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Uterovaginal ProlapseNCT06481436

Use of Artificial Intelligence by Urogynecologic Patients

A study testing Use of ChatGPT in people with Uterovaginal Prolapse and Urinary Incontinence, run by Hartford Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 89 years, women only
What is being tested?
Use of ChatGPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
1 siteUnited States
Study dates
22 Jul 2024to 1 Apr 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • any race/ethnicity
  • able to read or speak English or Spanish
  • able/willing to consent to participate

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Hartford Hospital

    Hartford, Connecticut, 06106

Other trials in United States

About this study

Official title: Use of Artificial Intelligence by Patients for Understanding of Diagnosis of Urogynecologic Conditions and Its Role in Treatment Decisions

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.

Read the detailed 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.

Being tested
Use of ChatGPT
Keywords
Artificial Intelligence
Medical subject headings
Urinary Incontinence, Lower Urinary Tract Symptoms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of ChatGPTBehavioural

    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.

Study groups in NCT06481436
Study groupRoleWhat they receive
Pre-Visit ChatGPT UseExperimentalAfter 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.
Receives: Behavioral: Use of ChatGPT
Post-Visit ChatGPT UseExperimentalAfter 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.
Receives: Behavioral: Use of ChatGPT
No ChatGPT UseNo interventionAfter 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline and three month follow-up

  4. 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.

    Measured: Baseline and three month follow-up

  5. 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.

    Measured: Baseline and three month follow-up

Secondary outcomes (4)

  1. 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.

    Measured: Baseline and three month follow-up

  2. 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.

    Measured: Baseline and three month follow-up

  3. 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.

    Measured: Three month follow-up

  4. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2024
  2. Study start22 Jul 2024
  3. Primary completion16 Dec 2024
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06481436
Sponsor's protocol ID
HHC-2024-0097
Status last verified
Dec 2024
First submitted
11 Jun 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37486359

  • 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.

    PubMed 18533119

  • 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.

    PubMed 21420230

  • 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.

    PubMed 36924907

  • 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.

    PubMed 38484238

  • 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.

    PubMed 37085095

  • Wood NJ, O'Sullivan DM, Tunitsky-Bitton E. Chatbot Use by Patients Seeking Urogynecologic Consultation: A Randomized Trial. Urogynecology (Phila). 2026 Jul 10. doi: 10.1097/SPV.0000000000001906. Online ahead of print.

    PubMed 42425711

  • Wood NJ, Ferrando CA, Tunitsky-Bitton E. Using Chatbot to Better Understand What Matters Most to Urogynecologic Patients. Urogynecology (Phila). 2026 Mar 1;32(3):172-179. doi: 10.1097/SPV.0000000000001778.

    PubMed 41626943

Questions about this trial

What is this clinical trial studying?

A study testing Use of ChatGPT in people with Uterovaginal Prolapse and Urinary Incontinence, run by Hartford Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient understanding of diagnosis and treatment - physician understanding of diagnosis (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06481436, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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