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Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes
NCT06382636 · View on ClinicalTrials.gov ↗
Study 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 preferen
Conditions Studied
Interventions
- BEHAVIORAL Standard Care
- BEHAVIORAL Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot
Study Locations (3)
Ohio
- Neighborhood Family Practice — Cleveland
- MetroHealth Medical Center — Cleveland
- Cleveland Clinic — Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2024-05-06 |
| Est. Completion | 2027-02-28 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06382636
The ClinicalTrials.gov registry entry for NCT06382636 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prenatal Disorder appearing as the primary indexed condition, and to 2 interventions — of which Standard Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06382636 reports 3 study locations spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06382636 about?
NCT06382636 is a clinical study titled "Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes". 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 fundame...
What is the current status of trial NCT06382636?
This trial is currently recruiting. It is a NA study. The enrollment target is 600 participants. The study started on 2024-05-06. Estimated completion is 2027-02-28.
What conditions does trial NCT06382636 study?
This clinical trial studies the following conditions: Prenatal Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06382636?
The interventions under investigation include: Standard Care (BEHAVIORAL), Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06382636?
This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06382636 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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