Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte, Copenhagen, Denmark; Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Biomedical Sciences, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.
Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Center for Cardiometabolic Implementation Science, Brigham and Women's Hospital, Boston, MA.
Am Heart J. 2023 Jun;260:58-71. doi: 10.1016/j.ahj.2023.02.009. Epub 2023 Feb 17.
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.
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.
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.
Clinicaltrials.gov: NCT05542004, registered September 15, 2022, https://clinicaltrials.gov/ct2/show/NCT05542004.
每年接种流感疫苗被广泛推荐给老年人和其他高危人群，包括患有心血管疾病的患者。由于接种率不理想，流感疫苗的实际效果受到限制，因此需要采取有效的策略来提高接种率。本试验旨在研究通过丹麦全国性强制性政府电子信系统以数字方式提供的行为提示是否可以提高老年人的流感疫苗接种率。
NUDGE-FLU 试验是一项随机实施试验，将丹麦所有年龄在 65 岁及以上且未免除丹麦强制性政府电子信系统的公民随机分为不接受数字方式提供的行为提示（常规护理组）或接受 9 封电子信中的一封（干预组）。试验已随机分配 964870 名参与者，随机化按家庭水平聚类（n=691820 个家庭）。干预信于 2022 年 9 月 16 日发出，目前正在进行随访。所有试验数据均使用全国性丹麦行政健康登记系统捕获。主要终点是在 2023 年 1 月 1 日之前接种流感疫苗。次要终点是接种时间。探索性终点包括临床事件，如因流感或肺炎住院、心血管事件、全因住院和全因死亡率。
这项全国性的随机 NUDGE-FLU 试验是有史以来规模最大的实施试验之一，将为高危人群提供有关最大化疫苗接种率的有效沟通策略的重要见解。
Clinicaltrials.gov：NCT05542004，2022 年 9 月 15 日注册，https://clinicaltrials.gov/ct2/show/NCT05542004。
