PREDICT-DOLOR VE: Validation of a Structured Triage Protocol for Chronic Pain
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversidad Central de Venezuela
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
PREDICT-DOLOR VE
Other interventionA 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Chronic pain patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At completion of each patient's assessment (single visit, approximately 15-20 minutes)2
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.
Time frame
At completion of each patient's assessment (single visit, approximately 15-20 minutes)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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