PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

University of California San Francisco (UCSF)

Status: Completed

Conditions: Influenza Vaccination

Treatments: Other: Messaging (M); Other: Question (Q)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05836818

R01AI166967-01 (U.S. NIH Grant/Contract)

21-34004B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 776 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults
2. Presenting to ED
3. Not already vaccinated for influenza in the current year
4. Able to provide informed consent
5. Fluent in English or Spanish
6. Anticipated ability to complete study intervention in ED i.e., able to watch a 3-minute videoclip

Exclusion criteria

1. Age < 18 years
2. Major trauma such that it will preclude survey
3. Inability to participate in a survey because of intoxication, altered mental status, or critical illness
4. Incarceration
5. Psychiatric hold
6. 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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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776 participants in 3 patient groups

Question (Q)

Experimental group

Description:

Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine

Treatment:

Other: Question (Q)

Messaging (M)

Experimental group

Description:

Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine

Treatment:

Other: Question (Q)

Other: Messaging (M)

Non intervention

No Intervention group

Description:

Usual care