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Development of a Definition of Postacute Sequelae of SARS-CoV-2 Infection
Thaweethai, Tanayott; Jolley, Sarah E; Karlson, Elizabeth W; Levitan, Emily B; Levy, Bruce; McComsey, Grace A; McCorkell, Lisa; Nadkarni, Girish N; Parthasarathy, Sairam; Singh, Upinder; Walker, Tiffany A; Selvaggi, Caitlin A; Shinnick, Daniel J; Schulte, Carolin C M; Atchley-Challenner, Rachel; Alba, George A; Alicic, Radica; Altman, Natasha; Anglin, Khamal; Argueta, Urania; Ashktorab, Hassan; Baslet, Gaston; Bassett, Ingrid V; Bateman, Lucinda; Bedi, Brahmchetna; Bhattacharyya, Shamik; Bind, Marie-Abele; Blomkalns, Andra L; Bonilla, Hector; Bush, Patricia A; Castro, Mario; Chan, James; Charney, Alexander W; Chen, Peter; Chibnik, Lori B; Chu, Helen Y; Clifton, Rebecca G; Costantine, Maged M; Cribbs, Sushma K; Davila Nieves, Sylvia I; Deeks, Steven G; Duven, Alexandria; Emery, Ivette F; Erdmann, Nathan; Erlandson, Kristine M; Ernst, Kacey C; Farah-Abraham, Rachael; Farner, Cheryl E; Feuerriegel, Elen M; Fleurimont, Judes; Fonseca, Vivian; Franko, Nicholas; Gainer, Vivian; Gander, Jennifer C; Gardner, Edward M; Geng, Linda N; Gibson, Kelly S; Go, Minjoung; Goldman, Jason D; Grebe, Halle; Greenway, Frank L; Habli, Mounira; Hafner, John; Han, Jenny E; Hanson, Keith A; Heath, James; Hernandez, Carla; Hess, Rachel; Hodder, Sally L; Hoffman, Matthew K; Hoover, Susan E; Huang, Beatrice; Hughes, Brenna L; Jagannathan, Prasanna; John, Janice; Jordan, Michael R; Katz, Stuart D; Kaufman, Elizabeth S; Kelly, John D; Kelly, Sara W; Kemp, Megan M; Kirwan, John P; Klein, Jonathan D; Knox, Kenneth S; Krishnan, Jerry A; Kumar, Andre; Laiyemo, Adeyinka O; Lambert, Allison A; Lanca, Margaret; Lee-Iannotti, Joyce K; Logarbo, Brian P; Longo, Michele T; Luciano, Carlos A; Lutrick, Karen; Maley, Jason H; Marathe, Jai G; Marconi, Vincent; Marshall, Gailen D; Martin, Christopher F; Matusov, Yuri; Mehari, Alem; Mendez-Figueroa, Hector; Mermelstein, Robin; Metz, Torri D; Morse, Richard; Mosier, Jarrod; Mouchati, Christian; Mullington, Janet; Murphy, Shawn N; Neuman, Robert B; Nikolich, Janko Z; Ofotokun, Ighovwerha; Ojemakinde, Elizabeth; Palatnik, Anna; Palomares, Kristy; Parimon, Tanyalak; Parry, Samuel; Patterson, Jan E; Patterson, Thomas F; Patzer, Rachel E; Peluso, Michael J; Pemu, Priscilla; Pettker, Christian M; Plunkett, Beth A; Pogreba-Brown, Kristen; Poppas, Athena; Quigley, John G; Reddy, Uma; Reece, Rebecca; Reeder, Harrison; Reeves, W B; Reiman, Eric M; Rischard, Franz; Rosand, Jonathan; Rouse, Dwight J; Ruff, Adam; Saade, George; Sandoval, Grecio J; Schlater, Shannon M; Shepherd, Fitzgerald; Sherif, Zaki A; Simhan, Hyagriv; Singer, Nora G; Skupski, Daniel W; Sowles, Amber; Sparks, Jeffrey A; Sukhera, Fatima I; Taylor, Barbara S; Teunis, Larissa; Thomas, Robert J; Thorp, John M; Thuluvath, Paul; Ticotsky, Amberly; Tita, Alan T; Tuttle, Katherine R; Urdaneta, Alfredo E; Valdivieso, Daisy; VanWagoner, Timothy M; Vasey, Andrew; Verduzco-Gutierrez, Monica; Wallace, Zachary S; Ward, Honorine D; Warren, David E; Weiner, Steven J; Welch, Shelley; Whiteheart, Sidney W; Wiley, Zanthia; Wisnivesky, Juan P; Yee, Lynn M; Zisis, Sokratis; Horwitz, Leora I; Foulkes, Andrea S
IMPORTANCE:SARS-CoV-2 infection is associated with persistent, relapsing, or new symptoms or other health effects occurring after acute infection, termed postacute sequelae of SARS-CoV-2 infection (PASC), also known as long COVID. Characterizing PASC requires analysis of prospectively and uniformly collected data from diverse uninfected and infected individuals. OBJECTIVE:To develop a definition of PASC using self-reported symptoms and describe PASC frequencies across cohorts, vaccination status, and number of infections. DESIGN, SETTING, AND PARTICIPANTS:Prospective observational cohort study of adults with and without SARS-CoV-2 infection at 85 enrolling sites (hospitals, health centers, community organizations) located in 33 states plus Washington, DC, and Puerto Rico. Participants who were enrolled in the RECOVER adult cohort before April 10, 2023, completed a symptom survey 6 months or more after acute symptom onset or test date. Selection included population-based, volunteer, and convenience sampling. EXPOSURE:SARS-CoV-2 infection. MAIN OUTCOMES AND MEASURES:PASC and 44 participant-reported symptoms (with severity thresholds). RESULTS:A total of 9764 participants (89% SARS-CoV-2 infected; 71% female; 16% Hispanic/Latino; 15% non-Hispanic Black; median age, 47 years [IQR, 35-60]) met selection criteria. Adjusted odds ratios were 1.5 or greater (infected vs uninfected participants) for 37 symptoms. Symptoms contributing to PASC score included postexertional malaise, fatigue, brain fog, dizziness, gastrointestinal symptoms, palpitations, changes in sexual desire or capacity, loss of or change in smell or taste, thirst, chronic cough, chest pain, and abnormal movements. Among 2231 participants first infected on or after December 1, 2021, and enrolled within 30 days of infection, 224 (10% [95% CI, 8.8%-11%]) were PASC positive at 6 months. CONCLUSIONS AND RELEVANCE:A definition of PASC was developed based on symptoms in a prospective cohort study. As a first step to providing a framework for other investigations, iterative refinement that further incorporates other clinical features is needed to support actionable definitions of PASC.
PMID: 37278994
ISSN: 1538-3598
CID: 5536662
Assessment of Patient Education Delivered at Time of Hospital Discharge
Trivedi, Shreya P; Corderman, Sara; Berlinberg, Elyse; Schoenthaler, Antoinette; Horwitz, Leora I
IMPORTANCE:Patient education at time of hospital discharge is critical for smooth transitions of care; however, empirical data regarding discharge communication are limited. OBJECTIVE:To describe whether key communication domains (medication changes, follow-up appointments, disease self-management, red flags, question solicitation, and teach-back) were addressed at the bedside on the day of hospital discharge, by whom, and for how long. DESIGN, SETTING, AND PARTICIPANTS:This quality improvement study was conducted from September 2018 through October 2019 at inpatient medicine floors in 2 urban, tertiary-care teaching hospitals and purposefully sampled patients designated as "discharge before noon." Data analysis was performed from September 2018 to May 2020. EXPOSURES:A trained bedside observer documented all content and duration of staff communication with a single enrolled patient from 7 am until discharge. MAIN OUTCOMES AND MEASURES:Presence of the key communication domains, role of team members, and amount of time spent at the bedside. RESULTS:Discharge days for 33 patients were observed. Patients had a mean (SD) age of 63 (18) years; 14 (42%) identified as White, 15 (45%) were female, and 6 (18%) had a preferred language of Spanish. Thirty patients were discharged with at least 1 medication change. Of these patients, 8 (27%) received no verbal instruction on the change, while 16 of 30 (53%) were informed but not told the purpose of the changes. About half of the patients (15 of 31, 48%) were not told the reason for follow-up appointments, and 18 of 33 (55%) were not given instructions on posthospital disease self-management. Most patients (27 of 33, 81%) did not receive guidance on red-flag signs. While over half of the patients (19 of 33, 58%) were asked if they had any questions, only 1 patient was asked to teach back his understanding of the discharge plan. Median (IQR) total time spent with patients on the day of discharge by interns, senior residents, attending physicians, and nurses was 4.0 (0.75-6.0), 1.0 (0-2.0), 3.0 (0.5-7.0), and 22.5 (15.5-30.0) minutes, respectively. Most of the time was spent discussing logistics rather than discharge education. CONCLUSIONS AND RELEVANCE:In this quality improvement study, patients infrequently received discharge education in key communication domains, potentially leaving gaps in patient knowledge. Interventions to improve the hospital discharge process should address the content, method of delivery, and transparency among team members regarding patient education.
PMID: 36939674
ISSN: 2168-6114
CID: 5502462
Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care
Mukhopadhyay, Amrita; Reynolds, Harmony R; Phillips, Lawrence M; Nagler, Arielle R; King, William C; Szerencsy, Adam; Saxena, Archana; Aminian, Rod; Klapheke, Nathan; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Mineralocorticoid receptor antagonists (MRA) are under-prescribed for patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVE:To compare effectiveness of two automated, electronic health record (EHR)-embedded tools vs. usual care on MRA prescribing in eligible patients with HFrEF. METHODS:BETTER CARE-HF (Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) was a three-arm, pragmatic, cluster-randomized trial comparing the effectiveness of an alert during individual patient encounters vs. a message about multiple patients between encounters vs. usual care on MRA prescribing. We included adult patients with HFrEF, no active MRA prescription, no contraindication to MRA, and an outpatient cardiologist in a large health system. Patients were cluster-randomized by cardiologist (60 per arm). RESULTS:The study included 2,211 patients (alert: 755, message: 812, usual care [control]: 644), with average age 72.2 years, average EF 33%, who were predominantly male (71.4%) and White (68.9%). New MRA prescribing occurred in 29.6% of patients in the alert arm, 15.6% in the message arm, and 11.7% in the control arm. The alert more than doubled MRA prescribing compared to control (RR: 2.53, 95% CI: 1.77-3.62, p<0.0001), and improved MRA prescribing compared to the message (RR: 1.67, 95% CI: 1.21-2.29, p=0.002). The number of patients with alert needed to result in an additional MRA prescription was 5.6. CONCLUSIONS:An automated, patient-specific, EHR-embedded alert increased MRA prescribing compared to both a message and usual care. Our findings highlight the potential for EHR-embedded tools to substantially increase prescription of life-saving therapies for HFrEF. (NCT05275920).
PMID: 36882134
ISSN: 1558-3597
CID: 5430312
Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists
Mukhopadhyay, Amrita; Reynolds, Harmony R; Xia, Yuhe; Phillips, Lawrence M; Aminian, Rod; Diah, Ruth-Ann; Nagler, Arielle R; Szerencsy, Adam; Saxena, Archana; Horwitz, Leora I; Katz, Stuart D; Blecker, Saul
BACKGROUND:Beart failure with reduced ejection fraction (HFrEF) is a leading cause of morbidity and mortality. However, shortfalls in prescribing of proven therapies, particularly mineralocorticoid receptor antagonist (MRA) therapy, account for several thousand preventable deaths per year nationwide. Electronic clinical decision support (CDS) is a potential low-cost and scalable solution to improve prescribing of therapies. However, the optimal timing and format of CDS tools is unknown. METHODS AND RESULTS/RESULTS:We developed two targeted CDS tools to inform cardiologists of gaps in MRA therapy for patients with HFrEF and without contraindication to MRA therapy: (1) an alert that notifies cardiologists at the time of patient visit, and (2) an automated electronic message that allows for review between visits. We designed these tools using an established CDS framework and findings from semistructured interviews with cardiologists. We then pilot tested both CDS tools (n = 596 patients) and further enhanced them based on additional semistructured interviews (n = 11 cardiologists). The message was modified to reduce the number of patients listed, include future visits, and list date of next visit. The alert was modified to improve noticeability, reduce extraneous information on guidelines, and include key information on contraindications. CONCLUSIONS:The BETTER CARE-HF (Building Electronic Tools to Enhance and Reinforce CArdiovascular REcommendations for Heart Failure) trial aims to compare the effectiveness of the alert vs. the automated message vs. usual care on the primary outcome of MRA prescribing. To our knowledge, no study has directly compared the efficacy of these two different types of electronic CDS interventions. If effective, our findings can be rapidly disseminated to improve morbidity and mortality for patients with HFrEF, and can also inform the development of future CDS interventions for other disease states. (Trial registration: Clinicaltrials.gov NCT05275920).
PMID: 36640860
ISSN: 1097-6744
CID: 5403312
Using Rapid Randomized Trials to Improve Health Care Systems
Horwitz, Leora I; Krelle, Holly A
Rapid randomized controlled trials have been surprisingly rare in health care quality improvement (QI) and systems interventions. Applying clinical trials methodology QI work brings two distinct fields together, applying the robustness of randomized controlled trials (RCTs) to the practical, operational learnings of the well-established QI field. Rapid trials also add a third element-speed-that enables health care systems to rapidly test multiple variations of an intervention in much the same way that A/B testing is done in the technology sector. When performed well, these rapid trials free researchers and health care systems from the requirement to be correct the first time (because it is low cost and quick to try something else) while offering a standard of evidence often absent in QI. Here we outline the historical underpinnings of this approach, provide guidance about how best to implement it, and describe lessons learned from running more than 20 randomized projects in the NYU Langone Health system. Expected final online publication date for the Annual Review of Public Health, Volume 44 is April 2023. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
PMID: 36400154
ISSN: 1545-2093
CID: 5385022
Increasing Rates of Prone Positioning in Acute Care Patients with COVID-19
Zaretsky, Jonah; Corcoran, John R; Savage, Elizabeth; Berke, Jolie; Herbsman, Jodi; Fischer, Mary; Kmita, Diana; Laverty, Patricia; Sweeney, Greg; Horwitz, Leora I
BACKGROUND:Prone positioning improves mortality in patients intubated with acute respiratory distress syndrome and has been proposed as a treatment for nonintubated patients with COVID-19 outside the ICU. However, there are substantial patient and operational barriers to prone positioning on acute floors. The objective of this project was to increase the frequency of prone positioning among acute care patients with COVID-19. METHODS:The researchers conducted a retrospective analysis of all adult patients admitted to the acute care floors with COVID-19 respiratory failure. A run chart was used to quantify the frequency of prone positioning over time. For the subset of patients assisted by a dedicated physical therapy team, oxygen before and after positioning was compared. The initiative consisted of four separate interventions: (1) nursing, physical therapy, physician, and patient education; (2) optimization of supply management and operations; (3) an acute care prone positioning team; and (4) electronic health record optimization. RESULTS:From March 9, 2020, to August 26, 2020, 176/875 (20.1%) patients were placed in prone position. Among these, 43 (24.4%) were placed in the prone position by the physical therapy team. Only 2/94 (2.1%) eligible patients admitted in the first two weeks of the pandemic were ever documented in prone position. After launching the initiative, weekly frequency peaked at 13/28 (46.4%). Mean oxygen saturation was 91% prior to prone positioning vs. 95.2% after (p < 0.001) in those positioned by physical therapy. CONCLUSION:A multidisciplinary quality improvement initiative increased frequency of prone positioning by proactively addressing barriers in knowledge, equipment, training, and information technology.
PMCID:8444473
PMID: 34848158
ISSN: 1938-131x
CID: 5449292
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.
PMCID:9597518
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.
PMCID:9559269
PMID: 36227557
ISSN: 1532-7558
CID: 5361052
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.
PMCID:9619808
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