AI Telemedicine Support for Primary Care Physicians in El Salvador

Официальное название

Pragmatic Randomized Clinical Trial of AI-Assisted Telemedicine to Improve Diagnostic Accuracy Among Primary Care Physicians in El Salvador

Обзор

The goal of this clinical trial is to learn whether access to an artificial intelligence (AI) clinical decision support assistant can improve diagnostic accuracy during real-world telemedicine consultations among primary care physicians in El Salvador. The main questions it aims to answer are: * Does access to the AI assistant increase the proportion of correct diagnoses compared to telemedicine without AI assistance? * Does the effect of the AI assistant differ according to the physician's prior experience using AI in telemedicine? Researchers will compare physicians with the AI assistant enabled to physicians with the AI assistant temporarily disabled to see if access to AI improves diagnostic accuracy. Participants (physicians) will: * Provide telemedicine consultations as part of their routine clinical duties. * Be randomly assigned to either have the AI assistant enabled or disabled during the study period. * Continue documenting clinical encounters in the electronic platform as usual. * Have their anonymized consultation notes reviewed by an independent expert panel to determine diagnostic accuracy.

Вмешательства

• Устройство DoctorSV AI Assistant
  An AI tool integrated into the telemedicine platform, built on Google's Gemini Large Language Models (LLMs). The system operates via two modules: (1) a clinical history assistant that supports structured documentation of patient information in real-time and (2) a pre-diagnosis tool that analyzes documented clinical data to generate differential diagnosis suggestions for the physician's consideration. The model uses contextual prompting to ensure suggestions are culturally and clinically appropr
• Другое Standard Telemedicine Workflow (No AI)
  Standard primary care consultation via videocall without the assistance of artificial intelligence tools. Physicians rely solely on their own clinical judgment and manual documentation without automated summaries or diagnostic prompts.

Первичные конечные точки

• Diagnostic Accuracy [Срок оценки: Through study completion, ~ 12-16 weeks]

Вторичные конечные точки (3)

• Diagnostic Concordance [Срок оценки: Through study completion, ~12-16 weeks]
• Diagnostic Accuracy Stratified by Physician Experience Level [Срок оценки: Through study completion, ~12-16 weeks]
• Diagnostic Accuracy Stratified by Clinical System [Срок оценки: Through study completion, ~12-16 weeks.]

Критерии участия

Критерии включения

• Must be a physician employed by the DoctorSV telemedicine program
• Must provide written informed consent to participate in the study
• Consultations must be for acute pathologies of the digestive, respiratory, or urinary systems, or acute ophthalmic infections manageable in primary care
• Consultation must be the first medical contact (first visit) for the current acute episode
• The condition must correspond to specific ICD-11 codes defined in the study protocol

Критерии исключения

• Physicians who are inactive on the platform for more than 4 consecutive weeks
• Physicians who transition to work modalities other than telemedicine or reduce their working hours to less than 20 hours per week
• Physicians whose employment contract ends (resignation, dismissal, or contract completion) during the data collection period
• Consultations classified by the physician as requiring immediate in-person attention
• Consultations requiring referral to another level of care or specialty for definitive management
• Consultations interrupted or incomplete due to connectivity or system failures
• Consultations solely for administrative purposes (e.g., certificates, repeat prescriptions without clinical evaluation)
• Consultations that are follow-up visits or controls for a previously evaluated episode

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

El Salvador · 1 центр

• Hospital Nacional El Salvador — San Salvador

Идентификаторы

NCT: NCT07406919 · CNEIS/2025/32

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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