Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal PainPT-AI-IMPNCT07507019
PainTrain-AI Implementation Trial in Primary Care (Competency Gaps and Gender Bias)
A study testing PainTrain-AI Educational Training and Usual Training / Standard Practice in people with Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal Pain, run by Francesc Valenzuela Pascual at 2 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal Pain
- What is being tested?
- PainTrain-AI Educational Training and Usual Training / Standard Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesSpain
- Study dates
- Mar 2029to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites
Institut Català de la Salut (ICS) - Primary Care Network
Lleida, Lleida
Fran Valenzuela Pascual, PhD, +34 973 702 459, fran.valenzuela@udl.cat
Specialized Care Comparative Setting
Lleida, Lleida
Fran Valenzuela Pascual, PhD, +34 973 702 459, fran.valenzuela@udl.cat
About this study
Official title: Implementation of the Digital Intervention PainTrain-AI in Primary Care: Competency Gaps and Gender Bias in the Management of Chronic Musculoskeletal Pain
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.
Read the detailed description
This study is a pragmatic, cluster-assigned implementation trial designed to evaluate the impact of the digital educational intervention PainTrain-AI on clinical decision-making in Primary Care. The intervention trains health professionals through standardized virtual patient simulations and brief interactive micromodules, using a retrieval-augmented generation (RAG) safety architecture that restricts all outputs to validated clinical content. PainTrain-AI does not generate new clinical information and is used exclusively for educational purposes.
The trial corresponds to Phase 3 of a broader research program described in the project protocol. In this phase, entire Primary Care centers are allocated to either the intervention arm (PainTrain-AI training) or the control arm (usual training/standard practice). A natural comparative setting in specialized care is included for analytical purposes, without access to master datasets and without receiving any financial support. The primary outcome is clinical adequacy, assessed through a validated 0-100 rubric applied to standardized clinical cases at three time points: baseline (T0), immediate post-training (T1), and follow-up (T2). Double-blind scoring and a third-reviewer arbitration process are used to ensure reliability (target kappa ≥0.70).
Secondary outcomes include changes in validated psychometric measures (NPQ-12, PABS-PT, HC-PAIRS, FABQ), adherence to PainTrain-AI micromodules, system usability (SUS), latency/friction metrics derived from platform logs, and indicators of low-value clinical practices. The trial incorporates a sex/gender randomization of clinical vignettes to identify and analyze potential gender bias in clinical decisions. All data collected refer to professionals, not patients. No identifiable clinical data are used; all datasets are pseudonymized according to the approved Data Management Plan (FAIR).
Assignment by clusters prevents contamination between arms, and all centers follow standardized operating procedures (PNT) for recruitment, training, and evaluation. The platform maintains audit logs, human-in-the-loop oversight, and ENS/RGPD-compliant security measures. Analyses will use mixed-effects models and Difference-in-Differences approaches to account for clustering, repeated measures, and baseline differences. Results will inform the feasibility, acceptability, and preliminary effectiveness of a digital simulation-based educational intervention intended to reduce the competency gap, decrease low-value practices, and mitigate gender bias in the management of chronic musculoskeletal pain in Primary Care.
- Being tested
- PainTrain-AI Educational Training, Usual Training / Standard Practice
- Keywords
- chronic musculoskeletal pain, clinical simulation, digital training, primary care professionals, educational intervention, usability SUS, concept shift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PainTrain-AI Educational TrainingBehavioural
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 PracticeBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Usual Training / Standard Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), immediate post-training (T1), and 3-month follow-up (T2)
Secondary outcomes (4)
System Usability Scale (SUS, 0-100)
Usability of the PainTrain-AI intervention will be assessed with the System Usability Scale (SUS), a validated 10-item questionnaire that produces a score from 0 (lowest usability) to 100 (highest usability). Higher scores indicate better usability. The feasibility threshold is SUS ≥70, with an optimal target ≥80.
Measured: Immediately after training
Adherence to PainTrain-AI micromodules (% completed)
Adherence will be measured as the percentage of scheduled micromodules or simulation sessions completed by each participant within the defined training period. Scores range from 0% (no modules completed) to 100% (all assigned modules completed). Higher percentages indicate greater engagement with the behavioral intervention.
Measured: During the training period (up to 4 weeks)
Low-value clinical practice indicators (count per case)
Low-value practice indicators will be measured using standardized clinical cases scored with the 0-100 adequacy rubric. For this outcome, low-value practices are counted as discrete events, with possible values ranging from 0 (no low-value decisions in a case) to a higher count indicating more inappropriate decisions. Indicators include inappropriate diagnostic imaging, unnecessary pharmacologic escalation, or early referral to specialized care when not clinically indicated. The measure reflects the number of low-value decisions per case at each time point.
Measured: Baseline, immediately after training, and 3 months after training
System latency (seconds)
Latency will be measured as the average system response time (in seconds) between user input and platform output during PainTrain-AI interactions. Scores range from 0 seconds (best possible performance) upward, with higher values indicating greater technological friction and lower technical performance. Latency is automatically recorded through system logs.
Measured: During the training period (up to 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study startMar 2029 (estimated)
- Primary completionMar 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 185 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francesc Valenzuela Pascual
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesc Valenzuela Pascual, Universitat de Lleida
- Investigators
- Fran Valenzuela-Pascual, PhD, Study director, IRBLleida / Universitat de LleidaEster García Martínez, PhD, Study director, Universitat de Lleida / IDIAP Jordi Gol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507019
- Sponsor's protocol ID
- PT AI FIS CLUST 2026
- Acronym
- PT-AI-IMP
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared because the study does not involve patient data or clinical individual-level information. All datasets refer to health professionals and are pseudoanonymized. Only aggregated results and anonymized usage datasets (logs, codebooks, processed data) may be shared after study completion following FAIR principles, as described in the Data Management Plan.
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Digital Intervention PainTrain-AI in Primary Care: Competency Gaps and Gender Bias in the Management of Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT07507019
- Acronym / sponsor ID
- PT-AI-IMP / PT AI FIS CLUST 2026
- Keywords
- chronic musculoskeletal pain, clinical simulation, digital training, primary care professionals, educational intervention, usability SUS, concept shift
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 185 participants (estimated)
- Lead sponsor
- Francesc Valenzuela PascualUniversity, hospital or other
- Study start
- Mar 2029 (estimated)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a pragmatic, cluster-assigned implementation trial designed to evaluate the impact of the digital educational intervention PainTrain-AI on clinical decision-making in Primary Care. The intervention trains health professionals through standardized virtual patient simulations and brief interactive micromodules, using a retrieval-augmented generation (RAG) safety architecture that restricts all outputs to validated clinical content. PainTrain-AI does not generate new clinical information and is used exclusively for educational purposes.
The trial corresponds to Phase 3 of a broader research program described in the project protocol. In this phase, entire Primary Care centers are allocated to either the intervention arm (PainTrain-AI training) or the control arm (usual training/standard practice). A natural comparative setting in specialized care is included for analytical purposes, without access to master datasets and without receiving any financial support. The primary outcome is clinical adequacy, assessed through a validated 0-100 rubric applied to standardized clinical cases at three time points: baseline (T0), immediate post-training (T1), and follow-up (T2). Double-blind scoring and a third-reviewer arbitration process are used to ensure reliability (target kappa ≥0.70).
Secondary outcomes include changes in validated psychometric measures (NPQ-12, PABS-PT, HC-PAIRS, FABQ), adherence to PainTrain-AI micromodules, system usability (SUS), latency/friction metrics derived from platform logs, and indicators of low-value clinical practices. The trial incorporates a sex/gender randomization of clinical vignettes to identify and analyze potential gender bias in clinical decisions. All data collected refer to professionals, not patients. No identifiable clinical data are used; all datasets are pseudonymized according to the approved Data Management Plan (FAIR).
Assignment by clusters prevents contamination between arms, and all centers follow standardized operating procedures (PNT) for recruitment, training, and evaluation. The platform maintains audit logs, human-in-the-loop oversight, and ENS/RGPD-compliant security measures. Analyses will use mixed-effects models and Difference-in-Differences approaches to account for clustering, repeated measures, and baseline differences. Results will inform the feasibility, acceptability, and preliminary effectiveness of a digital simulation-based educational intervention intended to reduce the competency gap, decrease low-value practices, and mitigate gender bias in the management of chronic musculoskeletal pain in Primary Care.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PainTrain-AI Educational Training (Cluster Implementation Arm) | Experimental | Behavioral: PainTrain-AI Educational TrainingParticipants 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. |
| Usual Training / Standard Practice (Control Arm) | Active comparator | Behavioral: Usual Training / Standard PracticeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PainTrain-AI Educational TrainingPainTrain-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. | Behavioural | PainTrain-AI Educational Training (Cluster Implementation Arm) |
| Usual Training / Standard PracticeParticipants continue with usual training and standard practice available at their institution. No exposure to PainTrain-AI occurs. This arm serves as the active comparator. | Behavioural | Usual Training / Standard Practice (Control Arm) |
Primary outcome
Clinical adequacy score (0-100 rubric)
Time frame: 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.
4 secondary outcomes
System Usability Scale (SUS, 0-100)
Time frame: Immediately after training
Adherence to PainTrain-AI micromodules (% completed)
Time frame: During the training period (up to 4 weeks)
Low-value clinical practice indicators (count per case)
Time frame: Baseline, immediately after training, and 3 months after training
System latency (seconds)
Time frame: During the training period (up to 4 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared because the study does not involve patient data or clinical individual-level information. All datasets refer to health professionals and are pseudoanonymized. Only aggregated results and anonymized usage datasets (logs, codebooks, processed data) may be shared after study completion following FAIR principles, as described in the Data Management Plan.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fran Valenzuela-Pascual, PhD study director
IRBLleida / Universitat de Lleida
Ester García Martínez, PhD study director
Universitat de Lleida / IDIAP Jordi Gol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PainTrain-AI Educational Training and Usual Training / Standard Practice in people with Educational Intervention for Primary Care Professionals on Chronic Musculoskeletal Pain, run by Francesc Valenzuela Pascual at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fran Valenzuela Pascual, PhD (+34 973 702 459, fran.valenzuela@udl.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical adequacy score (0-100 rubric) (time frame: Baseline (T0), immediate post-training (T1), and 3-month follow-up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.