Implementation and evaluation of a care bundle for prevention of non-ventilator-associated hospital-acquired pneumonia (nvHAP) - a mixed-methods study protocol for a hybrid type 2 effectiveness-implementation trial

Abstract

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 and its implementation is scarce. Therefore, we designed a mixed-methods hybrid type 2 effectiveness-implementation study to investigate both the effectiveness and implementation of a newly developed nvHAP prevention bundle.

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) prevention of dysphagia-related aspiration, 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 tailor the implementation strategy to local needs. Both effectiveness and implementation outcomes will be assessed using mixed-methods. As a 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). Additionally, 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, focus groups, and observations 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 hybrid mixed-methods study is designed to both, measure the effectiveness of a new nvHAP prevention bundle and multifaceted implementation strategy, while also providing insights into how and why it worked or failed. The results of this study may contribute substantially to advancing knowledge and patient safety in the area of a rediscovered healthcare-associated infection - nvHAP.

Trial registration: ClinicalTrials.gov : NCT03361085 . Registered December 2017.

Keywords: Aspiration pneumonia; Care bundle; Hospital-acquired pneumonia; Implementation science; Infection prevention; Mixed-methods study; Qualitative research.

Conflict of interest statement

None to declare for all authors.

Figures

Fig. 1

Conceptual model Legend: nvHAP = non-ventilator-associated healthcare-acquired pneumonia. This figure portrays the conceptual model of the nvHAP implementation process, in which the entire implementation process is moderated by the context in which the process is set. The contextual influencers of implementation include the larger organizational setting (i.e. the hospital and wider national context), the inner setting (i.e. the departments in which the bundle is being implemented), as well as the characteristics of individuals directly and indirectly involved in the implementation process. The contextual influencers moderate the effectiveness of specific intervention components used to implement the nvHAP bundle elements in participating departments, resulting in varying levels of implementation success, as reflected by levels of adherence to bundle components, and ultimately by the resulting outcome measures

Fig. 2

Study time table for department and hospital level (example of anticipated inclusion time points) Legend: Department and hospital baseline period (i.e. before implementation, light grey), followed by implementation period (i.e. during implementation, shaded), and intervention period (i.e. after implementation, dark grey)

Fig. 3

Study periods and data collection in a single exemplary department Legend: The baseline period of 12 months or longer is followed by an implementation period defined to be 2 months long, and an intervention period of again 12 months or longer. The figure depicts the data collection time points, with squares indicating quantitative data collection and circles indicating qualitative data collection time points