Despite COVID-19 vaccines being available to 12-17 year olds since May, 2021 and to 5-11 year olds since November, 2021, uptake of the vaccine series in this age group is sub-optimal. As of early September, 31% of 5-11 year olds and 61% of 12 to 17 year olds have completed the two-dose series and only 14% of 5-11 year olds and 29% of 12-17 year olds have received a booster (CDC, 2022). Vaccine hesitancy among parents is a primary factor driving these low rates of uptake (Alfieri et al., 2021; Rane et al., 2022, Scherer et al., 2021). Parents report safety concerns, fears about side effects, skepticism about the vaccine development and approval processes (Szilagyi et al., 2021), and the widespread perceptions that COVID-19 infection poses minimal risk to children and so the vaccine is unnecessary (Ruggiero et al., 2021). While combatting vaccine hesitancy will require collaboration across medical professionals, public health, and community organizations, research suggests that pediatricians will be the key messengers for parents. Parents have reported very high levels of trust in their child's pediatrician for information about the COVID-19 vaccine (Alfieri et al, 2021; Purvis et al, 2021; Scherer et al., 2021, Szilagyi et al, 2021), and many have reported a strong preference for their children to be vaccinated at their pediatrician's office (BLINDED FOR REVIEW; Scherer et al., 2021). Providers serving pediatric patients have echoed these sentiments, reporting that parents have expressed preferences for being able to bring their child to their primary care provider for the vaccine and wanting to hear from their own pediatricians about vaccine information (BLINDED FOR REVIEW).
As the pandemic continues, vaccinating children and adolescents remains a priority to enable them to more safely return to social activities and to avoid potentially serious health complications related to COVID-19 infection (Barrett et al., 2021; Delahoy et al., 2021; Molteni et al., 2021; Zimmermann et al., 2022). Given that vaccine hesitancy has been a growing problem (He et al., 2022) and we already have strategies to address this hesitancy (Jarrett et al., 2015), the goal should be to draw from and adapt these strategies and evidence-based interventions that have been successful in addressing hesitancy around other vaccines (Ryan et al., 2022). Two emergent themes relevant to addressing COVID-19 vaccination are the critical role of the provider in parental communication (Elingson et al., 2022; Gilkey et al., 2016) and success of multicomponent interventions (Jarrett et al., 20215). Thus, to increase parental confidence in COVID-19 vaccination and increase pediatric vaccination rates, these strategies and interventions need to be adapted for relevance to the unique and urgent context that we are currently experiencing.
Informed by rapid qualitative research conducted by our team and adaptation of evidence-based strategies developed for other vaccines, our team developed and implemented a multi-component practice-based intervention, CONFIDENCE: Clinicians for Effective COVID-19 Vaccine Conversations for Youth and Adolescents, to support healthcare providers in having conversations with vaccine hesitant and resistant parents. The purpose of this paper is to describe the development process and results of the beta-test of the CONFIDENCE intervention.
As shown in Figure 1
the confidence intervention consists of three key components, a 3-step communication training for providers, provider “my reasons why’ poster campaign, and parent facing educational materials.
3-Step Communication Training
We held a 1-hour online training in which we gave an overview of COVID-19 vaccine data, current vaccination rates, described the CONFIDENCE intervention and demonstrated the provider counseling component via role-playing videos. The CONFIDENCE counseling algorithm involves (1) a strong presumptive provider recommendation such as “All of our providers are committed to keeping your child as safe as possible from COVID-19 infection, so we are strongly recommending that all our patients get the vaccine as soon as possible. We can do that today at the end of your visit", (2) assess vaccine readiness and identify whether parent is hesitant or resistant, deliver tailored assistance, and plan follow up using motivational interviewing principles, (3) and sharing providers’ personal vaccine stories. The approach is intended to encourage hesitant parents, be collaborative, and not alienate resistant parents. Six providers (50% of clinic providers) attended the training.
Provider “My reasons why” Posters
For all interested providers, including nursing staff and residents, we held sessions with a professional photographer to take portraits and a research team member worked with providers to develop their vaccine stories centered on their personal vaccination motivations. For example, one pediatrician shared the following:
“I have 10-year-old twins that have asthma and a five-year-old. I got my children vaccinated to protect them and their grandparents. They all got their first dose at school and my 5-year-old got it on his birthday and proudly told everyone it was his first birthday present!”
These photographs and personal vaccine stories were used to create custom posters supporting COVID-19 vaccination which were displayed throughout the clinic.
Parent-Facing Educational Materials
During the 1-hour online provider training, we also introduced providers to our parent-facing educational materials. These educational materials were developed to address common questions and concerns raised by parents during the formative focus groups. Educational materials included a trifold fact sheet infographic with Q&A regarding COVID-19 vaccination for 5–11-year-old children and a single page fact sheet with general COVID-19 vaccine information for all age groups. We supplied these educational materials in 9 languages (English, Spanish, Portuguese, Vietnamese, Haitian Creole, Swahili, Pashto, Dari, Farsi) and kept them stocked in the exam rooms of the clinic throughout the beta testing period.
Beta-test and evaluation
We beta-tested the CONFIDENCE intervention in a pediatric primary care clinic associated with an academic medical center and the largest not for profit healthcare system in Central Massachusetts over a two-month period. The clinic was recruited through professional connections within our institution. In this process we identified a provider who served as the physician champion for this project and assisted with dissemination of materials and implementation logistics. The clinic began administering COVID-19 vaccines in July 2021 and has administered an average of 176 COVID-19 vaccines per month between July 2021 and April 2022.
We used a mixed-methods approach to evaluate the CONFIDENCE intervention, employing both provider interviews and pre-post parent surveys. Our Institutional Review Board determined that this project was not human subjects’ research.
Our primary measures were feasibility and acceptability for providers and parents. We conducted mid-point provider interviews four weeks post training. Our team emailed all the providers (n=6) who completed the webinar training to request participating in short interview via phone or video conferencing. We developed an interview guide to assess the following: participation in CONFIDENCE intervention components, acceptability, feasibility, as well as barriers and facilitators to implementation.
Acceptability was also assessed through parent surveys. These pre-post parent surveys (available in English, Spanish and Portuguese) were completed by parents/guardians after well-child visits. In addition to acceptability, surveys also assessed: demographic information about the parent and child; parent's COVID-19 vaccination status, child's COVID-19 vaccination status, satisfaction with conversation with provider about COVID-19 vaccination, and future COVID-19 vaccine intentions for child. Survey data collection began approximately two weeks prior to the webinar training which comprised the pre-test and continued for another eight weeks after the training which comprised the post-test.
To analyze interview data, we used rapid qualitative methods (Vindrola-Padros & Johnson, 2020). We developed a summary template using the primary topics addressed in the interview guide and two team members (NAMES BLINDED) completed a summary for one interview and then met to discuss and resolve any discrepancies. Through this process we added an additional domain to the template and then one team member (NAME BLINDED) completed the remaining template summaries. These summaries were then organized into a matrix of domains and participants. For survey data we generated frequencies and descriptive statistics. To account for small sample sizes, we used Fisher's exact test to explore pre-post differences.
The results of our beta-test of the CONFIDENCE intervention suggest that this approach has promise to support pediatric clinics in their efforts to promote COVID-19 vaccination. Specifically, intervention participants reported high levels of feasibility and acceptability of participating in the intervention and our survey data suggests positive trends in improving vaccine acceptance. However, we encountered several challenges related to implementing the CONFIDENCE intervention that will need to be addressed before conducting a larger-scale trial of the intervention.
We found promising results in terms of feasibility and acceptability as well as outcomes in the parent surveys. The principal component of the intervention was the 3-step communication training outlining the provider-delivered counseling algorithm that had a goal of empowering providers to improve communication with hesitant and resistant parents. The training outlined a process of giving a strong recommendation for the COVID-19 vaccine (Gilkey et al., 2016), followed by assessing vaccine readiness, exploring ambivalence, delivering tailored assistance and planning follow-up using motivational interviewing principles (Miller & Rose, 2009), and sharing a personal vaccine experience, if possible, their own child's vaccination experience (Massey et al., 2021; Perkins et al., 2020). Overall, providers reported high acceptability of this approach and ease of use in integrating it into their everyday practice. Increasingly, there is literature suggesting that the approaches used in our approach may be appropriate to reduce hesitancy around COVID-19 vaccination (Garbarda & Butterworth, 2021; Rutten et al., 2021). However, to date, we have not found established evidence on the effectiveness of combining these three approaches specifically for COVID-19 vaccine promotion in a pediatric population. In addition to our communication algorithm being acceptable to providers, there was also evidence of adoption of at least some of these strategies in the results from the parent survey. While our study was not powered to detect statistically significant pre-post differences, on nearly all measures related to the conversation with the provider about vaccination we saw more positive results in the post-test group. Importantly, we found that a higher percentage of parents in the post-test group reported their pediatrician discussed COVID-19 vaccination at the visit, that the pediatrician shared their personal vaccine story, and that they had made the decision to vaccinate their child at the appointment. Together these findings suggest successful integration of the training components into routine clinical practice
Challenges related to both the implementation of the CONFIDENCE intervention as intended as well as to our data collection process were identified. Related to implementation, providers reported not using or distributing the educational materials to parents. The parent-facing educational materials (fact sheets and tri-fold brochures) were available in all exam rooms, however, as one provider noted, simply making them available was not sufficient. To ensure broader dissemination of these materials, one strategy, as suggested by one of the providers in our study, may be to integrate them into electronic health record platforms so that providers could attach them to patients’ visit summaries. In terms of data collection, one logistical challenge we encountered was related to distribution of the surveys. The providers were responsible for distributing the survey to parents after their visit, however, as all the providers we interviewed noted, they did not always remember to do this. Moving forward, a more streamlined approach to data collection will be needed to ensure sufficient sample size to establish efficacy, and ultimately, effectiveness of this intervention. To resolve both of these challenges, one potential solution could be to use workflow mapping (Ozkaynak et al., 2013) to identify alternative options for survey dissemination and integrating the parent-facing materials into visits. It is likely that all clinics will have different processes for this and thus, implementation will need to be tailored to be appropriate for specific clinic workflows to ensure data collection is completed.
To date, the majority of the literature on pediatric COVID-19 vaccination has focused on understanding parental intentions (Scherer et al., 2021; Szilagyi et al., 2021) and factors affecting those intentions (Head et al, 2022; Rogers et al., 2021; Walker et al., 2021). Moreover, much of the literature on interventions to promote COVID-19 vaccination has explored either policy interventions (i.e. mandates (Mello et al., 2022; Sprengholz et al., 20220) and incentives, (Thirumurthy et al., 2021) or mass communication strategies (i.e. text messages, emails, social media) (Freeman et al., 2021; Saantos et al., 2021)). However, there have been few reports of clinic-based and provider-focused interventions that focus on reducing parental hesitancy for COVID-19 vaccination. While a multi-level approach that includes policy and communication approaches will be needed to encourage hesitant and resistant parents to vaccinate their children, previous literature on pediatric vaccine interventions has identified that providers are critical to vaccination efforts.(Frew et al., 2017; Oh et al., 2021). As COVID-19 vaccination rates in the pediatric population remain low, identifying these best practices and building an evidence base around clinic-focused interventions should be a priority. Our future research will prioritize adapting and further testing the CONFIDENCE intervention to support pediatric practices in these efforts.
Strengths and limitations
The primary strength of our approach for the CONFIDENCE intervention is that development and implementation was directly informed by our team's formative qualitative research (BLINDED FOR REVIEW) as well as existing evidence-based practices to promote vaccination (Ellingson et al., 2022; Gilkey et al., 2016). Additionally, the use of rapid qualitative methods both in our formative work and our evaluation of the beta-test allowed us to be responsive to current context by moving from intervention development to implementation, evaluation, and dissemination in under a year (Vinrola-Padros & Johnson, 2020).
However, our results are subject to certain limitations. We completed the beta-test in a single pediatric clinic within an academic medical center setting and thus we are unsure how this approach would translate in a community clinical setting. Moreover, since our goal was to establish feasibility and acceptability, we did not design this study to be powered to detect significant pre-posttest differences. Our ability to explore potential intervention effects was also limited by the challenges providers experienced in collecting survey data. Finally, it is important to note that parents’ levels of hesitancy are dynamic and while our intervention took place over a short time period (10 weeks) it is possible that the positive results we observed in vaccine acceptance could be due, in part, to changing public sentiments. Despite these limitations, we are encouraged by the positive results observed in this beta-test, and believe that future randomized clinical trials are warranted to establish stronger evidence for the CONFIDENCE intervention.