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

April 7, 2026 updated by: University of Colorado, Denver

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

22000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Ann and Robert Lurie's Children Hospital of Chicago
        • Principal Investigator:
          • Ravi Jhaveri, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Contact:
        • Principal Investigator:
          • Annika Hofstetter, MD, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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
Other Names:
  • Intervention A and B
Active Comparator: Existing inpatient influenza vaccination practices
Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site.
Other: Existing Influenza Vaccination Practices
Usual care is defined as the existing inpatient influenza vaccination practices that currently exist at a given site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaccine administration rate
Time Frame: 1 year
proportion of influenza vaccine administrations to eligible patients during hospitalization.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Seattle Children's Hospital
Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Suchitra Rao, University of Colorado, Children's Hospital Colorado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2024

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 9, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-1507

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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