Use of Artificial Intelligence by Urogynecologic Patients

NCT06481436 | Active Not Recruiting

• 1 other identifier: HHC-2024-0097
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uterovaginal Prolapse; Urinary Incontinence; Lower Urinary Tract Symptoms

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Patient satisfaction - medical visit

  Baseline and three month follow-up

• Patient satisfaction - Chatbot

  Baseline and three month follow-up

• Patient Chatbot use after urogynecology visit

  Three month follow-up

• Chatbot information accuracy

  Baseline

Study Arms (3)

Pre-Visit ChatGPT Use

EXPERIMENTAL

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.

Behavioral: Use of ChatGPT

Post-Visit ChatGPT Use

EXPERIMENTAL

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.

Behavioral: Use of ChatGPT

No ChatGPT Use

NO 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.

Interventions

Use of ChatGPT BEHAVIORAL

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; Pre-Visit ChatGPT Use

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

Related Publications (7)

• 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.

  PMID: 37486359 BACKGROUND

• 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.

  PMID: 18533119 BACKGROUND

• 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.

  PMID: 21420230 BACKGROUND

• 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.

  PMID: 36924907 BACKGROUND

• 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.

  PMID: 38484238 BACKGROUND

• 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.

  PMID: 37085095 BACKGROUND

• Wood NJ, Ferrando CA, Tunitsky-Bitton E. Using Chatbot to Better Understand What Matters Most to Urogynecologic Patients. Urogynecology (Phila). 2026 Feb 2. doi: 10.1097/SPV.0000000000001778. Online ahead of print.

  PMID: 41626943 DERIVED

MeSH Terms

Conditions

Urinary Incontinence; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole J Wood, MD

  Hartford Hosptial Division of Urogynecology

  PRINCIPAL INVESTIGATOR

• Elena Tuntisky-Bitton, MD

  Hartford Hosptial Division of Urogynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a non-blinded study
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 1, 2024
• Study Start: July 22, 2024
• Primary Completion: December 16, 2024
• Study Completion: April 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)