Infectious Diseases Experts as Part of the Antibiotic Stewardship Team in Primary Care: a Cluster-randomised Blinded Study (IDASP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,389
- 试验地点
- 1
- 主要终点
- To asses the impact of implementing an advanced-AMS program (inclusion of infectious diseases specialists) on the overall antibiotic consumption.
研究概览
简要总结
A cluster-randomised multicentre blinded clinical trial will be performed in six primary care centres located in the southern metropolitan area of Barcelona (Spain). The objective is to assess whether including experts on infectious diseases (ID) within the antimicrobial stewardship (AMS) team of primary care achieves higher reductions on overall antibiotic consumption and increases the quality of prescription in diagnosed upper respiratory and urinary tract infections.
Centres will be randomly assigned to receive a standard-AMS or an advanced-AMS (intervention). Advanced-AMS includes all standard-AMS strategies plus general practitioner chance to discuss clinical cases by telephone to ID expert on working days (8:00 am to 8:00 pm), and by biweekly meetings.
详细描述
SCOPE OF THE STUDY: A multicentre, cluster-randomised trial evaluating whether the direct integration of infectious disease specialists into primary care teams reduces total antibiotic consumption and enhances prescribing quality without compromising patient safety.
TIMELINE: From June to September 2021 standard-AMS will be promoted to increase understanding and acceptance of AMS by GP. Baseline data collection will begin on October 2021 and will last six months. After these six months, on 1 April 2022, centres will be randomly assigned to receive an advanced-AMS, or to continue the standard-AMS. The intervention will be spanned 12 months, until 31 March 2023.
STUDY GROUPS. The 6 centres will be assigned to receive an advanced AMS or a standard AMS, 3 in one and 3 in another. Take a look on study design and arms and interventions section.
RANDOMISATION. Take a look on the study design section.
BLINDING. The two secondary endpoints, unnecessary antibiotic therapy and adequacy of therapy, will be evaluated by blinded investigators. Discrepant decisions among them will be discussed with a third blinded antibiotic expert to reach a consensus. Due to the nature of the intervention, it is not possible to blind the primary care centres or the GPs.
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
- Single (Outcomes Assessor)
盲法说明
The two secondary endpoints, unnecessary antibiotic therapy and adequacy of therapy, will be evaluated by blinded investigators. Discrepant decisions among them will be discussed with a third blinded antibiotic expert to reach a consensus. Due to the nature of the intervention, it is not possible to blind the primary care centres or the GPs.
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at centre-level (clusters)
- •Primary care centres belonging to the Delta del Llobregat healthcare area.
- •Prior experience in clinical research and formal agreement to participate in the study.
- •Comparability of their reference populations.
- •All general practitioners of the 6 primary care centers will be included in our clinical trial, excepting paediatricians. Data collection will be performed on patients attended in these centres. Inclusion and
排除标准
- •will be applied on the patients attended by general practitioners:
- •Inclusion criteria at patient-level criteria (unit for secondary objectives)
- •Adult patients (aged >14 years).
- •Diagnosed with an acute URTI (including pharyngoamygdalitis, sinusitis, otitis) or UTI (including cystitis, prostatitis, pyelonephritis) during the study period.
- •Patients attended by a GP at the selected centres.
- •Eligible patients will be identified following the International Classification of Diseases (ICD-10) CM codes as follows:
- •URTI: J00, J01, J02, J03, J04, J05, J06, J31, J39, H60, H62, H65, H66, H67, H83 and H
- •UTI: N10, N30, N39, N41, R82 and O
- •Exclusion criteria:
- •Patients less than 14 years old.
- •Patients with indwelling urinary catheter.
- •Patients with congenital urinary tract abnormalities.
- •Pregnant women.
- •Patients undergoing urological surgery.
研究组 & 干预措施
Advanced AMS program
Three randomily assigned primary care centres in which an infectious diseases expert will be continuously in touch with primary care practitioners.
干预措施: Advanced AMS program (Behavioral)
Advanced AMS program
Three randomily assigned primary care centres in which an infectious diseases expert will be continuously in touch with primary care practitioners.
干预措施: Standard AMS program (Behavioral)
Standard AMS program
Three primary care centres in which a typical AMS will be promoted.
干预措施: Standard AMS program (Behavioral)
结局指标
主要结局
To asses the impact of implementing an advanced-AMS program (inclusion of infectious diseases specialists) on the overall antibiotic consumption.
时间窗: Through study completion
Antibiotic defined daily dose per 1,000 inhabitant's day (DHD).
次要结局
- Number of patients re-consulting after completing antibiotic therapy.(Through study completion)
- Number of cases who needs hospitalisation 30 days after antibiotic therapy.(Through study completion)
- Number of patients with unnecessary antibiotic prescriptions on urinary tract infections.(Through study completion)
- Number of patients with an adequate antibiotic treatment(Through study completion)
- Number of patients with unnecessary antibiotic prescriptions on upper respiratory tract infections.(Through study completion)
研究者
Ariadna Padullés Zamora
Principal Investigator
Institut d'Investigació Biomèdica de Bellvitge