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NCT05832307 | RECRUITING | Influenza


The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program
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.

Condition or disease

Influenza

Intervention/treatment

Existing Influenza Vaccination Practices

Standardized inpatient influenza vaccination program

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 22000 participants
Masking : NONE
Masking Description : Sites will be randomized 2:1 by the study statistician to intervention A vs. usual care. The randomization will be stratified by academic or academic plus community setting. This will ensure that the groups are balanced for site variables that may be correlated with the outcomes of interest. After the first intervention season, the 4 usual care sites and 6 lowest performing intervention sites (lowest change in vaccination rates from their baseline data) will be randomized 1:1 to intervention A vs. intervention B.
Primary Purpose : HEALTH_SERVICES_RESEARCH
Official Title : The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives
Actual Study Start Date : 2024-10-31
Estimated Primary Completion Date : 2027-07-31
Estimated Study Completion Date : 2027-07-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 6 Months to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

Location Details

NCT05832307


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Illinois

Ann and Robert Lurie's Children Hospital of Chicago

Chicago, Illinois, United States, 60611

RECRUITING

United States, Washington

Seattle Children's Hospital

Seattle, Washington, United States, 98105

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