Feasibility of blinding spinal manual therapy interventions among participants and outcome assessors: protocol for a blinding feasibility trial.

INTRODUCTION: Blinding is a methodologically important aspect in randomised controlled trials yet frequently overlooked in trials of spinal manual therapy interventions for back pain. To help inform the blinding methods of a future, double-placebo-controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain, we set four objectives: (1) to assess the feasibility of blinding participants, randomly allocated to an active or placebo-control spinal manual therapy intervention protocol, (2) to assess the feasibility of blinding outcome assessors within the trial, (3) to explore the influence of spinal manual therapy experience and low back pain on blinding, and (4) to explore factors contributing to perceptions about intervention assignment among participants and outcome assessors. METHODS AND ANALYSIS: Two-parallel-group, single-centre, placebo-controlled, methodological blinding feasibility randomised trial. We will recruit between 60 and 100 adults with or without back pain and with or without experience of spinal manual therapy from Zurich, Switzerland. Participants will be randomised to either an active spinal manual therapy or a placebo-control spinal manual therapy protocol-both interventions delivered over two study visits, up to two weeks apart. The primary outcome is participant blinding using the Bang blinding index within each intervention arm immediately after each of the two study visits. Secondary outcomes are participant blinding using the James blinding index, outcome assessor blinding (Bang and James blinding indices), self-reported factors influencing perceived intervention assignment among participants and outcome assessors, and participant-reported credibility and expectancy of study interventions. Other outcomes-included to blind the study objective from participants-are lumbar spine range of motion, self-rated general health, satisfaction with care, pain intensity, and function. Intervention provider outcomes include intervention component fidelity and quality of intervention delivery. ETHICS AND DISSEMINATION: The independent ethics commission of Canton Zurich granted ethical approval for this study (KEK 2023-00381). Written informed consent will be obtained from all participants. Findings will be disseminated in scientific conferences and a peer-reviewed publication and inform the blinding methods of a future double-placebo controlled trial comparing spinal manual therapy and nerve root injection for lumbosacral radicular pain-the SALuBRITY trial. TRIAL REGISTRATION: NCT05778396.

Involving patients and clinicians in the development of a randomised clinical trial protocol to assess spinal manual therapy versus nerve root injection for patients with lumbar radiculopathy: a patient and public involvement project to inform the SALuBRITY trial design.

BACKGROUND: Spinal manual therapy and corticosteroid nerve root injection are commonly used to treat patients with lumbar radiculopathy. The SALuBRITY trial-a two parallel group, double sham controlled, randomised clinical trial-is being developed to compare their effectiveness. By gathering patients' and clinicians' perspectives and involving them in discussions related to the trial research question and objectives, proposed trial recruitment processes, methods, and outcome measures, we aimed to improve the relevance and quality of the SALuBRITY trial. METHODS: We involved patients with lived experience of lumbar radiculopathy (n = 5) and primary care clinicians (n = 4) with experience in the treatment of these patients. Involvement activities included an initial kick-off event to introduce the project, establishing a shared purpose statement, and empowering patient and clinician advisors for their involvement, followed by semi-structured group and individual interviews, and questionnaires to evaluate the experience throughout the project. RESULTS: Both patient and clinician advisors endorsed the significance and relevance of the trial's objectives. Patients assessed the proposed trial methods as acceptable within the context of a trusting patient-clinician relationship. A trial recruitment and enrolment target time of up to five days was regarded as acceptable, although patients with chronic radiculopathy may need more time to consider their trial participation decision. All advisors reached consensus on the acceptability of a medication washout phase of 12- to 24-h before pain outcome measurement, with the inclusion of a rescue medication protocol. Both advisory groups preferred leg pain over back pain as the primary clinical outcome, with patient advisors advocating for personalized primary pain localization. Furthermore, patients requested expanding the pain, enjoyment, and general activity scale with peak pain intensity, rather than average pain alone. Patient and clinician advisors evaluated their engagement in clinical research as meaningful and impactful. CONCLUSION: Patient and public involvement resulted in important and relevant considerations for the SALuBRITY trial, spanning all research phases. These findings hold promise for enhancing the trial's quality and relevance and improving its translation into clinical practice.

Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study).

BACKGROUND: The implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial. METHODS AND ANALYSIS: This mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis. ETHICS AND DISSEMINATION: Ethics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences. PROTOCOL REGISTRATION NUMBER: Open science framework (OSF) https://osf.io/8t2ud Registered on 21 December 2022.

Prevention of non-ventilator-associated hospital-acquired pneumonia in Switzerland: a type 2 hybrid effectiveness-implementation trial.

BACKGROUND: Non-ventilator-associated hospital-acquired pneumonia (nvHAP) is a frequent, but under-researched infection. We aimed to simultaneously test an nvHAP prevention intervention and a multifaceted implementation strategy. METHODS: In this single-centre, type 2 hybrid effectiveness-implementation study, all patients of nine surgical and medical departments at the University Hospital Zurich, Switzerland, were included and surveyed over three study periods: baseline (14-33 months, depending on department), implementation (2 months), and intervention (3-22 months, depending on department). The five-measure nvHAP prevention bundle consisted of oral care, dysphagia screening and management, mobilisation, discontinuation of non-indicated proton-pump inhibitors, and respiratory therapy. The implementation strategy comprised department-level implementation teams who conducted and locally adapted the core strategies of education, training, and changing infrastructure. Intervention effectiveness on the primary outcome measure of nvHAP incidence rate was quantified using a generalised estimating equation method in a Poisson regression model, with hospital departments as clusters. Implementation success scores and determinants were derived longitudinally through semistructured interviews with health-care workers. This trial is registered with ClinicalTrials.gov (NCT03361085). FINDINGS: Between Jan 1, 2017, and Feb 29, 2020, 451 nvHAP cases occurred during 361 947 patient-days. nvHAP incidence rate was 1·42 (95% CI 1·27-1·58) per 1000 patient-days in the baseline period and 0·90 (95% CI 0·73-1·10) cases per 1000 patient-days in the intervention period. The intervention-to-baseline nvHAP incidence rate ratio, adjusted for department and seasonality, was 0·69 (95% CI 0·52-0·91; p=0·0084). Implementation success scores correlated with lower nvHAP rate ratios (Pearson correlation -0·71, p=0·034). Determinants of implementation success were positive core business alignment, high perceived nvHAP risk, architectural characteristics promoting physical proximity of health-care staff, and favourable key individual traits. INTERPRETATION: The prevention bundle led to a reduction of nvHAP. Knowledge of the determinants of implementation success might help in upscaling nvHAP prevention. FUNDING: Swiss Federal Office of Public Health.

Implementing organized colorectal cancer screening programs in Europe-protocol for a systematic review of determinants and strategies.

BACKGROUND: With a high mortality of 12.6% of all cancer cases, colorectal cancer (CRC) accounts for substantial burden of disease in Europe. In the past decade, more and more countries have introduced organized colorectal cancer screening programs, making systematic screening available to entire segments of a population, typically based on routine stool tests and/or colonoscopy. While the effectiveness of organized screening in reducing CRC incidence and mortality has been confirmed, studies continuously report persistent program implementation challenges. This systematic review will synthesize the literature on organized CRC screening programs. Its aim is to understand what is currently known about the barriers and facilitators that influence the implementation of these programs and about the implementation strategies used to navigate these determinants. METHODS: A systematic review of primary studies of any research design will be conducted. CENTRAL, CINAHL, EMBASE, International Clinical Trials Registry Platform, MEDLINE, PsycINFO, and Scopus will be searched. Websites of (non-)government health care organizations and websites of organizations affiliated with authors of included studies will be screened for unpublished evaluation reports. Existing organized CRC screening programs will be contacted with a request to share program-specific grey literature. Two researchers will independently screen each publication in two rounds for eligibility. Included studies will focus on adult populations involved in the implementation of organized CRC screening programs and contain information about implementation determinants/ strategies. Publications will be assessed for their risk of bias. Data extraction will include study aim, design, location, setting, sample, methods, and measures; program characteristics; implementation stage, framework, determinants, strategies, and outcomes; and service and other outcome information. Findings will be synthesized narratively using the three stages of thematic synthesis. DISCUSSION: With its sole focus on the implementation of organized CRC screening programs, this review will help to fill a central knowledge gap in the literature on colorectal cancer screening. Its findings can inform the decision-making in policy and practice needed to prioritize resources for establishing new and maintaining existing programs in the future. SYSTEMATIC REVIEW REGISTRATION: PROSPERO (CRD42022306580).

Implementation of infection prevention and control for hospitalized neonates: A narrative review.

BACKGROUND: The most prevalent infections encountered in neonatal care are healthcare-associated infections. The majority of healthcare-associated infections are considered preventable with evidence-based infection prevention and control (IPC) practices. However, substantial knowledge gaps exist in IPC implementation in neonatal care. Furthermore, the knowledge of factors which facilitate or challenge the uptake and sustainment of IPC programmes in neonatal units is limited. The integration of implementation science approaches in IPC programmes in neonatal care aims to address these problems. OBJECTIVES: The aim of this narrative review was to identify determinants which have been reported to influence the implementation of IPC programmes and best practices in inpatient neonatal care settings. SOURCES: A literature search was conducted in PubMed, MEDLINE (Medical Literature Analysis and Retrieval System Online) and CINAHL (Cumulative Index to Nursing and Allied Health Literature) in May 2022. Primary study reports published in English, French, German, Spanish, Portuguese, Italian, Danish, Swedish or Norwegian since 2000 were eligible for inclusion. Included studies focused on IPC practices in inpatient neonatal care settings and reported determinants which influenced implementation processes. CONTENT: The Consolidated Framework for Implementation Research was used to identify and cluster reported determinants to the implementation of IPC practices and programmes in neonatal care. Most studies reported challenges and facilitators at the organizational level as particularly relevant to implementation processes. The commonly reported determinants included staffing levels, work- and caseloads, as well as aspects of organizational culture such as communication and leadership. IMPLICATIONS: The presented knowledge about factors influencing neonatal IPC can support the design, implementation, and evaluation of IPC practices.

Hand hygiene improvement of individual healthcare workers: results of the multicentre PROHIBIT study.

BACKGROUND: Traditionally, hand hygiene (HH) interventions do not identify the observed healthcare workers (HWCs) and therefore, reflect HH compliance only at population level. Intensive care units (ICUs) in seven European hospitals participating in the "Prevention of Hospital Infections by Intervention and Training" (PROHIBIT) study provided individual HH compliance levels. We analysed these to understand the determinants and dynamics of individual change in relation to the overall intervention effect. METHODS: We included HCWs who contributed at least two observation sessions before and after intervention. Improving, non-changing, and worsening HCWs were defined with a threshold of 20% compliance change. We used multivariable linear regression and spearman's rank correlation to estimate determinants for the individual response to the intervention and correlation to overall change. Swarm graphs visualized ICU-specific patterns. RESULTS: In total 280 HCWs contributed 17,748 HH opportunities during 2677 observation sessions. Overall, pooled HH compliance increased from 43.1 to 58.7%. The proportion of improving HCWs ranged from 33 to 95% among ICUs. The median HH increase per improving HCW ranged from 16 to 34 percentage points. ICU wide improvement correlated significantly with both the proportion of improving HCWs (ρ = 0.82 [95% CI 0.18-0.97], and their median HH increase (ρ = 0.79 [0.08-0.97]). Multilevel regression demonstrated that individual improvement was significantly associated with nurse profession, lower activity index, higher nurse-to-patient ratio, and lower baseline compliance. CONCLUSIONS: Both the proportion of improving HCWs and their median individual improvement differed substantially among ICUs but correlated with the ICUs' overall HH improvement. With comparable overall means the range in individual HH varied considerably between some hospitals, implying different transmission risks. Greater insight into improvement dynamics might help to design more effective HH interventions in the future.

Documentation of adherence to infection prevention best practice in patient records: a mixed-methods investigation.

BACKGROUND: Healthcare-associated infections remain a preventable cause of patient harm in healthcare. Full documentation of adherence to evidence-based best practices for each patient can support monitoring and promotion of infection prevention measures. Thus, we reviewed the extent, nature, and determinants of the documentation of infection prevention (IP) standards in patients with HAI. METHODS: We reviewed electronic patient records (EMRs) of patients included in four annual point-prevalence studies 2013-2016 who developed a device- or procedure-related HAI (surgical site infection (SSI), catheter-associated urinary tract infection (CAUTI), ventilator-associated infection (VAP), catheter-related bloodstream infection (CRBSI)). We examined the documentation quality of mandatory preventive measures published as institutional IP standards. Additionally, we undertook semi-structured interviews with healthcare providers and a two-step inductive (grounded theory) and deductive (Theory of Planned Behaviour) content analysis. RESULTS: Of overall 2972 surveyed patients, 249 (8.4%) patients developed 272 healthcare-associated infections. Of these, 116 patients met the inclusion criteria, classified as patients with SSI, CAUTI, VAP, CRBSI in 78 (67%), 21 (18%), 10 (9%), 7 (6%), cases, respectively. We found documentation of IP measures in EMRs in 432/1308 (33%) cases. Documentation of execution existed in the study patients' EMRs for SSI, CAUTI, VAP, CRBSI, and overall, in 261/931 (28%), 27/104 (26%), 46/122 (38%), 26/151 (17%), and 360/1308 (28%) cases, respectively, and documentation of non-execution in 67/931 (7%), 2/104 (2%), 0/122 (0%), 3/151 (2%), and 72/1308 (6%) cases, respectively. Healthcare provider attitudes, subjective norms, and perceived behavioural control indicated reluctance to document IP standards. CONCLUSIONS: EMRs rarely included conclusive data about adherence to IP standards. Documentation had to be established indirectly through data captured for other reasons. Mandatory institutional documentation protocols or technically automated documentation may be necessary to address such shortcomings in patient safety documentation.

Involving patients and clinicians in a pilot randomised clinical trial of spinal manual therapy versus nerve root injection for lumbar radiculopathy: protocol of a patient and public involvement project.

INTRODUCTION: A patient and public involvement (PPI) project will be embedded within the SALuBRITY pilot trial, a two parallel group, double sham controlled, randomised clinical trial. The study aims to compare the effectiveness of spinal manual therapy and corticosteroid nerve root injections, two methods commonly used to treat patients with lumbar radiculopathy. We aim to gather patients' and clinicians' perspectives and involve them in decisions related to the research question and objectives, proposed trial recruitment processes and methods, and proposed outcome measures. METHODS AND ANALYSIS: A small group of patients with lived experience of lumbar radiculopathy and primary care clinicians with experience in the treatment of patients with lumbar radiculopathy are involved. An initial kickoff event will prepare and empower the advisors for involvement in the project, followed by semistructured patient group and one-on-one clinician interviews. We will follow the Critical Outcomes of Research Engagement framework for assessing the impact of patient engagement in research. We will summarise and feedback PPI content to the patient and clinician advisors during a member-checking process to ensure accurate interpretation of patient and clinician inputs. Inductive and deductive thematic analysis will be used for the qualitative analysis of the interviews. Two surveys will be completed at different points along the trial to track the advisors' and researchers' experiences over the course of the PPI project. Any modifications to the SALuBRITY trial methods due to PPI inputs will be thoroughly documented and recorded in an impact log. ETHICS AND DISSEMINATION: The independent research ethics committee of Canton Zurich confirmed that ethical approval for this PPI subproject was not required. PPI results will be disseminated in a peer-reviewed journal and presented at conferences.

A Modified Implementation Mapping Methodology for Evaluating and Learning From Existing Implementation.

When empirically supported interventions are implemented in real-world practice settings, the process of how these interventions are implemented is highly relevant for their potential success. Implementation Mapping is a method that provides step-by-step guidance for systematically designing implementation processes that fit the respective intervention and context. It includes needs assessments among relevant stakeholders, the identification of implementation outcomes and determinants, the selection and design of appropriate implementation strategies, the production of implementation protocols and an implementation outcome evaluation. Implementation Mapping is generally conceptualized as a tool to prospectively guide implementation. However, many implementation efforts build on previous or ongoing implementation efforts, i.e., "existing implementation." Learnings from existing implementation may offer insights critical to the success of further implementation activities. In this article, we present a modified Implementation Mapping methodology to be applied when evaluating existing implementation. We illustrate the methodology using the example of evaluating ongoing organized colorectal cancer screening programs in Switzerland. Through this example, we describe how we identify relevant stakeholders, implementation determinants and outcomes as well as currently employed implementation strategies. Moreover, we describe how we compare the types of strategies that are part of existing implementation efforts with those that implementation science would suggest as being suited to address identified implementation determinants. The results can be used for assessing the current state of implementation outcomes, refining ongoing implementation strategies, and informing future implementation efforts.

Factors Influencing the Implementation of Antimicrobial Stewardship in Primary Care: A Narrative Review.

Antimicrobial resistance (AMR) is directly driven by inappropriate use of antibiotics. Although the majority of antibiotics (an estimated 80%) are consumed in primary care settings, antimicrobial stewardship (AMS) activities in primary care remain underdeveloped and factors influencing their implementation are poorly understood. This can result in promising stewardship activities having little-to-no real-world impact. With this narrative review, we aim to identify and summarize peer-reviewed literature reporting on (1) the nature and impact of AMS interventions in primary care and (2) the individual and contextual factors influencing their implementation. Reported activities included AMS at different contextual levels (individual, collective and policy). AMS activities being often combined, it is difficult to evaluate them as stand-alone interventions. While some important individual and contextual factors were reported (difficulty to reach physicians leading to a low uptake of interventions, tight workflow of physicians requiring implementation of flexible and brief interventions and AMS as a unique opportunity to strengthen physician-patients relationship), this review identified a paucity of information in the literature about the factors that support or hinder implementation of AMS in primary care settings. In conclusion, identifying multilevel barriers and facilitators for AMS uptake is an essential step to explore before implementing primary care AMS interventions.

Characterising processes and outcomes of tailoring implementation strategies in healthcare: a protocol for a scoping review.

Background: Tailoring strategies to target the salient barriers to and enablers of implementation is considered a critical step in supporting successful delivery of evidence based interventions in healthcare. Theory, evidence, and stakeholder engagement are considered key ingredients in the process however, these ingredients can be combined in different ways. There is no consensus on the definition of tailoring or on a single method for tailoring strategies to optimize impact, ensure transparency, and facilitate replication. Aim: The purpose of this scoping review is to describe how tailoring has been undertaken within healthcare to answer questions about how it has been conceptualised, described, and conducted in practice, and to identify research gaps. Methods: The review will be conducted in accordance with best practice guidelines and the Preferred Reporting Items for Systematic Reviews and Meta-analysis extension for scoping reviews (PRISMA-ScR) will be used to guide the reporting. Searches will be conducted of MEDLINE, Embase, Web of Science, Scopus, from 2005 to present. Reference lists of included articles will be searched. Grey literature will be searched on Google Scholar. Screening and data extraction will be conducted by two or more members of the research team, with any discrepancies resolved by consensus discussion with a third reviewer. Initial analysis will be quantitative involving a descriptive numerical summary of the characteristics of the studies and the tailoring process. Qualitative content analysis aligned to the research questions will also be conducted, and data managed using NVivo where applicable. This scoping review is pre-registered with the Open Science Framework. Conclusions: The findings will serve as a resource for implementation researchers and practitioners to guide future research in this field and facilitate systematic, transparent, and replicable development of tailored implementation strategies.

Theoretical approaches to process evaluations of complex interventions in health care: a systematic scoping review protocol.

BACKGROUND: Complex interventions in health care are characterized by multiple interacting components as well as by numerous nonlinear interactions with the social systems within which they are being implemented. The process of developing, evaluating and implementing complex interventions is therefore challenging. Established guidance such as the MRC (Medical Research Council) framework for developing and evaluating complex interventions refers to process evaluations as an integral part of the development of complex evidence-based interventions. Even though the need for process evaluations is recognized, the realization of such approaches is challenging because methodological instruction is sparse, and the phenomenon of interest is complex. A number of theoretical approaches indicating how to conduct process evaluations of complex interventions in health care exist, but a systematic and comprehensive overview of these is missing. Thus, the objective of the systematic scoping review described herein is to provide an overview and analysis of theoretical approaches suitable for the planning and conducting of process evaluations. METHODS: The design and conduct of this review will follow the procedures of a systematic scoping review. The search strategy will be developed following the BeHEMoTh (Behaviour of interest; Health context; Exclusions; Models or Theories) template which has been conceptualized for structured reviews of theory. The systematic search of the MEDLINE (via PubMed), CINAHL (via EBSCO) and PsycInfo (via EBSCO) electronic databases will be complemented by "hand searching" techniques. Study selection, data extraction, and data analysis will be performed by tandems of two researchers independently of each other. Divergent decisions and judgements between the two researchers will be discussed by the whole review team. DISCUSSION: The findings from this scoping review will provide an overview and comparison of theoretical approaches suitable for process evaluations of complex interventions in health care. The review results will support researchers in choosing the theoretical approach that best fits the respective focus of their process evaluation study. SYSTEMATIC REVIEW REGISTRATION: This study has been registered with PROSPERO (International Prospective Register of Systematic Reviews) under registration number CRD42020211732 .

Determinants for voluntary participation in staff screening during an methicillin-resistant Staphylococcus aureus (MRSA) outbreak on a neonatal ward.

We investigated healthcare worker (HCW) behavior with regard to a voluntary methicillin-resistant Staphylococcus aureus (MRSA) staff screening during a MRSA outbreak in a neonatal ward. Avoiding MRSA transmission from HCWs to patients was the most important reason for participation. Inconvenient screening time was the most frequently cited reason for nonparticipation.

Silica nanoparticles with encapsulated DNA (SPED) - a novel surrogate tracer for microbial transmission in healthcare.

BACKGROUND: The increase in antimicrobial resistance is of worldwide concern. Surrogate tracers attempt to simulate microbial transmission by avoiding the infectious risks associated with live organisms. We evaluated silica nanoparticles with encapsulated DNA (SPED) as a new promising surrogate tracer in healthcare. METHODS: SPED and Escherichia coli were used to implement three experiments in simulation rooms and a microbiology laboratory in 2017-2018. Experiment 1 investigated the transmission behaviour of SPED in a predefined simulated patient-care scenario. SPED marked with 3 different DNA sequences (SPED1-SPED3) were introduced at 3 different points of the consecutive 13 touch sites of a patient-care scenario that was repeated 3 times, resulting in a total of 288 values. Experiment 2 evaluated SPED behaviour following hand cleaning with water and soap and alcohol-based handrub. Experiment 3 compared transfer dynamics of SPED versus E. coli in a laboratory using a gloved finger touching two consecutive sites on a laminate surface after a first purposefully contaminated site. RESULTS: Experiment 1: SPED adhesiveness on bare skin after a hand-to-surface exposure was high, leading to a dissemination of SPED1-3 on all consecutive surface materials with a trend of decreasing recovery rates, also reflecting touching patterns in concordance with contaminated fingers versus palms. Experiment 2: Hand washing with soap and water resulted in a SPED reduction of 96%, whereas hand disinfection led to dispersal of SPED from the palm to the back of the hand. Experiment 3: SPED and E. coli concentration decreased in parallel with each transmission step - with SPED showing a trend for less reduction and variability. CONCLUSIONS: SPED represent a convenient and safe instrument to simulate pathogen spread by contact transmission simultaneously from an infinite number of sites. They can be further developed as a central asset for successful infection prevention in healthcare.

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.

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.