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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05832307

Collaborator

Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed), Seattle Children's Hospital (Other)

22,000

Enrollment

Arms

51.4

Anticipated Duration (Months)

Study Details

Study Description

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	Intervention/Treatment	Phase
Influenza	Other: Existing Influenza Vaccination Practices Other: Standardized inpatient influenza vaccination program	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22000 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

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).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:

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.

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 17, 2023

Anticipated Primary Completion Date :

Jul 31, 2027

Anticipated Study Completion Date :

Jul 31, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Vaccine administration rate [1 year]
proportion of influenza vaccine administrations to eligible patients during hospitalization.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

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

Study Documents (Full-Text)

Informed Consent Form - Apr 3, 2023

More Information

Publications

None provided.

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05832307

Other Study ID Numbers:

22-1507

First Posted:

Apr 27, 2023

Last Update Posted:

Apr 27, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

vaccination

influenza

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Apr 27, 2023