The INFLUENTIAL Trial- Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices And Learning Collaboratives - PROJECT SUMMARY/ABSTRACT
Influenza infection causes high morbidity and mortality each year in the United States. Influenza vaccination of
children is one of the most effective strategies for reducing the burden of disease among individuals and
communities, yet coverage levels remain suboptimal. Hospitals are a promising setting for reaching a large
number of high-risk children. Recent studies, however, indicate that many influenza vaccine-eligible children
fail to receive this needed vaccine during hospitalization. Local data suggest that multimodal approaches
leveraging health information technology may increase influenza vaccine uptake among hospitalized children.
This project will build upon this existing evidence to establish a standardized pediatric inpatient influenza
vaccination program that can be readily disseminated and successfully implemented across diverse health
systems. In Aim 1 of this proposal, the study team will engage parents, nurses, providers and other key
stakeholders from Seattle Children’s Hospital, Children’s Hospital Colorado, and Lurie Children’s Hospital of
Chicago to create a best practice implementation guide for the inpatient influenza vaccination program. Core
components will include creating a multidisciplinary leadership team, maintaining end-user engagement,
utilizing novel electronic health record and data analytic tools, and enhancing evidence-based education and
communication of parents, nurses, and providers. The program will be piloted at the 3 lead sites and refined as
needed based upon evaluation metrics. In Aim 2, the study team will conduct a cluster randomized trial using a
Sequential Multiple Assignment Randomized Trial adaptive design at 12 health systems nationally to test the
effectiveness of the influenza vaccination program in improving influenza vaccination rates of hospitalized
children. In the first intervention season, sites will be randomized to implement the standardized influenza
vaccination program using the aforementioned implementation guide or usual care. In the second intervention
season, the usual care sites and lower-performing intervention sites will be re-randomized to the standardized
or intensified version of the program. The latter will include a learning collaborative, with monthly meetings of
site leaders as well as one-on-one meetings with the study team to facilitate successful implementation. In the
third intervention season, all sites will continue their influenza vaccination program to assess sustainability. In
Aim 3, the study team will use mixed methods and the Reach, Effectiveness, Adoption, Implementation, and
Maintenance (RE-AIM) framework to evaluate the program, including identification of key barriers, facilitators,
and considerations for future dissemination. This information will be used to optimize and expand the program.
This evidence-based program, which leverages novel clinical decision support tools in one of the most utilized
electronic health record systems and optimizes hospital infrastructure, has the potential to markedly increase
influenza vaccination of high-risk children. It also has broad public health implications, as the program could be
readily adapted and expanded to include other needed vaccines, patient populations, and healthcare settings.
