Grant List
Represents Grant table in the DB
GET /v1/grants?sort=-funder
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-funder", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-funder", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=2&sort=-funder", "prev": null }, "data": [ { "type": "Grant", "id": "10491", "attributes": { "award_id": "3R33AT010125-03S2", "title": "Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Drug Abuse (NIDA)" ], "program_reference_codes": [], "program_officials": [ { "id": 8626, "first_name": "Wendy J.", "last_name": "Weber", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-07-01", "end_date": "2023-08-31", "award_amount": 700000, "principal_investigator": { "id": 23249, "first_name": "Zev David", "last_name": "Schuman Olivier", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1582, "ror": "https://ror.org/059c3mv67", "name": "Cambridge Health Alliance", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1582, "ror": "https://ror.org/059c3mv67", "name": "Cambridge Health Alliance", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Opioid Use Disorder (OUD) is a national health crisis. Office-Based Opioid Treatment (OBOT) with buprenorphine/naloxone (B/N) prevents overdose deaths. Psychosocial stress and psychiatric problems (e.g., Anxiety) are major reasons for OBOT drop out and relapse. Many patients turn to benzodiazepines (BZD) to address anxiety and emotional distress with dangerous consequences. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for OUD treatment in most US counties. Mindfulness-Based Interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention, while reducing rates of relapse and overdose deaths. However, current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project originally proposed to adapt, refine, and compare the effectiveness of the 6-month live-online Mindful Recovery OUD Care Continuum (M-ROCC) versus a standard recovery group in primary care. M-ROCC is derived from the evidence-based, established Mindfulness Training for Primary Care (MTPC) program, which has been adapted for Opioid Use Disorder. M-ROCC includes a flexible, patient-centered, motivationally responsive design, including a Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an intensive Mindfulness Training for Primary Care (MTPC-OUD) Group. M-ROCC builds on the previously demonstrated ascending mindfulness practice dose ladder approach, which helps individuals with OUD nurture motivation and resolve ambivalence for mindfulness practice. MTPC has been shown to lower anxiety, stress, and depression, while increasing self-efficacy and capacity for behavioral change by engaging self-regulation mechanisms. During the R21 phase, we established the feasibility and acceptability of the M-ROCC program and prepared for the R33 phase by training providers and obtaining necessary approvals and site contracts. In the R33 phase, we planned to conduct a five-site RCT comparing M-ROCC versus Group-Based Opioid Treatment (GBOT). Due to the COVID-19 pandemic, we modified all aspects of the R33 phase to be conducted with a national sample in a remote, live-online, virtual format, comparing M-ROCC versus a standard online recovery group for 196 patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and anxiety. We all evaluate effects on cocaine and BZD use, as well as aspects of self-regulation needed for sustained addiction recovery. Participants in the online clinical trial are recruited from multiple U.S. states through provider outreach and social media advertising.", "keywords": [ "Abstinence", "Address", "Advertising", "Alcohols", "Anxiety", "Behavioral", "Benzodiazepines", "COVID-19 pandemic", "Cannabis", "Characteristics", "Clinical Trials", "Cocaine", "Code", "Continuity of Patient Care", "Contracts", "County", "Dangerousness", "Databases", "Dose", "Drops", "Enrollment", "Facebook", "Generations", "Geography", "Health", "Hearing", "Illicit Drugs", "Individual", "Informal Social Control", "Information Systems", "Maintenance", "Measurement", "Measures", "Mental Depression", "Mindfulness Training", "Motivation", "Opioid", "Outcome", "Pain interference", "Participant", "Patient Outcomes Assessments", "Patient Self-Report", "Patients", "Phase", "Primary Health Care", "Provider", "Psychosocial Stress", "Recovery", "Recovery Support", "Relapse", "Rural", "Rural Community", "Sampling", "Self Efficacy", "Site", "Stress", "Suboxone", "Support Groups", "Telemedicine", "Training", "acceptability and feasibility", "addiction", "base", "buprenorphine treatment", "chronic pain", "clinically relevant", "cocaine use", "comparative effectiveness trial", "compare effectiveness", "design", "emotion dysregulation", "emotional distress", "evidence base", "flexibility", "illicit opioid", "mindfulness", "mindfulness intervention", "opioid mortality", "opioid use", "opioid use disorder", "outreach", "overdose death", "patient oriented", "prevent", "programs", "recruit", "social media", "substance use", "virtual" ], "approved": true } }, { "type": "Grant", "id": "10555", "attributes": { "award_id": "1R21NS127265-01A1", "title": "Intranasal Delivery of Telomerase Reverse Transcriptase mRNA for Therapy ofTraumatic Brain Injury", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Neurological Disorders and Stroke (NINDS)" ], "program_reference_codes": [], "program_officials": [ { "id": 26568, "first_name": "HIBAH OMAR", "last_name": "Awwad", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-26", "end_date": "2024-08-31", "award_amount": 444125, "principal_investigator": { "id": 26569, "first_name": "Biana", "last_name": "Godin", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 26570, "first_name": "Sonia", "last_name": "Villapol", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1455, "ror": "", "name": "METHODIST HOSPITAL RESEARCH INSTITUTE", "address": "", "city": "", "state": "TX", "zip": "", "country": "United States", "approved": true }, "abstract": "It is estimated that annually ~3 million Traumatic brain injury (TBI) cases occur in the U.S. Moderate to severe TBI can cause significant impairments in mental and motor functions or death. There are no effective therapies to improve cognitive abilities after moderate-severe TBI. Many novel pharmacological approaches for TBI therapy are not effective enough. Gene therapy can provide an unmet solution in protecting against several neurodegenerative disorders, including TBI. Recent advances in mRNA therapeutics/ vaccines have drawn significant attention due to their ability to tackle unmet clinical needs. For instance, the prompt development of COVID-19 mRNA vaccines aided in controlling the pandemics worldwide. Efficient mRNA therapies require a Lipid Nanoparticles (LNP) carrier to protect mRNA from degradation. Telomeres, repetitive non-coding DNA sequences, have a pivotal role in tissue repair and aging. Telomere shortening in the brain results from blood flow impairment and cell-death related inflammation and affects tissue regeneration ability. A catalytic subunit of telomerase, an enzyme responsible for maintaining telomere length (TL) during cell division, is telomerase reverse transcriptase (TERT). TL dysfunction has been implicated in neuroinflammatory and neurodegenerative processes and proposed as a marker for TBI outcomes. Additionally, TERT was shown to be important in neuronal survival and cognition, protecting from oxidative stress and blocking neuronal apoptosis. While TERT is a potential target in neurological disorders, no studies evaluating RNA therapy to address TL in TBI were reported yet. Here we propose a transformational therapeutic approach for TBI therapy which includes intranasal (IN) TERT mRNA- LNP delivery to the brain. LNP protect mRNA en route to the target TBI tissue. The immediate focus of our work is an impairment in the brain's normal function caused by an impact to the head. Our data show that IN delivery of LNP bypasses BBB, enhancing drug transport to the brain. Our teams have demonstrated that TERT mRNA can enhance TL in vitro and in vivo improving prognosis in other degenerative conditions. We have also shown that there is a shortening of telomeres and reduction in TERT levels in our TBI mouse model. Our approach may radically change therapy for TBI, as well as other brain disorders. In this exploratory project, our central hypothesis is that IN administration of TERT mRNA will enable temporary expression of TERT in the affected brain tissue restoring cognitive functions after TBI. Our Specific aims are: (1) Design, characterization, and biocompatibility of mRNA-LNP in vitro: four TERT-mRNA-LNP systems will be designed, characterized, and assessed in vitro with various brain cells; (2) Evaluate the biodistribution and therapeutic efficiency of IN administration of TERT mRNA-LNPs in a mouse model of TBI (Controlled cortical impact, CCI). Biodistribution of reporter mRNA and fluorescently labeled LNP in the brains of mice with TBI will be performed. Efficiency will be tested based on TERT levels, TL, behavioral tests, and immunological markers. This exploratory project can be the first step in the development of a much-needed therapy for TBI.", "keywords": [ "Address", "Affect", "Aging", "Animal Model", "Animals", "Apoptosis", "Area", "Attention", "Biodistribution", "Biological Availability", "Biomedical Engineering", "Blood flow", "Brain", "Brain Diseases", "Brain Injuries", "Brain region", "Bypass", "COVID-19", "Catalytic Domain", "Cause of Death", "Cell Death", "Cell division", "Cells", "Central Nervous System Diseases", "Cessation of life", "Chromosome Structures", "Chromosomes", "Chronic", "Clinical", "Cognition", "DNA Damage", "DNA Repair", "DNA Sequence", "Data", "Degenerative Disorder", "Development", "Diagnostic", "Diffusion", "Drug Transport", "Effectiveness", "Enzymes", "Epigenetic Process", "Evaluation", "Event", "Functional disorder", "Head", "Health Care Costs", "Hour", "Immunologic Markers", "Impairment", "In Vitro", "Inflammation", "Injury", "Interruption", "Intranasal Administration", "Knowledge", "Label", "Length", "Link", "Longevity", "Longitudinal Studies", "Luciferases", "Measures", "Medical", "Messenger RNA", "Methodology", "Modeling", "Modification", "Morphology", "Motor", "Mus", "Nerve Degeneration", "Neurodegenerative Disorders", "Neurosciences Research", "Organ", "Outcome", "Oxidative Stress", "Patients", "Performance", "Persons", "Pharmaceutical Preparations", "Pharmacology", "Physiological", "Play", "Population", "Process", "Prognosis", "Property", "Proteins", "Psyche structure", "Quality of life", "RNA", "RNA vaccine", "RNA-Directed DNA Polymerase", "Regenerative capacity", "Reporter", "Reporter Genes", "Reporting", "Reproducibility", "Research", "Role", "Route", "System", "TBI treatment", "TERT gene", "Telomerase", "Telomere Shortening", "Testing", "Therapeutic", "Thinness", "Tissues", "Transfection", "Traumatic Brain Injury", "United States", "Untranslated RNA", "Vaccines", "Work", "base", "behavior test", "biomaterial compatibility", "brain cell", "brain tissue", "cell injury", "cerebrovascular", "cognitive ability", "cognitive disability", "cognitive function", "controlled cortical impact", "cyanine dye 5", "design", "disability", "effective therapy", "experience", "gene therapy", "genetic information", "high reward", "high risk", "improved", "improved outcome", "in vivo", "in vivo Model", "innovation", "insight", "lipid nanoparticle", "mRNA Expression", "mRNA Transcript Degradation", "microfluidic technology", "mouse model", "multidisciplinary", "nanoparticle delivery", "nervous system disorder", "neuroinflammation", "neuron apoptosi" ], "approved": true } }, { "type": "Grant", "id": "10547", "attributes": { "award_id": "1R01AA030243-01", "title": "Sexual Fluidity and Longitudinal Changes in Alcohol Misuse and Associated Health Consequences", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute on Alcohol Abuse and Alcoholism (NIAAA)" ], "program_reference_codes": [], "program_officials": [ { "id": 26558, "first_name": "Bradley Townsend", "last_name": "Kerridge", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-10", "end_date": "2025-06-30", "award_amount": 292882, "principal_investigator": { "id": 26559, "first_name": "Rebecca J", "last_name": "Evans-Polce", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 770, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT ANN ARBOR", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "In response to the Notices of Special Interest on Research on the Health of Sexual and Gender Minority Populations (NOT-MD-19-001) and Public Policy Effects on Alcohol-, Cannabis-, Tobacco-, and Other Drug- Related Behaviors and Outcomes (NOT-AA-21-028), this project will identify trajectories of alcohol misuse by sexual orientation and their associated health consequences. We will also examine risk and protective factors across individual, social, and policy domains. Sexual minorities are at heightened risk of alcohol misuse; however, existing research is often based on a static and unidimensional construct of sexual orientation rather than a fluid and multidimensional construct of sexual orientation, despite evidence indicating sexual orientation fluidity is common, especially among sexual minorities. Prior work has shown alcohol misuse and alcohol use disorder (AUD) symptoms are more prevalent and more severe among sexual minorities than heterosexuals. There is a lack of population-based longitudinal studies of alcohol misuse trajectories and related negative health consequences based on a fluid and multidimensional construct of sexual orientation. Additionally, studies examining risk and protective factors for alcohol misuse among sexual minorities have largely focused on individual-level factors and neglected factors at the social and policy level. There is a need to expand this research and draw on concepts from the Social Ecological Model to include upstream risk and protective factors, such as those at the social and policy level. To address these gaps, this project will use longitudinal data from a sample of U.S. adolescents and adults based on six waves of the Population Assessment of Tobacco and Health study (n=45,971; 2013-2021). This study design will allow us to explore changes in alcohol misuse based on sexual orientation before and after COVID-19 onset. Our study aims to: (1) Identify alcohol misuse trajectories over an 8-year period and determine if these associations differ by sexual orientation (a) concordance vs. discordance, and (b) stability vs. fluidity. We will also examine potential heterogeneity in risk by age, sex, race, ethnicity, and gender identity and compare changes in alcohol misuse before and after COVID-19 onset by sexual orientation. (2) Examine (a) how variation in alcohol misuse trajectories shape negative health-related consequences (e.g., AUD symptoms, other substance use disorder symptoms, polysubstance use, and negative physical health consequences) and (b) whether this differs across sexual orientation subgroups, by sexual orientation discordance vs. concordance, and sexual identity fluidity vs. stability. (3) Examine longitudinal relationships of individual- (e.g., internalizing symptoms), social- (e.g., degree of social interaction), and policy-level (e.g., antidiscrimination laws) protective/risk factors with trajectories of alcohol misuse and negative alcohol-related health consequences and determine if associations differ by sexual orientation concordance vs. discordance and sexual identity fluidity vs. stability.", "keywords": [ "Address", "Adolescent", "Adult", "Age", "Alcohols", "COVID-19", "Cannabis", "Complement", "Criminal Justice", "Data", "Dimensions", "Discrimination", "Distal", "Engineering", "Ethnic Origin", "Gender Identity", "Goals", "Health", "Healthcare", "Heterogeneity", "Heterosexuals", "Individual", "Intervention", "Laws", "Lesbian Gay Bisexual", "Liquid substance", "Longitudinal Studies", "Measures", "Medicine", "Modeling", "Movement", "Outcome", "Patient Self-Report", "Pharmaceutical Preparations", "Policies", "Population Assessment of Tobacco and Health", "Population Study", "Prevention", "Productivity", "Public Policy", "Race", "Reporting", "Research", "Research Design", "Risk", "Risk Factors", "Sampling", "Severities", "Sex Orientation", "Sexual Health", "Sexual and Gender Minorities", "Shapes", "Social Concepts", "Social Interaction", "Social Policies", "Subgroup", "Substance Use Disorder", "Symptoms", "Time", "Tobacco", "United States National Academy of Sciences", "Variant", "Work", "Youth", "alcohol measurement", "alcohol misuse", "alcohol related consequences", "alcohol risk", "alcohol use disorder", "base", "behavioral outcome", "cost", "fluidity", "gender minority group", "gender minority health disparity", "health data", "improved", "interest", "longitudinal design", "modifiable risk", "neglect", "physical conditioning", "polysubstance use", "population based", "protective factors", "public policy on alcohol", "response", "screening", "secondary analysis", "sex", "sexual identity", "sexual minority", "sexual minority women", "social", "stressor" ], "approved": true } }, { "type": "Grant", "id": "10539", "attributes": { "award_id": "1U01EB033305-01", "title": "A point-of-care device using Single Molecule Array (Simoa) to measure viral antigens in nasal swabs, saliva, and blood", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Biomedical Imaging and Bioengineering (NIBIB)" ], "program_reference_codes": [], "program_officials": [ { "id": 6433, "first_name": "Tiffani Bailey", "last_name": "Lash", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-22", "end_date": "2025-08-31", "award_amount": 1705157, "principal_investigator": { "id": 26550, "first_name": "David C", "last_name": "Duffy", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 26551, "first_name": "Nira", "last_name": "Pollock", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1940, "ror": "", "name": "QUANTERIX CORPORATION", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "The goal of this project is to develop a simple-to-use, low-cost, and small instrument and associated consumable for point-of-care (POC) diagnoses based on the ultrasensitive detection of proteins. The proposed system will combine detection of proteins using the Single Molecule Array (Simoa; Quanterix Corporation) technology and assay processing using digital microfluidics (DMF) to enable POC immunoassays with the sensitivity and specificity of nucleic acid amplification tests without the need for nucleic acid purification or amplification, and with the simplicity, sample type flexibility, and diagnostic performance to deliver central lab diagnostic quality in POC settings. The proposed system would be composed of a sample- to-answer, random access, benchtop instrument utilizing a universal consumable design accepting a broad range of minimally processed samples relevant to POC diagnosis of disease, including swab, saliva, and blood (including fingerstick) samples. We will first apply this technology to the diagnosis of COVID-19 and influenza, optimizing existing assays for SARS-CoV-2 N-protein and developing new multiplexed assays for influenza A and B antigens, along with simple sample preparation methods, for testing of nasal/nasopharyngeal (NP) swab (SARS-CoV-2/influenza) and saliva/blood (SARS-CoV-2 only) samples. This project—a collaboration between Quanterix (Dr. Duffy, co-PI), Boston Children's Hospital (Dr. Pollock, co-PI), and University of Toronto (Dr. Wheeler, co-investigator)—has four specific aims to achieve these goals. First, we will develop the key technologies to enable the POC system, namely: a low-cost Simoa imager with a small form factor; single molecule labels that do not require sealing in microwell arrays; and, the DMF building blocks for assay processing, resulting in an integrated Simoa-DMF device. Second, we will design, develop, and test Simoa POC instruments and consumables, first in prototype and then for test validation. Third, we will optimize/develop and validate analytically Simoa assays (including sample preparation options) for SARS- CoV-2 (nasal swab, saliva, blood) and multiplex influenza A/B (NP swab) antigens, and test them on the prototype Simoa POC system. Finally, we will clinically validate the POC antigen tests against gold-standard molecular tests for all sample types using discarded/banked clinical samples, and evaluate performance of the POC system in POC settings using contrived clinical samples. User feedback will inform development throughout the proposal. The long-term objective of this research is to develop a broadly enabling technology that would allow the diagnosis of diseases using ultrasensitive protein detection at the POC in a small, low-cost benchtop system. This type of capability is available for molecular testing but not for protein detection, and would combine high sensitivity with low cost and an alternative supply chain to support diagnosis of infectious diseases in diverse clinical settings. This system would be a critical new diagnostic tool ready both for routine POC diagnosis of infectious diseases and to benefit the world in the event of the next pandemic.", "keywords": [ "2019-nCoV", "Adult", "Anterior", "Antigens", "Biological Assay", "Blood", "Blood specimen", "Boston", "COVID-19", "COVID-19 assay", "COVID-19 diagnosis", "COVID-19 pandemic", "COVID-19 testing", "Child", "Childhood", "Clinical", "Collaborations", "Communicable Diseases", "Detection", "Development", "Devices", "Diagnosis", "Diagnostic", "Early Diagnosis", "Environment", "Enzyme-Linked Immunosorbent Assay", "Event", "FDA Emergency Use Authorization", "Feedback", "Goals", "Gold", "Immunoassay", "Infection", "Infection Control", "Influenza", "Influenza A virus", "Influenza B Virus", "Intervention", "Kenya", "Label", "Measurement", "Measures", "Methods", "Microfluidic Microchips", "Microfluidics", "Molecular", "Nose", "Nucleic Acid Amplification Tests", "Nucleic Acids", "Nucleoproteins", "Outcome", "Patients", "Pediatric Hospitals", "Performance", "Point of Care Technology", "Point-of-Care Systems", "Preparation", "Price", "Process", "Proteins", "Refugee Camp", "Research", "Research Personnel", "Running", "SARS-CoV-2 B.1.617.2", "SARS-CoV-2 antigen", "Saliva", "Sampling", "Sensitivity and Specificity", "Swab", "System", "Systems Development", "Technology", "Testing", "Time", "Universities", "Validation", "Viral", "Viral Antigens", "Virus", "Virus Diseases", "antigen detection", "antigen test", "assay development", "base", "communicable disease diagnosis", "cost", "design", "diagnostic tool", "digital", "disease diagnosis", "electric field", "flexibility", "imager", "improved", "innovation", "instrument", "microfluidic technology", "miniaturized device", "multiplex assay", "nasal swab", "nasopharyngeal swab", "novel diagnostics", "nucleic acid purification", "pandemic disease", "pathogen", "point of care", "point of care testing", "point-of-care diagnosis", "point-of-care diagnostics", "price lists", "prototype", "saliva sample", "seal", "single molecule", "targeted treatment", "usability", "user-friendly", "validation studies" ], "approved": true } }, { "type": "Grant", "id": "10523", "attributes": { "award_id": "1DP2AI171120-01", "title": "Crossing scales to predict and prevent bat virus zoonoses in a Madagascar ecosystem", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 6054, "first_name": "Eun-Chung", "last_name": "Park", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-05", "end_date": "2027-08-31", "award_amount": 460576, "principal_investigator": { "id": 26531, "first_name": "Cara", "last_name": "Brook", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "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": "The wide-reaching impacts of the COVID-19 pandemic highlight the extreme threat posed by the cross-species emergence of zoonotic pathogens. Bats (order: Chiroptera) are the natural reservoir hosts for the majority of the world’s most virulent zoonotic viruses, including Hendra and Nipah henipaviruses, Ebola and Marburg filoviruses, and SARS, MERS, and now SARS-CoV-2 coronaviruses. Remarkably, bats exhibit little demonstrable disease upon infection with viruses that cause extreme pathology in other mammals, likely in part due to their unique anti-inflammatory molecular adaptations, which are thought to have evolved to mitigate the accumulation of physiological damage accrued during flight. Surprisingly, isolated island bat communities around the world support the endemic circulation of numerous viruses in populations below the critical community size required for persistence of related pathogens in other hosts. Since cross-species spillover of several bat-borne viruses bears a distinctive seasonal signature, coincident with the timing of reproductive and nutritional stress for the bat hosts in question, disentangling the mechanisms governing the transmission, circulation, and persistence of these viruses in wild bat populations is of critical public health interest. In part with the research initiatives proposed here, we will use molecular and serological tools to develop a longitudinal time series of immunological and infection data for henipaviruses and coronaviruses circulating in wild fruit bats in Madagascar, leveraging samples collected in our longterm wildlife surveillance effort. Bats are widely consumed as a source of human food in Madagascar, and preliminary data from our research group demonstrates serological signatures of prior human exposure to these zoonotic viruses across the island. We propose to fit disparate dynamical models to the resulting population-level data in order to distinguish mechanisms underpinning seasonal viral shedding pulses and concomitant transmission in these bat hosts. In addition to population-level studies, we will also construct within-host models of viral control in a single bat immune system, which we will fit to experimental infection data from Betacoronavirus-challenged bats in the laboratory, with the aim of deciphering the mechanisms which motivate viral shedding. Our project aims to simultaneously develop molecular tools of bat cell lines and viruses with which to support within-host studies in our own Madagascar system. Finally, we will build on population-level and within-host studies to model and implement a vaccine intervention designed to eradicate circulating henipavirus from a test-population of Madagascar fruit bats. Broadly, our project aims to use a uniquely integrative combination of field, molecular, and modeling tools to enable the prediction and prevention of bat virus spillover events before they occur.", "keywords": [ "2019-nCoV", "Address", "African", "Animals", "Anti-Inflammatory Agents", "Biology", "Blood Circulation", "COVID-19 pandemic effects", "Canis familiaris", "Case Fatality Rates", "Cell Line", "Chicago", "Chiroptera", "Clinical", "Collaborations", "Communicable Diseases", "Communities", "Consumption", "Coronavirus", "Coupled", "Data", "Discipline", "Disease", "Doctor of Philosophy", "Ebola", "Ecology", "Ecosystem", "Evolution", "Exhibits", "Exposure to", "Filovirus", "Food", "Fruit", "Future", "Goals", "Hendra Virus", "Henipavirus", "Henipavirus Infections", "Human", "Immune", "Immune system", "Immunity", "Immunologics", "Infection", "Infection Control", "Innate Immune Response", "Intervention", "Island", "Jamaican", "Laboratories", "Learning", "Link", "Literature", "Madagascar", "Mammals", "Marburgvirus", "Measles", "Middle East Respiratory Syndrome", "Middle East Respiratory Syndrome Coronavirus", "Modeling", "Molecular", "Molecular Computations", "Molecular Immunology", "Monitor", "Nature", "Nutritional", "Paramyxovirus", "Pathology", "Pattern", "Periodicity", "Physiologic pulse", "Physiological", "Physiology", "Population", "Population Sizes", "Population Study", "Postdoctoral Fellow", "Prevention", "Process", "Public Health", "Rabies virus", "Recommendation", "Recrudescences", "Regimen", "Research", "Resources", "SARS coronavirus", "Sampling", "Seasonal Variations", "Series", "Serology", "Severe Acute Respiratory Syndrome", "Shapes", "Source", "Stress", "System", "Techniques", "Testing", "Time", "United States National Institutes of Health", "Universities", "Ursidae Family", "Vaccinated", "Vaccination", "Vaccines", "Viral", "Viral Load result", "Virulent", "Virus", "Virus Diseases", "Virus Shedding", "Work", "Zoonoses", "antiviral immunity", "bat-borne", "betacoronavirus", "chronic infection", "cost effective", "cross-species transmission", "design", "experience", "exposed human population", "field study", "health economics", "immunopathology", "infectious disease model", "innovation", "interest", "mathematical model", "molecular modeling", "novel", "pandemic preparedness", "pathogen", "post-doctoral training", "prevent", "professor", "reproductive", "spillover event", "stressor", "therapy design", "tool", "transmission process", "vaccine distribution", "viral transmission", "willingness", "zoonotic spillover" ], "approved": true } }, { "type": "Grant", "id": "15995", "attributes": { "award_id": "1IK2HX003695-01A2", "title": "Improving Specialty Care Through Virtual Care Models", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2026-01-01", "end_date": "2030-12-31", "award_amount": null, "principal_investigator": { "id": 44448, "first_name": "Rebecca", "last_name": "Tisdale", "orcid": "", "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 3442, "ror": "", "name": "VETERANS ADMIN PALO ALTO HEALTH CARE SYS", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "1 Background: Specialty care deserts—the absence of specialists in geographic regions—have led to an access 2 crisis for the VA. In addition to increasing wait times and causing delays in care, these access needs drive many 3 Veterans to seek care outside VA, resulting in fragmented care, increased risks for hospitalization and hospital 4 readmission, and higher costs. In response, VA has launched the Clinical Resource Hub (CRH) program, which 5 seeks to deliver virtual care from “hub” to “spoke” sites in VA. VISN 21 has begun implementing this model in 6 cardiology at several spoke sites, but little is known about how care utilization and quality within the program. 7 Significance/Impact: This work seeks to better understand the effects of a virtual model of specialty care, in 8 this case cardiology care, on Veterans’ care access and quality. In addition, it aligns closely with several VA and 9 HSR&D priorities, chiefly access to care, virtual care/telehealth, and advancing the goals of the MISSION Act. 10 Innovation: The CRH program and the virtual care model at its core have yet to be studied in depth, and there 11 is no research in progress regarding specialty CRH despite strong interest at the national VA level in 12 understanding how specialty CRH is used and associated outcomes. Given that virtual cardiology care was very 13 limited prior to the COVID-19 pandemic, cardiology CRH is particularly novel. Hence, this project would add to 14 the limited body of research examining virtual cardiology care in the VA. In addition, the proposed work seeks to 15 evaluate this virtual care model at a time of unprecedented choice for Veterans between in-person and virtual 16 care, and limited data on how best to integrate these modalities. 17 Specific Aims: The proposed CDA will offer mentorship and training for me to pursue the following aims: 18 Aim 1. Evaluate quality of cardiology care associated with CRH implementation with administrative data. 19 I will use adjusted difference-in-difference event studies to compare cardiology quality metric achievement for 20 patients who received cardiology care via CRH versus those who received conventional VA-based cardiology care. 21 Aim 2. Assess Veteran perceptions of quality of cardiology care delivered via CRH. 22 I will interview Veterans participating in the CRH program and their caregivers regarding their experiences and 23 perceptions of quality of CRH cardiology care and elicit suggestions for key metrics to focus on for improvement. 24 Aim 3. Construct intervention to track and improve access to high-quality, equitable care through CRH. 25 Building on finding from Aims 1 and 2, I will interview clinicians and employ a facilitated deliberative process with 26 an expert advisory group to construct and pilot an intervention to improve quality. 27 Methodology: In Aim 1, I will use a difference-in-difference event study design to assess the impact of the program 28 on a battery of validated and/or guideline-based quality of cardiology care metrics. In Aim 2, guided by the Fortney 29 model of care access and quality, I will conduct semi-structured interviews of Veterans and caregivers receiving 30 care through the VISN 21 CRH program to understand their experiences with the CRH program and what outcomes 31 they recommend to include in a quality improvement intervention. In Aim 3, I will interview clinicians (Aim 3.1) and 32 conduct a facilitated deliberation process (Aim 3.2) to inform the construction of an intervention (proactive panel 33 management using a clinical dashboard tool) to track and improve quality of care and pilot the intervention. 34 Next Steps/Implementation: To continue moving this research into practice to improve health outcomes for 35 Veterans, I will extend the analysis of cardiology quality of care to compare cardiology care in the community to 36 CRH care. In addition, I will assess the effect of the intervention constructed in Aim 3 on patient outcomes and 37 clinician satisfaction via a hybrid implementation-effectiveness trial. I will continue to work with operational partners 38 to ensure cardiology CRH is improving access to high-quality cardiology care for Veterans. This project supports 39 my goal of becoming an independent VA health services researcher and leader in optimizing cardiovascular 40 disease care access, value, and equity for Veterans through virtual care innovations and implementation.", "keywords": [ "Achievement", "Address", "Area", "COVID-19 pandemic", "California", "Cardiology", "Cardiovascular Diseases", "Cardiovascular system", "Caregivers", "Caring", "Characteristics", "Cladribine", "Clinical", "Clinical Services", "Communities", "Community Health Care", "Dangerousness", "Data", "Disease", "Ensure", "Equity", "Evaluation", "Event", "Geographic Locations", "Goals", "Guidelines", "Health", "Health Services", "Health Services Accessibility", "Heart failure", "Homogeneously Staining Region", "Hospitalization", "Hospitals", "Improve Access", "Intervention", "Interview", "Medical", "Mentors", "Mentorship", "Methodology", "Methods", "Modality", "Modeling", "Morbidity - disease rate", "Nevada", "Outcome", "Pacific Islands", "Patient-Focused Outcomes", "Patients", "Perception", "Persons", "Physicians", "Policies", "Positioning Attribute", "Process", "Qualitative Methods", "Quality of Care", "Recommendation", "Research", "Research Design", "Research Personnel", "Resources", "Risk", "Rural Health", "Safety", "Site", "Specialist", "Structure", "Suggestion", "Telemedicine", "Telephone", "Testing", "Time", "Training", "Training Activity", "Veterans", "Visit", "Wait Time", "Work", "adverse outcome", "care fragmentation", "care seeking", "care utilization", "clinical implementation", "connected care", "cost", "dashboard", "design", "effectiveness/implementation trial", "experience", "follow-up", "health economics", "hospital readmission", "hospitalization rates", "implementation efforts", "implementation science", "improved", "innovation", "insight", "interest", "intervention effect", "medical specialties", "mortality", "novel", "operation", "patient subsets", "pilot test", "preference", "programs", "rapid growth", "research to practice", "response", "rural counties", "satisfaction", "sociodemographics", "southern nevada", "telehealth", "therapy design", "tool", "virtual", "virtual delivery", "virtual health care", "virtual model" ], "approved": true } }, { "type": "Grant", "id": "10499", "attributes": { "award_id": "3R01MH127961-01A1S1", "title": "Utilizing All of Us data to examine the impact of COVID-19 on mental health among people living with HIV", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 24064, "first_name": "Lori", "last_name": "Scott-Sheldon", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-08-16", "end_date": "2023-11-30", "award_amount": 107340, "principal_investigator": { "id": 4919, "first_name": "Xiaoming", "last_name": "Li", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 930, "ror": "", "name": "UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA", "address": "", "city": "", "state": "SC", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 930, "ror": "", "name": "UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA", "address": "", "city": "", "state": "SC", "zip": "", "country": "United States", "approved": true }, "abstract": "In response to the NOSI (NOT-PM-22-002), we propose to expand the resilience conceptual framework in our parent grant (1R01MH127961-01A1, 12/2021-11/2026) to a different context (COVID-19) and a new population (people living with HIV [PLWH] in the United States). Further, we propose to explore if a resilience approach can be used to mitigate the negative impacts of COVID-19 on the mental health among PLWH. We will leverage multiple datasets from the All of Us program, including electronic health records (EHR), a series of COVID-19 Participant Experience (COPE) surveys, and other self-reported survey data. Integrating these data from about 12 thousand PLWH who participated in COPE, we will: 1) examine the trends and patterns of mental health outcomes (i.e., psychiatric disorder diagnoses via ICD-10 and mental health assessments via survey) among PLWH before and after the COVID-19 outbreak; and 2) identify protective factors at multiple socioecological levels including the individual level (e.g., resilience), interpersonal level (e.g., social support), and health institutional level (e.g., health service accessibility) that may mitigate the negative impacts of the COVID-19 pandemic on mental health outcomes among PLWH, especially the subgroups with socially disadvantaged status (low income and low education) and stigmatized identities (racial/ethnic minorities, sexual and gender minorities). Based on rich data from a large cohort of PLWH, the findings will advance our understanding of their mental health needs during the pandemic and mental health disparities of PLWH in the US and inform tailored health interventions to improve mental health outcomes among PLWH, especially those from disadvantaged subgroups. Our study goal is aligned with the Office of AIDS Research's and National Institute of Mental Health's research priorities in terms of social sciences studies and health disparities reduction. The proposed study will leverage existing NIH investment, capitalize on a rapid understanding of mental health needs among PLWH, stimulate additional collaborations with the All of Us program, and promote the translation of All of Us data to public health implications. The experience and preliminary data obtained from this supplement will position us for further efforts in utilizing All of Us data to improve mental and other health outcomes of PLWH in the US.", "keywords": [ "Acquired Immunodeficiency Syndrome", "Address", "Affect", "Age-Years", "Aging", "All of Us Research Program", "Anxiety", "Anxiety Disorders", "COVID-19", "COVID-19 impact", "COVID-19 outbreak", "COVID-19 pandemic", "COVID-19 pandemic effects", "COVID-19 vaccination", "Caring", "Chronic Disease", "Code", "Collaborations", "Complement", "Complex", "Data", "Data Analyses", "Data Science", "Diabetes Mellitus", "Diagnosis", "Disadvantaged", "Education", "Electronic Health Record", "Ethnic Origin", "Financial Hardship", "Fostering", "Fright", "Gender Identity", "Goals", "HIV", "Health", "Health Promotion", "Health Services Accessibility", "High Prevalence", "Hypertension", "Immune system", "Impairment", "Income", "Individual", "International Statistical Classification of Diseases and Related Health Problems Tenth Revision (ICD-10)", "Intervention", "Investments", "Knowledge", "Loneliness", "Low income", "Lung diseases", "Measures", "Mental Health", "Mental disorders", "Mental health promotion", "Mood Disorders", "National Institute of Mental Health", "Outcome", "Participant", "Patient Self-Report", "Pattern", "Personal Satisfaction", "Personality Disorders", "Persons", "Population", "Positioning Attribute", "Prevention", "Psyche structure", "Public Health", "Race", "Reduce health disparities", "Research", "Research Priority", "Risk Factors", "SARS-CoV-2 infection", "Sample Size", "Schizophrenia", "Series", "Services", "Sexual and Gender Minorities", "Social Identification", "Social Sciences", "Social support", "Stigmatization", "Stress", "Subgroup", "Substance Use Disorder", "Surveys", "Symptoms", "Testing", "Translations", "United States", "United States National Institutes of Health", "Vulnerable Populations", "base", "cloud based", "cohort", "comorbidity", "design", "disparity reduction", "effective intervention", "ethnic minority", "experience", "health assessment", "health disparity", "high risk", "improved", "large scale data", "multiple datasets", "negative affect", "pandemic disease", "parent grant", "parent project", "programs", "protective factors", "psychologic", "psychosocial wellbeing", "public health emergency", "racial and ethnic", "recruit", "resilience", "response", "sexual identity", "social disadvantage", "social stigma", "socioeconomic disadvantage", "stress related disorder", "theories", "trend" ], "approved": true } }, { "type": "Grant", "id": "10507", "attributes": { "award_id": "1R01MD017071-01A1", "title": "Can Medicaid Managed Care mitigate race/ethnic health disparities in diabetes?", "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": [ { "id": 23654, "first_name": "YEWANDE A", "last_name": "Oladeinde", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-23", "end_date": "2027-05-31", "award_amount": 525894, "principal_investigator": { "id": 26511, "first_name": "Mohammed Kumail", "last_name": "Ali", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 22259, "first_name": "Maria Liliana", "last_name": "Alva", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 181, "ror": "https://ror.org/05vzafd60", "name": "Georgetown University", "address": "", "city": "", "state": "DC", "zip": "", "country": "United States", "approved": true } ] } ], "awardee_organization": { "id": 181, "ror": "https://ror.org/05vzafd60", "name": "Georgetown University", "address": "", "city": "", "state": "DC", "zip": "", "country": "United States", "approved": true }, "abstract": "This study represents a timely investigation that addresses race/ethnic disparities in type 2 diabetes (T2DM) care over a period that included a major pandemic shock. T2DM is burdensome and disproportionately impacts vulnerable and disenfranchised populations; of note, there are stark race/ethnic disparities in T2DM care goals, emergency department (ED) visits, and hospitalizations. Medicaid covers 25% of Americans with T2DM. More than 80% of Medicaid beneficiaries nationally receive at least some of their care from Medicaid managed care organizations (MMCO). States contract with private (non-profit or for-profit) MMCOs to lower costs, increase quality, and pass on financial risks of covering Medicaid beneficiaries. Heterogeneity across and within state programs can have implications for quality of T2DM care and, specifically, race/ethnic disparities through benefit generosity or by affecting MMCO entry and post-entry behavior. State policymakers also have significant influence over marketplaces in which MMCOs compete, which can have consequences for race/ethnic disparities, given that Medicaid disproportionately covers non-white populations. Little is known about whether and how MMCOs and the state programs they operate in influence disparities in T2DM care and, if or how the COVID-19 pandemic changed the trajectory of health disparities. We propose to answer these unknowns using a convergent mixed-methods study: we will compile a database of MMCO/state program features that could influence care using a health disparities conceptual framework (Aim 1); we will empirically explore race/ethnic disparities among adults with T2DM and whether these vary by MMCO/state features and pre-/post-COVID-19 using comprehensive data from the Transformed Medicaid Statistical Information System over 2016-2025 (Aims 2 and 3); and we will collect and analyze qualitative data from Medicaid stakeholders to triangulate and contextualize the quantitative findings (Aim 4). We focus on non- disabled, non-pregnant 18-64-year-old adults with T2DM who tend to remain stably covered by Medicaid over time. To reduce selection bias, we focus our analyses on 12 states and the District of Columbia that mandate enrollment in comprehensive MMCOs. We will use panel data models to examine race/ethnic and sex-specific receipt of key T2DM services and ED visits and hospitalizations, overall and by MMCO/state features. We will also follow a continuously enrolled cohort over 2020-2025 to assess if and how MMCO/state program features moderate the pandemic’s effects on T2DM disparities. Sensitivity analyses will explore the influence of churn. Further, our preliminary analyses identify Kentucky and Florida as having the lowest and highest disparities in T2DM care, respectively; we will conduct interviews in these states to examine what MMCO/state features and implementation might explain these disparities. This policy-relevant work will provide critical insights into how Medicaid managed care programs can be designed to reduce disparities in chronic disease burdens.", "keywords": [ "Accident and Emergency department", "Acute", "Address", "Admission activity", "Adult", "Affect", "Age", "American", "Americas", "Amputation", "Behavior", "Black race", "COVID-19", "COVID-19 pandemic", "COVID-19 pandemic effects", "Caring", "Characteristics", "Chronic Disease", "Communities", "Contracts", "Data", "Data Analyses", "Data Set", "Databases", "Diabetes Mellitus", "Diagnosis", "District of Columbia", "Economic Burden", "Eligibility Determination", "Emergency department visit", "Enrollment", "Ethnic Origin", "Expenditure", "Florida", "Future", "Goals", "Health Care Costs", "Heterogeneity", "Hospitalization", "Hyperglycemia", "Incentives", "Indigenous", "Information Systems", "Insurance Carriers", "Interview", "Investigation", "Kentucky", "Latinx", "Lawyers", "Link", "Managed Care", "Managed Care Programs", "Medicaid", "Medicare/Medicaid", "Methods", "Minority", "National Institute on Minority Health and Health Disparities", "Non-Insulin-Dependent Diabetes Mellitus", "Obesity", "Occupations", "Outcome", "Patients", "Penetration", "Performance", "Persons", "Pharmaceutical Preparations", "Policies", "Population", "Poverty", "Preventive care", "Primary Health Care", "Privatization", "Process", "Quality of Care", "Race", "Research", "Risk", "Sampling", "Selection Bias", "Services", "Shock", "Testing", "Time", "Titrations", "Variant", "Vulnerable Populations", "Work", "base", "beneficiary", "black patient", "burden of illness", "care outcomes", "cohort", "comorbidity", "coronavirus disease", "cost", "data modeling", "design", "disenfranchised population", "disparity reduction", "ethnic disparity", "ethnic health disparity", "ethnic minority", "evidence base", "experience", "family burden", "foot", "health disparity", "high risk", "improved", "insight", "medical specialties", "member", "pandemic disease", "people of color", "post-COVID-19", "programs", "response", "service utilization", "sex", "socioeconomic disadvantage", "trend" ], "approved": true } }, { "type": "Grant", "id": "10531", "attributes": { "award_id": "1R01HL164835-01", "title": "Individualized Prediction of Treatment Effects Using Data from Both Embedded Clinical Trials and Electronic Health Records", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Heart Lung and Blood Institute (NHLBI)" ], "program_reference_codes": [], "program_officials": [ { "id": 23263, "first_name": "JANE", "last_name": "YE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-15", "end_date": "2025-07-31", "award_amount": 613247, "principal_investigator": { "id": 26541, "first_name": "GREGORY F.", "last_name": "COOPER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 26542, "first_name": "Christopher Warren", "last_name": "Seymour", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 848, "ror": "", "name": "UNIVERSITY OF PITTSBURGH AT PITTSBURGH", "address": "", "city": "", "state": "PA", "zip": "", "country": "United States", "approved": true }, "abstract": "More than 790,000 patients undergo mechanical ventilation for acute respiratory failure (ARF) in the United States each year at a cost of $27 billion. The in-hospital mortality for these patients is nearly 35%, and for patients with critical illness, such as acute respiratory distress syndrome (ARDS), mortality can approach 50%. In some patients, guideline-appropriate care with lung-protective ventilation or prone positioning will save lives, yet in many others, an individualized treatment is elusive. There is a need for advances in leveraging opportunities in data science to improve outcomes from respiratory failure. The primary method for generating new evidence is the randomized clinical trial (RCT). Yet they are often costly, take many years, and can be slow to accelerate learning and implementation at the bedside. In addition, RCTs usually enroll a moderate number of patients at high cost (100 to 1000s) and measure a limited range of covariates (10 to 100s). Thus, they do not lead to prediction of highly individualized treatment effects, as called for by the NHLBI Working Group on Research Priorities. In contrast, real-world evidence from electronic health records (EHRs) includes many patients (often millions) and covariates (often 1000s). They are inherently generalizable, less costly, and less timely to acquire than conducting RCTs. However, the estimation of treatment effects from EHR data is often biased due to confounding, which occurs when a treatment and its effect(s) are both causally influenced by one or more events. This project uses two Specific Aims to solve these challenges. Aim 1 proposes to develop and evaluate a new method for making individualized predictions of treatment effects using data from RCTs and EHRs. It uses “embedded” RCTs in which the clinical trial occurs within the context of usual care of a health system. The embedded RCT data are applied to control for confounding when using EHR data to predict treatment effects. Aim 2 will apply these methods to two embedded RCTs at UPMC that are studying treatments that may help prevent ARF. The OPTIMISE C-19 trial is studying monoclonal antibody therapy for non-hospitalized patients with SARS-CoV-2 infection. The PeriOp trial will be studying perioperative interventions to improve post-operative outcomes after major surgery. The hypothesis to be investigated is that the proposed new methods will predict the effects of treatment on acute respiratory failure and other outcomes more accurately than will using the clinical trial or the EHR data alone. Such results would provide support that these methods yield individualized predictions of treatment effects that can inform clinical care to help prevent ARF.", "keywords": [ "Acute Respiratory Distress Syndrome", "Acute respiratory failure", "Award", "Bayesian Method", "Big Data", "COVID-19 patient", "Caring", "Clinical Trials", "Companions", "Conduct Clinical Trials", "Cost Measures", "Critical Illness", "Data", "Data Science", "Data Set", "Deterioration", "Electronic Health Record", "Enrollment", "Equilibrium", "Event", "Funding", "Generations", "Guidelines", "Health system", "Hospital Mortality", "Individual", "Intervention", "Learning", "Lung", "Measures", "Mechanical ventilation", "Methods", "Modeling", "Monoclonal Antibody Therapy", "National Heart Lung and Blood Institute", "Operative Surgical Procedures", "Outcome", "Patients", "Perioperative", "Population", "Postoperative Period", "Prediction of Response to Therapy", "Prone Position", "Public Health", "Randomized", "Randomized Clinical Trials", "Research Priority", "Respiratory Failure", "SARS-CoV-2 infection", "Selection for Treatments", "Statistical Methods", "Strategic vision", "System", "Time", "Training", "Translational Research", "Treatment outcome", "United States", "United States National Institutes of Health", "Vision", "base", "clinical care", "cost", "design", "high risk", "improved", "improved outcome", "in silico", "individualized medicine", "innovation", "mortality", "novel", "personalized medicine", "personalized predictions", "prevent", "response", "treatment as usual", "treatment effect", "treatment response", "ventilation", "working group" ], "approved": true } }, { "type": "Grant", "id": "10515", "attributes": { "award_id": "1R01MH133226-01", "title": "Leveraging Noninvasive Transcutaneous Vagus Nerve Stimulation and Smartphone Technology to Reduce Suicidal Behaviors and Suicide Among Highly Vulnerable Adolescents", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 10326, "first_name": "Christopher S.", "last_name": "Sarampote", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2022-09-15", "end_date": "2027-07-31", "award_amount": 1014872, "principal_investigator": { "id": 26523, "first_name": "Theodore Patrick", "last_name": "Beauchaine", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 26524, "first_name": "Arielle Hope", "last_name": "Sheftall", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 26525, "first_name": "Kristin", "last_name": "Valentino", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 171, "ror": "https://ror.org/00mkhxb43", "name": "University of Notre Dame", "address": "", "city": "", "state": "IN", "zip": "", "country": "United States", "approved": true }, "abstract": "/ ABSTRACT Over the past two decades, suicide rates have increased nearly 35% in the U.S., with up- ward trends in nearly all demographic groups. Further increases have occurred since the COVID-19 pandemic began. Despite ambitious goals for reducing suicides and significant fed- eral and private investment, suicide rates continue to rise unabated. To date, the predominant approach to mitigating suicide risk in the U.S. is secondary prevention. Typically, these pro- grams identify risk of recurrence among those who have already attempted suicide at least once. Although secondary prevention is crucial, the majority of deaths by suicide occur on first attempt. Thus, targeted primary prevention earlier in development is essential. Most current pri- mary prevention programs are intensive, expensive, and delivered by highly trained mental health providers, who are in short supply. Traditional face-to-face therapy is also unavailable to many who live in underserved communities, and disliked by adolescents, who much prefer digi- tal delivery on their devices. This high-risk, high-reward proposal addresses these limitations and needs. We use an experimental therapeutics approach to evaluate the independent and combined efficacies of two unconventional but scalable interventions: transcutaneous vagus nerve stimulation (tVNS) to target emotion dysregulation, and a peer-support smartphone app to combat social isolation. These low-cost interventions, which hold strong promise but have not been used before, can reach large numbers of adolescents, with much potential to reduce pro- spective suicide risk. We will enroll 212 adolescents, ages 13-17 years, who show elevations on at least two prominent risk factors for suicide (e.g., self-injury, maltreatment). Using a 2 × 2 de- sign, adolescents will be assigned randomly to receive 30 days of treatment with (1) tVNS to tar- get emotion dysregulation, (2) a peer-support phone app to target social isolation, (3) tVNS + a peer-support phone app, or (4) enhanced treatment as usual with monitoring and access to re- sources. Intervention effects on mechanisms (emotion dysregulation, social isolation) proximal efficacy signals (e.g., physiological reactivity, self-harm) and target outcomes (suicidal ideation, suicidal behaviors) will be evaluated immediately post-intervention and at one-year follow-up. Treatment data will be monitored daily to fine-tune dosing of both interventions. This transforma- tive and innovative proposal tests two novel, scalable preventive interventions designed to “meet adolescents where they are\" by using digital technologies to address core mechanisms of suicide risk.", "keywords": [ "17 year old", "Address", "Adolescence", "Adolescent", "Age", "Biosensor", "Brain", "COVID-19", "COVID-19 pandemic", "Cause of Death", "Cellular Phone", "Data", "Depressed mood", "Detection", "Development", "Devices", "Dose", "Ear", "Effectiveness", "Emotional", "Emotions", "Enrollment", "Family", "Feeling suicidal", "Future", "Goals", "Health Personnel", "Intervention", "Investigational Therapies", "Investments", "Loneliness", "Mental Depression", "Mental Health", "Monitor", "Music", "National Institute of Mental Health", "Outcome", "Patient Self-Report", "Physiological", "Population", "Prevention", "Prevention approach", "Prevention program", "Preventive service", "Primary Prevention", "Privatization", "Protocols documentation", "Public Health", "Randomized", "Recording of previous events", "Recurrence", "Resources", "Risk", "Risk Factors", "Rural", "Secondary Prevention", "Secure", "Self-Injurious Behavior", "Sensitivity and Specificity", "Services", "Signal Transduction", "Social isolation", "Source", "Structure", "Suicide", "Suicide attempt", "Suicide prevention", "Technology", "Telephone", "Testing", "Training", "Vagus nerve structure", "Youth", "combat", "cost", "design", "digital", "digital delivery", "emotion dysregulation", "emotion regulation", "follow-up", "high reward", "high risk", "high risk behavior", "improved", "innovation", "innovative technologies", "insight", "intervention cost", "intervention delivery", "intervention effect", "maltreatment", "mental training", "negative affect", "neighborhood disadvantage", "novel", "peer", "peer support", "post intervention", "preference", "preventive intervention", "programs", "prospective", "recruit", "reducing suicide", "relating to nervous system", "response", "satisfaction", "scale up", "smartphone Application", "social", "suicidal", "suicidal adolescent", "suicidal behavior", "suicidal morbidity", "suicidal risk", "suicide rate", "therapy design", "treatment as usual", "treatment duration", "trend", "underserved community", "vagus nerve stimulation", "vulnerable adolescent", "ward" ], "approved": true } } ], "meta": { "pagination": { "page": 1, "pages": 1424, "count": 14236 } } }