Vaccination, Vaccination Pain, Vaccination Pharmacy, Vaccination Reaction
Conditions
Keywords
vaccination reaction, vaccination experience
Brief summary
This study is phase 2 of a cluster trial integrating the CARD (Comfort Ask Relax System) in community pharmacies affiliated with Wholehealth Pharmacy Partners. It involves continuing CARD in pharmacies randomized to CARD in phase 1 of the trial (2023-2024 fall/winter vaccination season), and initiating CARD in pharmacies randomized to Control (usual care) in phase 1 of the trial. Both groups will use CARD for delivery of vaccinations during the 2024-2025 fall/winter vaccination season.
Detailed description
This study is a continuation of a previous cluster trial. Pharmacies that participated in the original trial will be asked if they want to volunteer for the present study. They will all use the CARD system as the vaccination delivery system for their community pharmacies during the 2024-2025 fall/winter vaccination season. They will collect feedback from vaccine clients using a paper survey that tracks experiences, including symptoms, during vaccination. The responses will be compared between groups. The sample size is limited by the number of pharmacies that volunteer. We expect 8 pharmacies will participate in a 1:1 ratio (about 1/3 of all pharmacies in original cluster trial), with a total of at least 500 vaccination clients. We will collect data for all vaccinations that are conducted and for which client feedback data are available. Thus, the sample size is expected to deviate from the estimated sample size of 500.
Interventions
BEHAVIORALSustained CARD
This group is using CARD for the 2nd year in a row in participating pharmacies as the vaccination delivery framework (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter vaccination season).
BEHAVIORALFirst-time CARD
CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season).
Sponsors
Wholehealth Pharmacy Partners
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Vaccine clients are blinded to the hypothesis. Providers are aware of the intervention.
Intervention model description
Cluster trial involving at least 8 community pharmacies allocated in a 1:1 ratio to: 1) repeat use or 2) first-time use of the CARD system for vaccination delivery in 2024-2025 fall/winter vaccination season.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies
Exclusion criteria
* able to speak and write in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experience with vaccination | Within 15 minutes of vaccination | Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fear | Within 15 minutes of vaccination | Self-reported fear during vaccination (0-10) |
| Dizziness | Within 15 minutes of vaccination | Self-reported dizziness during vaccination (0-10) |
| Fainting | Within 15 minutes of vaccination | Self-reported fainting during vaccination (yes/no) confirmed by provider |
| Pain | Within 15 minutes of vaccination | Self-reported pain during vaccination (0-10) |
| Vaccination decision-making | Within 15 minutes of vaccination | Self-reported vaccination decision-making (5-point Likert scale, and dichotomized) |
| Implementation outcomes | Within 3 months of vaccination season ending | Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes) |
| Overall experience | Within 15 minutes of vaccination | Self-reported overall experience (5-point Likert scale, and dichotomized) |
Countries
Canada
Contacts
Primary ContactCharlotte Logeman, MPH
Backup ContactVictoria Gudzak, MSc
Outcome results
None listed