Artificial Intelligence (AI) in DiagnosisNCT07406919
AI Telemedicine Support for Primary Care Physicians in El Salvador
A study testing DoctorSV AI Assistant and Standard Telemedicine Workflow (No AI) in people with Artificial Intelligence (AI) in Diagnosis, run by Hospital El Salvador at 1 site in El Salvador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Artificial Intelligence (AI) in Diagnosis
- What is being tested?
- DoctorSV AI Assistant and Standard Telemedicine Workflow (No AI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteEl Salvador
- Study dates
- 17 Feb 2026to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pragmatic Randomized Clinical Trial of AI-Assisted Telemedicine to Improve Diagnostic Accuracy Among Primary Care Physicians in El Salvador
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:
Read more
- 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.
- Being tested
- DoctorSV AI Assistant, Standard Telemedicine Workflow (No AI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoctorSV AI AssistantDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: DoctorSV AI Assistant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, ~ 12-16 weeks
Secondary outcomes (3)
Diagnostic Concordance
The level of agreement between the physician's diagnosis and the expert reference diagnosis, measured using Cohen's Kappa coefficient. This measure evaluates the reliability of the diagnoses beyond simple percentage agreement, accounting for agreement occurring by chance.
Measured: Through study completion, ~12-16 weeks
Diagnostic Accuracy Stratified by Physician Experience Level
Evaluation of diagnostic accuracy (proportion of correct diagnoses) compared between subgroups of physicians with "High Experience" (≥1 year in the program or ≥20 consultations) versus "Low Experience" (<1 year in the program or <20 consultations).
Measured: Through study completion, ~12-16 weeks
Diagnostic Accuracy Stratified by Clinical System
The proportion of correct diagnoses stratified by the physiological system of the pathology: Respiratory, Digestive, Urinary, or Ophthalmic. This outcome assesses if the AI's performance or utility varies depending on the specific type of clinical condition.
Measured: Through study completion, ~12-16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start17 Feb 2026
- Primary completion26 Mar 2026
- Study completion26 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial Intelligence (AI) in DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Because participants are assigned to one of two arms and remain in that arm throughout the trial, this is a parallel study model.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital El Salvador
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Manuel Bello, MD, Principal investigator, Hospital Nacional El Salvador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406919
- Sponsor's protocol ID
- CNEIS/2025/32
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be sent or shared to servers external to those used by the DoctorSV platform to ensure security and privacy of the participants (physicians) as well as the patients. The data is restricted to the research team and the specific objectives of this study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Randomized Clinical Trial of AI-Assisted Telemedicine to Improve Diagnostic Accuracy Among Primary Care Physicians in El Salvador
- ClinicalTrials.gov ID
- NCT07406919
- Acronym / sponsor ID
- CNEIS/2025/32
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospital El SalvadorOther government
- Study start
- 17 Feb 2026 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 26 Mar 2026 (actual)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Because participants are assigned to one of two arms and remain in that arm throughout the trial, this is a parallel study model.
| Arm | Type | Receives |
|---|---|---|
| AI Disabled (Standard Telemedicine) | Experimental | Other: Standard Telemedicine Workflow (No AI)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. |
| AI Enabled (AI-Assisted Telemedicine) | Active comparator | Device: DoctorSV AI AssistantPhysicians in this arm will conduct telemedicine consultations with full access to the DoctorSV AI assistant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoctorSV AI AssistantAn 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. | Device | AI Enabled (AI-Assisted Telemedicine) |
| 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. | Other | AI Disabled (Standard Telemedicine) |
Primary outcome
Diagnostic Accuracy
Time frame: 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.
3 secondary outcomes
Diagnostic Concordance
Time frame: Through study completion, ~12-16 weeks
Diagnostic Accuracy Stratified by Physician Experience Level
Time frame: Through study completion, ~12-16 weeks
Diagnostic Accuracy Stratified by Clinical System
Time frame: Through study completion, ~12-16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No. The data will not be sent or shared to servers external to those used by the DoctorSV platform to ensure security and privacy of the participants (physicians) as well as the patients. The data is restricted to the research team and the specific objectives of this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manuel Bello, MD principal investigator
Hospital Nacional El Salvador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DoctorSV AI Assistant and Standard Telemedicine Workflow (No AI) in people with Artificial Intelligence (AI) in Diagnosis, run by Hospital El Salvador at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: Through study completion, ~ 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.