The influence of organizational context on quality improvement and patient safety efforts in infection prevention: A multi-center qualitative study

Social Science & Medicine 71 (2010) 1692e1701

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Social Science & Medicine journal homepage: www.elsevier.com/locate/socscimed

The influence of organizational context on quality improvement and patient safety efforts in infection prevention: A multi-center qualitative study Sarah L. Krein a, b, *, Laura J. Damschroder a, Christine P. Kowalski a, Jane Forman a, Timothy P. Hofer a, b, Sanjay Saint a, b a b

VA Ann Arbor Healthcare System, HSR&D (11H), 2215 Fuller Road, Ann Arbor, MI 48105, United States University of Michigan, Department of Internal Medicine, Ann Arbor, MI, United States

a r t i c l e i n f o

a b s t r a c t

Article history: Available online 28 September 2010

Patient safety is a healthcare priority worldwide, with most hospitals engaging in activities to improve care quality, safety and outcomes. Despite these efforts, we have limited understanding of why quality improvement efforts are successful in some hospitals and not others. Using data collected as part of a multi-center study, we closely examined quality improvement efforts and the implementation of recommended practices to prevent central line-associated bloodstream infections (CLABSI) in U.S. hospitals. We compare and contrast the experiences among hospitals to better understand ‘how’ and ‘why’ certain hospitals were more successful with practice implementation when taking into consideration specific aspects of the organizational context. This study reveals that among a number of hospitals that focused on implementing practices to prevent CLABSI, the experience and outcomes varied considerably despite using similar implementation strategies. Moreover, our findings provide important insights about how and why different quality improvement strategies might perform across organizations with differing contextual characteristics. Published by Elsevier Ltd.

Keywords: USA Quality improvement Hospital Patient safety Infection prevention Qualitative research

Introduction Over the last decade, the long-standing effort to improve patient safety has become a priority on the health policy agenda and most hospitals are engaged in numerous activities to improve care quality, safety and outcomes (IOM, 1999; WHO, 2008). Despite these efforts we have limited understanding of why quality improvement efforts are successful in some hospitals and not others or, when successful, how different quality improvement strategies might contribute to the observed outcomes (Benn et al., 2009; Grol, Bosch, Hulscher, Eccles, & Wensing, 2007; Ovretveit et al., 2002). A systematic review of nine studies of quality improvement collaboratives identified improvements in some but not all of the target outcomes in seven studies and there were no significant effects in two studies (Schouten, Hulscher, van Everdingen, Huijsman, & Grol, 2008). These results raise questions about the extent to which the collaboratives were responsible for improvements, potential determinants of success, and whether some organizations might respond better than others to this type of

* Corresponding author. VA Ann Arbor Healthcare System, HSR&D (11H), 2215 Fuller Road, Ann Arbor, MI 48105, United States. Tel.: þ1 734 845 3621. E-mail address: [email protected] (S.L. Krein). 0277-9536/$ e see front matter Published by Elsevier Ltd. doi:10.1016/j.socscimed.2010.07.041

intervention (Schouten et al., 2008). The marginal overall success of other quality improvement strategies, such as audit and feedback, raises similar questions (Grimshaw et al., 2004). The mixed success of quality improvement efforts has increased appreciation of organizational complexities and processes that influence the implementation of evidence-based practices in health care settings (Benn et al., 2009; Grol et al., 2007; Lukas et al., 2007; Pawson, Greenhalgh, Harvey, & Walshe, 2005). Yet, few studies have gone below the surface to examine these complex organizational factors. In “Organizing for Quality”, Bate and colleagues (Bate, Mendel, & Robert, 2008) suggest that one reason for the continuing lack of understanding of quality variation within and between healthcare systems has been the traditional focus on identifying ‘what’ works rather than ‘how’ or ‘why’ something works. With this in mind we use data collected as part of a mixedmethods study to closely examine quality improvement efforts and the implementation of recommended practices to prevent central line-associated bloodstream infections (CLABSI) in United States (U.S.) hospitals. Specifically, we identify CLABSI prevention practices implemented by each hospital, the quality improvement or implementation strategies employed to promote practice use, and the organizational context in which these activities occurred. We then compare and contrast the experiences among hospitals to better understand ‘how’ and ‘why’ certain hospitals were more

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successful with practice implementation. Our objective is to provide insights about which quality improvement activities have the greatest likelihood of success, given the organizational context, for improving the quality and safety of health care in U.S. hospitals. Methods Design and setting This study is part of a larger multi-center project investigating the prevention of hospital-acquired infections by U.S. hospitals (Krein et al., 2006). The project started with a survey to identify what practices hospitals were using to prevent hospital-acquired infections, followed by qualitative interviews and site visits to understand why hospitals were using certain practices and not others. The survey, conducted in May 2005, was sent to a random sample of U.S. general medical/surgical hospitals with 50 beds and an intensive care unit (ICU) (n ¼ 600) and to all Department of Veterans Affairs (VA) medical centers (n ¼ 119). Survey data were then used to purposively select 14 hospitals for qualitative interviews, based on use or non-use of key practices to prevent hospital-acquired infection and maximum variation of other relevant variables (e.g., VA or non-VA facility, academic affiliation) (Sandelowski, 2000). Using a conceptual framework based on Rogers’ diffusion of innovations (Rogers, 2003), we selected hospitals that reported using multiple recommended prevention practices (i.e., early adopters) and those that reported using few recommended practices (i.e., laggards). Finally, 6 of the 14 hospitals were selected for site visits to better understand local context and to explore further the themes identified in our ongoing analysis. Institutional review board (IRB) approval was obtained from the VA Ann Arbor Healthcare System as well as the local IRB for each of the hospitals that were visited. Data collection For this paper we focused on the six hospitals at which we conducted site visits since we had the most comprehensive information about these facilities. In addition to the survey data, we conducted a total of 38 semi-structured telephone interviews and 48 in-person interviews with personnel at these hospitals between July 2005 and October 2007. We interviewed the lead infection preventionist, than used snowball sampling to identify additional interviewees who were involved in decisions related to the use of at least one of our practices of interest. Additional interviews were conducted over the phone with hospital epidemiologists, ICU nurse managers, ICU physician directors and front-line clinicians. These interviewees were asked to identify which practices their hospital uses (or does not use) to prevent CLABSI, ventilator-associated pneumonia and catheter-associated urinary tract infection and to discuss in detail the process that led their organization to use (or not use) those practices. The site visits included interviews with senior executives, mid-level managers, and front-line clinicians, tours of each facility, and informal observation and interaction with staff. Data collected from the survey and the phone interviews and site visits were used to identify which prevention practices hospitals were using to prevent CLABSI, the implementation strategies they employed, and to characterize each hospital based on key contextual domains. Use of practices to prevent CLABSI In the survey, we asked how often certain infection practices were used (1e5 scale; 1 ¼ never; 5 ¼ always) and considered a response of 4 or 5 as indicating that the hospital regularly used that practice (Krein et al., 2007). We focused primarily on practices

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identified in published guidelines (O’Grady, 2002), which include use of: 1) maximal sterile barrier precautions (MSB) during central line insertion; 2) chlorhexidine gluconate (CHG) for site antisepsis; 3) antimicrobial central venous catheters; and, 4) a chlorhexidineimpregnated sponge (BiopatchÔ) placed around the catheter at the insertion site. We verified practice use, identified any additional practices or changes in practice use and collected detailed information about implementation during phone interviews and site visits. Implementation strategies and organizational context Qualitative interviews and site visits were our primary sources of information for identifying strategies used to implement CLABSI prevention practices and for characterizing organizational context. Of specific interest were the quality improvement or implementation strategies that are commonly described in the quality improvement and implementation science literature (Greenhalgh, Robert, Macfarlane, Bate, & Kyriakidou, 2004; Grol et al., 2007). These include externally-initiated activities, such as quality improvement or infection prevention collaboratives that often involve the use of practice bundles (e.g., Institute for Heathcare Improvement (IHI), Keystone ICU) (Berwick, Calkins, McCannon, & Hackbarth, 2006; Pronovost, 2008) as well as (or in combination with) internally-initiated strategies often motivated by local champions (Greenhalgh et al., 2004). Most quality improvement strategies described in the literature are focused on individual behavior and/or organizational-level change. Likewise, many recommended CLABSI prevention practices involve behavior change, such as use of MSB, which requires that clinicians change catheter insertion processes. However, some practices entail the use of new technology (e.g., antimicrobial central venous catheters) and are primarily a purchase decision or technology-based change. Our characterization of the organizational context surrounding practice implementation emerged as part of the qualitative analysis as described below. Analysis Analysis of the survey data focused on what practices each hospital reported using to prevent CLABSI and was used to provide an initial characterization of the site as well as select sites for the subsequent qualitative phases of the study (Sandelowski, 2000). Using a content analysis approach, we conducted descriptive qualitative analysis of interview transcripts, concurrent with data collection. Members of the study team met frequently to discuss and develop emerging themes (Patton, 2002). Given the complex nature of our data, the analysis was conducted using a group consensus approach to strengthen validity of our findings (Forman & Damschroder, 2008). Three of the key themes that arose inductively from the data were: 1) leadership, culture and resources; 2) people issues; and, 3) champions. Four team members, each focusing on one of these themes, independently constructed a summary for each of the six sites, and led a discussion in which the team debated and challenged preliminary findings and underlying evidence to refine each summary. These summaries were combined to form a comprehensive description of the prevention practices used, implementation strategies, and organizational context for each site. During the course of our analysis we found that the common organizational challenges to organizing for quality described by Bate and colleagues (Bate et al., 2008), corresponded with our results and provided a useful interpretive framework for our findings. These challenges are grouped into six organizational

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domains: structure, politics, culture, education, emotions, and physical or technological infrastructure. Four of these domains (structure, politics, culture and emotions) were closely aligned with our key themes (leadership, culture and resources; people issues; and champions). Thus, for the remainder of our interpretive work we used these four domains. Structure refers to the elements that influence planning and coordinating quality improvement efforts, such as leadership and resources. Politics refers to relationships within the organization, particularly in negotiating and establishing buy-in and engagement by stakeholders. Culture refers to the shared mindset, common mission or values espoused throughout the organization. The emotional component refers to the degree of commitment and passion for the organization and its mission. During our interpretive phase, each team member independently characterized each hospital along these four organizational domains based on our previous qualitative analysis findings. We recorded our assessment of each hospital for each domain using a simple positive (þ), negative () or mixed (þ/) scoring system with supporting data. These scores were derived through team deliberations using a consensus-based approach. We characterized all six hospitals that we visited. However, because of space constraints, our results focus on three contrasting cases that we present as exemplars to illustrate implementation experiences across sites with differing organizational context.

Results General site characteristics, practices used to prevent CLABSI, and implementation strategies the hospitals employed are shown in Table 1. All of the sites reported using MSB and CHG at some point during the study timeframe. The use of chlorhexidine during insertion was generally introduced at the same time as MSB; thus, these two practices are combined. Three sites used the BiopatchÔ

and two used antimicrobial catheters to prevent bloodstream infections. Most of the study sites used a mix of implementation strategies. Local champions played key roles in implementing prevention practices in all but one site. Three sites identified their participation in an infection prevention collaborative as contributing to practice use, particularly in implementing MSB. Three sites also used a purchase or technology-based strategy e either alone or along with other initiatives. Table 1 shows the summary scores characterizing the context at each site, while Table 2 provides additional quotations that support these characterizations for sites AeC (quotations for sites DeF are in the Appendix). There was considerable variability in context across sites, ranging from those that scored positively along all domains to those that were generally negative across all domains. For example, Site A had significant structural, political, cultural and emotional challenges, whereas Site B exhibited positive emotion, cultural cohesion, was strong and aggressive politically, and had considerable supporting resources for implementation efforts. Other sites had a mix of negative and positive contextual features. Of greatest interest, however, is how local context affected implementation of CLABSI prevention practices, which we illustrate with three contrasting cases.

Site A Site A, a small hospital with approximately 100 beds, was struggling to emerge from a substantial budget deficit that was blamed on mismanagement by a recently “out-placed” facility leader. The infection prevention program included two full-time equivalent (FTE) infection preventionists, and a hospital epidemiologist, but through much of the study period only one infection preventionist was on staff. Thus, not only were significant structural issues, including a lack of effective leadership and resource constraints, identified as major barriers to

Table 1 Organizational context, implementation strategies and use of practices to prevent central line-associated bloodstream infections. Hospital

A Small urban

B Large suburban

C Large urban

D Small urban

E Large urban

F Medium urban

a

Organizational contexta

 Structure e Politics e Culture e Emotion þ Structure þ Politics þ Culture þ Emotion þ/ Structure þ/ Politics þ Culture þ Emotion þ Structure  Politics þ Culture þ Emotion  Structure  Politics  Culture þ/ Emotion  Structure  Politics  Culture e Emotion

Central lineeassociated bloodstream infection prevention practices Maximal sterile barrier precautions (MSB) plus chlorhexidine gluconate (CHG)

Antimicrobial central venous catheter

BiopatchÔ

 Collaborative

 Technology/purchase

 Technology/purchase  Champion

 Technology/purchase  Champion

 Technology/purchase  Champion

 Champion  Collaborative

 Champion

 Champion

 Champion

 Collaborative

, þ and þ/ denotes the score on the specified domain as generally negative, positive or mixed.

 Technology/purchase  Champion

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Table 2 Example quotes for determining organization context in each domain for sites A, B and C. Domains

Site A

Site B

Site C

Structure (Coordination, resources, leadership)

[A major barrier to implementing evidence-based practices] “Getting people coordinated; who’s going to do it, who’s going to spearhead it, who’s going to monitor it.” [Infection Preventionist]

“.our administration has understood that.if we expect people to participate in certain venues, we need to recognize their time financially.so I have a separate budget for clinical, education, research, and administrative work.” [Chief of Medicine]

Politics (Relationships and engaging stakeholders)

“.it’s better received if it comes from the top down.” [Infection Preventionist]

Culture (Shared mission and values)

“.traditional, ‘this is how we always did it’ attitude.” [Director Medical Intensive Care Unit]

Emotion (Commitment and passion)

“We’re probably not implementing all these practices the way we should. I think we say we are but it’s a fantasy.it is too loose and I think the reason it’s so loose is it’s not clear to me that anyone here took charge of it with any vigor.” [Chief of Medicine]

“.key players with that was our medical director of the intensive care unit and one of the nurse managers from the ICU, very strong individuals that said, ‘We’re doing this.’” [Infection Preventionist] “We is everybody involved in the care of the patient.the intensivist sees every patient every day.the nurses are part of this, we, the residents are part of this, we, the patients and people that touch the patient are part of the care of the patient.” [Critical Care Medical Director] “.my philosophy has always been, what if it’s your mother, your father, your brother, we always want the best care for those that we love and try to bring that point home to everyone.” [Infection Preventionist]

“.all the budgets are interconnected and basically everybody is barely squeaking by [yet] everybody gets along well.we don’t always agree but when we disagree, we disagree amiably and usually still manage to make some progress.” [Hospital Epidemiologist] “This is a very egalitarian place.in general, we work together and that’s how we get things done.” [Chief of Staff]

implementing evidence-based practices, but these issues seem to have contributed to an emotional void. As one physician leader said: “Everybody is in their survival mode, the wagons are in a circle.” The political atmosphere was described as “entrenched” by several interviewees, which presented a challenge when introducing new practices. As one physician described: “We’ve been doing it this way for a long [time].that’s the way we’re doing it and we don’t have to change and you’re going to make us do extra work.”

“.people don’t settle for second best. They want it to be the best here; whether or not it’s the medical students or the residents or the attendings or the administrators. Everybody wants things to be the best.” [Chief of Staff] “.there’s a lot of energy and enthusiasm because it’s not always the easiest patients to work with and it’s in a relatively resource poor setting.” [Hospital Epidemiologist]

collaborative. In describing the collaborative, one physician stated: “I think that [the collaborative] was a starter.a big motivator for us to say okay, we’re trying to get ourselves to the same standard as everyone else’s standards.it tells people that we’re being watched as opposed if it’s an internal issue.” The fact that changes were made primarily in response to external forces appeared typical for this institution, as one interviewee noted:

Moreover, the culture at Site A is best characterized as fragmented. The interviews revealed an inconsistent description of organizational purpose or mission, and, according to a quality manager:

“I’ve seen things here that when they’re higher up the chain or at the front office, when things come down that say just do it, there’s grumbling.but it’s getting done.”

“.it sometimes can be very difficult to get people on the same definition of the mission.I mean, well ‘mission’ might come one or two below their own self interest.”

Nonetheless, despite the motivation and expert assistance provided by the collaborative, Site A reported ongoing challenges with implementing MSB. As observed by the infection preventionist:

Survey data showed that the site was using MSB, CHG, BiopatchÔ, and antimicrobial catheters. Thus, we initially viewed Site A as an early adopter for what appeared to be an aggressive approach to prevent CLABSI; however, subsequent qualitative data revealed significant problems with practice implementation and sub-optimal infection prevention results. Specifically, Site A did not have a coherent strategy for preventing CLABSI. They had been using antimicrobial catheters for many years, but the circumstances that led to their use was unclear. Site A was also in the process of implementing MSB as an infection prevention measure. However, while one interviewee noted that “the coated catheters didn’t work”, no one identified the perception that their bloodstream infection rates were still too high as motivation to implement MSB. Rather, the impetus was external, and came from participation in a community-wide

“.you should see a decrease by 50% in your line infections and that didn’t happen with us.We have not quite figured out what’s going on.” With further probing the infection preventionist revealed one possible explanation for their lack of success: “.we never got the backing monetarily or time wise, we didn’t get anybody to have their other duties relaxed so they could do this.” This lack of staff and time fostered an inability or lack of capacity to take on a new initiative. As a physician leader noted: “.we’re cutting staff and all I get every day from management is asking for more pieces of paper.and nursing is the same way.If we say, ‘here’s your new checklist for your process’

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they’re going to say, ‘And who’s going to fill this out?’ That’s a big barrier.”

the quality and safety of patient care. As one interviewee explained:

An additional explanation for the challenges in implementing MSB and reducing infection rates was that the site was also a hostile environment for potential champions, who may want to implement new practices. In fact, as explained by a physician:

“Our quality initiatives come at the highest level, from the present CEO of the system .he’s a big believer and he supports them”

“ .everyone thinks when they label you as a champion, everyone automatically thinks oh more work, more problems.” The only practice that was successfully “championed” at Site A was the BiopatchÔ. As described by one interviewee: “The BiopatchÔ was really championed by two people.one of the primary nursing staff on the IV Therapy Team as well as one of the infection control practitioners here.They were very strong proponents.” However, the BiopatchÔ does not, generally, require significant changes in behavior or established patterns of practice, and encountered little active resistance. As the hospital epidemiologist explained: “.I don’t know that I was convinced by the data [on the BiopatchÔ] but they felt very strongly, wanted to be very proactive about line infections,.and I don’t want to deflate that enthusiasm because I think it’s directed for the right purpose.” In summary, Site A had a decidedly negative organizational context: lack of a cohesive culture and emotional exhaustion, coupled with a lack of resources, contributed to the poorly reasoned and ineffective use of several practices for preventing CLABSI. While external facilitators such as a collaborative may have helped to promote practice use, it was not sufficient for Site A to overcome barriers, inherent in the organization, to successfully implement use of MSB. Moreover, constrained resources, specifically the human capital required for implementing a primarily behaviorally-driven practice proved to be a major barrier. On the other hand, resource constraints did not impede the use of the antimicrobial catheters, which are generally more expensive than the non-coated catheters, and the money required to purchase a specific technology was viewed as less of a barrier than the staff and time required for changing behavior. Despite these difficulties, however, organizational context is dynamic. By the time of the site visit, new leadership and organizational changes were underway at Site A, which appeared to be having a positive effect. As one interviewee noted: “.the change in personnel has made a big difference for me. There’s been a new chief.new directors .and they’ve all come in with more workable attitudes.”

Site B Site B is a large suburban hospital with over 500 hospital beds and more than 50 ICU beds. At the time of the study, the hospital was financially sound but had experienced frequent changes in leadership: “.we’ve been through lots of changes. in leadership it’s just basically who’s on first. Ten years that I’ve been here, I think I’ve seen five presidents.” However, this turnover did not appear to have a particularly negative effect on the site, and was perhaps countered by support from the larger healthcare system of which they were a part, and a cultural identity based on a unified commitment to

This spoken commitment to quality and safety was supported by the resources invested, with over 4 FTEs devoted to infection prevention. Interviewees exhibited strong positive emotions about the site and a passion for good patient care. For example, while talking about the hospital epidemiologist and the infection prevention program, the infection preventionist explained: “.it’s all about the safety of the patient; not getting caught up on the politics and bureaucracy of it, just saying, ‘Okay, let’s figure this out. Let’s make this work.’ That in itself energizes us.” Another striking characteristic of Site B was the power of physician leadership, as exemplified by the critical care medical director who unequivocally stated “.it’s our way or byeebye.” However, rather than creating a toxic political climate that stifled innovation or collaboration, this philosophy provided a strong, unifying force that promoted quality and evidence-based improvement: “.we have a very large group of assertive and aggressive intensivists.a lot of these things [infection prevention practices].were implemented through them.” Survey data from Site B suggested that the site was not regularly using MSB, CHG, BiopatchÔ or antimicrobial catheters, resulting in an initial characterization as a laggard. However, as with Site A, we quickly learned that this characterization was inaccurate, and while these examples were extreme cases of misclassification they shifted our focus from the number of practices used to the general approach to CLABSI prevention articulated by the site (e.g., using an incremental strategy whereby additional practices are added if infection rates do not decline). During our interviews we discovered that Site B had initiated the use of MSB and CHG after reviewing Centers for Disease Control and Prevention (CDC) guidelines for preventing CLABSI. As described by the infection preventionist: “We took a look at those guidelines [from the CDC].did a gap analysis and we identified several things that we weren’t doing and so working with the medical directors in our intensive care unit.we wrote up the proposal based on the CDC guidelines on this is what we want to do.[to] reduce infection at our institution. And then.it was accepted at our corporate level.” Thus, the initial push to use these practices was internally motivated, and championed by several individuals working together, including an infection preventionist and ICU medical director, and was supported by the system leadership. There was strong and visible support from both physician and nurse leaders for implementing the requisite changes in practice. Along with the nurse managers, the critical care medical director supported and expected the nurses to stop the insertion if the proper procedures were not being followed. He explained: “.you put a line in.you cannot use betadine, got to use the chloro-prep [CHG]. You have to have a full drape, gotta have a mask on, gotta have a hat on, gotta have a gown on [MSB]. Everybody in the room has to have a hat on, has to have a gown on.No hat on and a mask on? The nurses can tell the residents, ‘You cannot do the line. You’re not ready.’

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Occasionally, you’ll have a timid nurse but we tell the nurses, ‘We support you 100%’ [to stop the procedure].[so] unless it’s an unbelievably emergent line, you have the director of the ICU’s support that I will come in and rip them a new one, just as you should.” The critical care medical director also was credited with getting other physicians on board to facilitate implementation elsewhere in the hospital, including the operating room and emergency room (ER), while the infection preventionist played a key role by negotiating with a vendor for a “custom central line kit” and by adapting the process to fit the environment: “ER is somewhat of a chaotic environment and tight for space, they didn’t have room to store central line carts.so we had to figure out their whole process on how do you get supplies .So, we package it for them now.the sterile gown, a cap, and the mask, go into a gallon sized Ziploc bag with the checklist in there and it is right next to the central line kit.” In addition to having strong internal champions, the hospital also participated in infection prevention collaborative efforts, including a statewide initiative that e according to some interviewees e provided additional support for implementing certain practices. “I think the collaboratives are important from the standpoint that you get your CEO’s attention. You get all of the people at the top because there’s some dollars associated with this. You get their attention and it becomes important and they say you will do this and we will direct resources your way or we’ll provide this, we’ll support you.” However, external recommendations and participation in externally-initiated activities were carefully scrutinized. As a physician leader described: “We have had some discussion for example about the sepsis bundle that was being pushed.and that was one that I was very concerned about.there’s a lot that can come from the top down and I think that we need to look at those and really take a stand on some of those that we think are difficult.” Unlike Site A, Site B took a reasoned and cautious approach when deciding what practices to employ to prevent infection. For example, when asked about the use of antimicrobial catheters and the BiopatchÔ the infection preventionist explained: “ Our ICU committee.had wanted to go to [antimicrobial catheters].I wasn’t convinced that that was going to solve our blood stream infection problems. these guidelines are saying that we should be using chlorhexidine gluconate.we should be doing maximal sterile barrier precautions.[but] we’re not even doing these things.why would we jump to antimicrobial catheters and really bump the price up of implementing things when we could just do some basic things.so when we implemented this [MSB and CHG] and we saw the decrease that we saw, we didn’t see that we needed to go the extra step to an antimicrobial catheter. I mean a BSI in our ICU is a rare event.” In summary, Site B had a positive organizational context consisting of strong leadership support, staff time, and other resources; an aggressive political environment; a cohesive culture that was strongly supportive of quality improvement; and passionate emotional commitment to the site and to improving patient care. These characteristics combined to foster engaged and active champions who successfully implemented a behaviorally based infection prevention approach to CLABSI. Within this positive context, externally-facilitated activities, as promoted by a quality

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collaborative, were carefully evaluated and then embraced when they opted to participate. Moreover, despite the successful reduction in CLABSI, Site B continued to strive to be the best: “Nobody’s going to sit back and be comfortable. You’re going to push one another to go to that next level because having value and feeling like you make a difference is what makes you happy in your work.”

Site C Site C is a large, urban, public hospital with significant resource constraints. It is most notable for its passion and commitment to the patients it serves, many of whom are indigent. As the Chief of Staff explained: “.everybody who’s here, loves being here.no matter if you’re OB [obstetrics] or you’re psych or you’re surgery or medicine.they love to make a contribution because they get a chance to make a difference in peoples’ lives.” This commitment established a shared mission for the site with everyone working together to “.make sure that patients are cared for appropriately” The high level of emotion and strong culture at Site C were tempered, however, by resource and political challenges. For example, the hospital had only one infection preventionist for an extended period of time, thus being significantly understaffed for a facility with over 500 operating beds. Administrators were aware of the problem but had difficulty with hiring due to their inability to offer a competitive salary and political challenges associated with a dual administrative structure: “We are two administrations under one roof and we are two groups that have somewhat different priorities. The [government’s] job is to take care of people. The university’s priorities are research, teaching, and patient care, I think in that order .” These challenges were further compounded by a budgeting process, which as described by the Chief of Staff, was largely out of their control: “.so you have to get all the players in the room, you got to get the buy-in from the administration, you’ve got to have nursing on board, you’ve got to have everybody say, ‘.we need to have this thing done’ and then it has to stay on the high priority list because it can.[be] gutted out of the budget.at any time by the people who are downtown.” So, even with strong leadership and committed clinicians, there were structural circumstances that, according to some interviewees, confined the upper limits of their capacity for excellence. As described by a Quality Manager: “.we do very good with what we have, because of the strength in the individuals and their conscientiousness and I think that’s all we’re ever going to be able to do, given our environment, but we still strive for excellence and we still like to think of ourselves as being excellent.we’re as good as we can be.” Survey results indicated Site C was using MSB, CHG and the BiopatchÔ and therefore the site was classified as neither an early adopter nor a laggard but a typical case among hospitals of similar size and academic affiliation. During the interviews we learned that antimicrobial central venous catheters were also being used for some patients.

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Although Site C was participating in externally-initiated activities as part of a collaborative, the focus was not on CLABSI. Moreover, the hospital epidemiologist, while not completely opposed did express reservations about the collaborative approach and use of practice bundles:

BiopatchÔ and antimicrobial catheters) were being used. When asked about cost, all interviewees acknowledged that it was a consideration, but also noted that those involved in purchasing decisions could be convinced, given a reasonable argument for why something should be purchased, as described by the hospital epidemiologist:

“I have mixed feelings about some of the IHI [Institute for Healthcare Improvement] bundles.I think that we need a person who’s dedicated to doing it . [and] we just haven’t had the resources to do that.some of these things are really well meaning and I’m sure it will do good.but I’m not all that excited about the all or none bundle phenomenon when not everything in it is.completely evidence-based.”

“Cost is very important.but many of the things that we want to push through have sort of cost effectiveness data in the literature.if it’s for a new device, usually you can figure that out without too much difficulty.that what you’re trying to prevent [the infection] is fairly expensive and not rare. And so making a reasonable case that cost is important.”

While it was clear that participation in a quality collaborative was not a key driver for instituting the use of MSB and CHG at Site C, we heard varying accounts of how these practices were introduced and the degree to which they were being used successfully. One consistently identified key element was a peripherally-inserted central catheter (PICC) nurse who championed the use of these procedures for PICC insertions, and was a strong motivating force in the use of MSB and CHG during central venous catheter insertions throughout the facility. She also championed the use of the BiopatchÔ. Almost everyone interviewed identified the PICC nurse as a champion when it came to preventing CLABSI at the hospital. For example, the hospital epidemiologist said: “.our PICC nurse is [a].very dynamic and enthusiastic individual and she really wants PICC rates of infection to be zero.she does lots of training for the nurses, everyone knows her.she’s actually the type of person who will come to infection control committee and if we say that sounds good to us, then she’ll bump it up to nursing executive committee and medical executive committee and so then the changes get made and people will be convinced it’s a good thing.” Although not directly involved in the insertion of other central lines, the PICC nurse also contributed to the use of MSB as it began to diffuse into other units in the hospital and played an integral role in introducing chlorhexidine for insertion site antisepsis. As she described: “Oh they were still practicing with Betadine, I went to the cath lab.and I said-‘You’ve got to get the chlorhexidine [CHG] here’.I got the chlorhexidine people to come and meet with the cath lab people and.the one who purchases for the hospital.I showed her the CDC [guidelines]. It was enough for her.and I got it in hospital right away. Until I started doing PICC lines, chlorhexidine was not used in this hospital. I brought it into the hospital.” However, despite her many successes and the high-esteem in which she was held, the PICC nurse expressed ongoing difficulty with instituting practices that required behavior changes, which in her opinion was related to a significant lack of respect by some physicians. “They see me as a pest. I’m not talking about the new, young, non-surgical physician.but the surgical physicians are just sometimes unbearable. they [surgeons] don’t do maximum barrier, no.They do minimal barrier. Oh I tried, I walked into a room and I said, this is shameful. Now I see why you guys have such a high infection rates on central lines.I get invited by the non-surgery family practice and medical staff to give talks about PICC lines and central lines.teach them some stuff about it but.never the surgeons.” Given the substantial resource constraints at the site, it was a bit surprising that two purchase or technology-based strategies (i.e.,

In summary, Site C exemplified a mixed organizational context. While the political and structural domains included both positive and negative elements, this hospital displayed a strong and cohesive cultural identity, dedicated commitment to patients, firm belief in social justice, and an emotional commitment to these values. Nonetheless, there were some underlying tensions, which along with the dual administrative structure and associated misalignment of priorities, might have made certain types of change more difficult. Moreover, resource constraints played a role in defining the available infrastructure and even attitude about what could be accomplished for improving quality. However, the context was favorable for dedicated champions and supported a general willingness to participate in activities that were externally-initiated through a quality improvement collaborative. Furthermore, despite heightened attention to cost and budgetrelated pressures, there was a tendency toward purchase-based changes and recognition that changing behavior was not always an easy proposition. Finally, in support of our initial impression of the site as neither an early adopter nor laggard, the hospital epidemiologist stated: “.our general philosophy is you don’t necessarily want to be the first person to be doing everything because not every new practice is right or helpful but you probably don’t want to be the last person either.” Discussion Identifying and effectively implementing practices to improve quality and safety in health care is a clear priority (IOM, 1999; WHO, 2008). However, in addition to focusing greater attention on identifying what works (e.g., comparative effectiveness) we also need to better understand when, how, or even which practices and implementation strategies might work given the organizational context (Dougherty & Conway, 2008; Rycroft-Malone et al., 2009). Our results show that among a number of hospitals that focused on preventing CLABSI, despite using similar implementation strategies the experience and outcomes of these efforts varied considerably given the organizational context. Hospitals with a positive emotional and cultural context, as evidenced by strong emotional commitment to patients, a unified culture focused on patient care, and active and engaged clinical leadership (e.g., Sites B and C), appear especially conducive for fostering and encouraging internally motivated initiatives. Activities promoted through quality collaboratives or other externallyfacilitated efforts may also be successful in these types of organizations, although their contribution to what might already be an effective initiative could be marginal. As such, while the collaborative may help increase the pace of practice implementation, it may not be necessary to get the organization engaged in implementing a new practice. Moreover, such initiatives e if not carefully considered and managed e could work against organizations by diverting resources and impeding necessary changes in other areas.

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In contrast, for hospitals with a negative emotional, cultural and political context (i.e., lack of emotion, weak cultural identity and poor relationships among stakeholders as found in Sites A and F), externally-facilitated initiatives might be effective in providing the motivation, and sometimes resources, needed for implementation. However, this may still not be enough to produce the changes needed to significantly improve outcomes, especially if the practices to be implemented involve behavior changes, and the facility lacks actively engaged clinical leadership and/or dedicated resources to encourage, monitor and ensure adherence. Identifying and supporting champions can also be difficult since those who might rise to the challenge in a more conducive environment may succumb to feelings of futility and frustration in these struggling organizations. These findings are consistent with the theory of organizational readiness for change proposed by Wiener (Wiener, 2009), who posits that organizational readiness for change and the outcome of the change initiative is a function of shared commitment to the change among the organization’s members as well as confidence in their collective ability to implement the change (change efficacy). So, while a collaborative may have increased commitment to change in hospitals such as sites A and F, confidence in the ability to change among the hospital’s members remained low. In this context, other options, including technology-based rather than behavior-based practices, might be considered (Damschroder, 2009; Wiener, 2009); or, it could simply be a matter of time and turnover before effective change can occur. In fact, purchasing new technology appeared to be favored over behavior change by facilities with the greatest resource constraints. A potential explanation for this counter-intuitive finding is that the initial cost of acquiring certain technologies may be deemed more cost-efficient than the costs associated with changing behaviors. Supporting the emphasis on the importance of context in health care settings and implementation research (Benn et al., 2009; Rycroft-Malone et al., 2009; Rousseau & Fried, 2001), our findings highlight the potential impact and the need to measure e or at least consider e organizational context as a source of heterogeneity when evaluating and implementing quality improvement efforts across organizations. Some quality improvement interventions now include an explicit focus on changing certain aspects of organizational context to facilitate practice change (Jain, Miller, Belt, King, & Berwick, 2006; Pronovost, 2008). Given the

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complexity and number of factors that define organizational context, however, we believe that for some situations it may not be feasible to readily change the context and thus we also need to identify potential strategies that might be a better fit with, or tailored to, the current context. While tailoring is not an entirely new concept, its application to date has been limited (Bosch, van der Weijden, Wensing, & Grol, 2007) and additional research is clearly warranted. These results should be interpreted in the context of some limitations. Our intent was to better understand complex organizational issues affecting the implementation of infection prevention practices that can only be uncovered through in-depth analysis, rather than to generalize findings from our study sample to all hospitals. Qualitative methods are ideal for collecting and analyzing the type of detailed information required to more fully understand how different settings operate (Patton, 2002). Because such analyses are resource intensive, however, we chose to study six hospitals in detail rather than do less in-depth evaluation with a larger sample. Nonetheless, the richness of the information provided, including details of settings that were studied and discussion about how and why certain quality improvement strategies worked the way they did in each of those settings, provide important insights for implementing change by clinicians and managers who recognize some of the same contextual characteristics within their own hospitals. Acknowledgments The authors would like to thank the hospitals and individuals who participated in interviews as well as Todd Greene and Molly Harrod for their assistance and review during manuscript preparation. This project was supported by the Department of Veterans Affairs, Health Services Research and Development Service (SAF 04031) and the Ann Arbor VAMC/University of Michigan Patient Safety Enhancement Program. Dr. Saint was supported by an Advanced Career Development Award from the Health Services Research & Development Service of the Department of Veterans Affairs while this work was being conducted. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. None of the authors report relevant conflicts of interest related to the content of this manuscript.

Appendix Example quotes for determining organization context in each domain for sites D, E and F. Domains

Site D

Site E

Site F

Structure (coordination, resources, leadership)

“I think that this hospital has resources in terms of both manpower and finances that other hospitals don’t have.” [Nursing Executive] “People provide good quality of care in spite of the system . what I find myself increasingly doing is trying to make a system to patch up the gaps in the system between people who no longer understand the culture or how things are done.” [Chief Infectious Disease]

“There was a service line consolidation that happened a few years ago. an organizational tree was developed which was completely bizarre. it was a circle and so it was unclear who was responsible for what in the circle.and you don’t have people seeing eye to eye between the services.” [Chief General Internal Medicine]

“They [administration] are trying to blend the hospital so that things work more efficiently but it just doesn’t right now. It’s just hard to do things.” [Infection Preventionist] “.management changes so often that you kind of say, “Is it worth working with them because if when you are done you are just going to be starting all over again.” [Chief of Staff] (continued on next page)

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Appendix (continued ) Domains

Site D

Site E

Site F

Politics (relationships and engaging stakeholders

“Well it’s not top down.people really bridle around here when anybody tries to ram something down their throat. I would say that it’s largely laissez faire but that is not an entirely satisfactory situation. . “ [Chief Infectious Diseases] “it’s getting consensus that there is a problem. . Sometimes it’s like corralling cats. .everybody pretends they want to look at the evidence themselves. so there’s a lot of delay as people try to put their own opinions into it.” [Physician]

“I think there’s a hierarchy of open communication. the persons at the point of patient care don’t have the open communication that the chairmen have or the chiefs have. a chain of command type of format.” [Infection Preventionist] “.there’s communication issues between the care lines and the nurse executive office. I just don’t think there’s enough communication going on.”[Nurse]

Culture (shared mission and values)

“. everybody understands that we ought to get things done and we get in there to do it. I’ve been very impressed with the teamwork here.” [Nursing Executive] “I think people are striving to practice evidence-based medicine and.that’s a goal that’s held among our residents and certainly among our physicians and I think among the nurses.” [Director Medical Intensive Care Unit]

“Research is a priority. you know, we had an acting director for awhile and he picked up, he says to all of us,, “You know, you all do some wonderful work here. You do wonderful research, wonderful educators, you forgot the patients”. [Nursing Executive] “.we have a great work ethic here, you know, there’s always exceptions but in general, it’s a strong work ethic here.”[Deputy Director]

Emotion (commitment and passion)

“.this hospital has a visible commitment I think to good clinical care which you don’t always see [in other hospitals],. and I think you can sense it here.” [Nursing Executive] “. there are people out there, I am convinced, who just love taking care of the [patients] and love working here.” [Associate Chief of Medicine]

“There are actually a lot of, what I would describe as fairly dynamic and forward thinking people. . a lot of smart people who want to make change for the better, make the hospital a better place at a variety of levels.” [Physician] “.I think people are just trying to keep their heads above water and I think you know, it’s, seems like people are demoralized because of the ever increasing you know, demands on productivity.” [Chief General Internal Medicine]

“.most people at the administrative level.think we’re going to roll something out and we’ve got a vision here, and people need to do this and that doesn’t match how people respond at the front line.” [Vice President for Quality] “. you just constantly have people changing so you teach one group something and then a new group comes in and then if you have an attending who isn’t on board. then you’re going to go back to the old way with each group that comes in.[Infection Preventionist] “I sometimes think that our hospital is like a bunch of silos altogether in one group because each individual unit is managed a little bit differently.Overall, administration tries to show that we’re all working together and we’re a team and try to be positive in a no-blame kind of culture; whether that’s always true in every case, I can’t say.” [Infection Preventionist] “.my experience here is that the thing that makes the best argument is more reactive.[for example] “we had a bad outcome with a patient”, which is unfortunate.” [Director Medical Intensive Care Unit] “.they [the administration] have this new thing, it’s called “The Right Values” and it’s the way that you treat people and the way you have your customer service., how effective that is to some strong personalities, I don’t know that it is.” [Infection Preventionist]

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