PROmotion of FLU Vaccine Uptake in the Emergency Department - PROFLUVAXED

NCT05836818 | Completed Results

• 2 other identifiers: 21-34004BR01AI166967-01
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 8

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.

Conditions

Influenza Vaccination

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  30 days post index ED visit

Secondary Outcomes (2)

• Vaccine Acceptance

  during ED visit

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

  30 days post index ED visit

Other Outcomes (1)

• Influenza Vaccine Uptake at 30 Days Comparing Intervention M and Intervention Q

  30 days post index ED visit

Study Arms (3)

Question (Q)

EXPERIMENTAL

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

Other: Question (Q)

Messaging (M)

EXPERIMENTAL

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

Other: Question (Q); Other: Messaging (M)

Non intervention

NO INTERVENTION

Usual care

Interventions

Question (Q) OTHER

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

Messaging (M); Question (Q)

Messaging (M) OTHER

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

Messaging (M)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Duke University: collaborator
• Thomas Jefferson University: collaborator
• University of Washington: collaborator
• Baylor College of Medicine: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (8)

San Francisco General Hospital Emergency Department

San Francisco, California, 94110, United States

Location

University of California San Francisco Parnassus

San Francisco, California, 94143, United States

Location

Duke University Hospital

Durham, North Carolina, 27708, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Jefferson Torresdale Hospital

Philadelphia, Pennsylvania, 19114, United States

Location

Jefferson Methodist Hospital

Philadelphia, Pennsylvania, 19148, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Washington-Harborview Emergency Department

Seattle, Washington, 98104, United States

Location

Related Publications (1)

• 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.

  PMID: 38776635 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Robert Rodriguez
• Organization: University of California San Francisco

robert.rodriguez@ucsf.edu

925-457-2145

Study Officials

• Robert Rodriguez, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcomes assessor will not know arm assignment
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: October 1, 2022
• Primary Completion: February 28, 2023
• Study Completion: March 30, 2023
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)