Successfully implementing an intervention within a complex service delivery system requires multiple, inter-related adoption strategies. The Veterans Administration’s (VA) renewed emphasis on Hepatitis C treatment offered a perfect opportunity to study which strategies worked. In this post, I will review those findings. Then, I will discuss the importance of accounting for the complexity of strategy combinations in implementation science and evaluation.
Hepatitis C and the New Treatment Era
Hepatitis C is the most common chronic, blood-borne infection in the US. HCV infection prevalence is estimated to be around 1.8%, and the CDC estimates that around half of those infected aren’t aware of their infection status! Those at highest risk include people with direct exposures to blood (i.e., injection drug users, recipients of transfusions from HCV-positive donors, and hemophilia patients treated with clotting factors before 1987). In addition to the behavioral risks, the prevalence of infection also varies greatly by geography, age group, and institutional exposures.
The US Department of Veterans Administration (VA) treats a population that is at notably increased risk of chronic HCV infection. While the actual prevalence in veterans is unknown, it is estimated to be somewhere between 6.1% and 21.7% in large prevalence studies. At this point, the VA can believably claim that it has treated and cured more HCV patients than any other healthcare delivery system in the US.
Recently, the introduction of Direct Antiviral Agents for the treatment of hepatitis C (HCV) infection in recent years has radically altered the landscape of treatment options for HCV-positive individuals and populations. Treatment regimens that feature these new drugs consistently achieve successful treatment rates greater than 95% in less time than the previous standard treatment regimens featuring interferon and ribavirin.
Implementation of a New HCV Treatment Program in the VA
A recent study published in Medical Care, by Vera Yakovchenko and a whole network of VA–Academic investigators, took a look under the hood at 80 VA treatment centers to figure out what strategies led to the highest treatment rates, under the new testing and treatment protocols.
They did this by applying an intriguing method known as Configurational Comparative Methods (see Methodology Corner below for a more in-depth discussion of this approach) to find the best combinations of strategies. First, the team interviewed each site regarding the use of 73 implementation strategies when rolling out new HCV screening and treatment efforts. Then, they compared the strategies employed by the sites with the most (above 50th percentile) HCV treatment starts to those with the fewest (below the median performance). From this comparison, the authors published that they found five pathways (solo strategies or combinations) that explained 80% of top-half performances (sensitivity) with 100% “consistency” (meaning specificity, or no false positives; See Figures).
Figure 1. Key strategy configurations for the top-performing sites in the study.
Interpreting the Results
Given the novelty of the Configurational Comparative Methods (CCM) approach, it is essential to pause and consider how we interpret the results. These pathways were not the exclusive strategies adopted by the sites that implemented them – most of the successful sites adopted one or more of these pathways AND additional strategies beyond that (25 strategies on average, ±14 [range=1-59]). They were also not the only way to break into the top half. Remember that these pathways showed up in 80% of sites in the top half – but 0% in the bottom half of sites. Therefore, we can consider them highly contributory but cannot say with certainty that they are either sufficient or necessary.
Figure 2. Key strategy configurations (0/40 paths) for the bottom half of the sites in the study.
In other words: If you used one of these pathways, your site was ahead of the curve.
#1 The Champion
Strategy 24. Have someone from inside the medical center tasked with assisting the medical center.
This is easy to interpret as a sort of catchall. From an organizational behavior theory perspective, the aim here seems to be externalizing the authoritative power and implementation activities. I almost labeled this one “talk to that person over there.” Presumably, tossing responsibility to one implementation champion isn’t enough to succeed. This was just one crucial part of the solution. Every site adopting this first pathway also registered at least pieces of the other four pathways (See Figures).
#2 Participatory Culture
Strategy 34. Facilitate the formation of groups of providers and foster a collaborative learning environment.
Strategy 45. Recruit, designate, and/or train leaders.
The second pathway suggests engaging the program’s stakeholders through dedicated training and collaborative educational activities. With all the shifting processes and associated training demands in an overstimulating work environment, the importance of participatory engagement in educational activities is vital to keeping the attention of healthcare providers and staff. The option to recruit and then empower institutional leaders creates buy-in from personnel, first and foremost. Designation of thought leaders builds goodwill and increases the chances that learning activities are collaborative and engaging. Lifting up new leaders also deepens the pool of experience and insight included in the discussion. It can go a long way to support the success of a new service or intervention by increasing the likelihood that the right idea gets into the right room at the right time.
Alternative label: “Crowdsourcing the solutions.”
#3 Put it in Writing
Strategy 22. Develop resource sharing agreements.
Strategy 61. Develop a formal implementation blueprint.
Documentation is excellent for transparency and clear communication. And, it turns out successful HCV treatment programs are aided by the process of documenting and formalizing the implementation steps. It’s a sometimes frustrating fact that stable and productive relationships between medical providers and partners in the community require data-sharing agreements.
The specific step of developing an implementation blueprint is Design Thinking 101. The objective of a project blueprint [pdf, p45-48] is to get an overview of the various elements included in launching an intervention. It is also useful for identifying elements that need further support or consideration. Crucially, the blueprint can be reformulated, detailed, and expanded upon before or during implementation, as a living document.
#4 Outreach and Outward-Facing
Strategy 56. Visit other sites outside your medical center to try to learn from their experiences.
Strategy 71. Intervene with patients to promote uptake and adherence to HCV treatment.
Staying connected with patients helps to maintain the patient’s attention and improve treatment adherence. Interventions that successfully promote uptake and adherence with HCV treatment require adjustment along every step of the specialized care continuum for HCV, from testing and diagnosis, through linkage to care and follow up for initiation and ongoing throughout treatment. This was reinforced by the WHO’s globe-spanning systematic review from 2015, which found successful interventions to connect with HCV patients were able to improve process outcomes at each step along the way [pdf]. These practices also continue to be actively studied.
The strategy of visiting other sites to learn about best practices is likely reflective of a certain mindset – a willingness to learn – that bodes well for sites.
#5 Teams that Share and Engage
Strategy 18. Create new clinical teams.
Strategy 47. Share the knowledge gained from quality improvement efforts with other sites outside your medical center.
Strategy 70. Engage in efforts to prepare patients to be active participants in HCV care.
In some ways, this seems like a twist on the previous pathway. But, with the key addition that comes from creating new clinical service teams. These sites also seem to demonstrate a capacity to generate and then disseminate knowledge from these teams to other sites. Of course, these teams are most likely to succeed when they engage with patients about care planning and conduct.
Methodology Corner: CCM
Configurational Comparative Methods analysis is definitely a big highlight from this study. Showing a new way to think about the complex, inter-related dynamics of multiple program implementation strategies. The pathways identified by this study may show sites in the bottom half how to bring up their numbers. However, the real take away is that this kind of unsupervised modeling is likely the wave of the future.
While CCM has demonstrated usefulness in a wide range of fields, it is not widely used. The concept is a combination of the concepts of Boolean algebra and Set theory. The most common form of CCM is Qualitative Comparative Analysis (QCA). The study by Yakevchenko et al. specifically uses “crisp set” QCA.
It strikes me that CCM is a fantastic nod to realities and complexities in the “Web of Causation” [pdf] model proposed way back in 1960 (of course, CCM doesn’t offer as much in the way of causality as some supporters claim). CCM looks for patterns, acknowledging, and adopting multiple pathways. This is similar to the classic logic combinatorial sets of “sufficient, not necessary,” “necessary, but not sufficient,” and “neither sufficient nor necessary.” These findings from Yakovchenko et al. support their previous findings that individual strategies can interact synergistically, maximizing impact in the right combinations.
Overall, it’s pretty clear that CCM has a lot of potential, particularly as a complement to more traditional quantitative and qualitative methods.
Ben King