Tailoring an intervention to the context and system redesign related to the intervention: A case study of implementing shared medical appointments for diabetes

Although the concept of tailoring interventions is generally accepted, a systematic review of tailored strategies for behavior change in healthcare professionals revealed mixed results [20]. Moreover, much of the work describing tailored interventions has focused on individuals (end users), such as adaptation to patients' cultural background or adaptation of practice guidelines for healthcare professionals [21‐24]. Thus, the process by which an organization-level practice change intervention can be individualized and implemented has not been well described. We suggest that part of the problem is conceptualizing the process as simply that of tailoring interventions to the context, and not recognizing or adjusting the unique local context to optimize success of that intervention. In fact, there have been relatively few studies of adaptation at multiple organizational levels, from the individual level (both patient and healthcare professional) to clinical microsystem, mesosystem, macrosystem, and even supramacrosystem. Even fewer describe the adaptation process itself, i.e., the basis for the choices made in determining the makeup of the intervention, and the evolution of the intervention over time. We will describe in detail the implementation of a specific intervention – shared medical appointments/group visits – in a specific context in order to elucidate these many issues.

Shared medical appointments (SMAs) constitute a promising improvement strategy to help address the complexities and demands of managing chronic health conditions. There is evidence in support of this approach, including our own experience [25]. Shared medical appointments may also be called group visits, cluster visits, or chronic healthcare clinics. They have been described as a form of medical appointment with varying medical staff and patient populations and have been utilized for patients with chronic illnesses for whom education, self-management, and problem-solving skills are essential. The SMA is a patient medical appointment in which a multi-disciplinary team of providers (ranging from two to six) see a group of patients (eight to twenty) in a one and one-half to two hour visit. The implementation of SMAs was designed as a quality improvement project to improve intermediate outcome measures for diabetes – A1c, systolic blood pressure, low density lipoprotein cholesterol (LDL-cholesterol) – focusing on those patients at highest cardiovascular risk. We have previously reported the initial results in 44 patients who participated in these group visits: Levels of A1c, fell significantly post-intervention, with a mean (95% CI) decrease of A1c of 1.4% (0.8, 2.1) (p <0.001). The reduction in A1c was significantly greater in the intervention group relative to concurrent but non-randomized controls: 1.44 versus -0.30 (p = 0.002) [25].

While not all evaluations of outcomes associated with SMAs are as encouraging, the format remains appealing in an environment of growing demands and limited resources. In fact, the lack of success may be attributed to implementation challenges and issues that have not been adequately examined [26, 27]. The general structure and processes for conducting SMAs have been established, but there is a lack of specific guidance to ensure success. As with other complex interventions, SMAs necessitate a systemic redesign that intersects a wide range of levels of a system (micro- to supramacro) for successful implementation and sustainability: SMAs require reconfiguring various levels of an organization's model of primary care.

Our goal in this case study was to provide an in-depth analysis with the potential to identify themes and issues that will inform others interested in conducting or refining SMAs, or other organizational change. We describe the implementation and evolution of SMAs within a particular local context, a process that involved more than tailoring the intervention to the context; surprisingly, it also involved altering the context for intervention success. After initially considering the SMA as an addition to, or an enhancement of, the microsystem, we recognized over time that successful implementation required expansion of the clinical microsystem by creating an intra-meso structure within the constraints of the existing microsystem (one-on-one doctor-patient relationship) and mesosystem (primary care clinic) that is nested within a macrosystem (medical center) which in turn is nested within a supra-macrosystem, the Veterans Healthcare Administration (VHA) healthcare system.

This intervention was initiated within the primary care clinic of an urban academic medical center of the Veterans Health Administration. This clinic's primary care providers – five nurse practitioners (NPs), one physician assistant, eight part-time attending physicians, and 60 resident physicians – provide care for 11,000 patients, of whom 25% have diabetes. In addition to having a sophisticated electronic medical record, aspects of the Chronic Care Model routinely integrated into this clinic included nurse case management, and a clinical reminder system with feedback on performance [25]. The local context prior to initiating SMAs for patients with diabetes is outlined in Table 1, and follows a scheme adapted from Batalden et al [28]. The clinical microsystem is the small, frontline unit that is the primary clinical care unit (primary care provider and patient), which is nested within a mesosystem, and further nested within a macrosystem. Specifically, Table 1 defines the local context in January 2005 related to care for patients with diabetes and lists key elements related to diabetes care-based practices before introducing SMAs.

The microsystem prior to SMAs consisted of the patient care visit (primary care providers and patients). The visits consisted solely of one-on-one encounters with patients and differing providers (primary care provider, nurse, clinical pharmacist, and psychologist). The mesosystem was the whole primary care clinic where patients were seen. The clinic culture was characterized by a focus on individual responsibility of primary care providers rather than systems-based practice and there was relatively little interdisciplinary care. However, usual care also included referral to a dietician, certified diabetes educator, clinical pharmacist, or endocrine/diabetes specialty clinic at the discretion of the primary care provider. Thus, high-risk patients (part of the clinical microsystem) not meeting physiologic or process measure goals for diabetes were referred to any number of support staff for further education and treatment (mesosystem). A link back to the primary care provider existed via the electronic medical record. Additionally, different disciplines were not supervised by one director, but by leaders in their own discipline who did not work within the mesosystem. Changes in processes of care were difficult to achieve without many discussions with multiple discipline-specific supervisors. Improvement efforts previously were primarily top-down, based on mandates from the top management at the facility. At the macro-system level, the Cleveland VAMC was engaged in demonstrating quality measures for diabetes determined by the supramacro-system level of the VHA Central Office. At both supra and macro levels, there was increasing awareness of SMAs as a means to improve waiting times while meeting quality imperatives in an efficient manner. Organizational direction at the level of the macro- and supramacro-systems had a greater influence; there were mandates to conduct SMAs issued by the VHA, primarily to address issues related to waiting times and clinic access. Mandates from outside the local medical center aside, local leadership in general and in the primary care clinic in particular were strongly supportive of improvement efforts and open to the use of novel methods of care delivery. Moreover, the local facility has had a long history of support for and success in the implementation of clinical improvement allowing reliance on internal rather than external facilitation [29]. A committee formed to address the quality of diabetes care was an outgrowth of a day-long clinic retreat conducted off-site by two of the authors (SRK and DCA), among others. Clinic staff who previously had little involvement in system redesign began to take part.

We used a nested systems framework to help organize and summarize implementation and sustainability issues [28]. Figure 1 provides a visual representation and framework for understanding the system redesign associated with successfully tailoring the intervention and the local context. Specifically, the left side of Figure 1 depicts the initial conceptual model of our healthcare system. The microsystem links to the mesosystem in that patients are referred, as needed, to nursing and other services. The macrosystem level refers to the local organization. The local organization is also linked to the national organization (supramacro level). We represented the supramacro-system as a perpendicular layer to emphasize the role as a foundation and the distant though defining influence of the supramacrosystem on the local context. Figure 1 also depicts the conceptual model that evolved to describe the successful implementation of SMAs for patients with diabetes (right side of the figure; see below for discussion).

We used an in-depth case analysis approach focusing on the context and methods of implementation. This allowed us to describe the conceptual issues related to system redesign to implement an SMA for patients with diabetes [1, 2, 30‐35]. In particular, we used the characteristics of innovations framework of Grol et al. to characterize SMAs as an innovation in terms of the factors that might promote or hinder implementation processes [32]. We have used a participatory/action research approach where relevant parties of the process actively examine, plan, evaluate, and reflect throughout the cycles. [36] Such an approach best achieved our goals related to capturing the processes and key elements impacting on those processes. [37‐40]. Notes from meetings and debriefings, including feedback from primary care providers, patient surveys, e-mails, and meeting summaries (e.g., meetings of the team developing the related research grant application and the practice manual), were reviewed, cataloged, and coded for relevance to the implementation process. In addition, this quality improvement project took place in concert with the Academic Chronic Care Collaborative sponsored by the Association of American Medical Colleges and the Institute for Healthcare Improvement. Monthly reports submitted to this Collaborative were reviewed. This was done in an iterative process combined with interviews with key participants and observations. Seven local individuals familiar with the implementation processes of this project or SMAs were asked to independently review the summaries and findings. Six provided written feedback and were interviewed in a semi-structured format for validation purposes. The model presented here and the formats for structuring the presentation emerged from this participatory/action based and grounded-theory approaches [36, 41].

Once the decision was made to begin SMAs, it was necessary to create general guidelines about SMAs and translate those into the local context, with its resources and needs. Implementation fidelity is often presented as critical to achieving the levels of efficacy demonstrated in clinical trials. However, it became apparent that descriptions of SMA interventions provided insufficient detail to guide implementation into differing clinical settings. While decisions and potential options were sometimes discussed, guidance on translating and mapping out to the local context was not provided. Table 2 outlines the initial dimensions of the SMA innovation we identified (first column). The second column delineates our initial decisions or translation of the intervention to the needs of the local context. In order to maximize success and meet demanding clinical care needs, we began with diabetes as a focus because of the existing core team and its openness to change, some collaboration between key disciplines was loosely in place, the volume of patients with diabetes, the cost to the organization, and the high demand of resources required to manage patients with diabetes. However, as is true with most decisions, there were aspects of many decisions that included promoting factors but also came with hindering factors. Therefore, Table 2 also outlines the promoting and hindering factors associated with each of the initial decisions.

It is worth highlighting key promoting factors for the innovation that relate to the system levels because ultimate system redesign requires successful alignment and interplay between all levels. While the organizational structure is very hierarchical (Figure 1), there was openness to novelty. In fact, there was the supramacrosystem level mandate to begin SMAs, with considerable latitude given to how those mandates were achieved. Descriptions of the transformation of the VHA describe these seemingly contradictory strains [42]. Thus, at the supramacrosystem level, promoting factors included the mandate for action to address performance deficiencies, the so-called 'burning platform' and the simultaneous freedom and flexibility to pilot test to secure buy-in [43]. At the macrosystem level, there was similar support for innovation. At the mesosystem level, a strong core care team was essential that reflected multi-disciplinary members from the various services that would be linked. This team was open to new care models and expanding roles with a leader who had the ability to make changes at the microsystem level. Although Table 2 identifies a number of promoting factors, we believe that the most essential factors were the formation of a core team committed to quality and improvement, and the leadership provided by the clinic director that was supported strongly by the team members.

At the same time, there were several key innovation-hindering factors associated with the general mandate to conduct SMAs and the specific decision to translate the mandated innovation into the local context: limited resources (such as space); potential to alter longstanding patient-provider relationships; organizational silos (disconnected groups) with core team members reporting to different supervisors; difficulties in documenting workload for credit; and finally, the flexibility itself and absence of specific guidelines for meeting the mandates, resulting in a certain inefficiency and delay in the process. Implementation in a space-constrained facility that was in the midst of major construction and renovation meant that the choice of a location resulted in displaced providers who used the space, and limited access to computers available in the conference room. There was concern that group visits with different providers would disrupt established provider-patient relationships and inhibit those providers from referring patients. The different lines of authority for each of the core team members necessitated negotiations with four different supervisors, some of whom were more open to SMAs than others. In this organization, there is a strongly perceived need (varying among different clinical and administrative departments) for meticulous accounting of one's workload. It was not intuitively obvious how to account for SMA work within current accounting systems.

SMAs require complex changes that impact on care routines, collaborations, and various levels of the organization. As such, implementing the initial decisions involved more than putting decisions into place. As noted by others, implementers and champions of innovation are critical. This is particularly true the more complex the change and the need for system redesign. Those who conduct and carry out the implementation obviously play a key role in helping to initiate and sustain the intervention. Implementers for our SMA intervention included a physician who was the Medical Director of the clinic and an Endocrine Nurse Practitioner. The physician was an established leader of the Primary Care Clinic for two years prior to initiating the intervention and had some training in Quality Improvement. The physician felt ownership of the improvement processes overall and had the authority to solicit and get approval for staff in other disciplines to participate in the SMA. The Endocrine Nurse Practitioner was not a member of the Primary Care Clinic but was considered to be a content expert and opinion leader at our institution. She had worked with high-risk patients with diabetes for 20 years prior to the intervention and was willing to share her expertise with patients as well as other less knowledgeable team members. All members of the core team were strongly committed to working together and were key stakeholders at the mesosystem level.

Although the initial analysis and translation of the innovation (Table 2) provided a starting point and the implementers provided additional local motivation, further analysis of the SMA beyond the promoting and hindering factors associated with the decision to implement was necessary for guidance to tailor and adjust the innovation to the local context. Grol et al. identified a series of characteristics of innovations that might promote or hinder implementation processes [32]. The relationship between these factors and the local context is outlined in Table 3. While the relative advantage/utility was appreciated by the initiators early on, three other innovation characteristics also appeared to be critical to successful implementation: compatibility, involvement, and collective action. This innovation was very compatible with the norms and values of the institution in promoting improvement in chronic disease quality measures. The involvement of the core team who would be implementing the SMA was very high. Individuals met to collectively decide the specific details of the clinical experience for patients and providers. However, hindering factors included: low compatibility with the traditional one-on-one visit with a primary care provider, high complexity in that the innovation was difficult to explain, and low collective action from the primary care providers who did not have input into the SMAs into which their patients would be recruited.

The initial decisions and implementation endeavors began the process of practice change, but iterations of tailoring the intervention and negotiating system redesign were necessary. While not surprising that there would be issues on the path from start-up to sustainability, little attention has been given to identifying and categorizing them. Within our local context, the SMA process for patients with diabetes has changed over the last two years. These changes have occurred at the level of the clinical microsystem, mesosystem, and macrosystem. Within the microsystem, many changes have involved team structure, the patient population, and clinic flow. In Table 3, we have used the Grol et al. framework to list the key changes over time and strategies for promoting implementation and sustainability [32]. This framework identifies the flexibility and adaptability during implementation as a dimension which can either promote or hinder the process. We found that because our SMA had a strong core team, this was an important aspect to identify and maximize throughout implementation. Once identified, we could use this promoting factor to offset challenges encountered during implementation. The lack of clear designation of what the innovation and team members needed permitted the team to adapt the innovation to the local context and needs throughout the implementation process. As an example, we recognized after initiation of the SMA process that patients wanted to discuss dietary issues in detail, and we subsequently added a nutritionist. Another example is the response to the challenges of documenting the patient visit. We initially used the group note function in our electronic medical record. The group note field allows text to be entered that will appear in the note of every patient in the group. However, it was recognized early on that such a note did not allow for customization. Therefore, we initiated the development of a template note with embedded guidelines that was user-friendly and facilitated the efficiency of documentation and standardization and completeness of individual treatment plans. This development took place over a period of several months. Another characteristic is that of complexity of both the innovation (SMA) and its implementation. The SMA was something that was identified initially as a vague unknown type of clinical care which was not easy to explain to the primary care staff. This constituted a barrier to successful implementation. We decided to take advantage of a trial period with small numbers of patients to highlight success as well as allow clinic practitioners to sit in on one to three SMAs. Through identification of this barrier we were able to develop a strategy to overcome it.

The right side of Figure 1 depicts the conceptual model that evolved with the successful implementation of SMAs for patients with diabetes. The system redesign that resulted from implementing SMAs included continuous tailoring of the intervention to and continuous adjustment of the local context. This interplay of co-evolving components added a new clinical venue to which referral of patients was possible. SMAs were designed with the idea that they would exhibit the characteristics of a high-performing clinical microsystem; e.g., alignment of roles and training for efficiency and staff satisfaction; interdependence of the care team to meet patient needs; integration of information and technology into work flows; and supportiveness of the larger organization [36, 44]. However, we felt that to conceptualize SMAs as another clinical microsystem was confusing, given the co-presence of the more traditional microsystem and the unique way SMAs expanded and integrated other services and resources of the primary care clinics that was contrary to traditional thinking about care. Moreover, the primary responsibility for the patients seen in the SMAs was and would remain in the hands of the primary care provider in his or her microsystem. Accordingly, SMAs are identified as an intra-mesosystem component to recognize the linkages among and between other meso components (intra-meso) beyond the microsystem, and to emphasize the system redesign. Additionally, the SMA with its own iterative improvements and evolution seemed a separate system as opposed to a higher functioning system that already existed. This is in contrast to the initial system design where there was only the closed microsystem with the components within (intra-micro) the inner clinical microsystem.

System redesign is also reflected in the arrangement of the SMAs: the squares in Figure 1 represent participants on equal footing by recognizing the role of each discipline's expertise, including the patients who also bring expertise to the exchange. In addition, the graphic representation of the flow of communication underscores the mutual contributions and simultaneous, non-sequential nature of the interactions for patients and providers. Finally, the clinical microsystem and the intra-mesosystem (SMAs) are overlapping to reflect that SMAs do not eliminate the traditional clinical microsystem but rather offer another opportunity for care, with both approaches co-evolving. This point is particularly important to recognize, as one concern providers often expressed was the potential undermining impact SMAs might have on the individual provider-patient relationship.

The current local context and care-based practices related to diabetes are summarized in Figure 2. Changes or differences are denoted in italics, with items directly impacting on diabetes care aligned on the right side of the last column. The current state of the SMAs for patients with diabetes is summarized in the pull-out box that reflects the intra-mesosystem redesign level. Figures 1 and 2 help to identify the major changes and shifts in local context as well as the issues related to tailoring the intervention and adjusting the context.

It is worth highlighting some issues at each level of the care system. At the supramacro level, while continued improvement in information technology helps further support the SMA as configured at the local level, the mandates and priorities have changed. While this is to be expected, it does alert innovators and implementers to appreciating windows of opportunity. If the innovation has not taken off and achieved a force of its own (including demonstrating some levels or areas of success consistent with the organizational goals), changing priorities (new mandates), and the lack of success will create increasingly difficult challenges.

Given the demonstrated successes, leaders at the macrosystem system want the SMAs to be expanded to other conditions and possibly other care sites, e.g., the community-based outpatient clinics linked to the main facility. Some new or adjusted practices beyond the actual SMA venue at the mesosystem level have also come about because of SMAs (e.g., monthly clinic meetings to discuss resource allocation and group meetings among discipline representatives) and some will help to further propel SMAs forward (e.g., registry and protocol development to identify high-risk patients).

At the microsystem level, primary care providers are experiencing more pressure to meet performance measures of quality and productivity (and at the supramacrosystem level, the current context is also for more prescriptive approaches about how to achieve goals). The objectives of the diabetes SMA map out to the increased pressures experienced by providers. Seeing the successes of the SMA, providers began to send patients with A1c levels very close to goal. This was not necessarily all positive, as we were unable to accommodate those identified in the registry with an A1c of greater than 9%. While the magnitude of the increase in referrals to SMAs created some unanticipated adjustments, we have worked and continue to work and negotiate with providers to prioritize resources. Their clear desire to refer more patients to SMAs underscores the growing foundation for sustainability.

Many factors contribute to implementation and sustainability of the SMA within the mesosystem (intra-mesosystem component) and with regard to its relationship to the clinical microsystems. Most importantly is how the SMA is valued. The increased number of referrals is evidence of the value placed on SMAs by the mesosytem providers. SMAs are valued by the professionals on the team based on their experiences with patients and on their feelings of a high degree of 'teamness', or esprit de corps [45]. Team members meet after each SMA where various members take turns working a little extra to support the SMA during non-clinical time with activities like making extra phone calls, generating letters to new patients, tracking patient satisfaction data, and meeting to change flow, if needed. In addition, the flexibility of the individual team members is manifest during the SMA sessions; all staff members pitch in with clerical duties as needed, re-check blood pressures, and download glucometers. A weekly meeting after each SMA continues to occur to discuss patients and processes to assure that all team members have an open forum to voice concerns and make group changes, thus maintaining the high degree of shared governance. In addition, beyond improved clinical outcomes, patient satisfaction has helped confirm the added value to providers and to administration (macro- and supramacrosystems). Patient satisfaction surveys routinely are administered following the SMA. Typical comments from patients have included: 'I learned a lot', 'this clinic really takes such good care of patients' and 'I wish this kind of clinic existed 20 years ago.'