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

NCT06382636 | Recruiting DMC

• 1 other identifier: 23-101
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Patient activation

  Time spent in chatbot

  1-day

Study Arms (2)

Standard of care

PLACEBO COMPARATOR

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

Behavioral: Standard Care

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

EXPERIMENTAL

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.

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

Interventions

Standard Care BEHAVIORAL

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

Standard of care

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot BEHAVIORAL

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

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Pregnant females
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (3)

Neighborhood Family Practice

Cleveland, Ohio, 44102, United States

NOT YET RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

NOT YET RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Ruth Farrell, MD, MA

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Farrell, MD, MA

CONTACT

216-445-7085; farrelr@ccf.org

Christina Collart, MEd

CONTACT

216-470-9796; collarc@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: April 24, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (3)