Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake (NUDGE-FLU): Study protocol for a nationwide randomized implementation trial

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Background: Annual influenza vaccination is widely recommended in older adults and other high-risk groups including patients with cardiovascular disease. The real-world effectiveness of influenza vaccination is limited by suboptimal uptake and effective strategies for increasing vaccination rates are therefore needed. The purpose of this trial is to investigate whether behavioral nudges digitally delivered via the Danish nationwide mandatory governmental electronic letter system can increase influenza vaccination uptake among older adults. Methods: The NUDGE-FLU trial is a randomized implementation trial randomizing all Danish citizens aged 65 years and above without an exemption from the Danish mandatory governmental electronic letter system to receive no digitally delivered behavioral nudge (usual care arm) or to receive one of 9 electronic letters (intervention arms) each leveraging different behavioral science strategies. The trial has randomized 964,870 participants with randomization clustered at the household level (n = 691,820 households). Intervention letters were delivered on September 16, 2022, and follow-up is currently ongoing. All trial data are captured using the nationwide Danish administrative health registries. The primary end point is the receipt of an influenza vaccine on or before January 1, 2023. The secondary end point is time to vaccination. Exploratory end points include clinical events such as hospitalization for influenza or pneumonia, cardiovascular events, all-cause hospitalization, and all-cause mortality. Discussion: The nationwide randomized NUDGE-FLU trial is one of the largest implementation trials ever conducted and will provide important insights into effective communication strategies to maximize vaccination uptake among high-risk groups. Trial Registration: Clinicaltrials.gov: NCT05542004, registered September 15, 2022, https://clinicaltrials.gov/ct2/show/NCT05542004.

OriginalsprogEngelsk
TidsskriftAmerican Heart Journal
Vol/bind260
Sider (fra-til)58-71
Antal sider14
ISSN0002-8703
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
The authors wish to thank Cyril Jean-Marie Martel from Statens Serum Institut and the Danish Health Data Authority for collaborating on the study.

Funding Information:
The trial is funded by Sanofi. The trial design and protocol were developed in collaboration with the funder. The funder will be involved in the critical review of this and future manuscripts. The funder will not be involved in data collection, data analysis, data interpretation, or first drafting of any NUDGE-FLU-related manuscript. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of this paper and its final contents.

Publisher Copyright:
© 2023 The Author(s)

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