Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 45,000
- 试验地点
- 1
- 主要终点
- nvHAP Incidence rate
研究概览
简要总结
Background: Hospital acquired pneumonia (HAP) is divided in two distinct groups, ventilator-associated pneumonia (VAP) and non-ventilator-associated HAP (nvHAP). Although nvHAP occurs more frequently than VAP and results in similar mortality and costs, prevention guidelines and prevention focus almost exclusively on VAP. Scientific evidence about nvHAP prevention is scarce. Therefore, we designed a mixed-methods study to investigate the effectiveness of a newly developed nvHAP prevention bundle and factors that influence its implementation.
Methods: This single-centre project at the 950-bed University Hospital Zurich (UHZ) will engage the wards of nine departments with substantial nvHAP rates. The nvHAP bundle consists of five primary prevention measures: 1) oral care, 2) identification and treatment of patients with dysphagia, 3) mobilization, 4) stopping unnecessary proton pump inhibitors, and, 5) respiratory therapy. Implementation includes the engagement of department-level implementation teams, who sustain the 'core' intervention components of education, training, and environmental restructuring and adapt the implementation strategy to local needs. The effects of the implementation will be analysed by a mixed-method approach. As primary outcome, nvHAP incidence rates will be analysed by Poisson regression models to compare incidence rates before, during, and after the implementation phases (on the hospital and department level). In addition, the association between process indicators and nvHAP incidence rates will be analysed using longitudinal Poisson regression models. A longitudinal, qualitative study and formative evaluation based on interviews and focus groups identifies supporting or hindering factors for implementation success in participating departments dynamically over time. This accumulating implementation experience will be constantly fed back to the implementation teams and thus, represents an active implementation element.
Discussion: This comprehensive mixed-methods study is designed to accomplish both, measure the effectiveness of a new prevention bundle against nvHAP and provide insights into how and why it worked or failed. The results of this study may contribute substantially to patient safety in the area of a rediscovered healthcare-associated infection - nvHAP.
详细描述
Methods
Aim:
With this mixed-methods study, we aim to investigate the impact of the implementation of a newly designed nvHAP prevention bundle on the nvHAP incidence rate among inpatients in our tertiary care hospital. We will quantify the adherence to the individual bundle elements and qualitatively identify the factors that influence successful implementation.
Objectives:
- To determine the nvHAP bundle effectiveness on the nvHAP incidence rate
- To determine the adherence the nvHAP bundle and each of the bundle elements
- To relate adherence to nvHAP bundle elements with nvHAP incidence rate
- To qualitatively monitor changes and identify trends in implementation outcomes throughout the study periods
- To identify which factors in the implementation setting are associated with the actual degree of local implementation of the nvHAP bundle
研究设计
- 研究类型
- Interventional
- 干预模型
- Sequential
- 主要目的
- Prevention
- 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
- •The study population consists of all patients hospitalized in nine predefined medical and surgical departments and their corresponding wards chosen based on the following criteria
- •nvHAP rate above the 50th percentile according to UHZ nvHAP data from the year 2017
- •high absolute number of patients with nvHAP according to UHZ nvHAP data from the year 2017
- •organizational structure, e.g. departments sharing same nursing or medical personnel
- •representing both medical and surgical specialties.
排除标准
- 未提供
研究组 & 干预措施
Intervention
nvHAP-Prevention Bundle
干预措施: nvHAP Prevention Bundle (Procedure)
结局指标
主要结局
nvHAP Incidence rate
时间窗: up to 3 months post-discharge
non Ventilator-associated Hospital acquired Pneumonia according to ECDC definitions
次要结局
- Percentage of patients who passed away during hospitalization (in-hospital mortality)(up to 3 months post-discharge)
- length of stay(up to 3 months post-discharge)
