Clinical trial NCT05832307: The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program
Official title: The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Influenza
Keywords: vaccination
influenza
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: Seattle Children's Hospital
First posted: 2023-04-27
Enrollment: 22000
Sex: ALL
Minimum age (years): 6
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The investigators will conduct a cluster SMART to evaluate the effectiveness of an inpatient influenza vaccination program on influenza vaccination rates during hospitalization at 12 U.S. pediatric health systems over 3 influenza vaccination seasons (Study Years 3-5). Sites will be randomized to the standardized influenza vaccination program or usual care in the first intervention season (traditional cluster RCT). Usual care and low performing sites will be re-randomized to the standardized program (intervention A) or the standardized program with an intensified implementation strategy (intervention B) in the second season. Sites will continue their programs in the third season to assess sustainability. The unit of intervention (randomization) is the site (i.e., health system).
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study plans to learn more about whether a stakeholder-informed, standardized inpatient vaccination program will increase influenza vaccination rates of hospitalized children across US pediatric health systems. The first part of the study is to form a multidisciplinary team of stakeholders, including parents, providers, nurses, pharmacists, informaticists, data analysts and communication experts across three sites in synthesizing a best practice implementation guide for an inpatient influenza vaccination program, which will then be piloted at these three sites.

Detailed description: The overarching goal of this proposal is to determine whether a stakeholder-informed, standardized inpatient influenza vaccination program will increase influenza vaccination rates of hospitalized children across diverse U.S. pediatric health systems. Building upon preliminary data and experience with pediatric inpatient influenza vaccine delivery, the investigators will engage a multidisciplinary team of stakeholders in synthesizing a best practice implementation guide for an inpatient influenza vaccination program across three sites. The next phase of the study, using a novel adaptive trial design, will be to implement and test the program across 12 health systems. Finally, the investigators will evaluate the program's impact using an established dissemination and implementation framework.

Eligibility criteria: Inclusion Criteria:

* At least 6 months of age
* Admitted to an inpatient unit at a participating health system

Exclusion:

- Admission to critical care sites or hematology-oncology services

Exclusion Criteria:

* At least 6 months of age
* Admitted to an inpatient unit at a participating health system

Exclusion:

- Admission to critical care sites or hematology-oncology services

Primary outcomes:
measure: Vaccine administration rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann and Robert Lurie's Children Hospital of Chicago
state: Illinois
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: University of Colorado, Children's Hospital Colorado
name: Suchitra Rao
role: PRINCIPAL_INVESTIGATOR
References: