Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1419&sort=-program_officials
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-program_officials", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-program_officials", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1420&sort=-program_officials", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1418&sort=-program_officials" }, "data": [ { "type": "Grant", "id": "10991", "attributes": { "award_id": "5I01BX005469-02", "title": "COVID-19: Elucidating monoclonal and polyclonal seroantibody responses to the COVID-19 viral envelope", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-10-01", "end_date": "2023-09-30", "award_amount": null, "principal_investigator": { "id": 24795, "first_name": "Mohammad Mohseni", "last_name": "Sajadi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1532, "ror": "https://ror.org/036a0e562", "name": "Baltimore VA Medical Center", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1532, "ror": "https://ror.org/036a0e562", "name": "Baltimore VA Medical Center", "address": "", "city": "", "state": "MD", "zip": "", "country": "United States", "approved": true }, "abstract": "Background/Rationale: As the Coronavirus Disease 2019 (COVID-19) epidemic expands across the United States and the world, there are no proven therapies and little information is known regarding on immunity to this virus. At this stage of the pandemic, all prevention and treatment strategies that show promise must be explored. This proposal will focus on the polyclonal and monoclonal antibody responses to the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) envelope. Objectives: The overarching goal of this program is to obtain a comprehensive understanding of the polyclonal and monoclonal response to the SARS-CoV-2 envelope E, M, and S proteins. The specific aims of this proposal are: 1) Deconvolute the polyclonal antibody response against the viral envelope of SARS-CoV-2; 2) Isolate neutralizing and non-neutralizing monoclonal antibodies against various epitopes of spike protein (S), envelope protein (E), and membrane glycoprotein (M) of SARS-CoV-2; and 3) Map the corresponding epitope(s) of the monoclonal antibodies. Methods: We will obtain paired, acute and convalescent, samples from 60 inpatients and outpatients with COVID-19 (30 have already been enrolled from the VA Maryland Health Care System and the University of Maryland Medical System). We will screen samples by binding, live and pseudovirus neutralization. In this proposal, we also will have access to BSL3 facilities on this campus that run neutralization assay with live virus by one of the world experts in coronaviruses (Matt Frieman, PhD). Donors will be ranked on the basis of both neutralization potency and breadth, and binding. The top three donors in each of the inpatient and outpatient groups will be chosen for further study (top anti-RBD neutralization and breath, top anti- receptor binding domain (RBD)-depleted plasma neutralization and breath, and top spike binding titers with non-neutralizing plasma). In these six individuals, the anti-envelope antibody will be affinity purified; and fractionated using free- flow-electrophoresis. This technique can separate antibodies based on charge, which will lead to separation based on targeted epitopes as well. Individual fractions will be tested by binding and neutralization; and characteristic biochemical and functional signatures of antibodies targeting each epitope will be ascertained. Fractions of interest (different for each donor depending if neutralization or binding is targeted) will be sent for mass spectrometry. B cell libraries will also be made from the convalescent IgG and IgA memory B cell pools; and they will be interrogated using three complementary techniques including - acute phase plasmablast repertoire analysis, subtraction analysis, and antigen baiting to identify potential antibodies. Finally, mass spectrometry will be used to rank antibody candidates. 40 monoclonal antibodies (mAbs) will be made and again be screened by neutralization potency, breadth, and isoelectric point, with top neutralizing and binding antibodies (matching the respective profiles of the fractions that were targeted) to be moved forward for fine epitope analysis by X-ray crystallography. Impact: If successful, this project will yield a substantial understanding of neutralizing/non-neutralizing antibodies and epitopes in COVID-19 disease, providing mAbs that can be moved into animal/human testing. This research has direct relevance to the health of Veterans as any monoclonal antibodies isolated can potentially be used for treatment and/or prevention of COVID-19.", "keywords": [ "2019-nCoV", "Acute", "Affinity Chromatography", "American", "Animals", "Antibodies", "Antibody Response", "Antigens", "Award", "B-Lymphocytes", "Binding", "Binding Sites", "Biochemical", "Biological Assay", "COVID-19", "COVID-19 patient", "COVID-19 prevention", "Categories", "Cells", "Cessation of life", "Characteristics", "Charge", "Codon Nucleotides", "Coronavirus", "Disease", "Doctor of Philosophy", "Electrophoresis", "Enrollment", "Epidemic", "Epitope Mapping", "Epitopes", "Family", "Fractionation", "Goals", "HIV", "Hand", "Health", "Healthcare Systems", "Human", "Immunity", "Immunoglobulin A", "Immunoglobulin G", "Individual", "Infection", "Inpatients", "Isoelectric Point", "Knowledge", "Libraries", "Maps", "Maryland", "Mass Spectrum Analysis", "Medical", "Membrane Glycoproteins", "Memory B-Lymphocyte", "Methods", "Monoclonal Antibodies", "Nucleoproteins", "Outpatients", "Patients", "Persons", "Phase", "Plasma", "Plasmablast", "Plasmids", "Prevention strategy", "Production", "Proteins", "Protocols documentation", "Research", "Running", "SARS-CoV-2 antibody", "SARS-CoV-2 infection", "SARS-CoV-2 spike protein", "Sampling", "System", "Techniques", "Testing", "United States", "Universities", "Vaccines", "Veterans", "Viral", "Virus", "X-Ray Crystallography", "biosafety level 3 facility", "convalescent plasma", "env Gene Products", "experience", "experimental study", "interest", "multiple myeloma M Protein", "neutralizing antibody", "novel therapeutics", "novel vaccines", "pandemic disease", "participant enrollment", "polyclonal antibody", "programs", "receptor binding", "response", "treatment strategy" ], "approved": true } }, { "type": "Grant", "id": "10992", "attributes": { "award_id": "5I01HX003269-02", "title": "Social and Behavioral Determinants of Health in High-Risk Veterans", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-10-01", "end_date": "2025-09-30", "award_amount": null, "principal_investigator": { "id": 24796, "first_name": "MATTHEW L", "last_name": "MACIEJEWSKI", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1497, "ror": "", "name": "VETERANS ADMIN PALO ALTO HEALTH CARE SYS", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24797, "first_name": "Donna Michelle", "last_name": "Zulman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1497, "ror": "", "name": "VETERANS ADMIN PALO ALTO HEALTH CARE SYS", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Background. Social factors exert a substantially more potent impact on health than does health care, especially among disadvantaged populations such as VA users. Adverse social determinants of health (SDH)—factors such as housing instability, food insecurity, social isolation, and transportation barriers—are linked to problems with access, poorer clinical outcomes, and increased health care costs. Despite the clinical and business case for integrating SDHs into health care, these factors are not systematically assessed or addressed in clinical settings. Significance/Impact. This study will leverage a previous survey of Veterans at high-risk for hospitalization, and a new survey to be fielded to a nationally-representative sample of Veterans, to determine how SDHs influence clinical, health care utilization, and experience outcomes. Review of findings by key stakeholders will generate recommended SDH measures for universal screening within VA. These steps, coupled with qualitative interviews about implementation challenges, will inform the future integration of high-value patient-reported SDH measures into VA’s health record. Innovation. The proposed work is innovative in its evaluation of a broad array of SDHs in high-need Veterans to identify candidate measures for electronic health record (EHR) integration. The study will leverage a theoretically-driven survey of SDH measures with a data-driven approach to identifying the associations between these SDHs and a range of health, utilization, and patient experience outcomes. Results from these analyses will inform a facilitated deliberative process to prioritize high-value, validated, and actionable measures that are predictive of outcomes that are important to Veterans and the VA. Specific Aims. In Aim 1, we will use data from an Office of Primary Care-funded survey of Veterans at high-risk for hospitalization to examine relationships between patient-reported SDH measures and utilization, cost, and days in the community outcomes. In Aim 2, we will field a survey to a nationally-representative sample of VA patients to determine the association between SDH measures and key outcomes, and to examine the prevalence of SDHs in subpopulations of Veterans who are disproportionately affected by disparities (e.g., women, racial/ethnic minorities, and rural Veterans). Aims 1 and 2 will inform partner and stakeholder discussions in Aim 3 to identify measures that are associated with key outcomes and that are perceived by operations partners as actionable (i.e., addressable through VA or community services) and thereby good candidates for EHR integration. Methodology. In Aim 1, we will leverage data from an operations-funded survey that our team administered in 2018. Using survey data for 4,685 Veterans at high-risk for hospitalization, we will examine the association between patient-reported SDHs and utilization (i.e., VA and Medicare emergency department visits and hospitalizations), VA and Medicare costs, and days in the community. In Aim 2, we will field a similar survey to a nationally-representative sample of Veterans, evaluate the association between SDHs, patient experiences (e.g., perceived access and coordination), and 12-month VA emergency department visits, hospitalizations, and costs, and describe the prevalence of SDHs in the general VA population and Veterans who are at risk for health disparities. In Aim 3, we will use a facilitated deliberative process with key stakeholders to prioritize actionable SDH measures for EHR integration, and then conduct qualitative interviews with health system leaders, clinicians, staff, and patients to examine implementation barriers and facilitators to assessing select SDH measures at point of care. Implementation/Next Steps. This study addresses health equity, particularly relevant in light of COVID-19, and will be conducted with partners from VA’s Offices of Primary Care, Health Equity, Rural Health, and Women’s Health. The study is especially timely with VA’s transition to the new Cerner EHR as the proposed aims will identify SDH measures for potential EHR integration that are concise, actionable, and predictive of important outcomes.", "keywords": [ "Academy", "Accident and Emergency department", "Address", "Affect", "Area", "Bed Occupancy", "Behavioral", "Businesses", "COVID-19", "COVID-19 pandemic", "Caregivers", "Caring", "Clinical", "Communities", "Community Services", "Coupled", "Data", "Disadvantaged", "Economics", "Electronic Health Record", "Emergency department visit", "Environmental Risk Factor", "Evaluation", "Financial Hardship", "Funding", "Future", "Goals", "Health", "Health Care Costs", "Health system", "Healthcare", "Hospital Departments", "Hospitalization", "Hospitals", "Individual", "Integrated Health Care Systems", "Intervention", "Interview", "Lead", "Leadership", "Life", "Light", "Link", "Measurement", "Measures", "Medicare", "Medicine", "Methodology", "Minority", "Modeling", "Outcome", "Patients", "Population", "Positioning Attribute", "Predictive Value", "Prevalence", "Prevention", "Primary Care", "Procedures", "Process", "Recommendation", "Reporting", "Research", "Research Personnel", "Respondent", "Rest", "Risk", "Risk Adjustment", "Rural", "Rural Health", "Sampling", "Screening procedure", "Shapes", "Social Identification", "Social isolation", "Surveys", "System", "Transportation", "Trust", "United States Department of Veterans Affairs", "Validation", "Variant", "Veterans", "Veterans Health Administration", "Woman", "Women&apos", "s Health", "Work", "base", "candidate identification", "clinical care", "cost", "disadvantaged population", "economic outcome", "ethnic minority", "experience", "food insecurity", "health care service utilization", "health care settings", "health disparity", "health equity", "health record", "high risk", "housing instability", "implementation barriers", "implementation facilitators", "improved", "innovation", "interoperability", "operation", "outcome prediction", "patient population", "point of care", "racial and ethnic", "screening", "social", "social factors", "social health determinants", "social integration", "social vulnerability" ], "approved": true } }, { "type": "Grant", "id": "11000", "attributes": { "award_id": "5U19AG073172-02", "title": "Phenotyping and Biospecimen Core", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Aging (NIA)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2021-09-30", "end_date": "2026-08-31", "award_amount": 1440598, "principal_investigator": { "id": 24449, "first_name": "Stacy", "last_name": "Andersen", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 860, "ror": "", "name": "BOSTON UNIVERSITY MEDICAL CAMPUS", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 860, "ror": "", "name": "BOSTON UNIVERSITY MEDICAL CAMPUS", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "The Phenotyping and Biospecimen (P&B) Core's primary mission is to leverage two NIA-funded centenarian studies by sifting through their study participants in identifying centenarian cognitive superagers, offspring and offspring spouses for enrollment in the RADCO study, extending their phenotyping with annual uniform neuropsychological testing, plasma biomarkers of Alzheimer's disease (AD), and facilitating and facilitating neuroimaging and post-mortem neuropathological studies among willing participants. The P&B Core's successful conduct of its six aims is critical to RADCO's investigation of centenarians and their offspring as models of cognitive resilience and resistance to cognitive impairment and AD. Those 6 Specific Aims are: Specific Aim 1. Establish a cognitive superagers (n=496, ages 100-110 years), offspring (n=600), and offspring spouses (n=120) sample with baseline neuropsychological assessments, other phenotypic data, blood samples, and genetic and biomarker data provided by 2 ongoing NIA-funded centenarian studies. Specific Aim 2. Perform annual Covid-19-safe virtual neurocognitive assessments and other phenotypic data collection that are uniform with the ILO study and LCCP measures. Also, to enhance accuracy of the neurocognitive assessments by performing interdisciplinary expert diagnoses consensus conferences. Specific Aim 3. Employing REDCap, manage and perform QC, and make easily but securely available all of the data collected and generated by the RADCO Cores and Projects, including the neuropsychological, neuroimaging, neuropathologic phenotype and biomarker and transcriptomic data. Specific Aim 4. To receive from the ILO+LCCP studies and then longitudinally collect blood samples (centenarians annually, offspring and offspring spouses every other year) from RADCO participants for use by the two projects. To maintain samples in a biorepository as a sharable resource. Specific Aim 5. Support the RADCO Neuroimaging Core's aims by recruiting RADCO participants for local neuroimaging and linking scan data to clinical data. Specific Aim 6. Recruit RADCO participants for future brain donation, ensure that autopsies proceed smoothly, and link clinical data to anatomic, pathologic and molecular data generated by the P&B neuropathology efforts. These data will inform the resilient and resistant phenotypes delineated in Project 1. Brain area-specific tissues will be provided for RNA expression studies in Project 2.", "keywords": [ "Affect", "Age", "Alzheimer&apos", "s Disease", "Alzheimer’s disease biomarker", "Amyloid beta-42", "Anatomy", "Area", "Autopsy", "Biological", "Biological Assay", "Blood specimen", "Boston", "Brain", "COVID-19", "Centenarian", "Clinical Data", "Cognitive", "Consensus", "Data", "Data Collection", "Dementia", "Diagnosis", "Disease Marker", "Elderly", "Eligibility Determination", "Enrollment", "Ensure", "Familiarity", "Fasting", "Funding", "Future", "Gene Expression", "Genetic Markers", "Genetic Transcription", "Impaired cognition", "Impairment", "Investigation", "Knowledge Portal", "Lead", "Link", "Longevity", "Los Angeles", "Measures", "Mission", "Modeling", "Molecular", "Neurocognitive", "Neuropsychological Tests", "Neuropsychology", "New York City", "Outcome", "Participant", "Pathologic", "Patient Recruitments", "Phenotype", "Plasma", "RNA", "Research Personnel", "Resistance", "Resource Sharing", "Resources", "Sampling", "Scanning", "Secure", "Spouses", "Statistical Data Interpretation", "System", "Time", "Tissues", "Work", "base", "biobank", "cognitive function", "cytokine", "data de-identification", "data management", "data sharing", "exome", "experience", "innovation", "neuroimaging", "neuropathology", "offspring", "phenotypic biomarker", "phenotypic data", "protective factors", "recruit", "resilience", "success", "symposium", "tool", "transcriptomics", "virtual" ], "approved": true } }, { "type": "Grant", "id": "11005", "attributes": { "award_id": "5P50MD017349-02", "title": "VIDA: Virtual Diabetes Group Visits Across Health Systems", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Minority Health and Health Disparities (NIMHD)" ], "program_reference_codes": [], "program_officials": [], "start_date": "2021-09-24", "end_date": "2026-06-30", "award_amount": 622687, "principal_investigator": { "id": 24458, "first_name": "Arshiya Ahmed", "last_name": "Baig", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 289, "ror": "https://ror.org/024mw5h28", "name": "University of Chicago", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 289, "ror": "https://ror.org/024mw5h28", "name": "University of Chicago", "address": "", "city": "", "state": "IL", "zip": "", "country": "United States", "approved": true }, "abstract": "Of the 30 million adults with DM in the United States, 97% have at least one comorbid condition (e.g. hypertension, heart disease, kidney disease). DM and DM-related complications disproportionately affect people of color. The prevalence of DM is higher among Hispanics (12.5%) and African-Americans (11.7%) compared to non-Hispanic whites (7.5%); Hispanics and African-Americans have higher rates of diabetes-related complications, including amputations and CKD. Group visits (GVs) can provide patients with comprehensive care for their multimorbid chronic condition. Diabetes GVs—shared appointments where patients receive self- management education in a group setting and an individual medical visit—can improve glycemic control, decrease healthcare utilization, and provide social support and co-learning among peers. While virtual appointments have become a routine part of clinical care during the COVID-19 pandemic, group visits via virtual platforms remain uncommon and understudied. Before the model can be widely adopted, important questions about the effectiveness and implementation of the virtual diabetes GV model need to be addressed. We propose to build on an established program of in-person diabetes GVs and a virtual diabetes GV pilot by the University of Chicago and MidWest Clinician’s Network. We aim to implement the virtual GV model (VIDA: Virtual Diabetes Group Visits Across Health Systems) in two distinct health systems in the Chicago region: ACCESS and Advocate Aurora Health (AAH). ACCESS is one of the largest federally qualified health centers (FQHCs) in the U.S. with 35 sites across the Chicago metropolitan area, providing care for 175,000 medically underserved and low-income patients each year, including over 25,000 patients with diabetes. Advocate Aurora Health (AAH) is a large, diverse, integrated private not-for profit health system with more than 129 primary care clinics in Illinois serving over 117,000 patients with diabetes. The ability to train, implement and evaluate virtual group visits across two distinct health systems provides a unique opportunity to learn about adaptation and the barriers and facilitators for program implementation. This study will use a type I hybrid effectiveness-implementation design via a pragmatic cluster randomized trial to assess changes in clinical outcomes among adults with T2DM in virtual diabetes GVs versus usual care. We will first adapt and implement VIDA at one ACCESS FQHC center and one AAH primary care clinic using the Form and Function domains of the Complex Health Intervention Framework. We will assess integration of VIDA into clinical workflow and determine the type of and amount of training and technical support needed to assist staff in integrating virtual diabetes GV into the clinical setting. We will then conduct a pragmatic cluster randomized trial of virtual GVs across 9 intervention sites (180 adult patients with T2DM with A1C >9%) and 9 control sites (360 matched patients) and assess change in A1C from baseline to 12-months and change in other clinical outcomes including systolic blood pressure and body mass index. We will assess adoption, implementation, and maintenance of virtual GVs across systems using RE-AIM framework.", "keywords": [ "Chicago", "Chronic", "Diabetes Mellitus", "Health system", "Visit", "virtual" ], "approved": true } }, { "type": "Grant", "id": "11011", "attributes": { "award_id": "5U01IP001150-02", "title": "Surveillance for Vaccine Preventable Disease in Children", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2021-09-01", "end_date": "2023-08-31", "award_amount": 1936000, "principal_investigator": { "id": 24475, "first_name": "Julie Anne", "last_name": "Boom", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24476, "first_name": "Leila C", "last_name": "Sahni", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 566, "ror": "https://ror.org/02pttbw34", "name": "Baylor College of Medicine", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "Component A: Project Summary Texas Children’s Hospital (TCH) aims to continue inpatient and emergency department surveillance as part of the larger national New Vaccine Surveillance Network (NVSN) to assess the burden of pediatric respiratory and gastrointestinal illnesses and acute flaccid myelitis in hospitalized children and children seeking care in the emergency department. Specifically, we will operate year-round surveillance to assess the burden of multiple viral and bacterial respiratory pathogens, including but not limited to SARS-CoV-2, influenza, respiratory syncytial virus, human metapneumovirus, parainfluenza virus, coronavirus, rhinovirus, and emerging respiratory pathogens, such as enterovirus D68. A concurrent group of healthy, asymptomatic children presenting to Texas Children’s Pediatric practices for well child care will be enrolled as a control group. Nose and/or throat swabs will be collected from symptomatic and healthy control children and tested for a wide array of respiratory pathogens using molecular methods in the laboratory of Dr. Pedro Piedra, a national expert in pediatric respiratory disease. In addition, we will assess the burden of gastrointestinal pathogens such as rotavirus and norovirus. Stool specimens from symptomatic patients and healthy control children will undergo molecular testing in the labs of Dr. Robert Atmar and Dr. Sasirekha Ramani at Baylor College of Medicine. Complete vaccination histories will be obtained for all children based on our well-established process for gathering vaccination histories. We will calculate baseline and population-based rates of respiratory and enteric pathogens among hospitalized and ED patients. Using a test negative study design, we will calculate vaccine effectiveness for vaccine-preventable diseases such as influenza, rotavirus and SARS-CoV-2, comparing symptomatic patients who test positive for a pathogen of interest to symptomatic patients and asymptomatic, healthy controls who test negative for the specific pathogen. Importantly, TCH is an exemplary surveillance site due the large number of admissions each year (>36,000), racial and ethnic diversity of the Houston area, and the similarity of the TCH population to that of the community. Given the large number of admissions per year and depth of local neurologic expertise, TCH represents the ideal site for conducting year- round surveillance for children with acute flaccid myelitis (AFM) and comparing rates of AFM with rates of circulating respiratory and gastrointestinal pathogens.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "11040", "attributes": { "award_id": "1I01BX006014-01A1", "title": "Molecular Characterization of Anti-Tumor Activity Mediated by Extracellular Vesicles Derived from Natural Killer Cells", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-02-01", "end_date": "2027-01-31", "award_amount": null, "principal_investigator": { "id": 27012, "first_name": "JACKI", "last_name": "KORNBLUTH", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1981, "ror": "https://ror.org/014c68a74", "name": "St. Louis VA Medical Center", "address": "", "city": "", "state": "MO", "zip": "", "country": "United States", "approved": true }, "abstract": "Multiple myeloma (MM) is the second most common hematological cancer in the U.S and increasing in frequency. Veterans who served in Vietnam where herbicides like Agent Orange were sprayed may have increased risk of developing MM. Early-stage disease is often asymptomatic, so patients are diagnosed late, with bone pain, kidney dysfunction and infections. Although there has been progress in developing new therapies for MM, it remains incurable. Patients initially achieve remission but ultimately relapse. The disease returns more quickly, tumor cells become more resistant to treatment and the patient’s quality of life declines. Natural killer (NK) cells kill MM cells in vitro and in vivo. Clinical trials using NK cell-based immunotherapy are ongoing but not widely available. Several drugs for MM (bortezomib, carfilzomib, lenalidomide) sensitize MM cells to NK-mediated lysis and/or enhance NK killing activity. However, challenges remain. Therefore, new treatments are needed to extend survival and increase durability of remission in relapsed/refractory patients and those ineligible for front-line therapy. My laboratory developed NK3.3, the only normal human NK cell line. It was cloned from peripheral blood NK cells and kills an array of tumor cells. As NK3.3 cells grow in culture, they release small membrane-bound extracellular vesicles (EVs). We demonstrated that purified NK3.3 EVs kill MM cell lines and primary patient samples, without harming normal cells. NK3.3 EVs also kill drug-resistant and cancer stem cells (CSC). There are many advantages to using NK3.3 EVs for cancer treatment. They can be generated in large quantities, are stable, and can be frozen and thawed without loss of function. EVs are resistant to the hypoxic tumor microenvironment and unlike cellular therapy, do not induce a detrimental cytokine storm. NK3.3-derived EVs may provide the advantages of NK cell therapy without the challenges of expanding cells and side effects. The goal of these studies is to establish the feasibility of using NK3.3-derived EVs for MM treatment. We developed a murine xenograft model of minimal residual disease in MM, which approximates a human clinical condition. After intravenous injection of RPM1-8226 MM cells into immunodeficient mice, tumor cells disseminate, infiltrate bones, and induce osteolytic lesions, characteristics of MM. We will test the ability of NK3.3 EVs to prevent MM recurrence after chemotherapy treatment. Aim 1: Characterize NK3.3 EVs and establish best practices for production. We will develop optimal NK3.3 culture conditions for EV production. Proteomic and lipidomic analysis will be performed on EV preparations. NK3.3 EVs will be evaluated for killing MM cell lines and patient samples and for lack of toxicity against healthy bone marrow, peripheral blood lymphocytes and fibroblasts. Aim 2: Identify the mechanism(s) of NK EV-mediated killing. NK EVs induce caspase-mediated apoptosis. However, like NK cells, NK EVs likely kill via multiple mechanisms. We will evaluate caspase- dependent and independent killing pathways in EV-treated tumor cells. We will inhibit killing pathways by gene knockdown and chemical treatment. MM cell lines and primary tumor cells will be used to determine whether drug-resistant and CSC-like MM cells are sensitive to killing by NK3.3 EVs. Aim 3: Test the in vivo efficacy of NK3.3 EVs in preventing/delaying tumor recurrence in a murine model of minimal residual disease in MM. Different concentrations of NK EVs will be administered intravenously. Tumor dissemination will be monitored by bioluminescence imaging; bone lesions by X-ray and CT scanning. Toxicity will be assessed by analysis of body and organ weights and blood chemistry. Normal and tumor-bearing mice will be infused with labeled NK EVs to monitor biodistribution and half-life. These studies are the first step towards developing NK3.3 EVs as a treatment for MM patients who desperately need new options to improve their quality of life and prolong their survival.", "keywords": [ "3-Dimensional", "Apoptosis", "Area", "Binding", "Biodistribution", "Biological Assay", "Black American", "Blood Cells", "Blood Chemical Analysis", "Body Weight", "Bone Marrow", "Bone Pain", "Bortezomib", "Caspase", "Cell Line", "Cell Therapy", "Cells", "Cellular immunotherapy", "Characteristics", "Chemicals", "Chemoresistance", "Clinical", "Clinical Trials", "Cytolysis", "Development", "Diagnosis", "Disease", "Disease remission", "Dose", "Drug resistance", "Fibroblasts", "Fracture", "Freezing", "Frequencies", "Genes", "Goals", "Half-Life", "Hematologic Neoplasms", "Herbicides", "Human", "Immunodeficient Mouse", "In Vitro", "Infiltration", "Infusion procedures", "Intravenous", "Label", "Laboratories", "Lesion", "Lytic Metastatic Lesion", "Maintenance Therapy", "Mediating", "Membrane", "Modeling", "Molecular", "Monitor", "Multiple Myeloma", "Mus", "NK cell therapy", "Natural Killer Cells", "Normal Cell", "Organ Weight", "Osteolytic", "Pathway interactions", "Patients", "Penetration", "Peripheral Blood Lymphocyte", "Pharmaceutical Preparations", "Preparation", "Primary Neoplasm", "Process", "Production", "Proteomics", "Quality of life", "Recurrence", "Refractory", "Regimen", "Relapse", "Residual Neoplasm", "Resistance", "Risk", "Roentgen Rays", "Sampling", "Scanning", "Stable Disease", "Survival Rate", "Testing", "Time", "Toxic effect", "Tumor Burden", "Veterans", "Vietnam", "Visual", "Xenograft Model", "agent orange", "base", "bioluminescence imaging", "bone", "cancer cell", "cancer stem cell", "cancer therapy", "cell killing", "chemotherapy", "clinical development", "cohort", "cytokine release syndrome", "extracellular vesicles", "hydrogel scaffold", "improved", "in vivo", "in vivo evaluation", "innovation", "intravenous administration", "intravenous injection", "kidney dysfunction", "kidney infection", "knock-down", "lenalidomide", "lipidomics", "loss of function", "mouse model", "neoplastic cell", "novel therapeutics", "peripheral blood", "pomalidomide", "prevent", "relapse patients", "side effect", "stem-like cell", "tumor", "tumor hypoxia", "tumor microenvironment" ], "approved": true } }, { "type": "Grant", "id": "11048", "attributes": { "award_id": "1I01BX006162-01", "title": "Defining the Contribution of Mitochondrial DNA to Viral Infectious Diseases, Type 2 Diabetes, and their Interactions", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-01-01", "end_date": "2026-12-31", "award_amount": null, "principal_investigator": { "id": 27019, "first_name": "TODD M", "last_name": "HULGAN", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Mitochondria are at the intersection of metabolism and immunity. Mitochondrial DNA (mtDNA) and nuclear DNA (nDNA) variants affect mitochondrial function and diseases relevant to Veterans. This project includes a team with extensive experience studying the genetics of type 2 diabetes mellitus (T2D) and viral infectious diseases (VID). A new collaboration is proposed to define the mitochondrial genetic associations with and interactions between these two common and important phenotypes. The overarching hypothesis is that mitochondrial genetic information available in the Million Veteran Program (MVP) will be associated with T2D and VID, and will modify interactions between them. Important mechanistic connections through immune responses (both innate and adaptive) relevant for VID and T2D pathogenesis are regulated in part by mitochondria. Coronavirus disease 2019 (COVID-19) is a new VID that has infected >600,000 Veterans to date and highlights the bi-directional intersection between T2D and VID. COVID-19 includes profound immune dysregulation (particularly interferon [IFN] signaling and responses), metabolic derangements including exacerbation of T2D, and is also made more severe by these conditions. Several mitochondria-related effects of COVID-19 have already been reported. MVP genotyping currently contains 20 common and ~130 rare mtDNA variants in ~650,000 Veterans and will soon include whole genome sequencing (WGS) with more extensive mtDNA genotyping for 150,000 of these Veterans. This project will characterize, curate, and derive information from these variants in the MVP by established and novel methods to establish a new resource (“MitoMVP”) and perform new analyses. The following aims will enhance the understanding of mitochondria- related VID and T2D interactions, facilitate development of new therapeutic targets, and provide a data resource to accelerate broader mitochondria-targeted precision medicine efforts. First, MitoMVP, a curated dataset of mitochondrial genetic information in the MVP including expanded mitochondrial genetic information on quantity (mtDNA copy number) and quality (predicted pathogenicity) will be established. Next, mitochondrial genetic information and nDNA genetic variants associated with T2D and VID will be identified, and genetic interactions between them defined. Finally, phenotypic interactions between T2D and VID that influence genetic associations will be assessed through stratified analyses focused on severe COVID-19 as a prototype. Because T2D is a complex phenotype, information in the MVP will be used to define subgroups with T2D- related clinical and laboratory metabolic phenotypes (e.g., obesity, hyperglycemia, and dyslipidemia/low HDL cholesterol) for stratified analyses, potentially yielding new associations and important clues to mechanisms of gene-by-environment interactions. This aim will also include mitochondrial phenome-wide association studies (PheWAS) to identify novel genotype-phenotype associations of interest, providing additional MitoMVP information that will be available for future studies by other MVP investigators.", "keywords": [ "Accounting", "Address", "Affect", "Atlases", "Bioenergetics", "COVID-19", "COVID-19 impact", "Clinical", "Collaborations", "Communicable Diseases", "Complex", "Custom", "DNA", "Data", "Data Set", "Development", "Diabetes Mellitus", "Disease", "Dyslipidemias", "Future", "Genes", "Genetic", "Genetic Variation", "Genetic study", "Genotype", "Health", "High Density Lipoprotein Cholesterol", "Hyperglycemia", "Immune", "Immune response", "Immunity", "Infection", "Inflammation", "Innate Immune Response", "Interferon Type I", "Interferons", "Laboratories", "Link", "Measures", "Metabolic", "Metabolism", "Methods", "Mitochondria", "Mitochondrial DNA", "Non-Insulin-Dependent Diabetes Mellitus", "Nuclear", "Obesity", "Pathogenesis", "Pathogenicity", "Phenotype", "Regulation", "Reporting", "Research", "Research Personnel", "Resources", "Risk", "Signal Transduction", "Subgroup", "Variant", "Veterans", "Viral", "Virus Diseases", "Work", "data resource", "defined contribution", "diabetes risk", "disorder risk", "experience", "gene environment interaction", "genetic association", "genetic information", "genetic variant", "genome sequencing", "immune activation", "innovation", "interest", "metabolic phenotype", "new therapeutic target", "novel", "phenome", "precision medicine", "prevent", "programs", "prototype", "response", "severe COVID-19", "whole genome" ], "approved": true } }, { "type": "Grant", "id": "11085", "attributes": { "award_id": "1I21RX004409-01", "title": "Nitrite Supplementation to Mitigate Fatigability and Increase Function in Long COVID Patients", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-03-01", "end_date": "2025-02-28", "award_amount": null, "principal_investigator": { "id": 27057, "first_name": "Daniel E.", "last_name": "Forman", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Prevalence of long COVID is surging among Veterans, and Veterans afflicted with this disease typically incur progressive declines in function, diminished quality of life and increased disability. Skeletal muscle pathophysiology has been implicated as a significant determinant of long COVID pathophysiology and clinical declines. Dr. Forman is a cardiologist and geriatrician who is currently engaged in research studying benefits of nitrite supplementation with investigational new drug (IND) nitrite capsule supplements in older adults with sedentariness and/or heart failure. In that work, he is focusing primarily on the utility of nitrites to increase skeletal muscle mitochondrial respiration. Secondarily, he is exploring if mitochondrial respiration changes correlate to changes in physical function. In particular, he is studying if increased serum and skeletal muscle nitrite elevations correlate to improvements in cardiorespiratory fitness (i.e., peak oxygen utilization [VO2]), and to decreased fatigability (i.e., rating of perceived exertion [RPE] during steady-state submaximal [1.5 miles per hour] walking). In this SPiRE application, Dr. Forman proposes to redirect his expertise in nitrite therapeutics to Veterans with long COVID. Nitrites will be administered as nitrate-rich beetroot juice versus nitrate-poor placebo. When beetroot juice is ingested, nitrates are metabolized to nitrite. Compared to IND nitrite capsules, beetroot juice is relatively easier to administer, less expensive, and hemodynamically safer. Whereas serum nitrite levels have not been consistently high in studies of beetroot juice interventions as compared to nitrite capsules, this proposal aims to optimize nitrite levels using 210 ml per day of Beet-It nitrate beverage (James White Drinks Ltd., Ipswich, UK) to provide 16 mmol of nitrate/day for 14 days versus a 210 ml of nitrate- depleted placebo. All participants will also undergo physical therapy. Endpoints in this SPiRE study are oriented principally to physical function. Endpoints (measured pre- and post- the 2-week intervention) include fatigability as well as walking efficiency (VO2/kg) during steady-state walking. Furthermore, traditional functional indices of peak VO2, VO2 at anaerobic threshold, 6-minute walk distance, short physical performance battery, and pulmonary function tests will also be assessed. Nitrite levels (both serologically and in the skeletal muscle itself) will be measured to best ascertain the relationship of nitrite and putative clinical changes. In addition, analyses of skeletal muscle will clarify if nitrite-mediated changes in physical function correlate to changes in skeletal muscle respiration. Overall, this proposal aligns with the Veteran’s Affairs Office of Research and Development’s commitment to research that helps Veterans affected by COVID-19, and it also aligns with the Rehabilitation Research and Development’s mission to maximize Veterans’ functional independence, quality of life and participation in their lives and community. Dr. Forman anticipates applying the data and momentum from this compelling SPiRE-based analysis to pursue a subsequent MERIT trial that reinforces the value of nitrite therapeutics more definitively for long COVID patients.", "keywords": [ "Acute", "Address", "Adult", "Aerobic", "Amino Acids", "Anaerobic Threshold", "Arginine", "Beverages", "COVID-19", "COVID-19 impact", "COVID-19 patient", "Chronic Obstructive Pulmonary Disease", "Citrulline", "Clinical", "Communities", "Consumption", "Data", "Diet", "Disease", "Elderly", "Exercise", "Exertion", "Fatigue", "Foundations", "Functional disorder", "Health Care Costs", "Healthcare", "Healthcare Systems", "Heart failure", "Hour", "Ingestion", "Intervention", "Investigational Drugs", "Ischemia", "Juice", "Lead", "Left", "Long COVID", "Measures", "Mediating", "Mission", "Mitochondria", "Muscle Mitochondria", "Myalgia", "Nitrates", "Nitric Oxide", "Nitrites", "Oxygen", "Participant", "Personal Satisfaction", "Physical Function", "Physical Performance", "Physical therapy", "Physiological", "Placebos", "Plants", "Prevalence", "Principal Investigator", "Pulmonary function tests", "Quality of life", "Randomized Controlled Trials", "Regimen", "Rehabilitation therapy", "Research", "Residual state", "Respiration", "Risk", "SARS-CoV-2 infection", "Serology", "Serum", "Shortness of Breath", "Signal Transduction", "Signaling Molecule", "Skeletal Muscle", "Source", "Standardization", "Stress", "Supplementation", "Survivors", "Symptoms", "Therapeutic", "Therapeutic Uses", "United States Department of Veterans Affairs", "Veterans", "Walking", "Work", "capsule", "cardiorespiratory fitness", "coronavirus disease", "design", "disability", "efficacy study", "exercise regimen", "functional decline", "functional independence", "hemodynamics", "improved", "indexing", "innovation", "novel", "patient population", "post SARS-CoV-2 infection", "primary endpoint", "programs", "pulmonary function", "randomized placebo controlled trial", "rehabilitation research", "research and development", "research study", "sedentary", "young adult" ], "approved": true } }, { "type": "Grant", "id": "11211", "attributes": { "award_id": "1I01HX003519-01A2", "title": "The broken drug supply chain: The impact of COVID-19 on drug shortages and Veteran health", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-04-01", "end_date": "2027-03-31", "award_amount": null, "principal_investigator": { "id": 24732, "first_name": "KJ", "last_name": "Suda", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Background: Few of the drugs Veterans take as a cornerstone to prevent and treat disease are produced domestically; the majority of medications consumed in the U.S. are produced in foreign facilities. Thus, the drug supply chain is global and susceptible to disruption due to unanticipated events, such as the 2019 Coronavirus pandemic (COVID-19). Significance: However, little is known on the frequency of drug shortages causing medication treatment gaps and subsequent impact on adverse clinical outcomes. This is especially true in the outpatient setting, where the majority of drug shortages occur. Innovation and Impact: The research is innovative by conducting formative work on: 1) the impact of the pan- demic on drug supply and outcomes, 2) differences in shortages in VA priority groups, 3) incorporating stake- holders to inform methods, 4) direct involvement of VA operations and an expert panel of federal partners, and [unique access to operations data.]. The majority of Rx use and drug shortages in VA occur in outpatients, but prior research on drug shortages has focused on inpatients. We will also evaluate the impact of drug shortages by race, ethnicity, age, location, and co-morbidities. The results obtained here will guide VA policy-makers in the identification of the most effective policies to address this growing problem. Specific aims: 1) Determine the impact of the COVID pandemic on the drug supply chain in VA; 2) Assess the impact of drug shortages on outpatient medication treatment disruption in the VA; and 3) Determine the asso- ciation between drug shortage-related treatment disruption in outpatient prescription refills and serious adverse clinical outcomes. Methodology: Drug supply chain issues will be identified through U.S. reporting systems (e.g., FDA). We will leverage VA data for the quantity of drugs ordered and supplied nationally using VA purchasing and outpatient prescription data. For each drug potentially used in the outpatient setting with a reported supply chain issue, purchase changes will be assessed monthly pre- (2017-2019) and during the pandemic. Aim 1 will use inter- rupted time series (ITS) analyses to test whether the incidence of supply chain issues triggering a decrease in supply increased after pandemic start. Aim 2 will identify outpatient drug shortages leading to treatment disrup- tion using ITS and structural break models. Aim 3 will define cohorts based on the indication for drugs with identified shortages using a time to event analysis with entropy balance weighting to evaluate if adverse out- comes (hospitalizations, death, emergency/urgent care) were greater for patients using drugs affected by short- ages (the exposed group) compared to unexposed controls. Next steps and Implementation: Dissemination will be guided by an expert panel comprised of VA operational partners, other federal partners and experts in drug supply and shortages. The quantitative results will be as- similated with the expert panel discussions to develop a support guide to mitigate drug shortages in VA. The next step will be to; 1) inform the US list of essential medicines and criteria for production (e.g., domestically) and 2) determine effectiveness of our support guide and future VA policy implemented based on our work. Our future research will work to ensure access and equitable distribution of drugs with limited supply and/or at risk for shortages. Even after the pandemic, the research proposed will provide results to mitigate drug shortages which remains a crucial public health issue even in the absence of a national emergency. Thus, this will be one step in our long-term goal to plan for future global emergencies, drug shortages at large, and inform national policy to decrease the impact of drug shortages on patient outcomes.", "keywords": [ "Address", "Affect", "Age", "Area", "COVID-19", "COVID-19 impact", "Cessation of life", "Characteristics", "Chinese", "Clinical", "Consumption", "Coronavirus", "Data", "Department of Defense", "Disease", "Dosage Forms", "Drug usage", "Effectiveness", "Elderly", "Emergency Situation", "Ensure", "Entropy", "Equilibrium", "Ethnic Origin", "Event", "Exposure to", "Frequencies", "Future", "Goals", "Government", "Health", "Healthcare Systems", "Homogeneously Staining Region", "Hospitalization", "Incidence", "Individual", "Inpatients", "Interruption", "Knowledge", "Laws", "Location", "Manufactured form", "Measures", "Medicine", "Methodology", "Methods", "Modeling", "Monitor", "Multiple Partners", "Outcome", "Outpatients", "Patient-Focused Outcomes", "Patients", "Pharmaceutical Preparations", "Pharmacologic Substance", "Policies", "Policy Maker", "Predisposition", "Probability", "Procedures", "Production", "Public Health", "Race", "Reaction Time", "Reporting", "Research", "Research Design", "Retrospective cohort study", "Risk", "Rural", "Series", "Services", "Statutes and Laws", "System", "Testing", "Time", "Time Series Analysis", "United States Food and Drug Administration", "United States Indian Health Service", "Veterans", "Visit", "Voting", "Work", "acute care", "adverse outcome", "cohort", "comorbidity", "drug distribution", "effectiveness evaluation", "ethnic minority", "experience", "health equity", "improved", "innovation", "multiple chronic conditions", "operation", "pandemic coronavirus", "pandemic disease", "pandemic impact", "patient safety", "pharmacy benefit", "premature", "prevent", "public health emergency", "racial minority", "resilience", "rural dwellers", "time use", "tool", "urgent care" ], "approved": true } }, { "type": "Grant", "id": "11214", "attributes": { "award_id": "1I01HX003570-01A2", "title": "Impact of the Coronavirus Disease 2019 Pandemic on Cardiovascular HealthcareUtilization, Quality of Care, and Clinical Outcomes", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-04-01", "end_date": "2025-03-31", "award_amount": null, "principal_investigator": { "id": 27231, "first_name": "Paul Laurence", "last_name": "Hess", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 27232, "first_name": "Stephen", "last_name": "Waldo", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1828, "ror": "https://ror.org/04d7ez939", "name": "VA Eastern Colorado Health Care System", "address": "", "city": "", "state": "CO", "zip": "", "country": "United States", "approved": true }, "abstract": "Background: During the coronavirus disease 2019 (COVID-19) pandemic, Veterans have deferred inpatient care such as coronary revascularization in the context of an acute myocardial infarction. Simultaneously, cardiovascular care has been disrupted, with clinicians less likely to prescribe guideline indicated medications for common cardiovascular conditions such as stable coronary artery disease or heart failure. Excess deaths have also occurred during the COVID-19 pandemic, particularly among vulnerable populations, raising the possibility of suboptimal healthcare utilization or quality of care among those not directly infected by the virus. However, the extent to which cardiovascular healthcare utilization and quality of care have decreased during the pandemic compared with preceding time periods and whether these changes have impacted Veterans’ risk of mortality is unknown. Significance: Cardiovascular disease is the most common condition in the United States and the leading cause of excess, non-COVID deaths during the early pandemic. The proposed work may identify gaps in VA healthcare utilization and quality of care with the potential to directly inform national improvements in cardiovascular care for Veterans, leading to more accessible, higher-quality, more equitable care in the future. In addition, the evaluation of care for cardiovascular disease could serve as a model for future research in other disciplines within Veterans Affairs medical specialty care. Specific Aims: Aim 1: Compare inpatient and outpatient utilization (clinic visits / hospitalizations / diagnostic testing / procedural care) among Veterans with common cardiovascular diagnoses (atrial fibrillation / coronary artery disease / heart failure) during the COVID-19 pandemic compared with expected utilization based on the corresponding 3-year period preceding the pandemic. Aim 2: Compare quality of care (guideline indicated medication / transitions of care) among Veterans with common cardiovascular diagnoses (atrial fibrillation / coronary artery disease / heart failure) during the COVID- 19 pandemic with that expected based on the corresponding 3-year period preceding the pandemic. Aim 3: Evaluate whether potential pandemic-related changes in healthcare utilization and/or process of care quality metrics are associated with an increased risk for the clinical outcomes of all-cause mortality and/or cardiovascular mortality among Veterans with common cardiovascular diagnoses. Methodology: We propose an observational, retrospective, national cohort study of Veterans with cardiovascular disease. The primary data sources will consist of the VA Corporate Data Warehouse (CDW) and the Non-VA Care Program Integrity Tools (PIT) system. Using indirect standardization, we will compare potential decreases in cardiovascular healthcare utilization and quality of care and a potential increase in mortality to that which occurred prior to the pandemic, performing subgroup analyses focused on age, sex and gender, and race and ethnicity as allowed by sample sizes. In mediation analyses, we will then assess whether the changes in utilization and quality of care were associated with an increased risk of mortality. Next Steps/Implementation: A stakeholder advisory panel, led by VA operational leaders, investigators, and Veterans, will be convened to develop comprehensive recommendations to optimize the access, quality, and equity of VA cardiovascular care and guide VA policies in the late-COVID-19 and/or post-COVID-19 pandemic period.", "keywords": [ "Acute myocardial infarction", "Admission activity", "Age", "Ambulatory Care Facilities", "Atrial Fibrillation", "COVID-19", "COVID-19 pandemic", "COVID-19 pandemic effects", "Cardiology", "Cardiovascular Diseases", "Cardiovascular system", "Caring", "Cessation of life", "Clinic Visits", "Clinical", "Clinical assessments", "Cohort Studies", "Consensus", "Coronary", "Coronary Arteriosclerosis", "Data", "Data Sources", "Diagnosis", "Diagnostic tests", "Discipline", "Ensure", "Ethnic Origin", "Evaluation", "Federal Government", "Future", "Gender", "Guidelines", "Health Personnel", "Healthcare", "Healthcare Systems", "Heart Diseases", "Heart failure", "Hospitalization", "Hospitals", "Inpatients", "Integrated Health Care Systems", "International", "Investigation", "Mediation", "Methodology", "Modeling", "Outcome", "Outpatients", "Patient Admission", "Patients", "Pharmaceutical Preparations", "Policies", "Principal Investigator", "Procedures", "Process", "Professional Organizations", "Quality of Care", "Race", "Recommendation", "Reporting", "Research", "Research Personnel", "Resources", "Sample Size", "Standardization", "Subgroup", "System", "Time", "United States", "United States Department of Veterans Affairs", "Vascularization", "Veterans", "Virus", "Vulnerable Populations", "Work", "adverse outcome", "care delivery", "clinical risk", "cohort", "coronavirus disease", "data warehouse", "evidence base", "follow-up", "health care delivery", "health care quality", "health care service utilization", "health equity", "improved", "improved outcome", "inpatient service", "medical specialties", "mortality", "mortality risk", "pandemic disease", "pandemic potential", "patient safety", "percutaneous coronary intervention", "post-COVID-19", "post-pandemic", "pre-pandemic", "programs", "racial difference", "research clinical testing", "sex", "tool" ], "approved": true } } ], "meta": { "pagination": { "page": 1419, "pages": 1424, "count": 14236 } } }