Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis (REVAMP-Sepsis)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52,500
- 试验地点
- 8
- 主要终点
- Change in vancomycin use
研究概览
简要总结
The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU).
There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:
- Implementation of a clinical guideline indicating when vancomycin should and should not be used
- Unit-level feedback on overall vancomycin use within and across centers
- Clinician education.
详细描述
Vancomycin is among the most commonly prescribed antibiotics in United States children's hospitals, and inappropriate use of vancomycin is common. Given the high prevalence of acute kidney injury associated with vancomycin of up to 25%, reducing vancomycin overuse is a key opportunity to reduce preventable patient harm.
The primary objective of this study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care PICUs. This intervention will be informed by baseline data surrounding vancomycin use and infections due to organisms requiring vancomycin therapy which will allow selective use of vancomycin, as well as a concurrent mixed methods process and formative evaluation to inform implementation of the intervention.
During the baseline period, Electronic Health Record (EHR) data will be used to retrospectively quantify unit-level vancomycin use over 24 months (measured as vancomycin days of therapy [DOT]/1000 patient days), as well as the frequency of vancomycin use and prevalence of infections due to organisms requiring vancomycin therapy among patients with suspected and confirmed sepsis.
During the post-intervention period, which will last approximately 24 months, a multifaceted stewardship intervention to reduce vancomycin use informed by these baseline data, including:
- The creation of a consensus guideline for vancomycin use;
- Ad hoc education related to vancomycin overuse, and;
- Unit-level feedback on vancomycin prescribing. The feedback on vancomycin use will be provided to clinicians at each site, both within their site (to compare to past performance) and across sites (to compare local performance to the performance of other sites).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to one of the participating PICUs during the study period
排除标准
- •Clinician Inclusion Criteria:
- •PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
- •Age ≥ 18 years old
- •Employed by one of the participating sites
- •Clinician Exclusion Criteria:
- •Volunteers or other non-employee hospital staff
- •Limited English proficiency
结局指标
主要结局
Change in vancomycin use
时间窗: Baseline to 5 years
Vancomycin use will be measured as DOT per 1000 PICU patient days, measured monthly. Every day in which one or more doses of parenteral vancomycin is administered is classified as one vancomycin DOT. Every day or portion of a day a patient is admitted to the PICU is classified as one PICU patient day.
次要结局
- Hospital length of stay(Up to 3 years)
- PICU all-cause mortality(Up to 3 years)
- 30-day hospital readmission(Within 30 days of discharge from a hospital admission)
- Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.(Baseline to 5 years)
- 30-day PICU readmission(Within 30 days of discharge from a PICU admission)
- PICU length of stay(Up to 3 years)
- Use of other broad-spectrum antibiotics(Up to 5 years)
- Use of other anti-MRSA antibiotics(Up to 5 years)
- Prevalence of infections due to organisms requiring vancomycin(Up to 5 years)