Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1419&sort=-funder_divisions
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=-funder_divisions", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1424&sort=-funder_divisions", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1420&sort=-funder_divisions", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1418&sort=-funder_divisions" }, "data": [ { "type": "Grant", "id": "10987", "attributes": { "award_id": "5IK2RX003546-02", "title": "Enhanced Home-Based Exercise Therapy for Peripheral Arterial Disease through Mobile Health and Remote Monitoring", "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": "2026-09-30", "award_amount": null, "principal_investigator": { "id": 22750, "first_name": "Arash", "last_name": "Harzand", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "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": "An estimated 8.5 million Americans (or 7% of US adults) and nearly 10% of veterans are estimated to have peripheral arterial disease (PAD). Significantly debilitating and negatively impacting quality of life, the primary symptom of PAD is claudication (reproducible leg pain with ambulation) that leads to impaired mobility, loss of functional independence, and a heightened risk for amputation. Veterans are at an increased risk of developing symptomatic PAD due to their disproportionately high rates of PAD risk factors such as diabetes, smoking, and hypertension, the most prominent PAD risk factors. Supervised exercise therapy is proven to decrease claudication and enhance mobility in PAD; however, fewer than 25% of eligible patients enroll. Participation in this facility-based program requires travel to a rehabilitation center 3 times per week for 12-weeks, which can be burdensome and costly for Veterans, many of whom live in rural areas and on fixed incomes. There is, therefore, a need to develop a convenient and effective alternative exercise rehabilitation program for Veterans with PAD, particularly in light of safety considerations now associated with this population’s travel to group facilities in the current COVID pandemic. A promising approach to increase access to exercise rehabilitation for PAD is remote, home-based exercise therapy (HBET). Our group has successfully delivered a smartphone-enabled HBET program to Veterans with coronary artery disease with a 3-fold increase in participation and high satisfaction (80%). To this end, we are committed to utilizing technology innovations to implement HBET for Veterans with PAD successfully. HBET programs combine self-led walking exercises with health coaching and exercise tracking with a wearable activity monitor. Adapting HBET to PAD is difficult, however, due to the added complexity of an exercise prescription that requires the patient to walk until they experience near-maximal leg pain. Even with active coaching, successfully implementing HBET for PAD with long-term adherence has been difficult in the past. Our goal, therefore, is to leverage newer mobile health (mHealth) tools to adapt HBET for PAD. We propose to test our technology-enhanced approach for HBET by partnering with a successful VA lifestyle program, MOVE!, which has demonstrated success in achieving sustained weight loss and reduced diabetes onset through lifestyle modification. As increased physical activity is a core element of MOVE!, participation may help increase adherence with HBET for PAD. Our newly proposed program, Smart MOVE!, will be a multi-component program featuring a tailored version of MOVE! and a novel mHealth device called the LifeQ to improve convenience, access, and adherence to HBET for PAD. Aim 1 (Years 1-2): Identify barriers and facilitators to MOVE! participation among Veterans with PAD. Aim 2 (Years 1-2): Evaluate the feasibility of the LifeQ device to monitor exercise during HBET Aim 3 (Years 2-5): Determine the feasibility of proceeding with Smart MOVE! through a pilot randomized trial. As a VA physician actively treating Veterans with PAD, I have seen first-hand the challenges they face in accessing guideline-directed treatments such as supervised exercise. This study will lay the groundwork and provide evidence to proceed with Smart MOVE!, a much-needed patient-centered exercise rehabilitation program for PAD. Additionally, the proposed training plan will support my progress towards becoming an independent VA rehabilitation clinician-scientist focused on improving care quality and treatment outcomes for Veterans with PAD.", "keywords": [ "Accelerometer", "Activities of Daily Living", "Adherence", "Adult", "Affect", "American", "Amputation", "Behavioral", "Body Weight decreased", "COVID-19 pandemic", "Cardiac rehabilitation", "Cellular Phone", "Clinical", "Complex", "Coronary Arteriosclerosis", "Data", "Devices", "Diabetes Mellitus", "Elements", "Enhancement Technology", "Enrollment", "Exercise", "Exercise Therapy", "Face", "Goals", "Gold", "Guidelines", "Health", "Health Technology", "Home", "Hospitals", "Hypertension", "Impairment", "Income", "Indirect Calorimetry", "Intervention", "Interview", "Leadership", "Leg", "Life Style", "Life Style Modification", "Light", "Measurement", "Monitor", "Myocardial Infarction", "Oxygen Consumption", "Pain in lower limb", "Patient Education", "Patients", "Peripheral arterial disease", "Physical activity", "Physicians", "Population", "Provider", "Quality of Care", "Quality of life", "Rehabilitation Centers", "Rehabilitation therapy", "Reproducibility", "Resolution", "Risk", "Risk Factors", "Safety", "Scientist", "Smoking", "Stroke", "Structure", "Supervision", "Symptoms", "Technology", "Testing", "Time", "Training", "Travel", "Treatment outcome", "Vertebral column", "Veterans", "Walking", "aged", "base", "behavior change", "claudication", "cost", "design", "evidence base", "exercise prescription", "exercise program", "exercise regimen", "exercise rehabilitation", "experience", "functional independence", "functional loss", "functional outcomes", "high risk", "improved", "improved mobility", "informant", "innovation", "mHealth", "mortality risk", "multi-component intervention", "novel", "patient oriented", "primary outcome", "programs", "randomized trial", "remote monitoring", "rural area", "satisfaction", "success", "symptomatic improvement", "tool" ], "approved": true } }, { "type": "Grant", "id": "10988", "attributes": { "award_id": "5I01BX005616-02", "title": "Vaccine targeting HIV sites of vulnerability", "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": 22765, "first_name": "Catarina E", "last_name": "Hioe", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1533, "ror": "", "name": "JAMES J PETERS VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Effective HIV vaccines are not yet available. Of the phase 2b/3 vaccine trials, only the Thai RV144 trial showed efficacy (31%, p=0.04), and high levels of antibodies (Abs) against the V1V2 domain of HIV envelope (Env) were found to be the only primary immune correlate of reduced virus acquisition. Studies of vaccines in SIV or SHIV-challenged monkeys have since recapitulated these findings. To improve upon the RV144 vaccine, we have designed V1V2-targeted vaccine candidates and identified the most immunogenic: V1V2/A244-2J9C, a protein with V1V2 of CRF_01.AE strain A244 spliced into a bacterial trimeric protein scaffold, 2J9C. With our unique vaccine strategy centered on targeting V1V2 using novel recombinant subunit immunogens, we have demonstrated the capacity to induce an Ab response in plasma and vaginal secretion that was focused on V1V2 and diverted from other more immunodominant sites on Env. The elicited Abs displayed cross-reactivity with strains from multiple clades, durability of 1-2 years after the last boost, and antiviral functions including Ab- dependent cellular phagocytosis (ADCP), Ab-dependent cellular cytotoxicity (ADCC), and complement activation—activities that are not readily achieved by immunization with intact gp120. V1V2/A244-2J9C DNA has also been shown as an effective prime, focusing the Ab response on the specific V2 region that accounted for reduced infection in RV144. Altogether these data provide evidence supporting the validation of our lead vaccine candidate and vaccination approach. A US patent has been issued for our V1V2-scaffold designs, with the VA as one of the assignees. This application proposes to produce the lead immunogen V1V2/A244-2J9C under cGMP (current Good Manufacturing Practice) as both DNA plasmid and protein, and test its optimized delivery in order to pave the way toward a human phase I clinical trial. To accomplish this goal, four specific aims are proposed. Aim 1 is to generate a master bank of E. coli transformed with the V1V2/A244-2J9C-expressing DNA plasmid. In Aim 2 we will test the cGMP-grade V1V2/A244-2J9C-encoding DNA for protein production in transiently transfected 293T cells and for immunogenicity in rabbits. In vitro protein analysis will include expression efficiency, mass, oligomerization, glycosylation, stability, and reactivity with a panel of monoclonals Abs (mAbs). Aim 3 is to produce a master bank of HEK293T GnTi-/- cells and a pilot batch of V1V2/A244-2J9C protein using the plasmid from Aim 1. Finally, Aim 4 will test purification methods and conduct in vitro analysis for V1V2/A244-2J9C protein from Aim 3 and then perform in vivo rabbit immunogenicity testing with V1V2/A244-2J9C DNA and protein. The cGMP production will be done by Waisman BioManufacturing, associated with the University of Wisconsin-Madison, under the supervision of Drs. Carl A. Ross and Brian M. Dattilo. In vitro immunogen analysis, protein purification, rabbit vaccination, and immune assessment will be performed in the laboratory of Dr. Catarina Hioe (PI, James J. Peters VA Medical Center, JJP VAMC) in collaboration with Dr. Susan Zolla-Pazner (Mount Sinai School of Medicine, MSSM). The V1V2/A244-2J9C DNA and protein immunogens will be the first of their kind to move toward clinical trials. An effective vaccine to prevent HIV infection and/or disease is an essential portion of the Strategic National Vaccine Plan of the Departments of Health and Human Services and Veterans Affairs. An HIV vaccine is invaluable to protect Veterans who are at risk at home and abroad. This vaccine could as well serve as a prototype for vaccines against other diseases, like COVID19, where a focused Ab response to specific epitopes is requisite for protection.", "keywords": [ "2019-nCoV", "AIDS prevention", "Adherence", "Anti-Retroviral Agents", "Antibodies", "Antibody Formation", "Antibody Response", "Antigens", "Biomanufacturing", "COVID-19", "Caring", "Cells", "Clinical Trials", "Collaborations", "Complement Activation", "DNA", "Data", "Development", "Disease", "Epitopes", "Escherichia coli", "Future", "Glycoproteins", "Goals", "HIV", "HIV Envelope Protein gp120", "HIV Infections", "HIV vaccine", "Healthcare Systems", "Home", "Human", "Immune", "Immune response", "Immunization", "Immunize", "Immunodominant Epitopes", "Immunoglobulin G", "In Vitro", "Individual", "Infection", "Laboratories", "Lead", "Legal patent", "Macaca mulatta", "Mediating", "Medical center", "Methods", "Monkeys", "Monoclonal Antibodies", "Oryctolagus cuniculus", "Outcome", "Pathway interactions", "Phase", "Phase I Clinical Trials", "Plasma", "Plasmids", "Production", "Protein Analysis", "Proteins", "Provider", "Publishing", "RNA Splicing", "Recombinants", "Regimen", "Research", "Risk", "Risk Reduction", "SIV", "Scaffolding Protein", "Site", "Supervision", "Testing", "Transfection", "United States Department of Veterans Affairs", "United States Dept. of Health and Human Services", "Universities", "Vaccination", "Vaccine Clinical Trial", "Vaccines", "Vagina", "Validation", "Veterans", "Veterans Health Administration", "Virion", "Virus", "Virus Diseases", "Wisconsin", "antibody-dependent cell cytotoxicity", "antibody-dependent cellular phagocytosis", "cross reactivity", "design", "economic impact", "efficacy clinical trial", "env Gene Products", "glycosylation", "gp-120 Antigen", "immunogenic", "immunogenicity", "improved", "in vivo", "medical schools", "monomer", "nonhuman primate", "novel", "novel vaccines", "pandemic disease", "pathogen", "plasmid DNA", "prevent", "protein purification", "prototype", "rational design", "scaffold", "simian human immunodeficiency virus", "standard of care", "vaccine candidate", "vaccine efficacy", "vaccine strategy", "vaccine trial", "vaccine-induced antibodies", "virus envelope" ], "approved": true } }, { "type": "Grant", "id": "10989", "attributes": { "award_id": "5IK6HX003395-02", "title": "HSR&D Senior Research Career Scientist Award", "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": "2028-09-30", "award_amount": null, "principal_investigator": { "id": 24789, "first_name": "Denise M.", "last_name": "Hynes", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1518, "ror": "https://ror.org/02v3txv81", "name": "Portland VA Medical Center", "address": "", "city": "", "state": "OR", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 1518, "ror": "https://ror.org/02v3txv81", "name": "Portland VA Medical Center", "address": "", "city": "", "state": "OR", "zip": "", "country": "United States", "approved": true }, "abstract": "As a VA Core Investigator at the HSR&D Center to Improve Veteran Involvement in Care and the Evidence Synthesis Program Coordinating Center based at the Portland VA Healthcare System, my current research activities include Scholarly Research, Training emerging scientists, and leading and participating in Service to VA research and clinical programs. My current work is innovative and highly relevant for one of the most dynamic and transformative periods for healthcare systems broadly, and for VA healthcare especially. The overarching goal of my Scholarly Research activities is to understand and identify ways to improve chronic disease management, including access, quality, and economic outcomes. I direct research on the potential for care coordination models to improve chronic disease management for high risk/high need Veterans and to offset any adverse effects of multi-system health care use across the VA and non-VA health systems. My past research focused on Veterans with chronic kidney disease and cancer led to my current focus on high risk/high need Veterans, including ongoing research on Veterans recovering from COVID-19 illness. Our HSR&D grant pending “Care Coordination and Outcomes for High Risk Patients: Building the Evidence for Implementation”, seeks to identify the current care coordination processes and data resources necessary to conduct a VA implementation study aimed at improving patient and provider experience and health outcomes across VA and non-VA settings. The project also includes partnership with the VA Offices of Community Care, Nursing, and Social Work and other VA offices. Proactive dissemination of my research findings is done through briefings at stakeholder meetings and professional society meetings. I will continue to produce peer reviewed publications of my own research and seek a new opportunity to edit a journal supplement on care coordination as more evidence on implementation science grows and yields results. My research Training activities aim to develop the next generation of VA health services researchers with focus on skill development in methods, measurement, and applying health data resources. I am currently mentoring four VA early career clinician scientists and one PhD postdoctoral fellow. As a graduate program director in Health Management and Policy in my university role, I am and will continue to mentor MPH and PhD candidates and make them aware of the opportunities the VA offers in HSR&D research careers. Further, with faculty roles in Oregon State University (OSU) College of Public Health and Human Sciences, the OSU Center for Genome Research and Biocomputing, and Oregon Health and Science University, together with a new HSR&D Senior Research Career Scientist award, I will be uniquely positioned to develop a new training program that draws on these multi-institutional relationships. My vision is to develop a new training program in Data Science for Better Health, including data science to support care coordination process and outcome measurement and analytics. The goals of my research Service activities are to share my research expertise to inform clinical policy and practice and to contribute to the VA research programs. I will continue involvement in the national VA efforts to inform implementation of care coordination practice alongside our research. My contributions to research programs will include continued support of our Veteran engagement efforts, and participation in peer review activities and on advisory boards for critical VA research programs. An award as a Senior Research Career Scientist would provide me with the opportunity to continue and enrich these important research activities in conducting scholarly and impactful research, training the next generation of scientists, and enhancing the visibility of VA research through leadership and service, and ultimately benefiting the Veterans served by VA health systems.", "keywords": [ "Address", "Adverse effects", "Anemia", "Appointment", "Award", "Awareness", "COVID-19", "Caring", "Case Management", "Chronic", "Chronic Disease", "Chronic Kidney Failure", "Clinical", "Clinical Practice Guideline", "Collaborations", "Communities", "Cost Savings", "Data", "Data Analyses", "Data Science", "Depression screen", "Dialysis procedure", "Discipline of Nursing", "Disease Management", "Doctor of Philosophy", "Dose", "Erythropoietin", "Evaluation", "Faculty", "Family", "Fellowship", "Funding", "General Population", "Genome", "Geography", "Goals", "Grant", "Health", "Health Policy", "Health Services", "Health Services Accessibility", "Health system", "Healthcare", "Healthcare Systems", "Hearing", "Hemodialysis", "Homogeneously Staining Region", "Human", "Information Resources", "Information Systems", "Institution", "Intervention", "Joints", "Journals", "Kidney", "Kidney Diseases", "Knowledge", "Lead", "Leadership", "Link", "Managed Care", "Measurement", "Medical Economics", "Medicare", "Medicare/Medicaid", "Medication Management", "Medicine", "Mentors", "Methods", "Modeling", "Nurses", "Oregon", "Outcome", "Patients", "Peer Review", "Policies", "Positioning Attribute", "Postdoctoral Fellow", "Primary Care", "Private Sector", "Process", "Professional Organizations", "Provider", "Public Health", "Public Health Informatics", "Publications", "Quality of Care", "Quality of life", "Renal carcinoma", "Research", "Research Activity", "Research Personnel", "Research Training", "Resources", "Role", "Saran", "Savings", "Scholarship", "School Nursing", "Science", "Scientist", "Seminal", "Services", "Social Work", "Speed", "System", "Technical Expertise", "Training", "Training Activity", "Training Programs", "Translations", "Universities", "Veterans", "Vision", "Work", "active duty", "base", "biocomputing", "care coordination", "care costs", "care outcomes", "career", "clinical practice", "college", "community based care", "copayment", "cost", "data resource", "economic outcome", "experience", "health data", "health management", "high risk", "implementation efforts", "implementation research", "implementation science", "implementation study", "improved", "innovation", "integrated care", "meetings", "military veteran", "next generation", "patient engagement", "post-doctoral training", "professor", "programs", "routine practice", "skill acquisition", "socioeconomics", "subcutaneous", "symposium", "working group" ], "approved": true } }, { "type": "Grant", "id": "10990", "attributes": { "award_id": "5I01HX003304-02", "title": "Optimizing Veteran Recovery from Sepsis (OVeR-Sepsis)", "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": 24791, "first_name": "Hallie Christine", "last_name": "Prescott", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 24792, "first_name": "Jeremy Broder", "last_name": "Sussman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "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. Sepsis—life-threatening organ dysfunction triggered by infection—hospitalizes more than 25,000 Veterans each year, making it the 2nd most common reason for hospitalization in the VA. While most Veterans survive the acute episode, many suffer poor longer term outcomes. Approximately 1 in 3 survivors die in the year following sepsis, 1 in 5 have a potentially preventable rehospitalization, and 1 in 6 experience severe persistent physical or cognitive impairments. The dramatic increase in sepsis from COVID-19 brings new urgency to optimizing sepsis survivorship, but also new opportunity to learn from hospitals implementing recovery-focused practices to address the needs of Veterans surviving viral sepsis from SARS-CoV-2. Significance. Despite the prevalence of long-term morbidity after sepsis, there are no treatment guidelines focused on enhancing recovery from sepsis. OVeR-Sepsis will meet an urgent clinical need in VA, enhancing the recovery of the thousands of Veterans who survive sepsis each year (including viral sepsis from COVID). OVeR-Sepsis will validate best practices for enhancing recovery from sepsis that are responsive to Veteran and caregiver perspectives and identify feasible strategies for implementation. We will make these tools freely available, easy to use, and promote them nationally to encourage their use. Innovation and Impact. OVeR-Sepsis is innovative by studying sepsis survivorship systematically and broadly. We will study survivorship from both COVID and non-COVID sepsis, and consider how innovation in COVID sepsis survivorship practices can inform practice for non-COVID sepsis survivors. Our sequential explanatory mixed methods approach, with video site visits for 4-6 top- and 4-6 bottom- performing sites for sepsis survivorship, will allow us to study of clinical practices and implementation strategies that differentiate top-performing sites. We will then incorporate qualitative findings from our site visits into the evidence synthesis informing a modified Delphi panel to assess best practices for sepsis recovery. Specific Aims. (A1) Identify top- and bottom-performing VA hospitals for 90-day survival and quality of life after sepsis. (A2) Define practices that differentiate top-performing hospitals through electronic health record analysis, surveys, and video site visits. (A3) Prioritize best practices for sepsis recovery based on validity, improvement opportunity, and feasibility. Methodology. We will measure risk-standardized 90-day survival from sepsis across VA hospitals using hierarchical regression models and 2017-2020 CDW data. We will then empanel a cohort of N=600 Veterans from (25 Veterans per hospital, from 12 higher- and 12-lower survival hospitals) to measure quality of life and disability using telephone survey instruments with proxy respondent options. From those, we will select 4-6 top-performing (higher survival, high quality of life) and 4-6 bottom- performing hospitals for 360-degree video site visits. Through quantitative analyses of select practices, survey of current practices, and semi-structured interviews with a diverse set of 12-15 informants (clinicians, administrators, Veterans, caregivers), we will identify “best practices” for sepsis recovery and associated implementation strategies. Using a modified Delphi panel of experts, we will assess the validity, improvement opportunity, and feasibility of these best practices. Next Steps/Implementation. Upon successful completion of this research, we will work with our operational partners—who we have included even in the design stage of this IIR—to implement these best practices.", "keywords": [ "2019-nCoV", "Acute", "Address", "Administrator", "Adopted", "Awareness", "COVID-19", "COVID-19 pandemic", "Caregivers", "Caring", "Censuses", "Characteristics", "Chronic", "Clinical", "Clinical Research", "Clinics and Hospitals", "Cognitive", "Creativeness", "Critical Care", "Data", "Diffuse", "Diffusion", "Disasters", "Electronic Health Record", "Epidemiology", "Family", "Functional disorder", "Future", "Goals", "Guidelines", "Health system", "Hospitalization", "Hospitals", "Impaired cognition", "Incidence", "Infection", "Intervention", "Interview", "Learning", "Life", "Managed Care", "Marketing", "Measures", "Medical", "Methodology", "Methods", "Modeling", "Morbidity - disease rate", "Nursing Research", "Organ", "Outcome", "Patients", "Pharmaceutical Preparations", "Prevalence", "Primary Care", "Professional Organizations", "Proxy", "Public Health", "Qualitative Research", "Quality of life", "Recommendation", "Recovery", "Research", "Resolution", "Respondent", "Review Literature", "Risk", "Sepsis", "Sepsis Syndrome", "Series", "Site", "Site Visit", "Standardization", "Structure", "Surveys", "Survivors", "Telephone", "Validation", "Veterans", "Viremia", "Work", "World Health Organization", "World Health Organization Disability Assessment Schedule", "clinical implementation", "clinical practice", "cohort", "coronavirus disease", "design", "disability", "epidemiology study", "experience", "hospital readmission", "implementation strategy", "improved", "informant", "innovation", "multidisciplinary", "pandemic disease", "primary caregiver", "survivorship", "tool", "treatment guidelines", "treatment research", "virtual" ], "approved": true } }, { "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": "11004", "attributes": { "award_id": "5U18FD007516-02", "title": "Detection of SARS-CoV-2 and characterization of SARS-CoV-2 S-gene in major companion and food animals", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [ { "id": 26272, "first_name": "Megan", "last_name": "Miller", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2021-09-15", "end_date": "2024-08-31", "award_amount": 79038, "principal_investigator": { "id": 24457, "first_name": "Jianfa", "last_name": "Bai", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 197, "ror": "https://ror.org/05p1j8758", "name": "Kansas State University", "address": "", "city": "", "state": "KS", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [], "awardee_organization": { "id": 197, "ror": "https://ror.org/05p1j8758", "name": "Kansas State University", "address": "", "city": "", "state": "KS", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: SARS-CoV-2 is a major human respiratory pathogen that can cause COVID-19, a disease with symptoms similar to those caused by Influenza A (Flu A) and Influenza B (Flu B) viruses. A few major SARS-CoV-2 variants of concern (VOC) have been identified and associated with increased transmissibility in humans, including the UK variant B.1.1.7/Alpha, South Africa variant B.1.351/Beta, Japan/Brazil variant P.1/Gamma, California variants B.1.427/B.1.429/Epsilon, and India variants B.1.6.7.1/B.1.6.7.2/Delta (CDC, 2021a). SARS-CoV-2 has also been found in different animal species, including dogs, cats, tigers, lions, minks, ferrets etc. Transmission among individuals within an animal species has been reported (Halfmann et al, 2020; OIE, 2021), as well as limited reports of animal to human transmission (Hedman et al., 2021), yet more extensive studies may be needed to draw a conclusion. Both Flu A and Flu B are major human and animal respiratory pathogens, and cause symptoms sometimes difficult to differentiate from COVID-19. This proposal has three main goals: 1) Develop and validate a multiplex real-time PCR assay for detection of SARS-CoV-2, Flu A and Flu B viruses; 2) Screening animal respiratory samples submitted to KSVDL from Months 7-30 (2 years) of the grant period; and 3) Sequencing the spike protein- encoding gene (S-gene) of all SARS-CoV-2 positive samples to identify and characterize potential variants and their relationship to human strains. From 2018-2020, Kansas State Veterinary Diagnostic Laboratory (KSVDL) received an annual average of 11,065 animal respiratory samples, including an average of 69 feline, 491 canine, 123 equine, 1,070 swine and 9,296 bovine samples for each year. All feline and canine respiratory samples and selected samples from other species received in Months 7-30 during the grant period will be tested by the multiplex SARS-CoV-2/Flu A/Flu B assay developed in the study. S-gene sequencing of all SARS-CoV-2 positive samples will be attempted with a procedure optimized in this study and results compared to major VOC strains. Full or near-full S-gene sequences will be phylogenetically analyzed to further study the variation and genetic diversity of the SARS-CoV-2 strains identified from animal species. Analysis will also reveal if strains identified within an animal species have a closer genetic relationship than strains between species. The S-gene sequences of animal- and human-derived strains will be compared to determine if animal strains have been observed in humans. Main goals include: 1) Provide comprehensive SARS-CoV-2 positive rates, for a duration of two years, from samples collected from dogs, cats, horses, cattle and pigs; 2) Identify potential SARS-CoV-2 VOC strains from positive samples; 3) Phylogenetically analyze the S-gene from all sequenceable positive samples (Ct ≤ 32) to determine genetic diversity; 4) Identify and phylogenetically analyze similarities and differences of the S-gene of animal- and human-derived SARS-CoV-2 strains.", "keywords": [], "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": "11547", "attributes": { "award_id": "5I01HX003192-02", "title": "Understanding the Effects of the MISSION Act on VA's Specialty Care Referral Networks", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-05-01", "end_date": "2025-10-31", "award_amount": null, "principal_investigator": { "id": 22224, "first_name": "Megan Adkins", "last_name": "Adams", "orcid": null, "emails": "[email protected]", "private_emails": null, "keywords": "[]", "approved": true, "websites": "[]", "desired_collaboration": "", "comments": "", "affiliations": [ { "id": 1477, "ror": "https://ror.org/05eq41471", "name": "Veterans Health Administration", "address": "", "city": "", "state": "MI", "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: Recently, VA underwent two unprecedented disruptive changes that fundamentally altered how care is delivered to Veterans. First, the VA MISSION Act was implemented in June 2019. Arguably the biggest policy change in VA care delivery since the \"Kizer revolution,” MISSION’s purpose is to improve Veteran access to care, especially for services that have traditionally been resource-limited in VA due to geographic/ temporal barriers (e.g., specialty care). While VA healthcare systems were still in the early phases of adapting to MISSION, the COVID pandemic spread rapidly across the world, resulting in a sudden and prolonged ramp- down of elective outpatient care across the entire US healthcare system. VAMCs nationwide are independently adapting to these disruptive changes in ways that directly impact Veterans’ health and experience. Significance/Impact: Currently, we know little about MISSION’s early effects on where and how Veterans access specialty care (as moderated by COVID-related disruptions), or factors influencing community care referral. We also lack a clear understanding of how individual VAMCs are responding to these disruptive forces in realigning organizational strategy/structure to optimize performance. Addressing these knowledge gaps is critical to assessing the long-term impacts of MISSION and COVID on VA specialty care delivery and helping VAMCs to tailor adaptation approaches to their local setting to optimize the health and experience of Veterans. Innovation: Expansion of VA community care under the MISSION Act represents one of the largest natural experiments in delivery transformation in any U.S. healthcare system in modern times. Thus, VA community care expansion under MISSION offers an unparalleled opportunity to study the relationship between rapid environmental change, organizational adaptation, and long-term performance. The unanticipated system \"reset\" caused by COVID will only amplify and accelerate the adaptation process already underway. Specific Aims: Aim 1: Examine the relationship between VAMC organizational/environmental characteristics and longitudinal performance under MISSION/post-COVID, and the extent to which facility-level organizational adaptation measurably impacts performance. Aim 2: Characterize variation in organizational adaptation by high-performing tertiary VAMCs with different organizational/environmental characteristics. Aim 3: Explore how the experience of Veterans with specialty care needs differs at high-performing VAMCs with distinct organizational adaptation approaches. Methodology: In Aim 1a, using a longitudinal pre-/post- comparison analysis, we will examine the relationship between VAMC organizational/environmental characteristics and longitudinal performance under MISSION/post-COVID, including measures of access, care coordination, and community care referral. In Aim 1b, using a difference-in-differences approach, we will leverage differences in financial incentives between VAMCs to empirically assess the effect of VAMC organizational adaptation on longitudinal rates of VA community care referral and other outcomes. In Aim 2, we will interview leadership at 12 high-performing Level 1 VAMCs with varying organizational/environmental attributes to characterize variation in adaptation approaches under MISSION/post-COVID. In Aim 3, we will explore how VAMC organizational adaptation impacts Veterans’ specialty care experience through qualitative interviews of 48 Veterans at select Aim 2 sites. Implementation/Next Steps: This study will provide critical information about where and how Veterans access specialty care under MISSION/post-COVID, how high-performing tertiary VAMCs with different organizational/ environmental characteristics are adapting to enhance specialty care delivery under MISSION/post-COVID, and how variation in these adaptation approaches affects the Veteran experience of care. Grant products will provide vital information to VHA leaders about how tertiary VAMCs with unique facility-level characteristics can best adapt their organizational approaches to optimize performance and enhance the Veteran care experience.", "keywords": [ "Acceleration", "Address", "Affect", "Ambulatory Care", "COVID-19 pandemic", "Caring", "Case Study", "Characteristics", "Cirrhosis", "Communities", "Complex", "Enrollment", "Event", "Face", "Future", "Geography", "Goals", "Grant", "Health", "Health Services Accessibility", "Health system", "Healthcare Systems", "Individual", "Interview", "Knowledge", "Leadership", "Measurable", "Measures", "Methodological Studies", "Methodology", "Methods", "Modernization", "Natural experiment", "Nephrology", "Outcome", "Patients", "Performance", "Phase", "Policies", "Policy Making", "Population", "Process", "Ramp", "Recommendation", "Recovery", "Research", "Resources", "Sampling", "Services", "Site", "Specialist", "Structure", "System", "Telephone", "Time", "Variant", "Veterans", "care coordination", "care delivery", "comorbidity", "coronavirus disease", "economic impact", "environmental change", "experience", "financial incentive", "health care service organization", "health management", "improved", "innovation", "insight", "medical specialties", "post-COVID-19", "response", "time use", "virtual healthcare" ], "approved": true } }, { "type": "Grant", "id": "11550", "attributes": { "award_id": "5I01HX003412-02", "title": "Role of Non-pharmacological Pain Treatments in Safe and Effective Opioid Tapering in Chronic Pain", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2022-05-01", "end_date": "2026-04-30", "award_amount": null, "principal_investigator": { "id": 22420, "first_name": "WILLIAM C", "last_name": "BECKER", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 1492, "ror": "https://ror.org/000rgm762", "name": "VA Connecticut Healthcare System", "address": "", "city": "", "state": "CT", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 22421, "first_name": "Anne C.", "last_name": "Black", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 1492, "ror": "https://ror.org/000rgm762", "name": "VA Connecticut Healthcare System", "address": "", "city": "", "state": "CT", "zip": "", "country": "United States", "approved": true }, "abstract": "Background: Evidence of risks for serious adverse outcomes and limited benefit of long-term opioid therapy (LTOT) have driven VA recommendations for LTOT tapering or discontinuation when benefits no longer outweigh harms. However, LTOT tapering may also pose risks of harm. Significance: The study addresses a critical need for clear demonstration of LTOT tapering risks and a specific VA call for evaluation of nonpharmacological pain treatments including complementary and integrative health services (NPM/CIH). The goals of this project are to assess the role of NPM/CIH use in effecting safe and clinically meaningful reductions in LTOT regimens for Veterans with chronic pain. Changes in outcomes associated with two major periods -- the implementation of the Whole Health System of care (WHS) and COVID-19 – will be assessed. Innovation and Impact: In ongoing partnership with the Office of Patient-Centered Care and Cultural Transformation (OPCC&CT), the study will broaden the scope of ongoing NPM/CIH evaluation to include outcomes related to substance dependence and addiction. Partnering with Pharmacy Benefits Management Services’ VA Center for Medication Safety (MedSAFE), informed by new pilot data, our team will be one of the first to apply a novel method to optimize determination of LTOT tapering to improve analyses of tapering- related outcomes. The study will inform clinical guidelines addressing multimodal approaches to tapering. Specific Aims are to (1) Characterize NPM/CIH access and utilization among Veterans with LTOT, considering the impact of implementation of the VHA Whole Health System of Care and COVID-19; (2) Compare the effectiveness and safety of opioid tapering for Veterans with LTOT with and without NPM/CIH; (3) Assess the moderating effect of buprenorphine on NPM/CIH effects on outcomes. We hypothesize that use of NPM/CIH will be associated with higher rates of effectiveness and safety, and that use of buprenorphine will be associated with more positive effects of NPM/CIH on these outcomes. Methodology: The project will identify a retrospective cohort between 2016-2020 of approximately 200,000 Veterans receiving LTOT at ≥ 30 mg morphine equivalent daily dose (MEDD) across 54 VA facilities. Leveraging Veterans Health Administration (VHA) electronic health record data, Veterans’ utilization of NPM/CIH within VHA and in the community will be assessed. Applying a novel method developed by VA MedSAFE using VHA electronic pharmacy data within the Corporate Data Warehouse, we will develop models of opioid tapering within the target period. Using quasi-experimental methods, Veterans will be “assigned” to NPM/CIH treatment or no treatment based on their observed service utilization. Propensity score matching will balance baseline differences due to nonrandom assignment. In multilevel models, opioid tapering outcomes will be modeled as a function of NPM/CIH use. The primary tapering effectiveness outcome will be the proportion of Veterans achieving a reduction in prescribed opioid dose of ≥50% of baseline mg MEDD, maintained over six months in the absence of worsened pain intensity. Tapering safety will be measured as the proportion of Veterans experiencing any serious adverse event (SAE), allowing tapering to take all values, including no taper and dose increases. SAE will include hospitalization, emergency department visit, opioid overdose, new mental health disorder, new opioid or other substance use disorder, suicide attempt, and all- cause mortality. Models will assess moderation of NPM/CIH effects by buprenorphine treatment for opioid tapering and for chronic pain. Secondary models will assess the effect of NPM/CIH on LTOT-related side effects and differences in NPM/CIH effect by age, race/ethnicity and gender. Next Steps/Implementation: Operational partners and a Veteran engagement panel will guide interpretation of results and promote dissemination and translation to practice. 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