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RECRUITING
NCT06382636
NA

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

Sponsor: The Cleveland Clinic

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2024-05-06

Completion Date

2027-02-28

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

Standard Care

This group will utilize standard care with respect to healthcare provider practices.

BEHAVIORAL

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

This group will be exposed to the AI enabled healthcare chatbot.

Locations (3)

Neighborhood Family Practice

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States