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Набор скоро начнётся NCT07393568

The Influence of Patient Use of Artificial Intelligence on Doctor-Patient Interaction and Clinical Outcomes in Endometriosis Consultations

Наблюдательное Endometriosis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: using Chat gpt before outpatient clinic visit.
Кому может быть актуально
Состояния в реестре: Endometriosis. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Generative artificial intelligence (AI), including large language models such as ChatGPT, Gemini, and Copilot, is increasingly used by patients to obtain medical information and prepare for clinical encounters. Although these tools often provide guideline-consistent information, their responses may be incomplete, inaccurate, or lack personalization, potentially influencing patient expectations and clinical interactions. The impact of patient AI use on satisfaction, adherence, and physician-patient communication remains poorly understood. This prospective comparative study will evaluate the effects of patient AI use prior to gynecologic consultations for endometriosis. Women attending a specialized endometriosis clinic will be categorized as AI users or non-users based on their preparation for the visit. Patient-reported outcomes, including satisfaction, expectations, adherence to physician recommendations, and pain during physical examination, will be assessed using validated questionnaires and visual analogue scales. Physicians, blinded to AI use, will independently assess patient engagement, trust, and compliance. Visit duration will also be recorded. The primary objective is to determine whether AI use affects patient satisfaction and adherence to treatment recommendations. Secondary objectives include evaluating physician-perceived interaction quality and concordance between AI-generated guidance and physician recommendations. Findings from this study will provide critical evidence on how AI influences patient behavior and clinical care in endometriosis, informing best practices for integrating AI-informed patients into routine clinical encounters.

Подробное описание

Generative artificial intelligence (AI), including large language models, is increasingly used by patients to obtain medical information prior to clinical encounters. These tools provide rapid access to health-related content and may influence patient knowledge, expectations, communication style, and decision-making during physician consultations. The effect of patient use of AI tools on the doctor-patient interaction and short-term clinical outcomes in the context of endometriosis care has not been systematically evaluated.

This prospective comparative study is designed to examine differences in patient-reported and physician-reported outcomes between patients who used AI tools to prepare for an endometriosis-related consultation and those who did not. The study is conducted in a gynecology outpatient clinic specializing in endometriosis care. All eligible adult women attending the clinic during the study period are invited to participate. Following informed consent, participants are categorized into two groups based on self-reported use of AI tools for preparation prior to the clinic visit.

Data collection is performed using structured questionnaires administered before and after the clinical consultation. The pre-visit questionnaire captures baseline information regarding prior use of artificial intelligence tools, including use for medical information and preparation for the current visit. Baseline demographic and clinical characteristics are also collected. The post-visit questionnaire captures patient-reported satisfaction with the consultation, intention to adhere to the physician's treatment recommendations, perceived concordance between AI-provided information and physician guidance, perceived added value of the physician beyond AI, and perceived necessity of the in-person visit.

Physicians conducting the consultations are blinded to patient AI usage status and complete a structured assessment immediately after each visit. Physician-reported measures include perceived patient trust, compliance, engagement, and prior knowledge, as well as the duration of the consultation. Pain experienced during the physical examination is recorded using a visual analog scale.

No discussion of questionnaire responses occurs between physicians and participants during the visit. All physicians involved in data collection hold valid Good Clinical Practice certification and are listed as investigators or sub-investigators. Data are collected anonymously using coded identifiers and stored securely in accordance with institutional data protection policies.

Comparisons are performed between AI users and non-users to evaluate differences in patient satisfaction, intention to adhere to treatment recommendations, physician-perceived interaction quality, pain during examination, and visit duration. This study aims to provide structured evidence regarding the influence of patient use of artificial intelligence on the clinical encounter in endometriosis care and to inform future integration of AI-informed patients into routine clinical practice.

Вмешательства

  • Другое using Chat gpt before outpatient clinic visit
    This study involves a behavioral, non-randomized observational intervention based on patients' self-directed use of generative artificial intelligence (AI) tools prior to their clinical visit. The intervention group consists of patients who report using AI-based large language models (e.g., ChatGPT or similar tools) to prepare for their endometriosis-related consultation. AI use may include seeking information about symptoms, diagnosis, treatment options, prognosis, or formulating questions for

Первичные конечные точки

  • Patient Satisfaction and Treatment Plan Adherence After Consultation [Срок оценки: Immediately after the consultation (same day)]
Вторичные конечные точки (1)
  • Physician-Perceived Interaction Quality and Consultation Characteristics [Срок оценки: During and immediately after the consultation (same day)]

Критерии участия

Критерии включения

  • Women aged ≥18.
  • Attending clinic for endometriosis-related complaints.
  • Able to give informed consent.

Критерии исключения

  • Cognitive impairment or psychiatric conditions that affect communication or the ability to provide informed consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07393568 · 0423-25-HMO

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗