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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn about how Urogynecology patients use Artificial Intelligence (AI) Chatbots like ChatGPT, and how it affects healthcare decision making. The main question\[s\] it aims to answer are: * How does the AI Chatbot affect participants' understanding of diagnoses and participant satisfaction with a urogynecology consultation? * How accurate is the chatbot-provided diagnosis and counseling information? Participants will be asked to use the ChatGPT chatbot and ask it questions about the main problem the participant is seeing the doctor for, and will also be asked to fill out some questionnaires. Researchers will compare using the Chatbot before the visit, after the visit, or not at all to see if the way participants understand the information changes based on timing of use.

Research Team

Nicole J Wood, MD

Principal Investigator

Hartford Hosptial Division of Urogynecology

Elena Tuntisky-Bitton, MD

Principal Investigator

Hartford Hosptial Division of Urogynecology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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