gibson, Kelly S; Güthe, Nick; Habli, Mounira; Hackney, David N; Hoffman, Matthew K; Hoffman, M Camille; Hughes, Brenna L; Katz, Stuart D; Laleau, Victoria; Mallett, Gail; Mendez-Figueroa, Hector; Monzon, Vanessa; Palatnik, Anna; Palomares, Kristy T S; Parry, Samuel; Pettker, Christian M; Plunkett, Beth A; Poppas, Athena; Reddy, Uma M; Rouse, Dwight J; Saade, George R; Sandoval, Grecio J; Schlater, Shannon M; Sciurba, Frank C; Simhan, Hyagriv N; Skupski, Daniel W; Sowles, Amber; Thaweethai, Tanayott; Thomas, Gelise L; Thorp, John M; Tita, Alan T; Weiner, Steven J; Weigand, Samantha; Yee, Lynn M; Flaherman, Valerie J; ,
IMPORTANCE/OBJECTIVE:Pregnancy induces unique physiologic changes to the immune response and hormonal changes leading to plausible differences in the risk of developing post-acute sequelae of SARS-CoV-2 (PASC), or Long COVID. Exposure to SARS-CoV-2 during pregnancy may also have long-term ramifications for exposed offspring, and it is critical to evaluate the health outcomes of exposed children. The National Institutes of Health (NIH) Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC aims to evaluate the long-term sequelae of SARS-CoV-2 infection in various populations. RECOVER-Pregnancy was designed specifically to address long-term outcomes in maternal-child dyads. METHODS:RECOVER-Pregnancy cohort is a combined prospective and retrospective cohort that proposes to enroll 2,300 individuals with a pregnancy during the COVID-19 pandemic and their offspring exposed and unexposed in utero, including single and multiple gestations. Enrollment will occur both in person at 27 sites through the Eunice Kennedy Shriver National Institutes of Health Maternal-Fetal Medicine Units Network and remotely through national recruitment by the study team at the University of California San Francisco (UCSF). Adults with and without SARS-CoV-2 infection during pregnancy are eligible for enrollment in the pregnancy cohort and will follow the protocol for RECOVER-Adult including validated screening tools, laboratory analyses and symptom questionnaires followed by more in-depth phenotyping of PASC on a subset of the overall cohort. Offspring exposed and unexposed in utero to SARS-CoV-2 maternal infection will undergo screening tests for neurodevelopment and other health outcomes at 12, 18, 24, 36 and 48 months of age. Blood specimens will be collected at 24 months of age for SARS-CoV-2 antibody testing, storage and anticipated later analyses proposed by RECOVER and other investigators. DISCUSSION/CONCLUSIONS:RECOVER-Pregnancy will address whether having SARS-CoV-2 during pregnancy modifies the risk factors, prevalence, and phenotype of PASC. The pregnancy cohort will also establish whether there are increased risks of adverse long-term outcomes among children exposed in utero. CLINICAL TRIALS.GOV IDENTIFIER/BACKGROUND:Clinical Trial Registration: Unique identifier: NCT05172011.
PMID: 38128008
ISSN: 1932-6203
CID: 5612082

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

The reduction in non-COVID-19 hospitalizations during the pandemic: Problematic or beneficial? [Editorial]

Blecker, Saul B; Horwitz, Leora I
PMID: 36213943
ISSN: 1553-5606
CID: 5351882

Effects of Real-time Prescription Benefit Recommendations on Patient Out-of-Pocket Costs: A Cluster Randomized Clinical Trial

Desai, Sunita M; Chen, Alan Z; Wang, Jiejie; Chung, Wei-Yi; Stadelman, Jay; Mahoney, Chris; Szerencsy, Adam; Anzisi, Lisa; Mehrotra, Ateev; Horwitz, Leora I
Importance/UNASSIGNED:Rising drug costs contribute to medication nonadherence and adverse health outcomes. Real-time prescription benefit (RTPB) systems present prescribers with patient-specific out-of-pocket cost estimates and recommend lower-cost, clinically appropriate alternatives at the point of prescribing. Objective/UNASSIGNED:To investigate whether RTPB recommendations lead to reduced patient out-of-pocket costs for medications. Design, Setting, and Participants/UNASSIGNED:In this cluster randomized trial, medical practices in a large, urban academic health system were randomly assigned to RTPB recommendations from January 13 to July 31, 2021. Participants were adult patients receiving outpatient prescriptions during the study period. The analysis was limited to prescriptions for which RTPB could recommend an available alternative. Electronic health record data were used to analyze the intervention's effects on prescribing. Data analyses were performed from August 20, 2021, to June 8, 2022. Interventions/UNASSIGNED:When a prescription was initiated in the electronic health record, the RTPB system recommended available lower-cost, clinically appropriate alternatives for a different medication, length of prescription, and/or choice of pharmacy. The prescriber could select either the initiated order or one of the recommended options. Main Outcomes and Measures/UNASSIGNED:Patient out-of-pocket cost for a prescription. Secondary outcomes were whether a mail-order prescription and a 90-day supply were ordered. Results/UNASSIGNED:Of 867 757 outpatient prescriptions at randomized practices, 36 419 (4.2%) met the inclusion criteria of having an available alternative. Out-of-pocket costs were $39.90 for a 30-day supply in the intervention group and $67.80 for a 30-day supply in the control group. The intervention led to an adjusted 11.2%; (95% CI, -15.7% to -6.4%) reduction in out-of-pocket costs. Mail-order pharmacy use was 9.6% and 7.6% in the intervention and control groups, respectively (adjusted 1.9 percentage point increase; 95% CI, 0.9 to 3.0). Rates of 90-day supply were not different. In high-cost drug classes, the intervention reduced out-of-pocket costs by 38.9%; 95% CI, -47.6% to -28.7%. Conclusions and Relevance/UNASSIGNED:This cluster randomized clinical trial showed that RTPB recommendations led to lower patient out-of-pocket costs, with the largest savings occurring for high-cost medications. However, RTPB recommendations were made for only a small percentage of prescriptions. Trial Registration/ Identifier: NCT04940988; American Economic Association Registry: AEARCTR-0006909.
PMID: 36094537
ISSN: 2168-6114
CID: 5332742

Sex differences in the prognostic value of troponin and D-dimer in COVID-19 illness

Mukhopadhyay, Amrita; Talmor, Nina; Xia, Yuhe; Berger, Jeffrey S; Iturrate, Eduardo; Adhikari, Samrachana; Pulgarin, Claudia; Quinones-Camacho, Adriana; Yuriditsky, Eugene; Horowitz, James; Jung, Albert S; Massera, Daniele; Keller, Norma M; Fishman, Glenn I; Horwitz, Leora; Troxel, Andrea B; Hochman, Judith S; Reynolds, Harmony R
BACKGROUND:Male sex, elevated troponin levels, and elevated D-dimer levels are associated with more complicated COVID-19 illness and greater mortality; however, while there are known sex differences in the prognostic value of troponin and D-dimer in other disease states, it is unknown whether they exist in the setting of COVID-19. OBJECTIVE:We assessed whether sex modified the relationship between troponin, D-dimer, and severe COVID-19 illness (defined as mechanical ventilation, ICU admission or transfer, discharge to hospice, or death). METHODS:We conducted a retrospective cohort study of patients hospitalized with COVID-19 at a large, academic health system. We used multivariable regression to assess associations between sex, troponin, D-dimer, and severe COVID-19 illness, adjusting for demographic, clinical, and laboratory covariates. To test whether sex modified the relationship between severe COVID-19 illness and troponin or D-dimer, models with interaction terms were utilized. RESULTS:Among 4,574 patients hospitalized with COVID-19, male sex was associated with higher levels of troponin and greater odds of severe COVID-19 illness, but lower levels of initial D-dimer when compared with female sex. While sex did not modify the relationship between troponin level and severe COVID-19 illness, peak D-dimer level was more strongly associated with severe COVID-19 illness in male patients compared to female patients (males: OR=2.91, 95%CI=2.63-2.34, p<0.001; females: OR=2.31, 95%CI=2.04-2.63, p<0.001; p-interaction=0.005). CONCLUSION/CONCLUSIONS:Sex did not modify the association between troponin level and severe COVID-19 illness, but did modify the association between peak D-dimer and severe COVID-19 illness, suggesting greater prognostic value for D-dimer in males with COVID-19.
PMID: 36334466
ISSN: 1527-3288
CID: 5358922

"I Am Not the Same as I Was Before": A Qualitative Analysis of COVID-19 Survivors

Duan, Emily; Garry, Kira; Horwitz, Leora I; Weerahandi, Himali
BACKGROUND:Little is known about the illness experience of patients' long-term emotional and physical recovery from severe COVID-19 infection. This study aimed to expand upon the recovery process of COVID-19 survivors up to 6 months after hospital discharge. METHODS:Qualitative analysis of free-response answers from a cohort study of 152 patients ≥ 18 years hospitalized with laboratory-confirmed SARS-CoV-2 surveyed at 1-month post hospital discharge and 6-months post hospital discharge. Responses were analyzed with a grounded theory approach to identify overarching themes. RESULTS:Participants described persistent complications, both physical and mental, that have affected their recovery from COVID-19. Five overarching themes of post-acute patient experiences were generated: (1) an increased awareness of a mind and body connection, (2) feelings of premature aging, (3) an overall decline in quality of life, (4) a continued fear of infection, and (5) methods of coping. CONCLUSIONS:Patients described lasting changes to their mental health and overall quality of life in connection to physical complications after severe COVID-19 infection. Patients' reports of their experience call for a greater awareness of the psychological aspects of COVID-19 recovery to provide both physical and psychological rehabilitation services. Additional resources such as education around re-infection and financial resources are needed.
PMID: 36227557
ISSN: 1532-7558
CID: 5361052

Missed opportunities in medical therapy for patients with heart failure in an electronically-identified cohort

Mukhopadhyay, Amrita; Reynolds, Harmony R; Nagler, Arielle R; Phillips, Lawrence M; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:National registries reveal significant gaps in medical therapy for patients with heart failure and reduced ejection fraction (HFrEF), but may not accurately (or fully) characterize the population eligible for therapy. OBJECTIVE:We developed an automated, electronic health record-based algorithm to identify HFrEF patients eligible for evidence-based therapy, and extracted treatment data to assess gaps in therapy in a large, diverse health system. METHODS:In this cross-sectional study of all NYU Langone Health outpatients with EF ≤ 40% on echocardiogram and an outpatient visit from 3/1/2019 to 2/29/2020, we assessed prescription of the following therapies: beta-blocker (BB), angiotensin converting enzyme inhibitor (ACE-I)/angiotensin receptor blocker (ARB)/angiotensin receptor neprilysin inhibitor (ARNI), and mineralocorticoid receptor antagonist (MRA). Our algorithm accounted for contraindications such as medication allergy, bradycardia, hypotension, renal dysfunction, and hyperkalemia. RESULTS:We electronically identified 2732 patients meeting inclusion criteria. Among those eligible for each medication class, 84.8% and 79.7% were appropriately prescribed BB and ACE-I/ARB/ARNI, respectively, while only 23.9% and 22.7% were appropriately prescribed MRA and ARNI, respectively. In adjusted models, younger age, cardiology visit and lower EF were associated with increased prescribing of medications. Private insurance and Medicaid were associated with increased prescribing of ARNI (OR = 1.40, 95% CI = 1.02-2.00; and OR = 1.70, 95% CI = 1.07-2.67). CONCLUSIONS:We observed substantial shortfalls in prescribing of MRA and ARNI therapy to ambulatory HFrEF patients. Subspecialty care setting, and Medicaid insurance were associated with higher rates of ARNI prescribing. Further studies are warranted to prospectively evaluate provider- and policy-level interventions to improve prescribing of these evidence-based therapies.
PMID: 35927632
ISSN: 1471-2261
CID: 5285842

Identifying drivers of health care value: a scoping review of the literature

Landon, Susan N; Padikkala, Jane; Horwitz, Leora I
BACKGROUND:As health care spending reaches unsustainable levels, improving value has become an increasingly important policy priority. Relatively little research has explored factors driving value. As a first step towards filling this gap, we performed a scoping review of the literature to identify potential drivers of health care value. METHODS:Searches of PubMed, Embase, Google Scholar, Policy File, and SCOPUS were conducted between February and March 2020. Empirical studies that explored associations between any range of factors and value (loosely defined as quality or outcomes relative to cost) were eligible for inclusion. We created a template in Microsoft Excel for data extraction and evaluated the quality of included articles using the Critical Appraisal Skills Programme (CASP) quality appraisal tool. Data was synthesized using narrative methods. RESULTS:Twenty-two studies were included in analyses, of which 20 focused on low value service utilization. Independent variables represented a range of system-, hospital-, provider-, and patient-level characteristics. Although results were mixed, several consistent findings emerged. First, insurance incentive structures may affect value. For example, patients in Accountable Care Organizations had reduced rates of low value care utilization compared to patients in traditionally structured insurance plans. Second, higher intensity of care was associated with higher rates of low value care. Third, culture is likely to contribute to value. This was suggested by findings that recent medical school graduation and allopathic training were associated with reduced low value service utilization and that provider organizations had larger effects on value than did individual physicians. CONCLUSIONS:System, hospital, provider, and community characteristics influence low value care provision. To improve health care value, strategies aiming to reduce utilization of low value services and promote high value care across various levels will be essential.
PMID: 35773663
ISSN: 1472-6963
CID: 5278262

Evaluating the Effect of a COVID-19 Predictive Model to Facilitate Discharge: A Randomized Controlled Trial

Major, Vincent J; Jones, Simon A; Razavian, Narges; Bagheri, Ashley; Mendoza, Felicia; Stadelman, Jay; Horwitz, Leora I; Austrian, Jonathan; Aphinyanaphongs, Yindalon
BACKGROUND: We previously developed and validated a predictive model to help clinicians identify hospitalized adults with coronavirus disease 2019 (COVID-19) who may be ready for discharge given their low risk of adverse events. Whether this algorithm can prompt more timely discharge for stable patients in practice is unknown. OBJECTIVES/OBJECTIVE: The aim of the study is to estimate the effect of displaying risk scores on length of stay (LOS). METHODS: We integrated model output into the electronic health record (EHR) at four hospitals in one health system by displaying a green/orange/red score indicating low/moderate/high-risk in a patient list column and a larger COVID-19 summary report visible for each patient. Display of the score was pseudo-randomized 1:1 into intervention and control arms using a patient identifier passed to the model execution code. Intervention effect was assessed by comparing LOS between intervention and control groups. Adverse safety outcomes of death, hospice, and re-presentation were tested separately and as a composite indicator. We tracked adoption and sustained use through daily counts of score displays. RESULTS: Enrolling 1,010 patients from May 15, 2020 to December 7, 2020, the trial found no detectable difference in LOS. The intervention had no impact on safety indicators of death, hospice or re-presentation after discharge. The scores were displayed consistently throughout the study period but the study lacks a causally linked process measure of provider actions based on the score. Secondary analysis revealed complex dynamics in LOS temporally, by primary symptom, and hospital location. CONCLUSION/CONCLUSIONS: An AI-based COVID-19 risk score displayed passively to clinicians during routine care of hospitalized adults with COVID-19 was safe but had no detectable impact on LOS. Health technology challenges such as insufficient adoption, nonuniform use, and provider trust compounded with temporal factors of the COVID-19 pandemic may have contributed to the null result. TRIAL REGISTRATION/BACKGROUND: identifier: NCT04570488.
PMID: 35896506
ISSN: 1869-0327
CID: 5276672

Identifying high-value care for Medicare beneficiaries: a cross-sectional study of acute care hospitals in the USA

Herrin, Jeph; Yu, Huihui; Venkatesh, Arjun K; Desai, Sunita M; Thiel, Cassandra L; Lin, Zhenqiu; Bernheim, Susannah M; Horwitz, Leora I
OBJECTIVES/OBJECTIVE:High-value care is providing high quality care at low cost; we sought to define hospital value and identify the characteristics of hospitals which provide high-value care. DESIGN/METHODS:Retrospective observational study. SETTING/METHODS:Acute care hospitals in the USA. PARTICIPANTS/METHODS:All Medicare beneficiaries with claims included in Center for Medicare & Medicaid Services Overall Star Ratings or in publicly available Medicare spending per beneficiary data. PRIMARY AND SECONDARY OUTCOME MEASURES/METHODS:Our primary outcome was value defined as the difference between Star Ratings quality score and Medicare spending; the secondary outcome was classification as a 4 or 5 star hospital with lowest quintile Medicare spending ('high value') or 1 or 2 star hospital with highest quintile spending ('low value'). RESULTS:Two thousand nine hundred and fourteen hospitals had both quality and spending data, and were included. The value score had a mean (SD) of 0.58 (1.79). A total of 286 hospitals were classified as high value; these represented 28.6% of 999 4 and 5 star hospitals and 46.8% of 611 low cost hospitals. A total of 258 hospitals were classified as low value; these represented 26.6% of 970 1 and 2 star hospitals and 49.3% of 523 high cost hospitals. In regression models ownership, non-teaching status, beds, urbanity, nurse to bed ratio, percentage of dual eligible Medicare patients and percentage of disproportionate share hospital payments were associated with the primary value score. CONCLUSIONS:There are high quality hospitals that are not high value, and a number of factors are strongly associated with being low or high value. These findings can inform efforts of policymakers and hospitals to increase the value of care.
PMID: 35361641
ISSN: 2044-6055
CID: 5201362