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临床试验/NCT03361085
NCT03361085终止不适用

Modular Prevention Bundle for Non-ventilator-associated Hospital-acquired Pneumonia (nvHAP)

University of Zurich1 个研究点 分布在 1 个国家目标入组 45,000 人开始时间: 2018年1月1日最近更新:
适应症
干预措施

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:

  1. To determine the nvHAP bundle effectiveness on the nvHAP incidence rate
  2. To determine the adherence the nvHAP bundle and each of the bundle elements
  3. To relate adherence to nvHAP bundle elements with nvHAP incidence rate
  4. To qualitatively monitor changes and identify trends in implementation outcomes throughout the study periods
  5. 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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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