PainTrain-AI Pilot: Feasibility, Usability (SUS) and Concept-Shift in Primary Care and a Specialized Setting

Official title

Feasibility and Usability of a Digital Clinical Simulation (PainTrain AI) for Chronic Pain Training in Health Professionals: A Multicenter Pilot in Primary Care (ICS) and a Specialized Comparative Setting

Overview

This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.

Detailed description

This feasibility pilot will evaluate the use of PainTrain AI, a behavioral educational intervention designed to improve clinical reasoning about chronic pain through simulated dialogues with virtual standardized patients. The platform uses a Retrieval Augmented Generation (RAG) safety architecture that restricts all generated responses to validated pedagogical content and does not provide clinical advice. No patient information is collected.

The study includes health professionals from Primary Care and a specialized comparative setting. Participants will complete a baseline assessment and then interact with the PainTrain AI simulation for a defined training period. Usability will be assessed using the System Usability Scale (SUS). Concept shift will be measured as the reduction in predefined neurophysiology misconceptions scored through a standardized rubric. Additional metrics include adherence to micromodules and interaction latency as indicators of technological friction.

This pilot aims to determine feasibility, acceptability, and preliminary signals of educational effectiveness to inform a future implementation trial in Primary Care. The intervention is educational only, non diagnostic, and GDPR compliant.

Interventions

• Behavioral PainTrain-AI Behavioral 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 to ensure that all responses are generated only from validated pedagogical content. Participants engage in simulated dialogues with virtual standardized patients to practice biopsychosocial reasoning about chronic pain. The intervention is non-diagnostic, does not provide clinical advice, and does not involve pa

Primary outcome measures

• Usability (SUS, 0-100) [Time frame: 4-8 weeks after onboarding]

Secondary outcome measures (3)

• Concept Shift [Time frame: 4-8 weeks.]
• Adherence [Time frame: 4-8 weeks]
• Latency/friction [Time frame: 4-8 weeks]

Eligibility criteria

Inclusion criteria

• Health professionals in Primary Care (medicine, physiotherapy, nursing, psychology, nutrition) and specialized setting; willingness to use the platform; institutional approval.

Exclusion criteria

• lack of institutional access; unavailability during pilot window

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

Spain · 1 center

• Universitat de Lleida — Lleida

Identifiers

NCT: NCT07497997 · PT-AI-PILOT-2026

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗