provides a summary of the lessons learned about the implementation and spread of interventions into multilevel practice and policy. Several key themes emerged from our examination of these diverse examples.
Lessons learned from examples regarding implementation and spread of interventions into multilevel contexts*
Combinations and Phases of Multilevel Intervention Implementation
Attention to the nature of stakeholders at each level is key to successful implementation of a multilevel intervention, as is a strong understanding of how levels may interact. For example, in CHOICE, academic detailing was designed to prepare providers for patients activated by the decision aide. The HVMA delivered patient and provider reminders in parallel. Creating interdependencies also can be beneficial, for example, when local programs received tobacco control funding for mapping to state-level program activities or where local facilities received incentives for achieving compliance with CRC follow-up performance monitors. Determining the quality of the evidence (and continually integrated new evidence) for the interventions being deployed at each level also is important. However, when the evidence is lacking, blending scientific literature with experience from successful programs can be especially useful. Use of social marketing strategies also provided interventional messaging that penetrated multiple levels, though messages often have to be honed for each level's target audience (ie, what rivets the attention of patients likely differs from that of providers or policymakers). Several projects emphasized rapid cycle improvement pilots to test functions and effectiveness of implementation efforts within and across levels. This approach is especially important given the size and complexity of multilevel interventions and the importance of balancing fidelity and flexibility when adapting to local contexts.
Implementation also benefited from staged approaches, beginning with pilot testing within levels at a single practice or community followed by broader implementation as details and needs at each level become clearer (5
). Recognition of the time needed for changes to penetrate each level's members’ knowledge and behavior is often underappreciated. For example, many multilevel interventions rely on champions, which requires education/training of the champion and then their peers or constituents (either by the champion or project team) through formal or informal social networks (76
The direction of implementation—top–down vs bottom–up—also is an important distinction. In the Pool Cool program, the demand for and interest in the program went in different directions at different levels of the intervention. In some regions, motivated leaders at the top sometimes dictated program involvement, whereas in other regions, someone from a “lower level” (eg, a specific pool) was resourceful enough to find other sites and resources to bring the program to the local area. Tobacco control successes clearly moved from local and state levels to the national level for dissemination to other states that could emulate successful states’ practice-based experience, blended with evidence-based practices from controlled trials on specific interventions. TIDES also grew from a bottom–up intervention design guided by regional priorities and later was adopted nationally. Experiences from these programs, as well as others, also point to the importance of comprehensive process evaluations to measure the levers and directions of implementation, as well as the processes used, if any, to promote activity and align interests at different levels.
Partnerships Within and Across Levels
The importance of partnerships within and across levels and between researchers, clinicians, and managers was a clear and consistent theme across the examples, reflecting in large part the reduced control that researchers have over implementation dynamics on each level and the need to hand off intervention activities to nonresearchers—otherwise, it would not be “routine care” (5
). To fit local conditions, proactive and intentional adaptations to the environmental and organizational milieu represented by each partnership level (eg, practice tailoring) reduce the risk of failed implementation (77
). Such partnerships require shared knowledge, trust, and role specification; require time spent in relationship- and team-building before, during and after implementation (with changing roles over time); and continual identification of a growing network of stakeholders who will ultimately maintain and be responsible for the intervention components at their level. Few studies have documented the costs associated with such implementation, with the exception of TIDES, which demonstrated substantial contributed time by implementers and researchers (85
Strong support from senior leaders is also essential. Policy, community, practice, and other leaders help ensure engagement of members at their respective levels and frequently secure and allocate resources while also encouraging other participants who may need to be involved (eg, engaging gastroenterology and/or radiology specialists in primary care–based efforts to improve CRC screening). Senior leaders also are accountable for implementation and maintenance activities between research team contacts and may play a major role in coalition building. Partnerships with health information technology staff also were considered key, especially in settings with electronic medical records (EMRs).
Implementation Barriers and Facilitators
Consistent with the Institute of Medicine's Crossing the Quality Chasm
), our examples point to the importance of organizational supports for implementation. In some scenarios, such supports may be centralized across a large number of sites (eg, computerized decision support in practices with a shared EMR or state-level media campaigns for tobacco control) and may include direct grants, special funding allocations, and/or protected time for quality improvement and training. The degree of leadership control over a particular level may also increase the consistency of implementation, especially when supported by regular feedback of evaluation data. For example, in the HVMA CRC screening intervention, organizational leaders fully endorsed the programs being developed, allowing key quality improvement staff to participate actively in their design and implementation. However, implementation that requires interdisciplinary cooperation may be met with resistance when members at a particular level compete for resources or control or operate in silos where communication and coordination mechanisms may not have been developed. The perceived importance or value of implementation goals must be balanced with competing demands among busy members at any given level (87
). These kinds of implementation barriers may not be predictable, underscoring the value of planning phases, “pre-work,” and PDSA cycles as integral components of implementation efforts.
Understanding Policy Context, Fiscal Climate, and Performance Incentives
Insofar as all behavior is affected by context, our examples demonstrated the vital importance of understanding the contextual influences surrounding players at each level of implementation. For example, the policy context in Massachusetts during the time of the HVMA CRC screening initiative was a virtual “perfect storm” in favor of implementation, as confirmed in structured interviews with HVMA chief medical officers, another large integrated provider network in the same region, and two regional insurers. The National Committee for Quality Assurance (NCQA) had introduced a new Healthcare Effectiveness and Data Information Set (HEDIS) measure for CRC screening in 2004 (89
), with two of Massachusetts's four major insurers having participated in NCQA's field testing of the new measure. Pay-for-performance incentives for CRC screening rates also were being incorporated in some health-plans’ provider contracts, and a statewide quality monitoring program, Massachusetts Health Quality Partners (http://www.mhqp.org
), was preparing to release statewide public reports on medical groups’ CRC screening rates. In other states without this policy context, the same level of adoption and participation might not have been seen.
Similarly, the rapid adoption and implementation of practice-based evidence for tobacco control from California and Massachusetts was accelerated by the Master Settlement Agreement between the states’ attorneys-general and the tobacco industry, which infused large amounts of earmarked funds into state tobacco control budgets. Implementation in settings where the fiscal climate is more difficult requires advance assessment of practice priorities and placement of the intervention among competing demands, in addition to adapting to local constraints.
Determinants of Spread
Few examples of intervention spread are generally available. Among our examples, the spread of successful tobacco control programs benefited from CDC's best practices document as a touchstone for planning programs at a time when the Master Settlement funds became available from the lawsuit filed against the tobacco industry, making its publication both timely and immediately applicable. Although such timing may occur serendipitously, implementation clearly benefits when advances at different levels of influence co-occur.
In the 4 years since the HVMA CRC screening interventions were originally implemented, the CRC screening rates have continued to rise from 63% to about 85%, which is one of the highest publicly reported rates for any medical group, health-plan, or region in the United States. This high rate was achieved through a strong organizational commitment to CRC screening, an advanced EMR for tracking CRC screening and other preventive services, and an expanded capacity to perform screening colonoscopy (by about 300 procedures per month) at a new HVMA endoscopy center.
Champions can support spread in addition to implementation, for example, through initial practices’ sharing of their experiences and troubleshooting with spread practices. Such person-to-person support, however, may best be accomplished when augmented with tools that facilitate adoption in new locations (eg, tracking tools, compendia of evidence, listservs, resource websites), adaptation to new populations (or subgroups), and measurement and evaluation.
However, one of the keys to implementation and spread based on these examples is the explication of the handoffs of multilevel intervention activities from researchers to accountable individuals within and across levels. When researchers support implementation by offloading certain activities from providers, they are unintentionally creating a nonsustainable situation. Furthermore, when multilevel interventions engage several clinical disciplines and multiple levels of leadership, no single handoff strategy is likely to succeed. Better assessments of usual practice, development of explicit memoranda of understanding (ie, spelling out the details of new roles and responsibilities), and continual management of research–clinical partnerships help alleviate at least some of these issues.
Sustainability: End Game or Myth?
Implementation of current evidence remains painfully slow, and the evidence base itself may not change as fast or as dramatically as often implied. Nonetheless, one of the reasons it is difficult to implement and spread evidence-based practice is that the levels of implementation are often changing. Practices face provider and staff turnover and leadership changes, and the political environment is always evolving. Just as multilevel influences are in perpetual motion, so is the evidence base to support interventions. New trials are completed, whereas observational studies contribute new information to our understanding of the factors involved in patient, provider, or organizational behavior and beyond. It is therefore important to continually scan and integrate new evidence over time: Sustainability may be a myth as there is always new evidence to consider, new people to train, practices opening and closing, communities adapting to new contexts, and state and federal agencies and their priorities changing. Unfortunately, systematic reviews, in their typically exclusive reliance on randomized controlled trials, will not close the information gap in the strategies for implementation, spread, and sustainability.
Based on the examples we reviewed, the best evidence for sustainability is long-term and continual attention to influences within and across all levels, enabled by engagement of people and places with ever increasing and overlapping spheres of influence (90
). Integration of evidence into new national norms, regardless of how such norms are fostered or reinforced (eg, through performance measures, new reimbursement policies or legislation), is an essential method for sustaining multilevel change, though the path at the national level is complex and circuitous at best.
While full treatment of the range of study design and other methodological issues rooted in implementation and spread research are beyond the scope of this monograph, provides insights into the methodological approaches each example used, as well as the challenges they faced. Key issues span study design complexity, geographic scope, measures and data collection mapped to multiple levels and over multiple waves, and the inherent value of EMR systems for supporting evaluation and monitoring.