Influenza VaccinationPROFLUVAXEDNCT05836818
PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
A study testing Question (Q) and Messaging (M) in people with Influenza Vaccination, run by University of California, San Francisco at 8 sites in United States.
Trial summary
The goal of this research is to increase influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccination
- What is being tested?
- Question (Q) and Messaging (M)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Oct 2022to 30 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults
- Presenting to ED
- Not already vaccinated for influenza in the current year
- Able to provide informed consent
- Fluent in English or Spanish
- Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip
Who cannot join
- Age < 18 years
- Major trauma such that it will preclude survey
- Inability to participate in a survey because of intoxication, altered mental status, or critical illness
- Incarceration
- Psychiatric hold
- We will also exclude patients who state that they have already received an influenza vaccine and patients who are in the ED for suspected acute Covid or influenza illness.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Duke University Hospital
Durham, North Carolina, 27708
Baylor College of Medicine
Houston, Texas, 77030
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania, 19114
Jefferson Methodist Hospital
Philadelphia, Pennsylvania, 19148
San Francisco General Hospital Emergency Department
San Francisco, California, 94110
University of California San Francisco Parnassus
San Francisco, California, 94143
University of Washington-Harborview Emergency Department
Seattle, Washington, 98104
About this study
The goal of this research is to increase influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of FLU VA(X)ccination in the Emergency Department - PROFLUVAXED) that will address barriers to flu vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROFLUVAXED platforms in six EDs to determine whether their implementation is associated with greater flu vaccine acceptance and uptake in ED Usual Source of Care Patients.
Read the detailed description
Specific Aim I: To determine whether implementation of influenza vaccine trusted messaging platforms is associated with increased influenza vaccine uptake in unvaccinated ED patients.
At six EDs (Zuckerberg San Francisco General, UCSF Parnassus Medical Center [San Francisco, CA], Thomas Jefferson University Hospital [Philadelphia, PA], Ben Taub Hospital [Houston, TX], Harborview Medical Center [Seattle, WA], and Duke University Medical Center [Durham, NC]), investigators will conduct a cluster-randomized controlled trial of implementation of PROFLUVAXED trusted messaging platforms, with influenza vaccine uptake in the ED as the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine uptake in unvaccinated ED patients.
Specific Aim II: To determine whether implementation of influenza vaccine trusted messaging platforms in EDs is associated with increased influenza vaccine acceptance in unvaccinated ED patients. For this specific aim influenza vaccine acceptance in the ED assessed via ED survey will be the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine acceptance in unvaccinated ED patients.
Specific Aim III: To determine whether implementation of a protocol in which ED patients are asked whether they will accept an influenza vaccine in the ED (and notifying ED providers when they say they will accept it) is associated with increased influenza vaccine uptake in unvaccinated ED patients. Hypothesis: Implementation of an ED protocol in which patients are asked whether they will accept an influenza vaccine (and notifying ED providers when they say they will accept it) will be associated with increased influenza vaccine uptake in unvaccinated ED patients.
- Conditions
- Influenza Vaccination
- Being tested
- Question (Q), Messaging (M)
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question (Q)Other
Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
Messaging (M)Other
Flu vaccine educational materials -videos and flyers containing flu vaccine educational information
| Study group | Role | What they receive |
|---|---|---|
| Question (Q) | Experimental | Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine Receives: Other: Question (Q) |
| Messaging (M) | Experimental | Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine Receives: Other: Question (Q); Other: Messaging (M) |
| Non intervention | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention
Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:
- Receipt in emergency department during index (enrollment) visit
- Electronic health record review 30 days after index visit
- Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.
Measured: 30 days post index ED visit
Secondary outcomes (2)
Vaccine Acceptance
Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups
Measured: during ED visit
Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group
Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways:
- Receipt in emergency department during index (enrollment) visit
- Electronic health record review 30 days after index visit
- Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.
Measured: 30 days post index ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start1 Oct 2022
- Primary completion28 Feb 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Influenza VaccinationStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Parallel groups
- Model description
- A three-arm cluster randomized control trial to determine the effect of vaccine messaging and a question about acceptance, a question about acceptance without messaging, and standard care affect vaccine uptake in the ED.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 776 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, Thomas Jefferson University, University of Washington, Baylor College of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Robert Rodriguez, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05836818
- Sponsor's protocol ID
- 21-34004B
- Other IDs
- R01AI166967-01
- Acronym
- PROFLUVAXED
- Status last verified
- May 2024
- First submitted
- 19 Apr 2023
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez RM, Eucker SA, Rafique Z, Nichol G, Molina MF, Kean E, O'Laughlin KN, Bezek SK, Goicochea K, Ford JS, Morse D, White J, Arreguin MI, Shughart L, Chavez CL, Glidden DV, Rising KL. Promotion of Influenza Vaccination in the Emergency Department. NEJM Evid. 2024 Apr;3(4):EVIDoa2300197. doi: 10.1056/EVIDoa2300197. Epub 2024 Mar 26.
PubMed 38776635
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
- ClinicalTrials.gov ID
- NCT05836818
- Acronym / sponsor ID
- PROFLUVAXED / 21-34004B
- Conditions
- Influenza Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 776 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Duke University, Thomas Jefferson University, University of Washington, Baylor College of Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 1 May 2023 (actual)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research is to increase influenza vaccine acceptance and uptake in vulnerable populations whose primary (and often only) health care access occurs in emergency departments (ED Usual Source of Care Patients). Toward this goal, the investigators will conduct one on one interviews and focus groups with ED Usual Source of Care Patients and community partners and produce trusted messaging informational platforms (PROmotion of FLU VA(X)ccination in the Emergency Department - PROFLUVAXED) that will address barriers to flu vaccination, especially vaccine hesitancy. The investigators will then conduct a cluster-randomized, controlled trial of PROFLUVAXED platforms in six EDs to determine whether their implementation is associated with greater flu vaccine acceptance and uptake in ED Usual Source of Care Patients.
Detailed description
Specific Aim I: To determine whether implementation of influenza vaccine trusted messaging platforms is associated with increased influenza vaccine uptake in unvaccinated ED patients.
At six EDs (Zuckerberg San Francisco General, UCSF Parnassus Medical Center [San Francisco, CA], Thomas Jefferson University Hospital [Philadelphia, PA], Ben Taub Hospital [Houston, TX], Harborview Medical Center [Seattle, WA], and Duke University Medical Center [Durham, NC]), investigators will conduct a cluster-randomized controlled trial of implementation of PROFLUVAXED trusted messaging platforms, with influenza vaccine uptake in the ED as the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine uptake in unvaccinated ED patients.
Specific Aim II: To determine whether implementation of influenza vaccine trusted messaging platforms in EDs is associated with increased influenza vaccine acceptance in unvaccinated ED patients. For this specific aim influenza vaccine acceptance in the ED assessed via ED survey will be the primary outcome. Hypothesis: Implementation of PROFLUVAXED trusted messaging platforms in EDs will be associated with increased influenza vaccine acceptance in unvaccinated ED patients.
Specific Aim III: To determine whether implementation of a protocol in which ED patients are asked whether they will accept an influenza vaccine in the ED (and notifying ED providers when they say they will accept it) is associated with increased influenza vaccine uptake in unvaccinated ED patients. Hypothesis: Implementation of an ED protocol in which patients are asked whether they will accept an influenza vaccine (and notifying ED providers when they say they will accept it) will be associated with increased influenza vaccine uptake in unvaccinated ED patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A three-arm cluster randomized control trial to determine the effect of vaccine messaging and a question about acceptance, a question about acceptance without messaging, and standard care affect vaccine uptake in the ED.
| Arm | Type | Receives |
|---|---|---|
| Question (Q) | Experimental | Other: Question (Q)Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine |
| Messaging (M) | Experimental | Other: Question (Q), Other: Messaging (M)Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine |
| Non intervention | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults
- Presenting to ED
- Not already vaccinated for influenza in the current year
- Able to provide informed consent
- Fluent in English or Spanish
Key exclusion criteria (6 listed)
- Age < 18 years
- Major trauma such that it will preclude survey
- Inability to participate in a survey because of intoxication, altered mental status, or critical illness
- Incarceration
- Psychiatric hold
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 |
|---|---|---|
| Question (Q)Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine | Other | Messaging (M), Question (Q) |
| Messaging (M)Flu vaccine educational materials -videos and flyers containing flu vaccine educational information | Other | Messaging (M) |
Primary outcome
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention
Time frame: 30 days post index ED visit
Participant uptake of the influenza vaccine 30 days after enrollment assessed by confirmation of receipt of vaccine in one of 3 ways: 1. Receipt in emergency department during index (enrollment) visit 2. Electronic health record review 30 days after index visit 3. Follow up phone call to participant at 30 days - We are asking patients if they received a flu vaccine since their index emergency department visit.
2 secondary outcomes
Vaccine Acceptance
Time frame: during ED visit
Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group
Time frame: 30 days post index ED visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38776635Rodriguez RM, Eucker SA, Rafique Z, Nichol G, Molina MF, Kean E, O'Laughlin KN, Bezek SK, Goicochea K, Ford JS, Morse D, White J, Arreguin MI, Shughart L, Chavez CL, Glidden DV, Rising KL. Promotion of Influenza Vaccination in the Emergency Department. NEJM Evid. 2024 Apr;3(4):EVIDoa2300197. doi: 10.1056/EVIDoa2300197. Epub 2024 Mar 26.
- 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. This study is not recruiting at the moment.
Robert Rodriguez, MD principal investigator
University of California, San Francisco
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question (Q) and Messaging (M) in people with Influenza Vaccination, run by University of California, San Francisco at 8 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention (time frame: 30 days post index ED visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05836818, which also lists 1 linked publication.
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 31 May 2024.