Chronic PainPREDICT-VENCT07696676
PREDICT-DOLOR VE: Validation of a Structured Triage Protocol for Chronic Pain
An observational study of Chronic Pain and Pain Management, run by Universidad Central de Venezuela.
Trial summary
PREDICT-DOLOR VE is a structured clinical triage protocol for chronic pain that uses five internationally validated pain assessment instruments to help healthcare providers determine the appropriate level of care for patients with chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Pain, Pain Management, Neuropathic Pain
- What is being tested?
- PREDICT-DOLOR VE
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 2 Feb 2027
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with chronic pain of any etiology (duration of 3 months or longer) presenting at primary care, specialty, or referral centers in Venezuela, recruited consecutively across three participating sites: Hospital Universitario de Caracas, and two regional referral centers in Maracaibo and Valencia or Barquisimeto.
Who may be able to join
- Age 18 years or older
- Chronic pain of any etiology with duration of 3 months or longer
- Ability to complete the PREDICT-DOLOR VE digital assessment battery (with assistance if needed)
- Attending one of the three participating referral centers during the recruitment period
- Provision of written informed consent before any study procedure
Who cannot join
- Acute pain with duration less than 3 months
- Active oncological pain under chemotherapy or radiotherapy protocol (separate evaluation pathway required)
- Cognitive impairment that prevents completion of self-report instruments, even with assistance
- Active psychiatric emergency or suicidal ideation at time of assessment
- Refusal to provide informed consent
- Participation in another clinical trial that could influence triage outcomes
About this study
Official title: PREDICT-DOLOR VE: Prospective Multicenter Diagnostic Accuracy Study for the Validation of a Rule-Based Clinical Decision Support Tool for Chronic Pain Triage in a Low-Resource Setting in Venezuela
PREDICT-DOLOR VE is a structured clinical triage protocol for chronic pain that uses five internationally validated pain assessment instruments to help healthcare providers determine the appropriate level of care for patients with chronic pain. The tool operates on a free mobile-friendly platform and generates a four-level recommendation: primary care management, referral to physiatry or neurology, priority specialist evaluation, or evaluation for neurosurgical intervention.
This study will validate the diagnostic accuracy of the PREDICT-DOLOR VE algorithm by comparing its recommendations with the independent assessment of a panel of three specialists in adult patients with chronic pain (lasting 3 months or longer) across three referral centers in Venezuela. The study aims to determine whether this structured, low-cost approach can help connect patients with the right type of care more quickly and consistently.
Read the detailed description
Chronic pain affects a substantial proportion of the adult population in Venezuela and Latin America, yet patients often face long delays and inconsistent referral pathways before reaching the appropriate specialist. PREDICT-DOLOR VE addresses this gap through a structured, rule-based clinical decision support tool that integrates five validated instruments: the Numeric Rating Scale (NRS), the Douleur Neuropathique 4 (DN4; Neuropathic Pain Diagnostic Questionnaire) questionnaire, the Brief Pain Inventory (BPI), the Pain Catastrophizing Scale (PCS), and the Patient Health Questionnaire-9 (PHQ-9). Based on responses to these instruments, the tool generates one of four triage recommendations: Level 1 (management in primary care), Level 2 (referral to physiatry or neurology), Level 3 (priority specialist evaluation, including psychology referral when indicated), or Level 4 (evaluation for neurosurgical procedure by a multidisciplinary pain committee). The platform operates on Google Forms and Google Sheets at no cost to patients or healthcare facilities. This prospective multicenter diagnostic accuracy study will enroll 120 consecutive adult patients with chronic pain (duration of 3 months or longer) across three referral centers in Venezuela. Each participant will complete the PREDICT-DOLOR VE assessment. Independently, a panel of three specialists (neurosurgeon, neurologist, and physiatrist) blinded to the algorithm's recommendation will evaluate each patient using standard clinical assessment and reach a consensus triage classification. The primary outcome is the concordance, measured by Cohen's kappa coefficient, between the algorithm's recommendation and the specialist panel's consensus classification. Secondary outcomes include the time from first consultation to appropriate specialist evaluation, system usability among primary care physicians, and patient satisfaction with the triage process.
- Conditions
- Chronic Pain, Pain Management, Neuropathic Pain
- Being tested
- PREDICT-DOLOR VE
- Keywords
- chronic pain triage, clinical decision support tool, pain assessment, Venezuela, low-resource setting, interprofessional referral, diagnostic accuracy
- Medical subject headings
- Chronic Pain, Agnosia, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREDICT-DOLOR VEOther
A structured, rule-based clinical decision support tool integrating five validated pain assessment instruments (Numeric Rating Scale, Douleur Neuropathique 4, Brief Pain Inventory, Pain Catastrophizing Scale, and Patient Health Questionnaire-9) to generate a four-level triage recommendation for chronic pain management, operating on a free digital platform with no implementation cost.
| Study group | Role | What they receive |
|---|---|---|
| Chronic pain patients | Consecutive adult patients (18 years and older) with chronic pain of any etiology lasting 3 months or longer, evaluated at three referral centers in Venezuela. All patients complete the PREDICT-DOLOR VE digital assessment battery (NRS, DN4, BPI, PCS, PHQ-9) and receive an independent consensus evaluation from a panel of three specialists blinded to the algorithm's recommendation. Receives: Other: PREDICT-DOLOR VE |
What is being measured
The primary outcome is the main question the study is designed to answer.
At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Agreement between the four-level triage recommendation generated by the PREDICT-DOLOR VE algorithm and the consensus classification assigned independently by a panel of three specialists (neurosurgeon, neurologist, physiatrist) blinded to the algorithm's recommendation, measured using Cohen's kappa coefficient with 95% confidence interval.
Measured: At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Concordance between PREDICT-DOLOR VE algorithm and specialist panel consensus
Agreement between the four-level triage recommendation generated by the PREDICT-DOLOR VE algorithm and the consensus classification assigned independently by a panel of three specialists (neurosurgeon, neurologist, physiatrist) blinded to the algorithm's recommendation, measured using Cohen's kappa coefficient with 95% confidence interval.
Measured: At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion2 Dec 2026 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Central de Venezuela
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, juan jose valero quintero,MD, Universidad Central de Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07696676
- Sponsor's protocol ID
- PREDICT-DOLOR-VE-2026-001
- Acronym
- PREDICT-VE
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT-DOLOR VE: Prospective Multicenter Diagnostic Accuracy Study for the Validation of a Rule-Based Clinical Decision Support Tool for Chronic Pain Triage in a Low-Resource Setting in Venezuela
- ClinicalTrials.gov ID
- NCT07696676
- Acronym / sponsor ID
- PREDICT-VE / PREDICT-DOLOR-VE-2026-001
- Conditions
- Chronic Pain, Pain Management, Neuropathic Pain
- Keywords
- chronic pain triage, clinical decision support tool, pain assessment, Venezuela, low-resource setting, interprofessional referral, diagnostic accuracy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universidad Central de VenezuelaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 2 Dec 2026 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 10 Jul 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.
PREDICT-DOLOR VE is a structured clinical triage protocol for chronic pain that uses five internationally validated pain assessment instruments to help healthcare providers determine the appropriate level of care for patients with chronic pain. The tool operates on a free mobile-friendly platform and generates a four-level recommendation: primary care management, referral to physiatry or neurology, priority specialist evaluation, or evaluation for neurosurgical intervention.
This study will validate the diagnostic accuracy of the PREDICT-DOLOR VE algorithm by comparing its recommendations with the independent assessment of a panel of three specialists in adult patients with chronic pain (lasting 3 months or longer) across three referral centers in Venezuela. The study aims to determine whether this structured, low-cost approach can help connect patients with the right type of care more quickly and consistently.
Detailed description
Chronic pain affects a substantial proportion of the adult population in Venezuela and Latin America, yet patients often face long delays and inconsistent referral pathways before reaching the appropriate specialist. PREDICT-DOLOR VE addresses this gap through a structured, rule-based clinical decision support tool that integrates five validated instruments: the Numeric Rating Scale (NRS), the Douleur Neuropathique 4 (DN4; Neuropathic Pain Diagnostic Questionnaire) questionnaire, the Brief Pain Inventory (BPI), the Pain Catastrophizing Scale (PCS), and the Patient Health Questionnaire-9 (PHQ-9). Based on responses to these instruments, the tool generates one of four triage recommendations: Level 1 (management in primary care), Level 2 (referral to physiatry or neurology), Level 3 (priority specialist evaluation, including psychology referral when indicated), or Level 4 (evaluation for neurosurgical procedure by a multidisciplinary pain committee). The platform operates on Google Forms and Google Sheets at no cost to patients or healthcare facilities. This prospective multicenter diagnostic accuracy study will enroll 120 consecutive adult patients with chronic pain (duration of 3 months or longer) across three referral centers in Venezuela. Each participant will complete the PREDICT-DOLOR VE assessment. Independently, a panel of three specialists (neurosurgeon, neurologist, and physiatrist) blinded to the algorithm's recommendation will evaluate each patient using standard clinical assessment and reach a consensus triage classification. The primary outcome is the concordance, measured by Cohen's kappa coefficient, between the algorithm's recommendation and the specialist panel's consensus classification. Secondary outcomes include the time from first consultation to appropriate specialist evaluation, system usability among primary care physicians, and patient satisfaction with the triage process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic pain patients | – | Other: PREDICT-DOLOR VEConsecutive adult patients (18 years and older) with chronic pain of any etiology lasting 3 months or longer, evaluated at three referral centers in Venezuela. All patients complete the PREDICT-DOLOR VE digital assessment battery (NRS, DN4, BPI, PCS, PHQ-9) and receive an independent consensus evaluation from a panel of three specialists blinded to the algorithm's recommendation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic pain of any etiology (duration of 3 months or longer) presenting at primary care, specialty, or referral centers in Venezuela, recruited consecutively across three participating sites: Hospital Universitario de Caracas, and two regional referral centers in Maracaibo and Valencia or Barquisimeto.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Chronic pain of any etiology with duration of 3 months or longer
- Ability to complete the PREDICT-DOLOR VE digital assessment battery (with assistance if needed)
- Attending one of the three participating referral centers during the recruitment period
- Provision of written informed consent before any study procedure
Key exclusion criteria (6 listed)
- Acute pain with duration less than 3 months
- Active oncological pain under chemotherapy or radiotherapy protocol (separate evaluation pathway required)
- Cognitive impairment that prevents completion of self-report instruments, even with assistance
- Active psychiatric emergency or suicidal ideation at time of assessment
- Refusal to provide informed consent
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 |
|---|---|---|
| PREDICT-DOLOR VEA structured, rule-based clinical decision support tool integrating five validated pain assessment instruments (Numeric Rating Scale, Douleur Neuropathique 4, Brief Pain Inventory, Pain Catastrophizing Scale, and Patient Health Questionnaire-9) to generate a four-level triage recommendation for chronic pain management, operating on a free digital platform with no implementation cost. | Other | Chronic pain patients |
Primary outcome
At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Time frame: At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Agreement between the four-level triage recommendation generated by the PREDICT-DOLOR VE algorithm and the consensus classification assigned independently by a panel of three specialists (neurosurgeon, neurologist, physiatrist) blinded to the algorithm's recommendation, measured using Cohen's kappa coefficient with 95% confidence interval.
Concordance between PREDICT-DOLOR VE algorithm and specialist panel consensus
Time frame: At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Agreement between the four-level triage recommendation generated by the PREDICT-DOLOR VE algorithm and the consensus classification assigned independently by a panel of three specialists (neurosurgeon, neurologist, physiatrist) blinded to the algorithm's recommendation, measured using Cohen's kappa coefficient with 95% confidence interval.
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 10 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Pain Management, run by Universidad Central de Venezuela.
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 5 inclusion and 6 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 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At completion of each patient's assessment (single visit, approximately 15-20 minutes) (time frame: At completion of each patient's assessment (single visit, approximately 15-20 minutes)). The study lists 2 primary outcomes in all. 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 10 Jul 2026.