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

NCT07507019 | Not Yet Recruiting

• 1 other identifier: PT AI FIS CLUST 2026
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

chronic musculoskeletal pain; clinical simulation; digital training; primary care professionals; educational intervention; usability SUS; concept shift

Outcome Measures

Primary Outcomes (1)

• Clinical adequacy score (0-100 rubric)

  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.

  Baseline (T0), immediate post-training (T1), and 3-month follow-up (T2)

Secondary Outcomes (4)

• System Usability Scale (SUS, 0-100)

  Immediately after training

• Adherence to PainTrain-AI micromodules (% completed)

  During the training period (up to 4 weeks)

• Low-value clinical practice indicators (count per case)

  Baseline, immediately after training, and 3 months after training

• System latency (seconds)

  During the training period (up to 4 weeks)

Study Arms (2)

PainTrain-AI Educational Training (Cluster Implementation Arm)

EXPERIMENTAL

Participants in Primary Care centers allocated to the intervention cluster receive the PainTrain-AI behavioral educational training. The intervention consists of simulated clinical encounters with virtual standardized patients and interactive micromodules, using a RAG-fenced architecture restricted to validated clinical content. All participants in this arm complete T0, T1, and T2 assessments.

Behavioral: PainTrain-AI Educational Training

Usual Training / Standard Practice (Control Arm)

ACTIVE COMPARATOR

Participants in Primary Care centers allocated to the control cluster follow usual training and standard practice available at their institution. No exposure to the PainTrain-AI platform occurs during the study period. Centers continue their routine continuing medical education activities. All participants complete T0-T1-T2 assessments with the same standardized clinical cases and rubric. This arm serves as the active comparator for evaluating changes in clinical adequacy, low-value practice indicators, and gender-related decision patterns.

Behavioral: Usual Training / Standard Practice

Interventions

PainTrain-AI Educational Training BEHAVIORAL

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.

PainTrain-AI Educational Training (Cluster Implementation Arm)

Usual Training / Standard Practice BEHAVIORAL

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.

Usual Training / Standard Practice (Control Arm)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health professionals (medicine, nursing, physiotherapy, psychology, nutrition) working at participating Primary Care centers.
• Active clinical practice during the study period.
• Ability to access and use the digital platform (PainTrain-AI) and complete online assessments (T0, T1, T2).
• Provides informed consent.

You may not qualify if:

• Prior exposure to the PainTrain-AI platform within the previous 12 months (risk of contamination).
• Planned absence or temporary leave during the evaluation windows (T0, T1, T2).
• Inability to use the digital platform for technical reasons not solvable by support.
• Declines participation.

Sponsors & Collaborators

• Francesc Valenzuela Pascual: lead

Study Sites (2)

Institut Català de la Salut (ICS) - Primary Care Network

Lleida, Lleida, Spain

Location

Specialized Care Comparative Setting

Lleida, Lleida, Spain

Location

Study Officials

• Fran Valenzuela-Pascual, PhD

  IRBLleida / Universitat de Lleida

  STUDY DIRECTOR

• Ester García Martínez, PhD

  Universitat de Lleida / IDIAP Jordi Gol

  STUDY DIRECTOR

Central Study Contacts

Fran Valenzuela Pascual, PhD

CONTACT

+34 973 702 459; fran.valenzuela@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No participant or investigator masking is applied. Outcome assessors scoring the 0-100 clinical adequacy rubric are blinded to arm allocation and timepoint, with adjudication by a third reviewer in case of disagreement.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator (Sponsor-Investigator)

Model Details: Cluster-assigned parallel design in which entire Primary Care centers are allocated to either the intervention arm (PainTrain-AI) or the control arm (usual training/standard practice). Cluster allocation prevents contamination between groups. Outcomes are measured at T0, T1, and T2 for all participants within each cluster.

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 2, 2026
• Study Start (Estimated): March 1, 2029
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)