Use of Artificial Intelligence by Patients for Understanding of Diagnosis of Urogynecologic Conditions and Its Role in Treatment Decisions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Patient understanding of diagnosis and treatment - decision making
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
This is a non-blinded study
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient understanding of diagnosis and treatment - decision making
时间窗: Baseline and three month follow-up
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.
Patient understanding of diagnosis and treatment - physician understanding of diagnosis
时间窗: Baseline
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.
Patient understanding of diagnosis and treatment - physician perception of participant understanding
时间窗: Baseline
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.
Patient understanding of diagnosis and treatment - participant understanding of diagnosis and treatment plan
时间窗: Baseline and three month follow-up
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.
Patient understanding of diagnosis and treatment - understanding of diagnosis
时间窗: Baseline and three month follow-up
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.
次要结局
- Chatbot information accuracy(Baseline)
- Patient satisfaction - Chatbot(Baseline and three month follow-up)
- Patient satisfaction - medical visit(Baseline and three month follow-up)
- Patient Chatbot use after urogynecology visit(Three month follow-up)