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PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Not Applicable
Completed
Conditions
Influenza Vaccination
Interventions
Other: Question (Q)
Other: Messaging (M)
Registration Number
NCT05836818
Lead Sponsor
University of California, San Francisco
Brief 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). 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
776
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Messaging (M)Question (Q)Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine
Messaging (M)Messaging (M)Subjects receive vaccine messaging and are asked a question about whether they would accept a vaccine
Question (Q)Question (Q)Subjects receive no vaccine messaging, but are asked a question about whether they would accept a vaccine
Primary Outcome Measures
NameTimeMethod
Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention30 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.

Secondary Outcome Measures
NameTimeMethod
Vaccine Acceptanceduring ED visit

Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups

Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group30 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.

Trial Locations

Locations (8)

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

🇺🇸

Houston, Texas, United States

San Francisco General Hospital Emergency Department

🇺🇸

San Francisco, California, United States

University of California San Francisco Parnassus

🇺🇸

San Francisco, California, United States

Jefferson Methodist Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

University of Washington-Harborview Emergency Department

🇺🇸

Seattle, Washington, United States

Duke University Hospital

🇺🇸

Durham, North Carolina, United States

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