InfluenzaInfluentialNCT05832307
The INFLUENTIAL Trial- Evaluation of National Inpatient Influenza Vaccination Program
A study testing Existing Influenza Vaccination Practices and Standardized inpatient influenza vaccination program in people with Influenza, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Existing Influenza Vaccination Practices and Standardized inpatient influenza vaccination program
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22,000 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 99 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- At least 6 months of age
- Admitted to an inpatient unit at a participating health system
Who cannot join
- Admission to critical care sites or hematology-oncology services
- At least 6 months of age
- Admitted to an inpatient unit at a participating health system
- Admission to critical care sites or hematology-oncology services
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Ann and Robert Lurie's Children Hospital of Chicago
Chicago, Illinois, 60611
Ravi Jhaveri, MD, 312-227-4080, rjhaveri@luriechildrens.org
Ravi Jhaveri, MD
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Annika Hofstetter, MD, PhD, MPH, 205-884-1699, annika.hofstetter@seattlechildrens.org
Annika Hofstetter, MD, PhD, MPH
About this study
Official title: The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- Existing Influenza Vaccination Practices, Standardized inpatient influenza vaccination program
- Keywords
- vaccination, influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Existing Influenza Vaccination PracticesOther
Usual care is defined as the existing inpatient influenza vaccination practices that currently exist at a given site.
Standardized inpatient influenza vaccination programOther
Also called Intervention A and B
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Existing Influenza Vaccination Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine administration rate
proportion of influenza vaccine administrations to eligible patients during hospitalization.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start31 Oct 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 22,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Seattle Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Suchitra Rao, Principal investigator, University of Colorado, Children's Hospital Colorado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832307
- Sponsor's protocol ID
- 22-1507
- Acronym
- Influential
- Status last verified
- Apr 2026
- First submitted
- 9 Apr 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The INFLUENTIAL Trial - Inpatient FLU Vaccination Program Effectiveness: National Trial Implementing Best Practices and Learning Collaboratives
- ClinicalTrials.gov ID
- NCT05832307
- Acronym / sponsor ID
- Influential / 22-1507
- Conditions
- Influenza
- Keywords
- vaccination, influenza
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Seattle Children's Hospital
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Standardized inpatient influenza vaccination program | Active comparator | Other: Standardized inpatient influenza vaccination programIntervention 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. |
| Existing inpatient influenza vaccination practices | Active comparator | Other: Existing Influenza Vaccination PracticesUsual care is defined as the inpatient influenza vaccination practices that currently exist at a given site. |
Who may qualify
- Ages
- 6 months to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- At least 6 months of age
- Admitted to an inpatient unit at a participating health system
Key exclusion criteria (4 listed)
- Admission to critical care sites or hematology-oncology services
- At least 6 months of age
- Admitted to an inpatient unit at a participating health system
- Admission to critical care sites or hematology-oncology services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Existing Influenza Vaccination PracticesUsual care is defined as the existing inpatient influenza vaccination practices that currently exist at a given site. | Other | Existing inpatient influenza vaccination practices |
| Standardized inpatient influenza vaccination programAlso: Intervention A and BIntervention 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 | Standardized inpatient influenza vaccination program |
Primary outcome
Vaccine administration rate
Time frame: 1 year
proportion of influenza vaccine administrations to eligible patients during hospitalization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suchitra Rao principal investigator
University of Colorado, Children's Hospital Colorado
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Existing Influenza Vaccination Practices and Standardized inpatient influenza vaccination program in people with Influenza, run by University of Colorado, Denver at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Suchitra Rao (7207772823, suchitra.rao@childrenscolorado.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine administration rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.