Introduction/background
Implementation strategies are techniques designed to promote the uptake of clinical interventions into practice [
1] by targeting key modifiable barriers and facilitators (called implementation determinants) to adoption of these interventions [
2,
3]. Implementation science seeks to develop evidence to improve the accurate identification of (i) implementation barriers relevant to specific interventions [
4‐
6], and (ii) implementation strategies likely to address such barriers [
5,
7,
8]. While the evidence on effective implementation strategies is growing, much remains unknown about how best to select and enact these strategies for a given context. Currently, such planning usually focuses on which implementation strategies to use, typically informed by knowledge of/hypotheses about likely implementation barriers [
1,
3,
9‐
15], existing evidence about the effectiveness of the strategies [
1,
3,
9,
13‐
16], the experience of the implementation team [
17], guidance from conceptual models [
6,
18‐
25], and pragmatic concerns [
1,
3,
9,
15] including available resources [
4,
5,
13,
26]. However, these sources generally do not provide detailed guidance on how these strategies should be operationalized to maximize their impact.
The Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET) involved a set of implementation strategies, selected based on evidence demonstrating their ability to support practice change, their potential scalability, and pragmatic considerations (e.g., cost). These strategies included (i) creating and distributing educational materials, (ii) conducting educational meetings and ongoing trainings, (iii) using train-the-trainer strategies, (iv) facilitation, and (v) identifying and preparing champions [
27]. The study hypothesized that more intensive implementation support (e.g., more trainings; adding practice facilitation) would lead to greater improvements in the targeted outcomes. As such, the study was designed to test the impact of additive support, not the efficacy of any individual implementation strategy. The main SPREAD-NET analyses—of association between study outcomes and degree of implementation support—found that more intensive implementation support was not associated with greater improvements in the targeted outcomes (rates of guideline-concordant cardioprotective prescribing) [
28].
For the manuscript presented here, we re-analyzed the study’s mixed-methods data to identify factors associated with differences in study outcomes in individual community health centers. As initial results indicated that the interplay between study implementers (clinic staff tasked with leading change processes) and organizational context was key to the success of a given community health center, we then explored the organization-specific pathways through which these implementers promoted practice change. We note that the use of champions [
29‐
32] was one of the parent study’s implementation strategies chosen a priori; the intention was that the study implementers would act as champions. In this paper, however, and per implementation science definitions [
18,
27,
31], we use the term “champion” to describe only those study implementers who demonstrated a sustained commitment to implementation activities. In other words, all clinic staff tasked with leading change processes were study implementers, but only some acted as champions.
Little has been reported on how to effectively prepare people for the champion role, or on the specific pathways through which champions enact change [
31,
33,
34]. This paper presents a detailed assessment of how study implementers/champions impacted prescribing behavior in varied settings, to better understand how this role is optimally operationalized, and thus advance the specification and preparation of champions as an implementation strategy.
Results
Five community health centers demonstrated statistically significant increases in guideline-concordant statin prescribing over the course of the study (Table
2).
Table 2
Results of adjusted difference-in-difference model for statin prescribing, by CHC and study arm
1 | #1 | 1.23 | 1.16 | 1.29 |
1 | #2 | 1.03 | 0.95 | 1.12 |
1 | #3 | 1.14 | 0.99 | 1.32 |
1 | #4 | 1.01 | 0.96 | 1.05 |
2 | #5 | 1.06 | 1.02 | 1.10 |
2 | #6 | 1.22 | 1.14 | 1.30 |
2 | #7 | 0.90 | 0.80 | 1.02 |
2 | #8 | 1.18 | 1.08 | 1.29 |
3 | #9 | 1.10 | 0.99 | 1.22 |
3 | #10 | 1.01 | 0.97 | 1.06 |
3 | #11 | 0.99 | 0.92 | 1.06 |
3 | #12 | 1.09 | 1.02 | 1.16 |
The intersection of organizational investment and study implementer
Several factors, in combination, were associated with significant pre-post increases in guideline-concordant statin prescribing among the community health centers noted in Table
2. All were related to the characteristics of the study implementers and the organizational support they received. They included the following:
-
Engagement: Interest in and willingness to promote the intervention
-
Influence: Sufficient social capital to foster trust and the authority to prioritize implementation and stimulate practice change
-
Credibility: Conferred through prescribing privileges
-
Capacity: Time—and understanding of diabetes and cardiovascular care—sufficient to effectively advocate for the intervention
At each community health center that demonstrated a significant improvement in study outcomes, one or two implementers emerged as the de facto champions (see case studies, below). As noted in the “
Introduction/background” section, we use the term champion to describe only those study implementers who demonstrated a sustained commitment to implementation activities [
18,
27,
31] (Table
3). Study implementers who emerged as champions demonstrated each of the above elements (though at one community health center, the implementers were clinical pharmacists whose role included advising providers on prescribing decisions).
Table 3
Staff role of study implementers and emergent champions by CHC
1 | Clinic 1: Clinic medical director/practicing physiciana Clinic 2: Successive RNs | N/A | Yes |
2 | Practicing advanced practice provider, succeeded by clinic project coordinator | N/A | No |
3 | RN care managera | Practicing physician | Yes |
4 | 2 Clinical applications specialists, succeeded by clinical applications supervisor | CEO/advanced practice provider | No |
5 | 4 EHR technical support staff | Medical director/practicing physiciana | Yes |
6 | Practicing physiciana | N/A | Yes |
7 | Practicing physician | N/A | No |
8 | Successive advanced practice providers (2nd providera) | Practicing physician | Yes |
9 | Clinic 1: Practicing physician Clinic 2: RN | N/A | No |
10 | Clinic 1: Director of performance improvement and population health/RNa Clinic 2: Support staff manager Clinic 3: Clinic manager Clinic 4: Clinic manager Later succeeded by physician (no longer practicing) for all clinics | Practicing physician | Yes |
11 | Clinical data analyst, succeeded by clinic manager, succeeded by MA supervisor | Chief medical officer, practicing physician | No |
12 | Clinical pharmacists at their respective clinicsa | Practicing advanced practice provider | Yes |
We defined organizational support as the creation of an environment within which implementation activities could be expected to be taken seriously by clinic staff. In many cases, this support was indicated by the selection of a staff member with the potential to be an effective champion (as described above; many of the necessary qualities were suggested by the study team in the initial study communications). Community health centers that demonstrated organizational support also promoted the use of the CVD Bundle and/or guideline-concordant statin prescribing. While organizational support, or the lack thereof, could take many forms—as illustrated below—implementation success depended on both the presence of champions with the aforementioned attributes and the implicit or explicit backing of clinic leadership, and the interaction of the two.
Community health centers that did not show a significant improvement in prescribing rates lacked either an emergent champion, and/or organizational support. Implementers at these community health centers often were less engaged with the study/CVD bundle; did not have adequate influence at their clinic to be effective change agents for this intervention; and/or did not have a clinical background (and therefore the credibility to affect provider care decisions). Two community health centers (see Table
3) did have champions that met each of the elements noted above apart from prescribing privileges (both were RNs), but implementation approaches and organizational priorities precluded their ability to effectively promote the targeted practice change.
While the combination of the above implementer characteristics—engagement, influence, credibility, and capacity—and organizational support appeared key to enabling practice change, each community health center—champion combination followed unique implementation paths suited to the particular context. Case studies of the seven community health centers with emergent champions, five of whom achieved significant improvements and two who did not, illuminate this diversity.
Implementation efforts were led by a medical director [credibility], who had advocated for the organization’s participation in the study, and were effective primarily due to her efforts, position, and influence within the organization: she had a long history at the community health center and was respected and trusted by providers and staff [influence]. Despite practicing exclusively at the clinic where she served as medical director, she was instrumental in promoting the adoption of the targeted care guidelines at both clinics in the study. She was actively engaged in the implementation, conducting multiple trainings for providers and discussing the intervention, relevant guidelines, and the CVD bundle at organization-wide meetings [engagement, capacity]. She also led by example, consistently using the CVD bundle tools and developing relevant plan-do-study-act tests of change [engagement]. She worked closely with and directed the activity of an RN-turned EHR technical support staff member, who incorporated the CVD bundle into new staff trainings.
Implementation efforts were directed by the organization’s medical director, who had made the decision to participate in the study, and supported by EHR technical staff at each clinic who were assigned to the implementer role by the medical director. This community health center achieved a significant increase in guideline-concordant statin prescribing through the sustained, active engagement of a leadership figure within an organizational structure that prioritized hierarchy and standardization [influence]. This medical director, a practicing physician [credibility], was actively involved in developing reports that identified patients in a given providers’ panel who were indicated for but not on the target medications. These reports were regularly distributed to providers, and the medical director met with providers individually to review them [engagement, capacity]. She also incorporated statin guideline prescribing performance into provider evaluations [engagement]. She standardized EHR screen configurations organization-wide to maximize viewing the point-of-care alerts, and had most non-CVD bundle alerts turned off to minimize alert fatigue [engagement]. She modified the statin dosing table provided in the SPREAD-NET toolkit to include locations where statins were available at low cost, and taped it to providers’ monitors for easy access [engagement, capacity]. Under her direction, links to a CVD risk calculator were added to the organization’s EHR before it became available as part of the CVD bundle [engagement]. She integrated explicit cardioprotective prescribing guidance into the community health center’s residents’ training [engagement, capacity]. Under her guidance and supported by the EHR technical support staff, each clinic conducted outreach to patients who were (over)due for diabetes care; the intensity of this effort varied by clinic and care team.
Implementation efforts were enacted by an experienced, well-regarded physician [credibility] who had practiced at one of the clinics in this organization for many years and had previously served as medical director for the community health center [influence]. This provider was interested in research and volunteered to fill the study implementer role; her schedule already included 4 h a week of administrative time designated to community and research work [capacity]. This gave her the flexibility to innovate in her own practice and effect change through one-on-one engagement with other providers, including sharing alternative workflows for diabetes care, within an organizational culture that afforded substantial provider autonomy. In addition to experimenting with different workflows for diabetes care, this physician also met individually with all providers at both clinics, including during new provider onboarding, for a short, over-the-shoulder introduction of the study and the CVD bundle, and demonstration of the tools [engagement].
Early implementation activities were limited to an introductory presentation to providers and occasional reminders during staff meetings. This community health center replaced their study implementer approximately 1 year into the study, shifting the role to a provider who was newer to the organization but brought a wealth of experience in diabetes care [credibility]; both providers were appointed to the implementer role by organizational leadership. The community health center’s increase in guideline-concordant statin prescribing appeared to be due to a combination of awareness-raising efforts by this clinician, coupled with an increasing organization-wide emphasis on standardization and quality improvement throughout the study period [influence]. During this time, the organization was working on becoming an accredited patient-centered medical home, with an attendant focus on practice change capacity. The new implementer brought renewed focus to the statin guidelines, often discussing prescribing recommendations at organization-wide provider meetings [engagement, capacity]. She also requested and received the addition of a link to a CVD risk calculator on staff computers, and notified providers when it was added to the CVD bundle [engagement, capacity].
Implementation efforts were led by two clinical pharmacists, one of whom was the clinic’s director of clinical pharmacy. The pharmacy director chose to lead implementation activities at the main clinic; the second clinical pharmacist was asked to take on the role at the second clinic. Success at this site was largely due to the strength and credibility of the clinical pharmacy program at the organization, the dedicated time the pharmacists were able to spend supporting guideline-concordant statin prescribing [capacity], and parallel awareness-raising by clinical leaders that resulted in an increased emphasis on relevant prescribing guidelines by multiple influential actors at the organization. The clinical pharmacy department was well-resourced, trusted [influence], and guideline-focused. The clinical pharmacists incorporated updated statin guidelines into pharmacy protocols, met individually with patients to review their medications, reviewed patient charts for guideline-concordant prescribing [credibility], and followed up with providers in conversations or messages, as well as discussing the CVD bundle and relevant guidelines at clinic meetings [engagement]. The clinical pharmacists worked outside the daily patient encounter workflow, which challenged their ability to stimulate change at the provider and team level. However, the organization’s medical director and the chief operating officer, who had formerly worked as an RN at the organization, ensured that the statin guidelines were discussed and debated at provider meetings.
Implementation efforts were coordinated by an RN who served as the director of quality improvement for the community health center; she volunteered for the role and acted as the primary study implementer for the largest of the four clinics taking part in the study. The remaining three study implementers, all of whom held patient-facing administrative roles, were asked to manage implementation activities at the other three clinics. The four study implementers initially met multiple times to plan their implementation approach, introduced the CVD bundle to care teams at all four clinics, and identified and worked with a single provider to initiate a pilot project using the CVD bundle within his own patient panel. These efforts, however, never gained momentum. Organizational support was diffused by other activities occurring at the community health center during the study period, including simultaneous participation in other quality initiatives, the opening of a new clinic, and major construction projects and upgrades across the organization. Although the director of quality improvement did demonstrate engagement, influence, and capacity, she did not see patients herself and as an RN would have been unable to prescribe statins [lack of credibility]. The three other study implementers did not have clinical backgrounds and lacked the influence, credibility, and capacity (particularly a deep understanding of diabetes and cardiovascular care) to persuade providers to change their behavior; the additional clinician implementer, a practicing physician, did not play an active role in supporting implementation activities.
Implementation efforts at this community health center, a single clinic, were enacted by an RN diabetes care manager who was assigned to the study implementer position. She conducted a few initial presentations about the CVD bundle at provider meetings and occasionally discussed the study’s EHR tools with individual providers. However, as this RN personally met with most of the clinic’s patients with diabetes in her role as a diabetes care manager, most of her implementation activities focused on her own activities. She integrated review of statin prescriptions into her pre-visit chart review process and follow-up visits with diabetic patients, and followed up with the primary care provider to discuss a plan of care based on clinical recommendations. The effectiveness of this approach was limited because (i) the EHR tools were designed to fire during open encounters, not during pre-visit chart reviews; and (ii) the approach relied almost entirely on a single person without prescribing privileges [lack of credibility], with little effort put into raising awareness or buy-in from providers. In addition, although this study implementer actively worked to identify patients with diabetes who could benefit from a statin [engagement] and had the influence and capacity to advocate for the intervention, she occasionally expressed distrust in the guidelines underlying the CVD bundle and/or the algorithm behind the EHR tools. Finally, although this clinic had a standardized process for piloting and approving new interventions and workflows, this process was not applied to the clinic’s participation in SPREAD-NET—which appeared to limit organizational awareness of and support for implementation activities.
Discussion
Our study adds to implementation science by providing insight into the pathways through which champions may impact implementation outcomes, and advances understanding of how to identify and prepare implementers to be effective champions within their own particular environments. Notably, unlike the community health centers that did not demonstrate a significant change in prescribing behavior, the five community health centers that did have improved outcomes all had engaged and respected champions (study implementers) who were able to directly influence provider behaviors or alter institutional prescribing norms. This suggests that not only the selection of champions as an implementation strategy but also the appropriate operationalization of support (i.e., the identification and preparation of champions), are necessary for effective practice change; this is likely to also apply to other implementation strategies, and further research is needed to identify best practices for doing so. These findings also align with those of other studies that showed the potential for champions to successfully support introducing and maintaining practice change [
30‐
33,
49‐
52].
Implementation science emphasizes that identifying effective implementation strategies involves understanding the context-specific causal pathways through which these strategies can have impact [
3,
34]. The case studies presented here underscore this: effective champions were key to implementation success, but individual differences between study implementers and contextual differences between organizations produced different pathways to change. In some cases, change was effected through hierarchical directives and practice standardization; in others, the champion relied on trust-based relationships, advocacy, and leading by example. This underscores the importance of assessing and reporting how implementation strategies operate in a given setting.
These findings also help explain the overall study results (higher-intensity implementation support was not associated with better outcomes). A recent review [
3] found that variation in impact across implementation studies is often due to misalignment between implementation strategies and key contextual barriers and facilitators. A similar phenomenon occurred here: the selected strategy (champions) was appropriate, but as operationalized it had little impact. It was recommended that study clinics appoint study implementers with enthusiasm, credibility, influence, and clinical knowledge, but—in an effort to allow for organizational autonomy—these elements were not required. In addition, the study’s implementation support focused on adoption of the targeted innovation, rather than on increasing the study implementers’ effectiveness. Had the focus been on supporting the development of the implementers’ leadership skills and engagement with the intervention and/or had it been required that study implementers fulfill certain criteria, study results may have been different.
Recognizing this led us to question the process through which we initially selected and operationalized the implementation strategies compared in the SPREAD-NET study. After a period of reflection [
53] and extended team discussions, we recognized that a given community health center’s decision to participate in SPREAD-NET had triggered collective, unacknowledged assumptions by our study team regarding organizational support for the targeted change, and study implementer engagement in/capacity to effect that change. We assumed that the implementers designated by the community health centers would have the necessary attributes and qualifications to be effective champions, so the implementation support focused on the specifics of the innovation, and change management strategies. However, these assumptions did not hold true in all study sites, which appears to have influenced study outcomes.
Implications for implementation science
Social scientists have long argued that articulating tacit assumptions—beliefs that “you accept as true without question or proof” [
54]—is necessary to understand the impact of such assumptions on research processes and results [
53,
55,
56]. However, consideration of the impact of assumptions on study design and outcomes is largely absent in the implementation of science literature. We contend that reflexivity, or the active querying of one’s own assumptions and related decisions during the design phase—particularly as these assumptions relate to likely barriers and facilitators to intervention uptake—is essential to avoid a mismatch between implementation support and determinants [
3].
In addition, despite strong evidence on the importance of champions in implementation activities, little direction exists on how best to support/develop/prepare champions. Often, the literature implies that effective champions have certain intrinsic qualities that cannot be taught [
30,
31,
37]. The few articles that do address increasing champions’ efficacy recommend fairly vague strategies such as creating and sustaining learning communities, ongoing mentoring and feedback, fostering the development of leadership and change management skills, and valuing and rewarding champions for their contribution, coupled with hands-on practice and content-specific training [
36,
38]. Relevant recommendations note only the need to “identify and prepare individuals who dedicate themselves to supporting, marketing, and driving through an implementation” [
27]. A recent article on the attributes of effective champions suggested that many of the necessary skills can be learned, and that supporting the development of these skills may be key to successful implementation outcomes [
49].
Our findings also indicate that implementation science theories and frameworks that involve the use of champions should be refined to include detailed specifications on both necessary intrinsic champion attributes and guidance on developing and supporting effective champions. The analysis presented here contributes to the growing knowledge base within the field regarding what makes an effective champion [
31,
49,
57]; more research is needed to identify essential champion characteristics, distinguish between those that are context-dependent (e.g., status within the clinic hierarchy) versus those that can be taught, and identify specific, pragmatic techniques that effectively foster necessary skills—all while accounting for the impact of contextual factors on implementation approaches and outcomes.
Limitations
All of the study community health centers volunteered to participate, and may have shared unique motivations that limit the generalizability of study findings. Qualitative data collection did not occur evenly across community health centers due to lack of engagement and staff turnover at some community health centers, as well as the mid-study closure of one organization. Findings are presented at the organizational rather than clinic level; it is possible that a single clinic within a community health center may have driven the change in cardioprotective prescribing, although we believe this is unlikely. A major finding of the original analysis was that aspects of the CVD bundle itself proved a barrier to implementation [
28]. It is possible that weaknesses in the tools yielded a situation in which only sites with strong study implementers were able to make significant progress; better tools might have necessitated less reliance on champions. In addition, while our study used a cluster-randomized design to minimize bias introduced by unrecognized confounders, our randomization scheme was based on available and readily quantifiable factors such as clinic size, urban/rural location, and the prevalence of diabetes. Randomizing by such factors did not, however, ensure equal distribution of the factors ultimately recognized to be associated with differences in study outcomes.
Conclusion
This analysis adds to implementation science’s call for better approaches to selecting and operationalizing implementation strategies suitable to a given context [
2,
5,
9,
11,
15,
26]. Here, unexamined researcher assumptions, coupled with a lack of specification [
34] regarding how to prepare effective champions, led to implementation support that failed to address key barriers to success. These results also increase our understanding of the causal mechanisms through which champions may influence implementation outcomes. Implementation practitioners require detailed, pragmatic, context-specific, evidence-based recommendations on how to select and execute implementation strategies; thus, future research should focus on generating evidence on how to support the growth of effective champions.
Acknowledgements
The authors wish to acknowledge the contributions of Elisabeth Hicks, MA, Joanna E. Bulkley, PhD, and L. Kris Gowen, PhD. We also wish to thank OCHIN’s leadership, and the leadership and staff of the 29 OCHIN member clinics that volunteered to be part in this study.
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