Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
FEMALE
NCT06382636

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

Led by The Cleveland Clinic · Updated on 2026-02-27

600

Participants Needed

3

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 50Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to read and speak English
  • Able to provide consent to participate in the study
  • Offered routine aneuploidy screening and diagnostic testing
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Neighborhood Family Practice

Cleveland, Ohio, United States, 44102

Not Yet Recruiting

2

MetroHealth Medical Center

Cleveland, Ohio, United States, 44109

Not Yet Recruiting

3

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

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Research Team

R

Ruth Farrell, MD, MA

CONTACT

C

Christina Collart, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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