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?

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.

Will I have to stop taking my current medications?

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

Is the AI Chatbot for Prenatal Disorder safe for humans?

The research articles provided do not contain specific safety data about the AI Chatbot for Prenatal Disorder or its related names like OPUS. They focus on noninvasive prenatal testing and genetic counseling, but do not address the safety of the chatbot itself. ^{1 2 3 4 5}

How is the OPUS treatment for prenatal disorders different from other treatments?

The OPUS treatment is unique because it uses an AI chatbot to engage patients in prenatal genetic testing, providing personalized and accessible information, which is not typically available in standard prenatal care. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) for prenatal disorders?

Research on similar technology-driven solutions, like chatbots and web-based tools for genetic testing in cancer, shows promise in providing reliable information and counseling, which could be beneficial for prenatal genetic testing as well. These tools have been effective in managing large-scale results delivery and patient education, suggesting potential effectiveness for OPUS in prenatal settings. ^{3 4 5 7 10}

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

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 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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. Canada 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. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Patient Interactions With an Automated Conversational Agent Delivering Pretest Genetics Education: Descriptive Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

A Web-Based Tool to Automate Portions of Pretest Genetic Counseling for Inherited Cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Hereditary Cancer Risk Using a Genetic Chatbot Before Routine Care Visits. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Technology-Driven Noninvasive Prenatal Screening Results Disclosure and Management. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of repeat testing of a non-sequencing based NIPT test on a Finnish general-risk population. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

It's More Than a Blood Test: Patients' Perspectives on Noninvasive Prenatal Testing. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Reducing Preconception Risks Among African American Women with Conversational Agent Technology. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Patient assessment of chatbots for the scalable delivery of genetic counseling. [2020]

10. Ireland pubmed.ncbi.nlm.nih.gov

Ask Rosa - The making of a digital genetic conversation tool, a chatbot, about hereditary breast and ovarian cancer. [2022]