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| Name | Class |
|---|---|
| Wholehealth Pharmacy Partners | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sustained CARD | Experimental | CARD is being used for the 2nd year in a row as the vaccination delivery framework in participating pharmacies (It was used in the 2023-2024 fall/winter vaccination season and is now being sustained in the 2024-2025 fall/winter season). CARD comprises of education, environment, engagement and evaluation components. |
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| First-time CARD | Active Comparator | CARD is being used for the 1st time as the vaccination delivery framework in participating pharmacies (2024-2025 fall/winter vaccinations only). CARD comprises of education, environment, engagement and evaluation components. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sustained CARD | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Experience with vaccination | Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized) | Within 15 minutes of vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Pain | Self-reported pain during vaccination (0-10) | Within 15 minutes of vaccination |
| Fear | Self-reported fear during vaccination (0-10) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Logeman, MPH | Contact | 416-978-2889 | charlotte.logeman@utoronto.ca | |
| Victoria Gudzak, MSc | Contact | 416-978-2889 | victoria.gudzak@mail.utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Anna Taddio, PhD | Leslie Dan Faculty Of Pharmacy, University Of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leslie Dan Faculty of Pharmacy, University of Toronto | Toronto | Ontario | M5S 3M2 | Canada |
We do not have permission to share individual participant data.
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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.
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Vaccine clients are blinded to the hypothesis. Providers are aware of the intervention.
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| First-time CARD | Behavioral | CARD is being used for the 1st time in participating pharmacies as the vaccination delivery framework (2024-2025 fall/winter vaccination season). |
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| Within 15 minutes of vaccination |
| Dizziness | Self-reported dizziness during vaccination (0-10) | Within 15 minutes of vaccination |
| Fainting | Self-reported fainting during vaccination (yes/no) confirmed by provider | Within 15 minutes of vaccination |
| Overall experience | Self-reported overall experience (5-point Likert scale, and dichotomized) | Within 15 minutes of vaccination |
| Vaccination decision-making | Self-reported vaccination decision-making (5-point Likert scale, and dichotomized) | Within 15 minutes of vaccination |
| Implementation outcomes | Provider quantitative and qualitative feedback on surveys and interviews (assessing implementation outcomes) | Within 3 months of vaccination season ending |