Admin. Supplement to: Ensuring Patients' Informed Access to Noninvasive Prenatal Testing
- Funded by National Institutes of Health (NIH)
- Total publications:0 publications
Grant number: 3R01HG010092-04S1
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Key facts
Disease
COVID-19Start & end year
20172021Known Financial Commitments (USD)
$223,677Funder
National Institutes of Health (NIH)Principal Investigator
Ruth FarrellResearch Location
United States of AmericaLead Research Institution
Cleveland Clinic Lerner Com-CwruResearch Priority Alignment
N/A
Research Category
Clinical characterisation and management
Research Subcategory
Supportive care, processes of care and management
Special Interest Tags
N/A
Study Type
Non-Clinical
Clinical Trial Details
N/A
Broad Policy Alignment
Pending
Age Group
Adults (18 and older)
Vulnerable Population
Pregnant women
Occupations of Interest
Unspecified
Abstract
PROJECT Abstract: Prenatal genetic screening tests and diagnostic tests (referred to as prenatal genetic tests) are a fundamental component of the delivery of high-quality, evidence-based prenatal care. Current guidelines recommend that prenatal genetic tests should be offered to all pregnant patients to optimize obstetric outcomes, ideally offered early in pregnancy so that patients can make formative decisions about their prenatal care. Delay in access and utilization of prenatal genetic tests can have significant implications for pregnancy outcomes. The COVID-19 pandemic is an urgent clinical problem that has emerged with the potential to jeopardize women's access to genetic tests. Currently, it is not known how COVID-19 may impact pregnant women's access to and utilization of these critical tests. This includes concern not just for those pregnant women who become severely ill with COVID-19 but also those who fear exposure to SARS-CoV-2 by presenting to a healthcare facility have genetic testing by means of a blood draw or ultrasound-based procedure. The goal of this study is to study the effect of COVID-19 on prenatal healthcare delivery, specifically patients' ability to access prenatal genetic screen-ing and diagnostic tests in an informed and evidence-based fashion. By doing so, we will identify serious short term health issues for women, children, and families resulting from this pandemic and readily-deployable and scalable solutions to ensure women's informed access to high-quality prenatal care during future public health crises. This study is significant as its findings will lead to system-level improvements to support pregnant patients' informed access to prenatal genetic tests for the duration of the pandemic and future public health emergencies of similar magnitude. Additionally, this study will increase the impact of theNEST R01, providing an in-depth understanding of how COVID-19 affects shared decision-making, informed consent, and patient satisfaction regarding prenatal genetic testing decisions. In doing so, this proposal dove-tails with the objectives of the parent R01 to ensure that patients have informed access to advances in prenatal genetic technologies as crucial metrics of prenatal healthcare safety, access, and quality.