The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program

Study Overview
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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.

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

Conditions
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Influenza

Intervention / Treatment
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* Other: Existing Influenza Vaccination Practices
* Other: Standardized inpatient influenza vaccination program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standardized inpatient influenza vaccination program<br>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<br>* 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<br>* Other names: Intervention A and B;|
| Active Comparator: Existing inpatient influenza vaccination practices<br>Usual care is defined as the inpatient influenza vaccination practices that currently exist at a given site. | Other: Existing Influenza Vaccination Practices<br>* Usual care is defined as the existing inpatient influenza vaccination practices that currently exist at a given site.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccination, influenza