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OpenTrials
Completed

NCT Number: NCT05836818

PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

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.

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Key information

Conditions

Influenza Vaccination Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco General Hospital Emergency Department, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. Vaccine Acceptance

    Time frame: during ED visit

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

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

    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:

    • 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.

Other outcomes

  1. Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q

    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:

    • 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Baylor College of Medicine
  • Duke University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Thomas Jefferson University
  • University of Washington

Registry information

Acronym: PROFLUVAXED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 1, 2023
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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