The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program (Influential)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Influenza

Treatments: Other: Existing Influenza Vaccination Practices; Other: Standardized inpatient influenza vaccination program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05832307

22-1507

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22,000 estimated patients

Sex: All

Ages: 6 months to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22,000 participants in 2 patient groups

Standardized inpatient influenza vaccination program

Active Comparator group

Description:

Intervention A: The basic intervention is the inpatient influenza vaccination program, which will be comprised of the following core components: informatics and data analytic tools, evidenced-based education and communication, a multidisciplinary leadership team, and end-user engagement. Intervention B: The intensified intervention is the multifaceted influenza vaccination strategy (Intervention A) plus a learning collaborative with lead site facilitation during the trial period.

Treatment:

Other: Standardized inpatient influenza vaccination program

Existing inpatient influenza vaccination practices

Active Comparator group

Description:

Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site.

Treatment:

Other: Existing Influenza Vaccination Practices