Pragmatic Randomized Clinical Trial of AI-Assisted Telemedicine to Improve Diagnostic Accuracy Among Primary Care Physicians in El Salvador
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Diagnostic Accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
AI Disabled (Standard Telemedicine)
Physicians in this arm will conduct telemedicine consultations with the AI assistant features temporarily disabled. They will perform the standard clinical workflow without automated support for history taking or diagnostic suggestions. This arm represents the removal of the AI tool to measure its impact.
干预措施: Standard Telemedicine Workflow (No AI) (Other)
AI Enabled (AI-Assisted Telemedicine)
Physicians in this arm will conduct telemedicine consultations with full access to the DoctorSV AI assistant.
干预措施: DoctorSV AI Assistant (Device)
结局指标
主要结局
Diagnostic Accuracy
时间窗: Through study completion, ~ 12-16 weeks
The proportion of consultations where the primary diagnosis recorded by the participating physician matches the "gold standard" reference diagnosis. The reference diagnosis is established by a panel of three independent, blinded expert evaluators reviewing the anonymized clinical notes. A diagnosis is considered "correct" (value = 1) if it matches the reference diagnosis within the same clinically equivalent diagnostic group; otherwise, it is considered "incorrect" (value = 0). The analysis will compare the proportion of correct diagnoses between the AI-enabled and AI-disabled arms.
次要结局
- Diagnostic Concordance(Through study completion, ~12-16 weeks)
- Diagnostic Accuracy Stratified by Physician Experience Level(Through study completion, ~12-16 weeks)
- Diagnostic Accuracy Stratified by Clinical System(Through study completion, ~12-16 weeks.)