Antimicrobial Stewardship Effects of Interpretive Comments for Faecal PCR Tests
Bacterial gastroenteritis is a common condition seen in Aotearoa New Zealand, which is typically diagnosed by PCR testing on a stool sample. Most causes of bacterial gastroenteritis (e.g. Campylobacter spp, Salmonella spp, Yersinia spp) cause a self-limiting illness and antibiotic therapy is not required. Indeed, guidelines available for community healthcare providers in Aotearoa (e.g. Community HealthPathways, recently released national antimicrobial guidelines Te Whata Kura) recommend against antibiotic therapy for the vast majority of cases.
A recent internal analysis at Awanui Laboratories of community faecal pathogen PCR testing revealed that antibiotic prescribing was very common after a positive result (ranging between 20-40% for the various individual pathogens), which suggests many community healthcare providers may not be following the recommended approach for the management of these infections. Given how common infectious gastroenteritis is in Aotearoa, and the volume of tests performed (approximately 100,000 through the Awanui network per year), this prescribing behaviour may represent a large volume of unnecessary antibiotic use in our communities, with resultant potential harmful effects at the individual patient level and population level via side effects, disruption to the faecal microbiome, and impacts on antimicrobial resistance (AMR).
In previous work we have demonstrated that interpretive comments, when added to laboratory reports, can have a significant positive effect on prescriber behaviour (https://doi.org/10.1093/jac/dkad384), but this has not been examined in relation to faecal pathogen testing.
研究概览
详细说明
This is a cluster randomised crossover trial, where four laboratories within the Awanui Labs network in Aotearoa New Zealand will act as the clusters. Each laboratory will be assigned four intervention levels, which will be implemented in random order over the course of the 12 month study period (i.e. 3 months per intervention).
The intervention will consist of interpretive comments that are appended to laboratory reports where a stool sample has been submitted for faecal bacterial pathogen detection (predominantly tested via multiplex PCR methodology) and one of the target organisms has been detected. The target organisms are Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, and Aeromonas spp.
There will be four different intervention levels: 1. a comment that reminds requesters that most acute bacterial gastroenteritis does not require antibiotic treatment, as per local guidelines; 2. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic over use at the population level (i.e. AMR); 3. the same comment as 1 is used, plus an additional comment is added reminding requesters of the negative effects of antibiotic overuse at the individual patient level e.g. harms due to side effects; 4. is a the control group, where no comment is appended.
The four levels will be auto added by each lab, each for a three month period, in the random order allocated at the beginning of the study.
Outcome measures will relate to antibiotic use in the time period following the laboratory report, plus unplanned hospitalisation out to 30 days post report.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Max Bloomfield, MBChB
- 电话号码：+64272089584
- 邮箱：maxim.bloomfield@ccdhb.org.nz
学习地点
-
-
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Auckland、新西兰
- 招聘中
- Awanui Labs Auckland
-
接触：
- Max Bloomfield, MBChB
- 电话号码：0272089584
- 邮箱：maxim.bloomfield@ccdhb.org.nz
-
Christchurch、新西兰
- 招聘中
- Awanui Labs Christchurch
-
接触：
- Max Bloomfield, MBChB
- 电话号码：0272089584
- 邮箱：maxim.bloomfield@ccdhb.org.nz
-
Dunedin、新西兰
- 招聘中
- Awanui Labs Dunedin
-
接触：
- Max Bloomfield, MBChB
- 电话号码：0272089584
- 邮箱：maxim.bloomfield@ccdhb.org.nz
-
Wellington、新西兰、6012
- 招聘中
- Awanui Labs Wellington
-
接触：
- Max Bloomfield, MBChB
- 电话号码：0272089584
- 邮箱：maxim.bloomfield@ccdhb.org.nz
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Age over six months
- Stool sample submitted to Awanui Labs for faecal bacterial pathogen testing from a community health provider during the study period
- Test results report the detection of: Campylobacter spp, Shigella spp/Entero-invasive Escherichia coli, Salmonella spp, Yersinia spp, or Aeromonas spp.
Exclusion Criteria:
- Samples where only Clostridioides difficile or Helicobacter pylori testing has been requested will be excluded
- Samples sent for Public Health testing (e.g. testing for clearance of Salmonella spp) will be excluded.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Interpretive laboratory comment - guideline
Interpretive comment with advice to follow local guidelines
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
有源比较器：Interpretive laboratory comment - guideline + population harms
Interpretive comment with advice to follow local guidelines PLUS comment about population level harms of antibiotic overuse (i.e.
AMR)
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
有源比较器：Interpretive laboratory comment - guideline + individual harms
Interpretive comment with advice to follow local guidelines PLUS comment about individual patient harms of antibiotic overuse (e.g.
side effects)
|
Interpretive commend added to laboratory report - contents of comment will depend on associated arm
|
|
无干预：Control
No comment added to lab report
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Specific antibacterial dispensing
大体时间：Within 5 days of lab report
|
Antibacterial dispensing within 5 days of laboratory report for agents that are more specific for the treatment of bacterial gastroenteritis: amoxicillin, azithromycin, ciprofloxacin, doxycycline, erythromycin, co-trimoxazole
|
Within 5 days of lab report
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Any antibacterial dispensing
大体时间：Within 5 days of lab report
|
Antimicrobial dispensing within 5 days of laboratory report for any antibacterial agent
|
Within 5 days of lab report
|
|
Antibacterial dispensing within 30 days
大体时间：Within 30 days of lab report
|
Antimicrobial dispensing within 30 days of laboratory report
|
Within 30 days of lab report
|
|
Unplanned hospital admission
大体时间：Within 5 and 30 days of lab report.
|
Unplanned hospital admission within 5 and 30 days of laboratory report
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Within 5 and 30 days of lab report.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- FPC2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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