The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

Not Applicable

Recruiting

• Conditions: Influenza
• Interventions: Other: Existing Influenza Vaccination Practices; Other: Standardized inpatient influenza vaccination program

• Registration Number: NCT05832307
• Lead Sponsor: University of Colorado, Denver

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.

Study Timeline

• Study First Submitted: 2023-04-09
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-27
• Study Start: 2024-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2027-07-31
• Study Completion: 2027-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22000

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Existing inpatient influenza vaccination practices	Existing Influenza Vaccination Practices	Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site.
Standardized inpatient influenza vaccination program	Standardized inpatient influenza vaccination program	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.

Primary Outcome Measures

Name	Time	Method
Vaccine administration rate	1 year	proportion of influenza vaccine administrations to eligible patients during hospitalization.

Trial Locations

Locations (2)

Ann and Robert Lurie's Children Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States