PREDICT-DOLOR VE: Validation of a Structured Triage Protocol for Chronic Pain (PREDICT-VE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain; Pain Management; Neuropathic Pain
• Intervention / Treatment: Other: PREDICT-DOLOR VE

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 Type: Observational
• Enrollment (Estimated): 120

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

• Inclusion Criteria:
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: PREDICT-DOLOR VE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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.	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.	At completion of each patient's assessment (single visit, approximately 15-20 minutes)

Collaborators and Investigators

• Sponsor: Universidad Central de Venezuela

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: diagnostic accuracy; pain assessment; low-resource setting; Venezuela; clinical decision support tool; chronic pain triage; interprofessional referral
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Neuralgia; Agnosia
• Other Study ID Numbers: PREDICT-DOLOR-VE-2026-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No