Integration of CARD (Comfort Ask Relax Distract) for COVID-19 community pharmacy vaccination in children: Effect on implementation outcomes

Abstract

Introduction:

Community pharmacists report that providing vaccinations can be challenging, particularly if the vaccine recipient is a child, because of heightened levels of fear. The objective of this study was to determine acceptability and feasibility of the CARD (Comfort Ask Relax Distract) system as a vaccination delivery framework for children receiving COVID-19 vaccinations in a community pharmacy setting. CARD incorporates evidence-based interventions that reduce fear and immunization stress-related responses in vaccine recipients and was demonstrated to be effective and feasible in other vaccination settings providing vaccinations to children and adults.

Methods:

This mixed-methods study involved 5 independent pharmacies (with 6 vaccinators) offering COVID-19 vaccinations to children between 5 and 11 years of age. Vaccinating staff and implementation leads from the pharmacy organization participated in a small-scale CARD implementation project (before-and-after design). Afterwards, they filled in quantitative surveys and provided qualitative feedback about their perceptions and experiences in focus group discussions. Qualitative data were analyzed deductively, using the Consolidated Framework for Implementation Research (CFIR).

Results:

The study was conducted between January 16 and March 20, 2022. Across both quantitative and qualitative measures, vaccinating staff reported positive attitudes about CARD and alignment with their professional roles. They reported that CARD reduced children’s fear and improved the vaccination experiences in children and parents and for themselves. Vaccinators reported increased confidence due to CARD. They reported compatibility of CARD interventions within their practice and that it was time neutral. They maintained use of some interventions after the study. They also provided suggestions and shared concerns about fidelity and future feasibility of continuing various components of the program.

Conclusion:

CARD was demonstrated to be acceptable and feasible by vaccinators performing vaccinations in children in community pharmacies.

Introduction

Community pharmacy-based vaccinations are a convenient and efficient way of delivering vaccinations to the public. Pharmacists administering vaccinations, however, have identified challenges with providing these services, particularly in children, due to disruptions in their work processes and the high levels of fear that some children exhibit.^1,2 Insufficient training and experience have also been identified as contributing to reduced confidence in vaccinating children. ³ We recently developed a vaccine delivery framework—CARD (Comfort Ask Relax Distract)—to assist with vaccination planning and delivery activities. ⁴ CARD incorporates evidence-based interventions to reduce immunization stress-related responses (ISRR),^5,6 including fear and pain, and promotes more accessible and equitable delivery of high-quality care during vaccinations. CARD was demonstrated to be effective and feasible in mass vaccinations of children at school as well as public COVID-19 mass vaccinations in individuals aged 12 years and older.^7,8,9

To date, no data have been reported regarding experiences with integrating CARD in community pharmacy-based vaccinations. This study was part of a program of research, published in this supplement to the Canadian Pharmacists Journal, that examined community pharmacists’ experiences with COVID-19 vaccination, ¹⁰ perceptions of CARD, ² impact of CARD implementation in pharmacy-based COVID-19 vaccination delivery ¹¹ and perceptions of pharmacy technician students of a CARD training e-module. ¹² In our preliminary work leading up to this study, pharmacists identified children as the most relevant population for using CARD. ² In a subsequent small-scale implementation project that integrated CARD within community pharmacies during COVID-19 vaccinations in children aged 5 to 11 years, we demonstrated a reduction in ISRR and more positive experiences with vaccination in children and parents. ¹¹ In this article, we report on the perceptions and practices of participating vaccinators and implementation leads (i.e., those who were involved in CARD implementation from the pharmacy organization). The specific objectives were to examine the acceptability and feasibility of CARD. In separate articles in this series, we provide a guide to support pharmacies and pharmacy organizations with CARD implementation ¹³ as well as an introduction to the series. ¹⁴

Methods

The Knowledge to Action (KTA) ¹⁵ cycle and the Consolidated Framework for Implementation Research (CFIR) ¹⁶ were used to guide the project. The KTA ¹⁵ cycle articulates the translation of research evidence into practice as the interplay between knowledge creation and action. CFIR ¹⁶ defines a comprehensive list of constructs that positively and negatively affect implementation success for new interventions.

The project used an integrated knowledge translation approach, involving a multisectoral and multidisciplinary group of individuals with expertise in vaccination and mitigation of ISRR, community pharmacy practice and implementation science, and it included implementation leads. The objectives and methodologic approaches used prioritized child and family-centred care and a pragmatic approach due to the COVID-19 pandemic context.

The study used a before-and-after design (i.e., pre- and post-CARD implementation) in 5 community pharmacies providing COVID-19 vaccination services to children aged 5 to 11 years, including feedback with individuals involved in implementation. The participating pharmacies were members of the Wholehealth Pharmacy Partners group. The pharmacies were selected in collaboration with implementation leads at Wholehealth and were in different geographical locations across southern Ontario, serving diverse ethnic populations. In this article, we focus on feedback from individuals involved in implementation, including vaccinators and implementation leads. In another article in this supplement, we report on child- and parent-reported outcomes. ¹¹

For each pharmacy, a before-implementation period served as the control condition whereby no changes were made to usual practices. An after-implementation period followed and involved implementation of CARD. The time lag between the before- and after-CARD implementation phases ranged from same day to up to 7 days, according to appointment booking schedules of the participating pharmacies. If more than 20 appointments were booked on the same day, then both phases occurred on the same day.

Implementation team members, including research staff and one of the implementation leads from Wholehealth, were present at the pharmacies during before- and after-CARD implementation phases. Research staff observed and documented physical spaces and workflow/processes. They also invited children receiving vaccination services and parents/caregivers (herein, called parents) to complete standardized paper-based surveys before and after vaccination (see previous article in this supplement ¹¹ for details).

During the before phase, CARD implementation plans were created for each pharmacy based on observations of the physical spaces and vaccination processes against the recommended practices for CARD. Feedback from children and parents was used to validate recommendations and identify any site-specific issues. Changes were subsequently recommended to the physical environments for the waiting, injection and postvaccination (aftercare) areas (e.g., displaying posters and activities) and processes (e.g., asking children about preferred coping strategies) and child-vaccinator interactions (e.g., hiding needles, omitting alcohol skin antisepsis, promoting coping).

Vaccinating staff were provided with a summary of the suggested interventions by the lead researcher and one of the implementation leads. Education of vaccinators occurred verbally and was supplemented with review of paper and/or electronic copies of relevant CARD resources. This included, at minimum, the following 3 resources: (1) CARD vaccinator handout summarizing 3 interventional components of CARD—Environment, Education and Engagement (i.e., 3E’s); (2) CARD coping strategy checklist and demographic survey for children to select preferred coping strategies (herein “CARD checklist”); and (3) CARD poster/pamphlet providing an overview of CARD for children and families. Some vaccinators were provided with additional resources (e.g., pamphlets on “comfort positions” and “what to say”) for additional support and reference, according to level of interest and time constraints. Tools and supplies were provided to enable the changes to be made (e.g., posters, distraction toolkits, yoga mats, topical anesthetics, paper copies of child and parent feedback surveys). After review and discussion, the implementation plan was finalized with the vaccinator and incorporated in the vaccination process. The entire education and set-up process took less than 30 minutes. Vaccinators who were not educated on the same day could seek out additional information about CARD on their own.

A summary of the interventions used post-CARD are briefly described here. Waiting and vaccination spaces were altered to include CARD educational posters on the walls, distraction activities (e.g., colouring pages, mazes, pipe cleaners) and candy treats/rewards (e.g., lollipops, mini chocolates) for children. The CARD checklist was provided by research staff at appointment check-in when children and parents were introduced to the CARD acronym; children used the CARD checklist to select their preferred coping strategies for vaccination. Parents could help their children with filling in the checklist. Children and parents were invited to take the distraction items and candy treats with them while waiting for their vaccination and into the injection room. Distraction items and treats were also available in the injection room. Children were vaccinated in a private room with the door closed and independent of siblings. Furniture in the vaccination space was arranged so that children did not face equipment and so that needles were hidden from view. Seating was available beside children for parents. Vaccinators reviewed the completed CARD checklist to guide their interactions with and vaccinations of the children. Vaccinators performed all injections while sitting beside children. All injections were prepared ahead of time, and during vaccination interactions, vaccinators hid needles and omitted alcohol skin cleansing from the injection process. ¹⁷

Vaccinators completed 2 paper surveys after the postimplementation phase. The first survey inquired about attitudes about CARD, where vaccinators provided their level of agreement to a set of statements about CARD using 5-point Likert scales (strongly agree, agree, neutral, disagree, strongly disagree). The second survey inquired about changes in their practices after CARD implementation compared to before (less, same, more). Specific items and wording are presented within the results tables.

Vaccinating staff and implementation leads from Wholehealth were subsequently invited to participate in 1-hour virtual focus group discussions. These discussions were facilitated by one of the team members using a semi-structured interview guide. Participants were asked about their experiences with implementing CARD. This included their overall perceptions about it (vs the status quo or usual practice), specific interventions that are included, how they use it in their practice now and suggestions to support sustained use and training of others. All tools and methods are adapted from our prior studies and incorporated questions informed from the CFIR model.^4,8,9

The project received approval from the Research Ethics Board at the University of Toronto. Informed written consent was obtained for participation in focus groups. Consent was waived for other data collection to allow for population level data.

Sample size and analysis

The sample size for the study was based on clinical outcomes, which are described elsewhere in this supplement. ¹¹ For focus group interviews, we sought a maximum of 5 participants per session for up to 3 sessions, to account for the potential for multiple individuals to participate from each pharmacy. This number of participants has been demonstrated to be sufficient to understand barriers and facilitators to CARD implementation in our prior studies. ⁸

The pattern of responses to survey questions was summarized using descriptive statistics. Interviews were transcribed verbatim and analyzed using directed content analysis ¹⁸ guided by CFIR. Coding was led by 1 team member and reviewed by 2 other team members. Disagreements were resolved by consensus. Field notes and responses to surveys were reviewed to examine consistency with identified codes.

Results

The study was conducted between January 16 and March 20, 2022. Altogether, 6 vaccinators (5 pharmacists and 1 nurse) were involved in administering COVID-19 vaccinations in 152 children (71 in the before-CARD phase and 81 in the after-CARD implementation phase). Table 1 displays characteristics of vaccinators. All had experience vaccinating individuals for over 5 years.

Table 1.

Demographic characteristics of vaccinating staff (n = 6)

	Frequency
Professional role
Pharmacist	5 (83%)
Nurse	1 (17%)
Sex, male	3 (50%)
Number of injections administered in pre-phase (control)	8-22
Number of injections administered in post-phase (CARD)	9-27

Quantitative outcomes

Participating vaccinators held positive attitudes about CARD, believing it was aligned with their role and that it positively affected the vaccination process and experience (Table 2). Practice patterns of vaccinators after CARD implementation compared to usual practices are displayed in Table 3. Vaccinators reported higher use of various CARD interventions, including obtaining children’s preferred coping preferences and inviting children to ask questions. In addition, there was higher use of specific coping interventions, including distraction.

Table 2.

Summary of vaccinator attitudes about CARD (n = 6)

	Median (Range)
Attitudes about CARD
The CARD system is aligned with national professional pharmacy standards	1 (1, 2)
The CARD system is aligned with our organization goals	1 (1, 2)
I understand the individual components of the CARD system	1 (1, 2)
I believe that the CARD system improves the patient experience during vaccinations	1 (1, 3)
I believe that the CARD system improves pharmacy staff experiences during vaccinations	1 (1, 3)
I am confident in my ability to use the CARD system	1.5 (1, 2)
I am willing to try all components of the CARD system	1 (1, 2)
I believe the CARD system is being used in my pharmacy	2 (1, 4)
I believe that the CARD system improves the vaccination planning and delivery process	1 (1, 2)
I believe that the CARD system improves collaboration between pharmacy staff and patients	1 (1, 1)
I believe that the CARD system helps to promote vaccination	1 (1, 3)
I believe that the documentation involved in the CARD system is too time consuming	3.5 (2,4)
I would recommend the CARD system for pharmacy-based vaccinations	1 (1, 3)
I think it is realistic to continue to use the CARD system in our setting	2 (1, 3)
I am likely to continue to use the CARD system in the future	1.5 (1, 3)

Agreement with items assessing using 5-point Likert scale: 1 = Strongly agree; 2 = Agree; 3 = Neutral; 4 = Disagree; 5 = Strongly disagree.

Table 3.

Vaccinator-reported behaviours after implementation of CARD (vs status quo/usual practice) (n = 6)

	Frequency (%)
	Less	Same	More
Actions specific to vaccinators
Obscure needles	0 (0)	1 (17)	5 (83)
Allow seating for support person	0 (0)	3 (50)	3 (50)
Provide privacy to patients (door closed)	0 (0)	1 (17)	5 (83)
Use neutral language (e.g., say “vaccine” instead of “shot”)	0 (0)	3 (50)	3 (50)
Omit alcohol swab from injection process	0 (0)	0 (0)	6 (100)
Inject vaccine quickly (i.e., <2 seconds)	0 (0)	3 (50)	3 (50)
Interactions with children
Ask about preferred coping strategies	0 (0)	0 (0)	6 (100)
Invite questions before injection	0 (0)	0 (0)	6 (100)
Ask to keep arm loose and still	1 (17)	2 (33)	3 (50)
Ask about their symptoms after injection	0 (0)	4 (67)	2 (33)
End appointment on a positive note	0 (0)	4 (67)	2 (33)
Children’s actions
Use distraction items/activities	0 (0)	0 (0)	6 (100)
Use topical anesthetics	0 (0)	1 (17)	5 (83)
Have a support person present (e.g., parent)	1 (17)	3 (50)	2 (33)
Sit on parent’s lap	1 (17)	4 (67)	1 (17)
Receive injection while lying down	1 (17)	3 (50)	2 (33)

Qualitative outcomes

Two separate focus group interviews were conducted with a total of 7 individuals, including 5 pharmacist vaccinators (3 male, 2 female) and 2 implementation leads (1 male, 1 female). One of the implementation leads, involved in the implementation of CARD in all pharmacies, participated in both interviews. There was substantial overlap in feedback across CFIR categories; therefore, the results were condensed into 3 CFIR domains to reduce redundancy: 1) intervention characteristics; 2) inner setting; and 3) characteristics of individuals. Within each category, the perceptions of participants are described, with sample quotes displayed in Table 4.

Table 4.

Constructs from the Consolidated Framework for Implementation Research (CFIR) and selected participant quotes (n = 7)

CFIR category	Quote
1) Intervention characteristics
Relative advantage (of CARD implementation vs status quo/usual practice)
Overall	“Definitely with CARD—all of the activities, all of the support materials, all of the strategies that we used—made the entire process less stressful, more easy to do, for myself, as a vaccinator, for the child and also, the parents felt that, you know, this is a nice place to come and get this done.” P03
CARD checklist	“It’s a very useful tool. . . . The difference of having this piece of paper in front of me, prior to me giving the vaccination, is it gives me a lot of perspective already as to what this kid would prefer. So, it gives me that different level of understanding as well. And of course, I still have that option of verifying the information. But if there are certain things in there that maybe I should be aware of, really, like if they’re so fearful of the needle or something, at least that’s something that I can keep in mind before I even start the conversation with them. . . . The other thing that I’ve observed as I was doing it is because there’s already a lot of information available in the CARDs, it kind of minimizes the amount of information that I have to tell them. I did notice with the implementation of the CARDs, it’s almost like it’s not as lengthy as it was prior to CARD, I think it’s not in a negative way, but it really just kind of focuses on what the patients’ preferences are or the kids’ preferences as well.” P04 “Certain kids, they’re confident, where their fear level is 0, they are ready to go. They might not need that additional help with the CARD system but offering to everyone because you don’t know who stands at which level, I would say is a better approach to go with and it ultimately helps. . . . I found children were more comfortable asking questions, for example, how the needle is going to feel, whether it’s going to hurt, those kinds of questions. . . . That makes a positive impact overall, on the child to make them more comfortable with you to interact and ask what they need before getting the needle. . . . So, they were more comfortable and ready to go.” P07 “With the younger ages, I found it challenging to use CARD because we make them anticipate everything that’s happening, so I feel like they’ve been getting more scared because they are aware of what’s going on. I’m not sure, it’s maybe easier with the first dose, with the first injections in the pharmacy. Maybe with the second dose, you already know what they are going to have.” P01
Environmental changes to reduce fear cues	“So just reorienting the room a little, changing where people are looking and hiding things, like needles laid out on the table right in front of a child when the child’s already fussy, can keep the fear much lower. . . . Most pharmacists thought they were hiding needles but most were not or could do better. And I think that made a big difference, you know, repositioning, putting posters in front of where the needles were, very simple things. So, things that don’t require a whole lot of effort once they’re in place can really make the pharmacy more CARD-friendly.” P05
Privacy	“Separating the fearful children while they’re getting immunized, so the other children are not getting worked up. Offering that privacy, it really helped the whole flow of the day.” P05
Seating for support person	“That works better because that way the support person doesn’t have to stand up and kind of walk towards the person getting vaccinated. It’s almost like they’re ready, they’re available. If they need to maybe grab their hand, you know, to squeeze or to, you know, whatever it is that they need to do to comfort them or distract them.” P04
Order of sibling getting injection	“We used to start it with the one who is more willing to get the injection first. But we just changed to the total opposite. We do it for the person who’s more scared first after learning more about this program. It is for sure better.” P02
Complexity
CARD checklist	“Gathering that checklist from the patient, well, it’s not a lot. So, the parent sits there with the child and whoever gives the checklist gives them a sentence or 2 about CARD. And so they’re oriented to why they’re filling in the checklist. And then most parents are happy to go through that list with their child—It’s going to make it easier for my child, so, let’s go through this. And for the most part, parents were accepting of what their children checked. We did see a few rare exceptions to that. . . . Some parents were almost trying to convince children, you don’t need that (topical anesthetics). And it was powerful to see the child push back and say: No, I really do want that! And then parents accommodated, they wanted their child to have a good experience. They want what’s best for their child. It was a bit of an inconvenience for the parents, but I think it made the overall experience better and those very fearful children had an opportunity to settle down, maybe play with a pipe cleaner, do some colouring . . . and they really just settled in and then they were ready to go and then they didn’t feel the needle. And that positive experience will probably make their next vaccine much better, too, I think, because then they’ll think about it much differently.” P05 “With the average workflow, you can definitely incorporate that easily. If you have any technicians, you can even train the technician how to implement that, so they can even spend the time with the clients or patients, handing out the brochures or distraction techniques, so the children can do the drawing or relax themselves, providing them the comfortable positions or asking those questions before you, the pharmacist, is ready to administer the vaccine. So, the room is ready, everything is ready before the pharmacist walks in and that ultimately saves the time of pharmacists. . . . Even the pharmacist can provide those options, so, it’s not something that you cannot do because, ultimately, if you’re waiting, holding the needle in your hand and waiting, it ultimately saves the time for the vaccination compared to waiting for them to be ready.” P07
Education of vaccinators	“I think that there is a lot that we can do to help pharmacists understand. Sometimes you know, we’ll say in the tools to do one thing, but if we don’t actually show it or we don’t give examples, then it might be construed differently. Within the pilot, [researchers and organizational implementation lead] went into these pharmacies. When we roll out on a bigger scale, we won’t be able to do that. So maybe a way that we can do is, is if we video the way of setting up a particular pharmacy.” P06 “[Maybe] it’s the positioning of the room or maybe it’s some of the other specific strategies that make the biggest difference compared to you know, focusing on all the strategies at once. Once we roll out, I think it could be more feasible on a wider scale to maybe focus and hone in on those specific strategies that we know will really work. That we know will make a big impact on patients.” P06
Education of vaccine recipients	“I think we can add the checklist to the platform for the online booking. . . . So, I think the checklist can help everybody. So many people, they get worked up because of the injection. I think it is going to be helpful for whatever age, children or adult. It can be added to the online booking, for parents to, for the child to, fill.” P01
Costs of the intervention	“I don’t really think there is much cost. I think you might put up some posters and have some treats and some toys there that kids can play with, maybe colouring papers. But across the whole immunization season, once you’re set up, the added cost is not much. And if you make it part of your process, doesn’t really take more time either.” P05 “When we did CARD, we did do it in a kind of utopian environment, like what would be the best thing to do. You know, the best room with the best supplies, with the best posters, with the best staff, whoever was there with us, doing other things and you were helping also and so was (the organizational implementation lead). So, if one of my other pharmacists had done it, would they think this is more of a headache to do? What is the repeatability of this? What is the effect on productivity? What about the financial aspect of vaccinations? So, we have to really take a look at—it’s very nice and kids and the parents, you know, they felt very, very nice—is it repeatable all the time? Is it financially viable?” P03
	“In general, if we consider the average time for the vaccination without CARD and with the CARD, it’s roughly the same because after the initial process of the checklist, the administration time for the vaccine will be minimal versus answering those same questions or making the client uncomfortable in a certain position, when you try to convince them to get the vaccine. It takes the same amount of time.” P07
2) Inner setting
Compatibility	“These are independent pharmacies and each one is very different. So, it’s not like a corporate setting where everything is controlled, floor plans are the same, so each pharmacy is independently owned and some of them were set up well for immunizations and others, it was more challenging. Something as simple as, you know, enough room to, to sit an immunizer and a patient and a parent all together, like that for some pharmacies was hard. So, we found ways around it. . . . Each of the immunizers we had was using some of CARD already, but with a little bit of change, it was quite apparent to see the difference.” P05 “Even before we implemented the CARD system, we already had some of the logistics in place in the pharmacy in terms of how we do the vaccination in general. So, we have the different sites of the store—there is an intake and then after the intake, taking all the information, there is the injection room or the vaccination room and then there is also the post vaccination or the recovery area where we ask patients to wait for 15 minutes or so. . . . So, we have the specific areas we kind of designate already in the pharmacy. But what changes with the CARD system, they tweaked certain, you know, the way the chair was arranged. So instead of how the patient or the clients are facing the pharmacist during the vaccination, the chairs were kind of like arranged differently in such a way that they’re more on the side as opposed to facing each other. That way there is a way to hide, one is the needle or the injection and then, the chairs arranged side by side in such a way that whoever is the buddy or the caregiver was going to be going in with them. They kind of sit beside each other, instead of the way we arranged it before is there’s only one chair on one side and the other chair for whoever is the caregiver on the other side, they’re not beside each other. Then there are some posters that we put in there as well and some of the other materials that could be used to maybe distract them if they want to use those materials. But I think the biggest thing really is the change to the setup of the injection room in such a way that the patients are really not seeing the needles. And also, closing the door because at that point in time, we weren’t actually closing the door, it’s only because it’s not a very big room, so, we want to try to keep the air circulation in there and minimize them staying for an extended period of time and with them being inside the room with us.” P04
Tension for change	“It was interesting for me because the most challenging day for us during the past 2 months was Fridays, when we usually do COVID vaccinations for that age group (5- to 11-year-old children). So, it was a very, very good experience for me. And it’s been helping me a lot to manage our Fridays when we do vaccinations for that age group.” P02 “I did have experiences in the past with children that maybe they seemed to be okay at the beginning, but then when they see the needle—even if I don’t prep the needle or the injection when they are there, it’s already prepped ahead of time—when they see it in the basket, it does create anxiety for them. . . . I think that for me, had a huge impact. . . . I wished I had encountered this or known about the technique earlier on because, you know, I did have in a couple that, you know, weren’t successful even after so many tries. And you know, looking back, perhaps if I had the knowledge of this prior to those happening, that perhaps we could have made the vaccination more successful for those 2 kids.” P04
3) Characteristics of individuals
Knowledge and beliefs about CARD	“The (injection) technique itself is the technique. The nuances of small things you can do—making the child feel comfortable, giving the child autonomy and the ability to make the decision themselves . . . it certainly highlighted to me that as pharmacists, you know, we have so much more to offer than just dispensing medicines, right? And really, the biggest take-home for me was how much we have to offer as people, as health care practitioners. . . . And I think that this, or a version of this, should be the norm, right? We should start to do it and we should always do it. . . . It’s not hard to do, right? And ultimately, the end point is much better. . . . I mean, all-around positive reviews, right? You’d have to really be out of your mind as a parent or child to have a negative review about this, right?” P03 “Overall, it’s a great process—just implementing it in a proper way or setting up in the pharmacies. . . . It’s like a prescription that you drop off, you fill and you dispense. I feel for the CARD as well, if you implement that approach in your workflow, it would bring even more positive outcome. Because if you are lacking that opportunity of explaining every component of the CARD or if you don’t have enough time to interact with the patient or give them enough time to prepare themselves or distract themselves, it might compromise the results. But to have that integration process might help. The best way to do that is . . . to have most of the pharmacy staff aware of the CARD. So, one can cover another, provide that help to the patient, provide that information . . . answers to the questions. Even if there is just one pharmacist and one technician present, then even the technician can do certain components of the CARD.” P07
Self-efficacy	“[Vaccinating children] is a different experience, different worries as well, because with the children, if they’re not comfortable, you’re more worried about hurting them, basically because if they move their arm or not comfortable, that’s the main concern. So, to provide those things before giving the vaccine, that will definitely make you more comfortable to do the vaccines with that population. I was more confident after implementing CARD versus before implementing CARD to do the immunization in children. . . . It’s more like you have that technique to make them calm or relax, versus just doing the vaccination. You are ready for that challenging kid, to give them whatever they want. So, you don’t feel unsatisfied the way you wanted to provide that professional service. It’s like a win-win situation for professionals and the patients and family members.” P07
Stage of change	“There are also a lot of practices that I have been doing that, based on the best practice using the CARD system, may be the opposite of what could have been the better practice in order to improve children’s receptiveness to getting the vaccination and help minimize the chances of the pain and their fear and kind of makes them more comfortable getting the vaccinations. There’s a lot in there that I have learned, not just for how me as an injector, how can I change certain processes, but also even preparing the environment or the injection room as well. . . . We still have the posters, the treats and then some of the items that can be used for distractions and also hiding the needles. So those are some of the [strategies] that we have been doing ever since we had the CARD system. And we intend to keep it. And hopefully, with the CARD system, you know, using it, not necessarily just for children, but maybe for some of older or like younger adults as well, who may have had some sort of discomfort or reservation getting the needles as well.” P04 “[After the study], we did not use [the preferred injection room] all the time, because it’s a lot of walking backwards and forwards for me when dispensing alone and vaccinating. But what we did do is we keep the signage posters. In the counselling room, where we were doing the vaccinations [before CARD and now again after], we kept that nice big CARD poster on the fridge [for patients to see].” P03

Participants are denoted by number (P01-P07).

1) Intervention characteristics (key attributes of the CARD intervention)

Relative advantage (compared to vaccinations pre-CARD)

Focus group participants agreed that CARD was preferrable to the status quo with respect to reducing fear in children and leading to more positive vaccination experiences for children, parents and vaccinators. The participants commented on individual CARD interventions as well, such as the CARD checklist. The checklist was perceived to facilitate relationship building with children by allowing vaccinators to learn about the child, which in turn streamlined interactions. Confirmation of coping choices was recommended to verify selections. One pharmacist expressed concern that educating young children might make them more afraid. This participant also suggested that the checklist might be more useful with the first vaccine injection carried out in the pharmacy rather than subsequent injections. Pharmacists commented on the benefit of other CARD strategies as well, including arranging spaces to reduce fear cues, vaccinating children in private with the door closed, allowing spaces for a support person to sit and vaccinating the most fearful child first.

Complexity (CARD is a complex intervention)

Some pharmacists commented on the beneficial effects of having one of the implementation leads and research staff present to help support CARD implementation because it involved many components. They were concerned about being able to sustain specific CARD interventions—in particular, the CARD checklist—without this external support. Pharmacists mentioned soliciting CARD choices directly from children and/or training other pharmacy staff to assist. Pharmacists also recommended creating more resources to address specific aspects of CARD implementation in more detail (e.g., how to set up the space) to support more widespread adoption because external implementation personnel would not be physically available to support implementation. One participant suggested concentrating on the key components of CARD that all pharmacies could implement. Education of children and families ahead of time, at vaccination booking, was also recommended to reduce the amount of time required to educate them on the day of vaccination. The costs of implementing CARD were believed to be primarily related to materials related to set-up (e.g., posters) and distraction items for children. The time required for child/parent CARD education and soliciting coping choices (via CARD checklist survey) was believed to be offset by a shorter vaccination procedure duration.

2) Inner setting (structural, political and cultural features of the implementation context)

Compatibility

CARD was perceived to fit within usual pharmacy workspaces and systems. All pharmacies were able to accommodate environmental changes that made spaces more “CARD-friendly,” including providing physical spaces for waiting and injection areas with available seating, distraction items and activities and privacy during injection. Some processes were new, such as obtaining information about children’s baseline level of fear and coping choices, vaccinating siblings separately from one another and in private (with the door closed), vaccinating the most fearful child first, hiding needles and omitting alcohol skin cleansing prior to injection.

Tension for change

Pharmacists remarked on difficulty vaccinating children in this age range before CARD, resulting in more difficult clinic days. One pharmacist mentioned that if they had been aware of CARD previously, it might have led to a successful vaccination of 2 children who they were unable to vaccinate before because of fear. There was acknowledgement that CARD was helpful not only for the children who were visibly fearful but also for others who did not initially appear scared.

3) Characteristics of individuals (personal attributes)

Knowledge and beliefs about the CARD intervention

Pharmacists remarked on the alignment of CARD with their professional role to provide person-centred care and that it allowed them to excel within their role as health care providers. They believed that CARD invited participation of children and parents in the vaccination process and improved their interactions with them. Pharmacists believed that the effectiveness of CARD would be compromised if core domains of the intervention (education, environment, engagement) were dropped.

Self-efficacy

Pharmacists commented on having more confidence in their skills when vaccinating children, even children who are quite fearful, because of learning about CARD strategies.

Stage of change

Pharmacists reported learning about and integrating numerous CARD interventions in their ongoing vaccination processes since participating in the project, demonstrating progress to sustained use. The feasibility of some of the interventions was raised as an issue by one of the participants due to competing priorities, such as the need to fulfill dispensing and vaccination roles at the same time, which precluded using the ideal vaccination space and having to involve other pharmacy staff, who were not trained in CARD, to assist.

Discussion

This study evaluated the experiences of pharmacy vaccinators and implementation leads with CARD implementation for the delivery of pharmacy-based vaccinations in children aged 5 to 11 years. Responses to quantitative surveys and focus group discussions both revealed the acceptability and feasibility of CARD. Participants believed that CARD was aligned with the role of vaccinators and that it should be the standard of care because it reduced children’s fear and improved the experiences of children, parents and vaccinators when compared with the status quo. Recommended CARD interventions from each of the interventional components—3E’s (Education, Environment, Engagement)—were integrated into the vaccination-delivery process in all pharmacies, and vaccinators expressed increased confidence in their ability to carry out vaccinations in children because of the interventions. Many interventions were reported to continue to be used after the project, demonstrating progression to sustainability of CARD. There was some concern about the ability to use all interventions as intended, particularly those parts that vaccinators were not involved in carrying out, such as education of children and parents about CARD at vaccination appointment check-in. Participants believed that CARD was time neutral—any additional time that might be required to educate clients about CARD at appointment check-in was offset by a shorter vaccination procedure duration. Participants recommended education of vaccination clients about CARD ahead of time to reduce the potential for additional time for appointment check-in.

Vaccinators perceived that CARD reduced children’s fear and led to more positive vaccination experiences for children and parents. This perception is consistent with the results obtained from the children and parents who were the recipients of their vaccination services in our companion article that reports on patient-important outcomes. ¹¹ Health providers in our previous CARD projects have similarly been able to observe the benefits of CARD on clients’ vaccination reactions. ¹⁹ We targeted pediatric vaccinations for this project because community pharmacists have indicated that CARD would be particularly useful for vaccinations in this patient population. ² It is important to note that separately, CARD has also been demonstrated to be effective for adolescent and adult vaccinations as well. ⁹

CARD-recommended environmental interventions were able to be readily accommodated in all participating pharmacies, including a physical space for the waiting and vaccination areas, with available seating for children and a parent (support person), the ability to provide privacy during injection by closing the door, distraction items and activities (on the walls and for child use at any time) and removing or obscuring frightening items from view. Depending on the floor plans for individual pharmacies, however, it was not possible to implement all recommended CARD interventions in all pharmacies (e.g., prevaccination [waiting] and postvaccination [aftercare] spaces might be the same). Efforts were still made to improve the available spaces. Likewise, other pharmacies can still find ways to modify available spaces to achieve some benefit over the status quo. For instance, while all pharmacies in the study were able to provide private rooms for vaccination, privacy screens coupled with “white noise” machines can be used in the absence of private rooms. Posters can be placed on the door windows of the vaccination room to block the view from those outside the room, and gym mats can be placed on desks to allow children to lie down if this is their coping choice (e.g., those with a history of dizziness and fainting may prefer to lie down). To this end, feedback from vaccine recipients and pharmacy staff is recommended to ensure that interventions are achieving their intended purpose (i.e., they are effective) and to inform refinements. ⁸ Evaluation is part of CARD (4E’s—Education, Environment, Engagement, Evaluation) and should be part of every pharmacy’s practice when implementing new innovations. Records of patient preferences can also be incorporated into clinical notes to guide future practices.

It is important to note that CARD fit within usual activities. No changes were made to booking appointment allocations (usually 10 minutes). Vaccinators reported that there was more time involved in preparing for vaccination because of client education and the CARD checklist but this was offset by a shorter vaccination encounter. In our companion article reporting the clinical outcomes, there was a trend towards more children taking a very long time (>20 minutes) to complete their vaccinations for the control group (i.e., before CARD) compared to after CARD. ¹¹ It has been previously reported that children take more time for vaccinations than adults. ¹ Allowing adequate time between vaccination appointments is encouraged to prevent crowds from forming due to backed-up appointments and to prevent vaccinators from rushing, both of which have the potential to escalate levels of stress for children, parents and staff.^5,20

One vaccinator questioned the evidence base underlying some CARD interventions. This included the appropriateness of CARD for younger children and its utility in children who had prior experiences with vaccination. We found no evidence of a difference in child fear scores because of age, vaccine dose number or sex in our companion article reporting on patient-important outcomes. Hence, these variables should not predict whether CARD is offered. ¹¹ It should be noted that the comprehensive CARD framework, by design, integrates evidence-based strategies spanning the vaccination setting and processes, including providing vaccine recipients with choices, so removing any component of the framework can lead to diminished effectiveness.

Implementation of CARD was associated with some additional costs, including supplies and time for the corporate implementation leader and research staff. Wall posters (to educate, engage and distract), gym mats (to allow patients to lie down) and bins/trolleys (to contain distraction items) constituted supplies with a one-time cost, while distraction items (e.g., toys) and activities (e.g., colouring pages and crayons), candy treats, topical anesthetics, and paper copies of CARD pamphlets, checklists and feedback surveys constituted supplies with ongoing/maintenance costs. CARD implementation did not entail significant training time for vaccinators. Education occurred on the same day in some pharmacies, between patient appointments, with accompanying changes made simultaneously to the environment and work processes. This pragmatic approach to implementation was chosen because it allowed for the most efficient way of introducing CARD. Importantly, no participants stated that CARD added to the burden of the COVID-19 pandemic on their work-life stressors. ¹⁰

Some vaccinators voiced concerns about their ongoing ability to incorporate client education about CARD because of competing demands on their time and the lack of other pharmacy staff (e.g., pharmacy technicians) trained in CARD. They recommended that additional resources be developed to support the education of other vaccinators who want to implement CARD; these resources were seen as critical to those who would not have the benefit of coaching and support from external personnel about how to translate recommended interventions to site-specific alterations to their physical spaces and processes.

An extensive selection of CARD resources is available to assist pharmacies with integrating CARD, with more continuing to be developed over time. Most of them are posted at www.cardsystem.ca. One of them is a pamphlet with “before” and “after” pictures of some of the pharmacies that participated in this project, depicting environmental CARD interventions that were made (the direct link to this pamphlet is https://assets.aboutkidshealth.ca/AKHAssets/CARD_Before_and_After_Images.pdf). A CARD e-module and CARD implementation guide are also available to educate pharmacy professionals.^12,13 The CARD e-module can be accessed via the Canadian Public Health Association (https://learning.cpha.ca/) after creating a password. A CARD web game targeted to children is available that teaches children about CARD and can be used to prepare children ahead of time as well as be used as a distraction during vaccination (https://immunize.ca/card-game/). Separately in this supplement, we report on the positive perceptions about CARD of pharmacy technician students who learned about it (via review of the CARD e-module) during their injection training. ¹²

Strengths of the study included obtaining feedback from all individuals involved in implementation, which improves the likelihood that the breadth of opinions was captured. We demonstrated consistency between quantitative and qualitative feedback, and multiple coders were involved in coding and checking the qualitative data analysis, increasing the trustworthiness of the findings. There are limitations worthy of discussion. A relatively small number of pharmacies were included in this CARD implementation study, and the pharmacies and vaccinators involved may represent a select group of practitioners who were highly motivated to improve their vaccination services. In addition, CARD implementation was financed with external funding, and it is unclear whether pharmacists would implement CARD without these supports and their resulting perceptions about it. However, these costs were relatively low, and many items are reusable. Our prior work in this area suggests that most vaccinators believe they are already doing all that they can to make vaccinations a better experience and are largely unaware of how to operationalize the research evidence into their practice.^19,21 Hence, efforts are needed to disseminate and support integration of this information in practice.

In summary, this study demonstrated that pharmacy vaccinators have positive attitudes about CARD as a vaccination delivery framework for vaccinating children and recommend it for use as a standard of practice. Pharmacy sites and vaccination processes were quickly adjusted to incorporate CARD needs. CARD interventions were easily implemented and the process was deemed time neutral. Future implementation efforts can attempt to incorporate CARD education prior to vaccination day appointments and expand the CARD framework to include vaccinations performed across all ages. Finally, education about CARD is recommended for vaccinators to ensure they are practising using the best available evidence. Based on the current study, CARD implementation will be relatively inexpensive, including one-time costs associated with training and set-up and minimal ongoing supply costs primarily related to distraction and documentation items. CARD is expected to be time neutral as all activities can fit within usual workflows. The benefit will be improved vaccination delivery and satisfaction for all stakeholders involved—vaccine clients, vaccinators and onlookers. ■