Recruiting

Genetic Testing

Sponsor:

The Cleveland Clinic

Code:

NCT06382636

Conditions

Prenatal Disorder

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Standard Care

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

Study Details

Brief 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.

Conditions

Prenatal Disorder

Study ID

NCT06382636

Start date

May 6, 2024

Status verified date

Jul, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

600 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

placebo comparator: Standard of care

This group will utilize standard care with respect to healthcare provider practices for education and counseling surrounding prenatal screening and diagnostic testing options.

experimental: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

This arm will utilize an artificial intelligence AI enabled healthcare chatbot that provides patients with personalized information and decision-making support at different stages of the prenatal screen and diagnostic testing pathways.

Interventions

Standard Care

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

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

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

Primary outcome measure

  • Patient activation [ Time Frame: 1-day ]

Central Contacts and Locations

Central contacts

Ruth Farrell, MD, MA

216-445-7085farrelr@ccf.org

Christina Collart, MEd

216-470-9796collarc@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Ruth Farrell, MD, MA

216-445-7085farrelr@ccf.org

Christina Collart, MEd

216-470-9796collarc@ccf.org

More Information

Sponsor

The Cleveland Clinic

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Keywords

  • Prenatal Genetic Screening
  • Prenatal Diagnostic Testing
  • Shared Decision Making
  • Informed Choice
  • Decisional Regret

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-08-03.