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 fu- ture public health emergencies of similar magnitude. Additionally, this study will increase the impact of the NEST 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.

Public Health Relevance

The goal of this study is to study the effect of COVID-19 on prenatal healthcare delivery, specifically patients' ability to access prenatal genetic screening and diagnostic tests in an informed and evidence- based fashion. By doing so, we will identify whether serious short term health issues for women, children, and families are resulting from the pandemic and develop readily-deployable and scalable solutions to ensure women's informed access to high-quality prenatal care during future public health crises. This project is relevant to public health because it is critical to ensure that pregnant patients have continued access to prenatal genetic tests, a central component of prenatal care quality and obstetric outcomes, amidst a public health crisis that diverts major resources and attention away from routine healthcare delivery.

Agency
National Institute of Health (NIH)
Institute
National Human Genome Research Institute (NHGRI)
Type
Research Project (R01)
Project #
3R01HG010092-04S1
Application #
10165356
Study Section
Societal and Ethical Issues in Research Study Section (SEIR)
Program Officer
Boyer, Joy
Project Start
2017-09-15
Project End
2021-06-30
Budget Start
2020-09-17
Budget End
2021-06-30
Support Year
4
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Surgery
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195