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

NCT07696676 | Not Yet Recruiting

• 1 other identifier: PREDICT-DOLOR-VE-2026-001
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

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

Interventions

PREDICT-DOLOR VE OTHER

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.

Chronic pain patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Central de Venezuela: lead

MeSH Terms

Conditions

Chronic Pain; Agnosia; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neurosurgeon and Pain Medicine Specialist

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 2, 2026
• Study Completion (Estimated): February 2, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07