The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,052
- 试验地点
- 1
- 主要终点
- Penicillin Allergy Label Removal
研究概览
简要总结
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. Our objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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
- •VUMC patients age 18 or older with a penicillin allergy reported in their chart, and are medically stable, currently admitted to stepdown unit or regular floor bed.
排除标准
- •Patients with a penicillin allergy reported in their chart, but who are currently medically unstable.
- •Pregnant patients
研究组 & 干预措施
Penicillin Allergic Floor Patients- Experimental
The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.
干预措施: Penicillin Allergic Risk Stratification Best Practice Alert (Other)
Penicillin Allergic Floor Patients- Control
Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.
结局指标
主要结局
Penicillin Allergy Label Removal
时间窗: Hospital discharge at approximately 4 days after admission
The percentage of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.
次要结局
- Adverse Events (in Particular, Reported Allergic Events)(Hospital discharge at approximately 4 days after admission)
- Communication About Penicillin Allergy in Discharge Summary(Hospital discharge at approximately 4 days after admission)
- Antibiotic Utilization by Patients(Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up)
- Durability of Penicillin Allergy Label Removal(Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up)
- Receipt of Risk Stratification Tool Assessment(Hospital discharge at approximately 4 days after admission)
- Time to Penicillin Allergy Label Return(From 3-18 months of follow up)
- Penicillin Utilization by Patients(Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up)
- Cephalosporin Utilization by Patients(Hospital discharge at approximately 4 days after admission and from 3-18 months of follow up)
研究者
Cosby Stone
Instructor
Vanderbilt University Medical Center