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A large Danish clinical trial found that invitation letters designed using behavioral science principles increased influenza vaccination rates among older adults in Denmark. Here, in a preplanned secondary analysis, the investigators report the effects of the electronically delivered "behavioral nudging" letters on clinical outcomes. Visual Abstract. Clinical Outcomes With Electronic Nudges to Increase Influenza Vaccination: A large Danish clinical trial found that invitation letters designed using behavioral science principles increased influenza vaccination rates among older adults in Denmark. Here, in a preplanned secondary analysis, the investigators report the effects of the electronically delivered "behavioral nudging" letters on clinical outcomes. Background: In the NUDGE-FLU (Nationwide Utilization of Danish Government Electronic letter system for increasing inFLUenza vaccine uptake) trial, electronic letters incorporating cardiovascular (CV) gain-framing and repeated messaging increased influenza vaccination by approximately 1 percentage point. Objective: To evaluate the effects of the successful nudging interventions on downstream clinical outcomes. Design: Prespecified exploratory analysis of a nationwide randomized implementation trial. (ClinicalTrials.gov: NCT05542004) Setting: The 2022 to 2023 influenza season. Participants: 964 870 Danish citizens aged 65 years or older. Intervention: Usual care or 9 different electronically delivered behavioral nudging letters. Measurements: Cardiovascular, respiratory, and other clinical end points during follow-up from intervention delivery (16 September 2022) through 31 May 2023. Results: The analysis set included 691 820 participants. Hospitalization for pneumonia or influenza occurred in 3354 of 346 327 (1.0%) participants in the usual care group, 396 of 38 586 (1.0%) in the CV gain-framing group (hazard ratio [HR], 1.06 [95% CI, 0.95 to 1.18]; versus usual care), and 403 of 38 231 (1.1%) in the repeated letter group (HR, 1.09 [CI, 0.98 to 1.21]; versus usual care). In the usual care group, 44 682 (12.9%) participants were hospitalized for any cause, compared with 5002 (13.0%) in the CV gain-framing group (HR, 1.00 [CI, 0.97 to 1.03]; versus usual care) and 4965 (13.0%) in the repeated letter group (HR, 1.01 [CI, 0.98 to 1.04]; versus usual care). A total of 6341 (1.8%) participants died in the usual care group, compared with 721 (1.9%) in the CV gain-framing group (HR, 1.02 [CI, 0.94 to 1.10]; versus usual care) and 646 (1.7%) in the repeated letter group (HR, 0.92 [CI, 0.85 to 1.00]; versus usual care). Limitation: Prespecified but exploratory analysis, potential misclassification of events in routinely collected registry data, and results may not be generalizable to other health systems or countries with other racial compositions and/or cultural or societal norms. Conclusion: In a prespecified exploratory analysis, modest increases in influenza vaccination rates seen with electronic nudges did not translate into observable improvements in clinical outcomes. Seasonal influenza vaccination should remain strongly recommended. Primary Funding Source: Sanofi. [ABSTRACT FROM AUTHOR]