Use of Artificial Intelligence by Urogynecologic Patients
NCT Number: NCT06481436
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Uterovaginal Prolapse|Urinary Incontinence|Lower Urinary Tract Symptoms
Interventions: BEHAVIORAL: Use of ChatGPT
Sponsor: Hartford Hospital
Collaborators: Boston Scientific Corporation
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 125
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-07-22
Completion Date: 2025-12-01
Locations: Hartford Hospital, Hartford, Connecticut, 06106, United States

Summary:
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.

Primary Outcome Measures: Patient understanding of diagnosis and treatment - physician understanding of diagnosis, The effect of use of an AI Chatbot platform on participant understanding of diagnosis at the initial urogynecology visit. This will be measured by the incidence of agreement of participant-reported diagnosis with their physician-reported diagnosis. The physician will be asked the patient's primary diagnosis in one multiple choice question (part of Physician Questionnaire). There are no minimum or maximum values to this questionnaire, and there are no answers that would mean a better or worse outcome., Baseline|Patient understanding of diagnosis and treatment - physician perception of participant understanding, The effect of use of an AI Chatbot platform on participant understanding of diagnosis at the initial urogynecology visit. This will be measured by the incidence of agreement of participant-reported diagnosis with their physician-reported diagnosis. The physician will be asked about the participants' understanding of their diagnosis and treatment plans in three multiple choice questions (part of Physician Questionnaire). The questionnaire will ask for responses on a Likert Scale 1 - 5, with the minimum value of 1 being "Strongly Disagree" and 5the maximum value of 5 being "Strongly Agree." Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 15., Baseline|Patient understanding of diagnosis and treatment - participant understanding of diagnosis and treatment plan, The effect of use of an AI Chatbot platform on participant understanding of diagnosis at the initial urogynecology visit. This will be measured by the incidence of agreement of participant-reported diagnosis with their physician-reported diagnosis. The participant will be provided with a three-item questionnaire (Post Consultation Participant Questionnaire). Each item will have multiple choice options. The participant will be asked asked to select the participant's primary diagnosis, treatment options, and selected management plan. There are no minimum or maximum values to this questionnaire, and there are no answers that would mean a better or worse outcome., Baseline and three month follow-up|Patient understanding of diagnosis and treatment - understanding of diagnosis, The effect of use of an AI Chatbot platform on participant understanding of diagnosis at the urogynecology initial visit. This will be measured by rate of participant agreement to a medical decision making questionnaire (Understanding of Diagnosis Questionnaire). The questionnaire has three items, and will ask for responses on a Likert Scale 1 - 5, with the minimum value of 1 being "Strongly Disagree" and the maximum value of 5 being "Strongly Agree." Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 15., Baseline and three month follow-up|Patient understanding of diagnosis and treatment - decision making, The effect of use of an AI Chatbot platform on participant decision making at the urogynecology initial visit. This will be measured by rate of participant agreement to a validated medical decision making questionnaire (Decisional Conflict Scale). The questionnaire has sixteen items, and will ask for responses on a Likert Scale 1 - 5, with the minimum value of 1 being "Strongly Disagree" and the maximum value of 5 being "Strongly Agree." Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 80., Baseline and three month follow-up
Secondary Outcome Measures: Patient satisfaction - medical visit, The effect of use of an AI Chatbot platform on participant satisfaction with the urogynecology visit. This will be measured by rate of participant agreement to a satisfaction questionnaire (Patient Satisfaction Questionnaire). The questionnaire has four items, and will ask for responses on a Likert Scale 1 - 5, with the minimum value of 1 being "Very Unsatisfied" and the maximum value of 5 being "Very Satisfied." Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 20., Baseline and three month follow-up|Patient satisfaction - Chatbot, The effect of use of an AI Chatbot platform on participant satisfaction with the urogynecology visit. This will be measured by rate of participant agreement to a satisfaction questionnaire (Chatbot Satisfaction Questionnaire). The questionnaire has six items, and will ask for responses on a Likert Scale 1 - 5, with the minimum value of 1 being "Strongly Disagree" and the maximum value of 5 being "Strongly Agree." Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 30., Baseline and three month follow-up|Patient Chatbot use after urogynecology visit, The participant use of the Chatbot platform at home after the urogynecology visit. This will be measured by one yes or no question asking if the participant used the Chatbot after the Urogynecology visit (Three Month Questionnaire). The questionnaire has one yes/no item. There are no minimum or maximum values to this questionnaire, and there are no answers that would mean a better or worse outcome., Three month follow-up|Chatbot information accuracy, The accuracy of chatbot-provided diagnosis and counseling information via expert clinician review. This will be measured by expert review of all chatbot transcripts by two independent clinicians with a third for adjudication with assessment using the Patient Education Materials Assessment Tool (PEMAT). The questionnaire has twenty-six items, and will ask for responses on a two point scale of "Disagree" meaning 0 points, and "Agree" meaning 1 point. Higher scores mean a better outcome. Score will be assessed in aggregate with a total possible score of 26., Baseline