跳至主要内容
临床试验/NCT04310462
NCT04310462进行中(未招募)不适用

A Quality Improvement Study to Measure the Effectiveness of an E-prescribing Interface to Reduce Dosage of Hydroxychloroquine Above Current Guidelines

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2017年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
65
试验地点
2
主要终点
Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

研究概览

简要总结

Hydroxychloroquine (HCQ) is a disease-modifying, anti-rheumatic drug that regulates immune system activity and is typically prescribed to treat rheumatoid arthritis and systemic lupus erythematosus, as well as other immune conditions. Although generally well tolerated, study data have demonstrated that long-term use of HCQ may lead to irreversible and potentially vision-threatening retinal toxicity. The American Academy of Ophthalmology (AAO) issued guidelines in 2011, and again in 2016 that recommended dosing of HCQ be based on an individual's body weight, and also outlined how and when to screen for retinal toxicity. While clinicians have been aware of the potential side effects of HCQ for decades, studies have shown that many patients continue to receive higher than recommended doses.

The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). The investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines by randomizing clinicians to the new interface. Ideally, the eRX interface will result in a lower number of potential adverse events (i.e. retinal toxicity) associated with high-dose, long-term use of HCQ.

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
— 至 120 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All providers that prescribed hydroxychloroquine in the year previous to the intervention start date in rheumatology and dermatology clinics

排除标准

  • Inactive providers in rheumatology and dermatology clinics

结局指标

主要结局

Prevalence of dosage above guidelines: 6.5 mg/kg (2011)

时间窗: Post intervention: 3 years

Prevalence of dosage above 6.5 mg/kg

Prevalence of dosage above guidelines: 5.0 mg/kg (2016)

时间窗: Post intervention: 3 years

Prevalence of dosage above 5.0 mg/kg

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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