Evaluating a Clinical Decision Support Tool for Antiretroviral Therapy Optimization
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
研究概览
简要总结
This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging.
In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care.
The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HIV patients
- •Documented HIV-1 infection
- •Greater than 18 years of age
- •Genotype resistance testing previously conducted or scheduled through clinical care
- •HIV care providers who will determine treatment selections, with or without utilizing our clinical decision support tool
排除标准
- •HIV patients:
- •1. Refusal or inability to give informed consent
- •1. Refusal to give informed consent
结局指标
主要结局
Adherence of Prescribed ART Regimens to Evidence-Based Recommendations
时间窗: Assessed at completion of each patient prescribing session at Day 1
Proportion of antiretroviral therapy (ART) regimens that align with guideline-based recommendations. A regimen is considered adherent if it contains at least three fully active agents (defined as a total drug susceptibility score ≥280) and is not contraindicated based on patient-specific factors identified by the smART tool, including allergies, comorbidities, concomitant medications, pregnancy status, and/or major guideline restrictions.
次要结局
- Proportion of virally suppressed individuals(Assessed at between 1 month and 6 month after completion of each prescribing session)
研究者
Hayoun Lee
Associate Professor
Keck School of Medicine of USC