Normalizing inconvenience to promote childhood vaccination: a qualitative implementation evaluation of a novel Michigan program

Vaccine hesitancy, where individuals forgo or are reluctant to receive available vaccinations, was named as a major threat to global health by the World Health Organization in 2019 [1]. In the U.S., state-specific policies influence whether parents can act on their vaccine hesitancy: states decide which vaccines are required and whether parents can decline for nonmedical reasons. Lenient state laws and regulations permitting parents to decline are associated with greater rates of vaccine exemptions [2]. In contrast, stricter exemption laws and regulations lead to a reduction in exemptions and vaccine-preventable disease [3, 4]. States have taken different policy approaches to address rising exemption rates, such as California’s elimination of nonmedical exemptions and Washington’s requirement that parents have a conversation with a health care provider prior to forgoing mandatory child vaccinations [5, 6].

Michigan had among the highest kindergarten nonmedical exemption rates and least effective exemption laws of any state [7, 8]. In 2015, Michigan implemented a new rule requiring parents to attend an in-person education session at a local health department (LHD) prior to receiving a formal waiver from vaccination. Prior to this rule, a parent would only have to sign a form at the school in order to decline mandatory immunizations. The mechanism behind Michigan’s rule and resulting educational program is inconvenience, in that the process for declining immunizations is no longer more convenient than taking a child to receive the required immunizations [9]. Michigan’s immunization waiver education program enjoyed initial success in reducing the prevalence of nonmedical waivers. However, waiver rates have been creeping upward after the program’s first year, though not to pre-program levels [10]. A prior study described the state’s implementation role [11]. The purpose of this study is to assess program implementation from the LHD perspective, identify potential barriers to sustainability and long-term-effectiveness, and propose strategies for improvement.

This study utilizes Normalization Process Theory (NPT) to evaluate the implementation process and identify potential barriers to fidelity and sustainability at the LHD level. NPT was chosen because it focuses on the individual and organizational factors associated with successful long-term program performance. NPT has been widely used to examine how interventions become embedded into routine practice in organizations such as LHDs [12‐14]. If an intervention fails to become normalized, program fidelity is at risk and positive long-term results may be harder to attain. Program fidelity is the “degree to which an intervention was implemented as it was prescribed in the original protocol or as it was intended by the program developers” [15]. Fidelity is particularly important to the Michigan immunization waiver education program, as maintaining inconvenience requires that LHDs adhere to the aspects that make the program burdensome to its recipients. Understandably, this burden can anger vaccine-hesitant parents, which in turn exacts an emotional toll on waiver education staff [16]. Staff perceptions of a program as unhelpful to clients negatively influences implementation behavior [17]. Staff will use their discretion to try to make policies more meaningful to their clients and to manage the emotional toll of their work [18, 19]. Administrative theory suggests that LHD staff will seek out ways to lessen the burden on parents in order to lessen the burden on themselves, potentially undermining inconvenience, and fidelity, as a consequence.

Given the nature of Michigan’s approach, it is paramount that LHD staff continue administering it properly. This study evaluates Michigan’s novel local-level intervention, utilizing qualitative interviews with a representative sample of LHDs implementing the program. The purpose is to identify challenges to normalizing the program, and the potential inconvenience it represents to vaccine hesitant parents, into everyday practice. The alternative would be to have the inconvenience aspect erode over time in the face of public pressure—pressure that is present in some localities as well as at the state level [11]. The consequence would be a reduction in policy effectiveness.

Our evaluation identified several threats to the program’s long-term fidelity and sustainability. First, it was rare that LHDs engaged with stakeholders in the community when planning the waiver sessions. Relatedly, there was no clear consensus across the LHDs as to who the stakeholders were in the process. Third, while most identified feasible intervention goals, some indicated that they were aiming at more ambitious, unattainable goals. Fourth, formal evaluation was almost nonexistent, leaving open the opportunity for interviewees to assess the value of the intervention based on anecdotal experiences rather than aggregate results.

This article uses NPT and its components—sense-making, engagement, collective action, and reflexive monitoring—to understand the reasons behind the implementation challenges and examine whether embedding is at risk as a result [24]. Below, we also describe other studies that utilized the NPT framework to identify embedding failures and make suggestions about how to address risks to embedding in program implementation.

Through sense-making, implementers develop an understanding of the program to be delivered, which includes their perceptions of the program’s benefits and stakeholders [24]. While common stakeholder groups were mentioned, not all LHDs cited stakeholders such as parents/families and the general community. Additionally, one interviewee revealed a difficulty with the term stakeholder because waiver-seeking parents’ goals conflicted with departmental goals. Difficulty identifying stakeholders indicates that those implementing the program lack clarity about the intervention’s beneficiaries, as well as its value to these groups. This has a cascade effect, as implementers need to know who to engage as a precursor to involving them. Further, without a good understanding of program purpose and value, program staff may focus less on vital aspects of program fidelity. Anecdotal evidence from a Hepatitis B testing study indicated that staff weighed their discomfort of potential racial profiling against the benefit of targeting testing based on nation of birth, choosing not to implement the targeting part of the intervention [14]. Similar to this testing program, conducting the sessions with vaccine hesitant parents can cause staff some emotional discomfort [16]. In contrast, holding in-person educational sessions for vaccine-hesitant parents maintains program fidelity and is necessary to the rule’s mechanism of inconvenience. Immunization program managers at the LHD and state level should emphasize the benefits to children too young to be vaccinated or the immunocompromised in the community, for example, to help offset the discomfort that delivering the sessions presents. Thus, a broader understanding of benefits and stakeholders can assist with program fidelity and lessen negative aspects of program delivery.

Engagement addresses the relationship work needed to marshal resources for the program, including stakeholder involvement [24]. Stakeholder engagement provides a unique opportunity for researchers, practitioners, and patients to work together to improve a program’s likelihood of success. This innovative approach allows for a fundamental shift in the research paradigm: from the researcher acting as the sole expert to a partnership in which researchers and stakeholders co-lead research activities. Such an approach allows all stakeholders collectively to utilize their knowledge, skills, and experiences to identify meaningful research questions, develop culturally appropriate study design and data collection strategies, and facilitate dissemination of the research findings [27]. Similarly, human-centered design allows for meaningful involvement of stakeholders to promote sustainability and improvement in health outcomes [28].

Consequently, lack of engagement has consequences for program sustainability. For example, a study of a self-management support program for patients with chronic illnesses found that the intervention was not seen as relevant by either the practitioners or the patients, meaning that neither were willing to invest time and effort in the program [29]. The authors conclude that this is one of several reasons why the intervention failed to become embedded into practice. In this present study, interviews indicated that most LHDs did not engage with external stakeholders when planning the program, missing an opportunity to reinforce the program’s importance among staff and within the community. Engagement may influence program sustainability because it also serves the purpose of building a community coalition. This grassroots work has the potential to offset any backlash against the program by parents burdened by the new waiver process: community-level engagement can create a pool of organized advocates to counter-mobilize, particularly as the rule that created the waiver program is continually under threat in the Michigan state legislature [11].

Collective action includes whether the program aligns with the goals and activities of the implementing organization [24]. The vast majority of LHDs hold themselves to the goal of providing education to the waiver-seeking parent. This is also the goal identified in official state documentation about the underlying rule [30]. However, some LHDs also measure their success against generally unattainable goals, notably to persuade vaccine critical parents to vaccinate their child. Persuading vaccine critical parents has been shown to be quite difficult, as those with beliefs on vaccination who are presented with an opposing view generally reject the opposing view [31]. Additional research on waiver education has shown that health educators’ views on the purpose of the sessions evolve over time as they gained experience with the sessions, where persuasion eventually gave way to providing information in a respectful and trusting atmosphere [16]. Yet, this present study, which includes the perspectives of managerial staff in addition to direct service providers, indicates that these views can still persist despite these experiences. Striving for potentially unachievable goals creates challenges to embedding because it is counter to the stated intent of those that hold the LHD accountable, and harms program fidelity as a consequence. Unachievable goals also affect implementer’s perceptions of whether the intervention is working, and therefore worthwhile. Further, such goals indicate competing priorities, which has been shown to lessen the chances of an intervention becoming embedded [32]. Understandably, staff may be grappling with the fact that the mission of a health department is to prevent disease and promote health. Thus, those in management positions at the state and LHD level should continue to emphasize the informational goal of the program, its fit with the department’s mission, and a broad, community-wide view of the program’s stakeholders.

Reflexive monitoring includes implementers’ perceptions of the intervention’s impact, which are informed by participant and/or staff feedback and appraisals of the effects of the intervention [24]. With limited exception, LHDs did not formally evaluate the waiver program with parent attendees. Those that did monitor the sessions relied on staff debriefings and informal parent feedback. Additionally, it is not entirely clear whether formally evaluating participant satisfaction in the program would be useful, as the main mechanism behind its success is inconvenience. Yet, other modes of evaluation, such as assessing staff attitudes and knowledge, may reveal items for improvement, such as deviating goals. A prior study of a family violence screening program similarly found that formal evaluation was lacking, which may indicate to staff that the program was not a priority [33]. However, in the present case, it is likely that LHD perspectives are also informed by state-level waiver data, which is highlighted in state health department press releases and receives major media outlet attention. This likely keeps the waiver program on LHD agendas [10, 34].

The key mechanism of the immunization waiver education program, inconvenience, is a relatively new concept in the public administration literature and holds promise for disease prevention and health promotion. Yet, key examples of from the public administration literature focus on the negative consequences of inconvenience, termed an “administrative burden,” in that it can be used to deter qualified individuals from obtaining government assistance [35]. However, inconvenience can be deployed when value of individual rights and autonomy conflict with the pursuit of public health goals—a tension that is often present in the government’s role of protecting the public’s health [36]. One potential application is to limit the sale of tobacco-containing products during certain times of day, such as permitting electronic cigarette purchase only during school hours. This may lessen access for younger students who obtain them from older students. A second potential application is to require stores to locate foods above a certain added sugar threshold a certain distance from the checkout area, thereby rendering them less convenient to purchase. The opioid epidemic represents another application of inconvenience, where databases flag patients that attempt to obtain multiple prescriptions from different doctors and policies limit the number of pills a patient can receive at one time. Yet, in this instance, inconvenience may be causing additional harms that outweigh the benefits. Those with opioid use disorder are now turning to heroin and other drugs that can be purchased on the street. And, pill limits increase the treatment burden on chronically ill patients who must refill prescriptions more frequently. Thus, inconvenience must be wielded carefully, applying only to situations in which burdens are placed on people that can reasonably accommodate them and where the public health benefits outweigh the harms.

As vaccine hesitancy remains a global health concern, countries must consider various approaches to improving vaccination rates. Western democracies prioritize the balance of individual liberties with the protection of the public. Applying inconvenience as a strategy to manage vaccine hesitancy utilizes inconvenience as an incentive that successfully acknowledges individual liberties—while not imposing overly onerous administrative burdens—and encourages individuals to prioritize public health as is necessary for effective vaccine policy implementation. Overall, in the case of vaccine hesitancy, inconvenience is an effective approach that strikes the right balance of respecting individuals’ needs while reducing harm to public health. Future research should address the long-term viability of this inconvenience approach as a method of addressing vaccine hesitancy.

One limitation of this research is that only one interviewee represented the views of 7 of the 16 LHDs. Given the range of responses to certain items, it does not appear that there is an indication of adverse selection. And, in those LHDs where there were multiple interviewees, responses to questions generally aligned across the interviewees. Additionally, our results relied on themes across health departments rather than what is specific to one particular LHD. Finally, this is a cross-sectional analysis of a longitudinal process, meaning that limitations in terms of causality and the inability to capture changes over time apply.

Using NPT, this evaluation identifies challenges to the implementation of the immunization waiver program that have the potential to undermine fidelity and long-term policy successes. Interviews indicated a limited sense of who the key stakeholders are, which can lead to an inaccurate understanding of (and lack of commitment to) the program. Perhaps as a result, there was a lack of key stakeholder involvement in session planning. This is a lost opportunity to engage allies in favor of vaccination. Although most LHDs indicate that their goals are to provide education, others aim for goals that are more difficult to achieve. While formal evaluation is rare, and may be inappropriate in this case, waiver staff do debrief. However, the experiences shared may emphasize extreme cases, such as those parents who decide to vaccinate or who became angry, which in turn can affect staff perceptions of program value. These program aspects challenge the ability of LHDs to normalize it into regular departmental and immunization clinic operations. At the same time, interviewees are aware that they are accountable to entities such as their LHD and the state. It is imperative that these organizations continue to monitor and guide how LHDs are implementing the program, with the end result being that it remains no less inconvenient to receive the immunizations than it is to opt out.