Optimization of Antibiotic Treatment in Patients With a Reported Penicillin Allergy Using a Digital Clinical Decision Support Tool.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical study is to evaluate whether a digital decision support tool integrated into the electronic medical record improves antibiotic prescribing in hospitalized patients with a reported allergy to penicillin.
Around 5 out of 100 hospitalized patients at our center have a penicillin allergy label in their medical record. However, this allergy is confirmed in less than 10 out of 100 cases. Despite this, more than 90 out of 100 of these patients receive alternative antibiotics that may be less effective or less aligned with clinical guidelines.
This study includes adults older than 16 years treated at Hospital Sant Joan de Déu de Manresa (Althaia) for infections that require systemic antibiotic treatment. Participants are those with a recorded penicillin allergy in their medical record or who report an allergy during their current hospital admission.
The main questions this study aims to answer are:
Does the use of a digital decision support tool increase the use of beta-lactam antibiotics (such as penicillins and cephalosporins) in patients with a reported penicillin allergy? Does the tool reduce the use of alternative antibiotic treatments that are less aligned with hospital guidelines?
Participants will receive standard clinical care. In addition, healthcare professionals will use a digital tool integrated into the electronic medical record. This tool supports clinical decision-making by assessing individual allergy risk and aligning antibiotic selection with hospital treatment guidelines.
The study will last approximately 15 months and will be conducted at a single hospital center.
详细描述
Study design and setting
This is a prospective, open-label, single-center study conducted at Hospital Sant Joan de Déu de Manresa (Althaia University Healthcare Network). The study evaluates the implementation of a digital clinical decision support tool integrated into the electronic medical record (EMR) to optimize antibiotic prescribing in hospitalized patients with a reported penicillin allergy.
The study includes two phases:
Pre-implementation phase
A retrospective cohort is used to describe antibiotic prescribing patterns in patients meeting eligibility criteria before implementation of the digital tool. Patients are identified through a digital EMR filter implemented in March 2024 that detects hospitalized patients or emergency department visits longer than 16 hours with a recorded penicillin allergy label.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 16 years
- •Hospitalized patients
- •Diagnosis of infection requiring systemic antibiotic therapy
- •Documented penicillin and/or cephalosporin allergy in the electronic medical record or self-reported allergy during current admission
- •For the retrospective cohort: patients previously admitted to hospital or emergency department (≥16 hours) with a recorded penicillin allergy label
- •Ability to understand study information and provision of written informed consent (prospective cohort only)
排除标准
- •Patients with a reported penicillin allergy who do not require systemic antibiotic treatment
- •Patients admitted to intensive care or intermediate care units
- •Patients receiving outpatient hospital care or dialysis units
- •Patients in end-of-life care or receiving palliative care
- •Patients receiving antibiotics for surgical prophylaxis only