CARD (Comfort Ask Relax Distract) for school-based immunizations in Calgary, Canada: a pragmatic cluster trial.

ABSTRACT: School-based immunizations are fear-inducing events for many students and contribute to vaccine hesitancy. We developed an immunization delivery framework called the CARD (Comfort Ask Relax Distract) system that incorporates evidence-based interventions to improve the experience (eg, reduce fear, pain, dizziness). We evaluated CARD in grades 6 and 9 students in Calgary, Canada. In this pragmatic, hybrid, effectiveness-implementation, cluster trial, we randomized 8 Community Health Centres providing regional immunization services to CARD or control (usual care). In the CARD group, public health staff educated students about CARD and planned processes to reduce fear cues and support student coping choices during immunization. Students self-reported fear, pain, and dizziness during immunization using a 0-10 numerical rating scale; staff recorded procedure details, including vaccines administered, fainting episodes, and coping strategies used. Staff participated in focus groups afterward. Altogether, 8839 children from 105 schools in the 2019 to 2020 school calendar year were included. Fear was lower for CARD (mean = 3.6 [SD = 3.1] vs control 4.1 [3.2]; mean difference = -0.5; 95% confidence interval = -0.74 to -0.21; P < 0.001). Effectiveness persisted after stratification by student gender (male and female) and grade level (grade 6 and grade 9). Other symptoms did not differ. Compared with control, CARD students used peers, privacy, muscle tension, and topical anesthetics more; verbal distraction, deep breathing, and adult support were used less frequently ( P < 0.05, all analyses). Immunization rate did not differ. Staff reported positive to neutral attitudes about CARD. In summary, this pragmatic trial demonstrated that CARD improved the immunization experiences of students at school.

Feasibility of implementation of CARD™ for school-based immunizations in Calgary, Alberta: a cluster trial.

BACKGROUND: Negative experiences with school-based immunizations can contribute to vaccine hesitancy in youth and adulthood. We developed an evidence-based, multifaceted and customizable intervention to improve the immunization experience at school called the CARD™ (C-Comfort, A-Ask, R-Relax, D-Distract) system. We evaluated the feasibility of CARD™ implementation for school-based immunizations in Calgary, Canada. METHODS: In a mixed methods study, two Community Health Centres providing immunization services, including 5 schools each with grade 9 students (aged approximately 14 years), were randomized to CARD™ or control (usual care). In the CARD™ group, public health staff and students were educated about coping strategies prior to immunization clinics. Clinics were organized to reduce fear and to support student's choices for coping strategies. Public health staff in the CARD™ group participated in a focus group discussion afterwards. We sought a recruitment rate of 80% for eligible schools, an external stakeholder focus group (e.g., school staff) with 6 or more individuals, 85% of individual injection-related data acquisition (student and immunizer surveys), and 80% absolute agreement between raters for a subset of data that were double-coded. Across focus groups, we examined perceptions of acceptability, appropriateness, feasibility and fidelity of CARD™. RESULTS: Nine (90%) of eligible schools participated. Of 219 students immunized, injection-related student and immunizer data forms were acquired for 195 (89.0%) and 196 (89.5%), respectively. Reliability of data collection was high. Fifteen public health and 5 school staff participated in separate focus groups. Overall, attitudes towards CARD™ were positive and compliance with individual components of CARD™ was high. Public health staff expressed skepticism regarding the value of student participation in the CARD™ system. Suggestions were made regarding processes to refine implementation. CONCLUSION: While most outcome criteria were satisfied and overall perceptions of implementation outcomes were positive, some important challenges and opportunities were identified. Feedback is being used to inform a large cluster trial that will evaluate the impact of CARD™ during school-based immunizations. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov ( NCT03948633 ); Submitted April 24, 2019.

Student Feedback to Tailor the CARD™ System for Improving the Immunization Experience at School.

Increasing the comfort of vaccine delivery at school is needed to improve the immunization experience for students. We created the CARD™ (C-Comfort, A-Ask, R-Relax and D-Distract) system to address this clinical care gap. Originally designed for grade 7 students, this study examined the perceptions of grade 9 students of CARD™. Grade 9 students who had experience with school-based immunizations, either as recipients or onlookers (n = 7; 100% females 14 years old) participated. Students answered pre-post surveys, reviewed CARD™ educational materials and participated in a semi-structured focus group discussion. The Consolidated Framework for Implementation Research (CFIR) was used as the framework for analysis of qualitative data. Participants reported positive perceptions of CARD™ educational materials and that CARD™ could fit into the school immunization process. CARD™ improved knowledge about effective coping interventions and was recommended for education of both nurses and students. The results provide preliminary evidence that CARD™ is acceptable and appropriate for implementation in grade 9 school-based immunizations.