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临床试验/NCT05561777
NCT05561777撤回不适用

Implementation of Penicillin Allergy Risk Stratification and Delabeling of Low-Risk Patients: Provider-Targeted Clinical Decision Support Versus Pharmacist-Led Approach

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Allergy Delabeling Performed

研究概览

简要总结

Children are often reported to have antibiotics allergies, with approximately 10% of the US population labeled as allergic to an antibiotic, however, recent studies have demonstrated that the majority of symptoms reported as an allergy by parents are often non-IgE-mediated adverse reactions or symptoms of a viral illness (e.g. rash, vomiting, diarrhea). Additionally, over 90% of patients with reported penicillin allergy have negative skin testing results. Several studies in children have found that an allergy questionnaire can accurately identify those who are at low risk for severe antibiotic allergy and the allergy label can be safely removed. Appropriately delabeling antibiotic allergies has been shown to improve patient care through changing prescribing behavior and lowering health care costs.

In this study, the investigators will perform a randomized trial comparing a provider-targeted clinical decision support tool to a pharmacist-led approach. The physician-targeted CDS tool will inform providers of their patient's allergy risk stratification result, protocol, electronic health record order and documentation support. The pharmacist-led approach consists of electronic health record dashboard that includes identical information to the provider arm. The primary outcome will be the frequency of penicillin allergy encounters with an allergy label removed at the time of discharge. Secondary outcomes will include the percentage of encounter with a penicillin allergy label in the electronic medical record 3 months after discharge, hospital length of stay and antibiotic utilization.

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

入选标准

  • Pediatric Hospital Medicine service Existing penicillin allergy label in the EHR Screened as low-risk for true PCN allergy (based on usual-care nursing intake questions at time of admission)

排除标准

  • None, provider may opt out of CDS tool at any time

结局指标

主要结局

Allergy Delabeling Performed

时间窗: Within 1 day of discharge for each encounter

Percentage of enrolled encounters (intervention arm) in which providers perform allergy delabeling

次要结局

  • Allergy Label Adjustments in EHR(3 months after discharge for each encounter)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Antoon

Assistant Professor of Pediatrics

Vanderbilt University Medical Center

研究点 (2)

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