CARD System for Improving Vaccination Experience

Overseen By Victoria Gudzak, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Unable to understand English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve the vaccination experience by using a system called CARD in community pharmacies. CARD focuses on education, enhancing clinic spaces, fostering engaging interactions, and collecting feedback. The trial will compare this new approach to the usual vaccination methods in pharmacies. Ideal participants include individuals receiving vaccinations at these pharmacies or staff members working there, provided they can understand and read English. As an unphased trial, this study allows participants to contribute to enhancing vaccination experiences in their community.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CARD system is safe for improving the vaccination experience?

Studies have shown that the CARD system—Comfort, Ask, Relax, Distract—safely improves the vaccination experience. Research indicates it reduces stress, particularly in school settings. The system enhances comfort and reduces stress by altering vaccine administration, the environment, and staff interactions. Previous findings suggest positive responses to these changes, with no reports of serious safety issues. Overall, the CARD system is well-received and effective for those who have tried it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARD system because it introduces a holistic approach to the vaccination process, aiming to enhance the overall experience. Unlike standard care, which typically involves straightforward vaccine administration without additional support, CARD integrates education, environment improvements, engagement, and evaluation. This means that not only are patients more informed and comfortable, but their feedback is actively used to refine the process. The hope is that this method will reduce anxiety and improve vaccination rates, making it a potentially transformative approach for both patients and healthcare providers.

What evidence suggests that the CARD system is effective for improving the vaccination experience?

Research has shown that the CARD system, which stands for Comfort, Ask, Relax, Distract, can improve the vaccination experience. In this trial, participants in the CARD (multi-faceted intervention) arm will experience this system integrated into the pharmacy vaccination process. One study found that 48.8% of people using the CARD system during vaccination reported a positive experience, compared to only 28% who did not use it. The CARD system also reduces stress in students during school vaccinations. Participants found the system acceptable and satisfying, suggesting it could make vaccinations more comfortable. ^{1 2 3 5 6}

Who Is on the Research Team?

Anna Taddio, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for pharmacy staff and clients at community pharmacies involved in the study. Staff will use CARD strategies during vaccinations. Clients must be getting vaccinated at these pharmacies and able to understand and read English.

Inclusion Criteria

Pharmacy staff in community pharmacies participating in the project

Vaccine clients being vaccinated in community pharmacies participating in the project

Exclusion Criteria

Unable to understand and read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Integration of CARD in the pharmacy vaccination process, including education, environment, engagement, and evaluation

3 months

Ongoing visits as per vaccination schedule

Follow-up

Participants are monitored for implementation success and attitudes about vaccination

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CARD

Trial Overview The trial is testing the CARD system, which stands for Comfort, Ask, Relax, Distract techniques to see if it reduces pain or negative reactions during vaccinations in a community pharmacy setting.

How Is the Trial Designed?

Group I: CARD (multi-faceted intervention) Experimental Treatment 1 Intervention

CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback).

Group II: Control (standard care) Active Control 1 Intervention

There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials

51

Recruited

101,000+

Wholehealth Pharmacy Partners

Collaborator

Trials

2

Recruited

2,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12333031/

Using the CARD system for university-based pop-up ... The CARD system (Comfort, Ask, Relax, Distract) is a vaccination delivery framework that can improve the experiences of vaccine recipients and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X22002249

Impact of the CARD (Comfort Ask Relax Distract) system on ... CARD reduced stress-related responses in students undergoing vaccinations at school and was positively received by students and public health ...

3. academic.oup.com academic.oup.com/pch/article/24/Supplement_1/S42/5421503

CARD™ System for improving the vaccination experience at ... This small-scale implementation study provides preliminary evidence of the effectiveness of CARD™ in improving vaccination experiences for ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/21645515.2025.2488064

Full article: CARD (Comfort Ask Relax Distract) and ... Altogether, 2206 individuals received vaccinations. More vaccine recipients in the CARD group (vs. control) reported a better experience: 48.8% vs. 28.0%, p = .

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6438865/

The CARD™ System for improving the vaccination ... Participants reported acceptability, appropriateness, feasibility, and satisfaction with CARD™. Experimental group nurses were able to integrate ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03966391

Study Details | NCT03966391 | Effectiveness of CARD for ... Data will be collected for vaccination services carried out in grade 6 and grade 9 students in participating schools for the academic year 2019-2020. Official ...