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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Max Bloomfield, MBChB
- 전화번호: +64272089584
- 이메일: maxim.bloomfield@ccdhb.org.nz
연구 장소
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Auckland, 뉴질랜드
- 모병
- Awanui Labs Auckland
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연락하다:
- Max Bloomfield, MBChB
- 전화번호: 0272089584
- 이메일: maxim.bloomfield@ccdhb.org.nz
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Christchurch, 뉴질랜드
- 모병
- Awanui Labs Christchurch
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연락하다:
- Max Bloomfield, MBChB
- 전화번호: 0272089584
- 이메일: maxim.bloomfield@ccdhb.org.nz
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Dunedin, 뉴질랜드
- 모병
- Awanui Labs Dunedin
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연락하다:
- Max Bloomfield, MBChB
- 전화번호: 0272089584
- 이메일: maxim.bloomfield@ccdhb.org.nz
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Wellington, 뉴질랜드, 6012
- 모병
- Awanui Labs Wellington
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연락하다:
- Max Bloomfield, MBChB
- 전화번호: 0272089584
- 이메일: maxim.bloomfield@ccdhb.org.nz
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Interpretive laboratory comment - guideline
Interpretive comment with advice to follow local guidelines
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Interpretive commend added to laboratory report - contents of comment will depend on associated arm
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활성 비교기: 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)
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Interpretive commend added to laboratory report - contents of comment will depend on associated arm
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활성 비교기: 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)
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Interpretive commend added to laboratory report - contents of comment will depend on associated arm
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|
간섭 없음: Control
No comment added to lab report
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Specific antibacterial dispensing
기간: Within 5 days of lab report
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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
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Within 5 days of lab report
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Any antibacterial dispensing
기간: Within 5 days of lab report
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Antimicrobial dispensing within 5 days of laboratory report for any antibacterial agent
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Within 5 days of lab report
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Antibacterial dispensing within 30 days
기간: Within 30 days of lab report
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Antimicrobial dispensing within 30 days of laboratory report
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Within 30 days of lab report
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Unplanned hospital admission
기간: Within 5 and 30 days of lab report.
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Unplanned hospital admission within 5 and 30 days of laboratory report
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Within 5 and 30 days of lab report.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- FPC2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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