Background
Hospital acquired pneumonia (HAP) is defined as pneumonia with first symptoms ≥48 h after admission. It is divided into two distinct groups, ventilator-associated pneumonia (VAP) and non-ventilator-associated hospital acquired pneumonia (nvHAP). Together, HAP and lower respiratory tract infections were shown to be the most common healthcare-associated infections (HAI) in both the European point prevalence study of 2011/2012 and the multistate U.S. point prevalence study in 2011 [
1,
2]. In these studies, more than half of HAP - 67 and 61% - were nvHAP [
1,
2]. Further, nvHAP leads to substantial morbidity and was shown to have comparable mortality and similar costs as VAP [
3]. However, current research and prevention efforts still focus almost exclusively on VAP.
Scientific evidence about prevention of nvHAP is scarce and of limited quality [
4]. There are no formal recommendations or evidence-based guidelines for nvHAP, and the existing HAP prevention guidelines focus almost exclusively on VAP [
5‐
7]. In a narrative review, Passaro et al. highlighted that oral care is the most studied measure and was commonly associated with a decreased HAP rate, although a broad range of interventions are proposed [
4]. Evidence is lacking for other measures such as dysphagia programs, early mobilization, and head of bed elevation [
4]. The estimated proportion of preventable HAI in general ranges from 10 to 70% [
8,
9], and the preventable proportion of VAP specifically was reported to be 52–55% [
10,
11]. In a systematic literature review and meta-analysis about the proportion of HAI that could be prevented with multifaceted interventions only two of 132 included studies dealt with the prevention of nvHAP [
9]. Hiramatsu et al. found that an outpatient bundle of nvHAP prevention measures, comprising three procedures of breathing exercises, two procedures of oral care, a procedure of nutritional control and smoking cessation prior to planned surgery, was effective to prevent postoperative pneumonia among patients with oesophageal cancer [
12]. Kazaure et al. found that use of an incentive spirometer, oral hygiene with chlorhexidine, ambulation with good pain control and head-of-bed elevation to at least 30° and sitting up for all meals, accompanied by initial and ongoing education, progress reports, prevention measure documentation and order sets lead to a 43.6% decrease of postoperative pneumonia in non-cardiac surgical patients [
13]. To our knowledge, there are no studies evaluating the effectiveness of an nvHAP prevention bundle on a broad patient population.
Implementation science is the scientific study of methods to promote uptake of evidence-based best practices into routine healthcare practice [
14]. Although quality improvement studies often report on the effectiveness of studied interventions to improve both, process indicators and patient outcomes, little is usually reported about the context of the intervention and what factors played a role in the successful implementation of practice measures. Further, the implementation strategies used in such studies are often described in poor detail and lack theoretical justification, therefore hindering the development of an evidence base for their effectiveness [
15‐
17]. A detailed understanding of not only what works, but also how and why it works, is helpful to ensure that evidence-based practices of proven effectiveness can be successfully replicated and implemented in other settings. To simultaneously evaluate our multifaceted implementation strategy while also testing the effectiveness of the clinical nvHAP prevention bundle, we undertake a type 2 hybrid effectiveness-implementation study [
18,
19].
This comprehensive type 2 hybrid effectiveness-implementation study aims to assess the effectiveness and success factors of both, a new prevention bundle against nvHAP and a specifically designed department-based multifaceted implementation strategy in a medical and surgical patient population.
Discussion
With this mixed-methods study we will close critical knowledge gaps about the prevention of nvHAP, a neglected but common HAI. To date, literature about prevention measures against nvHAP is scarce [
4], and our study will provide further knowledge by assessing the effectiveness of a five element prevention bundle against nvHAP on lowering nvHAP incidence rates. To our knowledge, it is the first study testing an inpatient bundle of nvHAP prevention measures on a broad patient population. Moreover, as effective implementation is as important as choosing the right bundle elements [
14,
32], we place focus on a theoretically-informed implementation strategy.
The quantitative part of the study aims to not only measure the primary outcome parameter nvHAP incidence rate over time, but to also measure process indicators. This will help us to better understand if the implementation process was successful and to evaluate direct association between prevention measures and nvHAP incidence rate. As the nvHAP bundle cannot be effective if it is not well implemented, it is important to also measure implementation outcomes (e.g. acceptability, appropriateness, fidelity, and sustainability) as necessary preconditions for achieving the desired changes in clinical outcomes.
A major strength of this study is the mixed-methods approach, including an extensive formative qualitative study to provide insights about how and why departments succeeded, or faced challenges, in implementing the nvHAP bundle. With some notable exceptions [
33‐
36], many qualitative implementation evaluations are limited to inquiries conducted at a single point in time. Such inquiries are prone to participant recall biases and may be insufficient to telling the whole implementation story [
26]. Our longitudinal qualitative study aims to provide critical contextual insights to guide others hoping to implement the nvHAP bundle. Additionally, the participatory approach of our formative evaluation is intended to increase project commitment among stakeholders, particularly local implementation teams.
The limitations of our study are the following: First, our study does not include a control group. We abstained from conducting a randomized controlled trial due to anticipated high contamination between departments/wards within the same hospital. Second, the duration of the implementation period is determined to be 2 months not accounting for possibly longer duration due to the formative approach of the implementation strategy. We aim to address this point by analysing the results both on the hospital and department level. Third, by continuously collecting process indicators from EMR, we cannot preclude reporting bias (e.g. increased documentation of oral care). We address this issue by additionally measuring process indicators on an individual basis. Further, although we take efforts to demonstrate empathic neutrality during our qualitative data collection, we cannot entirely preclude the possibility that qualitative researchers may be perceived as being partial, leading to potential desirability bias in the qualitative data. Finally, we acknowledge that our formative process evaluation does in itself lead to changes in implementation plans and that these changes must be documented with great care to keep track of the exact implementation activities. Rather than purely a limitation, we view this as a strength of our study, and we anticipate that it should also be integrated into recommendations for those wishing to replicate results of our future nvHAP study.
In conclusion, with this innovative mixed-methods study design, we will assess the effectiveness of the nvHAP bundle, but also measure process indicators of the nvHAP bundle and contextual factors influencing implementation uptake. We will be able to triangulate our findings, i.e. correlate nvHAP rates with adherence data of the prevention bundle and again with qualitative measures of implementation success. Further, our mixed-method approach will be of great value to understanding the complex contextual interactions that influence implementation success, which are necessary to inform implementation guidance for other institutions planning to implement the nvHAP bundle.
Addendum: Due to the COVID-19 pandemic, the study data collection had to be terminated earlier than planned (i.e. end of February 2020). Additional file
7 informs about the details of early study termination.
Acknowledgements
The authors would like to thank the members of the interprofessional group of UHZ healthcare workers who helped to design the UHZ nvHAP bundle, namely Claudia Barfuss, Birgit David, Brigitte Eggenberger, and Dragos Ionescu.
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