Reanalysis of a Randomized Controlled Trial on Promoting Influenza Vaccination in General Practice Waiting Rooms: A Zelen Design

In 2014-2015, we conducted a randomized controlled trial (RCT) assessing the effect of an advertising campaign for influenza vaccination using posters and pamphlets in general practitioner (GP) waiting rooms. No effect of the intervention could be demonstrated, but the immunization uptake increased in both arms of the study. In 2019, we deepened the investigations explaining the increased uptake conducting a registry-based 4/2/1 cluster RCT designed by Zelen with two extra years of follow-up of the study cohort. The study population included 23,024 patients eligible to be vaccinated who were registered with 175 GPs. The main outcome remained the number of vaccination units delivered per study group. Data were extracted from the SNIIRAM warehouse claim database for the Lille-Douai district (northern France). No difference in vaccination uptake was found in the Zelen versus the control group of the initial RCT. Overall, the proportion of vaccinated patients increased in the cohort from 51.4% to 70.4% over the three years. Being vaccinated the previous year was a strong predictor of being vaccinated in a subsequent year. The increase in vaccination uptake, especially among people older than 65, can be explained by a cohort effect. Health promotion and the promotion of primary health care may play an important role in this increase.