CARD for Community Pharmacy Vaccinations

Study Overview
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Brief Summary
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To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

Detailed Description
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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.

Official Title
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CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations

Conditions
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Vaccination Pain, Community Pharmacy, Vaccination Reaction

Intervention / Treatment
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* Behavioral: CARD (Comfort Ask Relax Distract)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARD (multi-faceted intervention)<br>CARD will be integrated in the pharmacy vaccination process. This includes education, environment (e.g., clinic spaces), engagement (interactions), and evaluation (surveys/feedback). | Behavioral: CARD (Comfort Ask Relax Distract)<br>* CARD is a vaccine delivery framework/protocol to plan and deliver vaccinations<br>|
| No Intervention: Control (standard care)<br>There are no specific procedures being undertaken to plan or execute vaccine clinics. Usual practices will be instituted by participating pharmacies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Experience with vaccination | Vaccine client self-reported experience with vaccination (better or not) | within 15 minutes after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear | Vaccine client self-reported fear during vaccination (0-10) | within 15 minutes after vaccination | 
| Pain | Vaccine client self-reported pain during vaccination (0-10) | within 15 minutes after vaccination | 
| Dizziness | Vaccine client self-reported dizziness during vaccination (0-10) | within 15 minutes after vaccination | 
| Fainting | Fainting during/after vaccination (yes/no) | within 15 minutes after vaccination | 
| Utilization of coping strategies during vaccination | Use of individual coping strategies during vaccination (e.g., distraction, support person) (yes/no) | within 5 minutes of vaccination | 
| CARD satisfaction survey | 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 | within 15 minutes of vaccination | 
| Implementation success of CARD | 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. | within 3 months of vaccination clinics | 
| Attitudes about vaccination | 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. | within 3 months of vaccination clinics | 
| Vaccination behaviours | 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. | within 3 months of vaccination clinics | 
| Vaccine interaction survey | Perceptions of CARD and non-CARD immunizers about vaccination interaction [duration, satisfaction, CARD usefulness (intervention group only)]; responses reported for individual items. | within 5 minutes of vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination reaction, Vaccination experience