The Review and Improvement of Cardiac Implantable Device Infection Quality Initiative (RECTIFY) Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
研究概览
简要总结
The aim of this Quality Initiative (QI) demonstration project is to develop a model to increase guideline-driven care for patients with cardiovascular implantable electronic devices (CIED) infection. Multidisciplinary teams will be established to carry out the multifaceted intervention. This program seeks to improve early identification and diagnosis, appropriate treatment, and faster time to treatment of CIED infection.
详细描述
Retrospective data will be collected pre-intervention. The interventions will then be implemented for a total of six months and will continue through the data collection period. Prospective data collection will start three months after the intervention is started and will continue for a total of 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Cardiovascular Implantable Electronic Device (CIED) in place
- •Presumed CIED infection, as defined by:
- •Positive blood culture (two or more positive blood cultures for typical skin organisms (coagulase-negative staphylococci, Corynebacterium species, Propionobacterium species), or one positive blood culture for all other microorganisms), with no other source identified to explain the bacteremia
- •Cases with definite evidence of pocket infection (defined as localized erythema, swelling, pain, tenderness, warmth, erosion, or drainage), if treated with antibiotics before culture, even with negative culture, will be considered device infection
排除标准
- •Patients who are inappropriate for device extraction, for example those who are DNAR and not using therapy to prolong survival because any procedure is considered inappropriate and/or it is unlikely that extraction would change overall prognosis
- •Death within one week of definitive CIED systemic infection diagnosis or positive blood culture. Cases of bacteremia originating from a source other than the CIED that resolve without any evidence of CIED involvement should not be considered as CIED infection
- •Patients with left ventricular assist devices (LVADs)
研究组 & 干预措施
Quality Improvement Program
The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.
干预措施: Multidisciplinary Team (Other)
Quality Improvement Program
The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.
干预措施: Outreach Visits (Other)
Quality Improvement Program
The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.
干预措施: Multifaceted Intervention (Other)
Quality Improvement Program
The quality improvement program will consist of development and/or refinement of participating health system's patient care pathways tailored to address the gaps and barriers around recognition and treatment of CIED infections. Interventions will be customized and modified as needed based on regular reviews and implementation progress.
干预措施: Measurement and Feedback (Other)
结局指标
主要结局
Proportion of patients with CIEDs and positive blood cultures who receive extraction (per guidelines)
时间窗: Up to 12 months
Proportion of patients with CIEDs and positive blood cultures, who receive extraction
Proportion of patients with CIEDs and definite pocket infections who receive extraction (per guidelines)
时间窗: Up to 12 months
Proportion of patients with CIEDs and probable device infection, who receive extraction
次要结局
- Estimated healthcare utilization/costs(Up to 12 months)
- Patient satisfaction as measured by a qualitative survey(Up to 12 months)
- Number of patients with multi-organ failure or septic shock at time of extraction(Up to 12 months)
- Time from positive blood culture/clear pocket infection to extraction for those undergoing extraction(Up to 12 months)
- Number of patients identified with suspected CIED infection(Up to 12 months)
- Number of patients referred to both Extraction Center (from outside hospital) and electrophysiologists (at Extraction Center) for extraction(Up to 12 months)
- Proportion of patients with extraction within 7 days of diagnosis(Up to 12 months)
- Proportion of patients with extraction during index hospitalization(Up to 12 months)
- Number of actual extractions(Up to 12 months)
- Staff satisfaction as measured by a qualitative survey(Up to 12 months)