# Ensuring Patients' Informed Access to Noninvasive Prenatal Testing

> **NIH NIH R01** · CLEVELAND CLINIC LERNER COM-CWRU · 2020 · $637,676

## Abstract

PROJECT ABSTRACT
Noninvasive prenatal genetic testing (NIPT) is revolutionizing the practice of obstetrics. However, the technol-
ogy is expanding rapidly and in a way that has outpaced the rate at which evidence-based strategies for its in-
tegration can be developed and implemented. Initially, NIPT was used as a screen for a limited number of an-
euploidies and genetic conditions. Now, it is possible to confer information about numerous other fetal genetic
conditions with variable phenotypic severity never before a part of prenatal screening as well as providing in-
formation about markers that have undetermined significance. In addition, information gained from NIPT may
have unexpected consequences by identifying maternal or paternal factors that may be unwanted or unex-
pected. Thus, the decision-making process for NIPT is uniquely complex. An urgent clinical problem has
emerged: there is a lack of evidence-based tools to guide OB providers in effective and patient-centered edu-
cation and decision support for NIPT. The magnitude of this problem becomes evident when considering that
over four million women receive prenatal care in the U.S. annually and there are not enough prenatal genet-
ic counselors or maternal-fetal medicine specialists to meet this demand, particularly in rural and urban set-
tings that already face poorer obstetric outcomes due to barriers in access prenatal care. The primary goal of
this study is to ensure that all patients have informed access to NIPT by means of an effective communica-
tion tool reflecting the perspectives of patients, partners, and OB providers designed to support patients’
informed decision-making about its use. Our central hypothesis is that, by focusing on the dynamic interac-
tion between the patient and provider, the use of an evidence-based communication tool will result in a
shared decision-making process that, in turn, will increase patients’ ability to make an informed choice
about NIPT and decrease patients’ decisional conflict. We will examine this hypothesis using an evidence-
based communication tool and a series of validated quantitative measures combined with in-depth interviews
with key stakeholders in the NIPT translation process. This project is innovative because it will provide a new
framework for the informed decision-making process that focuses on the patient and provider as dyads in the
informed decision-making process. This work is significant because, once this point-of-care intervention is
available, it will help expectant parents have informed access to advances in prenatal genetic tests that use
next generation sequencing technologies. These results are expected to have an important positive impact on
public health, as informed access to advances in genetic technologies is not only foundational to the ethical
practice of medicine but also a key component of quality, access, and outcomes of personalized medicine. We
anticipate that this study’s findings will ultimately con...

## Key facts

- **NIH application ID:** 9961640
- **Project number:** 5R01HG010092-04
- **Recipient organization:** CLEVELAND CLINIC LERNER COM-CWRU
- **Principal Investigator:** Ruth Farrell
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $637,676
- **Award type:** 5
- **Project period:** 2017-09-14 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9961640

## Citation

> US National Institutes of Health, RePORTER application 9961640, Ensuring Patients' Informed Access to Noninvasive Prenatal Testing (5R01HG010092-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9961640. Licensed CC0.

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