Clinical trial NCT05836818: PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
Official title: PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza Vaccination
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Duke University
name: Thomas Jefferson University
name: University of Washington
name: Baylor College of Medicine
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-05-01
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A three-arm cluster randomized control trial to determine the effect of vaccine messaging and a question about acceptance, a question about acceptance without messaging, and standard care affect vaccine uptake in the ED.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Non Intervention
timeFrame: 30 days post index ED visit
Secondary outcomes:
measure: Vaccine Acceptance
timeFrame: during ED visit
measure: Influenza Vaccine Uptake at 30 Days Comparing Intervention Q and Non-Intervention Group
timeFrame: 30 days post index ED visit
Other outcomes:
measure: Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q
timeFrame: 30 days post index ED visit
Locations:
city: San Francisco
country: United States
facility: San Francisco General Hospital Emergency Department
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Parnassus
state: California
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Torresdale Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Methodist Hospital
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: University of Washington-Harborview Emergency Department
state: Washington
Study officials:
affiliation: University of California, San Francisco
name: Robert Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
References: