Impact of a Simple Automated Best Practice Alert (BPA) on Quantity and Quality of In-hospital Antibiotic Use - a Stepped-wedge, Cluster Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
研究概览
简要总结
The goal of the stepped-wedge cluster-randomized trial is to assess the impact of an antimicrobial stewardship intervention: a simple, automated Best Practice Alert (BPA) that reminds prescribers to reevaluate antibiotic therapy after 72 hours (or 24 hours for prophylaxis), in accordance with guideline recommendations. The primary hypothesis is that this simple BPA reduces antibiotic use in terms of quantity (amount and duration) and quality (spectrum breadth), measured by days of antibiotic spectrum coverage at the patient level (primary outcome), as well as at both patient and cluster levels using various metrics of antibiotic use. The trial will introduce the BPA in a stepwise manner, with all wards implementing it by the end. It will compare the intervention period to the baseline (pre-intervention) and control periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Cluster allocation will also be blinded to the wards and prescribers; however, prescribers may become aware of their cluster assignment when working across different wards in both intervention and control clusters, based on whether or not they receive the BPA.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All inpatient wards with at least 50 PA/year, except those listed in the
排除标准
- •Exclusion Criteria:
- •Ward level:
- •Emergency departments
- •Outpatient clinics
- •Haemato-oncologic stem cell transplant wards, where daily ID visits are performed
- •ICU wards, where daily ID visits are performed
- •Indvidual patient data for analysis
- •Refusal of institutional general consent for further use of patient data
研究组 & 干预措施
Best practice alert (BPA)
Intervention:
The BPA will appear to the prescribing physician for every patient on the respective ward.
Activation of the BPA is ward-based.
A total of 58 wards will be stratified according to their focus-surgical, medical, intermediate care, rehabilitation, or pediatric-and grouped based on their baseline antibiotic consumption, measured in days of antibiotic spectrum coverage per patient admission (DASC/PA). This stratification will result in 9 to 10 clusters across 6 groups.
The clusters will then be randomized to the timing of BPA activation, and all wards will sequentially switch to the BPA arm every 2 months over a 12-month period.
By the end of the trial, after 12 months, all wards will be using the automated BPA.
干预措施: Computerized decision support by best practice alert (BPA) (Behavioral)
Controls - No BPA
Control: standard patient care with no BPA activated. By the end of the trial, after 12 months, all wards will be using the automated BPA.
结局指标
主要结局
Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
时间窗: 12 months
Overall score of days of antibiotic spectrum coverage per patient admission. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values
Days of antibiotic spectrum coverage (DASC) per patient admission (PA)
时间窗: 12 months
Overall score of days of antibiotic spectrum coverage per patient admission. The score is composed of the breadth of the bacterial spectrum covered by the administered antibiotic (according to Kakiuchi 2022 - the broader the antibiotic spectrum, the higher the score), summed over the number of days the antibiotic is given. Accordingly, there are no maximum or minimum values
次要结局
- Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level(12 months)
- Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)(12 months)
- Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)(12 months)
- Antibiotic (AB) days per patient admission (PA)(12 months)
- In hospital mortality(12 months)
- Hospital length of stay (LOS)(12 months)
- Unplanned readmission within first 30 days after discharge(12 months)
- Patient admission to IMC/ICU from studied wards(12 months)
- Number of Infectious diseases (ID) consultation per patient admission (PA)(12 months)
- In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)(12 months)
- Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)(12 months)
- Days of antibiotic spectrum coverage (DASC) per patient antibiotic day (PAD)(12 months)
- Days of treatment (DOT) per 100 patient days (PD) and per patient admission on ward level(12 months)
- Defined daily doses (DDD) per 100 patient days (PD) and per patient admission (PA)(12 months)
- Antibiotic (AB) days per patient admission (PA)(12 months)
- In hospital mortality(12 months)
- Hospital length of stay (LOS)(12 months)
- Unplanned readmission within first 30 days after discharge(12 months)
- Patient admission to IMC/ICU from studied wards(12 months)
- Number of Infectious diseases (ID) consultation per patient admission (PA)(12 months)
- In hospital C. difficile infection incidence within hospital stay per patient admission (PA) and per 100 patient days (PD)(12 months)
- Inhospital incidence of multi-drug-resistant-organisms (MDRO) detection per100 patient days (PD) or per patient admission (PA)(12 months)