[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545494":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":84,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"The Cleveland Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Behavioral: Standard Care",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Behavioral: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Standard Care","This group will utilize standard care with respect to healthcare provider practices.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"This group will be exposed to the AI enabled healthcare chatbot.",[15],[31],{"name":32,"affiliation":5,"role":33},"Ruth Farrell, MD, MA","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","216-445-7085","farrelr@ccf.org",{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},"Christina Collart, MEd","216-470-9796","collarc@ccf.org",[44,63,74],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Neighborhood Family Practice","NOT_YET_RECRUITING","Cleveland","Ohio","44102","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-81.69541,41.4995,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":61,"phoneExt":26,"email":62},"Heidi Gullett, MD","216-368-0776","hlg31@case.edu",{"facility":64,"status":46,"city":47,"state":48,"zip":65,"country":50,"countryCode":51,"cosmosGeoPoint":66,"geoPoint":68,"contacts":69},"MetroHealth Medical Center","44109",{"type":53,"coordinates":67},[55,56],{"lat":56,"lon":55},[70],{"name":71,"role":36,"phone":72,"phoneExt":26,"email":73},"Angela Ranzini, MD","216-778-3513","aranzini@metrohealth.org",{"facility":75,"status":76,"city":47,"state":48,"zip":77,"country":50,"countryCode":51,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Cleveland Clinic","RECRUITING","44195",{"type":53,"coordinates":79},[55,56],{"lat":56,"lon":55},[82,83],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100545494","engaging-patients-in-prenatal-genetic-testing-decisions-as-a-pathway-to-improve-obstetric-outcomes-100545494",false,"NCT06382636","Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes","OPUS","Inclusion Criteria:\n\n* Able to read and speak English\n* Able to provide consent to participate in the study\n* Offered routine aneuploidy screening and diagnostic testing\n\nExclusion Criteria:\n\n* Less than 18 years of age\n* Not currently pregnant or an intrauterine pregnancy has not yet been established\n* Unable to provide informed consent for research participation\n* Unable to read and speak English","FEMALE","18 Years","50 Years",{"count":97,"type":98},600,"ESTIMATED","INTERVENTIONAL",[101],"NA","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.\n\nUsing 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.",[104],"Prenatal Disorder",[106,107,108,109,110],"Prenatal Genetic Screening","Prenatal Diagnostic Testing","Shared Decision Making","Informed Choice","Decisional Regret","2026-07-31",{"date":113,"type":114},"2026-08-03","ACTUAL",{"date":116,"type":114},"2024-05-06",{"date":118,"type":98},"2027-02-28",{"name":5,"class":6},3]