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Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes

Who can join

Ages 18 to 50 · Women

Inclusion Criteria:

* Able to read and speak English
* Able to provide consent to participate in the study
* Offered routine aneuploidy screening and diagnostic testing

Exclusion Criteria:

* Less than 18 years of age
* Not currently pregnant or an intrauterine pregnancy has not yet been established
* Unable to provide informed consent for research participation
* Unable to read and speak English

About the study

The goal of this study is to ensure that pregnant patients have the resources and support needed to access Prenatal Screening \& Diagnostic Testing (PS\&D) in an informed and evidence-based fashion by developing an innovative digital tool to support patients' decision-making and contributing fundamental knowledge to advance science in a way that promotes patients' access to new prenatal applications of genomic science and technology. Our central hypothesis is that, by focusing on patient engagement as a key driver to improve patient outcomes, the use of an evidence-based artificial-intelligence (AI) powered patient engagement tool will increase patients' ability to seek information and structure a decision-making process that, in turn, increases informed decisions about PS\&D and decreases decisional conflict associated with those decisions.

Using data from NEST (Ensuring Patients Informed Access to NIPT \[non-invasive prenatal testing\]), the investigators designed the next iteration of NEST, a point-of care shared decision-making tool powered by artificial intelligence (AI) to provide a personalized and dynamic decision support tool: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS). OPUS is an AI-enabled healthcare chatbot (a computer program capable of processing and simulating human conversation) that provides patients with personalized information and decision-making support at different stages of the PS\&D pathway. It functions using a series of questions contained in the NEST with a branching logic sequence of questions and answers based on the responses to and from the patient, using a conversational and adaptable interaction. It also contains nested tiers of information, ranging from introductory to detailed information about patient engagement, health literacy, the different PS\&D options, and resources to learn about insurance coverage for PS\&D. OPUS was designed to be accessed by patients with different technological resources and preferences, using a cell phone, a mobile device, or a computer.

What is being tested

• Standard Care (behavioral)
• Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot (behavioral)

Sponsor: The Cleveland Clinic · Participants: 600 · Started: May 6, 2024

Contact the study team

• Ruth Farrell, MD, MA · Phone: 216-445-7085
• Christina Collart, MEd · Phone: 216-470-9796

Official record on ClinicalTrials.gov — NCT06382636

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.