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NCT06382636 · ClinicalTrials.gov registry record · NA
Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes
A NA study of Prenatal Disorder, sponsored by The Cleveland Clinic.
- Recruiting
- Registry status
- NA
- Development phase
- 600
- Enrollment target
- 3
- Study locations
NCT06382636: Recruiting NA study of Prenatal Disorder, sponsored by The Cleveland Clinic.
NCT06382636 is a NA study of Prenatal Disorder that is actively recruiting participants, run by The Cleveland Clinic. The registered enrollment target is 600 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06382636, a NA study of Prenatal Disorder, is actively recruiting participants, sponsored by The Cleveland Clinic.
- RECRUITING
- Registry status
- NA
- Development phase
- 600 participants
- Enrollment target
- 3
- Study locations
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
Primary Outcome
Time spent in chatbot
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 |
What NCT06382636 shows while recruiting
NCT06382636 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (57% lower).
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.
NCT06382636 reports a single indexed study location in Ohio.
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.
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).
Who is sponsoring clinical trial NCT06382636?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT06382636's enrollment target sits among peer trials
600 162nd of 2000 higher than 1,828 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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