The INFLUENTIAL Trial- Evaluation of National Inpatient I... | NCT05832307

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

NCT05832307

Sponsor

University of Colorado, Denver

Status

Recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

22,000Estimated

Phase

Not Applicable

Conditions

Influenza

Interventions

Existing Influenza Vaccination Practices
Standardized inpatient influenza vaccination program

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2024Actual

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Jul 31, 2027Estimated

First Submitted Date

Apr 9, 2023

First Submission Date that Met QC Criteria

Apr 24, 2023

First Posted Date

Apr 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
Agency for Healthcare Research and Quality (AHRQ)	FED
Seattle Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suchitra Rao	Contact	7207772823		suchitra.rao@childrenscolorado.org

Overall Officials

Name	Affiliation	Role
Suchitra Rao	University of Colorado, Children's Hospital Colorado	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ann and Robert Lurie's Children Hospital of Chicago	Recruiting	Chicago	Illinois	60611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
ICF	No	No	Yes	Informed Consent Form	Apr 3, 2023	Apr 24, 2023	ICF_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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).

Masking Info

Masking

None (Open Label)

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.

Who Masked

Not provided