AI Chatbot for Urogynecologic Conditions

Overseen By Nicole J Wood, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Hartford Hospital

Disqualifiers: Male, Non-English/Spanish, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how using an AI Chatbot, like ChatGPT, affects patients' understanding of their urogynecology condition and their satisfaction with consultations. It explores the chatbot's accuracy in providing information about urinary issues or pelvic organ prolapse (when pelvic organs drop from their normal position). Participants will use the chatbot either before their visit, after their visit, or not at all to determine if timing influences outcomes. Women experiencing urinary incontinence, lower urinary tract symptoms, or pelvic organ prolapse who speak English or Spanish may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance patient education and satisfaction.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an AI chatbot for understanding urogynecologic conditions, so it's unlikely that medication changes are required.

What prior data suggests that this AI Chatbot is safe for use in healthcare decision making?

Research has shown that ChatGPT, an AI chatbot, is generally liked by users for its clear and reassuring answers. In studies where ChatGPT answered questions about women's pelvic health, users found its explanations easy to understand. While its accuracy can vary depending on usage, it typically performs well, achieving about 77.5% to 81% accuracy on specific medical questions.

As a software tool, ChatGPT does not have physical side effects like a drug might. The main concern is the accuracy of the information it provides. So far, studies suggest it is quite reliable for understanding medical information in women's pelvic health, making it a safe option for helping people learn more about their conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the innovative use of AI technology, specifically ChatGPT, in providing additional support for patients with urogynecologic conditions. Unlike traditional treatment options that typically involve direct medical intervention or advice from healthcare professionals, ChatGPT offers a unique, quick, and accessible way for patients to engage with information about their condition. This AI-driven approach could empower patients by enhancing their understanding and engagement with their healthcare, potentially leading to more informed discussions with their doctors and better overall management of their condition. The trial aims to uncover how this technology might improve patient satisfaction and health outcomes by providing personalized, on-demand information.

What evidence suggests that using an AI Chatbot is effective for improving understanding and satisfaction in urogynecology consultations?

Previous studies have shown that ChatGPT helps make urogynecological information easier to understand. Women found ChatGPT's answers clearer and more comforting than traditional medical advice. It was rated as accurate and complete as standard patient information leaflets for pelvic floor surgeries. Additionally, ChatGPT explains complex medical information, making it a useful tool for patients trying to understand their conditions. In this trial, participants will be divided into groups: some will use ChatGPT before their urogynecology visit, others after, and a control group will not use ChatGPT at all. These findings suggest that using ChatGPT can improve understanding and satisfaction during medical consultations. ^{1 4 6 7 8}

Who Is on the Research Team?

Nicole J Wood, MD

Principal Investigator

Hartford Hosptial Division of Urogynecology

Elena Tuntisky-Bitton, MD

Principal Investigator

Hartford Hosptial Division of Urogynecology

Are You a Good Fit for This Trial?

This trial is for patients experiencing urinary incontinence, lower urinary tract symptoms, or uterovaginal prolapse. Participants should be seeking urogynecology consultation and willing to interact with an AI chatbot like ChatGPT as part of their healthcare decision-making process.

Inclusion Criteria

Any race/ethnicity

I am seeing a specialist for the first time for urinary issues or pelvic organ prolapse.

Able/willing to consent to participate

Exclusion Criteria

Pregnant or lactating, as this may affect patient treatment counseling

Unable/unwilling to consent to participate

I am male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Initial Visit and AI Chatbot Interaction

Participants undergo an initial urogynecology visit and interact with the AI Chatbot either before or after the consultation to assess understanding of diagnosis and treatment options.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for understanding of diagnosis and treatment plan, and satisfaction with the visit, with a follow-up questionnaire administered three months after the initial visit.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• ChatGPT

Trial Overview The study tests how using the ChatGPT AI chatbot affects patient understanding of their condition and satisfaction with urogynecology consultations. It also evaluates the accuracy of diagnoses and advice provided by the chatbot. The timing of chatbot use (before or after a doctor's visit) will be compared.

How Is the Trial Designed?

Group I: Pre-Visit ChatGPT Use Experimental Treatment 1 Intervention

After being consented, the participant will be provided with ChatGPT-4 application and a brief orientation to the program. The participant will then be instructed to ask ChatGPT about the participant's primary presenting problem with will be discussed at their urogynecology consultation. The participant will be allowed up to five follow-up/clarification entries into the Chat GPT program, but may finish asking questions at any time. This should take no more than five minutes of the participant's time. After completing this, the participant will be returned to the waiting room, and will proceed through the urogynecology visit as normal.

Group II: Post-Visit ChatGPT Use Experimental Treatment 1 Intervention

After being consented, the participant will be returned to the waiting room and will proceed through the urogynecology visit as normal. After the visit, the participant will be provided with ChatGPT-4 application and a brief orientation to the program. The participant will then be instructed to ask ChatGPT about the participant's primary presenting problem with will be discussed at their urogynecology consultation. The participant will be allowed up to five follow-up/clarification entries into the Chat GPT program, but may finish asking questions at any time. This should take no more than five minutes of the participant's time. After completing this, the participant will be allowed to leave the visit.

Group III: No ChatGPT Use Active Control 1 Intervention

After undergoing the consent process, participants will be returned to the waiting room to await the beginning of the appointment. The participant will complete the urogynecology visit as normal.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology

Citations

1. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/aogs.70085

ChatGPT in urogynecology: Comparing large language model ... This exploratory study found that women rated ChatGPT's responses in urogynecology as clearer and more reassuring than those of a subspecialty ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38484238/

Evaluation of ChatGPT for Pelvic Floor Surgery Counseling ChatGPT is similarly accurate and complete when compared with standard patient information leaflets for common urogynecological procedures.

3. ovid.com ovid.com/journals/urogc/fulltext/10.1097/spv.0000000000001459~evaluation-of-chatgpt-for-pelvic-floor-surgery-counseling

Evaluation of ChatGPT for Pelvic Floor Surgery Counseling Seven urogynecologists compared the accuracy and completeness of ChatGPT responses to standard patient leaflets using 5-point Likert scales with a score of 3 ...

4. ajog.org ajog.org/article/S0002-9378(24)00122-4/pdf

Performance of chat generative pre-trained transformer ( ... The sling offered an effective, fast, and safe surgical management option and became the gold standard. Urogynecology and Reconstructive. Pelvic Surgery (URPS) ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2667164623000842

Comparative efficacy of ChatGPT 3.5, ... When synthesizing data, especially complex research in fields like gynecology or infertility, ChatGPT 3.5 effectively interprets findings, a capability ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021367/

Does chatGPT-4.0's awareness of conversing with a ... ChatGPT-4's accuracy on urethritis questions was 81% when not told it was talking to a urologist, and 77.5% when told, with no significant ...

7. researchgate.net researchgate.net/publication/396825736_ChatGPT_in_urogynecology_Comparing_large_language_model_responses_to_human_experts

ChatGPT in urogynecology: Comparing large language ... This study compared the quality of ChatGPT‐generated responses in urogynecology with those provided by a consultant urogynecologist, focusing on ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/36/NCT06481436/Prot_SAP_000.pdf

Use of artificial intelligence by patients for understanding of ... In this study, we hypothesize that use of AI Chatbot technology to discuss urogynecologic diagnoses will improve patient understanding of their ...