PainTrain-AI Implementation Trial in Primary Care (Competency Gaps and Gender Bias)

NCT07507019 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2026-04-02

No results posted yet for this study

Summary

Cluster trial to assess the effect of a digital clinical simulation (PainTrain AI) on clinical adequacy (0-100 rubric) across T0-T1-T2 in Primary Care. Secondary endpoints: SUS, adherence, low value practice indicators, and latency/friction. The intervention is educational/behavioral; the platform is non diagnostic and RAG fenced to validated content. Analysis per protocol: DiD and LMM/GLMM.

Conditions

  • Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal Pain

Interventions

BEHAVIORAL

PainTrain-AI Educational Training

PainTrain-AI is a behavioral educational intervention delivered through a digital clinical simulation platform. The system uses a retrieval-augmented generation (RAG) safety architecture that restricts all outputs to validated clinical content; the platform is non-diagnostic and does not generate new clinical information. Participants complete simulated consultations with virtual standardized patients and a series of brief micromodules designed to train biopsychosocial clinical reasoning for chronic musculoskeletal pain. The intervention is used exclusively for professional training and does not involve patient data. All participants in the intervention arm complete assessments at T0, T1, and T2.

BEHAVIORAL

Usual Training / Standard Practice

Participants continue with usual training and standard practice available at their institution. No exposure to PainTrain-AI occurs. This arm serves as the active comparator.

Sponsors & Collaborators

  • Francesc Valenzuela Pascual

    lead OTHER

Principal Investigators

  • Fran Valenzuela-Pascual, PhD · IRBLleida / Universitat de Lleida

  • Ester García Martínez, PhD · Universitat de Lleida / IDIAP Jordi Gol

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2029-03-31
Primary Completion
2030-03-31
Completion
2030-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07507019 on ClinicalTrials.gov