AI Telemedicine Support for Primary Care Physicians in El Salvador

NCT07406919 | Not Yet Recruiting

• 1 other identifier: CNEIS/2025/32
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Artificial Intelligence (AI) in Diagnosis

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  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.

  Through study completion, ~ 12-16 weeks

Secondary Outcomes (3)

• 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.

Study Arms (2)

AI Disabled (Standard Telemedicine)

EXPERIMENTAL

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.

Other: Standard Telemedicine Workflow (No AI)

AI Enabled (AI-Assisted Telemedicine)

ACTIVE COMPARATOR

Physicians in this arm will conduct telemedicine consultations with full access to the DoctorSV AI assistant.

Device: DoctorSV AI Assistant

Interventions

DoctorSV AI Assistant DEVICE

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 appropriate for El Salvador.

AI Enabled (AI-Assisted Telemedicine)

Standard Telemedicine Workflow (No AI) OTHER

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.

AI Disabled (Standard Telemedicine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital El Salvador: lead

Study Sites (1)

Hospital Nacional El Salvador

San Salvador, El Salvador

Location

Study Officials

• Manuel Bello, MD

  Hospital Nacional El Salvador

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Principal Investigator

CONTACT

212-203-3323; stella@saglobalhealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Because participants are assigned to one of two arms and remain in that arm throughout the trial, this is a parallel study model.

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)