Use of Artificial Intelligence by Urogynecologic Patients

Hartford Hospital

Status: Active, not recruiting

Conditions: Lower Urinary Tract Symptoms; Uterovaginal Prolapse; Urinary Incontinence

Treatments: Behavioral: Use of ChatGPT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06481436

HHC-2024-0097

Details and patient eligibility

About

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.

Full description

Artificial Intelligence (AI) in medicine and the use of machine learning to improve patient care and outcomes is a quickly developing field. Interest is building in the use and accuracy of AI chatbot programs such as ChatGPT for patient diagnosis and counseling. A recent study of Chat GPT accuracy compared with patient pamphlets about pelvic organ prolapse found comparable accuracy and completeness.Given the novelty of this field, no current literature exists regarding the use of AI chatbot technology for patient care and patient counseling in Urogynecology.

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.

Enrollment: 125 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female

• 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

• male
• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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125 participants in 3 patient groups

Pre-Visit ChatGPT Use

Experimental group

Description:

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.

Treatment:

Behavioral: Use of ChatGPT

Post-Visit ChatGPT Use

Experimental group

Description:

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.

Treatment:

Behavioral: Use of ChatGPT

No ChatGPT Use

No Intervention group

Description:

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.