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

8. Juli 2026 aktualisiert von: juan jose valero quintero,MD, Universidad Central de Venezuela

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.

Studienübersicht

Status

Noch keine Rekrutierung

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

120

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
At completion of each patient's assessment (single visit, approximately 15-20 minutes)
Zeitfenster: 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
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

2. Dezember 2026

Studienabschluss (Geschätzt)

2. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

3. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

10. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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