Vaccination Nudges From Pharmacists

NCT07161739 | Active Not Recruiting

• 1 other identifier: REB25-1205
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Influenza Human; Influenza Vaccines; Health Behavior Change; Travel-Related Illness; Stroke

Keywords

Pragmatic Randomized Control Trial; Policy Trial; Waiver of Consent; Behavioral Nudge

Outcome Measures

Primary Outcomes (1)

• Influenza and/or Travel Vaccination

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

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

Secondary Outcomes (1)

• Stroke Events

  From date of vaccination to the end of follow-up at 6 months post-vaccination.

Study Arms (2)

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.

Behavioral: Behavioural Nudge (Influenza Risk Reduction)

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.

Behavioral: Behavioural Nudge (Travel Vaccination Benefit)

Interventions

Behavioural Nudge (Influenza Risk Reduction) BEHAVIORAL

A behavioural nudge via mailed letter that discusses the benefits of the influenza vaccine in preventing influenza infection and reducing cardiovascular risk.

Influenza and Cardiovascular Risk Reduction

Behavioural Nudge (Travel Vaccination Benefit) BEHAVIORAL

A behavioural nudge via mailed letter that discusses the benefits of travel vaccines in preventing travel-related illnesses.

Travel Vaccination Benefit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Health services: collaborator
• Mint Health + Drugs: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (12)

• Public Health Agency of Canada, Statement on Seasonal Influenza Vaccine for 2014-2015. 2014, National Advisory Committee on Immunization: Ottawa.

  BACKGROUND

• McAlister FA, Straus SE, Sackett DL, Altman DG. Analysis and reporting of factorial trials: a systematic review. JAMA. 2003 May 21;289(19):2545-53. doi: 10.1001/jama.289.19.2545.

  PMID: 12759326 BACKGROUND

• Renosa MDC, Landicho J, Wachinger J, Dalglish SL, Barnighausen K, Barnighausen T, McMahon SA. Nudging toward vaccination: a systematic review. BMJ Glob Health. 2021 Sep;6(9):e006237. doi: 10.1136/bmjgh-2021-006237.

  PMID: 34593513 BACKGROUND

• Patel MS, Milkman KL, Gandhi L, Graci HN, Gromet D, Ho H, Kay JS, Lee TW, Rothschild J, Akinola M, Beshears J, Bogard JE, Buttenheim A, Chabris C, Chapman GB, Choi JJ, Dai H, Fox CR, Goren A, Hilchey MD, Hmurovic J, John LK, Karlan D, Kim M, Laibson D, Lamberton C, Madrian BC, Meyer MN, Modanu M, Nam J, Rogers T, Rondina R, Saccardo S, Shermohammed M, Soman D, Sparks J, Warren C, Weber M, Berman R, Evans CN, Lee SH, Snider CK, Tsukayama E, Van den Bulte C, Volpp KG, Duckworth AL. A Randomized Trial of Behavioral Nudges Delivered Through Text Messages to Increase Influenza Vaccination Among Patients With an Upcoming Primary Care Visit. Am J Health Promot. 2023 Mar;37(3):324-332. doi: 10.1177/08901171221131021. Epub 2022 Oct 4.

  PMID: 36195982 BACKGROUND

• Modin D, Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Jean-Marie Martel C, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Effect of Electronic Nudges on Influenza Vaccination Rate in Older Adults With Cardiovascular Disease: Prespecified Analysis of the NUDGE-FLU Trial. Circulation. 2023 May 2;147(18):1345-1354. doi: 10.1161/CIRCULATIONAHA.123.064270. Epub 2023 Mar 5.

  PMID: 36871213 BACKGROUND

• Johansen ND, Vaduganathan M, Bhatt AS, Lee SG, Modin D, Claggett BL, Dueger EL, Samson SI, Loiacono MM, Kober L, Solomon SD, Sivapalan P, Jensen JUS, Martel CJ, Valentiner-Branth P, Krause TG, Biering-Sorensen T. Electronic nudges to increase influenza vaccination uptake in Denmark: a nationwide, pragmatic, registry-based, randomised implementation trial. Lancet. 2023 Apr 1;401(10382):1103-1114. doi: 10.1016/S0140-6736(23)00349-5. Epub 2023 Mar 5.

  PMID: 36889332 BACKGROUND

• Saaksvuori L, Betsch C, Nohynek H, Salo H, Sivela J, Bohm R. Information nudges for influenza vaccination: Evidence from a large-scale cluster-randomized controlled trial in Finland. PLoS Med. 2022 Feb 9;19(2):e1003919. doi: 10.1371/journal.pmed.1003919. eCollection 2022 Feb.

  PMID: 35139082 BACKGROUND

• Holodinsky JK, Zerna C, Malo S, Svenson LW, Hill MD. Association between influenza vaccination and risk of stroke in Alberta, Canada: a population-based study. Lancet Public Health. 2022 Nov;7(11):e914-e922. doi: 10.1016/S2468-2667(22)00222-5.

  PMID: 36334607 BACKGROUND

• Yu AYX, Krahn M, Austin PC, Rashid M, Fang J, Porter J, Vyas MV, Bronskill SE, Smith EE, Swartz RH, Kapral MK. Sex differences in direct healthcare costs following stroke: a population-based cohort study. BMC Health Serv Res. 2021 Jun 29;21(1):619. doi: 10.1186/s12913-021-06669-w.

  PMID: 34187462 BACKGROUND

• Holodinsky JK, Lindsay P, Yu AYX, Ganesh A, Joundi RA, Hill MD. Estimating the Number of Hospital or Emergency Department Presentations for Stroke in Canada. Can J Neurol Sci. 2023 Nov;50(6):820-825. doi: 10.1017/cjn.2022.338. Epub 2022 Dec 20.

  PMID: 36536997 BACKGROUND

• Molinari NA, Ortega-Sanchez IR, Messonnier ML, Thompson WW, Wortley PM, Weintraub E, Bridges CB. The annual impact of seasonal influenza in the US: measuring disease burden and costs. Vaccine. 2007 Jun 28;25(27):5086-96. doi: 10.1016/j.vaccine.2007.03.046. Epub 2007 Apr 20.

  PMID: 17544181 BACKGROUND

• Schanzer DL, Sevenhuysen C, Winchester B, Mersereau T. Estimating influenza deaths in Canada, 1992-2009. PLoS One. 2013 Nov 27;8(11):e80481. doi: 10.1371/journal.pone.0080481. eCollection 2013.

  PMID: 24312225 BACKGROUND

Related Links

• Alberta Government. Alberta Influenza Statistics. 2023. \[cited 2023 May 25\];

MeSH Terms

Conditions

Stroke; Influenza, Human; Travel-Related Illness

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amity Quinn

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A two-arm individual-level pragmatic randomized policy trial with two letter dimensions, 1) a letter with an influenza and cardiovascular risk reduction message, and 2) 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

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 9, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)