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Colorado Clinical and Transational Sciences Institute

科罗拉多临床和转化科学研究所

基本信息

批准号：
10402976
负责人：
RONALD J. SOKOL
金额：
$ 324.99万
依托单位：
UNIVERSITY OF COLORADO DENVER
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-05-01 至 2024-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10402976
关键词：
Abbreviations Adult Advisory Committees Biomedical Research Biometry Center for Translational Science Activities Child Clinical Clinical Research Clinical Sciences Clinical Trials Collaborations Colorado Communities Computerized Medical Record Contracts Development Discipline of Nursing Elderly Ensure Environment Evaluation Funding Goals Grant Health Healthcare Home Hospitals Informatics Infrastructure Innovation Corps Institutes Institutional Review Boards Interdisciplinary Study Knowledge Longevity Maps Maternal and Child Health Measurable Medical Medical center Mentors Methodology Methods Monitor Multi-Institutional Clinical Trial Outcomes Research Participant Patient Care Patients Pediatric Hospitals Performance Pharmacologic Substance Pharmacy Schools Phase Procedures Process Program Development Public Health Public Health Schools Rare Diseases Research Research Design Research Personnel Research Training Resources Review Committee Safety School Dentistry Science Services Special Population System TNFSF15 gene Time Training Training Programs Training and Education Translating Translational Research Translations United States Department of Veterans Affairs United States National Institutes of Health Universities Workforce Development authority career development college community based participatory research community engagement community organizations cost effective effective therapy electronic data epidemiology study follower of religion Jewish improved innovation medical schools next generation novel pre-doctoral programs recruit success translational pipeline translational scientist

项目摘要

PROJECT SUMMARY Implementation of early and effective treatment for high-risk COVID-19 patients in the outpatient setting is an important public health tool to prevent healthcare systems from reaching a breaking point by enhancing early recovery and reducing hospitalizations. In early clinical trials, two neutralizing monoclonal antibody (nMAb) treatments, bamlanivimab and casirivimab/imdevimab, significantly reduced viral load, symptoms, and hospitalizations, leading the U.S. Food and Drug Administration to issue Emergency Use Authorizations for these agents in high-risk COVID-19 outpatients. Unfortunately, only a small fraction (<5%) of eligible outpatients are currently accessing nMAb treatment due to a number of logistical barriers and clinicians who are not aware or convinced of its therapeutic benefit. The medical and public health communities desperately need scalable solutions for rapid and equitable use of outpatient nMAbs, while simultaneously providing real- world confirmatory evidence of their effectiveness. The State of Colorado implemented a statewide random allocation system for nMAb allocation to eligible patients, the only state with such a system. Building on robust dissemination to enhance uptake of nMAb treatment, this random allocation system will facilitate rapid evaluation of real-world effectiveness of these novel treatments on clinically important, patient-centered outcomes, through a time-sensitive natural experiment. This project uses a type 2 hybrid implementation- effectiveness design to achieve the following specific aims: 1) Assess barriers and facilitators to use of nMAbs statewide, based on diffusion of innovations theory; 2) Develop, implement, and evaluate statewide strategies to optimize equitable nMAb access; and 3) Determine the real-world effectiveness and safety of nMAb treatment in high-risk COVID-19 outpatients. The approach will combine cutting-edge dissemination and implementation methods with a unique natural experiment leveraging the state random allocation system, along with with electronic health record, patient survey, and administrative claims data. This CTSA Administrative Supplement will provide urgently needed real-world T4 translational evidence for nMAb treatment and inform rapid dissemination of current and future outpatient COVID-19 therapies. The deliverables will advance `designing for dissemination' concepts; address pressing concerns to help patients and clinicians manage issues of uncertainty, risk, and urgency; and create a model for rapidly generating high quality real-world evidence in infectious disease pandemics and other future public health emergencies.

项目总结