PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Influenza Vaccination Clinical Trial

— PROFLUVAXED  

Official title:

PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05836818
• Other study ID #: 21-34004B
• Secondary ID: R01AI166967-01
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: March 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Influenza Vaccination

Intervention

Other:
• Question (Q)
Flu vaccine acceptance question: a question asked of participants about their willingness to accept a flu vaccine
• Messaging (M)
Flu vaccine educational materials -videos and flyers containing flu vaccine educational information

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Jefferson Methodist Hospital	Philadelphia	Pennsylvania
United States	Jefferson Torresdale Hospital	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	San Francisco General Hospital Emergency Department	San Francisco	California
United States	University of California San Francisco Parnassus	San Francisco	California
United States	University of Washington-Harborview Emergency Department	Seattle	Washington

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Baylor College of Medicine, Duke University, National Institute of Allergy and Infectious Diseases (NIAID), Thomas Jefferson University, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention	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	Vaccine Acceptance	Participants who responded they would accept a vaccine of asked in the ED. Comparing Intervention M and Intervention Q groups	during ED visit
Secondary	Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group	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