AI Chatbot for Prenatal Disorder

(OPUS Trial)

Recruiting at 2 trial locations

Overseen By Christina Collart, MEd

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: The Cleveland Clinic

Disqualifiers: Under 18, Not pregnant, others

Compensation: Varies

Number of Visits: 3

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an AI-powered chatbot designed to assist pregnant patients in making informed decisions about prenatal screening and diagnostic testing. The chatbot, called the Obstetric Prenatal Genetic Testing Engagement Solution (OPUS), offers personalized information and decision-making support through engaging conversations. Participants will either use OPUS or receive standard care to determine if the AI tool improves understanding and decision-making. This trial suits pregnant individuals who can read and speak English and have been offered routine prenatal screening and diagnostic testing. As an unphased trial, it provides participants the chance to contribute to innovative research that could enhance prenatal care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this AI chatbot is safe for prenatal decision-making?

Research has shown that AI chatbots like OPUS are generally safe for use in healthcare. Designed to provide information and support, these chatbots do not involve medication or medical procedures, so the risk of physical harm remains very low.

Studies have found that people usually find AI chatbots easy to use, as they simplify complex medical information. OPUS, specifically, aids in decisions about prenatal testing by offering personalized advice and information, which can reduce confusion and stress for patients.

Overall, AI chatbots in healthcare are considered safe and are widely used to help patients understand and engage with their health information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPUS AI Chatbot because it offers a personalized approach to prenatal genetic testing support, unlike traditional methods that rely heavily on healthcare providers for education and counseling. This AI-driven solution provides tailored information and decision-making assistance throughout different stages of prenatal screening and diagnostics, potentially enhancing patient understanding and engagement. By integrating AI technology, it has the potential to streamline the process, making it more accessible and less intimidating for expectant parents.

What evidence suggests that the OPUS AI chatbot is effective for prenatal screening and diagnostic testing?

Research has shown that AI chatbots, such as the Obstetric Prenatal Genetic Testing Engagement Solution (OPUS), which participants in this trial may receive, can assist pregnant women in making informed choices about prenatal testing. Studies have found that chatbots used for education improve understanding of testing options and are generally well-received by both patients and healthcare providers. As a result, OPUS might reduce confusion and stress during prenatal care by offering personalized information and support. These tools are also designed to function on various devices, making them accessible to many people. ^{1 2 6 7 8}

Who Is on the Research Team?

Ruth Farrell, MD, MA

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for pregnant individuals who need support in making informed decisions about Prenatal Screening & Diagnostic Testing (PS&D). Participants should be interested in using a digital tool, OPUS AI Chatbot, to help with their decision-making process. The eligibility criteria are not fully listed but would typically include factors like gestational age and health status.

Inclusion Criteria

I have been offered genetic screening tests for chromosome abnormalities.

Able to provide consent to participate in the study

Exclusion Criteria

Not currently pregnant or an intrauterine pregnancy has not yet been established

I am under 18 years old.

Unable to provide informed consent for research participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the OPUS AI chatbot for decision-making support regarding prenatal screening and diagnostic testing

Throughout pregnancy

3 key time points (T1, T2, T3)

Control

Participants receive standard counseling per usual care for prenatal screening and diagnostic testing

Throughout pregnancy

Follow-up

Participants are monitored for decision-making outcomes and decisional conflict after engaging with OPUS or standard care

Up to 23 weeks gestational age

What Are the Treatments Tested in This Trial?

Interventions

• Obstetric Prenatal Genetic Testing Engagement Solution (OPUS)

Trial Overview The study tests an artificial intelligence chatbot named OPUS designed to aid pregnant patients in understanding and deciding on genetic testing options during pregnancy. It compares the outcomes of those using this innovative digital tool against standard care without the chatbot.

How Is the Trial Designed?

Group I: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot Experimental Treatment 1 Intervention

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.

Group II: Standard of care Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

Noninvasive prenatal testing (NIPT) is viewed positively by pregnant women for its accuracy, early timing, and ease of testing, making it a superior option compared to conventional screening tests.

Despite its advantages, concerns about false results, anxiety, and costs may deter some women from choosing NIPT, highlighting the importance of informed and autonomous decision-making in prenatal genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's More Than a Blood Test: Patients' Perspectives on Noninvasive Prenatal Testing. Farrell, RM., Mercer, MB., Agatisa, PK., et al.[2022]

The pilot version of the Rosa chatbot, developed over two years with input from patients and healthcare professionals, aims to assist breast and ovarian cancer patients in understanding genetic BRCA testing, highlighting the importance of user-centered design in health technology.

Despite initial challenges with AI matching user questions to answers, the final version of the chatbot significantly expanded its database and received positive feedback from users regarding its layout and trustworthiness, indicating potential for real-world application in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ask Rosa - The making of a digital genetic conversation tool, a chatbot, about hereditary breast and ovarian cancer. Siglen, E., Vetti, HH., Lunde, ABF., et al.[2022]

In a feasibility study involving 103 primary care patients eligible for cancer genetic evaluation, 70% of those who completed a chat with a conversational agent expressed a desire to proceed with genetic testing, indicating the agent's effectiveness in providing pretest education.

The study revealed that while most users found the information sufficient to make a decision, a subset of participants who were unsure about testing spent more time interacting with the agent and requested additional information, suggesting that some patients may still need more personalized support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study. Chavez-Yenter, D., Kimball, KE., Kohlmann, W., et al.[2023]

The online preconception conversational agent 'Gabby' significantly reduced the number and proportion of preconception health risks among 100 African American women, with the Gabby group showing an average reduction of 8.3 risks compared to 5.5 in the control group over six months.

Participants in the Gabby group found the system easy to use, with 64% reporting they used the information to improve their health, indicating that Gabby may be an effective tool for addressing health disparities in preconception care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Preconception Risks Among African American Women with Conversational Agent Technology. Jack, B., Bickmore, T., Hempstead, M., et al.[2022]

The chatbot app, Rosa, was well-received by 175 healthy individuals at risk of hereditary breast and ovarian cancer, providing 24/7 access to reliable genetic information and helping users prepare for genetic counseling without increasing their anxiety about genetic testing.

Participants found Rosa to be a trustworthy source of information, preferring it over general search engines like Google, but they did not believe it could replace the need for traditional genetic counseling, highlighting its role as a supportive tool rather than a substitute.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Rosa Chatbot Providing Genetic Information to Patients at Risk of Hereditary Breast and Ovarian Cancer: Qualitative Interview Study. Siglen, E., Vetti, HH., Augestad, M., et al.[2023]

In a study of 545 average-risk pregnant women in Finland, the initial test failure rate for a non-invasive prenatal testing method was 1.5%, but this rate dropped to 0.2% after repeating the test with a second sample.

The ability to resolve 7 out of 8 test failures through repeat testing significantly enhances the reliability and clinical utility of the non-invasive prenatal testing, making it a more effective tool for prenatal screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of repeat testing of a non-sequencing based NIPT test on a Finnish general-risk population. Karlsson, F., Ahola, T., Dahlberg, J., et al.[2022]

In a study involving 95,166 patients, 64.2% engaged with a clinical chatbot designed to assess hereditary cancer risk, with 89.4% completing the risk assessment, indicating high acceptability and usability of the tool.

The chatbot identified that 25% of users met the criteria for genetic testing for hereditary cancer syndromes, and among those tested, 5.6% had a pathogenic variant, demonstrating its effectiveness in triaging high-risk patients for further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. Nazareth, S., Hayward, L., Simmons, E., et al.[2023]

Participants in focus groups found chatbots to be an engaging and acceptable method for consenting to genomic research and managing follow-up actions after receiving genetic results, indicating potential for broader use in healthcare.

Despite limited prior experience with chatbots, most participants expressed willingness to use them for sharing genetic information with relatives, suggesting that these technology-based tools could effectively facilitate communication in genetic counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient assessment of chatbots for the scalable delivery of genetic counseling. Schmidlen, T., Schwartz, M., DiLoreto, K., et al.[2020]

Over a 39-month period, a technology platform successfully delivered 67,122 noninvasive prenatal screening (NIPS) results, with 4,673 patients opting for genetic counseling, primarily after receiving negative results (95.2%).

The study highlights that combining web-based education, automated notifications, and telegenetic counseling can effectively manage the disclosure of NIPS results, aligning with professional guidelines and improving patient access to information and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Driven Noninvasive Prenatal Screening Results Disclosure and Management. Arjunan, A., Ben-Shachar, R., Kostialik, J., et al.[2021]

A web-based educational tool significantly increased knowledge and feelings of empowerment regarding genetic testing among 305 patients, regardless of their health literacy levels, indicating its effectiveness in educating patients before genetic counseling.

The tool may help address the shortage of trained genetic providers by streamlining the delivery of genetic services, as it was shown to enhance patient understanding without altering attitudes towards testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. Cragun, D., Weidner, A., Tezak, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06382636

Engaging Patients in Prenatal Genetic Testing Decisions ... This arm will utilize an artificial intelligence AI enabled healthcare chatbot that provides patients with personalized information and decision-making support ...

2. withpower.com withpower.com/trial/ai-chatbot-for-prenatal-disorder-eb195

AI Chatbot for Prenatal Disorder (OPUS Trial) Trial Overview The study tests an artificial intelligence chatbot named OPUS designed to aid pregnant patients in understanding and deciding on genetic testing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0738399124004245

Chatbot for patient education for prenatal aneuploidy testing Pre-test education via a chatbot can increase patient knowledge of prenatal testing choices, with high patient and provider satisfaction.

4. reporter.nih.gov reporter.nih.gov/search/M70ZCSPKRE-j8thjhoXEcw/project-details/10877772

Comparing Game Facilitated Interactivity to Genetic ... Aim 3: To compare the effectiveness of a prenatal screening education game to improve knowledge and reduce decisional conflict among partners of pregnant women.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07077707?aggFilters=status%3Anot

Prenatal Genetics Chatbot Trial: Prenatal GENEie Fill out a survey about how comfortable they feel with their decision to do or not do prenatal genetic testing. Detailed Description. Current recommendations ...

6. reporter.nih.gov reporter.nih.gov/project-details/11194281

A Randomized Trial of Chatbot for Prenatal Genetic ... The proposed public health research will yield high-quality evidence on the ability of an educational chatbot to increase patient knowledge and uptake of ...

7. lerner.ccf.org lerner.ccf.org/news/article/?title=Cleveland+Clinic+creates+chatbot+to+help+patients+understand+prenatal+genetic+testing+options&id=25e92232fd25facef1367848ae5bec2a8a92f685

Cleveland Clinic creates chatbot to help patients ... A chatbot to help patients navigate the complex and evolving field of prenatal genetic testing is being developed by researchers at Cleveland Clinic.

8. clinconnect.io clinconnect.io/trials/NCT06382636

Engaging Patients in Prenatal Genetic Testing Decisions The researchers are developing a new digital tool called OPUS, which is an artificial intelligence (AI) chatbot. This tool will guide patients through the ...