Surgical site infections (SSIs) can be catastrophic for patients Reference Tanner, Padley, Davey, Murphy and Brown1,Reference Merkow, Ju and Chung2 and expensive for hospitals. Reference Anderson, Kaye and Chen3–Reference Badia, Casey, Petrosillo, Hudson, Mitchell and Crosby6 The US Department of Health and Human Services set a goal of reducing SSIs by 30% by 2020. 7 To achieve this goal, healthcare institutions have developed and implemented bundles of evidence-based practices. Reference Kawamura, Matsumoto and Shigemi8–Reference Reese, Knepper, Amiot, Beard, Campion and Young11 However, evidence-based bundles can be difficult to implement and sustain due to complex bundles, patient and process variation, poor compliance, workflow and communication obstacles, and other barriers. Reference Leaper, Tanner, Kiernan, Assadian and Edmiston12–Reference Hockett Sherlock, Goedken and Balkenende14 Qualitative and implementation science approaches provide important perspectives regarding implementation of infection prevention measures, including care bundles.
The Study to Optimally Prevent SSIs in Select Cardiac and Orthopedic Procedures (STOP SSI) tested a bundle that included (1) screening patients for methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA and MRSA), (2) decolonizing S. aureus carriers, (3) giving MRSA carriers and patients whose carrier status was unknown vancomycin and cefazolin as perioperative prophylaxis, and (4) providing chlorhexidine baths for noncarriers. Full adherence to the bundle significantly reduced the incidence of S. aureus among patients undergoing cardiac operations or total hip or total knee arthroplasty at 20 Hospital Corporation of America (HCA)–affiliated hospitals. Reference Schweizer, Chiang and Septimus15
To successfully implement infection prevention bundles like STOP SSI, hospitals must identify factors that enable or obstruct successful bundle implementation. To examine barriers and facilitators of SSI-prevention bundles at diverse hospitals, we interviewed healthcare personnel who played key roles in bundle implementation at 2 hospitals that implemented the full STOP SSI bundle as well as 4 hospitals that implemented similar steps without screening. We analyzed the data using the Consolidated Framework for Implementation Research (CFIR) framework.
Methods
We conducted a qualitative evaluation to examine the contextual factors that influenced bundle adoption and implementation. We purposefully sampled healthcare personnel (HCP) who helped implement the bundle and conducted in-depth, semistructured interviews with 30 HCP (22 at academic hospitals, 8 at community hospitals). We first defined key informant roles as surgeons, laboratory personnel, hospital epidemiologists, infection preventionists, and clinic staff involved in implementation. Relevant staff roles differed across sites, and interview data demonstrated that other processes were important. Therefore, we interviewed a day-of-surgery-admission (DOSA) nurse, a pharmacist, and 2 anesthesiologists to identify further perspectives.
Settings
We interviewed staff at 2 academic, tertiary-care hospitals; 3 academic-affiliated, community hospitals; and 1 unaffiliated community hospital in the US Mid-Atlantic and Midwest regions. Two hospitals implemented the full STOP SSI bundle and 4 hospitals implemented similar steps without screening patients. None of these hospitals participated in the original STOP SSI study. Surgical services varied by hospital but included cardiothoracic surgery, orthopedic surgery, and neurosurgery. To safeguard confidentiality for participants and institutions, we report only the participants’ roles and the hospital type.
Data collection
A medical anthropologist (K.D.) conducted interviews in person or by phone; 29 interviews were recorded and transcribed. The interviewer took detailed notes during one interview because the participant declined to be recorded. We imported transcripts into MAXQDA10, 16 a qualitative data analysis management software.
Data analysis
To conduct thematic analysis, Reference Pope and Mays17 the team employed 2 phases. First, 2 medical anthropologists (K.D. and H.S.R.) read a subset of 4 transcripts and developed a consensus codebook including a priori codes defined by research questions and inductive codes that emerged during analysis. They coded 2 transcripts together to ensure agreement. K.D. then coded the remaining transcripts. Subsequently the team mapped codes in the initial codebook to constructs, or factors, using the CFIR developed by Damschroder et al Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery18 to provide a comprehensive set of constructs distilled from a range of implementation models. Principal CFIR constructs include inner and outer settings, processes, characteristics of the intervention, and characteristics of individuals involved in the intervention. Detailed definitions of all CFIR constructs and subconstructs are available. Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery18 As the team mapped their existing codes onto CFIR constructs, they identified 3 CFIR constructs most relevant to interpreting our data: intervention characteristics, inner setting, and process. Within each of these constructs, we also identified specific subconstructs that were most relevant. We have reported the connection of our results with CFIR constructs and subconstructs in Table 1. Additionally, using CFIR tools, 19,Reference Waltz, Powell and Fernández20 we identified implementation barriers (Table 2) and evidence-based strategies that may assist implementation (Table 3). Reference Powell, Waltz and Chinman21
An Adaptation of the Consolidated Framework for Implementation Research (CFIR) Constructs and Subconstructs Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery18
Note. The constructs and descriptions most relevant to the analysis for this study appear in bold font, along with the theme number in which constructs are discussed. Construct titles and descriptions are by Damschroder et al. Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery18
Reported Relevant Barriers as Framed by the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change (CFIR-ERIC) Barrier Buster Tool version 0.53 19
Twelve Expert Recommendations for Implementing Change (ERIC) Strategies Reference Powell, Waltz and Chinman21
The University of Iowa Institutional Review Board approved the study.
Results
In total, 30 HCP participated in interviews. We identified 3 principal themes about implementation barriers and facilitators; they are discussed in the following sections.
Theme 1. Complexity
The complexity of the intervention impeded implementation. Hardwiring through protocols and order sets as well as clear communication about the bundle itself reduced some barriers (Table 4).
The intervention’s complexity complicated both implementation and sustainment within surgical clinics and across the hospital. Participants noted that bundle fidelity required coordination with multiple hospital areas, including the laboratory and pharmacy, and across inpatient and outpatient domains with different processes for orders and documentation.
Theme 1: The Complexity of the Intervention Itself Impeded Implementation in which Hardwiring Through Protocols and Order Sets, and Clear Communication About the Bundle Itself, Reduced Some Barriers.
Note. Quotes lightly edited for clarity.
Some HCP noted that each bundle step required them to remember to complete multiple processes (eg, check the status of swabs, results, notifications, prescriptions, and prophylaxis). Additionally, HCP reported that approaches to managing the complexity were varied and sometimes individualized, even within a single hospital. This variation made it difficult to ensure intervention fidelity. In addition to the complexity of the bundle itself, some groups within each hospital varied in their ability to implement bundle elements depending on varied rules and flexibility. For example, within one academic hospital, the staff members who were permitted to swab patients’ nares, contact patients about their carrier status, and order mupirocin or perioperative antibiotics varied by surgical service.
Many HCP reported that protocols or electronic order sets helped ensure fidelity across clinics and improved clinical workflow. At some hospitals, the availability and acceptability of order sets and protocols, residents’ or advanced practice providers’ work responsibilities, or access to informatics staff who could revise order sets varied by service. However, some departments could not establish or adapt protocols or order sets. One community hospital used paper-based presurgical orders. In addition, they had to use flexible approaches to overcome barriers. Approaches included advocating for new protocols, adapting other services’ existing protocols, or making another service’s order set a “favorite” in the electronic medical record.
However, bundle processes could be pilot tested and adapted, which facilitated the implementation process. Hospitals tailored processes within the institution and sometimes adapted processes for specific clinics. Several hospitals pilot tested the bundle in one surgical area before extending it to other areas or populations. Adding pieces of the protocol onto existing screening or decolonization processes also facilitated implementation.
The way the intervention was described and presented also affected implementation. One nurse coordinator used a flowsheet to review each patient and to ensure that she had not missed steps, but the fuzzy photocopy used at another hospital confused HCP.
Theme 2. Implementation barriers
Implementation barriers varied with implementation climate and type of setting, and multiple strategies were required to overcome barriers (Table 5).
The hospital type affected the obstacles encountered. For example, academic hospital staff reported that surgical or anesthesiology residents or fellows often were unfamiliar with the bundle, and staff at a community hospital needed to persuade independent surgeons to accept the intervention. What CFIR describes as the implementation climate—including capacity for change, staff members’ receptivity, and organizational support for the intervention—also shaped implementation. For example, within a single hospital, HCP revealed that key personnel in one surgical area did not perceive a need to change processes, and thus resisted the intervention, while another surgical area had already integrated the bundle into their practice. Infection rates often influenced decisions of where to start the implementation or affected staff member’s willingness to change pre-existing practices. One academic hospital initially implemented the bundle on a specific surgical unit because the area had identified a number of SSIs. In contrast, surgeons in another specialty did not perceive a need to change practice. A few HCP noted that sometimes mandates were required. At one clinic that mandated bundle use, staff collaborated to overcome one surgeon’s resistance, partly by ensuring that he did not have to change his practice. A nurse practitioner commented, “We make it happen and he doesn’t have to really get involved at all.” At one community hospital, some patients were missed because a physician assistant and scheduler were reluctant to collaborate. Explicit surgical leadership support finally persuaded all staff to support full bundle implementation.
Theme 2: Implementation Barriers Can Vary With Implementation Climate and Type of Setting, and Required Multiple Strategies to Try to Overcome Them
Note. Quotes lightly edited for clarity.
Established communication pathways often helped staff implement this complex intervention but also differed across hospitals and services. For example, laboratory personnel noted that they could communicate relatively easily with clinics that had specific staff who guided patients’ preoperative evaluations or that identified specific staff members who received test results. In contrast, at one academic hospital, the laboratory could not deliver results to some clinics because staff members were not willing to receive them. Interviewees noted that coordinating across inpatient and outpatient settings often complicated implementation. Coordinating with diverse outpatient offices about swabbing and test results was sometimes difficult. However, dedicated staff facilitated coordination. At one community hospital, a dedicated nurse coordinator communicated with multiple affiliated surgeons from external offices. At an academic hospital, dedicated physician assistants facilitated implementation for outpatients on 2 surgical services. Staff at one academic hospital reported that implementation was more difficult on inpatient units due to the number and types of staff, different workflows and order protocols, and different practice standards.
Demonstrating a hospital’s readiness for implementation, HCP described engaging leaders, providing resources (money, training, education, space, and time), and ensuring access to knowledge and information. Some resources were provided once (eg, necessary laboratory equipment) but others were recurring needs. For example, staff turnover required hospitals to identify new champions and educate new personnel.
Theme 3. Collaborative planning
Collaboration in planning, engaging, and executing implementation needed to begin before the intervention and to be sustained (Table 6).
Strong communication and collaboration improved the implementation process. Across hospitals, HCP emphasized the importance of thinking through the whole process and identifying every worker or hospital area who would be affected, including staff in laboratories, anesthesia, pharmacy, hospital stores and supply chains, and information technology, as well as HCP directly involved in surgical patient care.
Theme 3: Collaboration in Planning, Engaging, and Executing Implementation Needed to Begin Before the Intervention and Need to be Sustained
Note. Quotes lightly edited for clarity.
Participants who described relatively easy processes of implementation also reported early and successful collaboration in planning, engaging appropriate stakeholders and champions, and executing the implementation as planned. Early partners included information technology staff members (eg, to develop templates for preoperative visits or revise order sets), staff members across inpatient and outpatient settings (eg, to identify opportunities for swabbing patients), laboratory staff, and schedulers in other clinics (eg, to identify appropriate timeframes for sending swabs to the laboratory). Across hospitals, both formally appointed implementation leaders and formal or informal champions helped drive the implementation and overcome indifference and resistance. HCP across surgery types and hospital settings emphasized the importance of recruiting champions, persuading surgeons and other staff, and including all relevant stakeholders in planning to improve engagement and commitment. Commonly identified bundle champions included surgeons, nurses and nurse managers, hospital epidemiologists, and infection prevention staff or infectious disease specialists.
At times, staff had to begin the planning process well before the intervention. Interviewees described the importance of planning to both implement and sustain the protocol. Several stated that they needed to work with the infection prevention program or committee to implement the intervention. Laboratory leaders needed time to develop or adapt processes and have them approved, time to rearrange laboratory space to facilitate rapid sample testing, and in one case, time to write a grant proposal to buy appropriate equipment. HCP in both academic and community hospitals noted that they had to provide surgeons with evidence before they accepted the intervention.
HCP sometimes encountered obstacles because key stakeholders had not been identified (eg, pharmacy, anesthesiology at one hospital) or had not been included in planning (eg, laboratory personnel at another hospital). Planning sessions allowed important stakeholders to be integrated into the process early on. However, some institutions identified stakeholders after the planning stage. Several HCP identified staff turnover as an implementation barrier, especially at community hospitals. Champions had to train or engage new staff, and new champions had to be identified if established champions left the hospital.
Hospitals developed different methods for engaging key staff and eliminating implementation obstacles. HCP at some sites emphasized the importance of engaging surgeons as champions, while at other sites, HCP reported that empowering nurses was key to success. At academic hospitals, participants noted that implementing the bundle for inpatients required targeted and ongoing training for nurses and aides, close collaboration between inpatient staff and outpatient clinics, and specific strategies to inform colleagues about bundle steps and to document adherence. Several participants at one hospital reported missed opportunities because anesthesiology or surgical residents rotated off the service.
Few HCP reported activities related to bundle implementation that involved systematic reflection or evaluation. However, some reported that such activities could improve implementation. Given the lack of feedback or sustained engagement, 2 HCP expressed ambivalence about the value of continuing the intervention.
Discussion
Our study identified key barriers and facilitators to bundle implementation for different surgical populations. Our findings have some important implications for the implementation of infection prevention bundles. Although sites agreed to implement a similar SSI prevention bundle, each hospital—and even different surgical areas within a hospital—implemented the protocol differently. Clinics and hospitals needed to adapt the bundle to their specific context, including workflow, patient population, and organizational culture.
Evidence-based recommendations can reduce the rate of preventable healthcare-associated infections including SSIs. Reference Berríos-Torres, Umscheid and Bratzler22,Reference Schreiber, Sax, Wolfensberger, Clack and Kuster23 Care bundles have reduced SSIs after some surgical procedures Reference Kawamura, Matsumoto and Shigemi8,Reference Fornwalt, Ennis and Stibich9 but not others. Reference Anthony, Murray and Sum-Ping13,Reference Bull, Wilson and Worth24 However, even evidence-based interventions like the STOP SSI bundle may not be implemented well, and HCP may not welcome the practice change. Although clinicians in our study valued both evidence and evidence-based practice, current infection rates shaped the willingness of some HCP to adopt or sustain the bundle. In other studies, hospitals have sometimes had difficulty adopting, sustaining, or complying with bundles. Reference Awad25 Hospitals have also had difficulty separating the efficacy of bundles or their constituent elements from each other, or from other infection control practices, Reference Kawamura, Matsumoto and Shigemi8,Reference Fornwalt, Ennis and Stibich9,Reference Anthony, Murray and Sum-Ping13,Reference Hockett Sherlock, Goedken and Balkenende14,Reference Albert, Bataller and Masroor26 potentially reducing their willingness to adopt bundles. Our findings agree with other reports about bundles, suggesting that implementation of bundles may face some common barriers across surgery types Reference Schreiber, Sax, Wolfensberger, Clack and Kuster23 and that bundles require careful planning and ongoing strategies to sustain them. However, each setting may need to find different solutions to these barriers.
Our findings on the need to tailor and adapt interventions to specific settings resonate with implementation science insights in other contexts. Reference Powell, Beidas and Lewis27,Reference Kilbourne, Goodrich, Miake-Lye, Braganza and Bowersox28 The implementation of evidence-based bundles often requires refinements on a local level and may need to be adjusted specifically for the type of hospital and surgical unit and for inpatient and outpatient settings. Both community and academic hospitals participating in our study often adapted bundle elements and implementation strategies to fit their clinical contexts, and 2 academic hospitals pilot tested the bundle in specific areas to identify processes and helpful adaptations. Similarly, different surgical clinics faced specific hurdles (eg, integration of residents and fellows) that required bundle adaptation or specific facilitators. Even within specialties, providers sometimes described population-specific concerns (eg, different infection concerns for adult or pediatric patients having spine operations). Implementation tools can help identify helpful strategies for site-specific barriers. 19–Reference Powell, Waltz and Chinman21
Similar to others studying implementation of evidence-based practices, Reference Hockett Sherlock, Goedken and Balkenende14,Reference Goedken, Livorsi and Sauder29–Reference Damschroder, Banaszak-Holl, Kowalski, Forman, Saint and Krein31 we found that local champions facilitated successful adoption, planning, adaptation, and monitoring. However, in our study, the HCP who championed the bundle varied by setting. Additionally, interprofessional collaboration facilitated successful and smooth implementation of the bundle. Yanke et al Reference Yanke, Moriarty, Carayon and Safdar32 found that implementation of a C. difficile infection control bundle was facilitated when HCP collaborated to identify barriers and facilitators. Hospitals interested in implementing an infection prevention bundle could identify all departments that should be directly or peripherally involved in the intervention and should facilitate early collaboration, engagement, and planning among representatives from each department. Interprofessional collaboration and champion engagement might circumvent the need for top-down approaches used by some HCP to push implementation.
Schweizer et al Reference Schweizer, Chiang and Septimus15 suggested previously that hardwiring steps into protocols or order sets facilitated implementation for the STOP SSI bundle. Hospitals committed to implementation should consider hardwiring elements as much as possible into departmental and hospital procedures (eg, protocols, order sets) to minimize unneeded variability among processes and units within the hospital, while allowing adaptation when needed. Hospitals that continually review the intervention and its constituent processes and work to simplify and adapt the intervention to local settings could improve their ability to sustain the intervention over time. Nevertheless, as shown in the implementation of an SSI-reduction bundle in colorectal surgery Reference Waits, Fritze and Banerjee33 and our previous STOP SSI study, Reference Schweizer, Chiang and Septimus15 our study also suggests that bundle adherence is easier to ensure with outpatient elective surgeries. Implementing the STOP SSI bundle for patients undergoing urgent or emergent operations may require targeted adaptation and sustained interprofessional collaboration.
This study had several limitations. Some key implementers did not agree to be interviewed, and high turnover at community hospitals meant that some key implementers had moved to other hospitals. Thus, the perspectives of our key informants may have differed from the staff we could not interview. Additionally, not all hospitals or units implemented an identical bundle, limiting comparisons of all steps across all settings. Given our small sample size and the diversity of roles and settings represented, we did not feel it appropriate to report relative overall frequencies for findings. However, interviewing HCP in diverse roles allowed the integration of expert perspectives on bundle implementation at both community and academic hospitals.
In conclusion, while the STOP SSI bundle seems like a simple intervention, it was complicated to embed in various practice settings. In this qualitative study, hospitals and surgical services varied in their approaches to implementation and their strategies for overcoming obstacles. A single set of clearly defined implementation strategies for an intervention that intersects multiple departments and services in a hospital, as well as outpatient settings, may not be effective across all settings. Repeated evaluation and feedback might better inform appropriate adaptations for specific settings and populations and improve bundle implementation, fidelity, acceptability, and sustainment.
Acknowledgments
We thank Sandra Cobb for transcribing the interviews. We are very grateful to the healthcare personnel who shared their critical insights and expertise during interviews. The authors of this manuscript are responsible for its content. Statements in the manuscript do not necessarily represent the official views of or imply endorsement by the Agency for Healthcare Research and Quality (AHRQ) or the US Department of Health and Human Services (HHS).
Financial support
This project was funded by the AHRQ (grant no. 1R18HS022467).
Competing interests
Dr. Reisinger is supported by an National Institutes of Health Clinical and Translational Science Award (grant no. UL1TR002537) through the University of Iowa’s Institute for Clinical and Translational Science. The remaining authors have no declarations of interest.
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