Community Pharmacy, Vaccination Pain, Vaccination Reaction
Conditions
Keywords
Vaccination reaction, Vaccination experience
Brief summary
To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.
Detailed description
It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance. The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.
Interventions
BEHAVIORALCARD (Comfort Ask Relax Distract)
CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations
Sponsors
Public Health Agency of Canada (PHAC)
Wholehealth Pharmacy Partners
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Vaccine recipients will not be aware of whether they are in the intervention or control group or the objective of the trial. Care providers who are trained in the intervention are aware of the group allocation. They will not communicate with care providers not trained in the intervention. Care providers that are in the intervention pharmacies will not deliver care to participants in the control pharmacies and care providers in the control pharmacies will not deliver care in the intervention pharmacies. Vaccine recipients are rating the primary outcome.
Intervention model description
Cluster trial involving at least 24 community pharmacies allocated to CARD or control (standard care) in a 1:1 ratio. Eligible pharmacies belonging to Wholehealth Pharmacy Partners from across Ontario, Canada, will be included.
Eligibility
Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* vaccine clients being vaccinated in community pharmacies participating in the project * pharmacy staff in community pharmacies participating in the project
Exclusion criteria
* unable to understand and read English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Experience with vaccination | within 15 minutes after vaccination | Vaccine client self-reported experience with vaccination (better or not) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain | within 15 minutes after vaccination | Vaccine client self-reported pain during vaccination (0-10) |
| Dizziness | within 15 minutes after vaccination | Vaccine client self-reported dizziness during vaccination (0-10) |
| Fainting | within 15 minutes after vaccination | Fainting during/after vaccination (yes/no) |
| Utilization of coping strategies during vaccination | within 5 minutes of vaccination | Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no) |
| Fear | within 15 minutes after vaccination | Vaccine client self-reported fear during vaccination (0-10) |
| Implementation success of CARD | within 3 months of vaccination clinics | Perceptions of implementation success of CARD program delivery as reported by CARD implementers (primary targets) using CARD Global Impression Checklist, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes. |
| Attitudes about vaccination | within 3 months of vaccination clinics | Perceptions of CARD and non-CARD implementers using CARD Attitudes survey, individual questions (5-point Likert Scale higher number represents better outcome); responses reported for individual items. This information is supplemented with focus group information and study notes. |
| Vaccination behaviours | within 3 months of vaccination clinics | Self-reported vaccine behaviours of immunizers using CARD Behaviour Survey, individual questions (rank as whether behaviours are done or not); responses reported for individual items. Includes CARD and non-CARD implementers. |
| Vaccine interaction survey | within 5 minutes of vaccination | Perceptions of CARD and non-CARD immunizers about vaccination interaction \[duration, satisfaction, CARD usefulness (intervention group only)\]; responses reported for individual items. |
| CARD satisfaction survey | within 15 minutes of vaccination | Vaccine client self-reported satisfaction with CARD (e.g., helpfulness, willingness to use again, willingness to return for next vaccination, vaccination decision-making, as applicable), responses reported for individual items |
Countries
Canada
Contacts
Primary ContactCharlotte Logeman, MPH
Backup ContactVictoria Gudzak, MSc
Outcome results
None listed