“‘Transition issues’ need to be addressed in moving something from one organization or from a pilot to a larger scale. So things like information systems are needed … training and identifying staff.”
Marie Schall, Institute for Healthcare Improvement
Taking a successful cardiovascular innovation to scale requires careful preparation. Because complex innovations often include multiple elements, it is critical to distinguish the innovation’s core elements from other elements that can and should be tailored to the particular requirements of different implementing contexts. Participants grappled with the challenge of balancing the need for maintaining fidelity to the innovations’ core elements with the need to tailor the innovation so that it can work well in other settings or populations. In addition, for broad scale up and spread of Million Hearts™ innovations, implementation packages consisting of support materials and services must be developed to assist potential adopters.
Identify Core Elements of the Innovation
“As I think about the intervention that you described and that you’re doing, it really strikes me that there are multiple interventions here. And so part of my challenge is trying to figure out which of these things really make a difference.”
Foster Gesten, New York State Department of Health
Many health care innovations, like the ones featured in the Million Hearts™ event, consist of complex combinations of new activities, organizational structures, and professional roles. The outcomes of these complex innovations result from the mix of planned interventions with the attributes—systems, policies, resources, and culture—of the organizational context in which the interventions were originally implemented. Thus, when these tested interventions are considered for scale up and spread, it is critical to identify the core components of the innovation—those critical items that “make the difference”—and distinguish these from other characteristics that are less central and may be modified as necessary, depending on the particular circumstances of the adopting settings. In fact, step one of the World Health Organization’s (WHO) nine-step plan for developing a scale up strategy is to identify the key components of an innovation (WHO 2010). Moderator Paul Plsek summarized threads of the participant discussions in terms of the importance of breaking an innovation down into “simple rules or minimum specifications”—the two to three key ingredients in each innovative program—and ensuring that efforts to scale and spread the innovation maintain fidelity to these key ingredients.
Throughout the Million Hearts™ event, participants and reactor panel members asked each innovator about the core elements that made his or her innovation successful, which would therefore have to be maintained in any spread initiative.
In the first fishbowl presentation of the event on the Heart360® program, innovator David Magid of Kaiser Permanente Colorado articulated the core elements of the program to include (1) a home blood pressure monitoring program and (2) clinical supervision of readings with prescription modification as needed. Magid explained how home blood pressure monitoring is not enough by itself to obtain the desired clinical outcomes and that the second element—clinical supervision and medication adjustments as needed—was necessary to achieve lower blood pressure results.
During discussions about the Language Concordance Health Coaches innovation, Foster Gesten, from the New York State Department of Health, identified five interventions: (1) focus on patients at highest risk of poor outcomes if they are not able to self-manage their chronic illness (at San Francisco General Hospital, they targeted diabetic patients with hgbA1c > 8); (2) health coaching, which entailed providing self-management support to patients; (3) language concordance (i.e., using health coaches who speak the patient’s preferred language); (4) monitoring patients’ progress and outcomes in monthly meetings; and (5) telephonic follow-up support with the patients after the visit and serving as a liaison between the patient and the clinician. After articulating these components of the Health Coaches innovation, Gesten challenged the innovator, Hali Hammer, to identify the core of her innovation. She responded: “The part of this that I think is really most valuable and that has the most far reaching multifaceted impact is training people who are not the most highly educated, highly trained, and expensive people on the health care team to provide self- management support and to teach people how to take their medications.”
In the fishbowl session on the Medication Therapy Management innovation, also referred to as the Asheville model, discussion centered on the core elements that distinguished this model from other disease management programs. The centrality of the pharmacist role to the innovation was a subject of debate. Although the innovator Barry Bunting argued that “there is a unique aspect that a pharmacist brings to the plate,” especially when the primary treatment is drug therapy, he conceded that a health care professional “touching [patients] more frequently than they’re currently being touched in the system” is what is most important. In other adaptations of the original Asheville model, the program has demonstrated success through the use of diabetes educators, nurses, and even respiratory therapists in asthma programs.
These discussions during the Million Hearts™ event underscored the realization that identifying the core of an innovation is not necessarily an easy task. It may be helpful to conduct formal analyses of the core components of innovative programs to identify what is essential for a program to succeed when replicated and which pieces are more flexible (DHHS/SAMHSA/CSAP 2002). However, such analyses may not always succeed in shedding light on this complicated question. Speaking about the Asheville Medication Therapy Management innovation, for example, Barry Bunting noted that, despite extensive analysis over 5 years, researchers at the University of North Carolina were unable to identify which elements in this innovation were most critical to its success.
Tailor the Innovation to Local Contexts
“What are the essential elements of the models that we were looking at, and then how can we look at different settings and see how they might be applied? … The understanding and the recognition for the need for adaption is certainly an important one.”
Marie Schall, Institute for Healthcare Improvement
As a counterpoint to the discussions on the importance of maintaining fidelity when implementing tested innovations, conversations throughout the Million Hearts™ Scaling and Spreading Innovation event focused strongly on the need for adaptation—specifically, tailoring interventions to the local context where they will be implemented. Conference participants agreed that it is essential to consider what tailoring may be needed so that the program will succeed when spread. Evidence of effectiveness is usually confined to the setting in which the data were generated. Typically, evidence on “external validity,” or how the findings may generalize to other contexts, is not available. Thus, the potential adopter faces the challenge of taking that successful model and implementing it using different health care providers or targeting a different population.
Health Care Providers
Tailoring the innovation to a new context may involve investigating whether the innovation’s basic parameters might need to be modified in the new setting. For example, who are the key players in implementing the innovation? The question that surfaced about the centrality of the pharmacist role in the Heart360® and Asheville innovations (discussed in the previous section) illustrates this avenue for adaptation. In Kaiser Permanente Colorado, innovator David Magid had utilized pharmacists to monitor the blood pressure readings and modify medication prescriptions. Gregory Pawlson of Blue Cross Blue Shield pointed out that other providers, such as panel managers, could review the blood pressure readings and follow up with nurse practitioners or physician assistants when abnormal readings are identified. Agreeing with the possible flexibility on this element of the innovation, Magid referenced a similar initiative in Great Britain wherein patients themselves made the changes to the blood pressure medication based on instructions from health care providers. Summing up the possibilities for altering the central role of the health care provider in other implementations of the Heart360® innovation, moderator Paul Plsek cited Clayton Christensen, an influential innovation theorist, who suggested that innovation often consists of finding someone less expensive and more accessible to fulfill functions that were traditionally carried out by more senior professionals.
A variation on considering who might be pivotal in implementing the innovation is to think in terms of using teams in place of individual professionals. Mark Smith, from the MedStar Institute for Innovation, suggested that the Asheville model could be tailored and improved upon by using a team of physicians and pharmacists. This care team could improve efficiencies in that it could “shorten the feedback loop of pharmacist’s observation, suggesting it required intervention, as opposed to having the patient have to then go to the doctor’s office. If they know and trust each other, a phone call, a message … and we’ll adjust the medication right then.”
Tailoring an innovation might take the form of changing the target population. For example, René Vega explained how Aetna’s culturally sensitive innovation to promote blood pressure control among African Americans can be tailored to a variety of populations, defined in ethnic (e.g., Latinos), age (e.g., Medicare), or economic (e.g., Medicaid) terms. The success of the early pilots has encouraged Aetna to implement the innovation within broader populations insured by Aetna. Similarly, Hali Hammer’s San Francisco innovation, Language Concordant Health Coaches, could easily expand beyond its current target population, high- risk patients with diabetes, to other high-risk populations, as well as to other populations with limited health literacy. In fact, participants in the Million Hearts™ event pointed out that the goals of the Health Coaches innovation—to improve self-management and quality of care—apply broadly to most populations who receive health care services.
Package the Innovation for Spread
“There’s all the (new) operations and implementation issues … you don’t want to reinvent the wheel every time. There’s a lot of opportunity for shared learning at that local level where they may have commonalities in those intricacies of implementation.”
Adam Zavadil, Alliance of Community Health Plans
Potential adopters of any novel care delivery process typically need significant assistance in implementing the interlocking processes, technologies, and organizational role changes that make up complex health care innovations. Meeting participants noted that, for the cardiovascular innovations to spread broadly across the country, the challenges of adopting and implementing new ways of working would be aided by the availability of support materials and services for the innovation. Their views are supported by an analysis of four national quality campaigns conducted by Yuan et al. (2010), which found that having practical implementation tools and guides to link innovations with widespread adoption was a key strategy for achieving spread of innovative programs.
However, while spread packages were identified as a critical element for the spread of healthy heart innovations, only one innovation of the four featured during the event, the Asheville Medication Therapy Management model, had moved to this stage of development. In 2005, the American Pharmacists Association (APhA) Foundation secured grant funding from several large pharmaceutical companies to spread the Asheville approach to ten cities, with a particular focus on diabetes. To launch the Diabetes Ten-City Challenge, the APhA developed materials and assistance for large employers implementing the program. The APhA Foundation subsequently supported adoption of the program for other conditions in these ten cities.
There is no well-developed checklist for what might constitute an innovation’s “spread package.” Examples of materials that might constitute a “spread package” may be seen in the Asheville innovation and other innovations that have been scaled and spread to multiple adopter organizations (e.g., the Nurse Family Partnership,4 the Hospital Elder Life Program [HELP],5 and the Green House® Project6 [Home-like Nursing Homes]). Some examples include communication about evidence of the program’s effectiveness, training materials, job descriptions and organizational charts, frequently asked questions (FAQs), step-by-step manuals/toolkits (“cookbooks”), and descriptions of workflow procedures. Additionally, information on procedures for quality control and auditing the program can help others maintain fidelity to the work product or measures conducted. Other useful materials include sample communication materials, such as letters, flyers, posters, etc., that can be used to publicize the initiative and garner support. In addition, the methods or approaches for conducting outreach can also be a helpful material for an adopter to access.
“Spread packages” might also include services as well as materials. The spread organizations noted above provide consultation and technical assistance in addition to implementation materials. Participants also pointed to the usefulness of peer learning networks that provide the opportunity for individuals who are implementing a program to talk to one another, keep momentum going, and troubleshoot implementation barriers. An example of this peer support and mentoring network was provided through the AHRQ Health Care Innovations Exchange to assist in the spread of the Community Care Coordination Pathways model.
The experience of the Asheville innovation and other national innovation campaigns points out that development of spread packages and assistance requires considerable resources and focused effort. Funding for the development of spread packages has typically come from the government agencies (e.g., CMS, AHRQ, and CDC) and philanthropic foundations (e.g., Hartford Foundation, The Robert Wood Johnson Foundation, and the American Heart Association). Discussions during the Million Hearts™ event suggested that complementary funding might be desirable from the private sector, such as from national and state business coalitions on health. Representatives from these types of organizations spoke about the interest among their employer members and potential willingness to support these kinds of services.
It is not obvious who should develop spread packages and at what point this effort lies with the innovator of the program or with spread organizations. More information pertaining to the relationship between innovators and spreaders is presented in the next section, “Connect Innovators with Spreaders.”