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The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

NCT ID: NCT05832307

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

22000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2027-07-31

Brief Summary

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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

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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.

Conditions

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Influenza

Keywords

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vaccination influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

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).
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Standardized inpatient influenza vaccination program

Intervention Type 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

Existing inpatient influenza vaccination practices

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

Group Type ACTIVE_COMPARATOR

Existing Influenza Vaccination Practices

Intervention Type OTHER

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

Interventions

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Existing Influenza Vaccination Practices

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

Intervention Type 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

Intervention Type OTHER

Other Intervention Names

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Intervention A and B

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Suchitra Rao

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Children's Hospital Colorado

Locations

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Ann and Robert Lurie's Children Hospital of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Suchitra Rao

Role: CONTACT

Phone: 7207772823

Email: [email protected]

Facility Contacts

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Ravi Jhaveri, MD

Role: primary

Annika Hofstetter, MD, PhD, MPH

Role: primary

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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22-1507

Identifier Type: -

Identifier Source: org_study_id