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Recruiting NCT05832307

The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

No phase Interventional Influenza

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Existing Influenza Vaccination Practices, Standardized inpatient influenza vaccination program.
Who it may be relevant to
Registry conditions: Influenza. Basic parameters: 6 months — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives

Overview

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.

Interventions

  • Other Existing Influenza Vaccination Practices
    Usual care is defined as the existing inpatient influenza vaccination practices that currently exist at a given site.
  • Other Standardized inpatient influenza vaccination program
    Intervention A: The basic intervention is the inpatient influenza vaccination program Intervention B: The intensified intervention is the multifaceted influenza vaccination strategy (Intervention A) plus a learning collaborative

Primary outcome measures

  • Vaccine administration rate [Time frame: 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 2 centers
  • Ann and Robert Lurie's Children Hospital of Chicago — Chicago
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT05832307 · 22-1507

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗