CARD (Comfort Ask Relax Distract) for Community-based Pharmacy Vaccinations - Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Experience with vaccination
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Vaccine clients are blinded to the hypothesis. Providers are aware of the intervention.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clients undergoing vaccination in participating pharmacies and providers working in participating pharmacies
排除标准
- •able to speak and write in English
结局指标
主要结局
Experience with vaccination
时间窗: Within 15 minutes of vaccination
Self-reported experience about how much CARD helped (4-point Likert scale and dichotomized)
次要结局
- Fainting(Within 15 minutes of vaccination)
- Pain(Within 15 minutes of vaccination)
- Fear(Within 15 minutes of vaccination)
- Dizziness(Within 15 minutes of vaccination)
- Overall experience(Within 15 minutes of vaccination)
- Vaccination decision-making(Within 15 minutes of vaccination)
- Implementation outcomes(Within 3 months of vaccination season ending)
研究者
Anna Taddio
Professor
University of Toronto