PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

NCT ID: NCT05836818

Last Updated: 2024-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 776 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-03-30

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.

Conditions

Influenza Vaccination

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Question (Q)

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

Group Type: EXPERIMENTAL

Question (Q)

Intervention Type: OTHER

Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine

Messaging (M)

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

Group Type: EXPERIMENTAL

Question (Q)

Intervention Type: OTHER

Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine

Messaging (M)

Intervention Type: OTHER

Flu vaccine educational materials -videos and flyers containing flu vaccine educational information

Non intervention

Usual care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Question (Q)

Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine

Intervention Type: OTHER

Messaging (M)

Flu vaccine educational materials -videos and flyers containing flu vaccine educational information

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Baylor College of Medicine

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

San Francisco General Hospital Emergency Department

San Francisco, California, United States

University of California San Francisco Parnassus

San Francisco, California, United States

Duke University Hospital

Durham, North Carolina, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, United States

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

University of Washington-Harborview Emergency Department

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38776635 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R01AI166967-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

21-34004B

Identifier Type: -

Identifier Source: org_study_id