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.
研究概览
详细说明
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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At completion of each patient's assessment (single visit, approximately 15-20 minutes)
大体时间:At completion of each patient's assessment (single visit, approximately 15-20 minutes)
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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.
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At completion of each patient's assessment (single visit, approximately 15-20 minutes)
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Concordance between PREDICT-DOLOR VE algorithm and specialist panel consensus
大体时间:At completion of each patient's assessment (single visit, approximately 15-20 minutes)
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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.
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At completion of each patient's assessment (single visit, approximately 15-20 minutes)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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