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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Eligibility

Primary outcome measure(s)

• Clinical adequacy score (0-100 rubric) — Baseline (T0), immediate post-training (T1), and 3-month follow-up (T2)
  Clinical adequacy will be assessed using a validated 0-100 rubric applied to standardized clinical cases. Scores range from 0 (lowest adequacy) to 100 (highest adequacy), and higher scores indicate a better clinical outcome. The rubric evaluates three domains: (1) evaluation/triage (appropriate tests and red-flag assessment), (2) therapeutic recommendation (prioritizing active strategies and evidence-based pain education), and (3) clinical communication (avoiding iatrogenic messages and establishing functional goals). Scores are generated by double-blinded assessors with adjudication by a third reviewer in case of disagreement (target kappa ≥0.70). Change will be analyzed from T0 to T1 and T2.

Trial sites (2)

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