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临床试验/NCT07161739
NCT07161739进行中(未招募)不适用

Vaccination Nudges Project: Behavioural Nudges From Pharmacists to Increase Influenza and Travel Vaccination Uptake: A Pragmatic Randomized Control Trial.

University of Calgary1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2025年11月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20,000
试验地点
1
主要终点
Influenza and/or Travel Vaccination

研究概览

简要总结

The goal of this individual-level pragmatic randomized policy trial is to learn about the impact of behavioural nudges via mailed letters on increasing influenza and travel vaccination uptake in Alberta, Canada. The primary outcome is the proportion of adults receiving influenza and/or travel vaccination. The secondary outcome is the number of stroke events in the 6 months following vaccination. As such, this research aims to answer two key questions:

  1. Do behavioural nudges increase influenza and travel vaccination in Alberta?
  2. If yes, is there a decrease in the number of stroke events in the 6 months following vaccination?

The two-arm individual level pragmatic randomized trial design includes two letter dimensions, a letter (a "nudge") with an influenza and cardiovascular risk reduction message and a letter with a travel vaccination benefit message, yielding the following groups:

Letter with an influenza and cardiovascular risk reduction message Letter with a travel vaccination benefit message

详细描述

Study Population Setting This research project will take place in Alberta, Canada and in partnership with Mint Health and Drugs (Mint Pharmacy), an Alberta-based pharmacy corporation. Participants will be recruited through Mint Pharmacy patient records.

Inclusion Criteria 18 years of age and older by September 1, 2025, and visited a Mint Pharmacy site within 1 year of September 1, 2025.

Study Procedures Sampling Size and Strategy Mint Pharmacy will be sending a letter to all active clients (defined as an adult who filled a prescription at their pharmacy in the last year). The investigators estimate this will be 20,000 clients with 10,000 receiving the influenza vaccine nudge and 10,000 receiving the travel vaccine nudge. This population size will allow the investigators to detect an absolute difference of 2% between the two groups with 80% power and α= 0.05.

Recruitment and Screening Mint Pharmacy analysts will pull the study sample from their patient records, including first and last name, date of birth, and sex. The list of participants will be shared with Alberta Strategy for Patient Oriented Research (AbSPOR) analysts for randomization and data linkage. AbSPOR analysts will share the randomized list of participants, including mailing addresses, with the approved mail vendor to print and mail the appropriate nudge letter that the participant has been randomized to receive. The investigators will stratify be geographic zone (North, Edmonton, Central, Calgary, and South) because of the geographic variation in vaccine uptake.

Intervention The Alberta Government provides free influenza vaccines from October through March annually, which corresponds with peak travel vaccine season. Travel vaccines are typically low cost or covered by private insurance. Vaccines are frequently administered by pharmacists in private pharmacies. As a pragmatic trial, there will be no in-person encounters with patients during the trial. The intervention will be delivered through mailed letters with different messages described below, to be delivered in mid-October 2025. The date of the initial letter will be defined as study baseline.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Visited a Mint Pharmacy site within 1 year of enrollment date
  • 18 years of age and older by enrolment date

排除标准

  • 未提供

研究组 & 干预措施

Influenza and Cardiovascular Risk Reduction

Experimental

Participants randomized to the Influenza Risk Reduction arm will receive a letter encouraging ("nudging") influenza vaccination as an influenza and cardiovascular risk reduction method.

干预措施: Behavioural Nudge (Influenza Risk Reduction) (Behavioral)

Travel Vaccination Benefit

Experimental

Participants randomized to the Travel Vaccination Benefit arm will receive a letter encouraging ("nudging") travel vaccination as a health benefit by reducing the risk of contracting a travel-related illness.

干预措施: Behavioural Nudge (Travel Vaccination Benefit) (Behavioral)

结局指标

主要结局

Influenza and/or Travel Vaccination

时间窗: From enrollment and randomization to the end of the intervention window at 6 months post-enrollment/randomization.

The proportion of participants who received an influenza and/or travel vaccination.

次要结局

  • Stroke Events(From date of vaccination to the end of follow-up at 6 months post-vaccination.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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