Investigating the implementation of a complex intervention to reduce central line-associated bloodstream infections in the Neonatal Intensive Care Unit, using Normalisation Process Theory

Investigating the implementation of a complex intervention to reduce central line-associated bloodstream infections in the Neonatal Intensive Care Unit, using Normalisation Process Theory | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Investigating the implementation of a complex intervention to reduce central line-associated bloodstream infections in the Neonatal Intensive Care Unit, using Normalisation Process Theory Victoria Payne, Mark Johnson, Katherine Hunt, Jacqui Prieto This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3952357/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 30 Jun, 2024 Read the published version in Journal of Neonatal Nursing → Version 1 posted You are reading this latest preprint version Abstract Background Translating evidence into practice has been notoriously difficult within the field of infection prevention and control (IPC). Care bundles- a form of complex intervention with multiple interacting components, may reduce neonatal CLABSIs by 60%. However, it may be unclear if it is the bundle, the implementation process, or a combination of both, that results in CLABSI reductions. Therefore, understanding what works, how it works, and in what settings, is important to improve the translation of evidence into practice. The aim of this study was to investigate the implementation of a care bundle aimed at reducing CLABSIs in a UK neonatal intensive care unit (NICU). Methods A mixed-methods, focused ethnography design underpinned by Normalisation Process Theory. Normalization MeAsure Development (NoMAD) surveys, observations of practice with retrospective, dyadic think aloud interviews, and semi-structured interviews were used to investigate implementation. CLABSI rates and bundle adherence rates were collected. Data analysis used descriptive statistics and thematic analysis. Results The introduction of a care bundle into a tertiary UK NICU did not result in sustained reductions in CLABSIs, despite apparent increases in bundle adherence. There was only partial bundle implementation, with minimal changes in survey scores and influences across individual, team and organisational levels moderating bundle adoption. Local organisational culture sometimes undermined implementation efforts. Ultimately, there were challenges relating to reinforcement and endorsement of the bundle. Recommendations to improve bundle adoption include improving reinforcement, building in accountability, and improving collective knowledge management. Conclusions The introduction of a care bundle into a tertiary UK NICU did not result in sustained reductions in CLABSIs, which is one of few negative studies. Understanding the mechanisms by which an intervention works (or not) in specific contexts is important to optimise the delivery of evidence-based care. Implementation science neonatal intensive care central line-associated bloodstream infections infection prevention Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 CONTRIBUTIONS TO THE LITERATURE Research suggests care bundles can reduce neonatal CLABSIs by up to 60% but what works in one setting is not always replicable in another. Understanding why things work (or not) is important for improving evidence translation. This study found that a complex intervention did not result in reduced CLABSI rates in a UK neonatal intensive care unit, despite increasing adherence rates. A limited collective approach coupled with a perceived lack of reinforcement, meant there were differences between the work as imagined and the work as done . Finding effective reinforcement strategies is important for improving complex intervention implementation in high-stakes settings. BACKGROUND Translating evidence into practice has been notoriously difficult within the field of infection prevention and control (IPC). Clinical guidelines rarely account for the complexities of clinical practice and often represent less than perfect knowledge [ 1 ]. This can result in individual interpretations of guidelines and variations in practice [ 2 ]. Poor staffing levels, resource availability, and impractical rules, are all self-reported reasons why agreed guidance may not be followed [ 3 ]. In addition, healthcare systems are complex adaptive systems, meaning that interactions between those doing the work within the system are dynamic, emergent, and unpredictable, challenging linear cause-and-effect models [ 4 ]. Complex situations- those which involve high uncertainty and high social conflict- can make sustaining change challenging [ 4 ]. Central line associated bloodstream infections (CLABSIs) are a complex problem, with multiple aetiologies and variations in definitions. The lack of real-time feedback between the potential cause (lapses in infection prevention practices) and the consequence (a CLABSI), together with the invisibility of micro-organisms, makes linking hospital acquired infections such as CLABSIs to professional’s behaviour particularly problematic [ 3 , 5 ]. In addition, uncertainties in the evidence may result in intense disagreement between those doing the work [ 2 ]. Passive education alone rarely results in sustained behaviour change [ 6 ] and failure to follow IPC guidelines may be a result of practice lapses rather than knowledge deficits. Hidden influences on healthcare professional behaviour such as complex social norms may impede knowledge translation: there can be disparities between knowing what should be done ( the work as imagined ) and how the work is done [ 7 ]. Interventions that include forcing functions, automation, simplification, and standardisation, as well as reminders and checklists, may be more effective at changing behaviour compared to education and training alone [ 6 ]. Complex interventions, such as care bundles, are one way to address complex problems in healthcare [ 7 ]. The complexity of an intervention depends upon the number components involved, the number of groups or settings involved, the range of behaviours targeted, as well as the degree of flexibility permitted [ 7 ]. The implementation of a CLABSI care bundle in Michigan was considered a huge success, reporting zero CLABSI rates post-implementation with low rates sustained for 10 years [ 8 ]. Whilst systematic reviews of observational studies suggest bundles may reduce CLABSI rates in a variety of healthcare settings by between 34%-60% [ 9 – 10 ], the evidence from randomised control trials is less convincing, and attempts to replicate the Michigan Keystone study in the UK have been less successful [ 10 – 11 ]. This has been attributed to small numbers, variations in infection rates, and a failure to demonstrate with confidence that improvements were directly attributed to the intervention [ 12 ]. As complex interventions target multiple behaviours and contain different degrees of interaction between bundled components, actors, and contexts, it is unlikely that a recipe from one or two successful social innovations can be directly translated into different contexts [ 12 ]. This is important. There is danger of a cargo-cult approach whereby successful interventions from one setting are directly translated into another without understanding the mechanisms by which change has occurred [ 12 ]. This may result in an unsuccessful or unsustainable intervention, and an ineffective use of resources. Eight studies have evaluated the implementation of a CLABSI care bundle [ 12 – 19 ], with two specifically in paediatric ICU populations [ 13 – 14 ]. Leadership, buy-in, resources and workloads were commonly cited influences on bundle implementation across all studies. Pre-existing improvement cultures and multi-disciplinary team working were believed to support implementation, whilst silo working, unclear roles, and professional hierarchies could hinder efforts. Checklists were believed to flatten social hierarchies and promote nurse empowerment [ 15 ]. However, there are limitations to the extent implementation processes could be explained, with some studies using self-reported adherence measures [ 13 , 16 – 17 ] or studying a single specific professional group [ 17 ]. Understanding the implementation of care bundles to reduce CLABSIs in neonatal units has not been studied, despite two thirds of UK neonatal units reporting using a central line bundle and variations in CLABSI rates [ 20 , 21 ]. The aim of this study was to investigate the implementation of a complex intervention-a care bundle- to reduce CLABSIs on a neonatal intensive care unit (NICU). Understanding how and why practices become routinely embedded in a high stake’s setting such as the NICU is important for the effective design and implementation of complex interventions. METHODS A focused ethnography was used to explore care bundle implementation in a tertiary NICU, underpinned by Normalisation Process Theory (NPT) [ 22 ]. NPT proposes that the normalisation of a new technology or practice is the result of the collective action of groups of people and how they work together to enact new processes, as opposed to solely attributing behaviour change to individual attitudes, beliefs, or intentions. NPT can therefore be used to evaluate the workability of an intervention and how it is integrated into everyday practice [ 22 ]. NPT was used as a lens to understand the mechanisms of action through which normalisation was achieved. The four constructs of NPT are described in Fig. 1 and the StaRI reporting standards for implementation studies have been followed (additional file 1) [ 23 ]. Figure 1: Normalisation Process Theory SETTING This was a single centre study in a tertiary NICU in the United Kingdom. A multi-disciplinary team reviewed local CLABSI rates and developed a care bundle to address practice need. This was informed by systematic review evidence [ 9 ], local microbiology data, historical local practices, and resource availability. Table 1 outlines the implementation timeline. Table 1 Implementation Timeline Date Intervention 2015 Formation of a multi-disciplinary team Surgical aseptic non-touch technique for all CVC access A two-person checklist for central line insertions Infectious diseases meeting to become a bedside ward round Central line insertion trolley 2015–2016 Multi-disciplinary late-onset sepsis prevention and management guideline developed January 2016 Surgical ANTT introduced for CVC access. Cascade training provided to all nursing staff January 2017 Two-person CVC insertion technique and CVC checklist introduced. Twice-yearly training on ANTT, a central line simulation study day, video training resources, and an insertion guideline Audit performed 6 months post-introduction October 2017 Late-onset sepsis guideline approved March 2018 Alcohol Impregnated Port Protectors (AIPPs) introduced Visual aids provided Daily audit for the first 3 months Ongoing Infection rates disseminated at regular intervals between 2017 to 2019 Infection rates part of local governance meetings AIPPs incorporated in a daily nursing checklist MDT = multidisciplinary team, ANTT = aseptic non-touch technique, AIPP = alcohol impregnated port protectors, NICU = neonatal intensive care unit Table 1 : Implementation Timeline DATA COLLECTION Data collection was performed between March 2018-September 2019, after bundle implementation had been completed, using both quantitative and qualitative methods (see Table 2 ). A timeline for data collection is provided in Fig. 2. Table 2 Data Collection Methods Technique Method Sampling Sample Data Analysis Data Integration Inclusion Exclusion Observations Non-participatory Overt Unstructured Purposive Events: CVC insertion & CVC access Staff eligible if insert or access CVCs Staff not inserting or accessing CVCs Previously participated in 2 observations Thematic analysis Constant comparison Informed sampling Data triangulation Dyadic Think Aloud Interviews Retrospective Think Aloud Techniques Interview prompts Purposive Participant pairs As above As above Thematic analysis Constant comparison Informed sampling NoMAD Survey Electronic & paper 4-monthly for 1 year Purposive Worked on NICU pre-bundle Daily work includes CVC management Staff employed after bundle implementation Daily work does not include CVC management Descriptive statistics Informed interview prompts Data triangulation CLABSI rates Routinely collected & anonymised Electronic patient records NNAP definition Prospective All admissions January 2015-January 2020 All neonates with a CVC > 72 days of age with a positive blood culture Neonates < 72 hours of age Neonates without a CVC Duplicate blood cultures for same episode Statistical process control Informed interview prompts Informed interpretation Bundle Adherence Routinely collected & anonymised Electronic patient records Quarterly spot audit Retrospective All neonatal inpatients with a CVC Umbilical venous and arterial lines Peripherally inserted central catheters CVCs inserted prior to admission excluded from insertion audit Descriptive statistics Data triangulation Informed interpretation Hand hygiene & ANTT adherence Quarterly observational audits 10 observations N/A N/A Descriptive statistics Data triangulation Semi-Structured Interviews Interview schedule Purposive Worked on NICU pre-bundle Daily work includes CVC management Staff employed after bundle implementation Daily work does not include CVC management Thematic analysis Constant comparison Informed sampling Data triangulation Figure 2 Data Collection Timeline Table 2 Data Collection Methods Normalizsation MeAsure Development (NoMAD) Survey The NoMAD survey was used as a measure of implementation over time. This is a validated instrument comprising of 20 questions on a Likert scale [ 24 ]. This was adapted to provide a numerical score (-2 through to + 2) which has been used previously [ 25 ]. Observations of Practice with Dyadic Think Aloud Interviews Central venous catheter (CVC) specific events- insertion and infusion fluid changes- were observed using an unstructured data collection form developed using NPT. Using retrospective think aloud interviews (RTAIs) with participant pairs after each observation, participants were asked to describe what they did, why, and when procedures may be performed differently. The process was piloted to ensure feasibility and acceptability. Purposive sampling was used across different professional groups (including job grades), years of experience, and combinations of dyad pairings. Semi-Structured Interviews Semi-structured interviews (SSIs) took place after survey and observations with dyadic RTAI data had been analysed, using loose topic guides incorporating preliminary findings. Constant comparison techniques informed sampling, seeking a breadth of perspectives, with attempts to find disconfirming sources. Data collection ceased when no new concepts relating to the phenomenon of implementation were found. Measures of Outcome (CLABSI) and Process (Audit) Routinely collected, anonymised data was collected on bundle adherence and CLABSI rates. Adherence to hand hygiene and aseptic non-touch technique (ANTT) were collected as part of prospective routine audits, and adherence to specific bundled elements (two-person insertion technique, insertion checklist, skin decontamination, alcohol impregnated caps) were collected quarterly using electronic patient records. A pragmatic definition of CLABSI was used, in keeping with the National Neonatal Audit Programme [ 20 ]. DATA ANALYSIS Quantitative data was analysed using descriptive statistics and statistical process control for CLABSI rates. A signal change in the data was defined as seven points above or below the median or in a single direction [ 26 ]. Survey data was tested for normality using Shapiro-Wilks. Likert scale responses were ranked from − 2 (strongly disagree) through to 2 (strongly agree) and radar plots used to visualise changes over time. Observational data were collated using a tabular framework for each observation, comparing the work as done (observations) and the work as described (interview data). This enabled cross-referencing between dyads and data sets, keeping the data for each observation and participant pairs together. Qualitative data were coded and analysed using an inductive approach using thematic analysis [ 27 ]. Transcripts were returned to participants and final themes were disseminated to all participants who were invited to comment on the findings. Following thematic analysis, the constructs of NPT were applied to the data to understand implementation at a theoretical level and develop a conceptual model for implementation. RESULTS NoMAD Survey There were 127 eligible staff, and response rates declined over time from 71–43%. Table 3 outlines participant characteristics. Radar plots representing median survey scores are presented in Fig. 3: the fuller the radar plot, the more normalised practices were. Whilst median scores for question 13 (is there sufficient training?) and 14 (are there sufficient resources?) improved over time, scores for question 7 (are you willing to work with others in new ways?) and question 8 (will you continue to support the bundle?) decreased. Median scores for the remaining questions were consistently 1 (agree) across all three surveys. Table 3 Participant Characteristics Participants NoMAD Survey 1 n, (%)* NoMAD Survey 2 n, (%)* NoMAD Survey 3 n, (%)* Observations with RTAI Interviews, n Semi-structured interviews, n Consultant 4 (4) 4 (6) 3 (7) 0 4 Specialist Registrar N/A N/A N/A 4 N/A Senior House Officer N/A N/A N/A 1 N/A MTI/Fellow 4 (4) 0 2 (4) 3 0 Nurse Band 8 3 (3) 3 (5) 3 (7) 2 2 Nurse Band 7 9 (10) 7 (11) 5 (11) 1 3 Nurse Band 6 24 (27) 24 (37) 16 (36) 5 4 Nurse Band 5 35 (39) 19 (30) 14 (31) 5 2 Nurse Band 4 11 (12) 6 (9) 2 (4) N/A N/A Missing 0 1 (2) 0 N/A N/A Total 90 (100) 64 (100) 43 (100) 21 15 Response rate 71% 56% 43% N/A N/A NoMAD = Normalization MeAsurement Development survey, RTAI = retrospective think aloud interviews, *Percentage of respondents Table 3 Participant Characteristics Figure 3 Survey Results Radar Plot Outcome and Process Measures CLABSI and bundle adherence rates are shown in Fig. 4 a and 4 b, respectively. Whilst there appeared to be an initial decrease in CLABSI rates, this was not sustained. Adherence rates improved over time. Adherence to ANTT was consistently reported as 100%, whereas adherence to the insertion checklist and two-person insertion improved from 49–89%, and 42–87% respectively. Figure 4 CLABSI and Bundle Adherence Rates Observations of Practice with Dyadic Think Aloud Interviews Twelve observations with RTAIs were performed, totalling six CVC insertions and six CVC fluid changes (see Table 3 ). Eleven observations took place during day shifts and one overnight. No emergency procedures were observed. Dyadic interviews lasted between 15–30 minutes. Semi-Structured Interviews Fifteen semi-structured interviews (see Table 3 ) were performed between July and August 2019, lasting approximately 50–70 minutes. Influences on Implementation Thematic analysis of observational, dyadic RTAI, and semi-structured interview data resulted in eight themes organised into three over-arching categories: individual, team, and organisational influences. Theme descriptors and supportive qualitative data are provided in additional file 2. Individual influences Bundle endorsement Participants discussed the extent to which there was buy-in for the bundle. This included beliefs about bundle utility and beliefs about the problem (CLABSIs). Broadly, participants believed that the new practices addressed aspects of practice thought to be poorly performed previously (RTAI 2, 3, 4, 5). Nurses believed AIPPs made their work easier and reduced variations in practice, however, unclear expectations and uncertain rules caused confusion. This included the frequency of CVC access, the use extension sets, and different ‘rules’ for difference devices. There was less collective endorsement for CVC insertion practices, specifically the two-person technique. Beliefs about its utility were mixed; some believed they had previously been doing this informally, whilst others believed it was more appropriate for less experienced colleagues. When asked how important the second person was, one participant commented: I didn't used to think it was! But the more I've done it with a second person, actually it makes the procedure easier, if you've always got somebody to monitor the baby and comfort the baby, but also to see things you haven't seen, like when turning round and your glove touches the port hole […] I think you're more aware of your own practice when you think someone's watching you. NURS0804, Interview 14 There was a disconnect between the intended purpose of the second person role, and how the role was enacted: the second person was actively involved in the procedure, donning sterile gowns and gloves, rather than monitoring the process using the checklist. This meant that some participants did not believe a second person was always necessary, nor that nursing involvement was legitimate. The expectations were not always clear and there were mixed beliefs about the value of specific bundled components, such as maximal barrier precautions (specifically hats and masks) and the insertion checklist. Hats and masks were infrequently worn, and the checklist was not observed being used. Semi-structured interviews revealed it was exclusively used retrospectively after the CVC had been inserted. Whilst all participants believed that reducing infections was important this was juxtaposed by beliefs that it was “ unrealistic to think you could eradicate” ( DOC01, Interview 3 ) them, and participants questioned if CLABSIs were a “genuine” infection (DOC04, Interview 12), or “a bad infection” (NURS0803, Interview 8). There was a broad consensus that the bundle had increased awareness of infection rates, which was perceived to be beneficial. Seeking Reinforcement Participants were actively seeking reinforcement, checking together in observations, and reflecting during RTAIs on how procedures could have been done differently. Participants believed they received limited feedback on CVC management, and identified problems with reporting CLABSI rates: So, I think there's various negative things that come back, in a very non-specific way, which means that no one does anything about it, because there's no ownership. […] but the only way of that being reported is a number in a governance meeting several months later, then it's not being fed back in a timely fashion, we're waiting to find out we've got a problem DOC01, Interview 3 Whilst local infection rates were disseminated, one participant recognised that it was “ difficult to extrapolate the data, for it to mean something” (NURS0801, interview 6). When shown local CLABSI rates, participants apportioned responsibility to other professions or roles. One participant noted that: We never think it’s us, do we? We always think, oh well, that’s the doctors, that’s the surgeons. As nurses, we feel that we get the blame for when infection rates rise […] its everyone, isn’t it? and we’re all responsible for it NURS0618, Interview 7 Only one participant reflected on their own behaviour, suggesting that “ it’s probably our fault and we can improve” (NURS0509, interview 8). Whilst some participants explained that they wouldn’t change their practice unless they received specific feedback on their own practice, this was juxtaposed by those in senior roles who expressed concerns about providing individual feedback. One consultant believed it would be an “ awful thing” to have the responsibility for an infection “laid at someone’s door” [SSI3, DOC01]. Participants across both professions used words such as “ moral distress”, “blame” , “ guilt ”, and “ morale” in relation to feedback on infection rates. This contrasted with data from the dyadic RTAIs, who were interviewed immediately after doing the work, who wanted reassurance that what they were doing was right. Without feedback, participants resorted to informal self-appraisal of bundle effectiveness. Nursing participants ‘felt like’ they were administering less antibiotics, equating that with a reduction in CLABSIs, believing new practices ‘ felt cleaner’ . However, two participants expressed concerns of a “feedback culture” [DOC03] and receiving feedback for “just doing your job” [DOC03, NURS0610]. Finding ways to use positive reinforcement strategies was believed to be important, such as celebrating central lines that completed their journey without an infection and reporting line-free infection days. Team Level Influences Division of Labour The division of work influenced bundle implementation. Nursing enactment of ANTT included clearly allocated roles which they believed made it easier to understand expectations. However, the second person role for CVC insertion was not implemented as intended: in observations, the second person was always actively involved in the procedure rather than acting as a monitor of practice. Participants reflected on how the second person could be helpful with one participant suggesting allocating roles at the start. There were some aspects of central line work where responsibility was unclear, such as the monitoring of CVC dressings. Some participants believed that the current division of labour was not appropriate; for example, one consultant believed that “ some of our more experienced nurses would be better placed” to change central line dressings (DOC03, interview 13). Participants referred to “ their work ” and “ our work ” suggesting a siloed division of labour. Whilst some participants believed the bundle had increased the collective responsibility of CVCs others believed there was no clear responsibilities for some aspects of care, such as assessing the need for the CVC: Well, I’d like to think it’s a Consultant role to think about it all, but- I think you can’t really expect a junior bedside nurse to think about that- but I think it’s everybody’s responsibility to think, is this still required and do we still need it, and if we still need it, is it safe and are we managing them well? DOC03, Interview 13 Both professions were unsure if involvement in CVC insertion was a legitimate nursing role. Competing workload priorities between teams also caused tension. The organisation of CVC fluids within nursing teams also caused discomfort, and there was a shared experience of guilt among nurses: There’s this feeling that you’re a failure if you hand over your patient to the night shift and go ‘I haven’t done any fluids. Haven’t done any infusions’. The response you get sometimes from some are like ‘What?! What have you been doing?!’ […] NURS0703, Interview 9 Knowledge regarding CVC care was role specific; not everyone had access to the same knowledge. For example, one nurse believed that they were unable to advise on CVC insertion because “ its not our job” (NURS0617), whilst a consultant recognised that nobody is “ thinking holistically” (DOC03). A lack of shared knowledge is likely to make monitoring practice difficult and participants believed that multi-disciplinary training could help improve this. Surveillance and Monitoring There was variation in bundle surveillance, and informal monitoring- such as checking together -was frequently observed: someone got their gloves on and they put their hair behind their ears and someone’s, “Oh what have you just done?” and started again! (Laughs) So, it’s not like it has to be judgmental, it’s just, “Oh, do you realise you’re -?” “Oh, I did not realise” … NURS0515, RTAI 8 However, not all participants engaged in informal monitoring, despite participants’ beliefs that behaviour may change if they are being observed, or that “ corners may be cut ” (NURS0804, interview 14) if no one is watching. One nurse explained that the process is “ automatic , you know what you’re doing” whilst another recognised that that she doesn’t “watch that intently what other people are doing ” (NURS0610, interview 11). One participant suggested incorporating more formal surveillance into their practice: We don't really have very much feedback, and whether we should be observing each other, having an outside observer… NURS0704, Interview 4 Monitoring of CVC insertion appeared to be ad-hoc, with one consultant feeling that “ sometimes the co-ordinators around just to keep an eye” (DOC13, interview 15) whilst another reflected that he “can’t say they [CVC practices] are being done properly” (DOC04, interview 2). In CVC insertions, the second person was implemented as an assistant rather than as a monitor of asepsis using the checklist prospectively. Participants reflected that it was difficult to question poor practice, despite believing this was important. When concerns were raised, some believed they were not always listened to. One solution was to give permission- to make it acceptable- to raise concerns, thereby providing a clear expectation of behaviour: […] and you can say to the nurse or the doctor with you, 'Keep an eye on it for me because I might not notice. Please tell me if you see that something's become desterilised,' and then that just takes that onus away from someone because actually then you can say it's all right, I'm expecting you to say that to me. DOC01, Interview 3 Learning and Teaching Participants across both professions described learning from each other, which was believed to be important for sharing tacit knowledge. Participants descriptions of learning were reminiscent of the ‘see one, do one, teach one’ approach which was reflected in observations. Participants believed that less experienced colleagues may not have learnt the high-risk moments for asepsis lapses, such as incubator portholes, something that was learnt through doing. Whilst nursing participants believed they were all taught a standardised approach to ANTT, some found it hard to teach others who may have been taught different techniques in different workplaces. Whilst there were few references to formal teaching resources in the dyadic RTAI interviews, participants in semi-structured interviews referred more explicitly to educational resources. Cascade training was believed to bring challenges such as introducing variation. This could create uncertainty, with one nurse recognising that “we make it confusing” by teaching new staff different things (SSI8, NURS0509). Participants felt that it was important to learn the right way to perform a task the first time it is taught and to not pick up ‘ bad habits’ (SSI12, DOC04). Visual aids were felt to improve implementation and refresher training was identified as being useful. One consultant believed that CVC education needed “a team” (SSI12, DOC04). Learning from others continued to be referred to as how practices were taught, triangulating with RTAI data: We just run through whether the person is able to do it and let them do it on their own, which we shouldn't be doing. DOC13, Interview 15 This highlights the absence of formal surveillance, suggesting the two-person technique-which was observed being used in all central line insertion observations- was not always used. Organisational influences Resources Resource availability, including easy access to equipment and the appropriate hand scrub, were identified as barriers. Insufficient staffing and competing demands were frequently cited as a barrier. The feeling of ‘being busy’ was a potential explanation for poor CVC hub decontamination: …and so particularly with the clean for 30 seconds, dry for 30 seconds and they’re standing there anyway everything’s a hurry, we’re busy, busy, busy, clean, dry, yeah, that’s 30 seconds. NURS0610, RTAI3 There was a perceived need to “ get on ” with tasks with nurses feeling they need to “ fit it all in ”, despite also recognising that it was a “ 24-hour service ” (NURS0515, RTAI8). Those inserting lines used words such as “ whip one in” and “ crack on” in keeping with a perception of busyness. Interruptions were also a potential cause of lapses in asepsis. Both professions felt that nurse staffing was a significant barrier to involvement in CVC insertions, with medical staff not wanting to increase nursing work. Insufficient staffing was believed to have become “normalised” (DOC01, interview 13) yet another participant felt it was “an easy card to play” (DOC03, interview 12). Some nurses felt that if nurse: patient ratios were improved, they could assist with CVC insertions. There were differences in the extent to which staffing and workload was considered an acceptable reason for practice variation. For CVC insertions, being busy was considered an acceptable reason to not have a second person, whereas for CVC access, it was not an acceptable reason for nurses to not adhere to hub decontamination: Yes, maybe you could be excused for not having a second pair of hands, but I don't think you can say, 'I was busy, so I didn't clean the hub for so many seconds', because I think, yes, you're busy, but then you can't compromise on safety just because you're busy, so I don't think that's acceptable. DOC13, Interview 15 The two-person insertion and checklist were not seen perceived as an essential safety process. Environment Observations revealed specific environmental challenges for asepsis, with limited space and increased traffic around sterile fields. Incubator portholes provided a physical obstacle for those inserting central lines. Participants suggested having a dedicated space and equipment trolleys, to limit interruptions and separate the task from competing cognitive demands. Culture Social norms- such as habits and rituals-alongside professional hierarchies, influenced how the work was done. This ultimately effected bundle endorsement. The process of performing ANTT was ritualistic: but when you put those gloves on it's like a costume to like, 'This needs to be done sterilely. I mustn't touch anything,' NURS0707, Interview 4 This shared mental model made it easier for nurses to informally monitor practice. Participants recalled examples of normalised deviance - socially accepted ways of working that were dissonant with beliefs about how the work should be performed. Participants shared examples such as not waiting for one minute for hub decontamination (observations 3, 5, interview 1, 7, 10, 11 14, 15), not checking CVCs “as closely as we should be” (NURS0610, interview 11), “ wandering around the unit” in sterile gloves and that a second person “ may join you halfway through” (NURS0804, Interview 14). One consultant felt “it was vital” to lead by example (DOC01, Interview 3) whilst another reflected that he could not expect others to wear a hat and mask if he didn’t (DOC04, interview 12). Hierarchies influenced surveillance. Nurses believed there were clear lines of escalation with a “strong” senior nursing team that would raise concerns. Whilst one nurse felt that her opinions were listened to since wearing a senior uniform (NURS0610, interview 19), others felt that they “nag, nag, nag, and then just give up” (NURS0618, interview 7). Hierarchies may influence asking for help: I think that the nurses probably find it okay to ask. The medics, I'm not sure. I feel there's a little bit more… Going back five or 10 years, I think we were a little bit a better team and we weren't necessarily a hierarchy as much. There's a bit more of a hierarchy at the moment. NURS0703, Interview 9 Making it acceptable to ask for help was believed to be important, though it was recognised that culture was difficult to change. Participants suggested giving colleagues permission to raise concerns may make it more socially acceptable. Changing the culture was strongly believed by all participants, across both professions, to be important to improve bundle adoption. Participants referred to creating a more open culture as an important part of improving CVC care. A Conceptual Model of Implementation A conceptual model was developed from the data using the constructs of NPT (Fig. 5). Whilst all participants believed reducing infections was important- there was collective buy in- there were inter and intra- professional differences in coherence - how participants made sense of both the purpose, and the components of, the bundled practices. It was not always clear how the new practices were different to previous ones. There was also limited inter-professional cognitive participation ; whilst the nurses had a shared mental model for central line fluid changes, this was not universal, sometimes resulting in tensions between professional groups. Nurses were unclear of the expectations for CVC insertion and felt unable to challenge practice or use the checklist. The role of a second person became endorsed as a teaching role rather than a safety role, meaning that nursing involvement was not legitimised, nor that a second person was necessary for experienced colleagues. The division of labour was therefore not as intended and there was limited collective knowledge around CVC practices. Ultimately, it was not always clear what best practice looked like, or who should do it. This uncertainty meant that it was sometimes difficult to monitor practice and there was limited collective action around the new practices. This resulted in informal mechanisms for appraising the new practices and feedback to participants on infection rates was not always meaningful, or accessible, to those doing the work. Limited individualised feedback on practice limited the extent to which reflexive monitoring could occur, and participants across both professions were actively seeking reinforcement. Figure 5A conceptual model of implementation DISCUSSION This focused-ethnography study found that the introduction of a care bundle into a UK NICU did not result in reductions in CLABSI rates, despite apparently increasing bundle adherence. It is one of few negative studies and contradicts systematic review evidence [ 9 – 10 , 28 ]. Meta-analysis of observational studies may over-estimate effect size and there is a risk of publication bias [ 9 ]. This study found there was only partial bundle implementation and the NoMAD survey results showed minimal changes in attitudes to implementation; it was not always as intended and there were differences between the work as imagined and the work as done . For example, the insertion checklist was used retrospectively; whilst reported adherence to the checklist was high, observations revealed the checklist was never used prospectively. Interview data corroborated its use after the central line was inserted. This negates the checklist’s intended purpose as a safety mechanism and limits its ability to flatten hierarchies and empower staff to stop the procedure, theorised to be successful in previous studies [ 15 ]. Adherence to ANTT was reported consistently to be 100%; however, this was not always the case, with individual components such as waiting for one minute for hub decontamination believed to be not consistently adhered to, and different professions performing the practice differently. In the Michigan Keystone study, collective responsibility for reducing CLABSIs was believed to be key to its success. In this study, whilst participants believed reducing infections was important, there was limited collective responsibility. Instead, participants often apportioned responsibility for infections to others. The development of a community of practice- informal groups with a shared or common interest- did not occur, and this may be important for implementation. Central line teams have been shown to reduce CLABSIs in US NICUs [ 29 – 31 ]. These may work by providing visible leadership, role modelling expected behaviours and providing educational outreach to staff. Future research should consider how these may be effectively implemented within UK NICUs. Despite collective buy-in for reducing infections in the NICU, there lacked a shared belief that CLABSIs were a genuine problem that could be eliminated. These findings are consistent with a qualitative study of three paediatric units, which found variable beliefs in CLABSIs, variations in practices, and complexities in monitoring adherence [ 14 ]. However, our study found that despite adherence monitoring, participants actively sought reinforcement and there were challenges in reflexive monitoring of the intervention. This raises the importance of how adherence data is used: not only what is measured, but how it is collected and its meaning to those doing the work. It has been proposed that audit and feedback- a commonly bundled component- works by restructuring peer group norms and expectations [ 32 ]. In this study, the use of multiple data sets revealed differences between the work as imagined and the work as done , which was different again to the work as reported through audit. This is important; reliance solely on quantitative measures of how the work is done may, in some cases, provide false reassurance to those undertaking surveillance work. Traditional audit measures are unlikely to capture work arounds or unintended consequences [ 33 ] and time delays between ‘lapses in practice’ and development of a CLABSI, means that associations between adherence and CLABSI rates are difficult to make. Prospective, real-time audits of practice with individualised and ward level feedback may provide both educational outreach and reinforce normative expectations. However, it is a resource intensive approach; Balla et al (2018) found that this was not sustainable in a tertiary NICU [ 34 ]. Future research should focus on finding an effective reinforcement strategy in complex and high-stakes settings. It has been suggested that striving for zero CLABSIs is unrealistic and may contribute to burnout [ 35 ], whilst others argue there is a need to change the mental model from inevitable to preventable [ 36 ]. Strategies to incorporate a Safety-II approach [ 7 , 35 ]- learning from when things go right- and the use of positive reinforcement strategies, may be helpful in high-stakes settings. Reporting infection-free days and reframing infections as avoidable infections may help change the narrative of these infections as inevitable. There are several limitations to this study. The anonymous survey meant that it was not possible to track if individual attitudes changed over time. There were no emergency CVC practices observed, which may have revealed additional insights into how procedures were performed. There was no definition of what constituted implementation success and applying concepts such as acceptability, intervention fidelity, and intervention-to-context fit [ 18 ] might improve consistency of reporting in future studies. However, this is one of few studies to investigate the implementation of a CLABSI care bundle in a neonatal context, and the development of a conceptual model of implementation may be useful to others wishing to implement complex interventions in a similar context. The use of real time observational data alongside dyadic RTAIs enabled cognitive dissonance between beliefs and behaviours to be explored, and the integration of both qualitative and quantitative data sets enabled data triangulation, strengthening the findings in this study. CONCLUSION The introduction of a care bundle did not reduce CLABSI rates in a UK NICU. This study found there was only partial implementation of the bundle, and some elements were not implemented as intended. Future research should identify effective positive reinforcement strategies that are meaningful and sustainable in a complex setting, to reduce avoidable infections in healthcare. Abbreviations AIPP Alcohol impregnated port protectors ANTT Aseptic non-touch technique CVC Central venous catheter CLABSI Central line-associated bloodstream infection IPC Infection Prevention and Control MDT Multi-disciplinary team NICU Neonatal Intensive Care Unit NNAP National Neonatal Audit Programme NoMAD Normalisation Measure Development survey NPT Normalisation Process Theory RTAI Retrospective think aloud interview SSI Semi-structured Interview UK United Kingdom Declarations Ethics approval Ethical approval granted by the University of Southampton (ERGO: 25154) and Health Research Authority approval was granted through the Integrated Research Application System (ID: 208128). Informed consent was obtained from all participants including for the use of anonymised quotations. Consent for publication Not applicable. Availability of data and materials The datasets generated and analysed during this study are available from the corresponding author on reasonable request. Detailed analysis frameworks are available in the University of Southampton Institutional Repository [https://eprints.soton.ac.uk/452408/] Competing interests The authors declare that they have no competing interests. Funding VP received funding from the Royal College of Nursing Professional Bursary scheme. The Royal College of Nursing was not involved in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript. MJ salary is supported by the NIHR Biomedical Research Centre Southampton. Author contributions VP, MJ and JP designed the study described in this paper. VP collected and analysed the data. MJ, JP and KH oversaw data analysis. VP drafted the original manuscript. All authors read and approved the final manuscript. Acknowledgements The authors would like to thank all the healthcare professionals who participated in this study. References Elwyn G, Wieringa S, Greenhalgh T. Clinical encounters in the post-guidelines era. BMJ. 2016;353:i3200. Gurses AP, Seidl KL, Vaidya V, Bochicchio G, Harris AD, Hebden J, et al. Systems ambiguity and guideline compliance: a qualitative study of how intensive care units follow evidence-based guidelines to reduce healthcare-associated infections. Qual Saf Health Care. 2008;17(5):351–9. Jenner EA, Mackintosh C, Scott GM. Infection control – evidence into practice. J Hosp Infect. 1999;42(2):91–104. Braithwaite J. Changing how we think about healthcare improvement. BMJ. 2018;361:k2014. Prieto J. Guest editorial. J Res Nurs. 2016;21(1):5–7. Soong C, Shojania KG. Education as a low-value improvement intervention: often necessary but rarely sufficient. BMJ Qual Saf. 2020;29(5):353–7. Hollnagel E, Wears RL, Braithwaite J, Middelfart. Denmark: Resilient Health Care Net; 2015. Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;n2061. Pronovost PJ, Watson SR, Goeschel CA, Hyzy RC, Berenholtz SM. Sustaining Reductions in Central Line–Associated Bloodstream Infections in Michigan Intensive Care Units: A 10-Year Analysis. Am J Med Qual. 2016;31(3):197–202. Payne V, Hall M, Prieto J, Johnson M. Care bundles to reduce central line-associated bloodstream infections in the neonatal unit: a systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2018;103(5):F422–9. Lavallée JF, Gray TA, Dumville J, Russell W, Cullum N. The effects of care bundles on patient outcomes: a systematic review and meta-analysis. Implement Sci. 2017;12(1):142. Bion J, Richardson A, Hibbert P, Beer J, Abrusci T, McCutcheon M, et al. Matching Michigan’: a 2-year stepped interventional programme to minimise central venous catheter-blood stream infections in intensive care units in England. BMJ Qual Saf. 2013;22(2):110–23. Dixon-Woods M, Leslie M, Tarrant C, Bion J. Explaining Matching Michigan: an ethnographic study of a patient safety program. Implement Sci. 2013;8(1):70. Woods-Hill CZ, Papili K, Nelson E, Lipinski K, Shea J, Beidas R, et al. Harnessing implementation science to optimize harm prevention in critically ill children: a pilot study of bedside nurse CLABSI bundle performance in the pediatric intensive care unit. Am J Infect Control. 2021;49(3):345–51. Goldman J, Rotteau L, Shojania KG, Baker GR, Rowland P, Christianson MK, et al. Implementation of a central-line bundle: a qualitative study of three clinical units. Implement Sci Commun. 2021;2(1):105. LeMaster CH, Hoffart N, Chafe T, Benzer T, Schuur JD. Implementing the Central Venous Catheter Infection Prevention Bundle in the Emergency Department: Experiences Among Early Adopters. Ann Emerg Med. 2014;63(3):340–350e1. Lee YSH, Stone PW, Pogorzelska-Maziarz M, Nembhard IM. Differences in work environment for staff as an explanation for variation in central line bundle compliance in intensive care units. Health Care Manage Rev. 2018;43(2):138. McAlearney AS, Hefner JL. Facilitating central line-associated bloodstream infection prevention: a qualitative study comparing perspectives of infection control professionals and frontline staff. Am J Infect Control. 2014;42(10 Suppl):216–22. Clack L, Zingg W, Saint S, Casillas A, Touveneau S, Da Liberdade Jantarada F, et al. Implementing infection prevention practices across European hospitals: an in-depth qualitative assessment. BMJ Qual Saf. 2018;27(10):771–80. Krein SL, Damschroder LJ, Kowalski CP, Forman J, Hofer TP, Saint S. The influence of organizational context on quality improvement and patient safety efforts in infection prevention: A multi-center qualitative study. Soc Sci Med. 2010;71(9):1692–701. NNAP National Neonatal Audit Programme (NNAP) 2020 annual report on 2019 data. 2020. London: RCPCH. Fraser C, Harron K, Dalton L, Gilbert R, Oddie SJ. Study on behalf of the P. Variation in infection prevention practices for peripherally inserted central venous catheters: A survey of neonatal units in England and Wales. PLoS ONE. 2018;13(11):e0204894. May C. Towards a general theory of implementation. Implement Sci. 2013;8(1):18. Pinnock H, Barwick M, Carpenter C, Eldridge S, Grandes G, Griffiths CJ, Rycroft-Malone J, Meissner P, Murray E, Patel A, Sheikh A. Taylor SJC for the StaRI Group. Standards for Reporting Implementation Studies (StaRI) statement. BMJ. 2017;356:i6795. May CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, et al. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit. BMC Health Serv Res. 2011;11(1):245. Finch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, et al. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT). BMC Med Res Methodol. 2018;18(1):135. NHSE and, Improvement NHS, Quality. Service Improvement and Redesign Tools: Statistical process control. 2022. Available at: https://www.england.nhs.uk/wp-content/uploads/2022/02/qsir-statistical-process-control.pdf [accessed 24/11/23]. Braun V, Clarke V. Successful Qualitative Research: A practical guide for beginners. 1st ed. London: Sage Publications Ltd; 2013. Karapanou A, Vieru AM, Sampanis MA, Pantazatou A, Deliolanis I, Daikos GL, et al. Failure of central venous catheter insertion and care bundles in a high central line–associated bloodstream infection rate, high bed occupancy hospital. Am J Infect Control. 2020;48(7):770–6. Savage T, Hodge DE, Pickard K, Myers P, Powell K, Cayce JM. Sustained Reduction and Prevention of Neonatal and Pediatric Central Line-Associated Bloodstream Infection Following a Nurse-Driven Quality Improvement Initiative in a Pediatric Facility. J Association Vascular Access. 2018;23(1):30–41. Stroever S, Boston K, Ellsworth M, Cuccaro P, McCurdy S. Qualitative process evaluation of a central line-associated bloodstream infection (CLABSI) prevention team in the neonatal intensive care unit. Am J Infect Control. 2020;48(9):987–92. Holzmann-Pazgal G, Kubanda A, Davis K, Khan AM, Brumley K, Denson SE. Utilizing a line maintenance team to reduce central-line-associated bloodstream infections in a neonatal intensive care unit. J Perinatol. 2012;32(4):281–6. Johnson MJ, May CR. Promoting professional behaviour change in healthcare: what interventions work, and why? A theory-led overview of systematic reviews. BMJ Open. 2015;5(9):e008592. Debono DS, Greenfield D, Travaglia JF, Long JC, Black D, Johnson J, et al. Nurses’ workarounds in acute healthcare settings: a scoping review. BMC Health Serv Res. 2013;13(1):175. Balla KC, Rao SPN, Arul C, Shashidhar A, Prashantha YN, Nagaraj S, et al. Decreasing Central Line-associated Bloodstream Infections Through Quality Improvement Initiative. Indian Pediatr. 2018;55(9):753–6. Smaggus A, Safety-I. Safety-II and burnout: how complexity science can help clinician wellness. BMJ Qual Saf. 2019;28(8):667–71. Suresh GK, Edwards WH. Central Line–Associated Bloodstream Infections in Neonatal Intensive Care: Changing the Mental Model from Inevitability to Preventability. Am J Perinatol. 2012;29(1):57–64. Supplementary Files Additionalfile1.docx Additional file 1 (*docx) Title: StaRI Reporting Standards File provides a completed StaRI reporting standards checklist. Additionalfile2.docx Additional file 2 (*.docx) Title: Theme descriptors and supporting data File provides description of each theme with additional supportive qualitative data in the form of participant quotations. It links the qualitative data to specific normalisation process theory constructs. Cite Share Download PDF Status: Published Journal Publication published 30 Jun, 2024 Read the published version in Journal of Neonatal Nursing → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3952357","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":275123165,"identity":"25078918-51cc-4572-a4be-b7cb43d708db","order_by":0,"name":"Victoria Payne","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAz0lEQVRIiWNgGAWjYFACxgaGBB4bJAEeglqYGxgeyKQxMLARr4W9gfGBzWEStBjcbmzdkJBz3p5fvvnYA4YaOwaDMwcIaLlzsO1GwpnbiTPb2NINGI4lMxicbcCvRXJGYtuNxJ7bCQbHeMwkGNgOMBicJ+AwiJZ/5+whWv4RoYVfAqglgecA4waQFsa2A4Qdxi8D8gtPMtAvaWkSiX3JPJKEvM8m3f7s5g8eO3t+5sPHJD58s5PjO5NAwGUSyJwEYiISVcsoGAWjYBSMAmwAAFi9Q3OevbSXAAAAAElFTkSuQmCC","orcid":"https://orcid.org/0000-0002-3436-2806","institution":"University of Southampton School of Health Sciences","correspondingAuthor":true,"prefix":"","firstName":"Victoria","middleName":"","lastName":"Payne","suffix":""},{"id":275123166,"identity":"9425b031-cd3e-466b-876a-ea067c7ffb2b","order_by":1,"name":"Mark Johnson","email":"","orcid":"","institution":"University Hospital Southampton NHS Foundation Trust","correspondingAuthor":false,"prefix":"","firstName":"Mark","middleName":"","lastName":"Johnson","suffix":""},{"id":275123167,"identity":"af38a61b-dadd-4bb9-8a09-f8b412dba2d3","order_by":2,"name":"Katherine Hunt","email":"","orcid":"","institution":"University of Southampton School of Health Sciences","correspondingAuthor":false,"prefix":"","firstName":"Katherine","middleName":"","lastName":"Hunt","suffix":""},{"id":275123168,"identity":"3e422616-245e-4d24-a27a-57edc56124c5","order_by":3,"name":"Jacqui Prieto","email":"","orcid":"","institution":"University of Southampton School of Health Sciences","correspondingAuthor":false,"prefix":"","firstName":"Jacqui","middleName":"","lastName":"Prieto","suffix":""}],"badges":[],"createdAt":"2024-02-13 01:33:39","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-3952357/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-3952357/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1016/j.jnn.2024.07.026","type":"published","date":"2024-07-01T03:29:33+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":51820641,"identity":"62c908f4-68d3-4baa-86ed-fb7cc3cd054e","added_by":"auto","created_at":"2024-02-29 16:01:43","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":426640,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eNormalisation Process Theory\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/24c3f6d389ff928709cc06c5.jpeg"},{"id":51820639,"identity":"9ce95620-0a71-48e0-bcc2-a336cde245bb","added_by":"auto","created_at":"2024-02-29 16:01:43","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":70743,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eData Collection Timeline\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eCogs represent iterative data analysis using a constant-comparison technique, back and forth between data sets. Data interpretation using the lens of Normalisation Process Theory performed after data analysis had occurred.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/cb29642f7f61f699591c47c7.png"},{"id":51820644,"identity":"ca729231-7d20-481b-a989-82c78190c34e","added_by":"auto","created_at":"2024-02-29 16:01:46","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":291745,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSurvey Results Radar Plot\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/609a44b57465ead9f2b9351e.jpeg"},{"id":51820638,"identity":"ea869dc5-d239-45cd-a810-560afeac0ea1","added_by":"auto","created_at":"2024-02-29 16:01:42","extension":"jpeg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":413259,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCLABSI and Bundle Adherence Rates\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage412.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/5ea0035c293e11c26dce9065.jpeg"},{"id":51820642,"identity":"31a6124f-4cda-43a2-8148-96e39468ec4e","added_by":"auto","created_at":"2024-02-29 16:01:45","extension":"jpeg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":216796,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eA conceptual model of implementation\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage6.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/167461126acfe3fcbf57319f.jpeg"},{"id":61203370,"identity":"b6bcbf90-e270-49cc-9f4c-d9328cc78817","added_by":"auto","created_at":"2024-07-27 03:29:43","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2321845,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/117e861b-067b-429f-be04-6aa18d86f5e5.pdf"},{"id":51820640,"identity":"1fd01bd9-a9ce-4725-96db-ead6f219f04c","added_by":"auto","created_at":"2024-02-29 16:01:43","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":81080,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional file 1 (*docx)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTitle: StaRI Reporting Standards\u003c/p\u003e\n\u003cp\u003eFile provides a completed StaRI reporting standards checklist.\u003c/p\u003e","description":"","filename":"Additionalfile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/1c4860ef6c2aeb5f18092f66.docx"},{"id":51820643,"identity":"4120d1af-de27-4cb8-bae7-9bbaac8ce6f9","added_by":"auto","created_at":"2024-02-29 16:01:45","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":25899,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eAdditional file 2 (*.docx)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTitle: Theme descriptors and supporting data\u003c/p\u003e\n\u003cp\u003eFile provides description of each theme with additional supportive qualitative data in the form of participant quotations. It links the qualitative data to specific normalisation process theory constructs.\u003c/p\u003e","description":"","filename":"Additionalfile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-3952357/v1/cd9c5337048e04f6fd7eec7b.docx"}],"financialInterests":"","formattedTitle":"Investigating the implementation of a complex intervention to reduce central line-associated bloodstream infections in the Neonatal Intensive Care Unit, using Normalisation Process Theory","fulltext":[{"header":"CONTRIBUTIONS TO THE LITERATURE","content":"\u003cp\u003eResearch suggests care bundles can reduce neonatal CLABSIs by up to 60% but what works in one setting is not always replicable in another. Understanding why things work (or not) is important for improving evidence translation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study found that a complex intervention did not result in reduced CLABSI rates in a UK neonatal intensive care unit, despite increasing adherence rates. \u0026nbsp;A limited collective approach coupled with a perceived lack of reinforcement, meant there were differences between the \u003cem\u003ework as imagined\u003c/em\u003e and the \u003cem\u003ework as done\u003c/em\u003e. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFinding effective reinforcement strategies is important for improving complex intervention implementation in high-stakes settings.\u003c/p\u003e"},{"header":"BACKGROUND","content":"\u003cp\u003eTranslating evidence into practice has been notoriously difficult within the field of infection prevention and control (IPC). Clinical guidelines rarely account for the complexities of clinical practice and often represent less than perfect knowledge [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. This can result in individual interpretations of guidelines and variations in practice [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Poor staffing levels, resource availability, and impractical rules, are all self-reported reasons why agreed guidance may not be followed [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. In addition, healthcare systems are complex adaptive systems, meaning that interactions between \u003cem\u003ethose doing the work\u003c/em\u003e within the system are dynamic, emergent, and unpredictable, challenging linear cause-and-effect models [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eComplex situations- those which involve high uncertainty and high social conflict- can make sustaining change challenging [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Central line associated bloodstream infections (CLABSIs) are a complex problem, with multiple aetiologies and variations in definitions. The lack of real-time feedback between the potential cause (lapses in infection prevention practices) and the consequence (a CLABSI), together with the invisibility of micro-organisms, makes linking hospital acquired infections such as CLABSIs to professional\u0026rsquo;s behaviour particularly problematic [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. In addition, uncertainties in the evidence may result in intense disagreement between those doing the work [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e].\u003c/p\u003e \u003cp\u003ePassive education alone rarely results in sustained behaviour change [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] and failure to follow IPC guidelines may be a result of practice lapses rather than knowledge deficits. Hidden influences on healthcare professional behaviour such as complex social norms may impede knowledge translation: there can be disparities between knowing what \u003cem\u003eshould\u003c/em\u003e be done (\u003cem\u003ethe work as imagined\u003c/em\u003e) and how the work \u003cem\u003eis\u003c/em\u003e done [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Interventions that include forcing functions, automation, simplification, and standardisation, as well as reminders and checklists, may be more effective at changing behaviour compared to education and training alone [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eComplex interventions, such as care bundles, are one way to address complex problems in healthcare [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The complexity of an intervention depends upon the number components involved, the number of groups or settings involved, the range of behaviours targeted, as well as the degree of flexibility permitted [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. The implementation of a CLABSI care bundle in Michigan was considered a huge success, reporting zero CLABSI rates post-implementation with low rates sustained for 10 years [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Whilst systematic reviews of observational studies suggest bundles may reduce CLABSI rates in a variety of healthcare settings by between 34%-60% [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e10\u003c/span\u003e], the evidence from randomised control trials is less convincing, and attempts to replicate the Michigan Keystone study in the UK have been less successful [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e10\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. This has been attributed to small numbers, variations in infection rates, and a failure to demonstrate with confidence that improvements were directly attributed to the intervention [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAs complex interventions target multiple behaviours and contain different degrees of interaction between bundled components, actors, and contexts, it is unlikely that a recipe from one or two successful social innovations can be directly translated into different contexts [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. This is important. There is danger of a cargo-cult approach whereby successful interventions from one setting are directly translated into another without understanding the mechanisms by which change has occurred [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. This may result in an unsuccessful or unsustainable intervention, and an ineffective use of resources.\u003c/p\u003e \u003cp\u003eEight studies have evaluated the implementation of a CLABSI care bundle [\u003cspan additionalcitationids=\"CR13 CR14 CR15 CR16 CR17 CR18\" citationid=\"CR13\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e19\u003c/span\u003e], with two specifically in paediatric ICU populations [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. Leadership, buy-in, resources and workloads were commonly cited influences on bundle implementation across all studies. Pre-existing improvement cultures and multi-disciplinary team working were believed to support implementation, whilst silo working, unclear roles, and professional hierarchies could hinder efforts. Checklists were believed to flatten social hierarchies and promote nurse empowerment [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, there are limitations to the extent implementation processes could be explained, with some studies using self-reported adherence measures [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e17\u003c/span\u003e] or studying a single specific professional group [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eUnderstanding the implementation of care bundles to reduce CLABSIs in neonatal units has not been studied, despite two thirds of UK neonatal units reporting using a central line bundle and variations in CLABSI rates [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. The aim of this study was to investigate the implementation of a complex intervention-a care bundle- to reduce CLABSIs on a neonatal intensive care unit (NICU). Understanding how and why practices become routinely embedded in a high stake\u0026rsquo;s setting such as the NICU is important for the effective design and implementation of complex interventions.\u003c/p\u003e"},{"header":"METHODS","content":"\u003cp\u003eA focused ethnography was used to explore care bundle implementation in a tertiary NICU, underpinned by Normalisation Process Theory (NPT) [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. NPT proposes that the normalisation of a new technology or practice is the result of the collective action of groups of people and how they work together to enact new processes, as opposed to solely attributing behaviour change to individual attitudes, beliefs, or intentions. NPT can therefore be used to evaluate the workability of an intervention and how it is integrated into everyday practice [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e22\u003c/span\u003e]. NPT was used as a lens to understand the mechanisms of action through which normalisation was achieved. The four constructs of NPT are described in Fig.\u0026nbsp;1 and the StaRI reporting standards for implementation studies have been followed (additional file 1) [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 1: Normalisation Process Theory\u003c/b\u003e \u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eSETTING\u003c/h2\u003e \u003cp\u003eThis was a single centre study in a tertiary NICU in the United Kingdom. A multi-disciplinary team reviewed local CLABSI rates and developed a care bundle to address practice need. This was informed by systematic review evidence [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e9\u003c/span\u003e], local microbiology data, historical local practices, and resource availability. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e outlines the implementation timeline.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eImplementation Timeline\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDate\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eIntervention\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2015\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFormation of a multi-disciplinary team\u003c/p\u003e \u003cp\u003eSurgical aseptic non-touch technique for all CVC access\u003c/p\u003e \u003cp\u003eA two-person checklist for central line insertions\u003c/p\u003e \u003cp\u003eInfectious diseases meeting to become a bedside ward round\u003c/p\u003e \u003cp\u003eCentral line insertion trolley\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e2015\u0026ndash;2016\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMulti-disciplinary late-onset sepsis prevention and management guideline developed\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eJanuary 2016\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eSurgical ANTT introduced for CVC access.\u003c/p\u003e \u003cp\u003eCascade training provided to all nursing staff\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eJanuary 2017\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eTwo-person CVC insertion technique and CVC checklist introduced.\u003c/p\u003e \u003cp\u003eTwice-yearly training on ANTT, a central line simulation study day, video training resources, and an insertion guideline\u003c/p\u003e \u003cp\u003eAudit performed 6 months post-introduction\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOctober 2017\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eLate-onset sepsis guideline approved\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarch 2018\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eAlcohol Impregnated Port Protectors (AIPPs) introduced\u003c/p\u003e \u003cp\u003eVisual aids provided\u003c/p\u003e \u003cp\u003eDaily audit for the first 3 months\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOngoing\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInfection rates disseminated at regular intervals between 2017 to 2019\u003c/p\u003e \u003cp\u003eInfection rates part of local governance meetings\u003c/p\u003e \u003cp\u003eAIPPs incorporated in a daily nursing checklist\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003eMDT\u0026thinsp;=\u0026thinsp;multidisciplinary team, ANTT\u0026thinsp;=\u0026thinsp;aseptic non-touch technique, AIPP\u0026thinsp;=\u0026thinsp;alcohol impregnated port protectors, NICU\u0026thinsp;=\u0026thinsp;neonatal intensive care unit\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e: \u003cb\u003eImplementation Timeline\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eDATA COLLECTION\u003c/h2\u003e \u003cp\u003eData collection was performed between March 2018-September 2019, after bundle implementation had been completed, using both quantitative and qualitative methods (see Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). A timeline for data collection is provided in Fig.\u0026nbsp;2.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eData Collection Methods\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"7\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eTechnique\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eMethod\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eSampling\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c5\" namest=\"c4\"\u003e \u003cp\u003eSample\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eData Analysis\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c7\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eData Integration\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eInclusion\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eExclusion\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eObservations\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNon-participatory\u003c/p\u003e \u003cp\u003eOvert\u003c/p\u003e \u003cp\u003eUnstructured\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePurposive\u003c/p\u003e \u003cp\u003eEvents:\u003c/p\u003e \u003cp\u003eCVC insertion \u0026amp;\u003c/p\u003e \u003cp\u003eCVC access\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eStaff eligible if insert or access CVCs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStaff not inserting or accessing CVCs\u003c/p\u003e \u003cp\u003ePreviously participated in 2 observations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eThematic analysis\u003c/p\u003e \u003cp\u003eConstant comparison\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eInformed sampling\u003c/p\u003e \u003cp\u003eData triangulation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eDyadic Think Aloud Interviews\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRetrospective\u003c/p\u003e \u003cp\u003eThink Aloud Techniques\u003c/p\u003e \u003cp\u003eInterview prompts\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePurposive\u003c/p\u003e \u003cp\u003eParticipant pairs\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAs above\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eAs above\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eThematic analysis\u003c/p\u003e \u003cp\u003eConstant comparison\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eInformed sampling\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eNoMAD Survey\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eElectronic \u0026amp; paper\u003c/p\u003e \u003cp\u003e4-monthly for 1 year\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePurposive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eWorked on NICU pre-bundle\u003c/p\u003e \u003cp\u003eDaily work includes CVC management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStaff employed \u003cem\u003eafter\u003c/em\u003e bundle implementation\u003c/p\u003e \u003cp\u003eDaily work does not include CVC management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eDescriptive statistics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eInformed interview prompts\u003c/p\u003e \u003cp\u003eData triangulation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eCLABSI rates\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRoutinely collected \u0026amp; anonymised\u003c/p\u003e \u003cp\u003eElectronic patient records\u003c/p\u003e \u003cp\u003eNNAP definition\u003c/p\u003e \u003cp\u003eProspective\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAll admissions\u003c/p\u003e \u003cp\u003eJanuary 2015-January 2020\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eAll neonates with a CVC\u0026thinsp;\u0026gt;\u0026thinsp;72 days of age with a positive blood culture\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eNeonates\u0026thinsp;\u0026lt;\u0026thinsp;72 hours of age\u003c/p\u003e \u003cp\u003eNeonates without a CVC\u003c/p\u003e \u003cp\u003eDuplicate blood cultures for same episode\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eStatistical process control\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eInformed interview prompts\u003c/p\u003e \u003cp\u003eInformed interpretation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eBundle Adherence\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eRoutinely collected \u0026amp; anonymised\u003c/p\u003e \u003cp\u003eElectronic patient records\u003c/p\u003e \u003cp\u003eQuarterly spot audit\u003c/p\u003e \u003cp\u003eRetrospective\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eAll neonatal inpatients with a CVC\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eUmbilical venous and arterial lines\u003c/p\u003e \u003cp\u003ePeripherally inserted central catheters\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCVCs inserted prior to admission excluded from insertion audit\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eDescriptive statistics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eData triangulation\u003c/p\u003e \u003cp\u003eInformed interpretation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eHand hygiene \u0026amp; ANTT adherence\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eQuarterly observational audits\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10 observations\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eDescriptive statistics\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eData triangulation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eSemi-Structured Interviews\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eInterview schedule\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePurposive\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eWorked on NICU pre-bundle\u003c/p\u003e \u003cp\u003eDaily work includes CVC management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eStaff employed \u003cem\u003eafter\u003c/em\u003e bundle implementation\u003c/p\u003e \u003cp\u003eDaily work does not include CVC management\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eThematic analysis Constant comparison\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c7\"\u003e \u003cp\u003eInformed sampling\u003c/p\u003e \u003cp\u003eData triangulation\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 2 Data Collection Timeline\u003c/b\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e \u003cb\u003eData Collection Methods\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eNormalizsation MeAsure Development (NoMAD) Survey\u003c/h2\u003e \u003cp\u003eThe NoMAD survey was used as a measure of implementation over time. This is a validated instrument comprising of 20 questions on a Likert scale [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. This was adapted to provide a numerical score (-2 through to +\u0026thinsp;2) which has been used previously [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e25\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eObservations of Practice with Dyadic Think Aloud Interviews\u003c/h2\u003e \u003cp\u003eCentral venous catheter (CVC) specific events- insertion and infusion fluid changes- were observed using an unstructured data collection form developed using NPT. Using retrospective think aloud interviews (RTAIs) with participant pairs after each observation, participants were asked to describe what they did, why, and when procedures may be performed differently. The process was piloted to ensure feasibility and acceptability. Purposive sampling was used across different professional groups (including job grades), years of experience, and combinations of dyad pairings.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eSemi-Structured Interviews\u003c/h2\u003e \u003cp\u003eSemi-structured interviews (SSIs) took place after survey and observations with dyadic RTAI data had been analysed, using loose topic guides incorporating preliminary findings. Constant comparison techniques informed sampling, seeking a breadth of perspectives, with attempts to find disconfirming sources. Data collection ceased when no new concepts relating to the phenomenon of implementation were found.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e \u003ch2\u003eMeasures of Outcome (CLABSI) and Process (Audit)\u003c/h2\u003e \u003cp\u003eRoutinely collected, anonymised data was collected on bundle adherence and CLABSI rates. Adherence to hand hygiene and aseptic non-touch technique (ANTT) were collected as part of prospective routine audits, and adherence to specific bundled elements (two-person insertion technique, insertion checklist, skin decontamination, alcohol impregnated caps) were collected quarterly using electronic patient records. A pragmatic definition of CLABSI was used, in keeping with the National Neonatal Audit Programme [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e20\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eDATA ANALYSIS\u003c/h2\u003e \u003cp\u003eQuantitative data was analysed using descriptive statistics and statistical process control for CLABSI rates. A signal change in the data was defined as seven points above or below the median or in a single direction [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e26\u003c/span\u003e]. Survey data was tested for normality using Shapiro-Wilks. Likert scale responses were ranked from \u0026minus;\u0026thinsp;2 (strongly disagree) through to 2 (strongly agree) and radar plots used to visualise changes over time.\u003c/p\u003e \u003cp\u003eObservational data were collated using a tabular framework for each observation, comparing the \u003cem\u003ework as done\u003c/em\u003e (observations) and the work as described (interview data). This enabled cross-referencing between dyads and data sets, keeping the data for each observation and participant pairs together. Qualitative data were coded and analysed using an inductive approach using thematic analysis [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e27\u003c/span\u003e]. Transcripts were returned to participants and final themes were disseminated to all participants who were invited to comment on the findings.\u003c/p\u003e \u003cp\u003eFollowing thematic analysis, the constructs of NPT were applied to the data to understand implementation at a theoretical level and develop a conceptual model for implementation.\u003c/p\u003e \u003c/div\u003e"},{"header":"RESULTS","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eNoMAD Survey\u003c/h2\u003e \u003cp\u003eThere were 127 eligible staff, and response rates declined over time from 71\u0026ndash;43%. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e outlines participant characteristics. Radar plots representing median survey scores are presented in Fig.\u0026nbsp;3: the fuller the radar plot, the more normalised practices were. Whilst median scores for question 13 (is there sufficient training?) and 14 (are there sufficient resources?) improved over time, scores for question 7 (are you willing to work with others in new ways?) and question 8 (will you continue to support the bundle?) decreased. Median scores for the remaining questions were consistently 1 (agree) across all three surveys.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eParticipant Characteristics\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNoMAD Survey 1 n, (%)*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eNoMAD Survey 2\u003c/p\u003e \u003cp\u003en, (%)*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eNoMAD Survey 3\u003c/p\u003e \u003cp\u003en, (%)*\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eObservations with RTAI Interviews, n\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eSemi-structured interviews, n\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConsultant\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4 (6)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecialist Registrar\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSenior House Officer\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMTI/Fellow\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4 (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurse Band 8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3 (3)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3 (5)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3 (7)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurse Band 7\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e9 (10)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7 (11)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5 (11)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurse Band 6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e24 (27)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e24 (37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e16 (36)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurse Band 5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e35 (39)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19 (30)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e14 (31)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurse Band 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e11 (12)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6 (9)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2 (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMissing\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1 (2)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eTotal\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e90 (100)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e64 (100)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e43 (100)\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e\u003cb\u003e21\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u003cb\u003e15\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e\u003cb\u003eResponse rate\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003e71%\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003e56%\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e\u003cb\u003e43%\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eN/A\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"6\"\u003eNoMAD\u0026thinsp;=\u0026thinsp;Normalization MeAsurement Development survey, RTAI\u0026thinsp;=\u0026thinsp;retrospective think aloud interviews, *Percentage of respondents\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eTable\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e \u003cb\u003eParticipant Characteristics\u003c/b\u003e\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 3 Survey Results Radar Plot\u003c/b\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eOutcome and Process Measures\u003c/h2\u003e \u003cp\u003eCLABSI and bundle adherence rates are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e4\u003c/span\u003ea and \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e4\u003c/span\u003eb, respectively. Whilst there appeared to be an initial decrease in CLABSI rates, this was not sustained. Adherence rates improved over time. Adherence to ANTT was consistently reported as 100%, whereas adherence to the insertion checklist and two-person insertion improved from 49\u0026ndash;89%, and 42\u0026ndash;87% respectively.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e4\u003c/span\u003e \u003cb\u003eCLABSI and Bundle Adherence Rates\u003c/b\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eObservations of Practice with Dyadic Think Aloud Interviews\u003c/h2\u003e \u003cp\u003eTwelve observations with RTAIs were performed, totalling six CVC insertions and six CVC fluid changes (see Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Eleven observations took place during day shifts and one overnight. No emergency procedures were observed. Dyadic interviews lasted between 15\u0026ndash;30 minutes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSemi-Structured Interviews\u003c/h2\u003e \u003cp\u003eFifteen semi-structured interviews (see Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e) were performed between July and August 2019, lasting approximately 50\u0026ndash;70 minutes.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eInfluences on Implementation\u003c/h2\u003e \u003cp\u003eThematic analysis of observational, dyadic RTAI, and semi-structured interview data resulted in eight themes organised into three over-arching categories: individual, team, and organisational influences. Theme descriptors and supportive qualitative data are provided in additional file 2.\u003c/p\u003e \u003cp\u003eIndividual influences\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eBundle endorsement\u003c/h2\u003e \u003cp\u003eParticipants discussed the extent to which there was buy-in for the bundle. This included beliefs about bundle utility and beliefs about the problem (CLABSIs). Broadly, participants believed that the new practices addressed aspects of practice thought to be poorly performed previously (RTAI 2, 3, 4, 5). Nurses believed AIPPs made their work easier and reduced variations in practice, however, unclear expectations and uncertain rules caused confusion. This included the frequency of CVC access, the use extension sets, and different \u0026lsquo;rules\u0026rsquo; for difference devices.\u003c/p\u003e \u003cp\u003eThere was less collective endorsement for CVC insertion practices, specifically the two-person technique. Beliefs about its utility were mixed; some believed they had previously been doing this informally, whilst others believed it was more appropriate for less experienced colleagues. When asked how important the second person was, one participant commented:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eI didn't used to think it was! But the more I've done it with a second person, actually it makes the procedure easier, if you've always got somebody to monitor the baby and comfort the baby, but also to see things you haven't seen, like when turning round and your glove touches the port hole [\u0026hellip;] I think you're more aware of your own practice when you think someone's watching you.\u003c/em\u003e \u003c/p\u003e\u003cp\u003eNURS0804, Interview 14\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThere was a disconnect between the intended purpose of the second person role, and how the role was enacted: the second person was actively involved in the procedure, donning sterile gowns and gloves, rather than monitoring the process using the checklist. This meant that some participants did not believe a second person was always necessary, nor that nursing involvement was legitimate. The expectations were not always clear and there were mixed beliefs about the value of specific bundled components, such as maximal barrier precautions (specifically hats and masks) and the insertion checklist. Hats and masks were infrequently worn, and the checklist was not observed being used. Semi-structured interviews revealed it was exclusively used retrospectively \u003cem\u003eafter\u003c/em\u003e the CVC had been inserted.\u003c/p\u003e \u003cp\u003eWhilst all participants believed that reducing infections was important this was juxtaposed by beliefs that it was \u0026ldquo;\u003cem\u003eunrealistic to think you could eradicate\u0026rdquo; (\u003c/em\u003eDOC01, Interview 3\u003cem\u003e)\u003c/em\u003e them, and participants questioned if CLABSIs were a \u003cem\u003e\u0026ldquo;genuine\u0026rdquo;\u003c/em\u003e infection (DOC04, Interview 12), or \u003cem\u003e\u0026ldquo;a bad infection\u0026rdquo;\u003c/em\u003e (NURS0803, Interview 8). There was a broad consensus that the bundle had increased awareness of infection rates, which was perceived to be beneficial.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003eSeeking Reinforcement\u003c/h2\u003e \u003cp\u003eParticipants were actively seeking reinforcement, checking together in observations, and reflecting during RTAIs on how procedures could have been done differently. Participants believed they received limited feedback on CVC management, and identified problems with reporting CLABSI rates:\u003c/p\u003e \u003cp\u003e \u003cem\u003eSo, I think there's various negative things that come back, in a very non-specific way, which means that no one does anything about it, because there's no ownership. [\u0026hellip;] but the only way of that being reported is a number in a governance meeting several months later, then it's not being fed back in a timely fashion, we're waiting to find out we've got a problem\u003c/em\u003e \u003c/p\u003e \u003cp\u003eDOC01, Interview 3\u003c/p\u003e \u003cp\u003eWhilst local infection rates were disseminated, one participant recognised that it was \u0026ldquo;\u003cem\u003edifficult to extrapolate the data, for it to mean something\u0026rdquo;\u003c/em\u003e (NURS0801, interview 6). When shown local CLABSI rates, participants apportioned responsibility to other professions or roles. One participant noted that:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eWe never think it\u0026rsquo;s us, do we? We always think, oh well, that\u0026rsquo;s the doctors, that\u0026rsquo;s the surgeons. As nurses, we feel that we get the blame for when infection rates rise [\u0026hellip;] its everyone, isn\u0026rsquo;t it? and we\u0026rsquo;re all responsible for it\u003c/em\u003e \u003c/p\u003e\u003cp\u003eNURS0618, Interview 7\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eOnly one participant reflected on their own behaviour, suggesting that \u0026ldquo;\u003cem\u003eit\u0026rsquo;s probably our fault and we can improve\u0026rdquo;\u003c/em\u003e (NURS0509, interview 8). Whilst some participants explained that they wouldn\u0026rsquo;t change their practice unless they received specific feedback on their own practice, this was juxtaposed by those in senior roles who expressed concerns about providing individual feedback. One consultant believed it would be an \u0026ldquo;\u003cem\u003eawful thing\u0026rdquo;\u003c/em\u003e to have the responsibility for an infection \u003cem\u003e\u0026ldquo;laid at someone\u0026rsquo;s door\u0026rdquo;\u003c/em\u003e [SSI3, DOC01]. Participants across both professions used words such as \u0026ldquo;\u003cem\u003emoral distress\u0026rdquo;, \u0026ldquo;blame\u0026rdquo;\u003c/em\u003e, \u0026ldquo;\u003cem\u003eguilt\u003c/em\u003e\u0026rdquo;, and \u0026ldquo;\u003cem\u003emorale\u0026rdquo;\u003c/em\u003e in relation to feedback on infection rates. This contrasted with data from the dyadic RTAIs, who were interviewed immediately after doing the work, who wanted reassurance that what they were doing was right.\u003c/p\u003e \u003cp\u003eWithout feedback, participants resorted to informal self-appraisal of bundle effectiveness. Nursing participants \u003cem\u003e\u0026lsquo;felt like\u0026rsquo;\u003c/em\u003e they were administering less antibiotics, equating that with a reduction in CLABSIs, believing new practices \u0026lsquo;\u003cem\u003efelt cleaner\u0026rsquo;\u003c/em\u003e. However, two participants expressed concerns of a \u003cem\u003e\u0026ldquo;feedback culture\u0026rdquo;\u003c/em\u003e [DOC03] and receiving feedback for \u003cem\u003e\u0026ldquo;just doing your job\u0026rdquo;\u003c/em\u003e [DOC03, NURS0610]. Finding ways to use positive reinforcement strategies was believed to be important, such as celebrating central lines that completed their journey without an infection and reporting line-free infection days.\u003c/p\u003e \u003cp\u003eTeam Level Influences\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eDivision of Labour\u003c/h2\u003e \u003cp\u003eThe division of work influenced bundle implementation. Nursing enactment of ANTT included clearly allocated roles which they believed made it easier to understand expectations. However, the second person role for CVC insertion was not implemented as intended: in observations, the second person was always actively involved in the procedure rather than acting as a monitor of practice. Participants reflected on how the second person could be helpful with one participant suggesting allocating roles at the start. There were some aspects of central line work where responsibility was unclear, such as the monitoring of CVC dressings. Some participants believed that the current division of labour was not appropriate; for example, one consultant believed that \u0026ldquo;\u003cem\u003esome of our more experienced nurses would be better placed\u0026rdquo;\u003c/em\u003e to change central line dressings (DOC03, interview 13).\u003c/p\u003e \u003cp\u003eParticipants referred to \u0026ldquo;\u003cem\u003etheir work\u003c/em\u003e\u0026rdquo; and \u0026ldquo;\u003cem\u003eour work\u003c/em\u003e\u0026rdquo; suggesting a siloed division of labour. Whilst some participants believed the bundle had increased the collective responsibility of CVCs others believed there was no clear responsibilities for some aspects of care, such as assessing the need for the CVC:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eWell, I\u0026rsquo;d like to think it\u0026rsquo;s a Consultant role to think about it all, but- I think you can\u0026rsquo;t really expect a junior bedside nurse to think about that- but I think it\u0026rsquo;s everybody\u0026rsquo;s responsibility to think, is this still required and do we still need it, and if we still need it, is it safe and are we managing them well?\u003c/em\u003e \u003c/p\u003e\u003cp\u003eDOC03, Interview 13\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eBoth professions were unsure if involvement in CVC insertion was a legitimate nursing role. Competing workload priorities between teams also caused tension. The organisation of CVC fluids within nursing teams also caused discomfort, and there was a shared experience of guilt among nurses:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eThere\u0026rsquo;s this feeling that you\u0026rsquo;re a failure if you hand over your patient to the night shift and go \u0026lsquo;I haven\u0026rsquo;t done any fluids. Haven\u0026rsquo;t done any infusions\u0026rsquo;. The response you get sometimes from some are like \u0026lsquo;What?! What have you been doing?!\u0026rsquo; [\u0026hellip;]\u003c/em\u003e \u003c/p\u003e\u003cp\u003eNURS0703, Interview 9\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eKnowledge regarding CVC care was role specific; not everyone had access to the same knowledge. For example, one nurse believed that they were unable to advise on CVC insertion because \u0026ldquo;\u003cem\u003eits not our job\u0026rdquo;\u003c/em\u003e (NURS0617), whilst a consultant recognised that nobody is \u0026ldquo;\u003cem\u003ethinking holistically\u0026rdquo;\u003c/em\u003e (DOC03). A lack of shared knowledge is likely to make monitoring practice difficult and participants believed that multi-disciplinary training could help improve this.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eSurveillance and Monitoring\u003c/h2\u003e \u003cp\u003eThere was variation in bundle surveillance, and informal monitoring- such as \u003cem\u003echecking together\u003c/em\u003e-was frequently observed:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003esomeone got their gloves on and they put their hair behind their ears and someone\u0026rsquo;s, \u0026ldquo;Oh what have you just done?\u0026rdquo; and started again! (Laughs) So, it\u0026rsquo;s not like it has to be judgmental, it\u0026rsquo;s just, \u0026ldquo;Oh, do you realise you\u0026rsquo;re -?\u0026rdquo; \u0026ldquo;Oh, I did not realise\u0026rdquo; \u0026hellip;\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eNURS0515, RTAI 8\u003c/h2\u003e \u003cp\u003eHowever, not all participants engaged in informal monitoring, despite participants\u0026rsquo; beliefs that behaviour may change if they are being observed, or that \u0026ldquo;\u003cem\u003ecorners may be cut\u003c/em\u003e\u0026rdquo; (NURS0804, interview 14) if no one is watching. One nurse explained that the process is \u0026ldquo;\u003cem\u003eautomatic\u003c/em\u003e, \u003cem\u003eyou know what you\u0026rsquo;re doing\u0026rdquo;\u003c/em\u003e whilst another recognised that that she doesn\u0026rsquo;t \u003cem\u003e\u0026ldquo;watch that intently what other people are doing\u003c/em\u003e\u0026rdquo; (NURS0610, interview 11). One participant suggested incorporating more formal surveillance into their practice:\u003c/p\u003e \u003cp\u003e \u003cem\u003eWe don't really have very much feedback, and whether we should be observing each other, having an outside observer\u0026hellip;\u003c/em\u003e \u003c/p\u003e \u003cp\u003eNURS0704, Interview 4\u003c/p\u003e \u003cp\u003eMonitoring of CVC insertion appeared to be ad-hoc, with one consultant feeling that \u0026ldquo;\u003cem\u003esometimes the co-ordinators around just to keep an eye\u0026rdquo;\u003c/em\u003e (DOC13, interview 15) whilst another reflected that he \u003cem\u003e\u0026ldquo;can\u0026rsquo;t say they [CVC practices] are being done properly\u0026rdquo;\u003c/em\u003e (DOC04, interview 2). In CVC insertions, the second person was implemented as an assistant rather than as a monitor of asepsis using the checklist prospectively.\u003c/p\u003e \u003cp\u003eParticipants reflected that it was difficult to question poor practice, despite believing this was important. When concerns were raised, some believed they were not always listened to. One solution was to give permission- to make it acceptable- to raise concerns, thereby providing a clear expectation of behaviour:\u003c/p\u003e \u003cp\u003e \u003cem\u003e[\u0026hellip;] and you can say to the nurse or the doctor with you, 'Keep an eye on it for me because I might not notice. Please tell me if you see that something's become desterilised,' and then that just takes that onus away from someone because actually then you can say it's all right, I'm expecting you to say that to me.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eDOC01, Interview 3\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eLearning and Teaching\u003c/h2\u003e \u003cp\u003e Participants across both professions described learning from each other, which was believed to be important for sharing tacit knowledge. Participants descriptions of learning were reminiscent of the \u0026lsquo;see one, do one, teach one\u0026rsquo; approach which was reflected in observations. Participants believed that less experienced colleagues may not have learnt the high-risk moments for asepsis lapses, such as incubator portholes, something that was learnt through doing. Whilst nursing participants believed they were all taught a standardised approach to ANTT, some found it hard to teach others who may have been taught different techniques in different workplaces.\u003c/p\u003e \u003cp\u003e Whilst there were few references to formal teaching resources in the dyadic RTAI interviews, participants in semi-structured interviews referred more explicitly to educational resources. Cascade training was believed to bring challenges such as introducing variation. This could create uncertainty, with one nurse recognising that \u003cem\u003e\u0026ldquo;we make it confusing\u0026rdquo;\u003c/em\u003e by teaching new staff different things (SSI8, NURS0509). Participants felt that it was important to learn the right way to perform a task the first time it is taught and to not pick up \u0026lsquo;\u003cem\u003ebad habits\u0026rsquo;\u003c/em\u003e (SSI12, DOC04). Visual aids were felt to improve implementation and refresher training was identified as being useful. One consultant believed that CVC education needed \u003cem\u003e\u0026ldquo;a team\u0026rdquo;\u003c/em\u003e (SSI12, DOC04). Learning from others continued to be referred to as how practices were taught, triangulating with RTAI data:\u003c/p\u003e \u003cp\u003e \u003cem\u003eWe just run through whether the person is able to do it and let them do it on their own, which we shouldn't be doing.\u003c/em\u003e \u003c/p\u003e \u003cp\u003eDOC13, Interview 15\u003c/p\u003e \u003cp\u003eThis highlights the absence of formal surveillance, suggesting the two-person technique-which was observed being used in all central line insertion observations- was not always used.\u003c/p\u003e \u003cp\u003eOrganisational influences\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eResources\u003c/h2\u003e \u003cp\u003eResource availability, including easy access to equipment and the appropriate hand scrub, were identified as barriers. Insufficient staffing and competing demands were frequently cited as a barrier. The feeling of \u0026lsquo;being busy\u0026rsquo; was a potential explanation for poor CVC hub decontamination:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026hellip;and so particularly with the clean for 30 seconds, dry for 30 seconds and they\u0026rsquo;re standing there anyway everything\u0026rsquo;s a hurry, we\u0026rsquo;re busy, busy, busy, clean, dry, yeah, that\u0026rsquo;s 30 seconds.\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eNURS0610, RTAI3\u003c/h2\u003e \u003cp\u003eThere was a perceived need to \u0026ldquo;\u003cem\u003eget on\u003c/em\u003e\u0026rdquo; with tasks with nurses feeling they need to \u0026ldquo;\u003cem\u003efit it all in\u003c/em\u003e\u0026rdquo;, despite also recognising that it was a \u0026ldquo;\u003cem\u003e24-hour service\u003c/em\u003e\u0026rdquo; (NURS0515, RTAI8). Those inserting lines used words such as \u0026ldquo;\u003cem\u003ewhip one in\u0026rdquo;\u003c/em\u003e and \u0026ldquo;\u003cem\u003ecrack on\u0026rdquo;\u003c/em\u003e in keeping with a perception of busyness. Interruptions were also a potential cause of lapses in asepsis.\u003c/p\u003e \u003cp\u003eBoth professions felt that nurse staffing was a significant barrier to involvement in CVC insertions, with medical staff not wanting to increase nursing work. Insufficient staffing was believed to have become \u003cem\u003e\u0026ldquo;normalised\u0026rdquo;\u003c/em\u003e (DOC01, interview 13) yet another participant felt it was \u003cem\u003e\u0026ldquo;an easy card to play\u0026rdquo;\u003c/em\u003e (DOC03, interview 12). Some nurses felt that if nurse: patient ratios were improved, they could assist with CVC insertions.\u003c/p\u003e \u003cp\u003eThere were differences in the extent to which staffing and workload was considered an acceptable reason for practice variation. For CVC insertions, being busy was considered an acceptable reason to not have a second person, whereas for CVC access, it was not an acceptable reason for nurses to not adhere to hub decontamination:\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003eYes, maybe you could be excused for not having a second pair of hands, but I don't think you can say, 'I was busy, so I didn't clean the hub for so many seconds', because I think, yes, you're busy, but then you can't compromise on safety just because you're busy, so I don't think that's acceptable.\u003c/em\u003e \u003c/p\u003e\u003cp\u003eDOC13, Interview 15\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThe two-person insertion and checklist were not seen perceived as an essential safety process.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003eEnvironment\u003c/h2\u003e \u003cp\u003eObservations revealed specific environmental challenges for asepsis, with limited space and increased traffic around sterile fields. Incubator portholes provided a physical obstacle for those inserting central lines. Participants suggested having a dedicated space and equipment trolleys, to limit interruptions and separate the task from competing cognitive demands.\u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eCulture\u003c/h2\u003e \u003cp\u003eSocial norms- such as habits and rituals-alongside professional hierarchies, influenced how the work was done. This ultimately effected bundle endorsement. The process of performing ANTT was ritualistic:\u003c/p\u003e \u003cp\u003e \u003cem\u003ebut when you put those gloves on it's like a costume to like, 'This needs to be done sterilely. I mustn't touch anything,'\u003c/em\u003e \u003c/p\u003e \u003cp\u003eNURS0707, Interview 4\u003c/p\u003e \u003cp\u003eThis shared mental model made it easier for nurses to informally monitor practice. Participants recalled examples of \u003cem\u003enormalised deviance\u003c/em\u003e- socially accepted ways of working that were dissonant with beliefs about how the work should be performed. Participants shared examples such as not waiting for one minute for hub decontamination (observations 3, 5, interview 1, 7, 10, 11 14, 15), not checking CVCs \u003cem\u003e\u0026ldquo;as closely as we should be\u0026rdquo;\u003c/em\u003e (NURS0610, interview 11), \u0026ldquo;\u003cem\u003ewandering around the unit\u0026rdquo;\u003c/em\u003e in sterile gloves and that a second person \u0026ldquo;\u003cem\u003emay join you halfway through\u0026rdquo;\u003c/em\u003e (NURS0804, Interview 14). One consultant felt \u003cem\u003e\u0026ldquo;it was vital\u0026rdquo;\u003c/em\u003e to lead by example (DOC01, Interview 3) whilst another reflected that he could not expect others to wear a hat and mask if he didn\u0026rsquo;t (DOC04, interview 12).\u003c/p\u003e \u003cp\u003eHierarchies influenced surveillance. Nurses believed there were clear lines of escalation with a \u003cem\u003e\u0026ldquo;strong\u0026rdquo;\u003c/em\u003e senior nursing team that would raise concerns. Whilst one nurse felt that her opinions were listened to since wearing a senior uniform (NURS0610, interview 19), others felt that they \u003cem\u003e\u0026ldquo;nag, nag, nag, and then just give up\u0026rdquo;\u003c/em\u003e (NURS0618, interview 7). Hierarchies may influence asking for help:\u003c/p\u003e \u003cp\u003e \u003cem\u003eI think that the nurses probably find it okay to ask. The medics, I'm not sure. I feel there's a little bit more\u0026hellip; Going back five or 10 years, I think we were a little bit a better team and we weren't necessarily a hierarchy as much. There's a bit more of a hierarchy at the moment.\u003c/em\u003e NURS0703, Interview 9\u003c/p\u003e \u003cp\u003eMaking it acceptable to ask for help was believed to be important, though it was recognised that culture was difficult to change. Participants suggested giving colleagues permission to raise concerns may make it more socially acceptable. Changing the culture was strongly believed by all participants, across both professions, to be important to improve bundle adoption. Participants referred to creating a more open culture as an important part of improving CVC care.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eA Conceptual Model of Implementation\u003c/h2\u003e \u003cp\u003eA conceptual model was developed from the data using the constructs of NPT (Fig.\u0026nbsp;5). Whilst all participants believed reducing infections was important- there was collective buy in- there were inter and intra- professional differences in \u003cb\u003ecoherence\u003c/b\u003e- how participants made sense of both the purpose, and the components of, the bundled practices. It was not always clear how the new practices were different to previous ones. There was also limited inter-professional \u003cb\u003ecognitive participation\u003c/b\u003e; whilst the nurses had a shared mental model for central line fluid changes, this was not universal, sometimes resulting in tensions between professional groups. Nurses were unclear of the expectations for CVC insertion and felt unable to challenge practice or use the checklist. The role of a second person became endorsed as a teaching role rather than a safety role, meaning that nursing involvement was not legitimised, nor that a second person was necessary for experienced colleagues. The division of labour was therefore not as intended and there was limited collective knowledge around CVC practices. Ultimately, it was not always clear what best practice looked like, or who should do it.\u003c/p\u003e \u003cp\u003eThis uncertainty meant that it was sometimes difficult to monitor practice and there was limited \u003cb\u003ecollective action\u003c/b\u003e around the new practices. This resulted in informal mechanisms for appraising the new practices and feedback to participants on infection rates was not always meaningful, or accessible, to those doing the work. Limited individualised feedback on practice limited the extent to which \u003cb\u003ereflexive monitoring\u003c/b\u003e could occur, and participants across both professions were actively seeking reinforcement.\u003c/p\u003e \u003cp\u003e \u003cb\u003eFigure 5A conceptual model of implementation\u003c/b\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThis focused-ethnography study found that the introduction of a care bundle into a UK NICU did not result in reductions in CLABSI rates, despite apparently increasing bundle adherence. It is one of few negative studies and contradicts systematic review evidence [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. Meta-analysis of observational studies may over-estimate effect size and there is a risk of publication bias [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThis study found there was only \u003cem\u003epartial\u003c/em\u003e bundle implementation and the NoMAD survey results showed minimal changes in attitudes to implementation; it was not always as intended and there were differences between the \u003cem\u003ework as imagined\u003c/em\u003e and the \u003cem\u003ework as done\u003c/em\u003e. For example, the insertion checklist was used retrospectively; whilst reported adherence to the checklist was high, observations revealed the checklist was never used prospectively. Interview data corroborated its use \u003cem\u003eafter\u003c/em\u003e the central line was inserted. This negates the checklist\u0026rsquo;s intended purpose as a safety mechanism and limits its ability to flatten hierarchies and empower staff to stop the procedure, theorised to be successful in previous studies [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Adherence to ANTT was reported consistently to be 100%; however, this was not always the case, with individual components such as \u003cem\u003ewaiting for one minute\u003c/em\u003e for hub decontamination believed to be not consistently adhered to, and different professions performing the practice differently.\u003c/p\u003e \u003cp\u003eIn the Michigan Keystone study, collective responsibility for reducing CLABSIs was believed to be key to its success. In this study, whilst participants believed reducing infections was important, there was limited collective responsibility. Instead, participants often apportioned responsibility for infections to others. The development of a community of practice- informal groups with a shared or common interest- did not occur, and this may be important for implementation. Central line teams have been shown to reduce CLABSIs in US NICUs [\u003cspan additionalcitationids=\"CR30\" citationid=\"CR30\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e31\u003c/span\u003e]. These may work by providing visible leadership, role modelling expected behaviours and providing educational outreach to staff. Future research should consider how these may be effectively implemented within UK NICUs.\u003c/p\u003e \u003cp\u003eDespite collective buy-in for reducing infections in the NICU, there lacked a shared belief that CLABSIs were a genuine problem that could be eliminated. These findings are consistent with a qualitative study of three paediatric units, which found variable beliefs in CLABSIs, variations in practices, and complexities in monitoring adherence [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e14\u003c/span\u003e]. However, our study found that despite adherence monitoring, participants actively sought reinforcement and there were challenges in reflexive monitoring of the intervention. This raises the importance of \u003cem\u003ehow\u003c/em\u003e adherence data is used: not only \u003cem\u003ewhat\u003c/em\u003e is measured, but \u003cem\u003ehow\u003c/em\u003e it is collected and its meaning to those doing the work.\u003c/p\u003e \u003cp\u003eIt has been proposed that audit and feedback- a commonly bundled component- works by restructuring peer group norms and expectations [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e32\u003c/span\u003e]. In this study, the use of multiple data sets revealed differences between \u003cem\u003ethe work as imagined\u003c/em\u003e and \u003cem\u003ethe work as done\u003c/em\u003e, which was different again to the \u003cem\u003ework as reported\u003c/em\u003e through audit. This is important; reliance solely on quantitative measures of \u003cem\u003ehow the work is done\u003c/em\u003e may, in some cases, provide false reassurance to those undertaking surveillance work. Traditional audit measures are unlikely to capture work arounds or unintended consequences [\u003cspan citationid=\"CR34\" class=\"CitationRef\"\u003e33\u003c/span\u003e] and time delays between \u0026lsquo;lapses in practice\u0026rsquo; and development of a CLABSI, means that associations between adherence and CLABSI rates are difficult to make. Prospective, real-time audits of practice with individualised and ward level feedback may provide both educational outreach and reinforce normative expectations. However, it is a resource intensive approach; Balla \u003cem\u003eet al\u003c/em\u003e (2018) found that this was not sustainable in a tertiary NICU [\u003cspan citationid=\"CR35\" class=\"CitationRef\"\u003e34\u003c/span\u003e]. Future research should focus on finding an effective reinforcement strategy in complex and high-stakes settings.\u003c/p\u003e \u003cp\u003eIt has been suggested that striving for zero CLABSIs is unrealistic and may contribute to burnout [\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e35\u003c/span\u003e], whilst others argue there is a need to change the mental model from \u003cem\u003einevitable\u003c/em\u003e to \u003cem\u003epreventable\u003c/em\u003e [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. Strategies to incorporate a Safety-II approach [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e35\u003c/span\u003e]- learning from when things go right- and the use of positive reinforcement strategies, may be helpful in high-stakes settings. Reporting infection-free days and reframing infections as \u003cem\u003eavoidable infections\u003c/em\u003e may help change the narrative of these infections as inevitable.\u003c/p\u003e \u003cp\u003eThere are several limitations to this study. The anonymous survey meant that it was not possible to track if individual attitudes changed over time. There were no emergency CVC practices observed, which may have revealed additional insights into how procedures were performed. There was no definition of what constituted implementation success and applying concepts such as acceptability, intervention fidelity, and intervention-to-context fit [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e18\u003c/span\u003e] might improve consistency of reporting in future studies. However, this is one of few studies to investigate the implementation of a CLABSI care bundle in a neonatal context, and the development of a conceptual model of implementation may be useful to others wishing to implement complex interventions in a similar context. The use of real time observational data alongside dyadic RTAIs enabled cognitive dissonance between beliefs and behaviours to be explored, and the integration of both qualitative and quantitative data sets enabled data triangulation, strengthening the findings in this study.\u003c/p\u003e"},{"header":"CONCLUSION","content":"\u003cp\u003eThe introduction of a care bundle did not reduce CLABSI rates in a UK NICU. This study found there was only partial implementation of the bundle, and some elements were not implemented as intended. Future research should identify effective positive reinforcement strategies that are meaningful and sustainable in a complex setting, to reduce avoidable infections in healthcare.\u003c/p\u003e"},{"header":"Abbreviations","content":" \u003cp\u003eAIPP Alcohol impregnated port protectors\u003c/p\u003e \u003cp\u003eANTT Aseptic non-touch technique\u003c/p\u003e \u003cp\u003eCVC Central venous catheter\u003c/p\u003e \u003cp\u003eCLABSI Central line-associated bloodstream infection\u003c/p\u003e \u003cp\u003eIPC Infection Prevention and Control\u003c/p\u003e \u003cp\u003eMDT Multi-disciplinary team\u003c/p\u003e \u003cp\u003eNICU Neonatal Intensive Care Unit\u003c/p\u003e \u003cp\u003eNNAP National Neonatal Audit Programme\u003c/p\u003e \u003cp\u003eNoMAD Normalisation Measure Development survey\u003c/p\u003e \u003cp\u003eNPT Normalisation Process Theory\u003c/p\u003e \u003cp\u003eRTAI Retrospective think aloud interview\u003c/p\u003e \u003cp\u003eSSI Semi-structured Interview\u003c/p\u003e \u003cp\u003eUK United Kingdom\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cem\u003eEthics approval\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval granted by the University of Southampton (ERGO:\u0026nbsp;25154) and Health Research Authority approval was granted through the Integrated Research Application System (ID: 208128). Informed consent was obtained from all participants including for the use of anonymised quotations.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eConsent for publication\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAvailability of data and materials\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and analysed during this study are available from the corresponding author on reasonable request. Detailed analysis frameworks are available in the University of Southampton Institutional Repository [https://eprints.soton.ac.uk/452408/]\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eCompeting interests\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eFunding\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eVP received funding from the Royal College of Nursing Professional Bursary scheme. The Royal College of Nursing was not involved in the\u0026nbsp;conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript. MJ salary is supported by the NIHR Biomedical Research Centre Southampton.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAuthor contributions\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eVP, MJ and JP designed the study described in this paper. VP collected and analysed the data. MJ, JP and KH oversaw data analysis. VP drafted the original manuscript. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAcknowledgements\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank all the healthcare professionals who participated in this study.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eElwyn G, Wieringa S, Greenhalgh T. Clinical encounters in the post-guidelines era. 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Decreasing Central Line-associated Bloodstream Infections Through Quality Improvement Initiative. Indian Pediatr. 2018;55(9):753\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSmaggus A, Safety-I. Safety-II and burnout: how complexity science can help clinician wellness. BMJ Qual Saf. 2019;28(8):667\u0026ndash;71.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSuresh GK, Edwards WH. Central Line\u0026ndash;Associated Bloodstream Infections in Neonatal Intensive Care: Changing the Mental Model from Inevitability to Preventability. Am J Perinatol. 2012;29(1):57\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Implementation science, neonatal intensive care, central line-associated bloodstream infections, infection prevention","lastPublishedDoi":"10.21203/rs.3.rs-3952357/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-3952357/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eTranslating evidence into practice has been notoriously difficult within the field of infection prevention and control (IPC). Care bundles- a form of complex intervention with multiple interacting components, may reduce neonatal CLABSIs by 60%. However, it may be unclear if it is the bundle, the implementation process, or a combination of both, that results in CLABSI reductions. Therefore, understanding what works, how it works, and in what settings, is important to improve the translation of evidence into practice. The aim of this study was to investigate the implementation of a care bundle aimed at reducing CLABSIs in a UK neonatal intensive care unit (NICU).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA mixed-methods, focused ethnography design underpinned by Normalisation Process Theory. Normalization MeAsure Development (NoMAD) surveys, observations of practice with retrospective, dyadic think aloud interviews, and semi-structured interviews were used to investigate implementation. CLABSI rates and bundle adherence rates were collected. Data analysis used descriptive statistics and thematic analysis.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe introduction of a care bundle into a tertiary UK NICU did not result in sustained reductions in CLABSIs, despite apparent increases in bundle adherence. There was only partial bundle implementation, with minimal changes in survey scores and influences across individual, team and organisational levels moderating bundle adoption. Local organisational culture sometimes undermined implementation efforts. Ultimately, there were challenges relating to reinforcement and endorsement of the bundle. Recommendations to improve bundle adoption include improving reinforcement, building in accountability, and improving collective knowledge management.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eThe introduction of a care bundle into a tertiary UK NICU did not result in sustained reductions in CLABSIs, which is one of few negative studies. Understanding the mechanisms by which an intervention works (or not) in specific contexts is important to optimise the delivery of evidence-based care.\u003c/p\u003e","manuscriptTitle":"Investigating the implementation of a complex intervention to reduce central line-associated bloodstream infections in the Neonatal Intensive Care Unit, using Normalisation Process Theory","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-02-29 16:01:25","doi":"10.21203/rs.3.rs-3952357/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9a5d06cc-15a3-4421-88d9-76a6aab7fee0","owner":[],"postedDate":"February 29th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2024-07-27T03:29:34+00:00","versionOfRecord":{"articleIdentity":"rs-3952357","link":"https://doi.org/10.1016/j.jnn.2024.07.026","journal":{"identity":"journal-of-neonatal-nursing","isVorOnly":true,"title":"Journal of Neonatal Nursing"},"publishedOn":"2024-07-01 03:29:33","publishedOnDateReadable":"July 1st, 2024"},"versionCreatedAt":"2024-02-29 16:01:25","video":"","vorDoi":"10.1016/j.jnn.2024.07.026","vorDoiUrl":"https://doi.org/10.1016/j.jnn.2024.07.026","workflowStages":[]},"version":"v1","identity":"rs-3952357","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-3952357","identity":"rs-3952357","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}