Background

Importance of healthcare-associated infections

Healthcare-associated infections (HAI) represent the most frequent adverse event affecting hospitalized patients, resulting in increased morbidity and mortality, longer hospital stay, and disability[1]. In the European Union, the annual number of HAIs can be estimated at approximately 4.5 million, with approximately 37,000 deaths as a direct consequence, and 16 million extra-days of hospital stay per year[2]. The risk of acquiring HAI is especially significant in intensive care units (ICU), where the World Health Organization (WHO) estimates that approximately 30% of patients are affected by one or more episodes of HAI with associated morbidity and mortality[3]. Catheter-related bloodstream infections (CRBSI) are among the leading HAI, together with urinary tract infections, surgical site infections, and ventilator-associated pneumonia[4]. CRBSI are both prototypical of the causes and preventive mechanisms of HAI, and are more distinctly defined than other HAIs[5]. Moreover, CRBSI rates are widely and consistently available among European hospitals[6].

Prevention of vascular catheter-related bloodstream infection

Evidence indicates that CRBSI rates are amenable to substantial reduction by the application of stringent procedures and technological inventions[7]. Hand hygiene promotion and implementation of a bundle of targeted interventions for catheter-related infections are effective to prevent CRBSI[8–11]. It has been estimated that at least 56% of CRBSI could be prevented[12, 13]. Guidelines typically include elements to assure sterile insertion and handling of central vascular catheters (CVC). These guidelines recommend less infection prone insertion sites, effective skin antisepsis, the use of specific catheter types, scheduled changes of device material and dressings, and formal training of involved healthcare workers with the use of checklists[14]. While dramatic successes in preventing CRBSI have been reported for more than a decade[8, 9] guidelines are most likely not uniformly and successfully implemented in all European hospitals[15–17]. As another approach to reduce HAI, hand hygiene promotion has been associated with reduced incidence of bloodstream infection[18–20], but evidence from a randomized controlled trial is still lacking[21]. Hand hygiene performance remains suboptimal in most healthcare settings[22].

Implementation of infection control best practices

It has now been widely accepted that infection control procedures be evidence-based. Yet, there is a large variability in how successfully hospitals implement programs and procedures to protect patients against HAI[23]. Only recently has more attention been devoted to finding out why wide variations exist in abilities of hospitals to translate evidence into practice[15–17]. Such variations in implementation success do not only depend on the quality of intervention programs but may likely be due to differences in the organizational context, which Øvretveit defines as ‘all factors that are not part of a quality improvement intervention itself’[24]. Contextual factors are often cited as playing a role in the varied success of best practice interventions; however, existing literature reporting on implementation strategies often lacks details about specific contextual factors, and provides limited information about the real barriers and facilitators to implementation[25, 26]. This is of particular importance given the present backdrop marked by a wide variety of cultures, healthcare organizations, and economies across European countries[27].

Thus, we are seeking to fill this gap in the field of infection control by following the call for further research by Greenhalgh et al. and answering the question: ‘By what processes are particular innovations in health service delivery and organization implemented and sustained (or not) in particular contexts and settings, and can these processes be enhanced?’[28].

Methods

The PROHIBIT consortium study and its work packages

PROHIBIT consortium overall study design

This protocol is nested in a larger, consortium-led, European Union-funded study under the title ‘Prevention of Hospital Infections by Intervention and Training’ (PROHIBIT)[29], part of the European Commission 7th Framework Program (FP7)[30]. The aim of PROHIBIT is: to understand existing guidelines and practices to prevent healthcare associated infections in European hospitals; to identify factors that enable and prevent compliance with best practices; and to test the effectiveness of interventions of known efficacy. Through its multiple work packages, PROHIBIT employs a mixed-methods approach, combining the strengths of a systematic review, quantitative surveys, qualitative research, and a randomized controlled intervention trial. Table1 lists and briefly describes the six work packages of PROHIBIT.

Table 1 PROHIBIT work packages and their objectives
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PROHIBIT work package 5: a randomized controlled intervention study

The PROHIBIT work package 4 (WP4), ‘InDepth’ follows the implementation of the CRBSI prevention initiative led by the PROHIBIT WP5 group out of Groningen, The Netherlands. WP5 tests the effect of two different approaches to CRBSI prevention (WHO hand hygiene promotion strategy and catheter bundle) in a three-arm, stepped wedged cluster-randomized controlled trial in a voluntary-based sample of 15 hospitals across Europe. The primary outcome for WP5 is the CRBSI rate. Secondary outcomes include compliance with hand hygiene and the CVC bundle.

The PROHIBIT WP5 organization and intervention strategies are described in Table2. Intervention strategies 1, 2 or both have been sequentially rolled out in the 15 study hospitals over a period of at least 12 months, preceded by a baseline period of at least 6 months and an intervention period of 12 to 24 months.

Table 2 PROHIBIT work package 5 (WP5) organization and interventions
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PROHIBIT ‘InDepth’ work package: a qualitative inquiry

The present manuscript focuses on ‘InDepth.’ We pursue our qualitative inquiry in 6 of the 15 PROHIBIT WP5 study hospitals.

The “InDepth” qualitative inquiry asks two questions:

  1. 1.

    ‘Why are some hospitals/ICUs better at implementing CRBSI prevention than others?’

  2. 2.

    ‘What are the main barriers and facilitators to successful implementation of best practice in CRBSI-prevention?’

Taking advantage of quantitative results on the process and outcome level produced by WP5, the findings produced by ‘InDepth’ will ultimately be reported as a mixed-methods study.

Theoretical framework for the ‘InDepth’ inquiry

Implementation model: diffusion of innovation

Our model of the PROHIBIT WP5 implementation scenario follows a simplified scheme in a temporal stream based on the ‘diffusion of innovation’ paradigm[28, 36]. Participating institutions would: 1) learn about PROHIBIT by invitation as members of the European Antimicrobial Resistance Surveillance System (EARSS); 2) make the decision to participate in PROHIBIT (adoption decision); 3) prepare the participation (appointing an onsite investigator, hiring a study nurse, informing ICU-leaders, building consensus); 4) start to monitor defined study outcomes (CRBSI-surveillance, hand hygiene observations); 5) launch their implementation process to align with the PROHIBIT protocol (re-writing of protocols, training of healthcare workers, evaluations, etc.); 6) institutionalize the intervention content. We are aware that, in reality, this process is likely to be much more iterative and complex.

Sensitizing schemes

Summarizing literature on diffusion of innovation[28] and implementation science[28, 37] served as sensitizing schemes for this inquiry. Furthermore, we exposed ourselves to the theories of sensemaking[38] and new institutionalism[39]. For our purposes, we interpret new institutionalism as prolongation of sensemaking. According to this logic, individuals discovering something new will undergo a period during which they should make sense of it (name, categorize and relate it to concepts they are already familiar with) before it becomes part of the institution, aligning with social norms and expectations. The ‘Consolidated Framework for Implementation Research’ (CFIR) served us as a landscape constituted of numerous validated theories that facilitate translation of research findings into practice[37]. This framework also incorporates the extensive literature review and diffusion of innovation framework by Greenhalgh et al.[28].

Researchers’ influential backgrounds

Most of our research team members are healthcare workers and infection control specialists with an extensive past of leading promotional schemes and research. Thus, at the outset of the study, the team was familiar with elements of good infection control and patient safety activities, and the common challenges faced in achieving quality clinical practice.

Study definitions and procedures

Qualitative research

Study design and execution of ‘InDepth’ follows established criteria for qualitative research[40, 41]. In the face of non-linear causality and complex interactions of adoption and implementation[42], qualitative research methods are particularly suitable to put quantitative findings into perspective, in particular when conceived as mixed-method studies[40, 43–45]. The setting in this study is extremely complex and its elements interconnected given the variation in culture, healthcare systems, political and economic background, and infection control policies in Europe. This has been confirmed by unpublished preliminary results of PROHIBIT Work Packages 2 and 3. All of these contextual factors play an important role in the varied success of best practice interventions. In the context of implementation, such factors have been referred to as ‘conditions for improvement’[24] and include elements that are both internal (e.g., interpersonal relationships, safety culture, structural organizational characteristics) and external (e.g., national regulations and financial incentives) to the implementing organization.

Case study method

We chose a case-study methodology with longitudinal follow-up to guide the qualitative investigation[46]. This approach is especially valuable for ‘InDepth’, as it allows for the investigation of the implementation phenomenon where the boundaries are not clearly defined between the context and the implementation itself. This may be intrinsically important to implementation success[47].

Case definition

The hospital is the unit of randomization considered for WP5, and consequently, we define each hospital as a primary case. Within each hospital case, we anticipate that individual nested case studies will emerge that detail the ICU-level or individual-level experiences, for example[46]. These nested, micro-case studies will serve to enrich the understanding of the overall primary cases.

Study hospital sampling strategy and procedure

Six hospitals were purposefully selected among the 15 WP5 intervention study hospitals based on the scheme of ‘extremes’ and ‘intensity’[46, 48]. Evaluation was performed by online questionnaire and telephone interviews with the onsite investigator to identify information-rich cases. While the questionnaire asks about concrete information like local healthcare, structure and organization of the institution and infection control, the interview confirmed questionnaire responses and provided more subtle information about the context of the institution. We identified six hospitals that would demonstrate the nature of the implementation process: three hospitals with a strong potential to succeed more easily, and three hospitals that would have to face more challenges to implement the PROHIBIT CRBSI and hand hygiene intervention.

Defining implementation success

Implementation success is defined and assessed on several levels in this study. Reduction of CRBSI will be the ultimate test for success, while high and sustained adherence to good practice will represent process quality. These measures will be produced under the WP5 protocol. To these numeric outcomes, we added a qualitative definition of successful implementation: the satisfaction of our interviewees with the intervention program, and the implementation process and outcome; the extent of ‘intervention fidelity’ (adherence to core content); and successful resolution of intervention-context fit issues (adaptation, local re-engineering, and innovation). Careful reflexivity and triangulation among the different sources of qualitative information will reflect the validity of this qualitative outcome measure[46].

On- and off-site data collection procedures

Onsite visits take place one month before and one year after the intervention launch (Figure1). They include 10 to 15 interviews (Table3) with key professionals from various levels and departments who were identified in advance or ad hoc (Table4), and 2 to 3 ethnographic observations of 2 to 3 hours each in the ICUs focusing on ergonomic outlines, work attitude, hand hygiene behavior, catheter handling, and collection of written protocols. Three months into the implementation, additional telephone interviews with the onsite investigator were conducted to follow up on the implementation process. In addition, these follow-up telephone interviews and second site visits allow for member checking, i.e., to verify our conclusions with study participants[46].

Figure 1
figure 1

Temporal scheme of study procedures.

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Table 3 A typical ‘InDepth’ interview guide
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Table 4 List of typical ‘ InDepth ’ criterion-selected interviewees
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Staying for two days rather than just one allows us to take advantage of the exposure re-exposure effect[46] and to account for any Hawthorn effect. More details on the ‘InDepth’ data collection procedures can be found in Table5.

Table 5 “InDepth” data collection process
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Ethics approval

‘InDepth’ procedures were part of the document approved by the Institutional Review Boards of the 15 institutions participating in the PROHIBIT WP5 trial.

Analysis

We employ a ‘grounded approach’ to data analysis, which provides the opportunity to empirically build theory and identify new determinants and patterns rather than fit observations to existing frameworks and models[40, 44, 46]. This research process is iterative and emergent such that interim findings may influence the ongoing data collection. The case-level analysis is informed by Strauss and Corbin’s defined processes of grounded theory[50, 51]. The conduct of the case-level analysis is detailed in Table6.

Table 6 ‘InDepth’ case-level analysis scheme
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Reporting

Through this process of multilevel, qualitative and quantitative research, we seek to reveal the barriers and facilitators to implementation success, and to further identify which factors are recurrent across institutions[46]. As formative research, the information gathered from this inquiry will provide tools that can be used by stakeholders at multiple levels of healthcare systems, such as the EU, national policy makers, managers, and medical professionals, to guide future HAI-prevention initiatives.

Anticipated outcome of the study

We anticipate finding a set of universal and local barriers and facilitators for the implementation of infection control practices from the analysis of all cases. We predict them to be possible at any level of the institution, from single individuals, physical environment and tools, to formal and informal networks; processes inside the institution or directly linked to the intervention and the institutions’ and countries’ political, financial and cultural context. We also hypothesize that combinations of barriers and facilitators (rather than single most important determinants) will predict implementation success or failure.

Lessons learned so far

Study hospitals started according to the WP5 protocol with CRBSI surveillance and process measures in January 2011, and the first three study centers were randomized to launch their intervention in July 2011, followed by further three centers every quarter, the last three launching in July 2012 (Figure1). Information and workshop days for study nurses were successfully conducted in Groningen, The Netherlands, and in Geneva, Switzerland. We completed our first series of before-launch site visits in six centers by June 2012. At this time, case study-level analysis has not been concluded, and cross-case synthesis has yet to start.

Centers are located in the following regions: Mediterranean, Baltic, British Isles, Alpine arc, and Visegard. We believe that the sample represents a balanced mix of different study intervention arms, geographical locations, and implementation success variation.

Three of the six included centers reside in regions outside of our group’s language fluency. We were, however, always able to organize the 10 to 15 interviews either in English or in the local language with the help of a local translator who was not part of the hospital or another authoritarian agency. We were welcomed in all hospitals and had no problems finding additional interviewees, mostly from frontline staff recruited during observations. The two days of presence in the field (including lunchtime and evenings in town) offered time for informal exchange with hospital contact people and/or the translator, which helped to enhance understanding of the wider context of these centers. In more than one instance, our stay was reported to have contributed to the dynamics of the PROHIBIT WP5 implementation process. In one instance, it was even seen as a breakthrough for the recognition of infection control by the institution’s leaders. This was unintended but not entirely avoidable, given our group’s background and affiliation with PROHIBIT. We tried to limit this by avoiding feedback or advice, even when solicited by centers. Moreover, we remained blinded to the quantitative outcome and performance results of PROHIBIT WP5 for each site throughout the inquiry.

Discussion

This longitudinal case study is designed to provide contextual information to complement the results of the PROHIBIT intervention study by adding a qualitative, in-depth inquiry following the implementation of a CRBSI-prevention and hand hygiene promotion strategies in European ICUs. The results are expected to explain and to illustrate the epidemiological findings of the quantitative randomized controlled intervention trial. Moreover, they are intended to make the findings applicable in the sense of formative research.

The sensitizing exposure to theoretical frameworks of best practice implementation and the investigators’ professional experience in the field of infection control will ultimately help to relate our findings to the existing literature in both fields. Following existing schemes may be a barrier to discovering novel findings. We chose a grounded theory approach for data retrieval and analysis to counteract such limitations.

Overall, qualitative research methods are particularly effective to detect concepts and relationships in the context of high variability and interconnectedness of variables[46]. These contexts are highly applicable to understanding implementation processes. Thus, implementation research is urgently needed given the demand for unified global schemes to improve patient safety and healthcare effectiveness. Production of guidelines, even if based on published evidence, do not necessarily change healthcare worker practice[52]. This may be due to the lack of knowledge about barriers and facilitators inherent in local contexts and multidimensional patterns. Scientific knowledge on how to best address structural and organizational issues is scarce; even large-scale, well-funded patient safety initiatives may not guarantee success. A multisite quality of care improvement intervention in the United Kingdom based on the Institute of Healthcare Improvement (IHI) template channeling top management support, ‘walk-arounds’ with administrators, and the engagement of external change agents still failed to improve and sustain patient safety to a large extent[53, 54]. The qualitative component of the cited study revealed enthusiastic top management buy-in at its commencement. However, enthusiasm failed to reach the healthcare workers at the bedside. Thus, we will pay special attention to the vertical alignment and frontline receptiveness of the PROHIBIT WP5 intervention.

Protocols and scientific reports on qualitative studies of implementation of infection control best practice by others

Although understudied, there is some published qualitative research in the field of organizational factors of infection control best practice implementation. Uchida et al. used 23 semi-structured interviews in six acute care hospitals to gain insight in current practice in infection control under mandatory surveillance and reporting[55]. They found themes on mandatory reporting, technology on HAI surveillance, role expansion, and impact of organizational climate. An interdisciplinary group at the Veteran Affaires Hospitals and Michigan University in Ann Arbor has conducted several studies on the implementation of infection control best practice focusing on catheter-associated urinary tract infections[23, 26, 56, 57]. They described the importance of champions in the implementation process and their dependency on working relationships within their organization[57]. It was considered ineffective to assign the role of champions, as these individuals are usually not intrinsically motivated.

Further, a published study protocol by Kyratsis and colleagues describes their qualitative research approach using in-depth comparative case study design to understand how healthcare managers draw upon sources of evidence, and how this translates into decisions about adoption and implementation of innovations in healthcare[58]. Via methods including in-depth semi-structured interviews, observations, and survey questionnaires in nine acute-care organizations, they aim to gain a broad understanding of organizational contextual dynamics, which could inform policy and decision makers responding to the present need for organizations to be innovation-ready.

Why is this study unique?

Several features make this study a unique opportunity to learn more about the conditions under which implementation of best practices in infection control is likely to be successful. First, the diverse context of varying cultural, political and healthcare systems of the study cases will add robustness to the findings. Second, this background will be further understood as a result of simultaneous PROHIBIT work packages on national regulations and guidelines (WP2), and infection control practices (WP3; for both, see Table1). Third, quantitative data for each hospital on CRBSI outcome, hand hygiene, and maximum barrier precautions adherence will allow for a state-of-the-art mixed-methods analysis[59].

A unique feature of our study methodology is that we follow the cases longitudinally with site visits before implementation and one year into the implementation of the PROHIBIT WP5 procedures. Just as a baseline measurement is essential in experimental study design, the site visits prior to implementation will be crucial in establishing a baseline estimate of the organization’s safety culture and implementation fitness and producing an inventory of CRBSI prevention measures already in place in the ‘InDepth’ study hospitals in order to identify what we call the ‘delta.’ This points to what CRBSI prevention elements the hospitals must actually implement or modify to achieve full PROHIBIT WP5 best practice implementation. Moreover, the second site visit allows for the detection of changes in the organization outside the PROHIBIT prevention initiative, since this implementation experience may trigger further changes towards best practice in other areas of the organization, the organizational structure, or even the safety culture in the sense of a halo effect.

Limitations

Selection bias

There is some potential bias in the selection of the participating hospitals in PROHIBIT WP5. Hospitals first had to be part of the European Antimicrobial Resistance Surveillance System (EARSS) to be invited to participate in PROHIBIT; they had to be of large size to provide a sufficient number of central catheters; they had to have English-speaking professionals to serve as onsite investigators; and they had to have an ICU. Furthermore, the hospitals had to agree to send physicians and nurses abroad for training. These are all factors that could bias our study towards hospitals more receptive to change. However, we believe that the barriers and facilitators to implementation will fundamentally apply to more challenged institutions, even so to a larger extent.

Potential bias in researchers

Two study group members were occasionally involved in the training of ICU physicians and nurses in the centralized workshops of PROHIBIT WP5. Here, they gained detailed information regarding participating hospitals and interacted with HCWs whom they would again see upon one of the site visits. Obtaining information before the site visit may contribute bias, but is also a source of useful information. Heightened attention to reflexivity serves as a safeguard against this type of bias[60].

Conclusions and outlook

With its longitudinal and mixed-method research design among a variety of healthcare contexts across a multicultural Europe, this study will provide actionable information about barriers and facilitators to the implementation of best practices in infection control. The multicultural background and numerous logistic and communication issues do pose some challenges for this research. After having completed the first round of site visits, however, we have gained firm confidence in its feasibility and potential for success. We anticipate that, some years later, these same cases could become the subject of further investigation into the question of sustainability.

Consent

Written informed consent was obtained from all informants for publication of this report.