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

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ClinicalTrials.gov Identifier: NCT05832307
Recruitment Status : Not yet recruiting
First Posted : April 27, 2023
Last Update Posted : August 29, 2023
Sponsor:
Collaborators:
Agency for Healthcare Research and Quality (AHRQ)
Seattle Children's Hospital
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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).
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
Estimated Study Start Date : September 17, 2023
Estimated Primary Completion Date : July 31, 2027
Estimated Study Completion Date : July 31, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  1. Vaccine administration rate [ Time Frame: 1 year ]
    proportion of influenza vaccine administrations to eligible patients during hospitalization.


Eligibility Criteria
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Ages Eligible for Study:   6 Months to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05832307


Contacts
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Contact: Suchitra Rao 7207772823 suchitra.rao@childrenscolorado.org

Sponsors and Collaborators
University of Colorado, Denver
Agency for Healthcare Research and Quality (AHRQ)
Seattle Children's Hospital
Investigators
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Principal Investigator: Suchitra Rao University of Colorado, Children's Hospital Colorado
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Informed Consent Form  [PDF] April 3, 2023

More Information
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT05832307    
Other Study ID Numbers: 22-1507
First Posted: April 27, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
vaccination
influenza
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases