Use of Artificial Intelligence by Urogynecologic Patients
NCT ID: NCT06481436
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
125 participants
INTERVENTIONAL
2024-07-22
2025-04-01
Brief Summary
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* 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.
Detailed Description
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This will be a single-center, prospective, randomized, non-blinded study examining patient use of AI Chatbot technology (Chat GPT4) at initial visits to supplement understanding of urogynecologic problems. The primary aim of this study is to investigate the effect of use of an AI Chatbot platform on patient understanding of disease processes and treatment options prior to or following a consult with a urogynecologist at the initial visit. The secondary aims are to evaluate the accuracy of the chatbot-provided diagnosis (for participants applicable through randomization) and counseling information, and to evaluate patient satisfaction with the visit.
This study will recruit patients with presenting problems of prolapse, lower urinary tract symptoms, or incontinence into one of three arms: use of an AI chatbot prior to seeing the urogynecologist, use of an AI chatbot following a consult with the urogynecologist, no use of an AI chatbot at the time of the visit. During time of their initial urogynecology visit, data will be collected including demographics, Pelvic Floor Disorders Inventory (PFDI) intake questionnaire data, health literacy, Chat GPT conversation, office consultation diagnoses/treatment, physician questionnaire, and post-consultation questionnaire (Diagnosis and Treatment, Decisional Conflict Scale, Patient Satisfaction, Chatbot Satisfaction). Patients will be asked three months after their visit to complete the post-consultation questionnaire again.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Pre-Visit ChatGPT Use
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.
Use of ChatGPT
Patients will be provided with the opportunity to ask ChatGPT questions about their primary presenting problem at a time point during their initial Urogynecology consultation visit.
Post-Visit ChatGPT Use
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.
Use of ChatGPT
Patients will be provided with the opportunity to ask ChatGPT questions about their primary presenting problem at a time point during their initial Urogynecology consultation visit.
No ChatGPT Use
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.
No interventions assigned to this group
Interventions
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Use of ChatGPT
Patients will be provided with the opportunity to ask ChatGPT questions about their primary presenting problem at a time point during their initial Urogynecology consultation visit.
Eligibility Criteria
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Inclusion Criteria
* presenting for their initial evaluation by a urogynecology physician for one of the following:
* urinary incontinence (UI)
* lower urinary tract symptoms (LUTS)
* pelvic organ prolapse (POP)
* greater than or equal to18 and less than or equal to89 years old
* any race/ethnicity
* able to read or speak English or Spanish
* able/willing to consent to participate
Exclusion Criteria
* primary presenting problem other than UI, LUTS, or POP
* non-English or non-Spanish speaking
* pregnant or lactating, as this may affect patient treatment counseling
* unable/unwilling to consent to participate
18 Years
89 Years
FEMALE
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Hartford Hospital
OTHER
Responsible Party
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Principal Investigators
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Nicole J Wood, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hosptial Division of Urogynecology
Elena Tuntisky-Bitton, MD
Role: PRINCIPAL_INVESTIGATOR
Hartford Hosptial Division of Urogynecology
Locations
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Hartford Hospital
Hartford, Connecticut, United States
Countries
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References
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Daykan Y, O'Reilly BA. The role of artificial intelligence in the future of urogynecology. Int Urogynecol J. 2023 Aug;34(8):1663-1666. doi: 10.1007/s00192-023-05612-3. Epub 2023 Jul 24.
Robinson CJ, Swift S, Johnson DD, Almeida JS. Prediction of pelvic organ prolapse using an artificial neural network. Am J Obstet Gynecol. 2008 Aug;199(2):193.e1-6. doi: 10.1016/j.ajog.2008.04.029. Epub 2008 Jun 4.
Serati M, Salvatore S, Siesto G, Cattoni E, Braga A, Sorice P, Cromi A, Ghezzi F, Bolis P. Urinary symptoms and urodynamic findings in women with pelvic organ prolapse: is there a correlation? Results of an artificial neural network analysis. Eur Urol. 2011 Aug;60(2):253-60. doi: 10.1016/j.eururo.2011.03.010. Epub 2011 Mar 21.
Grunebaum A, Chervenak J, Pollet SL, Katz A, Chervenak FA. The exciting potential for ChatGPT in obstetrics and gynecology. Am J Obstet Gynecol. 2023 Jun;228(6):696-705. doi: 10.1016/j.ajog.2023.03.009. Epub 2023 Mar 15.
Johnson CM, Bradley CS, Kenne KA, Rabice S, Takacs E, Vollstedt A, Kowalski JT. Evaluation of ChatGPT for Pelvic Floor Surgery Counseling. Urogynecology (Phila). 2024 Mar 1;30(3):245-250. doi: 10.1097/SPV.0000000000001459.
Acker A, Senapati S, Dokras A. Barriers to access: findings from an implementation study of an artificial intelligence-augmented 2-way chatbot for fertility care. Fertil Steril. 2023 Jul;120(1):199-201. doi: 10.1016/j.fertnstert.2023.04.016. Epub 2023 Apr 20. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HHC-2024-0097
Identifier Type: -
Identifier Source: org_study_id