PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Study Overview
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Brief Summary
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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
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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]), we 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.

Official Title
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PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Conditions
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Influenza Vaccination

Intervention / Treatment
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* Other: Question (Q)
* Other: Messaging (M)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Question (Q)<br>Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine | Other: Question (Q)<br>* Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine<br>|
| Experimental: Messaging (M)<br>Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine | Other: Question (Q)<br>* Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine<br>Other: Messaging (M)<br>* Flu vaccine educational materials -videos and flyers containing flu vaccine educational information<br>|
| No Intervention: Non intervention<br>Usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccine uptake at 30 days comparing intervention M and control | 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. | 30 days post index ED visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza vaccine uptake at 30 days comparing intervention Q and control | 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. | 30 days post index ED visit | 
| Influenza vaccine uptake at 30 days comparing intervention M and intervention Q | 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. | 30 days post index ED visit |