CARD (Comfort Ask Relax Distract) and community pharmacy vaccinations: Evaluation of implementation outcomes from a cluster randomized trial

The CARD system (Comfort Ask Relax Distract) is a protocol for vaccine delivery that includes interventions that facilitate vaccine recipient coping and improve the vaccination experience. CARD was compared to control (usual care) in a pragmatic hybrid effectiveness-implementation cluster randomized trial. Of 25 participating community pharmacies, 12 were randomized to CARD and 13 to control for all vaccines administered between November 2023 and January 2024. Implementation strategies planned to support CARD integration included an educational webinar, customized implementation recommendations, change equipment, online chat group, and audit and feedback. Educational outreach was added to improve intervention fidelity. This paper reports on implementation outcomes of the trial. Provider surveys and focus groups revealed acceptability and feasibility of CARD and implementation strategies. Vaccinators in CARD pharmacies (vs. control) reported higher satisfaction with vaccine recipient interactions and that overall, CARD was time neutral. They also reported higher utilization of some CARD-recommended injection techniques. Administrative data verified utilization of the CARD coping checklist, which solicits vaccine recipient coping preferences, in 96% of vaccine recipients that participated. Post-vaccination feedback surveys were available for 90% of vaccine recipients that participated. Implementation results were aligned with trial effectiveness outcomes, and support routine use of CARD in community pharmacies.<b>Trial registration</b> : NCT06098703.