- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07696676
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Beräknad)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PREDICT-DOLOR-VE-2026-001
Läkemedels- och apparatinformation, studiedokument
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