A Project to Enhance Dermatology E-consultations in Primary Care Centers Using Artificial Intelligence Tools.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 131
- Locations
- 1
- Primary Endpoint
- Referral appropriateness
Study Overview
Brief Summary
The goal of this observational study is to learn if an artificial intelligence (AI) tool helps primary care practitioners better identify skin conditions. The study focuses on adults with suspected skin pathologies, including tumor, inflammatory, and infectious diseases.
The main questions it aims to answer are:
- Does using the AI tool help doctors make more accurate diagnoses for multiple skin conditions?
- Does the tool help doctors better decide which patients need a referral to a dermatologist and which can be managed in primary care?
- Are doctors satisfied with how well the tool works and how easy it is to use in their daily work?
- Can the tool help doctors more accurately differentiate between benign lesions and skin cancer?
Participants will:
- Visit their primary care doctor for a regular skin checkup.
- Have photos taken of their skin condition using a smartphone or a dermatoscope.
- Provide informed consent for their photos and basic health information (such as age and sex) to be analyzed by the AI tool.
- Receive standard care from their doctor, with the tool providing a second opinion to assist in the clinical decision-making process.
Detailed Description
This prospective, observational study evaluates the clinical utility of an artificial intelligence (AI)-based computational software device designed to support primary care practitioners (PCPs) and dermatologists in managing skin pathologies. The research explores whether the device can enhance diagnostic accuracy and optimize the referral process from primary care to specialized dermatology services.
Study Methodology and Design
The investigation is designed as an analytical study of a clinical case series. Key technical aspects include:
- Investigational Tool: A software-only medical device using computer vision algorithms to analyze images of the epidermis and dermis to provide clinical data for assessment.
- Participant Roles: 15 HCPs (including PCPs and dermatologists) evaluated with a cohort of over 100 patients.
- Procedural Workflow: PCPs captured skin images using smartphones or mobile dermatoscopes, uploaded them to the platform, and provided a diagnosis guided by the AI results.
- Evaluation Baseline: HCPs acted as their own controls, allowing for a comparison of diagnostic performance with and without the AI tool.
Quality Assurance and Registry Procedures
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Tumor pathology:
- •Histiocytoma
- •Seborrheic keratosis
- •Precancerous:
- •Actinic keratosis
- •Suspected malignancy:
- •Basal cell carcinoma
- •Squamous cell carcinoma
- •Pigmented lesions:
- •Melanocytic nevus
- •Malignant melanoma
- •Inflammatory pathology:
- •Psoriasis
- •Atopic dermatitis
- •Urticaria
- •Hidradenitis suppurativa
- •Lichen planus
- •Infectious pathology:
- •Viral warts
- •Herpes simplex
- •Patients aged 18 years or older.
- •Patients who have signed the informed consent for the study.
Exclusion Criteria
- •Patients under 18 years of age.
- •Pregnant patients.
- •Patients who, in the opinion of the researcher, will not comply with the study procedures.
Arms & Interventions
Patiens with skin conditions treated in Primary care
This single-group cohort comprises adult patients presenting with diverse skin pathologies who were evaluated by healthcare professionals (HCPs) using an AI-based clinical decision support tool. The cohort includes individuals suspected of having tumoral (benign or malignant), inflammatory, or infectious conditions.
Intervention: Primary care practitioners aided by Legit.Health Plus (Device)
Outcomes
Primary Outcomes
Referral appropriateness
Time Frame: Baseline
This metric evaluates the appropriateness of patient referrals from primary care to specialized dermatology services. A referral is classified as "avoidable" or "unnecessary" when both the primary care practitioner and the expert dermatologist agree that the case can be effectively managed within primary care without a specialist consultation. The study's primary target for this metric was a minimum increase in referral adequacy of 15%. This threshold represents the minimum clinically important difference required to demonstrate the device's utility in optimizing clinical workflows and reducing healthcare costs.
Secondary Outcomes
- Area Under the ROC Curve (AUC) for Malignancy Detection(Baseline)
- Healthcare Professional Satisfaction (CUS Score)(4 months (practitioners completed the questionnaire twice: once at 2 months and again at 4 months after starting the study).)