The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

NCT05832307 | Recruiting

• 1 other identifier: 22-1507
• Study Type: interventional
• Target: 22,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Influenza

Keywords

vaccination; influenza

Outcome Measures

Primary Outcomes (1)

• Vaccine administration rate

  proportion of influenza vaccine administrations to eligible patients during hospitalization.

  1 year

Study Arms (2)

Standardized inpatient influenza vaccination program

ACTIVE COMPARATOR

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

Existing inpatient influenza vaccination practices

ACTIVE COMPARATOR

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

Other: Existing Influenza Vaccination Practices

Interventions

Existing Influenza Vaccination Practices OTHER

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

Existing inpatient influenza vaccination practices

Standardized inpatient influenza vaccination program OTHER

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

Also known as: Intervention A and B

Standardized inpatient influenza vaccination program

Eligibility Criteria

• Age: 6 Months - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 6 months of age
• Admitted to an inpatient unit at a participating health system

You may not qualify if:

• \- Admission to critical care sites or hematology-oncology services
• At least 6 months of age
• Admitted to an inpatient unit at a participating health system
• \- Admission to critical care sites or hematology-oncology services

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Seattle Children's Hospital: collaborator

Study Sites (2)

Ann and Robert Lurie's Children Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Suchitra Rao

  University of Colorado, Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suchitra Rao

CONTACT

7207772823; suchitra.rao@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a cluster SMART to evaluate the effectiveness of an inpatient influenza vaccination program on influenza vaccination rates during hospitalization at 12 U.S. pediatric health systems over 3 influenza vaccination seasons (Study Years 3-5). Sites will be randomized to the standardized influenza vaccination program or usual care in the first intervention season (traditional cluster RCT). Usual care and low performing sites will be re-randomized to the standardized program (intervention A) or the standardized program with an intensified implementation strategy (intervention B) in the second season. Sites will continue their programs in the third season to assess sustainability. The unit of intervention (randomization) is the site (i.e., health system).

Study Record Dates

• First Submitted: April 9, 2023
• First Posted: April 27, 2023
• Study Start: October 31, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)