Stepped-wedge Cluster Randomised Controlled Trial to Increase Antibiotic Appropriateness in Residential Aged Care Facilities: a Nurse-led Bundled Antimicrobial Stewardship Intervention.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
研究概览
简要总结
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities. The intervention will be assessed in a stepped-wedge cluster randomised controlled trial across 14 residential aged care facilities over an 18-month period.
详细描述
The study will explore the impact of a nurse-led bundled antimicrobial stewardship intervention on the appropriateness of antimicrobial use in residential aged care facilities (RACFs).
The antimicrobial stewardship intervention will include the following components:
- Education
- Focused on antimicrobial stewardship and appropriate antimicrobial use
- Delivered face-to-face, via workbooks and fact sheets to aged care staff, general practitioners (GPs), pharmacists, and residents and families. Education will be delivered by the research coordinator.
- Guidelines
- Aged care-specific guidelines for the assessment and antimicrobial management of urinary tract infections, respiratory tract infections and skin and soft tissue infections.
- Antimicrobial management recommendations including empirical oral therapy, doses and duration of therapy.
- Communication
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All residents from 12 RACFs will have de-identified data collected including antimicrobial use, infection, hospitalisation and mortality.
- •Residents or their guardians who provide informed consent to monthly biospecimen sampling and participation in one-on-one interviews or focus groups.
- •Health professionals:
- •Health professionals (including aged care staff and GPs) who provide informed consent to participate in one-on-one interviews or focus groups.
排除标准
- •Residents or their guardians who do not consent to biospecimen sampling and/or participation in interviews/focus groups.
- •Health professionals who do not consent to participate in interviews/focus groups.
结局指标
主要结局
Rate of total days of systemic antimicrobial therapy per 1,000 occupied bed days (OBD)
时间窗: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
Cumulative proportion of residents prescribed a systemic antimicrobial
时间窗: Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months
次要结局
- Proportion of appropriate antimicrobial use.(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Number of courses of systemic antimicrobial therapy per 1,000 OBD.(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Rate of Clostridium Difficile infection(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Frequency of carriage of antimicrobial-resistant organisms(Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).)
- All-cause mortality(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Change in facility-level antimicrobial susceptibility profile(Assessed over a 12-month period during the trial (at least 2 months pre-intervention and 2 months post-intervention).)
- Incidence of resident transfer to hospital for infectious indications(Assessed from commencement of the intervention at each facility until the conclusion of the trial at 16 months)
- Perceptions from stakeholders on quality and uptake of the intervention(Assessed at the conclusion of the trial at 16 months)